[Ip-health] MSF/DNP+ op ed: Towards a needs-based medical R&D system

[James ARKINSTALL]

Please contact communications@field.amsterdam.msf.org for any=0D
correspondence.=0D
James=0D
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http://www.thehindu.com/2007/11/10/stories/2007111055611300.htm=0D
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Towards a needs-based medical R&D system=0D
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Loon Gangte & Leena Menghaney=0D
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India has an unprecedented opportunity at the international level to=0D
influence a change in the global rules of medical R&D to prioritise=0D
people's health over profit.=0D
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Amit (name changed), our friend and colleague, died this year. His passing,=
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heartbreaking as it was, had been all the more distressing because he did=
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not receive the treatment that he needed to save his life.=0D
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Amit was HIV-positive and also infected with tuberculosis (TB). In India,=
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as in the rest of the developing world, doctors are struggling to treat and=
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diagnose new strains of drug resistant TB. The medical and clinical=0D
response is falling hopelessly short of the needs. Doctors and patients are=
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helpless because effective medicines and diagnostic tools are just not=0D
available.=0D
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There is a simple reason for this: the way the development of new=0D
medicines, diagnostics and vaccines is funded at present.=0D
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Today, the medical research and development (R&D) system relies heavily on=
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pharmaceutical companies recovering their investments through maximising=0D
profits, by charging high prices, and protecting them through patent=0D
monopolies. As a result, essential drugs are priced out of the reach of=0D
people and governments.=0D
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Of equal concern is that diseases such as TB or paediatric HIV that affect=
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people in developing countries do not get adequate attention and investment=
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into research as compared to diseases that have more lucrative markets. The=
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statistics speak volumes: only one per cent of the drugs reaching the=0D
market between 1975 and 2006 were developed for neglected diseases like=0D
kala-azar, malaria and TB; diseases that affect us. It has been evident for=
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some time now that the intellectual property system does not encourage R&D=
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into diseases prevalent in developing countries, and rather focusses on=0D
drugs for those illnesses such as diabetes and heart disease, for which=0D
there is a large market in the developed world.=0D
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Moreover, medicines and diagnostics that have been developed in wealthy=0D
countries are often ill-suited for use in resource poor settings in=0D
developing countries. Treating and diagnosing HIV and AIDS in children is a=
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clear example of this. As developed countries have been successful in=0D
preventing parent-to-child transmissions of HIV, there was no need felt to=
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develop paediatric formulations and diagnostic tests for children living=0D
with HIV. This has meant that medical practitioners and caregivers of these=
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children in India and the rest of the developing world have little option=
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but to split adult tablets.=0D
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This practice often results in children getting the wrong dosage of a=0D
medicine that is in any case too bitter and difficult to swallow.=0D
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India now has an unprecedented opportunity at the international level to=0D
influence a change in the global rules of medical R&D to prioritise=0D
people's health over profit. Representatives of governments from all over=
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the world including the Indian delegation from the Ministry of Health and=
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Family Welfare have gathered at the United Nations in Geneva to discuss,=0D
negotiate and reach an agreement to stimulate R&D for neglected diseases.=
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Facilitating this process is a body set up by the World Health=0D
Organisation. Its long name notwithstanding, the 'Intergovernmental Working=
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Group on Public Health, Innovation and Intellectual Property' is=0D
path-breaking as it is the first political body to consider the problems of=
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pricing barriers and the failure of current market driven incentives for=0D
R&D on pharmaceuticals, at the same time.=0D
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The discussions in Geneva offer an extraordinary chance for developing=0D
countries to set a global agenda for a needs-based R&D agenda that=0D
addresses both medical innovation and access to medicines in a manner that=
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does not pit one interest against the other. In other words, countries are=
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now looking at ways to ensure that medical R&D is tailored to the needs of=
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their citizens in a way that also makes the results of the R&D available=0D
and accessible for them. The international community also has a chance to=
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debate key issues such as funding, sharing technology and addressing=0D
intellectual property barriers for conducting R&D on neglected diseases.=0D
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The intergovernmental working group's mandate is one of the first steps at=
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the international level towards de-linking the cost of R&D from the price=
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of the medicines, diagnostics and vaccines.=0D
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The stakes are high for people in India. It is hoped that the Indian=0D
government will make the best use of this opportunity to prioritise and=0D
contribute resources, knowledge and technology to build an alternative=0D
incentive system for pharmaceutical R&D, thus fulfilling the vast medical=
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needs of India's growing population.=0D
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For the first time, developing and least developed countries through their=
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official submissions and negotiations have the potential to own the mandate=
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to set research priorities and design financing mechanisms that reward R&D=
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=E2=80=94 but do not rely on charging high prices.=0D
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The awakening of the global community to our health needs has come too late=
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for Amit. That the lives of those of us living with HIV, TB and hepatitis=
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and a myriad of other illnesses depend on this process is surely not lost=
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on our Government. It is important that governments like those of Brazil,=
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African countries, Thailand and India join hands in Geneva, as they have=0D
done so often in the past, to protect public health. For medicines to be=0D
judged and invested in based on their ability to prevent millions of=0D
avoidable deaths rather than the quantum of price they can command is an=0D
idea whose time has come and it is with great hope that we look forward to=
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the success of this process.=0D
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(Loon Gangte is President, Delhi Network of Positive People & Leena=0D
Menghaney is campaigner, Medecins Sans Frontieres, Campaign for Access to=
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Essential Medicines.)