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• Research article
• Open access
• Published: 11 March 2021

The role of intellectual property rights on access to medicines in the WHO African region: 25 years after the TRIPS agreement

• Marion Motari 1 ,
• Jean-Baptiste Nikiema 1 ,
• Ossy M. J. Kasilo 1 ,
• Stanislav Kniazkov 1 ,
• Andre Loua 1 ,
• Aissatou Sougou 1 &
• Prosper Tumusiime 1  

BMC Public Health volume  21 , Article number:  490 ( 2021 ) Cite this article

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It is now 25 years since the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the same concerns raised during its negotiations such as high prices of medicines, market exclusivity and delayed market entry for generics remain relevant as highlighted recently by the Ebola and COVID-19 pandemics. The World Health Organization’s (WHO) mandate to work on the interface between intellectual property, innovation and access to medicine has been continually reinforced and extended to include providing support to countries on the implementation of TRIPS flexibilities in collaboration with stakeholders. This study analyses the role of intellectual property on access to medicines in the African Region.

We analyze patent data from the African Regional Intellectual Property Organization (ARIPO) and Organisation Africaine de la Propriété Intellectuelle (OAPI) to provide a situational analysis of patenting activity and trends. We also review legislation to assess how TRIPS flexibilities are implemented in countries.

Patenting was low for African countries. Only South Africa and Cameroon appeared in the list of top ten originator countries for ARIPO and OAPI respectively. Main diseases covered by African patents were HIV/AIDS, cardiovascular diseases, cancers and tumors. Majority countries have legislation allowing for compulsory licensing and parallel importation of medicines, while the least legislated flexibilities were explicit exemption of pharmaceutical products from patentable subject matter, new or second use of patented pharmaceutical products, imposition of limits to patent term extension and test data protection. Thirty-nine countries have applied TRIPS flexibilities, with the most common being compulsory licensing and least developed country transition provisions.

Conclusions

Opportunities exist for WHO to work with ARIPO and OAPI to support countries in reviewing their legislation to be more responsive to public health needs.

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The adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights [ 1 ] (TRIPS Agreement) in 1994 by Member States of the World Trade Organization (WTO) was a watershed event, which gave rise to a new global intellectual property protection (IPP) regime with significant effects on access to medicines. Some of these effects include high prices of medicinal products [ 2 ], prevention of local manufacture of generic products through reverse engineering of patented products, importation of cheaper medicinal products from off-patent countries or under licensing agreements and delayed market entry for generic products.

The potential impact of the TRIPS Agreement on access to medicines in developing and least developed countries, has caused debate with some commentators arguing that IPP makes it possible for pharmaceutical companies to recoup their Research and Development (R&D) costs and hence act as an incentive for investment in biopharmaceutical research [ 3 ] and innovation [ 4 ]. However, this incentive structure has failed to spur R&D investments for diseases that predominantly affect people living in countries with a high prevalence of neglected diseases [ 5 ], leading to the emergence of alternative product development partnership (PDP) models such as the Drugs for Neglected Diseases Initiative (DNDi) [ 4 ], proposals for a global R&D treaty, Footnote 1 and the promotion of public health interests by using existing TRIPS flexibilities [ 6 ] or through revisions to the TRIPS Agreement. Footnote 2

Although this paper focuses on the role of intellectual property rights on access to medicines, it is recognized that limited access to medicines in countries of the World Health Organization (WHO) African Region Footnote 3 is a multidimensional problem. It is affected by other factors such as lack of public financing for health care and over-reliance on out of pocket expenditur e[ 7 ], fragile logistics, storage challenges and high transport and distribution costs [ 2 ] and inadequate or inappropriate medicines regulatory frameworks [ 8 ]. These factors are further exacerbated by insufficient scientific, technological and local manufacturing capabilities in the Region [ 9 ].

The occurrence of public health emergencies of global concern such as Ebola [ 10 ] and COVID19 Footnote 4 [ 11 ], have served to highlight further the tensions between IPP and access to medicines [ 12 ]. For example, in March 2020, Gilead Sciences, the makers of remdesivir which is a drug initially studied in clinical trials for Ebola Virus Disease (EVD) and has received US FDA emergency use authorization Footnote 5 for the treatment of adults and children hospitalized with severe COVID-19 disease, made an application for orphan drug status for the drug, which has since been rescinded. Footnote 6 Orphan drug designation for remdesivir would have granted Gilead Sciences 7 years of market exclusivity in addition to the standard 20 years of patent protection guaranteed by the TRIPS Agreement Footnote 7 and other benefits such as tax credits of up to 50% of qualified clinical development spending, exemption from certain FDA fees and access to special FDA technical advice [ 13 ]. Gilead Sciences has since signed non-exclusive license agreements with pharmaceutical manufacturers in Egypt, India and Pakistan for the supply of remdesivir in 127 low and middle-income countries, Footnote 8 which include all countries of the WHO African Region.

WHO, intellectual property and access to medicines

The earliest articulation of WHO’s mandate to work on the interface between access to medical products, R&D in rare and tropical diseases, and trade can be traced back to 1996, in a World Health Assembly (WHA) resolution on the Revised Drug Strategy Footnote 9 which requested the WHO Director-General (DG) to support Member States in their efforts to improve access to essential drugs; to encourage the promotion of R&D of drugs for rare and tropical diseases; and to report on the impact of WTO concerning national drug and essential medicines policies and make recommendations for collaboration between WTO and WHO as appropriate. This mandate has been continually reinforced through subsequent assembly resolutions. Footnote 10 It has been extended over time to include upon request, providing technical and policy support to Member States, on formulating coherent trade and health polices and the implementation of TRIPS flexibilities in collaboration with other relevant international organizations.

In 2003, WHO member states agreed through resolution WHA56.27 to establish a Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) which recommended Footnote 11 that “WHO should develop a global plan of action to secure enhanced and sustainable funding for developing and making accessible products to address diseases that disproportionately affect developing countries” and “ … continue to monitor from a public health perspective, the impact of intellectual property rights … on the development of new products as well as access to medicines and other health care products in developing countries”. These recommendations led to the adoption Footnote 12 of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA-PHI) in 2009 and in the same year the WHO-WIPO-WTO trilateral cooperation, which is an interagency collaboration on public health, intellectual property and trade was commenced.

Most recent are assembly decisions WHA 71(8) of 2018 on ‘Addressing the global shortage of, and access to, medicines and vaccines’, which requested the DG to “elaborate a roadmap report, in consultation with Member States, outlining the programming of WHO’s work on access to medicines and vaccines including activities, actions and deliverables for the period 2019 – 2023; and WHA71(9) of 2018 on the ‘Global strategy and plan of action on public health, innovation and intellectual property (GSPOA-PHI): overall programme review’, which requested the DG to “implement the recommendations addressed to the Secretariat … in an implementation plan, consistent with the global strategy and plan of action on public health, innovation and intellectual property”. Additionally, in 2019 resolution WHA72.8 on ‘Improving the transparency of markets for medicines, vaccines, and other health products’, requested the DG to “continue supporting existing efforts to determine patent status of health products and promote publicly available user-friendly patent status information databases for public health actors, in line with the GSPOA-PHI and to work with other relevant international organizations and stakeholders to improve international cooperation, avoid duplication of work, and promote relevant initiatives”.

Technical assistance for the implementation of TRIPS and the role of WIPO

Within the framework of the WHO-WIPO-WTO trilateral cooperation, the 3 agencies work collaboratively to each fulfill their respective mandates without duplicating efforts and within existing resource constraints. By virtue of the 1995 Agreement Footnote 13 between WIPO and WTO, and recommendations Footnote 14 of the WIPO Development Agenda (2007), WIPO plays an important role in providing developing countries with technical assistance to implement the TRIPS Agreement. Recommendation 1 states that “WIPO technical assistance shall be development-oriented, demand-driven and transparent, taking into account the priorities and the special needs of developing countries, especially LDCs”. An analysis of information provided on the WIPO website Footnote 15 indicates that 24 countries Footnote 16 of the WHO African Region have received technical assistance Footnote 17 specific to the development of national IP strategies, policies and/or for legislative assistance. Based on the same information, Gabon, Ghana and South Sudan have not received any form of WIPO technical assistance.

Aims of the study

The WHO commitments highlighted above and the fact that it is 25 years since the adoption of the TRIPS Agreement provide a good backdrop for reviewing the status of intellectual property rights and the use of TRIPS flexibilities in WHO African Region Member States. The study presents a situational analysis of patenting activity and trends at the African Regional Intellectual Property Organization Footnote 18 (ARIPO) and the Organisation Africaine de la Proprieté Intellectuelle Footnote 19 (OAPI), the two African regional patent offices. It reviews the intellectual property regulation and governance landscape affecting countries of the WHO African Region, including regimes established by ARIPO and OAPI. Finally, the study provides an assessment of the Region’s preparedness to respond to public health emergencies by analyzing how countries have implemented available TRIPS flexibilities in national legislation, including the disincentives and challenges experienced. The findings of the study provide a baseline for WHO’s work towards the implementation of the Health Assembly’s decision WHA 71(8) and resolution WHA72.8 mentioned above.

Patenting trends

The patent data used in this study was obtained from the ARIPO and OAPI offices in April 2019. Face-to-face meetings were organized with officers of the two organizations to explain the objectives of the study and to clarify that the data required was in the areas/fields that can potentially be applied in medical inventions using the World Intellectual Property Organization (WIPO) international patent classification (IPC) codes. Table 2 (see Appendix 1 ) presents the codes for patents falling within the scope of this study.

Officers of both patent offices conducted a data search using parameters defined and provided the requisite data as downloaded files in MS Excel. The total number of health-related patents registered in ARIPO and OAPI databases as of April 2019 was 3458 and 2811 respectively. This study only reviewed and analysed patents that had been granted within the past 20 years. Consequently, the patents analyzed were 960 (28%) for ARIPO and 2274 (81%) for OAPI. In order to identify the specific disease(s) a patent can be associated with, we used the patent short title, and in instances where the short title did not mention the disease, the patent abstract was consulted. Those that did not mention a specific disease were left out of the analysis. In doing the analysis the diseases covered by the patents were clustered in broad categories namely: inflammatory diseases, cancers, tumors and abnormal cell proliferation, cardiovascular diseases, viral infections, neurodegenerative diseases, diabetes and diabetes-related conditions, infections, pain, HIV/AIDS, tuberculosis, malaria, mental disorders, nervous system diseases, digestive system diseases, weight related disorders, lung diseases, eye diseases and vaccines.

Application of TRIPS flexibilities

This study conceptualizes flexibilities as understood within the context of the TRIPS Agreement, its amending Protocol and the Doha Declaration on the TRIPS Agreement on Public Health (Doha Declaration). Footnote 20 We define TRIPS flexibilities through the lens of Articles 1.1 Footnote 21 and 8.1, Footnote 22 which provide policy space for countries to implement the TRIPS Agreement in a manner appropriate and responsive to their contexts, as different options which consider national interests and can be transposed into national law.

The study conducted a desk review of available patent laws and policy frameworks Footnote 23 of WHO African countries with the aim of analyzing whether or not they have implemented TRIPS flexibilities within their national legal frameworks. To supplement this analysis, the study used data from The TRIPS Flexibilities Database, found on http://tripsflexibilities.medicineslawandpolicy.org/ , which is a searchable publicly accessible database maintained by the Medicines Law and Policy group. Footnote 24 The database contains records of instances when national authorities of WTO member countries have invoked the application of a TRIPS flexibility for public health reasons since 2001 to 2020. Finally, the study analysed information elicited from an online questionnaire administered by WIPO, and available on https://www.wipo.int/scp/en/exceptions/ to identify the most often cited challenges by respondent WHO African countries, Footnote 25 in implementing TRIPS flexibilities.

The TRIPS Agreement uses the term flexibility in paragraph 6 of the preamble and in Article 66.1 in the context of the need for least developed countries (LDC) to create a viable technological base and their readiness to implement it. Paragraph 4 Footnote 26 of the Doha Declaration reaffirms the right of WTO members to use full provisions of the TRIPS Agreements and provides a contextual basis for understanding flexibilities while Paragraph 5 clarifies that they include;

applying customary rules of interpretation of public international law so that all provisions of the TRIPS Agreement are read in light of the object and purpose as expressed in its objectives (Article 7) and principles (Article 8);

the right of each member to grant compulsory licenses and the freedom to determine the grounds for granting such licenses;

the right of each member to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises include those relating to HIV/AIDS, tuberculosis, malaria and other epidemics; and

the freedom of each member to establish its exhaustion of IPR regime without challenge subject to the national treatment (Article 3) and most-favored-nation treatment (Article 4) provisions.

Given that Paragraph 5 does not provide an exhaustive enumeration of flexibilities, the study highlights a number of applicable TRIPS flexibilities that African Region countries may evoke to enhance access to medicines. These flexibilities, which are discussed in detail in Table 3 (see Appendix 2 ), include:

An interpretation of Article 27.1 of the TRIPS Agreement in national legislation in a manner that excludes new uses, formulations, dosages or combinations of previously patented medicines from patentability criteria. This legislative measure coupled with the implementation of substantive patent examination procedures would serve to prevent frivolous patent applications, ever-greening and creation of patent thickets around one invention.

Allowing limited exceptions to exclusive rights conferred by patents for purposes of scientific experimentation (research exception); and for facilitating regulatory and market entry approval (Bolar exception) in accordance with Article 30 of the TRIPS Agreement. The research exception makes it possible for countries to develop their local scientific and technological capacities and competencies to reverse engineer pharmaceutical products for generic production and for developing them further to better suit local conditions. On the other hand, the Bolar exception allows the use of a patented invention during the patent term without consent of the patent holder for purposes of developing information to obtain market approval and facilitates market entry by competitors immediately after the patent term expires hence ensuring early access to generic medicines.

Compulsory licensing under Article 31 of the TRIPS Agreement, which allows for the exploitation of patented subject matter through government authorization without the patent holder’s consent, for reason of national emergency and public non-commercial use.

Exhaustion of rights and parallel importation under Article 6 of the TRIPS Agreement and Paragraph 5 (d) of the Doha Declaration which make provision for importation and resale in a country without consent of the patent holder of a patented medicine put on the market of the exporting country by the patent holder or in a legal manner.

Patent term extension – Countries may consider disallowing/limiting patent term extension in national law for pharmaceutical products.

Limits on test data protection – Article 39.3 of the TRIPS Agreement allows countries to determine how to protect test data in the public interest. This provision demands protection from unfair commercial use and does not demand data exclusivity. Countries may therefore incorporate in domestic legislation the right of regulatory authorities to rely on available data to assess new drugs for market entry.

Least Developed Countries (LDCs) transition periods – These include the TRIPS Council decision Footnote 27 for the extension of the transition period for LDCs under Article 66.1 of the TRIPS Agreement to 1 July 2021; the TRIPS Council decision Footnote 28 and TRIPS General Council decision Footnote 29 stating that LDC member states are not obliged to protect pharmaceutical patents, or to provide means for filing patents and provide exclusive marketing rights for pharmaceutical products until 1 January 2033.

Creation of patent opposition (pre and post patent grant), as required by Article 62.4 of the TRIPS Agreement, to serve as an additional administrative layer of patents review to prevent the grant of invalid patents.

Figure 1 below depicts health-related patent application trends at ARIPO and OAPI. Data shows that there was a sharp increase in patent applications at both offices from 1994 to 1999, which started to decline in the period 1999–2000. This trend matches that reported in a study on inventions and patenting in Africa [ 14 ]. The observed increase in patent applications in the late-1990s may have been caused by developments in molecular biology, genetics and genomics and their application in the biopharmaceutical sector. Footnote 30

Health-related patent application trends at ARIPO and OAPI

According to the 2018 Report on the State of Health in the WHO African Region [ 15 ], the main five causes of morbidity and mortality in the Region, are lower respiratory infections, HIV/AIDS, diarrheal diseases, malaria and tuberculosis. Other top causes of morbidity and mortality include stroke and ischemic heart diseases, preterm birth complications, birth asphyxia and congenital anomalies.

An analysis of the top 10 diseases covered by patents granted at ARIPO and OAPI corresponds to a certain extent, with the top 10 causes of morbidity as illustrated by Figs. 2 and 3 below. In both repositories the three top categories of diseases covered by granted patents were inflammatory diseases; cancers, tumors and abnormal cell proliferation; and cardiovascular diseases. Within the inflammatory diseases category, there were patents for lower respiratory diseases such as chronic obstructive pulmonary disease and asthma. HIV/AIDS, which was the second cause for morbidity and mortality, was 7th among the top 10 ARIPO patents and 10th for OAPI. Stroke and ischemic heart diseases which ranked 4th and 5th as causes of mortality respectively, fall within the broad category of patents covering cardiovascular diseases, which ranked 3rd on the list of top 10 diseases covered by patents at ARIPO and OAPI.

Fig. 2 Top 10 diseases covered by patents granted by ARIPO

Fig. 3 Top 10 diseases covered by patents granted by OAPI

Diarrheal diseases, tuberculosis and malaria, which are among top causes of mortality and morbidity did not appear among the top diseases covered by patents in the Region. There were only 23 TB patents at ARIPO and 25 at OAPI, while there were only 37 malaria patents at ARIPO and 47 at OAPI.

The top 10 categories of diseases covered by patents taken at ARIPO and OAPI were the same, the only difference being in the ranking. Another interesting finding, whose implications merit further interrogation, is the ranking of cancer-related patents, which was 2nd at both patent offices.

An analysis of the countries of origin of health-related patents at ARIPO and OAPI shows that the top 10 sources of patents at ARIPO were USA, Great Britain, the European Patent Office, France, India, China, South Africa, Germany, Italy and Denmark. South Africa was the only African country in the top 10 list. The top 10 sources of patents at OAPI were USA, France, Great Britain, Germany, India, Belgium, Japan, Cameroon, Switzerland and Ireland. Cameroon was the only African country in the top 10 list. The African Region countries that had health-related patents at ARIPO were Kenya, Mauritius, Namibia, Zambia, and Zimbabwe and Egypt from the Eastern Mediterranean Region (EMRO) of the WHO. While in OAPI the African Region countries were Burkina Faso, Benin, Central African Republic, Congo Republic, Cote d’Ivoire, Cameroon, Guinea, Mali, Mauritius, Namibia, Nigeria, Senegal, Togo, South Africa and Egypt and Morocco from EMRO.

