A panel of European Parliament lawmakers gave unanimous backing on Wednesday (29 May) to new draft EU rules on clinical trials that could represent a huge step forward for research on new, life-saving drugs.
The General Court of the European Union has ordered the European Medicines Agency (EMA) not to release documents on clinical trials, after two access-to-documents were requested, at least until the Court has issued a final ruling.
The European Commission's proposed revision on the Clinical Trials Directive is an important step forward, but does not go far enough, says the Cochrane Collaboration, a healthcare NGO which advocates more transparency in clinical trials.
Since the European Commission tabled its proposal to revise the Clinical Trials Directive last July, the focus in the debate has broadly shifted from supporting European research to patient safety and transparency, suggesting health campaigners have gained the upper hand over big pharmaceutical firms. The legislation will be debated in the European Parliament’s Environment Committee on 24 April.
The European Medicines Agency, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny, a move that is creating tensions with drugmakers worried about preserving business confidentiality.
Too few women are taking part in clinical tests to develop new drugs, putting their lives at risk as women's bodies react differently to medicines, health experts said ahead of International Women's Day.
The OECD is urging its member governments to harmonise their clinical trial approval processes, citing a decline in the pharmaceutical sector in the EU, where the number of applications for clinical trials fell 25% between 2007 and 2011.