Just as 2011 was drawing to a close—and, by coincidence, on the same day that the fate of Europe's single currency was under
discussion at yet another make-or-break summit of Europe's leaders—the Director General of EFPIA made an ostentatious bid
to persuade European policymakers to adopt a more ambitious approach to considering the future for healthcare and medicines.
Richard Bergström, still new in his post, lacks nothing in terms of style. He had issued hundreds of printed invitations to
the "first annual EFPIA Director General's lecture," in one of Brussels' largest and most prestigious venues. His chosen theme
was, "Is society ready for the new science," and his discourse ranged across the opportunities that pharmacogenomics and personalized
medicine offered. But his optimism was shot through with warnings of unfulfilled potential, unless a better fit could be engineered
between the challenging new developments in medicine and the inertia and lack of imagination that current regulatory systems
Much of Bergström's thesis is well known and uncontroversial. Disease patterns are changing, development costs are rising,
payers remain increasingly cautious about reimbursing innovations, many diseases remain untreated ... But he departed from
the customary narrative with his flat rejection of the widely held view that there is any crisis in discovery. Research output
remains good, he said, brandishing recent examples of effective new therapies in fields ranging from hepatitis to melanoma.
The real crisis, in his view, is that the collective efforts of the pharmaceutical industry are not meeting the collective
needs of society, because the signalling between the two is deeply imperfect. The organizations that make regulatory or funding
decisions on behalf of society are ill-coordinated between one another within countries, and across the international market
from country to country, and their approaches to innovation are clumsy and insensitive. In consequence, industry reacts to
ill-judged constraints and incentives, and the pathway to the clinical exploitation of new science is obscured or strewn with
unnecessary and inappropriate obstacles.
Bergström provided fewer answers than questions. His chief objective, it seems, was to issue a cry of alarm, and to provoke
What's in Store?
As 2012 opens up before us, what are the chances of a happier new year? There is certainly no lack of activity programmed
at a European level in relation to healthcare and the provision of pharmaceuticals. Brussels bristles, it might be said, with
plan and projects.
Among the first to emerge—perhaps this month, even as you read this—will be the legislative proposal to update the European
Union's rules on pricing and reimbursement procedures: the Transparency Directive. Delayed from 2011 by last-minute haggling
among EU officials over how far it is reasonable to oblige national authorities to come clean (and move more quickly) on reaching
their decisions, this measure will offer no panacea to the sort of problems that keep Bergström awake at night. It is largely
procedural in effect, since it leaves intact the autonomy that each EU member state enjoys over what prices and reimbursement
levels it chooses to set for the products on its market.
However, this largely administrative measure will catalyze and focus much wider discussion during the year on some of the
fundamental issues of healthcare economics. It might be legitimate, for instance, for national authorities to take a little
longer to reach a reimbursement decision if they are going to conduct a fuller assessment of the overall value to the healthcare
system of a particular innovative treatment. But that raises questions about what approach they might be using, how valid
its methodology, how rigorous its application, how comparable or compatible it may be with methodologies being employed by
national authorities in other countries (and, a fortiori in the EU, in other EU member states—that in theory constitute a single market).
Step forward at this point the EU's network on health technology assessment, EUnetHTA, which has been struggling over the
last few years to come up with harmonized—or, at any rate, soundly based—approaches to evaluation. The same day that Bergström
was stoking the fires of controversy in Brussels, EUnetHTA was holding its annual conference in Gdansk, Poland, to debate
European collaboration in policymaking on health technology assessment in national and cross-border healthcare. The industry
is cautious about the developments in this area, and at the very moment Bergström was addressing his audience, his federation
(along with half a dozen other European health industry federations) released, in Gdansk, a highly skeptical analysis of the
process, accompanied by an unambiguous demand for industry to be admitted to the magic circle that is developing and applying
health technology assessment. 2012 will see battle joined across a broad front in this fight for influence over the way that
decisions vital to the industry are made, and on what basis.