update
Moving EMA to DG Enterprise will increase risk of adverse events says NGO
Last week, EC president-elect Jean-Claude Juncker said responsibility for the European Medicines Agency (EMA) – the organisation that assesses the safety and efficacy of drugs sold in Europe – would switch from health organisation DG Sanco to DG Enterprise and Industry.
The move – which would reverse a 2009 decision that saw DG Sanco take charge of the EMA in light of concerns about DG Enterprise and Industry’s ability to cope during a flu pandemic – was met with strong opposition from European Non-Governmental Organisations (NGOs).
Tim Reed, director of Dutch NGO Health Action International (HAI), told in-Pharmatechnologist.com “Moving medicinal units D5 and D6 [which include the EMA] from the portfolio of the Health Commissioner to the new Commissioner for Internal Market, Industry, Entrepreneurship and SMEs puts the commercial interests of the pharmaceutical industry—rather than patients and consumers—at the heart of European policymaking on medicines.”
He added that: “We’ve seen, time and again, how commercial interests can be at odds with what’s good for public health. Further to that, beyond the borders of the European Union, it sends the same terrible message of profits before patients to a watching world.”
Patient safety
Reed said moving the EMA from the purview of Europe’s health directorate to a DG whose mandate is to promote business will create a conflict of interest that could put patient safety at risk.
“We’re particularly concerned about the impact that the move of the EMA will have on clinical trial data transparency in the European Union,” he said, citing the agency’s management of a planned database of clinical trial results under DG Enterprise direction as a potential issue.
“MEP, Glenis Willmott [who negotiated the trial data transparency regs] has publicly stated that DG Enterprise wanted to ‘water down’ these rules. If this were to happen again as a result of the transfer of the portfolio, patients will be at greater risk than necessary of adverse drug reactions” Reed said.
Any impact on EMA trial transparency activites would not be welcomed by the UK National Institute for Health and Care Excellence (NICE), which announced this week that it would approach regulators if drug firms fail to provide the data it needs to determine if a new medicine should be available on the National Health Service (NHS) in England and Wales.
Why?
EC president-elect Jean-Claude Juncker gave no justification for the proposed reshuffle, which prompted some like European Public Health Alliance (EPHA) president Peggy Maguire to suggest it was a result of drug industry pressure.
“It [moving the EMA] sends a terrible message during times when criticism is being levelled at Europe: the College of Commissioners should work for the interest of citizens and not anonymous corporate masters.”
Reed voiced similar concerns and went further telling us “we suspect that the European Federation of Pharmaceutical Industries Associations (EFPIA) has had a hand in the process” without providing any further information.
We asked EFPIA if it did have a hand in the decision and a spokesperson told us the organisation "welcomes the new EC structure with vice-presidents that oversee several Commission DGs, aiming to bring down silos. EFPIA has consistently called for much greater coherence within the Commission on health and life science policy issues. One cannot work without the other.
"Securing high quality and equal access to health services, including access to safe and effective medicines, must be at the top of that agenda. Achieving those objectives in a way that ensures financial sustainability for health systems and promotes a healthy European life sciences community is what we have suggested in our Health and Growth strategy and is the only way of delivering against the vision set out in the Vilnius Declaration, of which EFPIA remains in full support."
EMA view
When asked, the EMA told us that the proposed changes – which are due to come into effect in the next three months – were unlikely to impact how it operates day to day.
Spokesman Martin Harvey told us “We have worked with various different DGs for the past 20 years," Harvey said, adding that "the move to DG Enterprise and Industry is not going to change our role."
He explained that representatives for both DG Sanco and DG Enterprise and Industry have always sat on the EMA's management board, which is an arrangement that is unlikely to change.
