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The push and pull of third world drugs

Diseases can be classified as Type I (those that are incident in both rich and poor countries); Type II (those that are incident in both rich and poor countries but with a substantial proportion in poor countries, for example tuberculosis [and malaria]) and Type III (those that are overwhelmingly or exclusively incident in poor countries, for example, African trypanosomiasis [and leishmaniasis and Chagas' diseases]). Type II diseases are often termed as neglected diseases and Type III as very neglected diseases.

-– Public Health Innovation and Intellectual Property Rights, Report of the Commission on Intellectual property Rights, Innovation and Public Health, World Health Organization, Geneva. CIPIH, 2006, p 25.

It is these demarcation lines drawn between the three “types” of diseases that has, in many ways, led to disease in what we used to call the Third World to be all-but ignored except in terms of media lamentation. One might suggest that the phrase “developing world” paints too rosy politically correct a picture despite serious poverty, malnutrition, and disease. Indeed, it’s almost as if labelling diseases in this way resurrects the old First, Second, and Third World ethos, although some observers point out that people in the pharma industry don’t actually use the terms Type I, II, and III.

Despite the introduction of stronger patent protection in India in the wake of the World Trade Organization’s TRIPS (Trade Related Aspect of Intellectual Property Rights) agreement, the pharma multinationals are not addressing Type III diseases. Even so-called compulsory licensing (a euphemism that gives “authorisation to a government or company to make and sell a pharmaceutical drug without the permission of the patent holder”, has not seen disease in India, China, Brazil and elsewhere challenged in any serious way.

Writing in IJTG, Sudip Chaudhuri of the Indian Institute of Management Calcutta, in Kolkata, West Bengal, India, suggests that a policy shift that more openly encourages partnerships between public and private sector is now needed, and the same approach might be adopted in Brazil and China, too.

In general, multinational corporations do not find diseases in poor nations attractive enough for research and development (R&D) investment. The markets are enormous, but there is not enough hard cash circulating to provide a big enough return on investment to keep shareholders happy. Some companies, AstraZeneca and GlaxoSmithKline, among them, have realised that drugs must be developed for neglected diseases regardless, while there has definitely been a perceptible increase in R&D driven by not-for-profit organisations and foundations such as the Drugs for Neglected Diseases Initiative, Medicines for Malaria Venture (MMV). Regarding India in particular, GSK’s donation program for lymphatic filariasis is having a great impact. And also in India, Merck announced a new partnership (The MSD Wellcome Trust Hilleman Laboratories) that is not only based in India, but will address developing world needs from there.

Nevertheless, it’s a never-ending battle and more needs to be done. The G-FINDER survey, funded by the Bill and Melinda Gates Foundation, highlights how much various people and organisations are investing in neglected tropical diseases.

The motives for pharmaceutical R&D can be twofold: Push incentives include public support (underpinned by direct public spending on R&D grants or tax credits). According to Chaudhuri, an National Institute for Health Care Management (NIHCM) foundation study revealed that 48 of the 50 of the best-selling drugs approved by the US Food & Drug Administration (FDA) during the 1990s were developed with some government funding during the product cycle. The major pull incentive is the likelihood of profit guaranteed by the patent system.

Unfortunately, in India, and presumably the other Type III countries, much of the pull incentive is irrelevant. “Pull mechanisms offer a better return for the output of R&D,” explains Chaudhuri, “It presupposes that the companies have the capacity and capability to undertake R&D. If they do not have this, if they cannot generate an output in the first place, obviously the question of benefiting from the higher value of the output promised does not arise.”

“In the developing countries, even if drugs were to be developed for neglected diseases, the return despite market exclusivity would be very low because of the low purchasing power and virtual absence of any health insurance,” he adds. Without an incentive to innovate companies in these regions of the world will either ignore Type III diseases or else produce illicit generic versions of patented drugs.

But, is it possible through government intervention and public sector collaboration to develop the infrastructure and funding for new drug R&D? In promoting new drugs for neglected diseases, governments of developing nations could provide both the push and the pull.

Efforts towards this goal have already been made in recent years, explains Chaudhuri. Indeed, all the major national laboratories in the drugs field (including CDRI, IICT, NCL, CCMB and IICB), academic institutes (including Indian Institute of Science, Bangalore, All India Institute of Medical Sciences, New Delhi, National Institute of Pharmaceutical Education and Research, Chandigarh) and about 50 pharma companies (Dr. Reddys, Ranbaxy, Dabur, Glenmark, Lupin, Cadila Pharmaceuticals and Alembic) are working towards this goal.

Moreover, the Open Source Drug Discovery (OSDD) initiative led by the Council of Scientific and Industrial Research (CSIR) is pushing R&D for new drugs for neglected tropical diseases such as malaria, tuberculosis and leishmaniasis by providing a collaborative platform for scientists, doctors, software professionals, students and others to facilitate drug discovery. Medicines themselves are only part of the problem and various pharma company initiatives are in place: http://www.globalhealthprogress.org

Unfortunately, regulatory approval and the obligatory clinical trials carried out in developed countries are a current stumbling block for all efforts. Chaudhuri and colleagues are now campaigning to expand the public-provate partnerships to include organisations from other innovative developing countries such as Brazil and China. They are also looking to make it possible for clinical trials for drugs against Type III diseases to be considered valid in India, Brazil, and China, where they are much cheaper to run than in the developed world.

At the time of writing, The Global Network for Neglected Tropical Diseases, an initiative of the Sabin Vaccine Institute, was set to host a briefing in conjunction with the Congressional Malaria and Neglected Tropical Diseases (NTD) Caucus on current and future efforts to control and eliminate NTDs. Merck’s Ken Gustavsen told me that, “As with any problem, more can be done – pushes and pulls – to address this. And with continued attention by all partners (companies, NGOs, governments, etc.), progress will continue to be made.”

If we are to have demarcation lines on types of diseases, then surely the same lines should be applied to testing the drugs to treat them. It’s not a matter of push and pull, but give and take for pharmaceutical R&D.

Research Blogging Icon Sudip Chaudhuri (2010). R&D for development of new drugs for neglected diseases in India Int. J. Technology and Globalisation, 5 (1/2), 61-75

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