Drug Information? Forget it!


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-07-01-2012
Volume 21
Issue 7

Proposed rule changes on public information in Europe never make it to fruition.

If any managers were worried that they might have to divert resources away from clinical trials to meet the requirements of new European rules on information to the public, they can relax. That's one set of rules that is not going to happen anytime soon.

Peter O’Donnell

Not that this particular legislative initiative of the European Union presented any major threat to the operation of clinical trials—the connection between information to the public on prescription medicines and the development of new medicines is only indirect. But the saga of this ill-fated piece of legislation does say something about the navigational capacity of the European Union in the healthcare field—and that is a message that no one working in pharmaceuticals should ignore.


To start from the end, the conclusion of this long-running bid to update EU rules on medicines information came late in June, at a meeting of EU health ministers. Like the chronicle of a death foretold, a statement to the ministers frankly admitted "widespread skepticism among member states towards these proposals originally presented in December 2008."

The statement came from the Danish health ministry. Denmark has presided over meetings of EU ministers since the beginning of this year, taking its turn in the EU's bizarre rotating chair, which gives a different member state the privilege—or purgatory—every six months. It went on to note that, in its role as the presidency, instead of immediately accepting defeat, it had "decided to explore possible ways of taking the proposals forward through bilateral consultations with member states." Eventually, bilateral consultations were carried out across nearly all the 27 member states. But, as the statement concludes, "the presidency was not able to identify common ground."

The health ministers meeting could do no more, in these circumstances, than to pronounce the proposal clinically dead. Its passing will not be widely lamented.

From the moment the European Commission published its proposal, there was sharp criticism from nearly all sides.

The European pharmaceutical industry saw risks of additional bureaucracy and cost in provisions to control product information more closely. Associations representing consumers and patients—and the majority of the European Parliament—claimed it represented a charter for direct-to-patient advertising of prescription medicines, which remains a taboo subject in Europe. And national governments feared it would generate huge amounts of work for very little constructive result. Even a late-2011 rejig of the proposals to placate critics (and an emergency re-presentation of them in early 2012) failed to win sufficient support.

Unwanted from the start

The question that this shambles provokes is why the European Commission came up with a proposal that, in the end, nobody wanted.

It was Günter Verheugen, the then-European Commissioner responsible for industry, who proposed it in the first place. His strong sympathies for industry in general were long evident, not least in his open support for the car industry, particularly the big-car manufacturers in his native Germany. When Verheugen's term of office came to an end in 2010, responsibility for the pharmaceutical industry did not pass to his successor, the new industry commissioner Antonio Tajani. Instead, in a re-allocation of responsibilities that delighted health activists across Europe, pharmaceuticals were shifted across from the industry portfolio to the health department within the Commission—which had just become the responsibility of Health and Consumer Affairs Commissioner John Dalli.

Modified proposal

Dalli hesitated slightly at the taste of the poisoned chalice that had been put in front of him, but instead of dashing it to the ground as undrinkable, he promised to listen to a wide range of views before deciding what to do. It took the best part of a year before the European Parliament came up in late 2010 with its damning assessment of the proposal—claiming that it was biased far too much in favor of industry and far too little in favor of patients. Dalli promised to take account of the Parliament's views, which he did very largely, in his recast of the proposals—but it took him another year to get around to that. In addition, when he published his modified proposal in late 2011, he chose to link it with another proposal, on pharmacovigilance, which had been rapidly drafted during the year to plug gaps in the EU drug monitoring system exposed by the Mediator scandal in France.

The modified proposal enjoyed no more success than its predecessor. It was still widely criticized, and—critically—it was shunned by national governments.

In fact, so unenthusiastic were governments that they more or less demanded that it should be stripped away from the pharmacovigilance proposal—which they considered important and urgent—and relegated to a lower priority.

Dalli duly complied with this, and in March this year he re-presented both the pharmacovigilance proposal and the information proposal as separate measures.

Since then, agreement has been reached on the pharmacovigilance proposal among national governments, the European Parliament, and the European Commission (in record time in EU terms). But the information proposal lingered on, unloved and unattended, and has only now, mercifully, been given the last rites and duly buried.

It has wasted a lot of time for a lot of people with many other more important things to do. It has illustrated a serious lack of political sensitivity among the officials that proposed it, and among the officials who subsequently declined to recognize that it was dead in the water.

And it has offered further unwelcome evidence of the inefficiency of the EU's legislative machinery. On top of that, if there were any problems with the provision of information about medicines (and few would maintain that there are not), those problems are no nearer to a solution now than they were back in 2008 when the proposal first emerged.

Dalli's recipes

Anyone wishing to know how firm is the commission's strategic grasp on healthcare need only glance at the pronouncements of Health Commissioner John Dalli.

He admitted in a recent speech that "The European Union is going through a challenging period: we are fighting a long and deep fiscal and economic crisis. At the same time, the aging of our society puts additional strain on our healthcare systems, and health inequalities are widening." He said that these challenges can be met only by "an inspired vision for healthcare."

The growth in healthcare expenditure in the European Union, driven by increasing life expectancy, higher citizens' expectations, and technological innovation, "is unsustainable in the long run," Dalli recognized. "We therefore face a double challenge. We need to contain costs, starting now, while building modern, responsive, and sustainable health systems fit for the future," he observed, before setting out his "personal vision" of how to respond.

Dalli's credo has, he says, three key elements. The first is sustainability and affordability. "Our health systems must—and can—become more cost-effective. We can provide better care at lower cost. The key is to use the vast potential of innovation in products and services. Innovation is not just a cost driver. If used intelligently, it can bring down costs significantly."

High on his list of mechanisms for achieving this goal is the search for a common methodology for health technology assessments. Another is improving adherence to treatment regimes—particularly among older patients; Dalli says that at present only 79% of patients take their "once daily" dose, and only 51% of patients required to take four per day actually do so. And he places great reliance on the prospects for e-health.

The second element is availability and universal access. He says he is determined to fight "the growing health inequalities in Europe," emphasizing that universal access to necessary healthcare is indispensable. One of the initiatives he has taken in relation to pharmaceuticals is to start an inquiry into why smaller markets sometimes suffer from lack of availability of some medicines.

The third element consists of a combination of quality and safety. "The healthcare that patients receive in the European Union must be of the highest quality, and it must be safe," Dalli says—citing the new pharmacovigilance legislation and efforts to combat falsified medicines as examples of what he is doing.

Unfortunately, on the one subject of most interest to readers of Applied Clinical Trials, he has revealed little of what is planned for the impending review of the EU clinical trials rules. But there is talk in Brussels that the long-awaited proposal may emerge in July. Watch this space!

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

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