Statement made by Ellen 't Hoen, Médecins Sans Frontières (MSF) at the Conference on Fixed Dose Combination (FDC) Drug Products: Scientific and Technical Issues Related to Safety, Quality, and Effectiveness

Gaborone, Botswana
March 30, 2004

Madam Chairperson,

Thank you for this opportunity to make a few comments during this general discussion session.

Yesterday, at the beginning of the meeting, Dr. Mark Dybul of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) - one of the organizers of this meeting - said that "conceptually, FDCs are an urgent good." As we know, fixed-dose combinations (FDCs) are not a concept, they are a reality, and their availability has dramatically improved the ability of treatment programs in poor countries to scale up access to antiretrovirals (ARVs) and to reach people in remote settings. Their availability in countries where this is not the case yet is indeed urgent.

He also said that it is "important to have an agreed set of principles so we can use money to buy drugs that the US Food and Drug Administration (FDA) has not approved."

This meeting has shown that an internationally agreed upon set of principles on how do deal with regulatory questions with regard to FDCs exists.

There is also an internationally recognized system for prequalifying medicines, including FDCs, headed by the World Health Organization (WHO).

Many governments, NGOs, UN agencies, and donors, including the Global Fund to Fight AIDS, Tuberculosis and Malaria and the World Bank, rely on WHO's advice when registering, purchasing, or funding medicines. The WHO has been instrumental in helping to make FDCs available to people who need them.

We call upon the United States to join this international consensus.

Failing to do so will lead to the setting up of parallel systems. We cannot stress enough how disruptive it would be to set up parallel systems. Different treatment regimens in the same country - in same cases even in the same health care facility - would be disastrous. It would also be disastrous with regard to the development of urgently needed new FDCs, in particular pediatric formulations, which is unlikely to happen if FDCs are not endorsed by one of the key donors.

MSF has had several interactions with PEPFAR over the past several months, and we have shared our experience and data on the use of FDCs from our field projects openly. And we are willing to continue to do that.

However, we cannot but get the impression that in our attempts to provide the U.S. administration with data to convince them of the efficacy, safety, and quality of - and urgent operational need for - the FDCs we use, the goal posts are being moved every time a particular concern has been addressed.

We would like to be proven wrong.

The PEPFAR representative said that this meeting is not an attempt to avoid using FDCs - "it is the opposite," he said. We now need to see the evidence of this.

Thank you.

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