Seeing Through the Transparency Directive

May 01, 2011

For such a big subject, it is receiving studiously little public attention. No matter how much pharma executives eulogize the heady prospects for personalized medicine or the protean potential of pharmacogenomics, and no matter how often health authorities intone mantras about access to medicines and equality of care, everything all comes down, at the end of the day, to money. So when the European Union opens up the Pandora's box of its rules on pricing and reimbursement of drugs—the so-called "transparency directive"—you might expect a tidal wave of high-profile comment.

Yet no major debate has exploded across Europe, despite the consultation that the EU launched in March on how those rules might be tweaked to fit the 21st century. Of course, the specialized press, with its keen interest in pharma affairs, revels in exploring how the EU is going to update its 1989 requirements that member states come clean on how they make decisions on pricing and reimbursement. And of course the corridors of Brussels (and most European capital cities with a significant pharma industry presence) are hearing constant mutterings. But for all the importance of pricing and reimbursement, this remains a discreet discussion, away from the glare of TV lights and front-page headlines in the mass-circulation media. Even the usual suspects that journalists routinely turn to for a comment on new developments in European pharma policy have remained oddly silent this time around.

Why is this?

Drumroll Please

One reason may well be battle fatigue. The drug industry depicts itself as (and often, these days, is) at the vortex of malevolent European forces. Certainly it has taken a battering in terms of recent pricing and reimbursement decisions in nearly every country across the continent. And the announcement of a lengthy bureaucratic consultation process on EU rules does not amount to a promise of instant salvation—particularly since the transparency directive has, it must be admitted, only a marginal on-the-ground influence on the fate of most products.

This, of course, is an obvious second reason for the apparent indifference. The ambition of the transparency directive is limited. Its essential purpose is not to guarantee that drug firms get decent prices. It was designed merely to oblige the member states to provide clarity on their national procedures and criteria, and to observe time limits for reaching decisions. So even if the directive was working well—and for the last 20 years it certainly hasn't— it would not be a determinant influence on the health of the industry. And since most of the EU's 27 member countries (nearly twice the number of members in 1989, when the legislation was adopted) frequently ignore its requirements, the chances are slim of nirvana resulting from a review of its functionality.

Another possible reason for the low-key response is that the initiative springs from the much-criticized European commissioner responsible for industry, Italy's Antonio Tajani. This man is widely perceived as overpromoted and underachieving, and many in the pharmaceutical industry are hesitant about engaging too closely in any of his projects. Those who, for good or ill, are obliged to study these things will recall that Tajani was robbed of responsibility for pharmaceuticals in the last big reshuffle of the European Commission. Ever since then he has tried to recoup some of those losses (the pharma sector is, after all, one of the jewels in the crown of European industry).

But some of his interventions have proved difficult to comprehend, even for those with years of weary experience of reading the Brussels runes. He has, for instance, embarked on a curious venture into pharmaceutical industry territory that claims simultaneously to combine corporate social responsibility with access to medicines in Europe and medical assistance to the third world. All worthy goals, no doubt, but it is no surprise that European pharmaceutical executives are keeping a cautious distance from the initiative at present. That sentiment may well be conditioning industry's response to his consultation on the transparency directive.

lorem ipsum