The main role of drug regulatory agencies is to protect the public and improve public health. 

 During the 1980s and 1990s, most countries of the world established drug regulatory agencies responsible for ensuring the efficacy, safety and quality of medicines, and the validity of information relating to them.

The main role of these agencies is to protect the public and improve public health, not to defend the short-term economic interests of pharmaceutical companies.

However, decades on, drug regulatory agencies continue to maintain secrecy to a far greater extent than the law demands, and conflicts of interest at the highest level of these institutions undermine their credibility.

Transparency is in the public interest
Several public health disasters in recent decades were caused by the serious adverse drug reactions: rofecoxib (Vioxx°), benfluorex (Mediator°), rimonabant (Acomplia°), and others. Yet these drugs had all been authorised by drug regulatory agencies despite an unfavourable harm-benefit balance.

Drug regulatory agencies hold vast quantities of data (clinical trial results, pharmacovigilance data, etc.) that they use to decide whether or not to grant marketing authorisation to a particular drug, or to allow previously authorised drugs to remain on the market.

The scientific community and the public need access to these data so that medicines agencies can be subjected to public scrutiny, the data providing a basis for making sure that agencies are acting efficiently, reliably and honestly in the public interest.

Transparency in this area is also needed to ensure the rational use of drugs.

A general principle: freedom of information about medicines
The importance for public health of the principle of freedom of information about medicines was highlighted as long ago as 1996 in the international Uppsala Declaration on transparency and accountability in drug regulation: “in principle information available within regulatory agencies should be freely available to any party requesting it”.

The Uppsala Declaration, drafted almost 30 years ago by an international working group convened by Health Action International (HAI) and the Swedish Dag Hammarskjöld Foundation, is still relevant today.

The Uppsala Declaration reviews the origins of confidentiality in the pharmaceutical field, explains how excessive secrecy developed, then stresses both the benefits of openness about drug information and the harmful consequences for public health of withholding crucial safety data.

> Read the full text of the Uppsala Declaration

©Prescrire November 2014