TWN Info Service on Health Issues No. 3

MSF criticises WHO's weakness in drug prequalification project

By Kanaga Raja
Geneva, 18 May 2005

The lack of commitment from the leadership of the World Health Organization (WHO) with respect to its drug prequalification project is crippling the effort to improve access to affordable versions of needed drugs, Medecins Sans Frontieres (MSF) said Tuesday.

The international NGO raised these concerns in a letter addressed to delegates attending the 58th World Health Assembly (WHA) here from 16-25 May.

At a press briefing, an MSF official said that the WHO's prequalification project was important in facilitating greater access to cheaper generic versions of medicines, as those generic drugs that have been included in the WHO's list of prequalified drugs would enjoy the confidence of governments and others responsible for procuring these medicines. MSF was thus concerned that the WHO strengthen the project.

The WHO prequalification project, established in 2001, provides a reliable international reference to countries in procuring essential medicines, said the MSF statement. The project assesses product dossiers containing relevant data on safety, quality and efficacy; bio-equivalence studies where appropriate; and manufacturing sites' compliance with WHO Good Manufacturing Practice.

So far, a total of 98 pharmaceutical products have been prequalified by WHO, of which 88 are for HIV/AIDS, eight for tuberculosis and two for malaria. Fifty-three of these products are generics.

MSF has said that in addition to enabling wider access to medicines, the project has contributed to improving standards of generic producers and helped enhance countries' capacity to produce quality medicines.

The need for a WHO prequalification system has been widely recognized by care-givers and developing country governments. The 2004 World Health Assembly, in its resolution WHA 57.14, has asked the WHO Director-General to "take measures to improve access of developing countries to pharmaceutical and diagnostic products to diagnose, treat and manage HIV/AIDS, including by strengthening WHO's prequalification project."

However, MSF expressed dismay that, despite the mandate given to the WHO leadership by the WHA, the prequalification project, with only 3.5 permanent staff supported by a limited number of external evaluators, remains considerably understaffed and under-resourced. In addition, there has been no increase in the project's financial resources since 2004.

MSF was thus of the view that the prequalification project today suffers from the same lack of support from WHO leadership as it did a year ago.

The NGO cited the April decision by the Global Fund (the single largest aid funder of medicines for AIDS, tuberculosis and malaria) to only fund medicines approved either by the WHO prequalification project or by "a stringent drug regulatory authority", saying that this has brought the urgent need to expand the project into even sharper focus.

Continuing to assist countries in the procurement of quality medicines for AIDS, tuberculosis and malaria is becoming "a mission impossible" for the project's current staff, MSF said, adding, for example, that of the 31 tuberculosis drugs listed on the WHO Essential Medicines List, 26 do not have even a single source prequalified, including all second-line tuberculosis drugs.

According to MSF pharmacist Fernando Pascual, for malaria, there are two drugs on the List, a single molecule and a fixed dose combination. Many countries have been using the fixed dose combination on the recommendation of the WHO but the only fixed dose combination that has been prequalified is suffering from a shortage.

Thus, what these countries do is to go back to using the old protocols such as chloroquine where there is resistance to the drug in several countries. This, Pascual said, is an example of the effects of having a short list of drugs that are prequalified. There is an acute shortage of malaria drugs, he added. Of the 60 million doses needed, only 8 million have been produced so far.

MSF said that if the WHO Director-General does not increase the capacity of this vital programme as requested by the WHA, the project's original objectives will be reversed, and risks becoming a barrier to, rather than a tool for, expanding access to medicines.

Speaking to the media Tuesday, Dr Rowan Gilles, president of MSF's International Council, said that the prequalification programme is the gateway to more affordable medications for MSF's patients and others worldwide, especially those suffering from malaria, HIV/AIDS and tuberculosis.

MSF currently treats 25,000-27,000 AIDS patients with anti-retrovirals and 70% of these patients are on fixed dose combinations that have been prequalified by the WHO. Without this process, it would be very difficult to have this many patients on treatment, he said.

The problem, he added, is that while the current prequalification project is good, it is very small and does not seem to have political support from the WHO leadership. If it stays as it is, it will at best remain a small part of what is required, and at worst, it may become a bottleneck for access to treatment for people throughout the world.