An analysis of the African country patents shows that the top three disease categories covered are HIV/AIDS, cardiovascular diseases, and cancer and tumors. Table  1 below provides a summary of the main diseases covered by African country patents.

The intellectual property regulation and governance landscape in the WHO African region

Countries of the WHO African Region operate within a multi-layered IP regulation and governance landscape. The Paris Convention for the Protection of Industrial Property (1883) and the TRIPS Agreement (1994) regulate the global IP framework within which African Region countries operate. Most countries (40 out of the 47) in the Region are members of the World Trade Organization (WTO) and are Parties to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement), which provides a minimum standard for the regulation of intellectual property. Article 1.1 of the TRIPS Agreement states that signatory Members States may, but shall not be obliged to, implement in their law more extensive protection than is required by TRIPS, making it open for them to determine the appropriate level of implementing it within their own legal system and practice. At the time of writing this article Algeria, Comoros, Equatorial Guinea, Eritrea, Ethiopia, Sao Tome and Principe, and South Sudan were not members of the WTO. All countries with the exception of Eritrea had commenced accession discussions leading to eventual membership.

At the Regional level, countries are either signatories to the Harare Protocol on Patents and Industrial Design (1982), which is administered by ARIPO or the Bangui Agreement (1977) administered by OAPI.

The African regional intellectual property office (ARIPO) system and TRIPS flexibilities

The African Regional Intellectual Property Office (ARIPO) was established by the Lusaka Agreement in 1976; and has 20 member states, 18 Footnote 31 of whom are members of the WHO African Region. The objective of ARIPO is to promote the harmonization and development of intellectual property laws appropriate to the needs of its members, fostering the establishment of a close relationship between its members on intellectual property matters and establishing such common services or organs as may be necessary or desirable for the co-ordination, harmonization and development of intellectual property activities affecting its members.

The Harare Protocol on Patents and Industrial Designs (Harare Protocol) was adopted in 1982 and came into force in 1984. There are 18 contracting parties to the Harare Protocol namely Botswana, Eswatini, Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mozambique, Namibia, Rwanda, Sao Tome and Principe, Sierra Leone, Sudan, Tanzania, Uganda, Zambia and Zimbabwe. Of these, Gambia, Lesotho, Liberia, Malawi, Mozambique, Rwanda, Sao Tome & Principe, Sierra Leone, Uganda, Tanzania and Zambia are classified as LDCs.

Under the Harare Protocol, an application for the grant of a patent is made with any Contracting Party or directly with ARIPO, in which the applicant designates any one of the Contracting Parties in which they wish the invention to be accorded protection. The Protocol establishes a regional mechanism that administers the filing, examination and grant of patents, in all fields of technology, including the pharmaceutical field (section 3.10.a). A review of how the TRIPS flexibilities identified in the methods section above are implemented by the Harare Protocol shows that patentability criteria extends to cover pharmaceutical products under Rule 10 of the Regulations to the Harare Protocol. Additionally, Rule 7 (3) on drafting patent claims implies that ARIPO allows claims relating to second uses of known and already patented pharmaceutical products, which is likely to encourage frivolous patent applications and ever-greening.

Rule 3.3 of the Regulations to the Harare Protocol makes provision for ARIPO to, upon request, undertake or arrange for the substantive examination of a patent application. According to one of the ARIPO officials interviewed for this study, substantive examination is ordinarily conducted at ARIPO. However, ARIPO has bilateral agreements with the European Patent Office (EPO), the Australian, German and Swedish patent offices as well as with WIPO, for the conduct of substantive examination in technical fields or for complex inventions that ARIPO may not have adequate examination capacity. Footnote 32 A study conducted in 2014 [ 16 ] revealed that ARIPO had only 6 patent examiners at the time, which is a grossly low number of examiners. Rule 19bis of the Regulations to the Harare Protocol provides for the publication of patent applications as soon as possible after the expiry of 18 months from the date of filing or from priority date, and does not make provision for opposition of patents granted by ARIPO.

The organisation Africaine De La Propriété Intellectuelle (OAPI) system and TRIPS flexibilities

The Organisation Africaine De La Propriété Intellectuelle (OAPI) was created in 1977 by the Bangui Agreement and has the objective of implementing and applying common administrative procedures deriving from a uniform system for the protection of industrial property, providing services related to industrial property, and promoting the economic development of Member States by means of effective protection of intellectual property and related rights, according to Article 2.1 of the Agreement. According to Articles 2 (2), 8 (1) and 8 (2) of the Bangui Agreement OAPI serves as both a national and central patent documentation body for all its member countries and for Member States party to the Patent Cooperation Treaty (PCT). In this case, OAPI serves as the national, designated, elected, and/or receiving office within the context of Article 2 Footnote 33 of the PCT, and the Bangui Agreement is the law governing industrial property rights in each of its member states. This being the case, patent applications at OAPI are designated for protection in all OAPI member countries.

The countries signatory to the Bangui Agreement are Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Congo Republic, Cote d’Ivoire, Gabon, Guinea, Guinea-Bissau, Mali, Mauritania, Niger, Senegal and Togo. Out of the 15 Member States, only 4 countries are not LDCs namely Cameroon, Congo Republic, Cote d’Ivoire, and Gabon.

According to the Bangui Agreement a patentable invention is defined as a product or process that is new, involves an inventive step and is industrially applicable. This broad definition of patentability criteria is construed to cover both pharmaceutical products and processes. In accordance with provisions of Article 20 of the Annex to the Bangui Agreement, OAPI is a formality and not a substantive examination office. Therefore all patent applications that meet the formality examination requirements namely, Articles 6, Footnote 34 14.1, Footnote 35 and 15 Footnote 36 of the Annex to the Agreement, are granted under Article 22. The Bangui Agreement just like the Harare Protocol does not make provision for a patent opposition system that would serve to prevent granting of invalid and or frivolous patents.

Implementation and application of TRIPS flexibilities by WHO African region countries

Table 4 (see Appendix 3 ) below presents a summary how the TRIPS flexibilities identified in the methods section and discussed in Table 3 (on Appendix 2 below) have been enacted into law by African Region countries. The summary is based on a review of all WHO African countries’ patent legislation and IP policies as accessed through the WIPO Lex depository. Footnote 37

The analysis shows that 3 countries, namely Namibia, Footnote 38 Rwanda Footnote 39 and Zambia Footnote 40 have specific legislation on patentability of pharmaceutical products based on what constitutes novelty to limit ever-greening of patents. These countries have explicit legislation against new or second use patents of already patented pharmaceutical products. Twenty one (21) countries Footnote 41 make provision for limited exceptions to exclusive patent rights for purposes of research and scientific experimentation (research exception), while twelve Footnote 42 allow for the use of patented knowledge during the patent term for purposes of developing information necessary for attaining regulatory and market-entry approval (bolar exception). The Bangui Agreement as currently enforced, does not make provision for research and bolar exceptions for signatory member states.

The most commonly legislated flexibilities are compulsory licensing and parallel importation where 45 out of the 47 (95%) countries have enacted legislation to allow for compulsory licensing, and 40 (85%) for exhaustion of rights and parallel importation. The 2 countries that do not legislation on compulsory licensing were Eritrea and Madagascar and the 7 without legislation on parallel importation are Angola, Cabo Verde, Comoros, Ethiopia, Eritrea, DRC and Malawi.

The least commonly legislated flexibilities were those imposing limits to patent term extensions and on test data protection. Only Angola Footnote 43 and Zimbabwe Footnote 44 were found to have legislative provisions that could be used to limit pharmaceutical product patent term extensions, while only Uganda has legislation which allows the medicines regulatory authority to rely on available data to assess new generic drugs for market entry.

Out of the 30 WHO African Region member states who are classified as LDCs Footnote 45 and qualify for pharmaceutical product patent waivers, until 1 January 2033, on the mailbox provision and exclusive marketing rights for pharmaceuticals relating to Articles 70.8 and 70.9 of the TRIPS Agreement, only Angola, Footnote 46 Madagascar, Footnote 47 Liberia, Footnote 48 Rwanda Footnote 49 and Uganda Footnote 50 have explicitly excluded pharmaceutical products from patentability criteria in their national laws. Burundi’s Industrial Property law Footnote 51 states that this exemption was valid until 1 January 2016. Least developed countries signatory to the Bangui Agreement and members of OAPI do not exempt pharmaceutical products from patentable subject matter. Algeria, Angola, Eritrea, Ethiopia, Madagascar, Nigeria, Sierra Leone and all OAPI countries were found not to have any patent opposition procedures (whether pre and/or post grant) in place.

An analysis of the TRIPS flexibilities database Footnote 52 summarized in Table 5 (see Appendix 4 ) below shows that 39 out of the 47 African Region Countries have used one or more TRIPS flexibility at one time or another. African Region countries that were not recorded on the TRIPS flexibilities database as having applied any flexibility are Algeria, Botswana, Madagascar, Mali, Mauritius, Namibia, Nigeria, and Seychelles. Majority of the applications were for sourcing treatments for HIV/AIDS, except in the cases of Angola, Cape Verde, Chad, Gambia, Kenya, Lesotho, Malawi, Niger, Rwanda, South Sudan, Tanzania and Togo that applied flexibilities for sourcing all medicines.

The analysis shows that only three flexibilities are recorded in the database as having been applied, namely Article 31 of TRIPS which allows for compulsory licensing including for non-commercial use; paragraph 7 of the Doha Declaration on LDC country transition periods and paragraph 5 (d) of the Doha Declaration allowing for parallel importation. The most commonly applied flexibility is paragraph 7 of the Doha Declaration on transition provisions with 27 countries having applied it, followed by Article 31, allowing compulsory licensing, which has been applied by 16 countries. Parallel importation has only been used by Kenya once (in 2002) for the importation of generic medicines.

Some countries have applied flexibilities more than once; the highest being five times by Kenya, four times by Zimbabwe, and three times by Benin, Congo, Gabon, Ivory Coast, Mozambique, Togo and Zambia. Central African Republic, Chad, the Gambia, Guinea, Lesotho, Malawi, Niger, Rwanda and Sierra Leone have all applied flexibilities twice respectively. Guinea, Mozambique and Zambia adopted a mixed approach of using both Article 31 and paragraph 7, and Kenya both Article 31 and paragraph 5 at different times. In the case of Kenya, it did not execute 4 of its applications which were under Article 31 for HIV/AIDS medications. The pharmaceutical companies involved in these cases, GSK and Boehringer Ingelheim, entered into voluntary license agreements with a Kenyan manufacturing company Cosmos Ltd. The 5th application by Kenya, and the only one to be executed was under paragraph 5 and related to sourcing of generic drugs. Cameroon and South Africa too did not execute their flexibilities applications which were both under Article 31 and were both for HIV/AIDS drugs. The database does not record why Cameroon did not execute its application. In the case of South Africa, the concerned pharmaceutical companies GSK and Boehringer Ingelheim entered into a voluntary license with Cipla, an Indian manufacturing company.

An analysis of responses provided by twelve WHO African countries Footnote 53 to an online questionnaire administered by WIPO, Footnote 54 identifies a number of challenges that countries experience in applying TRIPS flexibilities to meet public health needs. The most often cited challenge in the survey was insufficiency or no local manufacturing capacity [ 17 ] to produce generic pharmaceutical products in relation to the use of compulsory licensing. This arose from the fact that Article 31 (f) Footnote 55 and (h) Footnote 56 of the TRIPS Agreement, before entry into force of Article 31 bis in 2017 , which made it impossible for countries with insufficient or no pharmaceutical manufacturing capacity to use compulsory licensing to access patented medicines. It was however noted from the survey that the considerable burden of proof on governments and potential users of the Article 31 bis system Footnote 57 remains to be a challenge. Another challenge identified from the WIPO survey and in literature [ 18 , 19 ], is the risk of having counterfeit pharmaceutical products introduced into the market through parallel importation.

The WHO African Region is characterized by what could be termed as a collage of member states as far as IP regulation and governance is concerned. To begin with, we have countries such as Algeria, Comoros, Equatorial Guinea, Eritrea, Ethiopia, Sao Tome and Principe and South Sudan who are not yet signatories to the TRIPS Agreement and are exempt from any intellectual property protection requirements imposed by the Agreement that may hinder access to medicine. Out of the other 40 WHO African Region Member States, 21 Footnote 58 signatories to the TRIPS Agreement are unlikely to benefit from the LDC transition waivers under Article 66.1 for fully implementing the TRIPS Agreement until 1 July 2021; and on obligations under Article 70.8 Footnote 59 and 70.9, Footnote 60 with respect to mailbox applications and provision of exclusive marketing rights of pharmaceutical products until 1 January 2033 Footnote 61 since they are signatories to the Harare Protocol or the Bangui Agreement (1977). The Harare Protocol and the Bangui Agreement require these Member States to attain a TRIPS – plus standard, where patentability criteria extends to pharmaceutical products and process, hence more onerous than the one required under TRIPS.

The IP frameworks imposed on ARIPO and OAPI Member States are inconsistent and misaligned with the TRIPS Agreement and are more onerous than the minimum standard provided by TRIPS. Areas of misalignment that have an impact on access to medicines in countries is the uniform treatment of LDC member states with non LDCs hence the lack of differentiation between obligations for LDCs and non LDC; the absence of capacity to conduct substantive patent examination to ensure that patentability criteria are met prior to granting patents, the absence of patent opposition procedures, failure to impose limits on pharmaceutical patent term extension and on test data protection to prohibit data exclusivity especially in the interest of public health.

In the years following the adoption of the TRIPS Agreement, developing countries experienced challenges in applying TRIPS flexibilities such as compulsory licensing (Article 31) and parallel importation (Article 6) of drugs in their bid to address the HIV/AIDS crisis that was facing most developing countries towards the end of the twentieth century. One such example in the African Region was South Africa, which enacted the Medicines and Related Substances Control Amendment Act 1997 that allowed for parallel importation and compulsory licensing of pharmaceuticals in the country. These amendments to the law led to a backlash from pharmaceutical companies and culminated into legal action against the South African government, which was later withdrawn [ 20 , 21 ]. Over time and with a lot of public pressure on the pharmaceutical industry African countries have been able to put in place legislation allowing them to exploit some available TRIPS flexibilities to address public health needs. Though some positive strides have been made by WHO African Region countries, a lot more can be done by legislating for a wider range of flexibilities such a more rigorous application of the LDC transition waivers, adopting rigid patentability criteria which prohibits new or second use of already patented pharmaceutical products, limiting patent term extensions and limiting test data protection to facilitate faster entry of generic medicines into the market.

Compulsory licensing was a commonly evoked flexibility by countries, which in some instances was not executed, hence the conclusion that these may have served to encourage pharmaceutical companies to enter into voluntary licensing arrangements.

We observe that exhaustion of rights and parallel importation is not commonly applied in the Region, despite being one of the most legislated flexibility. This could be due to the fact that some countries have adopted a national exhaustion approach such, while those governed by the Bangui Agreement have precluded international exhaustion and restricts parallel importation to the regional exhaustion regime within OAPI countries. It could also be due to fears of proliferation of substandard and counterfeit medicines into the market.

The experiences of the HIV/AIDS pandemic in the nineties, and most recently, the search for an effective treatment and vaccine for COVID-19 highlight the tensions between intellectual property rights and public health interests. There is evidence that learning has taken place from the lessons of the HIV/AIDS pandemic. Some of these lessons include the willingness by pharmaceutical companies such as Gilead Sciences to enter into voluntary licensing agreements with manufacturing companies in developing countries to serve less developed markets. The speed with which countries such as Canada, Germany, Chile and Ecuador have amended their respective patent laws to prohibit market exclusivities and to allow for compulsory licensing, should it become necessary, of COVID-19 medicinal products are examples of how TRIPS flexibilities can be deployed to address health needs.

The low levels of patenting activity by African Region countries calls for the need to develop and strengthen health innovation systems in the Region. This can be done through policies that support health research systems and a local incentive structure that focuses research on local health challenges. Other aspects of developing health innovation systems would include developing local scientific and biomedical research capacities and local manufacturing capabilities.

The findings of this study provide an opportunity for the WHO Regional Office for Africa to work closely with ARIPO and OAPI to develop and promote a Regional IP framework that is responsive to public health challenges of the Region; and to support countries in reviewing national IP laws taking into account available flexibilities especially the LDC transition waivers and those not commonly used in the Region such as research exception, regulatory review exception and patent term extension.

Availability of data and materials

The datasets generated and/or analysed during the current study are not publicly available due to the fact that they are held by ARIPO and OAPI patent depositories but are available from the corresponding author on reasonable request.

In 2012 the WHO Consultative Expert Working Group on R&D: Financing and Coordination (CEWG) recommended that governments begin negotiations over a global medical R&D convention to address the problems of the current medical R&D system in a systematic way. See full report on https://apps.who.int/iris/bitsream/handle/10665/254706/9789241503457-eng.pdf;sessionid=DD5FA93B35229C40C7D989BBF9B8E6F8?sequence=1 (accessed on 19 June 2020)

In January 2017 Article 31 bis came into force thus amending Article 31(f) and (h) of the TRIPS Agreement to allow countries producing generic medicines under compulsory licensing to export those medicines to LDCs lacking manufacturing capacity

These are Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cabo Verde, Cameroon, Central African Republic, Chad, Comoros, Congo, Cote d’Ivoire, Democratic Republic of Congo, Equatorial Guinea, Eritrea, Eswatini, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome & Principe, Senegal, Seychelles, Sierra Leone, South Africa, South Sudan, Togo, Uganda, United Republic of Tanzania, Zambia, Zimbabwe

Was first identified in December 2019 as a respiratory illness caused by a novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2). See generally Helmy YA et.al. The COVID-19 pandemic: a comprehensive review of taxonomy, genetics, epidemiology, diagnosis, treatment, and control. J Clin Med 2020; 9 (4) E1225

USFDA. Coronavirus (COVID-19) update: FDA issues Emergency Authorization for Potential COVID-19 Treatment. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment (Accessed on 27 July 2020)

Gilead Sciences. https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-request-to-rescind-remdesivir-orphan-drug-designation (accessed on 28 July 2020)

It is noted that some low and middle income countries such as Albania, Argentina, Bolivia, Brazil, Colombia, Ecuador, Iran, Iraq, Jordan, Malaysia, Kosovo, Lebanon, Mexico, Montenegro, Paraguay, among others, are not covered under these non- exclusive license agreements

For example WHA56.27 (2003) on Intellectual Property Rights, Innovation and Public Health; WHA59.24 (2006) on Public Health, Innovation, Essential Health Research and Intellectual Property Rights: Towards a Global Strategy and Plan of Action; WHA59.26 (2006) on International Trade and Health; WHA60.30(2007) on Public Health, Innovation and Intellectual Property; WHA 62.16 (2009) on Global Strategy & Plan of Action on Public Health, Innovation and Intellectual Property; WHA65.22 (2012) on Follow up to the Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination

CIPIH Report (WHO, 2006)

Through resolution WHA62.16

Article 4 (1)

Cluster A on Technical Assistance and Capacity Building

https://www.wipo.int/directory/en/

Algeria, Botswana, Burundi, Cameroon, Central African Republic, Chad, Congo, Democratic Republic of Congo, Eswatini, Gambia, Kenya, Lesotho, Liberia, Malawi, Mali, Mauritius, Mozambique, Namibia, Nigeria, Rwanda, Sao Tome and Principle, Seychelles, Sierra Leone and Uganda.

