Promises Not Delivered
It isn't the only ambition that has gone unfulfilled in EU pharmaceutical policy over recent years. When the proposed update
of the rules on information to patients emerged in late 2008, it formed part of what can best be described as a fanfare of
good intentions and forward thinking—a three-ring circus of plans for the future. The Commission accompanied its legislative
proposals with a strategy document boldly entitled "Safe, Innovative, and Accessible Medicines: A Renewed Vision for the Pharmaceutical
Its scope was broad; two of the three legislative proposals it made at the time have fared better than the information-to-patients
proposal, have since been adopted, and are set to come into full effect over the coming months and years: an update to the
rules on pharmacovigilance and tighter controls to combat counterfeit medicines.
But for all its expressions of anguish over "the complex landscape in the EU," the Commission's proposed actions have in most
cases yet to see the light of day. It said it would improve the EU rules on pricing and reimbursement to promote "genuinely
transparent and speedy" decisions—but no deadline was set for any of these moves, and all that has resulted so far is a public
consultation launched in March on what might be changed in its pricing and reimbursement rules—accompanied by a disclaimer
that member states in any case will remain, as they are now, free to do more or less what they want. Similarly brave words
about introducing "more efficient market mechanisms" went, in the end, no further than urging price competition for non-reimbursed
medicines—and that has still not happened across Europe.
Another of the deficiencies that the 2008 strategy document noted was that European patients were not enjoying equal access
to medicines, particularly in smaller markets, and again it promised a response. But although the commission set itself a
2010 deadline to develop "options to improve the availability of medicinal products for patients in need, with a particular
focus on smaller markets," news of any action has yet to emerge.
The Good with the Bad
On some of its promises, the strategy document has, of course, made good—with the approval of new rules on cross-border healthcare,
with greater international cooperation on use of foreign clinical trial data or the import of ingredients, with the ongoing
review of the widely-criticized EU rules on clinical trials, with promotion of research into rare diseases, and with continued
development of the public/private research partnership known as the Innovative Medicines Initiative.
It should not be a surprise that some promises have been kept. That is, after all, in the nature of making promises. What
is surprising is that so many have not been kept. The EU as a whole faces other challenges—the sovereign debt crisis of some
member states, foreign policy dilemmas raised by the Arab spring, security of energy supply, or the fight against climate
change. But that hardly justifies the Commission blithely ignoring commitments it has chosen to make in the area of pharmaceutical
The Commission's 2008 strategy document expressed no doubts about the value of the pharmaceutical sector: its role as a provider
of innovative medicines and as an agent for economic growth, employment, and exports earned it the accolade of "a strategic
sector for Europe." If it so strategic, why is it not receiving strategic attention?
Reflector is Pharm Exec Europe's anonymous columnist, a commentator so close to the action in Europe that his identity must remain secret