Responsibility for pharmaceuticals is moving from the Directorate for Enterprise and Industry (now to be Industry and Entrepreneurship), following lobbying from patient and consumer groups, which point out, rightly, that in member states supervision of the drugs industry is the responsibility of health departments.
The first chance to see how the transfer will play out came last week at the confirmation hearing of Commissioner-to-be John Dalli.
It is pretty evident that the pharmaceutical industry does not have a big fan base in the European Parliament’s health and consumer care committee. The tenor of the questioning can be summed up by one member who welcomed the responsibility for pharmaceuticals moving, as she complained that all MEPs experience “intense lobbying” from pharma.
Another accused the industry of scaremongering about swine flu, leading to expensive stockpiles of vaccines and anti-viral drugs against H1N1, which governments in western Europe are now looking to offload
So from the perspective of industry, Dalli’s opening statement in which he promised to put, “patients first, consumers first,” can’t have been very reassuring. Nor was his later comment that, “Making enemies comes with the job: that won’t frighten or derail me on what needs to be done for the consumer.”
The pharmaceutical sector resisted the move from the Enterprise and Industry Commissioner’s portfolio on the grounds that as one of Europe’s most economically important industries, and the number one private investor in research and development, it is critical that the business needs of pharma aren’t neglected.
As the European Federation of Pharmaceutical Industries and Associations (EFPIA) commented to Science|Business, “The new Commissioner must recognise the industry’s dual roles of meeting the health needs of Europe’s patients and its significant contribution to Europe’s economic well-being - via a significant positive trade balance, high-quality employment and substantial investment in European-based research.”
Even before responsibility for the industry was shifted, the EFPIA, representing 31 national bodies and 44 companies, claimed it was not getting the support it needs. One compelling piece of evidence is the flight of R&D from Europe: Between 2001 and 2006, eighteen R&D laboratories closed in Europe and two opened; meanwhile in Asia fourteen opened and one closed.
For comparison, in the US six R&D labs opened and five closed over the same time, according to data gathered by EFPIA from 22 global pharma companies.
In a recent statement EFPIA complained that the European marketplace is characterised by, “A highly fragmented environment, with 27 separate markets, coupled with major cost-containment measures and insufficient reward for innovative products.”
It should provide a fragment of comfort to the industry that Dalli has experienced the patients versus pharma argument from both sides, having worked as a government minister in both Finance, and the Health and Social Services departments, in his native Malta.
This was reflected when he told MEPs it is necessary to balance the need for a strong pharma industry and the needs of patients. “We can’t sacrifice patient interest for anything, but a strong pharma industry is in the interests of patients,” he said.
Dalli also told MEPs that innovation is a very important priority for him, and pledged that policy will be science-based.
The sub-text, for MEPs that care to read it, is that in an ideal world the commercial imperatives of pharmaceutical companies would be in harmony with the medical needs of the patients and consumers they serve.
Alas, this is not an ideal world. And on the evidence of Dalli’s confirmation hearing, moving the oversight of pharmaceuticals into the Health and Consumer Care Directorate will push the balance of interests between patient and industry even further out of kilter.