WIPO technical assistance may also be in the form of support to attend meetings, workshops and/or training and also for buying equipment.

https://www.aripo.org/

http://www.oapi.int/index.php/fr/

http://wto.org/english/thewto_e/min01_e/mindecl_trips_e.htm (Accessed on 19 June 2020)

Which states that countries ‘…shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice’

Which makes specific mention of public health protection and states that “Members may … adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.”

Available on WIPO Lex at https://www.wipo.int/wipolex/en/index.html

https://medicineslawandpolicy.org/

At present only 12 WHO African Region Member States namely, Algeria, Burkina Faso, Congo, Gambia, Kenya, Madagascar, Sao Tome and Principe, South Africa, Uganda, Tanzania, Zambia and Zimbabwe have responded to the online WIPO questionnaire.

It states ‘the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health’ and that it ‘can and should be interpreted and implemented in a manner supportive of WTO Member’s rights to protect public health and, in particular to promote access to medicines for all’

WTO, IPC/C/64

WTO, IP/C/73

WTO, WT/L/971

Botswana, Eswatini, the Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mauritius, Mozambique, Namibia, Rwanda, Sao Tome and Principe, Sierra Leone, Uganda, United Republic of Tanzania, Zambia and Zimbabwe (Somalia and Sudan are the other 2 members and are members of the WHO Eastern Mediterranean Region)

Discussions with study key informant, April 2019

Article 2 (xii – xv) defines what a national, designated, elected and or receiving patent office are respectively.

Which defines non-patentable subject matter

Which provides for patent application requirements, including the documents required

which provides that a patent application shall be restricted to a single principal subject and that it shall have a title that describes in a precise and succinct manner the purpose of the invention

https://www.wipo.int/wipolex/en/index.html

Section 17 (1) (j) Industrial Property Act No. 11 of 2017

Article 18.5 of Law No. 31/2009 on the Protection of Intellectual Property

Section 17 (e) Patents Act No. 40 of 2016

Algeria, Botswana, Burundi, Cabo Verde, Democratic Republic of Congo, Eswatini, Ethiopia, Ghana, Kenya, Lesotho, Liberia, Madagascar, Mauritius, Mozambique, Namibia, Rwanda, Sao Tome & Principe, Seychelles, Sierra Leone, Tanzania, Uganda

Botswana, Cabo Verde, Kenya, Liberia, Namibia, Rwanda, Sao Tome & Principe, Seychelles, South Africa, Uganda, Zambia, Zimbabwe

Article 6 (2) of Law No. 3/92 of February 28, 1992 on Industrial Property states that once the patent validity period of 15 years expires, the subject of the patent shall fall into the public domain

Section 24B (2) of the Zimbabwe Patents Act, 2002 states that where test batches of a patented product (through Bolar exception)… the term of a patented product shall not be extended.

Angola, Benin, Burkina Faso, Burundi, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Eritrea, Ethiopia, Gambia, Guinea, Guinea Bissau, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mozambique, Niger, Rwanda, Sao Tome & Principe, Senegal, Sierra Leone, South Sudan, Togo, Uganda, Tanzania, Zambia

Article 4 (d) of Law No. 3/92 of February 28, 1992 on Industrial Property

Section 1 (8) (1) (v) Ordinance No. 89–019 of July 31, 1989 establishing Agreements for the Protection of Industrial Property

Section 13 (2) (b) Liberia Intellectual Property Act 2016

Article 18 (8) Rwanda Law on Protection of Intellectual Property 2009

Section 8 (3) (f) Uganda Industrial Property Act 2014

Article 17 of Law No 1/13 of July 28, 2009 relating to Industrial Property in Burundi

Found on http://tripsflexibilities.medicineslawandpolicy.org/

Available on https://www.wipo.int/scp/en/exceptions/

This provision states that compulsory licensing shall be authorized predominantly for the supply of the domestic market of the country authorizing it

Which states that ‘the right holder shall be paid adequate remuneration in the circumstances of each case,

taking into account the economic value of the authorization’

See a supporting view in Correa, C.M. Will the Amendment to the TRIPS Agreement Enhance Access to Medicines? South Centre Policy Brief No. 57 January 2019

Namely Benin, Burkina Faso, Central African Republic, Chad, Gambia, Guinea, Guinea-Bissau, Lesotho, Liberia, Malawi, Mali, Mauritania, Mozambique, Niger, Rwanda, Senegal, Sierra Leone, Togo, Uganda, Tanzania and Zambia

Article 70.8 provides “Where a Member does not make available as of the date of entry into force of the WTO Agreement patent protection for pharmaceutical and agricultural chemical products commensurate with its obligations under Article 27, that member shall:

notwithstanding the provisions of Part IV, provide as from the date of entry into force of the WTO Agreement a means by which applications for patents for such inventions can be filed;

apply to these applications, as of the date of application of this Agreement, the criteria for patentability as laid down in this Agreement as if those criteria were being applied on the date of filing in that Member or, where priority is available and claimed, the priority date of the application; and

provide patent protection in accordance with this Agreement as from the grant of the patent and for the remainder of the patent term, counted from the filing date in accordance with Article 33 of this Agreement, for those of these applications that meet the criteria for protection referred to in subparagraph (b).

Article 70.9 states “Where a product is the subject of a patent application in a Member in accordance with paragraph 8 (a), exclusive marketing rights shall be granted, notwithstanding the provisions of Part IV, for the period of 5 years after obtaining marketing approval in that Member or until a product patent is granted or rejected in that Member…”

Abbreviations

Acquired Immune Deficiency Syndrome

African Regional Intellectual Property Organization

Antiretrovirals

Azidothymidine

Corona Virus Disease of 2019

Director General

Deoxyribonucleic Acid

Drugs for Neglected Diseases Initiative

Eastern Mediterranean Region

Ebola Disease Virus

GlaxoSmithKline

Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property

Human Immuno Deficiency Syndrome

Intellectual Property

International Patent Classification

Intellectual Property Protection

Intellectual Property Rights

Least Developed Countries

Organisation Africaine de la Propriete Intellectuelle

Product Development Partnership

Research and Development

Ribonucleic Acid

Tenofovir Disoproxil Fumarate

Agreement on Trade-Related Aspects of Intellectual Property

United States of America

United States Food and Drug Administration

World Health Assembly

World Health Organization

World Intellectual Property Organization

World Trade Organization

World Trade Organization (WTO), Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994).

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Acknowledgements

We are grateful to the two regional patent offices ARIPO and OAPI and the World Intellectual Property Organization (WIPO) who provided relevant information and patent data from their respective depositories. The article contains the perceptions and views of the authors only.

This study was supported by unrestricted program funds of the WHO Regional Office for Africa Universal Health Coverage/Life Course Department. The WHO staff involved in this study are listed as co-authors to the paper and their roles were as follows, JBN who is the Team Leader for the Medicines, Health Infrastructures and Equipment maintenance programme, provided technical guidance for the study and with OMJK contributed to the study conception and design. JBN and OMJK accompanied MM, the lead author, to data collection missions at ARIPO (Harare) and OAPI (Cameroon). SK, AL and AS are members of the Medicines, Health Infrastructures and Equipment maintenance team who read different versions of the manuscript and provided useful suggestions and inputs to the manuscript. PT is the Director of the Universal Health Coverage/Life Course Cluster under whose leadership the Medicines, Health Infrastructures and Equipment maintenance programme falls. PT provided overall leadership and guidance for the project.

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MM contributed to conception and design, data collection, analysis and writing of the manuscript. JBN and OMJK contributed by providing inputs to the study conception and design and in data collection. SK, AL, AS and PT provided inputs in the analysis of the manuscript. All authors read and approved the final manuscript.

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Motari, M., Nikiema, JB., Kasilo, O.M.J. et al. The role of intellectual property rights on access to medicines in the WHO African region: 25 years after the TRIPS agreement. BMC Public Health 21 , 490 (2021). https://doi.org/10.1186/s12889-021-10374-y

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Twenty years of TRIPS agreement and access to medicine: a development perspective

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The Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS) changed the landscape of international Intellectual Property (IP) regime by setting a common minimum standard for the protection and enforcement of IP. In the context of 20 years of the entry into force of the TRIPS Agreement and completion of 11 years of implementation of product patent protection in many developing countries, this paper examines the challenges faced by developing countries with regard to patent and access to medicines. The paper argues that the Agreement is a classic case of corporate capture of international law making and it spearheaded a new chapter of struggle for access to medicines. It provides a brief survey of experiences of developing countries with regard to access to patented medicines as well as research and development (R&D), foreign direct investment (FDI) and technology transfer in the pharmaceutical sector during the post TRIPS period. It analyses major challenges faced by developing countries in the actual use of TRIPS flexibilities to address access to medicines and thereby meeting the developmental and public health needs. The paper focuses on the need to restructure the TRIPS and TRIPS plus IP regime, which not only prevent access to affordable medicine, but also failed to deliver access to R&D needs of developing countries. It emphasises providing enough policy space for countries to design their patent laws, especially to address product access to medicine, and scrapping of the compulsory product patent protection under the TRIPS Agreement as critical to serve this purpose.

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Intellectual Property Exhaustion and Parallel Imports of Pharmaceuticals: A Comparative and Critical Review

Conclusion: TRIPS, Drug Production in the Global South and Access to Medicines

Does One Size Fit All? Patents, the Right to Health and Access to Medicines

TRIPS Agreement provided five years of transition period. It provided two transition periods for developing and least developed countries (LDC). First, transition period to implement the provisions of the Agreement, except the product patent protection. Second, transition period for the introduction of product patent protection. The transition period for developing countries ended on 31 December 1999 and 31 December 2004. The original transition period for the LDCs, i.e. 10 years, was extended two times as per Article 66.1. Currently LDCs are in the transition period till 1 July 2021 for the implementation of the TRIPS Agreement, except product patent protection, and 31 December 2032 for the product patent protection.

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A Rahmatian, Neo-Colonial Aspects of Global Intellectual Property Protection, 12(1) J World Intellectual Property (2009) 40–74.

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Even though there was 10 years’ transition period under the TRIPS Agreement for developing countries to implement product patent protection, many developing countries like South Africa and Brazil introduced product patent protection during the first five years of the Agreement. The product patent protection has resulted in the high prices of medicines for the treatment of HIV/AIDS. See, William W. Fisher III & Cyrill P. Rigamonti, The South Africa AIDS Controversy. A Case Study in Patent Law and Policy < http://cyber.law.harvard.edu/people/tfisher/South%20Africa.pdf >.

Unlike many developing countries, India used the 10 years’ transition period available under the TRIPS Agreement and introduced product patent protection to pharmaceutical inventions only in 2005.

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Many Indian generic companies are producing the generic version of Gilead’s Hepatitis C medicine either under voluntary license or an expected invalidation of patents. However, compared to pre-product regime these companies face several restrictions on the production and sales of these medicines. Producers under the voluntary license can sell only in 90 countries listed in the license.

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See, Spain Hepatitis Patients Protest over Spending Cutbacks That 'Block Vital Drugs < http://www.straitstimes.com/world/europe/spain-hepatitis-patients-protest-over-spending-cutbacks-that-block-vital-drugs >.

MSF, Untangling the Web of Antiretroviral Price Reductions, 16 edn (July 2013) 5

< https://www.msfaccess.org/sites/default/files/AIDS_Report_UTW16_ENG_2013.pdf >.

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Gilead Sciences press release (15 September 2014) < http://www.gilead.com/news/press-releases/2014/9/gilead-announces-generic-licensing-agreements-to-increase-access-to-hepatitis-c-treatments-in-developing-countries >.

MSF, Press Release (8 April 2014) < http://www.msf.org/article/global-response-hepatitis-c-hangs-access-new-oral-drugs >.

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See, IMS Topline Market Data < http://www.imshealth.com/deployedfiles/imshealth/Global/Content/Corporate/Press%20Room/Global_2013/Top_20_Global_Therapy_Classes_2013.pdf >.

Cancer in the Developing World Worse than AIDS, The Economist (1 March 2014) < http://www.economist.com/node/21597962/comments >.

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supra note 93.

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K. M. Gopakumar is legal advisor and senior researcher with the Third World Network, New Delhi. His area of focus is the global intellectual property regime and its impact on developing countries.

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Gopakumar, K.M. Twenty years of TRIPS agreement and access to medicine: a development perspective. Indian Journal of International Law 55 , 367–404 (2015). https://doi.org/10.1007/s40901-016-0022-7

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Trips agreement and access to drugs in developing countries

Carlos m. correa.

The TRIPS Agreement brought about very important changes in international standards relating to intellectual property rights. Because of its far-reaching implications it is one of the most controversial components of the WTO system. On the initiative of developing countries, the concerns raised regarding the implications of the TRIPS Agreement on public health were reflected in the adoption of the Doha Declaration on the TRIPS Agreement and Public Health, in 2001. The Declaration was followed by a Council for TRIPS Decision in 2003 on the implementation of its paragraph 6. In this article, the author states that as adopted, the implementation of paragraph 6 is unlikely to put strong pressure on patent owners to lower their prices or negotiate voluntary licenses. The author highlights that controversies are likely to continue, especially as developed countries seek TRIPS-plus protection via interpretation or negotiation of bilateral and regional agreements, and as patents over trivial developments are granted and used to block or delay generic competition.

Health | Trade | WTO | Intellectual property | Doha Declaration

The Doha Declaration on TRIPS and public health

The World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) 1   brought about very important changes in international standards relating to intellectual property rights. Because of its far-reaching implications, particularly with respect to developing countries, the agreement has been one of the most controversial components of the WTO System. Strong disagreements on the scope and content of the Agreement emerged during the Uruguay Round negotiations, both between developed and developing countries and among developed countries themselves. Implementation of the Agreement and its review under the “built-in agenda” have also been contentious. 2

This has notably been the case in relation to pharmaceuticals. By their very essence, patents enable pharmaceutical manufacturers to charge prices above marginal costs, recover research and development expenditures and make a profit. The AIDS crisis in Africa, and growing evidence on the negative implications of patents for access to medicines by the poor, have brought the relationship between TRIPS and health to the forefront. With more than 30 million people living with HIV, most of them in the poorest regions of the world, the need to address the problem of access to patented medicines has emerged as a global priority. While it is true, as argued by the pharmaceutical industry, that other factors such as infrastructure and professional support play an important role in determining access to drugs, 3   it is also true that the prices resulting from the existence of patents ultimately determine how many will die from AIDS and other diseases in the years to come.

The concerns raised about the implications of the TRIPS Agreement on public health were reflected in the adoption of the Doha Declaration on the TRIPS Agreement and Public Health 4   upon the initiative of developing countries, at the Fourth WTO Ministerial Conference (9-14 November 2001). The Doha Declaration recognizes the “gravity” of the public health problems afflicting many developing and least developed countries, especially – but not limited to – those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. However, the Declaration reflects the concerns of developing and least developed countries regarding the implications of the TRIPS Agreement on public health in general, without limitation to certain diseases.

While acknowledging the role of intellectual property protection “for the development of new medicines”, the Declaration specifically recognizes concerns about resulting effects on prices. The Declaration affirms (paragraph 4) that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health, and that it should be interpreted accordingly:

We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ rights to protect public health and, in particular, to promote access to medicines for all.

In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.

The Doha Declaration clarifies members’ rights to adopt an international principle of exhaustion of rights (under which parallel imports may be accepted). 5   It states that “the effect of the provisions in the TRIPS Agreement … is to leave each member free to establish its own regime for such exhaustion without challenge” (paragraph 5d). Similarly, the Declaration confirms the members’ rights to grant compulsory licenses on grounds determined by each member. It also allowed least developed countries to delay the introduction of pharmaceutical patents until 2016. The Declaration also makes clear that “public health crises” can represent “a national emergency or other circumstance of extreme urgency”. “Emergency” in this context may be either a short-term problem, or a long-lasting situation.

Confirmation that the TRIPS Agreement leaves room for flexibility at the national level has important political and legal implications. It indicates that the pressures to impede the use of available flexibilities run counter to the spirit and purpose of the TRIPS Agreement. In legal terms, it means that panels and the Appellate Body must interpret the TRIPS Agreement and laws and regulations adopted to implement it in light of the public health needs of the individual members.

In paragraph 6 the Doha Declaration instructed the Council for TRIPS to address this delicate issue: how can members lacking or having insufficient manufacturing capacities make effective use of compulsory licensing. 6   The basic problem underlying paragraph 6 is that many developing countries lack or have an insufficient capacity to manufacture medicines on their own. Manufacturing capacities of pharmaceuticals are distributed very unevenly in the world. Not many countries have the capacity to produce both active ingredients and formulations, and very few countries maintain significant research and development capabilities.

