European Commission to transfer responsibility for medicines to DG Enterprise

Europe’s research-based pharmaceutical industry association has said that it did not lobby for the new European Commission to remove responsibility for medicines from the Directorate-General for Health and Consumers and give it back to DG Enterprise.

Commission President-elect Jean-Claude Juncker’s controversial plan to take responsibility for medicines - including the European Medicines Agency (EMA) - from DG SANCO, which it had held since 2009, and give it back to DG Enterprise, has been roundly condemned by health activists. The European Public Health Alliance (EPHA) has urged Members of the European Parliament (MEPs) to make a reversal of the decision a requirement of their endorsing the new Commissioners-designate when questioning them this week.

 

However, Richard Bergstrom, director-general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), has said that “having everything for pharmaceutical companies in one unit makes a lot of sense.”

 

Speaking at a debate this week in the European Parliament, organised by European Ombudsman Emily O’Reilly and reported by EurActiv.com, Mr Bergstrom said that while the industry group had suggested that the Commission should develop a coordinated, comprehensive life sciences strategy, it had not lobbied or expressed a view of how such a unit should be structured.

But Mr Juncker’s proposal “looks good,” he said. “As an EU citizen, I think the design is impressive, I think this is something new, and we need something new. I think my members will support it,” said Mr Bergstrom, although he added that he was “not surprised by the reactions.”

But Dr Ben Goldacre, author of Bad Pharma, told the debate that the proposed move was “very dangerous to public health” and looked “incredibly seedy. This will create a lack of trust,” he warned.

The debate in Parliament, which was held as part of International Right to Know Day, also examined how transparent scientific data is - and specifically clinical trial data - for the benefit of patients, doctors and researchers.

In May, Ms O’Reilly had written to EMA director Guido Rasi, telling him that while her office welcomed the Agency’s announcement of a new pro-active transparency policy, she had received documents showing that EMA was planning to limit access to clinical data which, she warned, “could undermine the fundamental right of public access to documents established under EU law.”

During this week’s Parliamentary debate, the Ombudsman said that she had opened three ransparency investigations relating to EMA and public access to data during the last five months. “I will continue to examine closely whether the EMA continues to be committed to transparency,” she added.

Responding, Dr Rasi told the discussion that EMA’s management board is set to finalise the new version of its policy on access to clinical trial data this week, approving it on October 2. The new policy will spell out clearly what the principles to gain access will be, but the decisions will always be taken by EMA, he said. 

“That should give us, from the start of 2015, the possibility to start to actively make data available. By 2016, we should have the first clinical trials available,” Dr Rasi told Parliament.

Source: PharmaTimes