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