When the TRIPS Agreement becomes fully operative (after 2005), many countries may face difficulties in acquiring medicines at affordable prices. Today, for example, some countries, such as India, do not provide patent protections for pharmaceutical products, and produce generic versions at a fraction of the price of the patented products. A member country where the price of patented products is high has the option of issuing a compulsory license to permit import from such countries. The problem is that, as countries fully comply with the TRIPS Agreement by 2005 at the latest, they will no longer be able to produce and export cheap generic copies of patented medicines. Consequently, the sources of affordable new medicines will dry up and countries without sufficient manufacturing capacity and market demand will not be able to grant a compulsory license either for the local production or for the importation of such medicines: they will become entirely dependent upon expensive patented versions.

The Doha Declaration requested the Council for TRIPS “to find an expeditious solution to this problem and to report to the General Council before the end of 2002” by the end of 2002. An agreement was only reached on August 30, 2003, 7   after a diplomatic battle, when the United States finally accepted a text covering all diseases, as mandated by the Declaration. 8   The agreed “solution” is based on a compromise developed by the Chair of the TRIPS Council 9   and on a “Statement by the Chair” proposed by the US as a condition to accept the deal and satisfy the American pharmaceutical industry.

For the purposes of the Decision, “eligible importing member” means any least developed country member, as well as any other member that has made a notification to the Council for TRIPS of its intention, to use the system as an importer. Some countries have notified the Council that they will only use the system in cases of national emergencies or in other circumstances of extreme urgency or in cases of public non-commercial use, and in others that they will not use the system. The eligible importing country must make a notification to the Council for TRIPS, that:

• specifies the names and expected quantities of the product(s) needed;

• confirms that the eligible importing member in question, other than a least developed country member, has established that it has insufficient or no manufacturing capacities in the pharmaceutical sector for the product(s) in question; and

• confirms that, where a pharmaceutical product is patented in its territory, it has granted or intends to grant a compulsory license in accordance with Article 31 of the TRIPS Agreement and the provisions of this Decision.

In addition, the compulsory license issued by the exporting member shall contain the following conditions:

• Only the amount necessary to meet the needs of the eligible importing member(s) may be manufactured under the license and the entirety of this production shall be exported to the member(s) which has notified the Council for TRIPS of its needs.

• Products produced under the license shall be clearly identified as being produced under the system set out in this Decision through specific labeling or marking. Suppliers should distinguish such products through special packaging and/or special coloring/shaping of the products themselves, provided that such distinction is feasible and does not have a significant impact on price.

• Before shipment begins, the licensee shall post on a website the following: (1) the quantities being supplied to each destination; and (2) the distinguishing features of the product(s).

Further, the exporting member shall notify the Council for TRIPS of the granting of the license, including the conditions attached to it. Where a compulsory license is granted by an exporting member, adequate remuneration pursuant to Article 31.h of the TRIPS Agreement 10   shall be paid to that member taking into account the economic value to the importing member of the use that has been authorized by the exporting member. This means that, although the remuneration would be paid by the exporter, the “economic value” taken into account to determine the amount of remuneration is that of the importing country. Where a compulsory license is granted for the same products to the eligible importing member, the obligation of that member under Article 31.h shall be waived in respect of those products for which remuneration is paid by the exporting member.

One of the main concerns voiced by developed countries during the negotiation of the Decision, was the possible diversion of the exported products to rich countries. 11   The Decision establishes that eligible importing members shall take all reasonable measures within their means, proportionate to their administrative capacities and to the risk of trade diversion to prevent re-exportation of products that have actually been imported into their territories under the system. In the event that an eligible importing member that is also a developing country member or a least-developed country member experience difficulty in implementing this provision, developed country members shall provide, on request, and on mutually agreed terms and conditions, technical and financial cooperation in order to facilitate its implementation. Additionally, members shall ensure the availability of effective legal means to prevent the importation into, and sale of, within their territories, products produced under the system set out in this Decision and diverted to their markets inconsistently with its provisions, using the means already required to be available under the TRIPS Agreement. If any member considers that such measures are proving insufficient for this purpose, the matter may be reviewed in the Council for TRIPS at the request of that member.

The Chair’s Statement added that the special conditions (as set out in paragraph 2b(ii) of the Decision) 12   apply not only to formulated pharmaceuticals but also to active ingredients produced and supplied under the system as well as to finished products that have been produced using such active ingredients. The Statement also adds (though there is no evidence to support this statement), that it “is the understanding of members that in general special packaging and/or special coloring or shaping should not have a significant impact on the price of pharmaceuticals”. In addition the Statement introduces a monitoring system, including verification of how the member in question has established that it has insufficient or no manufacturing capacities in the pharmaceutical sector. 13

The Statement also indicates that members recognize that the system “should be used in good faith to protect public health and, without prejudice to paragraph 6 of the Decision, not be an instrument to pursue industrial or commercial policy objectives”. The only reasonable reading of this statement is that the importingcountry should use the system for public health reasons, but it certainly does not exclude the supply of the required medicines which have a profit objective by commercial entities. Without the possibility of making a profit, potential suppliers will lack the incentive to make the investments (including the covering of legal costs) necessary to satisfy the requirements of countries without manufacturing capacity.

Changing national laws

The Decision takes the form of an interim waiver, which allows countries producing patented products under compulsory licenses to export the products to eligible importing countries, provided that a compulsory license has also been granted in the importing country and that various other conditions, as discussed above, are met. The waiver would last until the TRIPS Agreement is amended. 14

It is important to note that the system under paragraph 6 of the Doha Declaration will operate in a scenario in which there is only one world supplier of a patented drug and, therefore, there will be no available source of generic products. The use of such a system will be necessary when the patent owner refuses to supply a patented drug in a country (with insufficient or no manufacturing capacity in pharmaceuticals) at a price or under other conditions acceptable to the interested country. The basic assumption for the application of the system is, therefore, a situation where (a) a drug is available andcouldbe sold to the country in need by the patent owner, and (b) the patent owner refuses to do so.

This means that whatever humanitarian reasons underlie the country’s demand for a given drug, nothing in the adopted system will compel the patent owner to supply the needed drugs. He may just passively watch how the country in need strives to fulfill the conditions imposed by the Decision, while people remain without treatment. He may also facilitate the process by conferring a voluntary license to a potential exporter. It may also occur that the patent owner exploits the intricacies and complexities of the system, and exercises his rights under the relevant national laws to block the unauthorized use of his patent. The system under paragraph 6 may, in fact, be applied in a context of conflict between the demanding country and the patent owner unwilling to supply.

A WTO waiver means that a member shall not initiate a complaint against another member if the latter acts under the terms of the adopted waiver. But to the extent that the national law is not aligned with the waiver, it will not prevent the patent owner from invoking provisions in the national laws to prevent the acquisition of the patented drug from other sources. Therefore the actual implementation of the Decision will depend on the extent to which national laws allow the waived acts.

Under the adopted system, for instance, is recognized the possibility (fully consistent with the TRIPS Agreement) of granting a compulsory license to import a patented drug. The problem, however, is that many developing countries provide for the granting of compulsory licenses for the manufacture of patented subject matter, and not for importation. Hence, in order to make operative any solution under paragraph 6, those developing countries would need to amend their national patent laws accordingly. This may be unnecessary if the national laws included provisions for non commercial government use of patented inventions, allowing for either local manufacturing or importation. 15

Similarly, amendments to national laws will be necessary in the potential exporting countries. Compulsory licenses are granted under grounds specified by national laws. The supply of export markets is not an accepted ground in most national laws. 16   Moreover, in implementing Article 31.f of the TRIPS Agreement, 17   WTO members have established compulsory licenses to supply “predominantly” the domestic market. If a company receives a request under paragraph 6 to supply a foreign country, it would not be able to obtain a compulsory license exclusively to export, unless the national law has been amended accordingly. The extent to which governments will be willing to start the complex process of amending the patent law – especially on the basis of an interim waiver – is open to question. Nothing in the Decision precludes developed countries from acting as exporters of generic drugs under the system, but it is uncertain how their governments would react if requested to amend their laws and grant compulsory licenses for supplying under paragraph 6. In fact, most observers expect the large generic producers in the developing world (such as India, China, Brazil, Thailand and South Africa) to undertake this production and export. 18

The effective use of a compulsory license in both the importing and exporting country will also depend on procedures. In some countries (e.g. Argentina) an appeal by the patent owner against the grant of a compulsory license does not suspend its immediate execution (e.g. Article 49, Argentine Patent Law n. 24481, as amended). In other countries, this may not be the case. The patent owner may file an appeal or obtain an injunction and thereby stop exports under a compulsory license until a final administrative or judicial decision is taken, perhaps a few years later. National patent laws, hence, will have to be amended, as necessary, in order to make the use of compulsory licenses for export an effective mechanism to address public health needs.

Conditions for use of the waiver

Numerous conditions are established in the text of the Decision, as interpreted by the Chair’s Statement, for allowing exports of patented medicines. In order to get the supply of drugs under this mechanism the following steps must be followed: 19

1. Unless the prior request of a voluntary license does not apply, 20   an entity in the importing country must seek a voluntary license from the patent owner. 21

2. Failing this, an application for a compulsory license must be submitted to the government of the importing country and the license be obtained there (unless there is no applicable patent in that country).

3. The importing country must assess the capacity of its generic industry to produce the required medicine locally.

4. If capacity is insufficient, it must notify the WTO of its decision to use the paragraph 6 system.

5. The interested importing party must identify a potential exporter.

6. That exporter must in turn seek a voluntary license from the patent owner on commercially reasonable terms for a commercially reasonable period of time.

7. If the voluntary license is refused, the potential exporter must seek a compulsory license (to be granted on a single-supply basis) from its own government.

8. The exporter will need to seek product registration and prove bio-equivalence and bioavailability, as required by national law.

9. If exclusive rights (as promoted by the US) are granted 22   in the importing country with regard to data submitted for registration of a medicine, the supplier will have to obtain authorization by the possessor of the data to use them, or to develop its own studies about toxicity and efficacy (unless the use of such data is authorized under the compulsory license).

10. Before shipment begins, the licensee shall post on website information about the quantities being supplied and the distinguishing features of the product.

11. The exporting member must notify the Council for TRIPS of the granting of the license, including the conditions attached to it.

This process must be fulfilled over and over, since only the amount necessary to meet the needs of one particular eligible importing member may be manufactured under the license, and the entirety of this production shall be exported to the member that has notified its needs to the Council for TRIPS.

Economic feasibility

As discussed elsewhere, 23   in order to be effective, a solution to the problem described in paragraph 6 should be economically viable, and not only diplomatically acceptable. Does the Decision provide the incentives to encourage potential suppliers to make the necessary investment and take the associated risks? In addition to complying with the legal procedures involved in the application of a compulsory license and the marketing approval of the product, the potential exporter will have to develop (when produced for the first time) the chemistry and formulate the drug, and then produce the active ingredients and/or formulations with shape, color, label and packaging different from of the patent owner’s product, and at a low price affordable to the acquiring party. Pharmaceutical firms are unlikely to make the required investment if there is no reasonable profit expectation.

The Decision recognizes that the viability of the “solution” largely depends on the existence of economies of scale that justify production. According to paragraph 6 of the Decision, however, the realization of economies of such scale is only envisaged in cases where the importing country is a party to a regional trade agreement with at least half of its current membership made up of least developed countries. In this case the obligation of that member under Article 31.f of the TRIPS Agreement shall be waived to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory license in that member to be exported to the markets of those other developing or least developed country parties to the regional trade agreement that share the health problem in question. Given the requirement about participation of least developed countries, this exception will only apply to some regional agreements in Africa but not in other regions, 24   thereby limiting the effect on economies of scale that could have been obtained.

As noted by Maskus (2003, op. cit.), though overall needs in the poor nations are immense, “even if some poor countries in a trade agreement covered by this exception pooled their demands for a particular medicine, the scale may be still too low to become attractive for potential suppliers … because the eligible import markets in really small countries will not be large, generic producers may not be interested in producing such small volumes and foregoing chances for economies of scale”.

Conclusions

The implementation of the Decision on paragraph 6 of the Doha Declaration will require adaptations in national laws and entail, in particular cases, significant transaction costs. As adopted, it is unlikely to put strong pressure on patent owners to lower their prices or to negotiate voluntary licenses, nor is it likely to provide incentives to potential suppliers to make the investments necessary to develop and produce the needed drugs. Subventions from the international organizations and donor governments made be necessary to make this “solution” workable. 25

Despite the quite obvious limitations of and many constraints imposed by the examined Decision, countries in need of acquiring patented drugs should test the viability of the system. The Decision should be interpreted, in line with the Doha Declaration on the TRIPS Agreement and Public Health, in a manner that facilitates an increase in the supply of medicines to poor countries. It is also necessary to elaborate a permanentsolution to the problem affecting countries with limited or without manufacturing capacities in this field, based on an amendment to the TRIPS Agreement. Such an amendment should be based on a simpler and more straightforward approach, 26   which provides the economic incentives for the solution to be effective.

It is also important to note that the system under paragraph 6 seems to be built upon the assumption that a patent owner is legitimized to prevent access to products under his control, even in the presence of compelling humanitarian reasons. This is certainly not consistent with the Doha Declaration on the TRIPS Agreement and Public Health (particularly paragraph 4), nor with States’ commitments under the International Covenant on Economic, Social and Cultural Rights, especially its Article 12 (recognizing the human “right of everyone to the enjoyment of the highest attainable standard of physical and mental health” and obliging the taking of steps to fully realize this right, including “those necessary for … the prevention, treatment and control of epidemic, endemic, … and other diseases”). The adoption of the Decision, hence, cannot prevent the use of other means when the owner of the relevant patent or patents refuses to supply a needed drug. Countries should be encouraged to develop disciplines to deal with such refusals in the context of the “essential facilities” doctrine, 27   or other concepts under competition and public health law.

Finally, it should be recalled that paragraph 6 only describes one of the problems arising in the context of the TRIPS Agreement with regard to public health. The intellectual property protection of pharmaceuticals will continue to pose significant challenges to public health policies in developing countries, even if the agreed “solution” were proven to be viable and effective. The agreement on paragraph 6 does not mean an end to the controversies around intellectual property and public health. They are likely to continue, especially as developed countries seek TRIPS-plus protection via interpretation 28   or negotiation of bilateral and regional agreements, 29   and as patents on marginal or trivial developments (sometimes called “ever-greening” patents) are granted and used to block or delay generic competition. 30

* Published in Emory International Law Review, vol. 17, n. 2. Atlanta (Ga.), 2003.

1. The TRIPS Agreement provides for minimum standards for the protection of patents, trademarks, copyrights and other intellectual property rights. See the text of the agreement in www.wto.org .

2. See, e.g. various contributions in Brigitte Granville (ed.), The Economics of Essential Medicines(London: The Royal Institute of International Affairs, 2002); and Peter Drahos & Ruth Mayne (ed.),Global Intellectual Property Rights. Knowledge, Access and Development (New York: Palgrave Macmillan-Oxfam, 2002).

3. International Intellectual Property Institute, “Patent Protection and Access to HIV/AIDS Pharmaceuticals in Sub-Saharan Africa” (Washington DC, 2001), p. 23.

4. WT/MIN(01)/DEC/W/2, 14 November 2001, hereinafter the Doha Declaration.

5. According to the principle of international exhaustion of rights, a patent holder “exhausts” his rights after the first legitimate sale of patented products in a foreign country. Hence, he cannot prevent the subsequent transborder movement of such products.

6. A “compulsory license” is the authorization given by a judicial or administrative authority to a third party for the use of a patented invention, without the consent of the patentee, on various grounds of general interest (e.g., absence of working, public health, anticompetitive practices, emergency, national defense).

7. See IP/C/W/405, available at www.wto.org (hereinafter “the Decision”).

8. The US initial position aimed at limiting the possible solution to HIV/AIDS, malaria and tuberculosis.

9. See the text of the Chairman of the Council for TRIPS of 16 December 2002 (JOB(02)/217). Available at www.wto.org .

10. Article 31.h: “the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization”.

11. The risk of diversion has probably been overstated. Trade in medicines is subject to stringent national regulations that erect effective barriers to market access. The European Commission has noted that “the industry acknowledges that to date there is no re-importation of medicines from the poorest developing countries into the European Union, i.e. the problem of re-importation is still largely theoretical”, in European Commission (DGTrade, 2002). “Tiered Pricing for Medicines Exported to Developing Countries, Measures to Prevent their Re-Importation into the EC Market and Tariffs in Developing Countries” (Brussels: Working Document, 22 April), p. 10.

12. Article 2(b)(ii): “The products produced under the license shall be clearly identified as being produced under the system set out in this Decision through specific labelling or marking. Suppliers should distinguish such products through special packaging and/or special coloring/shaping of the products themselves, provided that such distinction is feasible and does not have a significant impact on price”.

13. One of the noticeable ambiguities in the Decision is the concept of “manufacturing capacity”. It is unclear, in particular, whether such capacity should be determined on technical grounds only, or taken into account the economic feasibility of manufacturing. This latter interpretation seems the most reasonable on efficiency grounds, and given that economic feasibility may be as an important barrier for local manufacturing as the lack of technical capacity.

14. According to paragraph 11, “… This Decision, including the waivers granted in it, shall terminate for each member on the date on which an amendment to the TRIPS Agreement replacing its provisions takes effect for that member. The TRIPS Council shall initiate by the end of 2003 work on the preparation of such an amendment with a view to its adoption within six months, on the understanding that the amendment will be based, where appropriate, on this Decision and on the further understanding that it will not be part of the negotiations referred to in paragraph 45 of the Doha Ministerial Declaration (WT/MIN(01)/DEC/1)”.

15. It is to be noted that the Decision only refers to “compulsory licenses” and not to government use for non-commercial purposes. However, the waiver is adopted with regard to Article 31, paragraphs (f) and (h) of the TRIPS Agreement, which equally covers both forms of uses without authorization of the patent holder. Any good faith interpretation of the Decision, therefore, should admit such government uses.

16. However, Article 168 of the Australian Patent Act and Article 55(2) of the Patent Act of New Zealand, permits exports under an agreement with a foreign country to supply products required for the defense of that country. Article 48B(d) and (i) of the UK Patent Act provides for a compulsory license in respect of a patent whose proprietor is not a WTO proprietor when the owner’s failure to license the patent on reasonable grounds means that a market for the export a patented product made in the UK is not being supplied. Article 45.g of the Argentine patent law permits the granting of a compulsory license not predominantly for the domestic markets when necessary to remedy anticompetitive practices or in cases of health emergencies or national security.

