Statement |

Issues for the 107th WHO Executive Board 2001 (January 15-23, 2001)

Proposals by MSF with regard to the WHO essential drug policy to increase access to essential drugs

The WHO Model List of Essential Drugs (EDL) has been one of the most important public health instruments of the last two decades to increase access to needed medicines and promote 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 form”. The first EDL was published in 1977 and the list has since then been regularly revised and updated.

The EDL is still an important public health tool. The list suggests a limited number of drugs with a good benefit/risk ratio. As affordability is a criteria for inclusion on the EDL, most drugs are off-patent and in most cases multiple generic sources are available.

The need to increase access to medicines including new medicines has been reaffirmed by a series of WHA resolutions. The most recent are: HIV/AIDS: confronting the epidemic WHA53.14 in May 2000 and the Revised Drug Strategy WHA 52.19 in 1999.

In view of (1) epidemiological changes, in particular the AIDS epidemic and increasing resistance to the most basic treatments to combat infectious diseases, and (2) the way medicines are traded in a globalised world, there is an urgent need to reinforce the basic concept of the EDL – which is as a medical tool. It is vital that the different criteria for inclusion in the EDL are clarified and prioritised, and that new medicines of medical importance are included in the list, even when the originator’s brand products are costly.

MSF held a meeting with international experts, including the WHO, entitled ‘Translating the Essential Drug Concept in the 2000's Context’ in Geneva, 19 September 2000. The meeting discussed the need for reinforcing and expanding the EDL. Participants agreed that drugs medically essential for the rich are also essential for the poor and proposed the following two-part EDL.

The core list would include well-documented drugs with a good benefit/risk ratio that are affordable and linked to guidelines that are updated, reliable and relevant to the developing world.

A second part would list drugs with a good benefit/risk ratio, but that are very expensive, difficult to use, or lacking adequate evidence of field efficacy and therefore require operational research. This second part will also list medical areas where new drugs are needed, i.e. "missing" drugs.

The second part would help public health institutes, donors, politicians, and other actors to prioritise policy agendas. Furthermore, the drugs on the second part would have priority to move onto the core list. The meeting agreed that the UN, in particular the WHO, should be responsible for ensuring that steps are taken to resolve the issues that have confined the drugs to the second part of the list.

MSF proposes that the 54th World Health Assembly supports the WHO’s efforts to update the EDL concept and to expand the EDL with a second part that contains expensive products but are nevertheless essential to treat current diseases. To help Member States and others involved in drug procurement and policy, this second list should be accompanied with information about prices and possible providers and patent status in the different Member States. The sources need to be validated for assured quality by WHO in collaboration with other relevant UN agencies such as UNICEF. This information will help Member States to identify the most appropriate providers. The Member States acknowledged the need for greater price transparency last year at the 53rd WHA (See resolution: HIV/AIDS: confronting the epidemic WHA53.14.) Finally, the WHO should take a strong leading role in overcoming barriers that may result from intellectual property protection by assisting countries and regions to develop and implement laws and regulations that will help overcome pricing issues.

The Executive Board could help to make this happen by proposing to the World Health Assembly to support the following actions by WHO:            

  • to strengthen the WHO Model List of Essential Drugs with a listing of essential medicines not yet included because of price or cost consideration, but that are therapeutically needed;
  • to provide information on prices of these products in a price database which will enable Member States to identify affordable sources of quality essential medicines;
  • to collaborate with WIPO to include in the price database information about patent status in the Member States of new essential drugs;
  • to provide Member States with model laws and regulations on compulsory licensing and other legal measures to overcome barriers to access to expensive medications;
  • to encourage operational research to identify and simplify the best available treatments and to promote the rational use of drugs;
  • to define a need driven research and development agenda to assist policy makers, funding agencies and the research community in setting the right priorities in addressing the needs of developing countries with regards to pharmacotherapy;
  • to actively pursue strategies to encourage a global policy for equity pricing of essential medicines in developing countries.