Gilles said that MSF had written a number of letters to the WHO leadership about this, but had received no reply. It thus decided to come out with a letter addressed to the delegates of the 58th World Health Assembly to highlight the problem. Gilles added that MSF would like to see strong political commitment from the WHO leadership to support the prequalification project.

According to MSF, only 750,000 or roughly 10% of the nearly six million people in need of anti-retroviral treatment in developing countries have access to it. Most of the anti-retroviral medicines currently available at affordable prices - and 70% of those used in MSF's own AIDS projects in developing countries - come from India. Half of the people currently receiving anti-retrovirals in the developing world rely on Indian generics. India has been able to produce affordable generic versions of these drugs because, until now, the country did not have product patents on medicines.

MSF said that from 2005 onwards, all new drugs may be subject to at least 20 years of patent protection everywhere except in the LDCs. While most first-line anti-retrovirals, in particular, user-friendly fixed dose combinations, are available from generic sources today, this will likely not be the case for any newer medicines.

Ellen T'Hoen, MSF Director of Policy Advocacy and Research, pointed to three positive elements in the scaling up of treatment for people living with HIV/AIDS. Firstly, the price of first-line medications have come down to about $200-300 per patient per year. Secondly, access to more affordable generic versions of these medicines have been enabled through the WHO's prequalification project, as the project had given confidence to governments and others responsible for procuring these medicines. Thirdly, there has been increased financing to procure these generic medications.

However, things have also gone in the opposite direction, in the area of WTO patent law implementation, which will have an enormous effect on the availability of medicines in the future.

She noted that this year, India, "the last bastion of generic production capacity", had amended its patent act in order to be in compliance with the TRIPS agreement. "Over time, we will see the consequences of that."

The amended Indian Patent Act, which T'Hoen said "may lead to access problems in the long term unless other measures are taken", has one immediate remedy in place in that the act says that if an Indian company is already producing the generic version of a drug and has made considerable investment on it even when a patent for that drug is granted, the company can continue to produce that drug and only needs to pay a reasonable royalty to the patent holder. T'Hoen thought that this could provide a model to deal with the problems in the long-run.

T'Hoen cited the example of Brazil as a preview of what could happen if there is limited or no access to multiple sources of medicines. She said that Brazil at the moment is struggling with its AIDS programme. Four patented anti-retrovirals (lopinavir/ritonavir, tenofovir, efavirenz and nelfinavir) are now taking up 70% of the total national AIDS budget.

There has been a 12-fold increase in price of treatment when patients in MSF AIDS programmes need to switch from first-line anti-retroviral treatment to newer second-line treatment.

T'Hoen was of the view that it was time for Brazil to issue compulsory licenses, as for years now, Brazil has been in fruitless negotiations with the pharmaceutical companies concerned. Brazil is well placed to do so as it has the production capacity to produce the medications. Also, since it is a large country, it will be able to stand up to pressure not to do so. She added that Brazil had played an absolutely key role internationally in the coming into being of the WTO Doha Declaration on TRIPS and Public Health.

If the problem is not addressed at the international level, there will be a drying up of sources of more affordable medicines, she warned.

When asked for possible reasons as to why the WHO leadership has been reluctant to give full support to the prequalification programme, T'Hoen said that the WHO has recommended the use of fixed dose combinations for AIDS and has prequalified the use of combinations that have been produced in India, for example, where today, patent barriers on putting molecules together into one tablet do not exist.

On a medical level, there has been enormous progress but it has been highly controversial politically, as the WHO in a way was sanctioning the developing countries to use these generic products. This has not sat well with the countries that are home to the larger pharmaceutical companies that are not able to make these kinds of fixed dose combinations, and these companies have been lobbying hard to maintain their monopolistic position with regards to the production and sale of medicines.

Implicitly, she said, the WHO would be saying to countries that if there are patent barriers to using these medicines, it recommends that countries overcome this. This, therefore, would be a politically sensitive activity for the WHO.

"We fear that this is what is behind the WHO leadership's reluctance to give full support to the project that it needs," T'Hoen added.