The EU Pharma Switch

The chair of the first session of the joint meeting between the European Medicines Agency (EMEA) and The Organization for Professionals in Regulatory Affairs (TOPRA) in London this week was quick to point out that the event was not scheduled to coincide with last Friday’s announcement that European Commission (EC) responsibility for EMEA is finally to move from the industry to the health commissioner.

But, notwithstanding the implications of the move, it’s hardly as if it was a surprise announcement. Lobby groups and Members of the European Parliament (MEPs) have been pushing for the change for a long time. In November 2008, a group of 20 NGOs representing patients, consumers and health insurers called on European Commission President José Manuel Barroso for public health to be treated as a higher priority, and earlier this year the European Patient Health Alliance (EPHA) hit out at “flaws” in how pharmaceutical policy is organized within the EC.

Speaking at this week’s event, EMEA’s UK director Thomas Lonngren agreed that, after 15 years, it was time to “refresh” the Agency. He also announced that it will now be abbreviated as EMA (the second ‘E’ has long seemed redundant, even though the Agency’s official name was the European Medicines Evaluation Agency). But he was eager to maintain that, despite EMEA’s new face and new corporate identity, “I don’t see any change to the way we run the industry.” Similarly, other EMEA and EC speakers at the event played down any disruption the move might cause.

But surely this is the real objective. And, certainly, there is no denying that there will be implications for the EU’s ongoing set of initiatives (concerning pharmacovigilance, counterfeiting and patient information) that make up the ‘pharmaceutical package’. Indeed, as EPHA complained earlier, because the pharmaceutical package was the responsibility of the Industry commission, “it barely addresses health at all, focusing instead on marketing and competitiveness.”

EPHA added: “EU pharmaceutical policy in general, and the provision of information to patients in particular, should be the responsibility of a health-focused directorate to ensure that this complex and critical industry is regulated with citizens’ needs are addressed, and not put second place to those of the industry.”

News of the move to the EC’s health commission (DG Sanco) will no doubt please the EPHA, just as it has pleased — as Pharm Exec Europe’s Brussels correspondent Reflector puts it — “everyone from the European doctors’ association to the Belgian health minister.” But the wheels of European healthcare regulation and the pharmaceutical package, already very slow-turning, are surely to be stalled again while this seemingly simple but potentially gargantuan shift is completed.