Responsibility for setting pharmaceutical policy across the European Union shifted in late November from the European Commission's Enterprise & Industry department to its Health department.
The move is widely seen as a coup for health campaigners who long had been lobbying for such a shift. The drug industry is concerned that this change will mean less emphasis on its contribution to trade, innovation and job creation, and more focus on its role as health care provider.
Indeed, the new health commissioner - whose purview includes pharmaceutical policy, but also the European Medicines Agency (now known as EMA rather than EMEA) and the biotechnology, pesticides and health unit - is John Dalli, currently minister for social policy in Malta. Dalli was appointed as part of EC President José Manuel Barroso's unveiling of an entirely new team of commissioners, who will determine the Brussels agenda for the next five years.
"It's not a total surprise," says Colin Mackay, director of communication for the European Federation of Pharmaceutical Industries and Associations. "But our concern, if there is one, is that we want to be sure the dual nature of pharma is still recognized." Sure, he continues, the industry plays a key role in health care provision, but "we're also a major industrial sector in Europe, we contribute significantly to the balance of trade, are a major employer, and make a substantial contribution to research."
In other words, as long as Dalli recognizes those commercial and economic contributions, the industry is okay with the change. Is that likely?
At first glance, Dalli's current position - as social policy minister - doesn't bode well. Plus, "he's not a big name; he's never been an MEP [member of the European Parliament] or a Prime Minister, so there's a touch of unknown," observes Mackay.
But, as Mackay acknowledges, Dalli does have a strong background in finance; indeed, he was the island's longest-serving finance minister. So he may be "reasonably business-friendly," Mackay speculates.
A source close to Dalli on the island of Malta backs up this confidence. "John [Dalli] was minister of finance for eight years, and drove the Maltese economy well, while it was thriving. He's a very business-minded sort of person," the source continues.
As finance minister, Dalli "always found a balance between the industry and consumer points of view, as is required in that position. I imagine he will continue to balance those elements well," says the source.
Dalli doesn't have any experience in pharmaceuticals or health, however. But according to Ludovic Lacaine, director of the health care sector within EuropaBio, the European Association for BioIndustries, "he has a multi-sectoral background which may help him to take a comprehensive view of all the issues around pharmaceuticals" - be they business- or health-related.
Biopharma Competitive Unit Stays In Enterprise
Another point that should assuage the industry's concerns is that the EC unit responsible for the biopharmaceutical industry's competitiveness remains within the Enterprise directorate, unsurprisingly perhaps given that competitiveness is clearly an industry issue rather than a health issue. (Broad pharma policy, in contrast, has always sat rather awkwardly between "business" and "health.") This may be good news for small and mid-sized biotechs, whose interests may become more prominent within the directorate. The unit's responsibilities include improving access to finance, IP rights, market access and promoting European biotech clusters.
For now, though, the impact for pharma is all about "maybes." Indeed, the designates - including Dalli - haven't even been confirmed in their roles yet, let alone put together cabinets or voiced their policy priorities. As such, "we won't have a proper statement on the potential impact of this decision until the New Year," declared EuropaBio's Lacaine.
What is clear is that the European Commission's proposed package of pharmaceutical legislation, announced about a year ago, will continue on its path through the European Parliament and Council. Its final form will depend largely on the outcome of the current parliamentary debate, due early in February 2010. It's unlikely a new health commissioner should halt or divert that train at all.
The package includes new measures to tackle counterfeit drugs, new pharmacovigilance practices and proposals on the kinds of information drug companies can supply to patients (1 'The Pink Sheet,' Jan. 5, 2009).
- Melanie Senior ( 3 m.senior@elsevier.com )
This article also appeared in "The Pink Sheet" – Dec 14, 2009
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