In June 2013, member states of the World Trade Organisation (WTO) agreed to extend the transition period for adherence to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) among least-developed countries (LDCs). What this meant was that LDCs need not comply with international rules of intellectual property rights (IPR) protection for pharmaceutical patents till up to July 1, 2021.
This decision has major implications for public health. Access to essential medicines has been a pressing concern for several decades. Countries such as India — and others in its geography of south Asia as well as the 10 co-members of the World Health Organisation South-East Asia Region (WHO SEAR) — need to use this opportunity to productively and imaginatively promote access to medical products such as medicines, vaccines and diagnostics.
To be fair, this is not a new issue. The period since the adoption of WTO’s Doha Declaration in 2001 has seen dramatic growth in the quantum and diversity of participants in international policy debates concerning innovation and access to medical technologies. Access to medical products in the context of intellectual property protection was initially examined within the WHO by the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), set up in 2003.
In April 2006, the CIPIH published its report. It contained a number of recommendations aimed at fostering innovation and improving access to medicines. In 2008, a World Health Assembly resolution referred to the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.
It aimed to promote new thinking on innovation and access to medicines, for needs-driven, essential health research and development, relevant to diseases that disproportionately affected developing countries.
It has been established that prices fall steeply as soon as drugs go off patent and when there are generics competitors. Logically, the price fall seems to be greater when more generics competitors enter the market. There is a need to use the policy space available with the extension in the TRIPS agreement and encourage price reductions by facilitating the entry of generics producers.
For India this places a dual challenge — as a user of medicines and a society committed to minimising health-access inequity and as an economy with a robust pharmaceutical industry, especially in the generics space.
For many developing countries, including some of India’s partners in the WHO’s Southeast Asia Region (SEAR), options are limited by the small size of their markets and lack of indigenous technological, productive and regulatory capacities. This lack of capacity to create a competitive environment needs to be addressed. The critical issue is that the economics of supply to an individual country with a limited market may be insufficient to attract potential generics suppliers. To allow, therefore, for economies of scale and a degree of competition, it is important that small markets engage together as much as is possible.
International institutions — such as the WHO or the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) — could be associated to assist SEAR countries in facilitating and financing group purchases from both branded and generics manufacturers to promote access to medical products.
This is also a time for such countries to consolidate new approaches to intellectual property management for public health. From the time that Indonesia focussed the attention of the global health community on sharing of viruses that led to the WHO Pandemic Influenza Preparedness (PIP) Framework, a new platform for benefit sharing has emerged. The Framework enables the sharing of benefits derived from such viruses and includes new methods of management of related intellectual property (IP) through developing Standard Material Transfer Agreements.
In turn, these provide for a range of options for biological material recipients, such as influenza vaccine manufacturers, to enter into benefit-sharing agreements.
This is for the first time that the use of genetic resources and associated right of prior informed consent, primarily under the domain of the Convention on Biological Diversity — and in keeping with the principles of the “Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation”, which of course awaits ratification — has been applied to health products.
The success of the PIP framework has opened the door to exploring future collaborations in access to medicines, both traditional and modern. India has a wide variety of genetic resources and we need to explore strategies to optimise the lessons of PIP in the context of medical products. It is known that traditional medicine provides leads for the development of new treatments. Many modern medicines were originally based on herbal products.
For example, oseltamivir, used to treat various influenza infections, is based on shikimic acid, which is isolated from Chinese star anise, a cooking spice used in traditional Chinese medicine. Current malaria treatments contain synthetic derivatives of artemisinin, which is derived from a plant, sweet wormwood or Artemisia annua. This is an ancient Chinese medicine that was in fact used to treat malaria-stricken soldiers during the Vietnam War and was developed, through an international partnership, into a widely-used pharmaceutical product for malaria treatment.
These are noteworthy precedents. We have to learn from them, and use the intellectual-property window over the next eight years to address the issue of access to medicines for the longer term.
(The writer is a public health specialist and currently Advisor, International Health, at the Ministry of Health and Family Welfare)
