english.prescrire.org > Positions > Transparency > Energy

Theme: Transparency

Transparency means full disclosure of the interests — and conflicts of interest — that come into play at all levels of the healthcare system. Prescrire consistently calls for – and practices – full transparency.

Themes

Energy

In Europe, particularly in France, the principle of transparency of drug regulatory agencies has been enshrined in law. This represents a major advance for patients and for healthcare professionals. There may be a long delay before the law is fully applied, but energy and tenacity can guarantee that it will be implemented.

Until recently, many in France thought that the meetings of marketing authorisation or pharmacovigilance committees ought to be held behind closed doors.

Today, the same people who 5 or 10 years ago defended the "necessary confidentiality" of all data held by drug regulatory authorities, now talk of transparency and access to data. What led to such an about-face? Evidence-based medicine and clinical trial registries have become familiar concepts. A few highly publicised pharmacovigilance cases have shown that secrecy concerning adverse effects is dangerous. But above all, in Europe, and particularly in France, the principle of transparency of drug regulatory agencies (including the French Healthcare Products Agency and the Health Authority) has been enshrined in law.

It took a lot of energy and tenacity on the part of the Medicines in Europe Forum for this principle to be spelled out in European Directive 2004/27/EC(1). And also a good deal of energy on the part of the Medicines in Europe Forum’s French members, including Prescrire, to finally have this principle properly transposed into French law.

This major advance for patients and healthcare professionals, recognised by the more farsighted officials, has been a source of concern in the pharmaceutical industry and among its supporters in the drug regulatory agencies. There may be a long delay until the law is fully applied, but energy and tenacity can guarantee that it will indeed be implemented.

Source: "Énergie" Rev Prescrire 2007; 27 (281): 168.