Time for drug trial secrecy is over

Last week was a fruitful one for public health and medicine. While the European Parliament adopted a new law boosting the transparency of drug trials, pharmaceutical company Abbvie dropped its legal case in the European Court of Justice against the European Medicines Agency’s  policy on publication of drug trial data.

The European Parliament voted by a massive majority to make all trial information available on an EU database. Such a move aims to correct the fact that only half of clinical drug study results are publicly available today. The more published and accessible data, the fewer trials repeated unnecessarily.

Ilaria Passarani, Head of BEUC’s Food and Health Department, commented:

“This data belongs not only to the pharma companies, but to society at large. With the EU’s new Clinical Trials Regulation, the veil of secrecy is about to be lifted , something that is long overdue. Consumers have the right to know more about the medicines they take.”

The law also puts an end to the “commercially confidential” excuse the pharmaceutical industry has hid trial data behind and away from the public. This is precisely the grounds used by drug manufacturers Abbvie and InterMune when they filed a lawsuit against EMA, the European pharmaceutical regulator, in February 2013.

Background - Responding to increasing public demand for transparency, in 2010 the EMA adopted a new policy on document access. It published over 1.5 million pages of requested clinical trial data on safety issues, some of the disclosure dealt with Abbvie and InterMune products.

Over one year after litigating, Abbvie has withdrawn its complaint against the EMA. The intentions of joint-complainant InterMune remain unknown. BEUC has backed the European Medicines Agency from the outset and has been officially participating in the case since September 2013.

Ilaria Passarani continued:

“The fact AbbVie has dropped its lawsuit against the European Medicines Agency disclosing drug trial data is a significant first step. It is our strong hope that InterMune will follow suit.

“A large majority of the European Parliament adopted the Clinical Trials Regulation, increasing transparency and disclosure of information. Public attention paid to these issues has risen in the past year. All this confirms the time for secrecy is over and the cases against EMA seem all the more anachronistic.”