Personalized Medicine Yet Again Expecting a European Boost

Applied Clinical Trials, Applied Clinical Trials-04-01-2021, Volume 30, Issue 4

A new partnership, to be known as EP PerMed, aims to bring public and private sector interests together.

A European Partnership on Personalized Medicine is about to be born—to add to the list of European-flavored but often unproductive and ill-digested initiatives in this contentious field. The new partnership, to be known as EP PerMed, aims to bring public and private sector interests together to set priorities for research funding, align the current diversity of personalized medicine strategies, develop educational and literacy strategies, and support policy development.

It is the latest stage in Europe's long and occasionally meandering exploration of personalized medicine that has left it still trying to chart a clear route. The EU organized a series of desultory conferences a decade ago, then ventured into framing a plan in a 2013 working document entitled "Use of '-omics' technologies in the development of personalized medicine". This boldly concluded that EU pharmaceutical legislation "is flexible enough to address current needs and to authorize personalized medicines in a timely manner," and confidently predicted that "the revision of the Clinical Trials Directive is expected to simplify the conduct of clinical trials and consequently facilitate the authorization of research in therapies using personalized medicine." With that update of the clinical trials rules still not in force today, and with a proposal for updating EU pharmaceutical legislation only freshly landed on the table—in which one of the "flagship initiatives" is to adapt to personalized medicine—the complacency and glibness of that early document is all too clearly revealed.

A trail of good intentions litter the European landscape. During its EU presidency in 2015, Luxembourg valiantly persuaded EU health ministers offer formal support for personalized medicine—but the conclusions they adopted stopped short of any meaningful discussion of mechanisms. The International Consortium on Personalized Medicine, which the EU launched at a major conference in Brussels in 2016, was scheduled to produce a roadmap of its future actions by the end of that year but failed to do so, and although it still exists under the guise of ICPermed, it still struggles to deliver. Estonia spent much of its 2017 presidency trying to build a coalition around the concept, to disappointingly little effect. In 2018, Andrzej Rys, a Commission director for health, was still urging the need to engage scientists, health systems, healthcare professionals and patients to "take this innovation into the regulatory framework".

Now personalized medicine is on the point of winning the status of a European partnership under the EU's Horizon Europe research program for the next seven years, which is in the final stages of agreement. ICPermed, which is enthusiastic about the project, says EP PerMed "will have a major impact on enabling personalized medicine implementation for citizens, ensuring that Europe is at the forefront of personalized medicine research and innovation, hand in hand with international partners." And tellingly, ICPermed looks forward to it allowing "the defragmentation of the personalized medicine field."

According to a joint concept paper from ICPerMed and ERA PerMed (yet another EU initiative in the field), the new partnership "will be a prime driver for developing and implementing personalized medicine." "A lot has been achieved in the field of personalized medicine by a large number of international, pan-European, national as well as regional activities and initiatives," they say, but "there is a need of an even closer collaboration and effort which could be achieved by a European Partnership for Personalized Medicine." The two organizations are now jointly preparing guidelines to support "national and regional authorities, ministries, funding organizations and policy makers as well as the stakeholder community in preparation," on which they will also collaborate with (another!) EU initiative, Regions4PerMed. Meanwhile, a new ICPerMed Stakeholder Forum was launched in February, also aimed at sharing of ideas, identifying research fields, setting up new communication channels and "fostering new partnerships & networks."

With so much partnering and communicating and sharing ideas going on—and for such a long time now—with so few evident results other than further partnerships and communication and sharing of ideas, it might tempt skeptics into wondering if personalized medicine was more of a talk shop than a workshop.

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