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Why has the EU still not managed to update its rules on information about medicines?
When Hungary took over the rotating presidency of the European Union (EU) at the start of 2011, it identified as one of its explicit priorities "a positive outcome regarding the draft legislation on information to patients on medicinal products."
Nearly five months into its six-month term chairing the EU council, Hungary doesn't have much to report. It has not initiated a single discussion of the draft legislation among its fellow member states.
Incompetence? Improvidence? Inertia? None of these things.
Although the updated information rules were proposed as far back as 2008, Hungary is not to blame for the failure to move the legislation ahead. Its hands are tied by the procedures that govern the creation of new EU rules.
As with all other EU legislation, the starting point for this proposal was the European Commission, the EU's central civil service. The Commission's 2008 proposal was duly discussed over the following two years in one of the EU's two co-legislators, the European Parliament.
The discussions were meant to move ahead in the EU's other co-legislator, the council, which is made up of ministers from the 27 EU member states. But these discussions haven't started, because everyone is still waiting for the Commission to fulfil a promise it made in November 2010 to modify the proposal.
It was John Dalli, the European health commissioner, who made the promise. From the time he took over as commissioner at the start of 2010, Dalli had repeatedly made plain his distaste for the proposal he had inherited. He said it focused on the needs of industry rather than the needs of patients. He told the parliament during the final debate there, late last year, that he would come forward with a modified proposal reflecting his pro-patient view—a view that the parliament supported.
But at press time, half a year on from Dalli's promise, the modified proposal is nowhere to be seen. And consequently, no one else can move either.
As the Hungarian presidency pointed out recently, in a tone of disappointment, the dossier is stuck in the commission, not in council. "It is a top priority for the presidency, but the Commission still hasn't come back with its updated version," said a presidency spokesman. "The chair and everyone are keen to start working on it as soon as the Commission comes out with something," he added at the time.
Already by that stage, the presidency's best hope had been reduced to preparing a general approach for the meeting of Council that will bring health ministers together in June. But even that scaled-down objective depended on the Commission producing its modified proposal by mid-May. Mid-May has come and gone, without any modified proposal being launched into the gap. The presidency "is bound to remain idle for want of a proposal to discuss, not for want of ambition," said the spokesman. Hungary is now certain to hand over the presidency to Poland at the end of June with this ambition unfulfilled.
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 Sector."
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.
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 policy.
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