• Sustainability
  • DE&I
  • Pandemic
  • Finance
  • Legal
  • Technology
  • Regulatory
  • Global
  • Pricing
  • Strategy
  • R&D/Clinical Trials
  • Opinion
  • Executive Roundtable
  • Sales & Marketing
  • Executive Profiles
  • Leadership
  • Market Access
  • Patient Engagement
  • Supply Chain
  • Industry Trends

Hungary Fails to Fill Patient Information Gap


Hungary?s failure to advance EU legislation on information to patients is not the country?s fault, says Reflector.

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. So why is this? Incompetence? Improvidence? Inertia? Well, it's 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 EUÕs 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.