Do patents help stimulate research on medicines developing countries need? Are they a barrier to accessing medicines?
Nathan Ford, Access to Medicines Adviser, Mdecins Sans Frontires
Chris Strutt, Vice-President, External Relations, Worldwide and International, GlaxoSmithKline
Charles Clift, DFID
1. Introducing the speakers, Charles Clift remarked that in preparing the report of the Commission on Intellectual Property Rights, there was a suggestion that "intellectual property policy should not be developed by the people with the deepest pockets or the loudest voices". It would be interesting to hear the views of representatives from each of these constituencies - from business and NGOs respectively.
2. Nathan Ford explained that Médecins Sans Frontières sees first-hand the problem of access to drugs in many developing countries where it works. He then gave a graphic description of the problem of access to drugs in developing countries, discussed the ways in which more research on the diseases of poor countries might be engineered, and laid out a programme for improving access to existing drugs. He concluded with a discussion of new roles for both the public and the private sectors.
3. It was clear that developing countries were substantially disadvantaged by the lack of effective, affordable, and easy-to-use medicines. Many existing drugs were too expensive. There was increasing resistance to older medicines. Production of some effective medicines had been discontinued. And very few new drugs had been, or were being developed, to tackle the major diseases of the poorest countries. As just one example, nearly 1,400 new chemical entities had been marketed between 1975 and 1999. Only 16 of these had been relevant to tropical diseases and tuberculosis, yet these diseases account for over 11% of the global disease burden. This was a market failure, caused by the fact that drug development was largely targeted at profitable Western markets; but also a public policy failure because there was a social case for greater drug provision to help poor people - drug development should not be left exclusively up to the private sector. Intellectual property regimes were at the heart of both the problem and the remedial possibilities. There is an imbalance between rights and obligations within the TRIPS Agreement. The public sector gives massive incentives to industry through patent protection (and tax credits and the benefits of public research), but has no say over what is being innovated. This system almost entirely fails to meet the needs of the poor in the developing world.
4. With regard to the problem of access to existing drugs, it was again clear that the poor were not being reached. For example, it had been estimated that of the six million people in developing countries who need anti-retroviral therapy right now, only 300,000 were being reached. Four approaches were discussed:: (a) differential pricing to lower the price of drugs in developing countries; (b) legal protection of production under voluntary licensing agreements in developing countries; (c) global procurement and distribution systems; and (d) increased competitiveness in the pharmaceutical market. Increased competition is the only sustainable way to bring prices down, as shown by the fact that every time the price of generic antiretrovirals fell, brand prices followed. It also promotes local capacity-building in affected countries. The Doha Declaration was key to affirming countries rights to produce generic medicines, but was being undermined by the current disputes around paragraph 6 (developing countries' right to export generics to other developing countries in need. This should not be restricted to particular diseases, or to epidemics; rather, developing countries should be allowed to define their own health problems.
5. Nathan Ford concluded that ensuring access to medicines was a public responsibility the commercial sector should help ensure the development and availability of new health tools; but that public policies were needed to safeguard access.
6. Chris Strutt made a presentation from the perspective of the pharmaceutical industry. He addressed two key questions: (a) the role of intellectual property regimes in the development of new drugs and vaccines for the developing world; and (b) whether intellectual property protection was a barrier to access to medicines.
7. On the first question, he argued strongly that intellectual property protection was necessary to underpin research: "No patents, no cures". Of course, R&D was a necessary but not sufficient condition: new medicines would not be developed by the private sector unless there were both intellectual property protection and a market. Solving one without the other would not do.
8. Chris Strutt argued that the public sector would not be able to deliver a flow of new medicines because it lacked the expertise. Given the market constraint, it was also unlikely that the private sector would be able to deliver what was needed. However, there was real potential in public-private partnerships. For example, the public sector could underwrite research and ensure that a sufficient attractive market was created to provide drugs for poor people. A number of examples could be cited, including the global alliance of vaccination and immunisation, and the medicines for malaria venture.
9. On the second question, whether intellectual property protection was a barrier to access, Chris Strutt argued that most essential drugs were not patented. For example, 95% of 308 drugs on the WHO 'Essential Medicines' list were not patented. Similarly, most anti-retrovirals were not patented. This did not mean (and to emphasise a point made earlier) that drugs would necessarily reach people who needed them: three million TB and malaria deaths were registered each year, even though relevant drugs were patented. The point was, however, that intellectual property protection did not act as a barrier.
10. The evidence was that the pharmaceutical industry was now playing its part in public-private partnerships, and in helping to improve access by the poor. GlaxoSmithKline was involved in community partnerships, had invested in not-for-profit pricing, and had also set up voluntary licensing agreements. Chris Strutt hoped these innovations would be deepened over time.
11. A number of points were raised in discussion, several relating back to the argument of the Commission on Intellectual Property Rights which had helped to shape the debate. Some participants thought the report was a good and balanced presentation of the issues. On the other hand, it was also argued that the report was unbalanced and did not give sufficient importance to intellectual property protection.
12. On the question of public-private partnerships, there were many models on offer, some of which would be more beneficial than others. Ensuring access to the end product was vital. Important criteria for assessing PPPs were who would own the drug technology at the end of the process and who had benefited from the investment of resources. Some fears were expressed that PPP innovations of the kind described could distort health priorities in developing countries. It was suggested that alternative intellectual property arrangements could be explored for PPPs.
13. There was an extensive discussion about the TRIPS agreement. It was noted that there was some risk that the general principles established at Doha about the importance of poor country access to drugs would be rolled back under pressure from pharmaceutical interests and Western governments.
14. The demand side/market problem was discussed. Clearly, improved supply of appropriate drugs and the ability to pay for them had to go hand-in-hand. In another context, it would be important to talk about health insurance systems in developing countries.
15. A final point was made about the importance of seeing health as a human right. A new report was about to be published in the name of the UN Special Rapporteur on the human right to health.
This event discussed the problem of access to drugs in developing countries.