17. Article 31.f: “any such use shall be authorized predominantly for the supply of the domestic market of the member authorizing such use”.

18. K. Maskus, “TRIPS, Drug Patents and Access to Medicines-Balancing Incentives for R&D with Public Health Concerns”, in Knowledge Economy, Development Gateway (2003), at old.developmentgateway.org/download/206719/Maskus_on_TRIPS . Last access on 12 September 2005.

19. See Brook K. Baker, “Vows of Poverty, Shrunken Markets, Burdensome Manufacturing and other Nonsense at the WTO” (Health GAP, 27 August 2003). Available at IP-Health website: www.healthgap.org/press_releases/03/092703_HGAP_BP_WTO_Cancun.html . Last access on 7 September 2005.

20. This would generally be the case – depending, however, on national law – when an authorization is given on grounds of extreme urgency, anti-competitive practices or non-commercial public use (Article 31 (f) and (k) of the TRIPS Agreement).

21. In requesting a compulsory license both in the importing and the exporting country, it will be necessary to identify and include all the patents that may affect the supply of a drug, since normally there are patents covering the active ingredient, acceptable formulations, polymorphs, manufacturing processes etc. of the same drug. On patenting practices in pharmaceuticals, see Correa, Trends in Drug Patenting (Buenos Aires: Corregidor, 2001).

22. See Correa, “Protection of Data Submitted for the Registration of Pharmaceutical Products. Implementing the Standards of the Trips Agreement” (Geneva: South Centre, 2002).

23. See Correa, Implications of the Doha Declaration on the TRIPS Agreement and Public Health (Geneva: World Health Organization, 2002), p. 33. Available at www.who.int/medicines/library/par/who-edm-par-2002-3/doha-implications.doc . Last access on 7 September 2005. See also “Integrating Intellectual Property Rights and Development Policy” (London: Commission on Intellectual Property Rights, 2002). Available at www.iprcommission.org . Last access on 7 September 2005.

24. For instance, Mercosur and the Andean Community do not qualify under the Decision as a single market for the purposes of the Decision.

25. See K. Maskus, 2003, op. cit.

26. For instance, on 3 October 2002, the European Parliament adopted Amendment 196 to the European Medicines Directive, which provides that “manufacturing shall be allowed if the medicinal product is intended for export to a third country that has issued a compulsory license for that product, or where a patent is not in force and if there is a request to that effect of the competent public health authorities of that third country”.

27. See John Taladay & James Carlin Jr., “Compulsory Licensing of Intellectual Property under the Competition Laws of the United States and European Community” (George Mason Law Review 10, n. 3, Spring 2002), p. 443.

28. The United States Trade Representative (USTR), for instance, interprets that Article 39.3 of the Agreement requires the granting of an exclusive period of protection for data submitted for the marketing approval of pharmaceuticals and agrochemicals.

29. See, e.g, the recent US–Chile and US–Singapore bilateral agreements.

30. “Ever-greening” refers to the acquisition of patent rights over minor or trivial modifications or formulations of existing drugs, with the aim of delaying the entry of generic competition. See Correa, 2001, op. cit.

Lawyer and economist, professor at the University of Buenos Aires, Argentina.

Original in English.

• Short report
• Open access
• Published: 09 December 2005

TRIPS, the Doha Declaration and increasing access to medicines: policy options for Ghana

• JC Cohen 1 ,
• M Gyansa-Lutterodt 2 ,
• K Torpey 3 ,
• LC Esmail 4 &
• G Kurokawa 5  

Globalization and Health volume  1 , Article number:  17 ( 2005 ) Cite this article

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There are acute disparities in pharmaceutical access between developing and industrialized countries. Developing countries make up approximately 80% of the world's population but only represent approximately 20% of global pharmaceutical consumption. Among the many barriers to drug access are the potential consequences of the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Many developing countries have recently modified their patent laws to conform to the TRIPS standards, given the 2005 deadline for developing countries. Safeguards to protect public health have been incorporated into the TRIPS Agreement; however, in practice governments may be reluctant to exercise such rights given concern about the international trade and political ramifications. The Doha Declaration and the recent Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health may provide more freedom for developing countries in using these safeguards. This paper focuses on Ghana, a developing country that recently changed its patent laws to conform to TRIPS standards. We examine Ghana's patent law changes in the context of the Doha Declaration and assess their meaning for access to drugs of its population. We discuss new and existing barriers, as well as possible solutions, to provide policy-makers with lessons learned from the Ghanaian experience.

Introduction

The disparity in pharmaceutical access between developed and developing countries is stark. Developing countries make up approximately 80% of the world's population but only represent approximately 20% of global pharmaceutical consumption[ 1 ]. Market failures, government failures and income differences account for this persisting inequity[ 2 ]. Specifically, high drug costs, weak or corrupt institutions, contributing to less than effective pharmaceutical purchasing and distribution systems, and the potential consequences of the Trade Related Aspects of Intellectual Property (TRIPS) Agreement all constrain drug access.

Many developing countries have recently modified their patent laws to conform to TRIPS standards, raising the urgency of TRIPS' potentially detrimental impact on drug supply and access. However, recent developments such as the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health may offer developing countries more freedom to use TRIPS safeguards to address public health needs.

This article focuses on Ghana, a developing country that recently changed its patent laws to conform to TRIPS standards. While Ghana has made strides in improving public health, the country has urgent and serious health needs that cannot be met by the existing system. Improving pharmaceutical access is one of the core challenges facing the Government. As such, there is a menu of choices available for possible use. These include "Paragraph 6", compulsory licensing, parallel importing and attracting investment for the local production of essential medicines to combat HIV/AIDS, malaria and tuberculosis. In this paper, we discuss a selection of pharmaceutical policy choices available to governments that may lead to improved access to medicines. We do this specifically through the case of Ghana. As a test case, Ghana represents the dilemma faced by many developing countries -"make or buy." That is to say, should a government invest more in local production or continue to import medicines? In short, we examine Ghana's patent law changes in the context of the Doha Declaration and assess their meaning for access to drugs of its population. New and existing barriers will be discussed and options for addressing them proposed, to provide policy-makers with lessons learned from the Ghanaian experience.

This paper is based on research conducted for the UK Department for International Development (DfID)[ 3 ]. Our study implicitly focuses on the basic pharmaceutical public policy issues that currently face decision-makers in Ghana: 1) how to improve pharmaceutical coverage for the majority of Ghanaians and most importantly for the poor; 2) how to make treatment and drugs more affordable; and 3) how to ensure the government gets maximum value from its pharmaceutical budget. We collected data through: a review of "hard" documents (recent academic literature, policy documents, recent country studies, laws and regulations relating to drug access issues in Ghana and internationally), interviews with key stakeholders and informants to identify major gaps in drug access in Ghana, and inputs from the Access to Medicines Ghana Initiative Advisory Group.

We organize our paper as follows: first, we describe Ghana and its pharmaceutical system; second, we discuss the TRIPS Agreement and the Doha Declaration; third, we discuss Ghana's 1992 Patent Law and 2003 Patent Act; fourth, we discuss Ghana's new Patent Act in the context of the Doha Declaration and of pharmaceutical access in Ghana, followed by conclusions.

The State of Pharmaceuticals in Ghana

Ghana has made significant improvements in its overall health status over the past few decades, with life expectancy reaching 57 years in 2002 and infant mortality declining to 56 per 1000 live births. Despite these improvements, there are significant health issues facing the country: approximately 3.6% of the population is infected with HIV/AIDS, malaria accounts for 40% of outpatient visits and 25% of mortality under the age of five and the annual risk of tuberculosis infection is approximately 1–2%[ 4 ]. High mortality rates, frequent epidemics, unequal access to health services, and uneven health outcomes throughout the country are also major problems.

Pharmaceuticals are available in many health facilities across the country; however, access is largely limited due to financial barriers for most of the population, particularly the poor. According to the World Bank, Ghana had a per capita income of US$380 (2004), which is about one-fifth below the average of US$490 for sub-Saharan Africa. Moreover, a recent study indicates that 40 percent of Ghana's population earns less than minimum wage with this proportion increasing in rural areas[ 5 ]. As a result, the poverty level makes it difficult for patients to purchase drugs. For example, HIV/AIDS patients receiving one-month of anti-retroviral therapy paid for by the Global Fund are still required to pay 10% of the costs of medicines, at approximately 50,000 cedis (over $US 5). In real terms, it would require a person who is earning the minimum wage more than 5 working days to cover the co-payment. In a small random sample of interviews with patients at the HIV/AIDS Clinic in St. Martin's Hospital, Agomanya, we observed that many patients were not working at all and had to borrow money from family members to cover this co-payment.

Until recently, Ghana's public health and pharmaceutical system operated under the "cash & carry" (C&C) model, which assumes that drug co-payments can help finance and, therefore, improve the delivery of primary health care services. This system involved a series of self-financing revolving drug funds (RDF), which cascaded down each institutional level, marking up the basic purchase price for drug products to obtain revenue to re-supply the products. Additively, these mark-ups could also increase the price of a drug well beyond the reach of most Ghanaians. The government provided exemptions for co-payments for specific categories, including TB patients, psychiatric patients, children under five years of age, the indigent, pregnant women and the elderly. Identifying who is truly indigent is difficult to do in Ghana because poverty is viewed from a socio-cultural point of view as "shameful" and many poor people are reluctant to admit it. Essentially, this system did not achieve its intent to provide widespread affordable access to medicines for the population.

The Government of Ghana declared its intention to abolish the C&C system and passed a National Health Insurance Bill in 2003, which recently has been implemented. Several districts have also introduced health insurance in their localities. These insurance measures may serve to improve access to medicines; however, their effectiveness is yet to be observed. Importantly, the draft minimum package for pharmaceuticals includes medications for outpatient and inpatient services. Antiretrovirals are covered under different arrangements using the Global Fund to fight AIDS, Tuberculosis and Malaria. The Ministry of Health is reviewing exemption policies and the proposed National Health Insurance drug list to ensure consistency with the Essential Drug List. Despite the difficulties noted above, the Insurance system hopes to use local structures to identify who is "poor" to ensure these categories can access care. A national pricing policy, informed by a comprehensive examination of pharmaceutical pricing models internationally, can also facilitate better financial access of the population to medicines.

Pharmaceutical mark-ups are another policy issue that needs reform. The international research-based and generic pharmaceutical industries provide discounted medicines to Ghana, however once products arrive in Ghana, mark-ups between 11% to 275% wipe out many price advantages[ 3 ]. Tax and tariff rates vary but are applicable to all medicines, except public sector procurement done according to the Essential Drug List. In the private sector, depending on the local agent or manufacturer, the cost of antiretrovirals can exceed 32.5% more than the discounted price obtained through the Accelerated Access Initiative (AAI). In some cases, the private health facility adds further margins to increase the cost. In order to effectively address mark-ups, national tax, tariff and mark-up policies need to be reviewed to determine what policy changes could facilitate more affordable prices. Government can regulate wholesale and retail mark-ups on essential medicines. Policies regarding the private sector management chain and public sector supply management chain need examination and adjustment to make medicines more affordable for patients.

Ghana has potential to supply more of its medicine needs; local manufacturing accounts for 20% of the pharmaceutical market share. There are about 30 pharmaceutical manufacturing facilities in Ghana and about 17–18 produce all year round. Most raw materials needed for local manufacture are imported and subject to duties, taxes and tariffs, which erode the potential cost advantage that local manufacturing can provide. Currently, manufacturers pay 12.5% VAT (Value Added Tax), 0.5% EDIF (Economic Development Investment Fund), 0.5% ECOWAS levy, handling and inspection charges, GCNet charges (0.004% of cost and freight)[ 3 ]. However, Schedule 1A of the 34 materials of Active Ingredients of Essential Medicines are exempt from tax. Manufacturers apply a mark up that can range from 10 to 40%. Wholesalers add a further 10 to 20% when selling to the retailer. Then, the retailer adds another margin of 20 to 50%. All of these margins obviously increase the price of the drug for the patient, thereby contributing to the financial barrier to medicines. To help local industry, the government restricts the importation of 17 pharmaceutical products (e.g. paracetamol, chloroquine). Local production is beneficial given that it also provides employment for the population; however the barrier of limited human and technological capacity must first be overcome.

The TRIPS Agreement and the Doha Declaration

By way of brief background, the TRIPS Agreement provides minimum standards for intellectual property law and procedures and remedies that should be available so rights holders can enforce their rights effectively[ 6 ]. The default principle concerning patents is that they should be available for any invention, whether product or process, in all fields of technology without discrimination[ 6 ]. With respect to pharmaceutical patents, the minimum TRIPS obligations include 20 years of patent protection from the inventor's filing date (Article 33), patent rights free of discrimination against the origin of invention or production (Article 27.1), and exclusive marketing rights for the entire patent duration (Article 28)[ 7 ]. Transitional periods are granted before TRIPS requirements for patent protection must be met; the deadline for least-developing country members was ultimately extended to 2016 (Articles 65 and 66)[ 6 ].

The TRIPS Agreement also outlines provisions around patent rights for member states. For example, Articles 8.2, 31(k) and 40 offer flexibility to member countries to prevent or remedy anti-competitive practice[ 8 ]. Article 30 facilitates an early working provision, allowing the limited use of an invention without the patent holder's authorization[ 9 ]. Generic companies can use this provision to obtain product approval, facilitating immediate entry into the market after patent expiration. Article 31 permits a government to issue a compulsory license to a third party without the patent holder's consent, if justified in the public interest[ 7 ]. Compulsory licensing allows governments to pursue the local production of medicines as one strategy to improve access of the population to essential medicines. Parallel importing, legally pursuant to TRIPS Article 8.1 and Article 6, is the import and resale in a state without the consent of a patent holder, of a patented product in another market. Its rationale is to allow governments and others to "price shop" internationally for pharmaceutical products, based on the underlying principle that the patent holder has been rewarded through the first sale and thus has "exhausted" rights. Compulsory licensing and parallel importation are the focus of this paper.

In practice, governments may realistically be reluctant to exercise TRIPS provisions given some concern about political and economic ramifications, particularly in the area of trade sanctions. The Doha Declaration, issued by the WTO in November 2001, partially aimed to address this concern. It states " [the] TRIPS Agreement does not and should not prevent members from taking measures to protect public health... [and it] should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all" [emphasis added][ 10 ]. Furthermore, the Declaration specifically reaffirms member countries' rights to determine the grounds on which compulsory licenses may be issued, to determine what constitutes a national emergency or circumstance of extreme urgency, and to determine their own regime for the exhaustion of intellectual property rights.

The WTO has, however, not explicitly defined the legal status of the Declaration. An unofficial explanation of the Declaration, available on the WTO website, states that the Declaration provides "important guidance" to individual members and WTO dispute settlement bodies in the interpretation of TRIPS[ 11 ]. Correa identifies the Declaration as a "strong political statement" and "a 'subsequent agreement' between the parties regarding the interpretation of a treaty or the application of its provisions, under Article 31.3(a) of the Vienna Convention on the Law of the Treaties"[ 12 ]. Ultimately, the functional application of the Declaration is to interpret TRIPS[ 13 ], however as Reichman and Hasenzahl note[ 14 ], the exact legal status of the Declaration will not be clear until its practical application has been observed through future WTO panels and the Appellate Body.

The Declaration was partially an effort to interpret Article 31(f) of the TRIPS Agreement, which states that compulsory licensing shall be "predominantly for the supply of the domestic market." Given that the majority of developing countries lack the domestic capacity or technical expertise to manufacture on-patent pharmaceuticals, the interpretation of this terminology is crucial for ensuring access to medicine for the poor in many developing countries. On August 30, 2003, the WTO issued a temporary solution, the "Decision on the Implementation of Paragraph 6 of the Doha Declaration on TRIPS Agreement and Public Health"[ 15 ]. The Decision temporarily waives Article 31(f), permitting countries with local manufacturing capacity to issue compulsory licenses to produce and export drugs to countries without adequate manufacturing capacity, in return for a pledge from countries not to use the Decision "...to pursue industrial or commercial policy objectives"[ 16 ]. Eligible importing countries include least-developed countries or a country that can demonstrate insufficient or no manufacturing capacity for the purpose of meeting its needs. No country, at the time of writing, has yet notified the WTO of its intention to operate as an importer under this decision. Countries may in fact be reluctant to do so as a result of economic and political pressure.

Ghana's Patent Law

The Patent Law of 1992 provided for the protection of patents in Ghana until recently. This law provided that all inventions, products or processes which were "new, involve an inventive step and are industrially applicable," were patentable (Sec.2)[ 17 ]. Pharmaceuticals were considered patentable inventions and patent duration was 10 years (Sec.31(1)). The law permitted compulsory licensing in cases of no or insufficient local working of the patented invention (Sec.45(1)), based on the interdependence of patents (Sec.46), and for products or processes declared to be of vital importance to defence, economic or public health interests (Sec.47). Section 30 considered the patent holder's right exhausted only when he put his patented product on the Ghanaian market, rendering parallel importation impossible. To meet all TRIPS obligations and take advantage of its safeguards, the Ghanaian government reviewed the Patent Law of 1992 and passed a bill to replace it in early 2003.

The changes introduced in the 2003 Patent Act removed some legal tools that may have helped improve access to medicines[ 18 ]. Under Section 7 of the 1992 Patent Law, the Ghanaian government had the authority to temporarily exclude inventions or discoveries, such as pharmaceuticals, from patentability "... in the interests of national security, economy, health or any other national concern." The 2003 Patent Act removed this exception. Arguably, the government of Ghana could have excluded specific pharmaceutical products from patentability as a temporary means to address urgent public health concerns. Temporary excludability is particularly useful when procedural requirements to compulsory licensing cannot be met[ 9 ]. However, as Correa explains, a literal interpretation of Article 27.1 does not allow the exclusion of pharmaceuticals[ 9 ]. He notes that under TRIPS Article 27.2 ordre public and Article 8.1 "...pharmaceuticals might conceivably be excluded from patentability, but neither appear sufficient to justify this exclusion except in limited circumstances,"[ 9 ]. In any case, the option of using temporary excludability appears unviable at the present time.

