Regulatory reform

Posted on 2 November 2009

Jens Van Roey and Myriam Haxaire-Theeuwes
Tibotec, Mechelen, Belgium

A new or improved regulatory pathway is necessary to facilitate access to medicines developed specifically for developing countries. The main focus of the US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) is the registration of new drugs for use in the US and European markets and drugs that have been developed or tested domestically, not the registration of drugs intended for use in developing countries. Furthermore, the FDA and EMEA processes are time consuming and do not consider benefits or risks beyond their domestic contexts. This complicates drug registration throughout the world, as many countries approve medicines on the basis that they have been licensed and used in the US or Europe. Because of the technical complexity of the registration process, coupled with the insufficient capacity of many regulatory authorities in developing countries, access to new medicines is almost always delayed.

In order to offer life-saving medicines in a timely manner to patients in developing countries and to ensure that the medicines are of high quality and efficacious, the current regulatory system needs to undergo major reforms. Current efforts, including the FDA tentative approval process for AIDS relief, EMEA Article 58 of Regulation (EC) No. 726/2004 and the WHO Prequalification Project, are important steps towards improving the efficiency of registration, yet they do not provide an ideal solution. Potential options to consider include: increasing the capacity of regulatory authorities in developing countries, constructing regional bodies, using an external entity, or harmonising the regulatory process. Using an external entity is attractive because it avoids duplication of effort; between medicines regulatory authorities, this is sometimes considered the “ultimate objective of harmonizing procedures and data resources”. This would enable optimal use of limited resources, alleviate the regulatory burden on developing countries and remove over-restrictive national sovereignty considerations. It is likely that a multi-prong solution and political will are required to reduce or eliminate redundancy in international registration, increase resources, regional exchanges, training and capacity as well as to reformulate benefit-risk ratios and fast-track medicines targeting priority public health concerns. A new approach needs to be taken by the international community to guarantee prompt access to innovative and life-saving medicines in developing countries.

Do you think that regulatory reform will help increase access to medicines developed specifically for developing countries?  And what is the best way to go about this? Why not share your views on MeTA Dialogue: http://medicinestransparency.com/, or if you are involved with MeTA, on one of the MeTA DGroups.