english.prescrire.org > Positions > Regulatory issues > WHO is mandated at last to do essential biomedical research

Theme: Regulatory issues

Drugs regulatory bodies ought to be the public’s principal defence against medicines that are useless, unproven or downright dangerous. Yet regulators increasingly depend upon financing from the pharmaceutical industry itself.  

WHO is mandated at last to do essential biomedical research

A system in which biomedical research is funded by sales of patented products cannot be expected to meet all the healthcare requirements of people living in poor countries. World Health Organization member states finally adopted a resolution giving WHO a central role in research on diseases that "disproportionately affect developing countries".

WHO is mandated to do essential biomedical research
 
In July 2008, Roche, a company that has been active in the antiretroviral drug market, announced that it was planning to suspend its research activities in the field of HIV/AIDS because it was unlikely to discover any worthwhile new drugs in the near future (1).

This is probably a good short-term management decision for a private company, but patients were shocked. This decision underscores the dangers of delegating too much medical research to the private sector.

A failing system A system in which biomedical research is funded by sales of patented products cannot be expected to meet all the healthcare requirements of people living in poor countries (2,3). Important research is not carried out because poor patients do not make a market, and new drugs are sold at prices that many patients cannot afford (2).

World Health Organization (WHO) member states finally reacted to this situation at the WHO meeting held in May 2008 (2): they adopted a resolution giving WHO a central role in research on diseases that “disproportionately affect developing countries”, and not just on tropical diseases. The main aims are to identify healthcare needs and priorities, to strengthen research capabilities in both hemispheres, to improve the distribution and the accessibility of innovations, and to generate supplementary funding (2).

An unprecedented move The resolution is remarkable for the fact that it embraces the idea of new research incentives unrelated to market forces, such as easier access to databases on patents and drug substances, patent pooling, exploration of new funding mechanisms such as awards for discoverers of new substances, and “an essential health and biomedical R&D treaty” (2).

WHO seemed to drag its heels somewhat while preparing this resolution. But no matter: it now has a clear mandate that allows its most strongly motivated staff and member states to move forward.

Both North and South, new incentive mechanisms for biomedical research are needed.

©Prescrire 2009

Prescrire Int 2009; 18 (99): 35.

References:
1- “Roche to suspend HIV research, seeing no advances” Reuters 11 July 2008: 1 page.
2- Sixty-first World Health Assembly “Global strategy and plan of action on public health, innovation and intellectual property - WHA 61.21 24 May 2008” www.who.int accessed 5 August 2008: 55 pages.
3- Prescrire Editorial Staff “Research on neglected diseases almost at a standstill” Prescrire Int 2003; 12 (63): 32.