Section 13(2) addresses the royalty rate for compulsory licenses: "... [t]he exploitation of the invention...shall be subject to the payment to the owner of an adequate remuneration, taking into account the economic value of the Minister's decision as determined in the decision..."[ 18 ]. Adequate remuneration is undefined, allowing for the negotiation of prices, which could have either positive or negative effects on price control and access to medicines. The Ghanaian government has since developed administrative guidelines, proposing the creation of a committee that would determine the level of compensation to be given to a patent holder. It proposed that remuneration for drugs used to treat HIV/AIDS, TB and malaria not exceed 1% of the retail price. In Canada, a country with extensive history of compulsory licensing, a royalty rate of 4% was used[ 19 ]. Furthermore, Canada's recent Jean Chrétien Pledge to Africa Act may offer useful guidance, as the royalty rate varies from 4 to 0.02% depending upon the importing country's standing on the UN Human Development Index[ 20 ].

Section 12(1) of the 2003 Patent Act incorporated Article 33 of TRIPS, doubling the period of patent protection to 20 years. The result will be a delay in the entry of generic competition, and since generic competition tends to lower drug prices, a reduction in overall cost-savings is likely[ 21 ]. This provision does not offer any flexibility to member countries; therefore the ensuing barriers will require circumvention via other TRIPS safeguards or policy alternatives. As noted earlier, the Ghana's major disease burden includes malaria, TB and HIV/AIDS. While these diseases can be treated with off-patent medications, extended patent life will be problematic in situations where no other therapeutic options are available[ 22 ]. Specifically, evidence of resistance to traditional antimalarial therapy ( e.g ., chloroquine) exists and patients who develop resistance to anti-retroviral medications or experience treatment failure will need access to new, patented medicines in the future. The increase in duration of patent protection impedes Ghana's autonomy over defining their population's therapeutic needs.

Changes were also introduced in the 2003 Patent Act that may promote access to medicines. Section 11(4a) of the 2003 Patent Act allows the international exhaustion of intellectual property rights. This legalizes the parallel importation of lower-priced pharmaceuticals from other countries into Ghana, which will be discussed in detail below. Compulsory licenses can now be issued in circumstances of anti-competitive practice, which allows Ghana to remedy abusive practices and excessive prices, potentially increasing the availability of affordable medicines[ 9 ]. Potential also exists to use TRIPS' anti-competitive provisions, accompanied by appropriate national competition policy, to promote the development of the local pharmaceutical industry[ 8 ]. The successful suit by the Aids Law Project (ALP) against two major pharmaceutical companies with the South African Competition Commission in 2002 illustrates this potential. Other positive changes include new procedures in granting compulsory licenses: a waiver to seek a voluntary license in "cases of national emergency or other circumstances of extreme urgency," (Section 13(10)) and ministerial authorization instead of the previous lengthy and resource-intensive requirement of legislative authorization (Sec.13(1)).

The 2003 Patent Act widens the provision for issuing a non-voluntary license under local working requirements. Local working requires the manufacturing of a patented product to a minimum degree within the country, potentially stimulating growth of the local pharmaceutical industry. Specifically, the 2003 Patent Act allows non-voluntary licenses in situations where "...the patented invention is not exploited or is insufficiently exploited by working the invention locally, or by importation in the country," (Sec.14(1)) [ 18 ]. Whereas the 1992 Patent Act listed four relatively specific instances, where the compulsory license could be invoked if the invention was not being worked, the 2003 Patent Act makes this more open-ended. The limits of this new clause will likely be drawn by the TRIPS agreement and legislative intent during drafting the Patent Bill in Ghanaian courts; its exact interpretation is still unclear. Given the USTR complaint against Brazil regarding its local working requirement, however, the current political feasibility of including and invoking such a clause is tenuous[ 19 ].

How will these developments impact access to medicines in Ghana?

Compulsory licensing.

Ghana's 2003 Patent Act, TRIPS and the Doha Declaration offer Ghana sufficient legal ground to use compulsory licensing to address its public health concerns. Compulsory licensing can be used for either local pharmaceutical production or importation, however the latter may be more feasible in the short-term. This will be discussed below. Paragraph 5b of the Declaration explicitly reaffirms the right of countries to "...grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted." As Correa notes, Paragraph 5b merely states the obvious: Article 31 of TRIPS only requires certain conditions for the granting of compulsory licenses, "but it does not limit the grounds on which such licenses can be granted"[ 12 ]. Paragraph 5(c) further facilitates compulsory licensing through the recognition that "public health crises ... can represent a national emergency or other circumstance of extreme urgency" and clarifies that members need not declare a "fully-fledged national emergency"[ 23 ].

From a political perspective, the feasibility of using compulsory licensing to address public health concerns has also become more favourable. One event suggesting this is the abandonment of a pharmaceutical industry lawsuit seeking to remove South Africa's amendment in its Medicines and Related Substances Act, which would permit compulsory licensing and parallel importation. The suit was abandoned due to international pressure and the resolve of the South African government. Other events include Brazil's successful use of the threat of compulsory licensing in negotiations to obtain significant discounts of 40–65% on patented antiretrovirals from Roche and Merck and a public statement by Boehringer-Engelheim in 2003 that it will not interfere in the issuance of compulsory licenses and will respect the Doha Declaration[ 24 ]. The World Health Organization (WHO) also explicitly supports developing countries in the use of TRIPS safeguards to promote access to medicines[ 25 ]. Given these developments, political and legal repercussions from other powerful countries are less likely. For a country to make effective use of compulsory licensing a number of other potential barriers must be addressed and certain requirements must be met.

Effective implementation of compulsory licensing requires the adequate know-how and administrative infrastructure, however many developing countries, including Ghana, do not have this requisite capacity[ 26 ]. Article 67 of the TRIPS Agreement requires developed countries to provide technical assistance, "on request and on mutually agreed terms and conditions", to developing and least-developed countries to help address such gaps. Developing countries like Ghana should use this provision and approach developed countries and international organizations for support.

The usefulness of compulsory licensing, for local production or as a negotiating tool, largely depends on whether the appropriate technological and production capacity exists and whether appropriate human resources are available. The experience of Brazil provides an illustrative example on this point. Cohen and Lybecker argue that Brazil's success is based on three main factors: first, the threat posed by Brazil is credible in that it has a viable local industry; second, Brazil's market is "...one of the largest in Latin America and among the top ten globally;" third, Brazil initiated its threats with the strong support of the international community[ 24 ]. As we noted earlier, the international community continues to be supportive of developing countries' use of compulsory licensing to address public health needs. In comparison to Brazil, however, Ghana's pharmaceutical market is small which may make the process economically unfeasible. The viability of Ghana's local industry is also questionable as approximately 30 pharmaceutical manufacturing facilities exist but only 17–18 produce throughout the entire year. Careful cost-benefit analysis of the value of domestic production versus the importation of pharmaceuticals is necessary to determine whether Ghana can benefit from compulsory licensing for local production, as it is commonly more economical to import medicines than to produce them locally.

• Parallel Importation

Parallel imports are of particular importance in meeting public health needs since the pharmaceutical industry generally sets differential prices globally for the same medicine. Thus, parallel importation of a patented medicine from a country where it is sold at a lower price will enable more patients in the importing country to gain access to cheaper drugs (whether international exhaustion applies to medicines produced under compulsory licensing, however, is still a live debate; see Abbott 2002). Paragraph 5(d) of the Declaration explicitly reaffirms members' freedom to determine their own regimes for the exhaustion of intellectual property rights without challenge. Ghana's 2003 Patent Act finally facilitates this by incorporating this provision; it allows parallel importation only under the condition that the product to be imported is already "put on the market in any country by the owner of the patent or with the owner's consent," (Sec.11(4a)).

Parallel importing introduces more challenges. Administrative capacity issues exist with parallel importation as with compulsory licensing. In Ghana, import permits for companies engaged in the parallel importation of drugs are difficult to obtain at this time, which may pose another barrier. Parallel importation increases the opportunity for the influx of sub-standard products and thus attendant recall problems. Some critics argue that parallel importing acts as a disincentive to differential pricing by research-based pharmaceutical companies due to a risk of diversion of low-cost products to lucrative, developed country markets; however, as Outterson notes "...empirical evidence to date does not indicate a sizable arbitrage market in ARVs from low income countries into the high income countries"[ 20 ]. Furthermore, there have been no reported cases of diverted drugs from Ghana to other markets. The European Commission's (EC) May 2003 Regulation to facilitate differential pricing may provide another option while lessening some of the industry's re-exportation concerns. The EC regulation provides anti-diversion measures against specific pharmaceutical products and requires manufacturers to reduce their essential medicines export prices to developing countries by "75% off the average 'ex factory' price in OECD countries, or at the cost of production plus 15%"[ 27 ]. If parallel importation is to be useful to Ghana, administrative, institutional and managerial capacity must be developed for effective implementation, to prevent the unlawful importation and exportation of products and to ensure quality control.

Importation Pursuant to Paragraph 6

If Ghana decides against using its' local industry for the production of generic medicines, Paragraph 6 may offer another potential solution. While some critics have viewed this provision favourably, others have criticized it as too administratively complex for developing countries. Correa explains that the implementation of the Paragraph 6 Decision requires a number of steps, among which include: 1) in most cases, compulsory licenses issued by importing and exporting countries, 2) the importing country's establishment of insufficient or no local manufacturing capacity in the specified pharmaceutical sector, 3) importer notification to the WTO of its intention to use the system detailing product(s) requested and quantities (accompanied by confirmation of insufficient manufacturing capacity and that a compulsory license is or will be granted), and 4) notification of the exporting country's compulsory license to the WTO and the conditions attached[ 28 ]. Paragraph 4 of the Decision requires the importing country to "take reasonable measures within their means ... to prevent re-exportation"; this requires countries to implement anti-diversion measures including special marking and labelling of the product(s)[ 15 ]. An obstacle might be introduced with strict data protections laws, as exporters must either obtain authorization from the patent holder to obtain efficacy and toxicity data or when denied, perform its own clinical studies to collect this data; this can increase the exporter's costs, therefore increasing the drug cost in the importing country[ 28 ]. Additional obstacles and delays may depend on the importing country's national laws on product registration and the exporting company's capacity to manufacture the specified product[ 28 ]. Lastly, the Decision limits the exporting country's compulsory license to a "single-supply basis," implying that this entire process must repeat for each new request[ 28 ].

Clearly, administrative barriers may hinder some developing countries from using this; however, Article 67 may be used to obtain external assistance to overcome these gaps. Some critics have also claimed that the Decision will not benefit smaller-sized markets, providing minimal incentive to exporting manufacturers. Paragraph 6 of the Decision may help alleviate this problem. It waives the obligations of TRIPS article 31(f) "to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory license in that member to be exported" to other developing or LDCs that are party to the same regional trade agreement and share the health problem in question. Theoretically, this allows a country like Ghana to harness economies of scale and generate more incentive for generic manufacturers to export. However, such a regional trade area must have been formed in conformity with the provisions of Article XXIV of GATT[ 15 ].

To date, only Canada, Norway and the Netherlands have passed legislation to allow export of pharmaceuticals under this provision[ 29 , 30 ]. To implement Paragraph 6, developing countries will have to address barriers introduced by these exporting countries. For instance, the recently passed Canadian bill contains a restrictive list of medicines that can be produced for the purposes of Paragraph 6. Norway's legislative counterpart is less restrictive. Whether exporting countries will be able to satisfy the global demand for affordable, generic drugs will be observed.

It is also unclear whether a developing country like Ghana can use Paragraph 6 and if so, under what circumstances. LDCs are automatically eligible, but since Ghana is a developing country, it is required to examine its local manufacturing capacity and establish that "...excluding any capacity owned or controlled by the patent owner, it is currently insufficient for the purposes of meeting its needs"[ 15 ]. Ghana has been classified as a country that can reproduce drugs as long as it imports the active ingredients, therefore a cost-benefit analysis is necessary to determine whether or not local manufacture is both technically and economically viable[ 10 ]. Whether the lack of economic viability would be considered as "insufficient local manufacturing capacity" in the event of a dispute is questionable. Correa argues that if low-priced medicines cannot be produced because "...meaningful economies of scale have not been reached..." then one of the main objectives of the Doha Declaration, "to promote access to medicines for all," cannot be reached[ 12 ]. However, reports indicate that the US informed the Philippines and other countries that it does not consider "economic efficiency" as valid ground for the use of Paragraph 6[ 31 , 32 ]. It is also important to note that the General Council Chairperson's Statement on 30 August 2003, includes a mechanism that allows any member to challenge another member's "interpretation and implementation" of the Decision "with a view to taking appropriate action"[ 16 ]. The legal implications of the Chairperson's Statement must still be observed; it is unclear whether a developing country like Ghana will be able to use Paragraph 6 without legal challenge or political and/or economic consequences.

Strengthen local industry capacity

The TRIPS Agreement has several provisions, which deal explicitly with the issue of technology transfer. For instance, article 7 states, "The protection and enforcement of intellectual property rights should contribute to technological innovation and to transfer and disseminate technology , to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare and to a balance of rights and obligations" [emphasis added]. Despite such provisions, little technology transfer to developing countries has taken place[ 33 ]. To strengthen local industry, developing countries like Ghana should still pursue initiatives to absorb new technology. Public-private partnerships (PPPs) may be one mechanism to achieve this. Generally, PPPs require private sector companies to provide the technology and expertise while public sector partners provide development funding and help ensure access to the medications. PPPs can facilitate technology transfer to developing and least-developed countries while creating opportunities to initiate research into developing country diseases[ 23 ].

Pooled Procurement

Pooled procurement is a cost-containment strategy that can assist developing countries in financing of the drug needs of their populations, as it is the one area of the drug supply management cycle that can offer the greatest amount of cost savings. For example, the Eastern Caribbean Drug Service (ECDS) used pooled procurement to lower pharmaceutical expenditure by an average of 44%[ 34 ]. The recently established West Africa Manufacturers Association has put in place mechanisms to take advantage of the economics of scale in the pooled procurement of both raw materials and finished products. In (Economic Community of West African States), political realities have to be addressed given that Francophone West-African countries are already involved in pooled procurement procedures. Thus, if Ghana participates, it would have to comply with established procedures. Ghana must carefully examine the costs and benefits of different procurement policies to determine which ones are most viable and cost-effective. Effective implementation, to be sure, demands institutional capacity, financial management systems, quality assurance and transparency.

Voluntary Differential Pricing Arrangements

Ghana can also pursue the procurement of affordable drugs through voluntary differential pricing arrangements. These arrangements can operate through supplier's charity, desire for favourable public relations, or other criteria not immediately or apparently related to market forces. Currently, limited implementation of differential pricing outside of anti-retroviral therapies occurs in Ghana. As noted earlier, the research-based pharmaceutical industry often cites the risk of re-exportation of these drugs to developed country markets as a barrier to scaling up these initiatives, despite the lack of sufficient evidence. To mitigate these concerns, pharmaceuticals firms often require that recipients of their drugs sign a supply agreement that indicates that the recipient will take measures to ensure the security of the drug supply they receive. To further lessen this risk, companies have special packaging and labelling of drugs provided under special programmes like the Accelerated Access Initiative. Developing countries like Ghana can comply with these measures with assistance from firms and established programs to further encourage differential pricing arrangements.

In this paper, we discuss several possibilities for working within the TRIPS regime to gain better access of the population to medicines. These options include compulsory licensing, parallel importing, technology transfer, local production and voluntary differential pricing. We put forward some favoured policy choices for Ghana. First, we encourage Ghana and its Access to Medicines (ATM) Advisory Committee to consider local production. Local manufacturing can be an effective option if human and technological capacity is scaled up. However, we emphasize that this option should only be pursued if it makes economic sense. As a start, an objective cost-benefit analysis should be done to determine whether it makes economic sense for Ghana to pursue local production. Among the alternatives available to strengthen local industry include more aggressive technology transfer.

Next, we encourage the use of compulsory licensing. If Ghana decides to pursue compulsory licensing, it must then address administrative and knowledge barriers. This can be achieved through obtaining support from developed countries and/or international organizations on the effective implementation of compulsory licensing. There is great potential for Ghana particularly given the Government's commitment to build up its knowledge base in this area. In September 2004, members of the Ghanaian Access to Medicines (ATM) Advisory Committee visited Canada to learn about Canada's past experience with compulsory licensing and what measures could be applied to Ghana. If, however, Ghana determines that it is more technically or economically feasible to pursue importation, Paragraph 6 may provide an option. Ghana will first have to establish insufficient manufacturing capacity in the pharmaceutical sector in question, and then consider what political or economic repercussions may follow. More concrete alternatives for importation include parallel importation or the voluntary tiered-pricing arrangement proposed by the European Commission. Importantly, it is critical to monitor any public policy reform to assess whether or not they are achieving attendant outcomes and adjust accordingly. This will require baseline assessments and regular review at intervals.

The opportunities presented above can only be effective in addressing access to medicines in Ghana if other existing barriers are simultaneously addressed. First and foremost, the development and implementation of an effective exemption policy for the poor without co-payments is vital. Policies can vary such as implementing a national pricing policy that control prices on the supply side by regulating actual drug costs or the demand side, through reimbursement schemes such as reference-based pricing or generic substitution policies. Furthermore, reduction of mark-ups in the public sector may generate competition and drive private sector prices down. A hard but necessary policy reform is needed in the area of national tax, tariff and mark-ups to determine what changes could facilitate more affordable prices for the population.

Is the Ghana case generalisable for other African countries? We hope that as a minimum this case adds to the debate in other African countries about public policies they should pursue to improve access to medicines. Some policies may be more applicable than others depending on economic and political realities. There is not a "one-size-fits-all" policy menu that should be applied. Governments need to make informed policy choices when it comes to improving access to medicines and assess which measures are most needed and viable for their particular country.

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Acknowledgements

The Department for International Development (DfID), UK provided funds for the initial policy option analysis for increasing access to medicines in Ghana.

The authors declare that they have no competing interests. However, for the record, please note that Jillian Clare Cohen, Martha Gyansa-Lutterodt and Kwasi Torpey were DfID consultants in Ghana in 2003.

