The World Health Organization (WHO) [1] said it would look at whether the international drug patent system prevents developing countries from obtaining needed medicines, vaccines and diagnostic tests [2]. The 192 WHO members agreed at an annual meeting in Geneva to launch an intergovernmental group to look for gaps in medical research and development, and draw up a global strategy to ensure the health needs of poor people are met. The report, commissioned by the WHO in 2003, did not call for a weakening of patent rights but urged big companies to reduce the price of medicines sold to developing countries and to avoid filing for patent protection there.
The report of the Commission on Intellectual Property Rights, Innovation and Public Health [3] contends that the current system works well in developed nations but not in developing countries. While pharmaceutical industry insists that the current system is crucial for encouraging and financing the invention of new drugs, others claim it fails because people in the developing world often cannot afford to pay for high-priced new drugs, and because they sometimes need treatments that offer little profit for drug companies.
Governments should therefore develop and finance an alternate system for drug development and distribution in the developing world, the report concluded. More controversially, it suggested that drug companies should not seek patents in poor countries. An example are AIDS drugs costing $10,000 a year, too expensive for residents of African nations afflicted with the disease.
Another example is the FDA recommended approval of the first vaccine to prevent cervical cancer, the leading cause of death from cancer among women in poor countries, with 80 percent of the world’s cases. In the developed world, routine tests usually detect the disease in its treatable, precancerous stages. At $500 for the series of three shots, it is unaffordable in poor countries.
In the past, drug companies offered deals with poorer countries for discounted rates and foundations and international projects purchase and distribute costly drugs in pilot projects but these fall far short of meeting the global need. Drug companies won’t develop drugs unless they can charge for the drugs. Big surprise.
The WHO report generally concludes what we already know. That is, “Governments have the major responsibility to mobilize funds and promote new financing and incentive mechanisms to meet our shared goals.” It’s easy for governments, rich and poor, to shirk their responsibility of providing healthcare to teir people by blaming drug companies.
Admnittedly, healthcare is not the same as wanting to buy some patented, high-tech toy and not wanting to pay the MSRP but the burden for caring for the sick falls on all of us.
What does the report say?
- Intellectual property rights are a general incentive provided by governments to promote innovation in all fields. In respect of public health, they are embedded in a set of other incentives which influence the pattern of innovation. They need to be looked at as part of a bigger picture.
- In particular, because the market demand for diagnostics, vaccines and medicines needed to address health problems mainly affecting developing countries is small and uncertain, the incentive effect of intellectual property rights may be limited or non-existent.
- Because intellectual property rights may not be an effective incentive in this area, there is a need for other incentives and financial mechanisms to be put in place and for collaborative efforts between different stakeholders.
- Without access to the products of innovation, there can be no public health benefits. Defining the conditions by which products can be accessed is therefore an important aspect of the report.
- There has been significant progress in recent years, in particular initiatives taken by different stakeholders to promote innovation in health-care products e.g. increased funding by foundations and the formation of public-private partnerships for product development.
- This momentum for change is welcome but is insufficient.
- More needs to be done. There are unsettled and debated issues in intellectual property for example the effectiveness of the recent amendment to TRIPS in increasing access to medicines in countries without manufacturing capacity, the impact of data exclusivity laws and the impact of intellectual property provisions in bilateral trade agreements.
- And there is a need to ensure enhanced financing on a sustainable basis of innovation and access and promote synergy between the different partners.
- Ultimately it is a responsibility that governments must accept if these objectives are to be achieved.
- It is appropriate that WHO should now take the lead in promoting a more sustainable and better-funded effort and addressing unresolved issues.
- WHO should accordingly develop a Global Plan of Action to secure enhanced and sustainable funding for developing and making accessible products to address diseases that disproportionately affect developing countries.
The World Health Assembly will decide which steps WHO should then take to follow-up the implications of the report.
Click here to get the entire Report: Public health, innovation and intellectual property rights [4].