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?
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.