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Cohen, J., Gyansa-Lutterodt, M., Torpey, K. et al. TRIPS, the Doha Declaration and increasing access to medicines: policy options for Ghana. Global Health 1 , 17 (2005). https://doi.org/10.1186/1744-8603-1-17

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Received : 05 July 2005

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DOI : https://doi.org/10.1186/1744-8603-1-17

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Impact of the Trade-Related Aspect of Intellectual Property Rights Agreement on Pharmaceutical Industry in Developing Countries: A Scoping Review

Pharmaceutical companies in developing countries are heavily influenced by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and economic liberalization rules. To adjust to the new patent regime, pharmaceutical companies had to adopt some strategies. A systematic review was conducted on the experiences of the pharmaceutical industry in developing countries and strategies adopted by local pharmaceutical companies to survive after the TRIPS agreement. Scopus, PubMed, and ProQuest databases were searched, and twenty-five papers were reviewed. The pharmaceutical industry experiences have been classified into successful and unsuccessful experiences based on criteria developed by the authors. Firm strategies were also divided into four categories based on external and internal factors: aggressive, conservative, competitive, and defensive strategies. Companies were able to survive and even grow after the TRIPS agreement by rebuilding their structures, improving their competencies, and adopting appropriate strategies in line with the new conditions.

Introduction

The impact of the healthcare industry on the economic growth of countries is remarkable. The economic development of a country relies on the health of society. Healthier people are more productive and more able to create opportunities to participate in economic growth ( 1 ). Any company or organization that provides clinical services, manufacture drugs, and medical equipment, and healthcare-related support services such as medical insurance are considered as the healthcare industry. The pharmaceutical industry, as the most important industry related to the healthcare industry, creates jobs for many people and contributes to the export earnings. As a result, a well-functioning pharmaceutical industry would lead directly to social wellbeing ( 2 ). This industry is recognized by UN Millennium Development Goals “as an actor that can contribute to economic development” ( 3 ). The pharmaceutical industry is one of the most profitable business sectors in the world which contributes as much as 7 to 10 percent to the development of the Gross Domestic Product (GDP) of the top 10 economies of the globe ( 2 ). Several papers have studied the impact of the pharmaceutical industry on the economic development of Low and Middle-Income Countries (LMICs) ( 4 – 7 ). In general, the production level of the pharmaceutical industry in the GDP of developing countries is 0.5% on average, which is not significant ( 7 ). The contribution of the pharmaceutical sector in India’s GDP is 2% and 12% of the manufacturing sector GDP by 2013 ( 3 ). India, as a developing country, has a large and developed pharmaceutical industry. Indian pharmaceutical industry accounts for an estimated 10% of global production. India ranks third in terms of volume and tenth in terms of value in the pharmaceutical sector of the global market ( 8 ).

Medicines are exceptionally high-tech commodities, most of which are directly life-related products. For these reasons, most governments or states control all aspects of medicines from their first trials in animals, through manufacturing and distribution to post-marketing pharmacovigilance.

The distinctive feature of this industry is that pharmaceutical products are so unique and irreplaceable by other goods ( 3 ) that the issue of Intellectual Property Rights (IPR) in this industry is particularly prominent. In the pharmaceutical industry, trade has been strongly linked to IPR to prevent imitation and to increase returns on research and development ( 9 ).

With the establishment of the World Trade Organization (WTO) and the introduction of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement on January 1, 1995, and its transitional periods for developing countries that lasted till 2005, all member countries except the Least Developed Countries (LDCs) were required to adopt minimum standards of intellectual property ( 10 – 13 ). The expiration of the transitional periods for the LDCs to introduce the pharmaceutical patent was January 1, 2016, which was later extended until January 1, 2033 based on requests from the LDCs ( 15 ). Members have to make patents available for inventions, whether products or processes, based on the standard patent criteria (novelty, inventiveness, and industrial applicability) in all fields of technology, without discrimination between domestic and multinational industries ( 16 ).

Based on the Doha Declaration on the TRIPS Agreement and Public Health, the proper interpretation and implementation of the TRIPS Agreement would protect public health and promote access to medicines for all ( 16 ).

Economic liberalization and the TRIPS agreement are major challenges for pharmaceutical companies in developing countries. Due to ease of access to the global markets, there will be opportunities for sectors and companies that do not have much government support and have the required capabilities to compete with multinational companies. One of the main concerns for the world’s leading pharmaceutical companies is the different responses to intellectual property rights in different countries. The WTO agreement on TRIPS established uniform IP standards between countries to reduce the variability of IPR protection among countries ( 18 ).

Pharmaceutical regulations need to be reformed by WTO members to protect local generic producers. Some policy options should be adopted to ensure access to affordable medicines and save the local generic industries ( 15 ). Any wrong selection of rules or policies can lead to the destruction of many local pharmaceutical companies ( 19 ); instead, implementing appropriate policies will lead to the growth of this industry. Pharmaceutical companies should adapt to these policies to develop and grow by converting threats into opportunities or even by taking advantage of existing opportunities ( 20 , 21 ).

The unique position of the Indian pharmaceutical industry among the countries in the developing world is due to its strong generic pharmaceutical industry, which produces medicines with the lowest price among the world. Since multinational corporations are experiencing slow growth in the production of new drugs and a large number of patented drugs are expected to be off-patent in the next few years, more attention has been paid to generic drugs ( 22 ).

As a signatory member of the TRIPS agreement, India has experienced radical shifts in its pharmaceutical industry ( 23 ), but this agreement accelerates the Indian pharmaceutical industry’s movement towards innovative Research and Development (R&D) ( 16 ). A period of 10 years has been given to the Indian pharmaceutical industry to amend patent laws. A vast majority of Indian pharmaceutical firms have strengthened their positions in the domestic markets and international markets ( 24 ). Harmonizing pharmaceutical rules with the TRIPS agreement, using the flexibilities of TRIPS, and protecting national companies from unfair international policies and rules by the Indian government have led to suitable conditions for the growth and development of the Indian pharmaceutical industry. Hence, in the new patent regime, Indian companies have adopted different strategies, such as producing generic drugs, investing in research and development departments to create new medicines, partnership with multinational companies in research areas, marketing their patented drugs, and producing them through signing contracts with their owners ( 19 ).

To prevent the domination of foreign pharmaceutical companies in the Chinese pharmaceutical market, the government has encouraged Mergers and Acquisitions (M&A) in the pharmaceutical industry to raise resources and form larger companies and has supported research and development projects through government subsidies ( 25 ). Investors in East Asia use China as an export platform for the western markets because China encourages foreign direct investment and Joint Ventures (JVs) to establish a commercial presence ( 9 ). The direct import content of exports by FJV’s in China is high ( 25 ), and trade links between China and the East Asian economies have been well strengthened due to the ownership structure of these enterprises and the high import content of their manufacturing ( 9 ).

Unlike India and China, the situation in the Brazilian pharmaceutical industry has not been particularly promising after the TRIPS agreement. Inaccurate enforcement of intellectual property laws may be one of the causes for the lack of innovation in the Brazilian pharmaceutical sector. On the other hand, early adherence to the TRIPS agreement has failed to encourage the emergence of technological innovations in the Brazilian pharmaceutical industry ( 27 ). This is due to the lack of infrastructure, rules, and conditions required for the new patent regime. It should be noted that in addition to the negative effects of the TRIPS agreement on the Brazilian pharmaceutical industry, the new IP regime has had some positive impact, which is the creation of new regulatory frameworks such as industrial property law and its revision, generic law, the establishment of the National Agency for Health Monitoring (ANVISA), and Innovation law ( 28 ).

The Jordanian pharmaceutical industry has also experienced severe conditions after the accession to the WTO in 2000. This country was required to introduce TRIPS-plus provisions in its national patent laws after accession to the WTO in 2000. The US-Jordan Foreign Trade Agreement (FTA) is a new framework of TRIPS-plus rules which allows multinational pharmaceutical companies to prevent generic competition with their products. Data exclusivity, as a TRIPS-plus rule, prohibits generic competition for many medicines. The US-Jordan FTA was formally enacted on December 17, 2001 ( 12 ).

New contribution

Despite numerous studies about the impact of the TRIPS agreement on the pharmaceutical companies in developing countries, there has been no systematic evaluation of the experiences of the pharmaceutical industry in developing countries after the TRIPS agreement yet. The present study attempts to look at the successful and unsuccessful experiences of pharmaceutical industries in developing countries after the TRIPS agreement came into effect. In our review, we were particularly interested in studying strategies of local pharmaceutical companies in developing countries after the TRIPS agreement. This review seeks to address the strategies adopted by local pharmaceutical companies in developing countries to survive and thrive under the new patent regime.

A scoping review is a type of study which has great potential to generate new knowledge by identifying, selecting, and analyzing secondary data. The five-step methodology proposed by Arksey and O’Malley (2005) has been used in this study. The steps include identifying the research questions, determining the research strategy, finding the relevant studies through electronic databases, selecting studies related to the issues, analyzing the data, and finally collating, summarizing, and reporting the results ( 29 ).

For the first step, we clearly defined the research questions:

What are the experiences of the pharmaceutical industry in developing countries after the TRIPS agreement?

What strategies are adopted by local pharmaceutical companies in developing countries to survive and thrive under the new patent regime?

As the second step, we went through the Scopus, PubMed, and ProQuest databases. Keywords selected in the search strategy included “world trade organization”, “WTO”, “Trade-Related Aspects of Intellectual Property Rights”, or “TRIPS”, and “pharmaceutical companies”, “pharmaceutical firms”, or “pharmaceutical industry”. This stage was carried out in December 2019; nevertheless, there was no time limitation in selecting articles.

In the third step, the initial search was conducted, and after eliminating the duplications, 187 studies were collected. We tried to select the most related articles which met our criteria. Therefore, we have restricted our search to the papers which include “developing countries” in English. After the exclusion, we were left with 63 papers. To reinforce the validity of the findings and decrease subjective bias, two members of the research team reviewed and assessed the titles and abstracts of included documents independently. In case of disagreement, the research members first tried to convince each other, and if they did not reach a consensus, the third person from the research team would make the decision as to the suitability of the article for inclusion. In this stage, papers regarding the accessibility of drugs and the rules of trade in the post TRIPS era were excluded since they did not meet the criteria. Therefore, 45 studies were selected. Eventually, after reading the full manuscripts of the remaining studies, unrelated papers were eliminated, and 25 studies were selected for the final analysis. Irrelevant papers included 4 articles about the principles of negotiation with multinational pharmaceutical companies, 6 articles concerning rules of compulsory licensing,3 articles about parallel imports, 7 articles regarding existing laws and regulations about data protection and IP in developing countries. Figure 1 is the PRISMA statement of the process of the study selection.

The screening and selecting articles in accordance with the PRISMA statement

In the following, we show what experiences the pharmaceutical industry has had in developing countries after the TRIPS agreement, and we have divided these experiences into two categories of successful and unsuccessful. Then, the firm strategies of countries with successful experiences are shown in the Strength, Weakness, Opportunity and Threat (SWOT) and Internal & External (IE) matrix.

SWOT analysis is an essential instrument for decision-making and is commonly used to systematically analyze an organization’s internal and external environments ( 29 ). This technique is attributed to Albert Humphrey, who led a convention at Stanford University in the 1960s and 1970s using data from Fortune 500 companies ( 31 , 32 ).

SWOT analysis divides the main parts of the information into two major categories: (A) Internal factors: These factors indicate the strengths and weaknesses of the organization. Strengths and weaknesses are factors in the system that enable the organization to either achieve its goal or avoid it. (B) External factors: These are opportunities and threats imposed on the organization by the external environment. Opportunities and threats, as external factors, facilitate or limit the organization in obtaining its goals, respectively ( 33 ).

The SWOT analysis is used to understand the various conditions in the organization, to determine the strategies, and finally, to choose the best strategy ( 34 ).

SWOT Matrix Formation and Strategy definition: SO strategies consist of internal strengths with external opportunities. WO strategies consist of internal weaknesses with external opportunities. ST strategies consist of internal strengths with external threats. WT strategies consist of internal weaknesses with external threats.

Internal and External Analysis by Internal–External Matrix: IE matrix is used to analyze internal and external factors concurrently and to determine the strategic position of an organization ( 34 ). The proportional area of strategies in the SWOT framework is highlighted by the IE matrix.

The experiences of the pharmaceutical industry

After the TRIPS agreement, the experiences of the pharmaceutical industries in developing countries differ from one country to another. The industrial and technological policies and, consequently, the development strategies adopted by pharmaceutical companies are quite different, leading to different experiences in the pharmaceutical industry in developing countries.

The experiences of the pharmaceutical industry in developing countries after the TRIPS agreement is described in Table 1 .

Different kinds of experiences in the pharmaceutical industry in developing countries after the TRIPS agreement

The experiences of the pharmaceutical industry in developing countries have been classified into successful and unsuccessful experiences based on such criteria as the number of Drug Master File (DMF) and Abbreviated New Drug Application (ANDA), filing or licensing activities, R&D intensities, innovations, R&D expenditures, different types of alliances with Multinational Companies (MNCs), introduction of New Chemical Entities (NCEs), generic competition, number of Contract Research And Manufacturing Services (CRAMS), and government supportive policies.

Table 2 contains the criteria explaining successful and unsuccessful experiences of the pharmaceutical industry in developing countries after the TRIPS agreement.

The criteria with the explanation of successful and unsuccessful experiences of the pharmaceutical industry in developing countries after the TRIPS agreement

Although the pharmaceutical industry experiences in developing countries are different after the TRIPS agreement, the frequency of each experience varies in the studied papers. The most frequent successful and unsuccessful experiences of the pharmaceutical industry in developing countries are demonstrated in Figure 2 . Successful experiences are shown at the top of the chart with positive numbers, and unsuccessful experiences are shown at the bottom of the chart with negative numbers.

The successful and unsuccessful experiences of the pharmaceutical industry in developing countries after the TRIPS agreement. CRAMS= Contract Research and Manufacturing Services, NCE = New Chemical Entities, DMF= Drug Master Files, ANDA= Abbreviated New Drug Application, R&D = Research, and Development

The strategies adopted by pharmaceutical companies

Every company is dealing with various conditions, which can comprise potential stimulants or possible obstacles to the company’s performance or the objectives the company wishes to achieve. Adopting strategies tailored to different requirements plays a vital role in the success of firms. The correct interaction of business management with its environment leads to successful performance in a company. This environment can be internal or external. The external environment consists of variables existing outside the company. Examples of these variables, which are considered as a direct environment, are the shareholders, the government, the suppliers, the local authorities, the competitors, and the clients. The examples of variables that are considered as indirect environments include economic, socio-cultural, technological, political, and juridical influences. The internal environment of the company consists of variables within the company itself, including the company structure, the company culture, and the resources of the company ( 52 ).

The strategies adopted by pharmaceutical companies after the TRIPS agreement are summarized and shown in Figure 3 . Given the strengths and weaknesses of companies and the opportunities and threats that have arisen after the TRIPS agreement, firm strategies are divided into four categories based on the external and internal factors: aggressive, competitive, conservative, and defensive.

Internal–External (IE) matrix and strategies adopted by pharmaceutical companies after the TRIPS agreement. API = Active Product Ingredient, NCE = New Chemical Entities, R&D= Research, and Development

Aggressive strategies use internal strengths to take advantage of external opportunities. According to the IE matrix, aggressive strategies adopted by pharmaceutical companies after the TRIPS agreement consists of the international acquisition, setting up production facilities, entering into marketing alliance abroad, API supply, traditional knowledge, and herbal medicine.

Conservative strategies aim to exploit opportunities in the external environment to improve internal weaknesses. Conservative strategies of the pharmaceutical companies of developing countries after the TRIPS agreement based on IE matrix include collaborative R&D, contract research, contract manufacturing, joint venture, in-licensing arrangement, out-licensing of innovation, co-marketing, clinical trial, contract research, and manufacturing service.

Competitive strategies use the organization’s strengths to reduce the effects of external threats. According to the IE matrix, competitive strategies of pharmaceutical companies in developing countries after TRIPS agreement include research on NCE, biopharmaceutical research, novel drug delivery system, innovation, specialty generics, development of the non-infringing process, positive patenting, and defensive patenting.

The objective of the defensive strategies is to reduce internal weaknesses and avoid threats from the external environment. In this case, the organization tries to reduce its activities to maintain its survival, merge with other organizations, declare bankruptcy, or eventually dissolve.

Based on our preceding discussion, the pharmaceutical industries in developing countries have had various experiences in the post TRIPS agreement period. The pharmaceutical industries in some countries have had successful experiences and have continued to grow and survive after the TRIPS agreement. In contrast, the pharmaceutical industries in some countries have had unsuccessful experiences and have failed to grow in the new patent regime and market liberalization.

For example, Brazil enacted the rules for liberalizing its economy in the 1990s and followed the new technology regime only two years after the TRIPS agreement. As White and Linden (2002) have stated, organizations would not survive if the pace of economic reforms exceeded the pace at which organizations can adopt appropriate strategies ( 53 ). These problems include ( 1 ) prohibiting the local production of patented drugs and replacing them with imported products from the companies that have the patents of these drugs, ( 2 ) allocating resources to imported products instead of investing these resources in national R&D and purchasing other drugs, ( 3 ) inability to export local products due to the unpreparedness and incompatibility of Brazilian ports and airports with export rules ( 54 ).

Chittoor et al. (2008) have shown in their study that the prominent features of India’s institutional environment include a combination of private and public sector enterprises, substantial presence of foreign firms, better quality institutions, and gradual acceleration of institutional changes, which has led to local firms that have relatively higher knowledge or experience about market economies ( 24 ).

The strategies adopted by companies with successful experiences were studied in this paper. The pharmaceutical industry is shaped by external forces, such as economic reform, health system reform, industrial policy regimes, and changing business ethics alongside internal forces, such as enterprise competition ( 25 , 39 ).

As mentioned earlier, choosing a proper strategy should be in line with the external and internal environment of firms. Due to their strengths and weaknesses, pharmaceutical companies of developing countries are taking advantage of the opportunities created in the new patent regime, penetrating new and regulated markets, and enhancing their capabilities and innovativeness, either by collaborating or by competing with MNCs.

