MSF Statement for the WHO Executive Board

Highlighting the Important Role WHO Must Play in Increasing Access to Essential Medicines

Statement urging the EB to examine issues concerning the Essential Drugs List, equity pricing, prequalification of low-cost producers, the Doha declaration, and the gap in research and development for neglected diseases.

Contents:
Next steps for the Essential Drugs List (EDL)
Equity pricing
Pre-qualification of low cost producers
The Doha declaration on TRIPS and public health
Gap in research and development

MSF would like to take the opportunity of the WHO Executive Board to highlight a series of issues related to the WHO and the important role it must play in increasing access to essential medicines in developing countries.

Next steps for the Essential Drugs List (EDL)

The EDL is one of the most important public health tools, promoting access to vital medicines and their rational selection and use. Essential drugs are those that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in the appropriate dosage forms, and at a price that individuals and their communities can afford. The Essential Drugs concept guides countries in selection of drugs, in decisions about procurement and pricing policies and rational drugs use. The essential drugs concept also provides guiding principles for NGOs.

MSF welcomes the revised procedure for updating WHO’s Model List of Essential Drugs as outlined in document EB109/8. The procedure ensures an evidence-based, transparent, and independent process for revising the EDL. We particularly welcome the fact that expensive drugs, when their use is justified, will no longer be excluded from the list solely because of price.

The expansion of the EDL should go hand-in-hand with measures to ensure that these medicines become affordable for the individuals and communities involved.

Equity pricing

WHO should actively support equity pricing of essential medicines, many of which are currently too expensive for developing countries. While some progress has been made in bringing the prices of certain medicines down, a lot remains to be done by governments and international organisations. An equity pricing system should include political and legal measures to increase generic competition, global/regional procurement and distribution, local production through compulsory or voluntary licensing and technology transfer.

MSF would like to warn against unwarranted optimism with regard to the multinational industry’s willingness to bring drug prices down to an affordable level. Equity pricing will not be achieved by relying on voluntary actions by pharmaceutical companies only. Without decisive action from key players such as the WHO, the price of medicines for many diseases will remain too high. For example, the price of an essential drug used to treat AIDS-related meningitis, fluconazole, varies greatly depending on who produces it and where it is sold: in Thailand, a generic producer sells it for US$ 0.29 (per 200 mg capsule; June 2000) but in Guatemala, where the drug is patented and manufactured by Pfizer, it costs as much as US$ 27.60.

In the case of a high-profile disease such as AIDS, where public pressure and media attention is intense, lack of transparency from the pharmaceutical companies about pricing their products in different countries is emerging as a new challenge. Obtaining up-to-date pricing information is difficult, and negotiating drug prices with different companies for each individual product is time-consuming for the governments of poor countries. WHO should support across the border negotiations regarding the pricing of medicines for neighbouring countries with similar needs.

MSF is pleased to work with the WHO, UNAIDS and UNICEF on providing information on drug prices and welcomes the collaboration within the NGO Roundtable process on development of price monitoring methodology for NGOs. We hope to expand the work on drug price information even further in the future.

Pre-qualification of low cost producers

Medicines should be essential, available, affordable and of quality. To offer treatment to the highest number of people possible in developing countries, it is essential that all funds be used to buy quality medicines at the best possible price. This is simple mathematics: using the lowest cost suppliers, whether proprietary or generic companies, will increase the number of people who can be treated and will allow for greater investments in other important components of care and prevention.

The WHO should support countries and NGO’s in procuring affordable medicines for these particular diseases by identifying quality producers through a pre-qualification process. This will also facilitate procurement that will take place as a result of the activities of the Global Fund for TB, malaria and HIV/AIDS. Cheaper alternatives of important products, such as antiretrovirals, are becoming available on the markets of developing countries, and it is paramount to assist countries to assure the quality of these products. The added value of the pre-qualification process cannot be underestimated.

The Doha declaration on TRIPS and Public Health

2001 was marked by progress in the discussions on patent barriers to access to medicines at the World Trade Organisation (WTO). The Doha declaration on TRIPS and Public Health lays out the options countries have to take measures when prices of existing patented drugs are too high for their populations. 2002 is the perfect opportunity for the WHO to take up the challenge, together with other relevant international organisations, to provide practical technical assistance to make sure that the Doha declaration makes a difference at the national level. One pragmatic and effective way of doing this is to provide countries with examples or models of intellectual property legislation that will allow them to develop TRIPS compliant laws – all the while making maximum use of the safeguards of the TRIPS agreement to ensure that pharmaceutical patents do not hamper access to medicines.

Gap in research and development

2002 is also the time to improve the availability of essential medicines to treat neglected diseases, such as leishmaniasis, sleeping sickness and Chagas disease, affecting populations with no purchasing power and no vocal advocacy groups. MSF would like to see firm action to compensate for the lack of research and development into these diseases, and other infectious diseases such as malaria and tuberculosis – an issue that was flagged in Doha but not resolved.

Again, this is where the WHO clearly must play a major role, along with governments and donor countries, in determining the R&D needs and stimulating R&D activities. R&D for neglected diseases cannot be left to the market place. Public Private partnerships alone will not offer a solution because there is insufficient market incentive. Radical new approaches are needed to kick-start R&D, including new funding mechanisms in areas that are now totally abandoned. Not-for-profit drug development initiatives should be explored to take drug R&D for neglected diseases out of the marketplace altogether.


MSF looks forward to contributing to an active dialogue and joint action to resolve the issues addressed above.