This paper discusses how patent pools and regional integration can be deployed as mechanisms for assuaging the African access to medicines imbroglio
Regional Integration, Patent Pools and Access to Medicines
by Olasupo Owoeye*
Doctoral Researcher, Faculty of Law, University of Tasmania
The connection between intellectual property protection and access to medicines remains a highly topical issue. Scarcity of medicines continues to be an issue of significant global concern. As noted in the World Health Statistics 2013:
Even the cost of the lowest-priced generics can put common treatments beyond the reach of low-income households in developing countries. The greatest price is paid by patients suffering chronic diseases. Even though effective treatments exist for the majority of conditions contributing to the global burden of chronic disease, universal access remains out of reach.
The pharmaceutical patents debate has attracted an inundating degree of commentaries and various recommendations have been made on how to maximise the use of the available flexibilities in international intellectual property law to make medicines available at affordable prices to people in developing countries. This paper discusses how patent pools and regional integration can be deployed as mechanisms for assuaging the African access to medicines imbroglio.
The TRIPS Agreement and the Pharmaceutical Patents Debate
The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) is the major international agreement on intellectual property protection with significant implications for access to medicines due to its unprecedented harmonisation of the standards for the protection of intellectual property rights in the 159 member countries of the World Trade Organization (WTO). A major flexibility available to developing countries that are seeking access to affordable patented medicines is the option of granting a compulsory or non-voluntary licence for the production of generic versions of patented drugs. Fulfilling the requirements for the use of compulsory licences can however be daunting especially where the country in need is without pharmaceutical manufacturing capacity and generic versions are not available from other sources. A country in such a situation will then have to import under the WTO decision on the Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health or the Protocol Amending the TRIPS Agreement.
It would appear that developing countries with little or no manufacturing capacity may not be in a position to make maximum use of compulsory licences under the TRIPS Agreement especially where they have to import such drugs under the Doha paragraph-6 system. This is particularly so in Africa where many countries are still in the United Nation’s list of least developed countries. One must however hasten to add that the access to medicines problem in Africa is not all about patents or intellectual property protection. The administrative, economic and political environments in which the health sector operates in Africa are also a significant part of the problem.
Regional Integration and Patent Pools
Given the acute shortage of essential medicines in the continent, it is important for African nations to consider the development of a strong pharmaceutical manufacturing capacity as a top priority. Nonetheless, to address immediate and pressing public health needs, steps should be taken to achieve short-term public health goals in relation to access to affordable medicines in the continent. The procurement of essential medicines in Africa is an issue that deserves some substantial attention. In this respect, the patent pool option can be very helpful. A patent pool can be defined as an arrangement whereby two or more patent owners agree to aggregate or pool their patents and license them to one another or to independent third parties upon the payment of a given fee. The patent pool option has already been recommended as a mechanism countries seeking access to affordable medicines might want to explore. Patent pools can serve a useful purpose in facilitating the use of voluntary licensing at cheaper rates. For Africa, the various existing regional economic communities can obtain voluntary licences from patent pools to meet their public health needs. There currently exist the following 8 regional economic communities in Africa:
- the Community of Sahel-Saharan States (CEN-SAD);
- the Common Market for Eastern and Southern Africa (COMESA);
- the East African Community (EAC);
- the Economic Community of Central African States (ECCAS);
- the Economic Community Of West African States (ECOWAS);
- the Intergovernmental Authority on Development (IGAD) in Eastern Africa;
- the Southern African Development Community (SADC); and
- the Union du Maghreb Arabe (UMA)
These communities can obtain licences from patent pools to supply drugs to member countries within each community at affordable rate. It has already been suggested in another article that the amalgamation of the existing regional economic communities in Africa into a single community can go a long way in facilitating the use of compulsory licences and the development of a strong pharmaceutical manufacturing capacity in the continent. Such an economic alliance can also go a long way in giving African nations leverage in negotiating the terms of voluntary licences, especially from patent pools, whilst facilitating the bulk procurement of essential medicines for the continent.
The United Nations’ supported Medicines Patent Pool (MPP) is a good example of a patent pool that holds great prospects for Africa and the continent can benefit immensely from the licensing schemes administered by the MPP. The Medicines Patent Pool signed its first licence agreement with a pharmaceutical patent holder, Gilead Sciences, in July 2011. The licence covers active pharmaceutical ingredients (APIs) and product licences for Gilead Sciences antiviral agents including; tenofovir (TDF), emtricitabine (FTC), cobicistat (COBI), elvitegravir (EVG) and the Quad [a combination of TDF, FTC, COBI, and EVG]. Not less than six sub-licences have already been granted pursuant to the agreement. In August 2013, another agreement was signed with F. Hoffmann-La Roche for the sale of Valganciclovir, an antidote for HIV related cytomegalovirus infections, at considerably discounted rates in poor countries and the licensing of the right to manufacture generic versions of the drug. In December 2013, the MPP signed an agreement with a pharmaceutical company, Bristol-Myers Squibb to increase access to a major HIV drug, atazanavir, in up to 110 developing countries through a technology transfer package that will facilitate the production of the drug. More recently on 1 April 2014, the MPP and ViiV Healthcare signed two licensing agreements to improve access to dolutegravir (DTG), a new antiretroviral for both adult and paediatric care.
Although the MPP only covers patented anti-retroviral drugs, the licensing schemes available in the MPP can be highly beneficial to Africa and a collaborative use of the scheme by the existing African economic communities is highly recommended. Whilst patent pools may not necessarily enhance the use of compulsory licences, they can substantially reduce the costs of voluntary licensing thereby reducing the need for compulsory licences and the financial burden involved can be considerably reduced if African regional economic communities could jointly apply for licences on behalf of their member countries. Patent pools initiatives can also be developed to cover other tropical diseases affecting people in Africa. Thus, although the development of a long term local pharmaceutical manufacturing plan in Africa is a desideratum, African countries can still address immediate and pressing public health needs by having a collaborative framework for making maximum use of the current initiatives for facilitating access to medicines in developing countries.
*Dr. Olasupo Owoeye (email@example.com) is currently completing his doctoral research in international intellectual property law at the Faculty of Law, University of Tasmania, Australia. He is admitted as a barrister and solicitor in Nigeria, New Zealand and Australia