Looking Beyond the Euro Turmoil

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-02-01-2012, Volume 21, Issue 2

Europe's struggling economies may have unexpected effects on the pharmaceutical sector.

The turbulence buffeting Europe's economies is having multiple negative consequences—including in the pharmaceutical sector. Cash-strapped healthcare agencies are faced with ever-tighter public spending controls. Drug firms with significant presence in the eurozone are revising downwards their sales estimates and reconsidering their investment strategies. Uncertainty over the future is hitting long-term—and even shorter-term—planning in clinical development departments.

Peter O'Donnell

Inner core

Amid all the desperate macro-economic remedies being canvassed, there are some that contain nuggets of thinking that could, over time, prove beneficial to pharmaceuticals in Europe.

The talk, in Brussels and beyond, is increasingly of a two-speed Europe—in other words, a rejigging of the 27-country European Union to create an inner core of more closely integrated countries with sound economies. Thus relegating less successful member states to an outer circle, a waiting room until they are ready to graduate to the elite class.

Just who would qualify for the inner core is still an open question, and need not detain us long here. Certainly it will not be the same as the 17-member eurozone—Greece, Portugal, Spain, and Italy would clearly not be eligible in the near future. Certainly it will not be just the prosperous countries, because consistently successful Sweden does not even use the EU's single currency, and rich Norway is not even a member of the EU. Certainly it will not be just the big countries, because the UK is strongly opposed to the concept of closer links. But whatever its membership, the fuller integration it presupposes may contain the seeds of a solution to a dilemma that has made Europe a difficult arena for pharmaceuticals for half a century.

An avant-garde of EU member states that pursue further and closer cooperation would have to decide how far that cooperation might go to ensure harmonious development. Already a new treaty is in the process of finalization among volunteer states that will bind them as never before on budgetary as well as monetary policy. There are other issues equally critical to closer economic alignment, such as taxation; labor market policy; and social policy, that have until now been jealously and ferociously guarded as the private preserve of individual member states.

Health policy

For the pharmaceutical sector, a shift towards alignment of health policy—also until now a matter reserved purely for autonomous national decision-making—could, if it occurred, mark the start of a revolution. It could mean the end of that still-unbridged gulf between the European and national dimensions of medicines policy that has bedeviled drug supply and development in Europe. No longer would distinct national pricing and reimbursement systems complicate product launch. No longer would national regulatory agencies insist on treating the same product in different ways. And no longer would multinational clinical trials have to fight their way through a jungle of conflicting national views.

It's a big if. And there is no guarantee that a monolithic system across the inner-core countries would always choose to harmonize drug prices upward and burdensome regulation downward. But the seismic shifts that the economic crisis is generating in Europe are promoting a new open-minded approach to ideas that were, only recently, taboo. If member states are now prepared to accept the indignity of submitting their national budgets for prior approval at EU level every year—and that is what they are signing up to already—then some new coordination in health policy is no longer beyond the bounds of the imagination.

Straws in the wind

While we are in the straws in the wind department (although on a less cosmic level), it is worth noting in passing that two major—but hitherto proudly separate—European industry associations in the healthcare area have just decided to join forces. EDMA, the European Diagnostic Manufacturers Association, and Eucomed, the European medical technology industry association, say their declared aim is to "ensure the place of in-vitro diagnostics and medical technology at the forefront of 21st century healthcare and healthcare policy." Working together will, they say, "enhance the effectiveness of the healthcare industry by providing our joint contribution to public health and research policies in Europe."

One of the triggers for their decision is the evolving healthcare environment. They speak of "the need to further their close cooperation with regulators and policy makers on the upcoming revision of the legal framework for medical devices, which needs to be adapted to the specifics of new and emerging technologies." There they address accurately another strategic shift, as new science and new applications move remorselessly toward more personalized medicine, in which the previously watertight boundaries between industry sectors are progressively eroded.

During 2011, some of Europe's pharmaceutical sector thinkers invested time and effort in exploring closer links between diagnostics and therapeutics and admitted that they were not progressing at a rate compatible with emerging possibilities in healthcare. The same imperfect fit is evident between device and medicine manufacturers in the field of advanced therapeutic products too. Regulators in Europe nowadays repeatedly allude to the challenges posed by these cleavages. How long will it take before even more wide ranging mergers between industry associations occur?

Back in the more immediate world of current affairs in strictly pharmaceutical affairs, it is impossible to ignore the fact that Europe is in a heightened state of expectation over the impending release of the proposal for an update of the clinical trials directive, which is still not out as of presstime.

Tightening pharmacovigilance

One of the chief preoccupations of the European Medicines Agency for 2012 will be implementing the EU's new pharmacovigilance legislation and balancing its introduction with budgetary and other resource constraints. From July 2012 it will start putting the plan into action. The new Pharmacovigilance Risk Assessment Committee will have its inaugural meeting in July, and the revised Coordination Group will start operating in September, at the same time that the agency begins to use the new urgent procedure and public hearings.

It won't be simple. The agency will give priority to the elements in the legislation that contribute to public health. The next priority will be activities increasing transparency and improving communication. Only after that, if resources allow, will attention be given to simplification measures.

As if that wasn't complex enough, the European Union is also aiming to introduce yet more pharmacovigilance legislation this year. The proposal, which tightens up drug monitoring rules, and, notably, prevents companies from discreetly withdrawing products without any clear explanation, was the sole focus of the EU Council's working group on pharmaceuticals, which met in Brussels in mid-January. The new elements are designed to plug the loopholes that were revealed as the Mediator safety case unfurled in France.

Early last year, EU officials initiated stress-tests to see how far their newly-adopted drug-monitoring rules were capable of preventing another similar case. The tests showed gaps, which is why these additional proposals were quickly put together. In addition to requiring companies to explain any product withdrawal, these planned changes will provide for an automatic pharmacovigilance procedure. This will apply even to products that have not been authorized through the European Medicines Agency's centralized procedure.

The automatic check is intended to come into effect "in the cases of specific serious safety issues with nationally authorized products, with a view to ensuring that the matter is assessed and addressed in all member states where the medicinal product is authorized."

Electronic health records

Look for an increasing shift towards electronic data use. A European survey claims wide support for using electronic health records for clinical research. One of the projects supported by the Innovative Medicines Initiative checked out opinions among researchers in academia; the pharmaceutical industry; system providers; and patients' organizations, and it reports that more than nine out of 10 respondents favor this approach. The goal of the project is to come up with a platform and business model to enable the re-use of data from such records for clinical research in Europe. Most of the responders to the survey highlighted the need to ensure that using electronic records is not going to fall foul of legislative, regulatory, ethical, and privacy requirements. But the impartiality of the results may be influenced by the nature of the project, whose title is a clear indication of its intention: Electronic Health Records for Clinical Trials.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.