Pharmaceutical companies that are strong enough in drug discovery research activities begin to compete with the world’s leading pharmaceutical companies in the new patent regime. Therefore, they follow competitive strategies such as research on NCE, biopharmaceutical research, novel drug delivery system, innovation, specialty generics, development of the non-infringing process, positive patenting, and defensive patenting.

The availability of financial resources is an essential constraint that companies face in competing with multinationals. Local firms’ strategies for building internal capabilities and meeting international standards include modernizing manufacturing plants, investing in R&D, and importing technology depending on the availability of financial resources ( 25 ).

Because of the limited funds, pharmaceutical companies in developing countries collaborate with MNCs through contract agreements to obtain foreign funds to build their own product-research cultures and competitive capabilities ( 55 ). Hence, strategies like collaborative R&D, joint venture, in-licensing arrangement, out-licensing of innovation, co-marketing, clinical trial, contract research and manufacturing service have been followed by these firms. On the other hand, many MNCs tend to cooperate with local pharmaceutical companies in developing countries to reduce costs, increase development capacity, and shorten the “market entry time” for new drugs.

In his study, Rai (2008) shows that the Indian pharmaceutical industry is adopting a mix of competitive and collaborative business and R&D strategies to overcome the challenge posed by the new patent regime. He mentions that business strategies, comprised of in-licensing, out-licensing, and co-marketing alliances, are adopted by firms that have branded products but do not have adequate sales networks. They would be able to use the existing sales network of alliance companies by entering into such alliances. He also mentioned that Indian companies are increasingly seeking to create in-licensing arrangements with MNCs to launch their products in India. The arrangement covers a wide range of relationships, from marketing relationships (including Joint Ventures) to local production by Indian companies and sharing part of the profits with MNC. To produce innovative products, the in-licensing arrangement strategy is cheaper and less risky than buying companies or conducting research and development, which are much more expensive. Companies would be able to bring novel drugs into the country at a reasonable price with the help of the in-licensing strategy. Since these products have already been approved for marketing in other countries, they will be directly studied in the bio-equivalence study and phase-III trial, so regulatory procedures are more accessible and faster.

He also believes that companies trying to increase their market share and expand into regulated markets are pursuing strategies such as international acquisition, creation of production facilities abroad, and marketing alliance abroad ( 40 ). Active Product Ingredient (API) supply, focus on traditional knowledge, and emphasis on herbal medicine are other aggressive strategies that pharmaceutical companies in developing countries have adopted to expand their market in the new patent regime. On the other hand, small pharmaceutical companies that cannot compete with multinationals have merged with MNCs in the form of a conservative strategy ( 22 ).

Rai (2008) has argued that pharmaceutical firms have adopted two sets of strategies: High-End Competitive Strategies (HECS) and Low-End Competitive Strategies (LECS). HECS focuses on innovation, research on NCE, positive patenting, defensive patenting, and biopharmaceutical research, while LECS emphasizes specialty generics, non- infringing processes, and Novel Drug Delivery Systems (NDDS). Compared to LECS, HECS requires higher investment and more technical knowledge and skills ( 40 ).

Yin et al. (2003) have stated that among the strategies adopted by Chinese pharmaceutical companies, M&A had the most significant impact on the pharmaceutical industry and market. M&A led to the development of better management methods. Many failed pharmaceutical companies survived by being sold to major companies. Thus, the risk of bankruptcy and downsizing is avoided ( 25 ).

Globalization causes fundamental changes in the external and internal environment of enterprises. The reduction of trade restrictions and the inflow of foreign investment are the critical components of economic liberalization. Reducing trade tariffs leads to less protection of domestic companies against imports ( 24 ). New regulatory environments or radical innovations are changes that occur in fast-changing business environments. Various studies have testified that after the TRIPS agreement, the different strategies and policies for the pharmaceutical sector were adopted by companies in developing countries. Companies were able to survive and even grow in the face of remarkable changes resulting from the TRIPS agreement by rebuilding their structures, improving their competencies and capabilities, and adopting appropriate strategies in line with the new conditions. Comparing the pharmaceutical industry experiences in developing countries related to industrial development and technological capability after the TRIPS agreement indicates that adopting suitable strategies is not enough to succeed in the industry. Factors such as the industry background, government approach to industry development and technological capability, market liberalization, technological infrastructures, human resources, sectoral regulation, and macroeconomic aspects help companies survive and thrive under the new patent regime. The impact of government-adopted industrial policies to support the pharmaceutical industry following the TRIPS agreement is significant in developing countries. To increase R&D spending, the governments have provided incentives such as various tax exemptions for the pharmaceutical companies and have facilitated collaboration between the private sector and the publicly funded research institutes ( 10 , 39 ).

This study aims to review the experiences of the pharmaceutical industry in developing countries after the enactment of the TRIPS Agreement. The paper focuses on different firm strategies adopted by successful local companies to respond to the new patent regime. Comparing the experiences of the pharmaceutical industry of developing countries, it can be concluded that the varying positions of the pharmaceutical industry of developing countries in the global market are due to the significant differences in the strategies adopted by the pharmaceutical companies in those countries. Considering internal and external factors, it can be concluded that firm strategies were divided into four categories: aggressive, competitive, conservative, and defensive. Each category included the most suitable strategies that are in line with the specific situation of the company and its environment.

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Competing interests

The authors have no competing interests to declare.

Author’s contributions

Implementing the research strategy and methodology, searching through databases, analyzing data, and preparing the paper draft have been conducted by MF. NY gave consultation on the design of the study and has defined keywords boundaries, and reviewed and commented on the manuscript. FP has supervised the methodology. All authors read and approved the final manuscript.

Acknowledgments

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Editorials for 22-April-2024

By vajiram & ravi, changes in law will just make medicines more expensive, not better.

Why in News?

• India's healthcare system heavily relies on affordable medicines , with the generic pharmaceutical industry playing a pivotal role in providing quality drugs at reasonable prices.
• Medicines constitute a significant portion of healthcare costs , with nearly 50% of expenses incurred by individuals attributed to purchasing medications.
• However, the high costs of medicines, primarily driven by patenting, pose a significant barrier to accessing essential treatments.

The Role of Generic Pharmaceutical Companies

• Generic pharmaceutical companies play a crucial role in addressing the affordability challenge by providing cost-effective alternatives to patented drugs.
• The Indian generic industry has been recognised globally for its contribution to supplying essential medicines at affordable prices.
• The evolution of India's patent regime has shaped its pharmaceutical industry and its ability to produce generic medicines.
• Historically, the Indian Patent Act of the early 1970s restricted patent protection to the process of manufacturing drugs, rather than the products themselves.
• This approach fostered the growth of the generic industry , establishing India as a leading exporter of generic drugs by the late 1980s.
• However, recent amendments to the Indian Patent Law threaten to disrupt this ecosystem and undermine access to affordable healthcare.

Impact of TRIPS Agreement on India's Pharmaceutical Industry

• One of the most significant changes brought about by the TRIPS Agreement was the requirement for member countries to grant patents for both products and processes, including pharmaceuticals.
• This transition from process to product patents posed challenges for India's generic pharmaceutical industry, which had thrived under a regime that allowed to produce generic versions of patented drugs.
• The introduction of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 1995 had a profound impact on India's pharmaceutical industry , shaping its trajectory and global standing.
• The introduction of product patents threatened to disrupt India's generic pharmaceutical industry , which had become known for its ability to produce affordable versions of essential medicines.
• Product patents granted exclusive rights to the inventor , limiting the scope for generic manufacturers to produce and distribute low-cost alternatives.
• The TRIPS Agreement placed pressure on India to align its intellectual property laws with international standards , including the protection of pharmaceutical patents.
• This necessitated amendments to India's Patent Act to ensure compliance with TRIPS obligations while safeguarding the interests of its generic pharmaceutical industry and public health priorities.
• Despite the challenges posed by TRIPS, India adopted measures to safeguard access to affordable medicines.
• Provisions such as Section 3(d) of the Indian Patent Act, introduced in 2005, aimed to prevent the grant of frivolous patents for incremental innovations that lacked significant therapeutic benefits.
• This provision upheld the principle of affordable access to medicines while complying with TRIPS requirements.
• The TRIPS Agreement presented India with a delicate balancing act between fostering innovation and ensuring access to essential medicines.
• While patents incentivise innovation and investment in research and development, they also have the potential to restrict access to life-saving treatments, particularly in developing countries with limited healthcare resources.
• Despite the challenges posed by TRIPS, India emerged as a global leader in generic drug manufacturing, leveraging its manufacturing capabilities and adherence to TRIPS flexibilities.
• The country's generic pharmaceutical industry continued to thrive, supplying affordable medicines not only domestically but also to markets around the world.

Section 3(d) and Flexibilities in India’s Patent Laws

• Section 3(d) of the Indian Patent Act is a critical provision that embodies the flexibilities inherent in India's patent law.
• Section 3(d) addresses concerns related to "evergreening ," a practice employed by pharmaceutical companies to extend the patent life of their products by making minor modifications or incremental innovations.
• This provision aims to prevent the grant of patents for incremental innovations that lack significant therapeutic efficacy or novelty, thereby safeguarding access to generic versions of essential medicines.
• Under Section 3(d), for pharmaceuticals and chemical substances, patent protection is granted only if the invention demonstrates enhanced efficacy compared to existing formulations.
• This requirement ensures that patents are granted for inventions that represent genuine advancements in therapeutic efficacy, rather than minor variations or modifications of existing drugs.

Current Challenges in India's Patent Regime

• One of the primary challenges arises from amendments to the Indian Patent Rules that have made it more difficult to file opposition to patents at the pre-grant stage.
• These amendments weaken the mechanism for challenging the grant of patents, potentially facilitating the grant of patents for inventions that lack genuine novelty or therapeutic efficacy.
• The amendments to the pre-grant opposition process could have adverse effects on competition in the pharmaceutical market and contribute to higher drug prices.
• By limiting the ability of generic manufacturers and civil society organisations to challenge frivolous patents , the amendments stifle competition and impede the availability of affordable generic alternatives to patented drugs.
• The amendments to India's patent rules reflect pressure from pharmaceutical multinational corporations, particularly from Western and Japanese companies.
• These companies have lobbied for changes that align with their interests and seek to weaken India's patent regime to facilitate the grant of patents for incremental innovations and extend market exclusivity for their products.
• The amendments pose a threat to the flexibilities inherent in India's patent law, particularly provisions such as Section 3(d) that impose stringent patentability criteria based on enhanced efficacy.
• By limiting opportunities for challenging frivolous patents and weakening provisions that prevent evergreening, the amendments undermine India's ability to safeguard public health priorities and promote access to affordable medicines.
• Another challenge arises from the imposition of fees on opponents to patents , which could deter patients, civil society organisations, and generic manufacturers from filing pre-grant oppositions.
• The financial burden associated with challenging patents could limit the ability of stakeholders to protect public health interests and promote access to affordable medicines.
• Furthermore, the amendments affect the issuance of compulsory licences, which are essential for ensuring access to medicines in situations where patents impede availability.
• By weakening provisions that facilitate compulsory licensing and limit evergreening, the amendments undermine efforts to address healthcare disparities and promote equitable access to essential medicines.
• Ensuring access to affordable medicines is essential for promoting public health and achieving universal healthcare coverage.
• By preserving the flexibility in patent law, promoting competition, and safeguarding the interests of patients and public health , policymakers can uphold the principles of affordability, accessibility, and quality in healthcare delivery.

The amendments to the Indian Patent Rules must be carefully evaluated and revised to mitigate their adverse impact on access to essential medicines and public health outcomes. 

Q) What are Indian generic medicines?

Indian generic medicines are unbranded pharmaceutical drugs that contain the same active ingredients as their branded counterparts. They are produced by pharmaceutical companies in India and are often much cheaper than branded drugs due to the absence of patent protection.

Q) Why are Indian generic medicines popular globally?

Indian generic medicines are popular globally because they offer affordable alternatives to expensive branded drugs, making healthcare more accessible to people around the world. Additionally, India's robust pharmaceutical industry adheres to high-quality standards and has earned trust for producing safe and effective generic medications. Source: T he Indian Express

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URUGUAY ROUND AGREEMENT: TRIPS

Part I — General Provisions and Basic Principles

• PART I General Provisions and Basic Principles
• PART II Standards Concerning the Availability, Scope and Use of Intellectual Property Rights
• 1. Copyright and Related Rights
• 2. Trademarks
• 3. Geographical Indications
• 4. Industrial Designs
• 6. Layout-Designs (Topographies) of Integrated Circuits
• 7. Protection of Undisclosed Information
• 8. Control of Anti-Competitive Practices in Contractual Licences
• PART III Enforcement of Intellectual Property Rights
• 1. General Obligations
• 2. Civil and Administrative Procedures and Remedies
• 3. Provisional Measures
• 4. Special Requirements Related to Border Measures
• 5. Criminal Procedures
• PART IV Acquisition and Maintenance of Intellectual Property Rights and Related Inter-Partes Procedures
• PART V Dispute Prevention and Settlement
• PART VI Transitional Arrangements
• PART VII Institutional Arrangements; Final Provisions

Article 1 Nature and Scope of Obligations

1.  Members shall give effect to the provisions of this Agreement. Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement, provided that such protection does not contravene the provisions of this Agreement. Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.

2.  For the purposes of this Agreement, the term “intellectual property” refers to all categories of intellectual property that are the subject of Sections 1 through 7 of Part II.

3.  Members shall accord the treatment provided for in this Agreement to the nationals of other Members.  (1) In respect of the relevant intellectual property right, the nationals of other Members shall be understood as those natural or legal persons that would meet the criteria for eligibility for protection provided for in the Paris Convention (1967), the Berne Convention (1971), the Rome Convention and the Treaty on Intellectual Property in Respect of Integrated Circuits, were all Members of the WTO members of those conventions.  (2) Any Member availing itself of the possibilities provided in paragraph 3 of Article 5 or paragraph 2 of Article 6 of the Rome Convention shall make a notification as foreseen in those provisions to the Council for Trade-Related Aspects of Intellectual Property Rights (the “Council for TRIPS”).

Article 2 Intellectual Property Conventions

1.  In respect of Parts II, III and IV of this Agreement, Members shall comply with Articles 1 through 12, and Article 19, of the Paris Convention (1967).

2.  Nothing in Parts I to IV of this Agreement shall derogate from existing obligations that Members may have to each other under the Paris Convention, the Berne Convention, the Rome Convention and the Treaty on Intellectual Property in Respect of Integrated Circuits.

Article 3 National Treatment

1.  Each Member shall accord to the nationals of other Members treatment no less favourable than that it accords to its own nationals with regard to the protection  (3) of intellectual property, subject to the exceptions already provided in, respectively, the Paris Convention (1967), the Berne Convention (1971), the Rome Convention or the Treaty on Intellectual Property in Respect of Integrated Circuits. In respect of performers, producers of phonograms and broadcasting organizations, this obligation only applies in respect of the rights provided under this Agreement. Any Member availing itself of the possibilities provided in Article 6 of the Berne Convention (1971) or paragraph 1(b) of Article 16 of the Rome Convention shall make a notification as foreseen in those provisions to the Council for TRIPS.

2.  Members may avail themselves of the exceptions permitted under paragraph 1 in relation to judicial and administrative procedures, including the designation of an address for service or the appointment of an agent within the jurisdiction of a Member, only where such exceptions are necessary to secure compliance with laws and regulations which are not inconsistent with the provisions of this Agreement and where such practices are not applied in a manner which would constitute a disguised restriction on trade.

Article 4 Most-Favoured-Nation Treatment

  With regard to the protection of intellectual property, any advantage, favour, privilege or immunity granted by a Member to the nationals of any other country shall be accorded immediately and unconditionally to the nationals of all other Members. Exempted from this obligation are any advantage, favour, privilege or immunity accorded by a Member:

(a)  deriving from international agreements on judicial assistance or law enforcement of a general nature and not particularly confined to the protection of intellectual property;  

(b)  granted in accordance with the provisions of the Berne Convention (1971) or the Rome Convention authorizing that the treatment accorded be a function not of national treatment but of the treatment accorded in another country;  

(c)  in respect of the rights of performers, producers of phonograms and broadcasting organizations not provided under this Agreement;  

(d)  deriving from international agreements related to the protection of intellectual property which entered into force prior to the entry into force of the WTO Agreement, provided that such agreements are notified to the Council for TRIPS and do not constitute an arbitrary or unjustifiable discrimination against nationals of other Members.

Article 5 Multilateral Agreements on Acquisition or Maintenance of Protection

  The obligations under Articles 3 and 4 do not apply to procedures provided in multilateral agreements concluded under the auspices of WIPO relating to the acquisition or maintenance of intellectual property rights.

Article 6 Exhaustion

  For the purposes of dispute settlement under this Agreement, subject to the provisions of Articles 3 and 4 nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights.

Article 7 Objectives

  The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

Article 8 Principles

1.  Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.

2.  Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.

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• 1. When “nationals” are referred to in this Agreement, they shall be deemed, in the case of a separate customs territory Member of the WTO, to mean persons, natural or legal, who are domiciled or who have a real and effective industrial or commercial establishment in that customs territory.  Back to text
• 2. In this Agreement, “Paris Convention” refers to the Paris Convention for the Protection of Industrial Property; “Paris Convention (1967)” refers to the Stockholm Act of this Convention of 14 July 1967. “Berne Convention” refers to the Berne Convention for the Protection of Literary and Artistic Works; “Berne Convention (1971)” refers to the Paris Act of this Convention of 24 July 1971. “Rome Convention” refers to the International Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organizations, adopted at Rome on 26 October 1961. “Treaty on Intellectual Property in Respect of Integrated Circuits” (IPIC Treaty) refers to the Treaty on Intellectual Property in Respect of Integrated Circuits, adopted at Washington on 26 May 1989. “WTO Agreement” refers to the Agreement Establishing the WTO.  Back to text
• 3. For the purposes of Articles 3 and 4, “protection” shall include matters affecting the availability, acquisition, scope, maintenance and enforcement of intellectual property rights as well as those matters affecting the use of intellectual property rights specifically addressed in this Agreement.  Back to text

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