Europe Says Goodbye to Another Type of Transparency

Applied Clinical Trials

After nearly five years of argument, the European Union's proposal to update its transparency directive for medicines has been dropped.

So that's it. After nearly five years of argument, the European Union's proposal to update its transparency directive for medicines has been dropped-because, says the new-broom European Commission run by Jean-Claude Juncker, there is "no foreseeable agreement" among the member countries.

But before everyone rushes off in glee-or relief-to conceal the trial results that they didn't want to reveal, or bridles with indignation at another bureaucratic assault on freedom of information about medicines, it is appropriate to point out that this proposal was nothing to do with all the discussion about transparency of clinical data that has been such a prominent feature of EU arguments (and indeed of reports about Europe in ACT) over recent years. What the Commission has dropped is a proposal to update the 1989 directive "relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance system." This is the measure that sets out certain requirements governing the form-but not the content-of decisions that member states make about pricing and reimbursement of medicines. In other words, national authorities could retain their autonomy about whether and at what level to grant prices and reimbursement to medicines, but they were subject to timetables, and were obliged to act in a non-discriminatory fashion.

Being more than 20 years old, these rules had become rather out of date, and in 2010 the Commission initiated a review of how they were working. It followed this up with legislative proposals in early 2012. "Basic conditions of procedural transparency must be met" it said. The rationale was that although member states are entitled to make their own decisions, they should do so in a way that doesn't disrupt trade. "National measures to control the funding of medicines and manage their consumption in the framework of healthcare systems are susceptible to create barriers to trade as they affect the capacity of pharmaceutical companies to sell their products in domestic markets," the Commission said. The proposed update was targeted at preventing pricing and reimbursement measures discriminating against imported medicinal products, and ensuring they were "based on objective and verifiable criteria."

The need for an update to the old rules arose-the Commission argued when it made its proposal two years ago-from the rise of generics over the intervening 20 years, and member countries moves to devise more complex and innovative pricing and reimbursement systems as a way of containing costs. But irrespective of what the Commission, and subsequently the European Parliament, thought, the member states didn't see the same pressing need-or didn't agree it the solutions the Commission was proposing. So over and over again, successive EU presidencies have picked up the thorny topic and organized discussions on it in the EU Council, only to meet implacable resistance from the member states-on pretexts as diverse as excessive interference in national matters, insufficient precision, sheer impracticality, or inadequate legal grounds.

Juncker, in his bid to make EU business more efficient, has bowed to what he considers the inevitable-and has junked the proposal. Juncker by name, junker by action. What is not clear, however, is how the admitted challenges in pricing and reimbursement systems are to be met. While the solutions have been rejected, there has never been any real opposition to the Commission analysis that underlay its proposal. The current framework (which will stay in place unamended, despite now being a quarter of a century old) "does not fully achieve its objectives in the present context," said the Commission. The situation "results in legal uncertainties" and "negatively affects the smooth functioning of the internal market to the detriment of European patients and pharmaceutical companies." In addition, the time limits for pricing and reimbursement decisions "are regularly exceeded by member states," and "this leads to delays in the marketing of medicinal products, which in turn slows down the availability of valuable treatments for patients."

The overall objective of the 2012 proposal was to clarify the procedural obligations on member states and to ensure the effectiveness of the rules both in avoiding delays in pricing and reimbursement decisions and in preventing barriers to pharmaceutical trade. If that was the case then, it might seem that the same predicament and the same challenges exist now. So what is Juncker aiming to do to fill the gap he has created by killing off the attempt to fix it?