Since 2005, Indian generic drug producers have to implement the WTO-Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and acknowledge patent monopolies on new drugs. Therefore, they are no longer allowed to produce newly designed drugs. Many developing countries, however, rely on generic medicine from India for the treatment of their AIDS patients. Suffering from severe side effects and drug resistance, many patients need the newly designed drugs, yet national health systems of poor countries cannot afford these.
The example of South Africa illustrates the problem: Most patients receive the standard first-line drug combination based on Stavudine, an off-patent drug with vicious side effects. In the developed world it is hardly used any more. In South Africa, every fifth patient (on Stavudine) develops serious, at times life-threatening, adverse reactions.
Tenofovir (TDF) is the best substitute. It is safe and only administered once a day. In rich countries, it is a standard component of ART regimens. In South Africa and other developing countries, few patients get TDF. Due to patent law, Gilead Sciences is via its partner Aspen Pharmacare the only provider of TDF. For lack of generic competition, the drug is too expensive to be routinely used in national treatment programmes. The Stavudine-based standard triple therapy costs $ 77 per patient yearly in South Africa. TDF alone would cost exactly three times as much – not including the complementary drugs needed. Doctors are thus forced to prescribe medicine of minor value. 14 years after the end of apartheid, some South Africans are once more being treated as second-class citizens.
To solve this problem, the parameters of the global pharmaceutical market would need to be changed. And for the first time in years there is hope: Several trends are unfolding and they could change the access to AIDS drugs and pharmaceuticals in South Africa and other affected countries.
First, consensus has grown that patent monopolies have been granted in an inflationary way. Originally designed as incentives to promote the generation of new knowledge, patents are increasingly abused to monopolise existing knowledge. Recently the US Patent Office revoked four key patents on TDF, as the substance lacked novelty when the applications were filed. Should Indian authorities come to the same conclusion, the doors would be opened for generic production of TDF. Moreover, people are waking up to the reality that multinational corporations are using inventions that were made possible thanks to public subsidies. However, public interests are hardly considered, let alone those of the patients in developing countries. In the USA, where most AIDS drugs are developed, medical colleges and research institutions recently issued a joint call for ensuring that the developing world has access to university-driven innovations. Since November 2008, the German BUKO Pharma Campaign announced collaboration on patent rights with the Medical Center Berlin (Charité) and the University of Bremen. The goal is to analyse the use of pharmaceutical knowledge generated in universities by private companies and come up with licensing agreements to promote access in the developing world. Most of the research on TDF was done by universities in the Czech Republic and Belgium.
Finally, and most fundamentally, the World Health Organisation (WHO) recently adopted a global strategy and plan of action on public health, innovation and intellectual property. It clearly states the need of new mechanisms to incentivise research and development for pharmaceutical pro-ducts with a particular focus on patients in developing countries – beyond the existing patent system.
These ideas sound revolutionary. The WHO is finally taking a lead by acknowledging that access to drugs is a core public responsibility. It is now up to civil society, aca-demia, industry and government to support these processes. The thrust of improving access to medicines in the developing world must never be lost out of focus.