Research and development for drugs for neglected diseases

The past thirty years have witnessed unprecedented improvements in global health, but the benefits of these advances in medicine have not been distributed evenly. For people suffering from diseases for which treatment options are inadequate, or do not exist, the future looks bleak.

They continue to receive archaic treatment because little is being done to find new cures to treat diseases such as malaria, tuberculosis, leishmaniasis, sleeping sickness and Chagas disease, which affect populations with little purchasing power and no advocacy groups. WHO has so far failed to play a leadership role and minimises the R&D crisis by almost exclusively focusing on existing tools.

By acknowledging and actively communicating on the extent of the crisis, WHO could mobilise additional activity in both the private and public sectors. WHO must help set the research agenda for diseases that have fallen off the radar screen of private industry and received little attention from public research institutes. Instead of helping countries learn to live with an ever shrinking pool of effective drugs for neglected diseases, WHO should make R&D a part of its overall strategy to increase access to essential medicines.

Yet, the issue of R&D for drugs for neglected diseases is absent from this year’s World Health Assembly. Radical new approaches are needed to kick-start R&D, including new funding mechanisms in areas that are now totally abandoned. At current funding rates, both TDR and newer partnerships for R&D are condemned to failure.

The Doha Declaration on TRIPS and public health 2001 was marked by progress in the discussions on intellectual property barriers to access to medicines at the World Trade Organisation (WTO) and clear primacy given to public health over intellectual property. The Doha declaration on TRIPS and Public Health clearly laid out the measures countries can take when prices of existing patented drugs are too high for their people to afford.

However, certain outstanding issues urgently need addressing. In particular, action must be taken to overcome the practical hurdle of Article 31.f of the TRIPS Agreement, which requires compulsory licenses to be used "predominantly for the supply of the domestic market".

This clause prevents countries that are not able to produce medicines from making effective use of compulsory licenses. It is time for WHO to take a leadership role in the trade and health area. Passive observation is not sufficient and betrays the mandate given by previous Health Assemblies for the WHO to become actively engaged in trade and health.

The issue of access to medicines should not be left to experts at the WTO and WIPO who do not have health as a central part of their mandate. In June, when the TRIPS Council discusses the export issue related to compulsory licensing, WHO should go on record with recommendations supporting the developing countries’ call for exceptions to allow export of essential medicines produced under compulsory licensing. WHO should also continue monitoring the effects of TRIPS on access to medicines, and provide practical technical assistance to countries implementing the Doha declaration.

Malaria treatment

On Africa Malaria Day this year, boldly challenging the status quo, WHO urged countries faced with growing resistance to classical antimalarials to switch to more effective artemisinin-based combination therapy (ACT).

This treatment has been used successfully in China for decades and in South East Asia for more than ten years. A key barrier to switching to ACT is that it is ten to twenty times more expensive than currently used antimalarials. Some developing countries have indicated that they will switch to ACT only if promised long-term international help to subsidise the increased cost.

So far, only Zanzibar has received international funding to introduce ACT on a widespread basis (through the Global Fund). At least ten African countries need urgent financial support to stem mounting resistance and associated mortality. Endemic countries will need to increase their funding for malaria, but without international help it will be impossible to meet the ambitious millennium goals of halving malaria mortality in Africa by 2010.

It is not acceptable that an African child dies of malaria every thirty seconds when safe and effective treatment is available. Recommendations regarding choice of treatment are a very positive first step, but WHO/RBM must now lay out clear plans for rapid implementation of ACT in countries with high levels of resistance, including changes of national protocols. This can be accomplished through technical support and advocacy for more funding.

In-country support so far has at best been patchy and at worst detrimental. WHO/RBM can also assist countries by validating additional and less expensive sources of artemisinin derivatives (as is being done for antiretroviral drugs).

Essential Medicines List (EML)

Last month, the Essential Medicines Committee added ten antiretroviral drugs to the core essential medicines list (EML). WHO also published specific guidelines for HIV/AIDS treatment, practical monitoring standards and simplified regimen recommendations.

Together, these tools should help developing country governments to implement antiretroviral treatment programmes. The process for adding or deleting medicines to/from the list was also revised, making it faster, more transparent, and based on systematic reviews of scientific evidence.

MSF particularly welcomes the fact that expensive drugs will no longer be excluded from the list solely because of price. But the fact remains that prices of medicines, in particular antiretrovirals, are still too high.

WHO should use its technical expertise to help countries enact measures to bring down prices both by stimulating competition (through compulsory licenses and parallel imports) and working toward unrestricted systematic differential pricing policies..

Prequalification of generic manufacturers

In March this year, the World Health Organization released its first list of prequalified AIDS drugs, including patented drugs and generic versions.

The list included 41 different drug formulations, of which 11 were antiretroviral drugs and five were drugs for opportunistic infections of HIV/AIDS.

This list will be of great assistance to countries seeking to gain access to affordable HIV/AIDS drugs without compromising on quality. It will also facilitate procurement that will take place as a result of the activities of the Global Fund for TB, malaria and HIV/AIDS.

MSF urges WHO, as part of its standard-setting role, to expand pre-qualification work to drugs for malaria, tuberculosis and other major infectious diseases, and urges Member States to increase financial support for these efforts.