But the prospects for personalized medicine that Bergström evoked are also going to be governed in part by how regulation
relating to product authorization is adapted. And again, a major discussion will start early in 2012, when the EU is due to
make its proposals for revising its 2001 rules on clinical trials.
In this area, even the EU's commissioner for health, John Dalli, recognizes the need for change. "We will have to look into
whether improvements are needed to make personalized medicine products more rapidly available to patients," he admitted last
month. "For example, does a defined or limited patient population pose additional challenges for conducting clinical trials?"
he mused. The revision of the current clinical trials rules will open a Pandora's box of fevered debate on the very essence
of what testing methods are appropriate for selected patients—and how such trials can make effective comparisons with standard
treatments, or how far their results can be extrapolated to wider populations.
Developments in personalized medicine will also depend increasingly on new approaches to companion diagnostics—and that too
imposes the need for radical changes in the regulatory environment. Here too, Dalli accepts the principle and anticipates
upcoming debates: "The regulatory pathways for the placing on the market of medicinal products and of diagnostic medical devices
are different because the nature of the products regulated is different," he noted, looking ahead to the planned 2012 revision
of the EU's medical devices legislation as "an opportunity to ensure that diagnostic medical devices used in the context of
personalized medicine offer the appropriate level of safety and performance." In addition, his officials are already engaged
in preparing a major report that Dalli is committed to present in the middle of 2012 on the use of 'omics' technologies in
pharmaceutical research and development.
At the same time, 2012 will see crucial reports presented on some of the other broad Brussels-sponsored programs already under
way in Europe. The EU's self-styled "flagship" program on exploiting innovation to assure healthy aging will come of age with
the implementation of a strategic implementation plan agreed to in late 2011 by the pharmaceutical industry and other organizations
in the partnership. So too will the EU's e-health program, which is dignified by the personal participation of no lesser a
figure than GlaxoSmithKline's Andrew Witty. A major new public/private partnership to fill the gaps in the antibacterial armamentarium
will get under way. And a dozen working groups set up by the European industry commissioner—on subjects ranging from biosimilars
to ethics, and from OTC switching to managed entry schemes—are due to finalize their work.
It will be a turbulent year for pharmaceutical policy in Europe. Whether Bergström's hopes will be realized for a profound
rethink of the approach to new science is doubtful—but rather like his speech, 2012 is a year that will certainly pose a lot
of new questions. As to whether the EU's single currency will survive long enough to pay for the exploitation of any of these
new opportunities, this columnist declines to speculate.
Reflector is Pharm Exec Europe's anonymous columnist, a commetator so close to the action in Europe that his identity must remain secret