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

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,¹ and the promotion of public health interests by using existing TRIPS flexibilities [6] or through revisions to the TRIPS Agreement.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 Region³ 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 COVID19⁴ [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 authorization⁵ 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.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 Agreement⁷ 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,⁸ which include all countries of the WHO African Region.

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, 21⁵⁸ 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 70.8⁵⁹ and 70.9,⁶⁰ with respect to mailbox applications and provision of exclusive marketing rights of pharmaceutical products until 1 January 2033⁶¹ 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.