Are TRIPS flexibilities fully leveraged for pharmaceutical access in Africa?
Adekola Tolulope Anthony
The entry into force, more than two decades ago, of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), established a new principle at the level of international law that patents should be available for pharmaceutical inventions. This principle was contentious during the negotiations on TRIPS, and the adoption and implementation of the principle have hardly stilled policy debate in this area. The debate has raged for nearly three decades and has been centred on whether and to what extent intellectual property rights (IPRs) lead to increased innovation and life-saving medical technologies or unfairly restrict access to those technologies. In their recent paper titled, ‘Pharmaceutical Patent Law and Policy in Africa: a Survey of selected SADC member states’, Bryan Mercurio, Adekola Tolulope and Tsega Chimdessa examine the status of pharmaceutical patent law vis-à-vis the utilization of TRIPS flexibilities in the Southern African Development Community (SADC). The SADC serves as a useful case study as the region has the highest prevalence of HIV and AIDS, second highest in Malaria and primarily relies on generic drugs to treat diseases. The selected countries — Botswana, Malawi, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe — represent a mix of both major and modest economies. The key findings in the paper will now be discussed.
Outdated laws: decolonising patent law
Surprisingly, the paper finds that despite the advent of the TRIPS Agreement there have been relatively few changes to the legal regimes of SADC member states. The laws for most of these states date back to colonial-era legislation or remain based on a colonial model — for instance, South Africa’s patent law dates to 1978, while others such as Malawi (1986) and Tanzania (1994) maintain pre-TRIPS legislation. A slight amendment was only made to the Patents Act of South Africa in 1997 to provide 20 years duration for a patent, in accordance with the TRIPS Agreement. Since then, despite sustained calls for South Africa to reform its patent laws, the necessary reforms are not forthcoming.
Shockingly low patenting trends
Another finding of the paper is that few patents and even fewer pharmaceutical patents are filed in these countries. If patents are not filed, there is no protection and no domestic impediment to local manufacturing, importation, and distribution. This is not to say, however, that the TRIPS Agreement does not have an effect. On the contrary, patent status in other countries still impacts whether and how easily a SADC country can import pharmaceuticals, as importation can only occur if the product can be legally exported from a third country. While the TRIPs Agreement, and pharmaceutical patent protection more generally, have been blamed for the worsening health situation in these countries, the low rate of patenting in Africa generally and in the surveyed countries demonstrates that pharmaceutical patents may not be the chief challenge to pharmaceutical access. Other issues of importance include pharmaceutical manufacturing capacity; technical and infrastructural capacities for medicines regulation; regulating anti-competitive practices; and pharmaceutical market intelligence.
Transition period: an unused flexibility
On transition periods, three of the selected SADC countries — Malawi, Tanzania, and Zambia — are LDCs and therefore enjoy the extended WTO transition periods during which they may choose not to grant pharmaceutical patents. This period was extended most recently until 1 July 2034. None of these countries, however, takes full advantage of the extension. This is not to imply that the countries comply with TRIPS — there are anomalies. Only Zambia provides for a protection period of 20 years from the filing date of the patent application. In contrast, Malawi and Tanzania provide a term of protection of 16 years and 10 years respectively. Moreover, despite the existence of the specific WTO waiver for pharmaceuticals, the LDCs do not exclude pharmaceutical products or processes from patentability in their domestic laws.
Standard of patentability and the imperative of substantive examination
On standards of patentability, the paper finds that all the surveyed countries lack substantive patent examination systems. Even South Africa, which has the highest number of patents, does not carry out substantive search and examination of applications before grant. Although Article 27 of TRIPS leaves ample room for WTO Members to tailor their laws to meet specific needs and objectives and provide the meaning and scope of each of the criteria for patentability, the absence of substantive examination defeats this possibility. The recommended approach for the surveyed countries is therefore to 1) ensure that substantive examination on patent applications is carried out and 2) embrace strict rules with patentability that will guard against overprotection and interests that may negate their broader objectives for driving access to affordable medicines. These will ensure that new technologies for which patents are granted emerge not only as abstract scientific publications but as effective, proven technologies that are actually disseminated to the broader public, for overall welfare outcomes.
Compulsory licensing: a panacea?
All the surveyed countries allow for compulsory licensing for a variety of reasons, including public interest, failure to licence on reasonable terms and in order to combat anti-competitive behaviour. The paper finds that in practice it is often the threat to issue a compulsory license (as opposed to the actual use) that serves an important purpose as it is a key bargaining chip for countries negotiating purchases from pharmaceutical companies. Moreover, a compulsory licence cannot facilitate the transfer of the know-how and technical knowledge needed to exploit complex inventions nor can it drive the market competition needed to reduce the price of pharmaceuticals (being a single market licence) on a large-scale sustainable basis. Hence, while the availability of compulsory licensing can assist in facilitating access to medicines, the starting point for some these countries is to investigate whether it is feasible to develop pharmaceutical manufacturing in order to harness more effectively the gains of the flexibility.
Parallel Importation: call for international exhaustion regime
On parallel importation, it remains unclear whether the South African legal framework provides for the parallel importation of pharmaceuticals. The Malawian Patent Act similarly does not clearly define the principle of exhaustion of IPRs. In general, the best approach for the surveyed countries remains an unrestricted international exhaustion regime.The patent laws of the surveyed countries must be unequivocal in this regard. The rationale for this recommendation is that these countries are net IP importers dependent on pharmaceutical importation. International exhaustion can benefit by helping facilitate the importation of patented products from the cheapest global market in order to assist in meeting prevailing health needs.
Conclusion: necessary national response
The conclusion is straightforward: while the current literature contains widespread assertions on the impact and effect of TRIPS on access to medicines in these countries, there is a lack of explicit and workable provisions implementing key TRIPS flexibilities in domestic laws. Hence, where available TRIPS flexibilities have not been well utilised, it is often the complicated and unworkable domestic framework — rather than TRIPS — which becomes the stumbling block to pharmaceutical access. The conclusion is straightforward: countries must ensure that domestic laws maximise flexibilities and avoid enacting measures that impose higher obligations than necessary which could potentially reduce the potency of the flexibilities.
