Personalized Medicine -- Now You See it, Now You Don't


Applied Clinical Trials

Europe’s on-off relationship with personalized medicine continues its uneven course, with the latest expression of ambivalence coming just this week from the Europe Union’s health commissioner, John Dalli.

“Personalized medicine offers tremendous opportunities for better care”, he said in the European Parliament in Brussels. He went on to recite the customary litany of expectations: targeting the right patients with the right medication, reducing non-responses and side effects, avoiding suffering and waste of money...

But then he went into the ‘buts’. And there are plenty of them. “Much remains to be done to exploit the potential of personalized medicine to the full”, said Dalli.

The first target in his own personalized approach to policy was industry. “A great deal of research and development is necessary.  Efforts by the pharmaceutical and the medical devices industries need to be stepped up, and collaborations and partnerships between academia and industry enhanced.”

Then there was the regulatory environment. Here he was less critical – because this is the area he is responsible for. “The EU legal framework for pharmaceuticals enables industry to bring safe, efficacious and quality medicines to the market”, he claimed. In addition, since personalized medicine relies so closely on inter-linkage between pharmaceuticals and companion diagnostics, the Commission is just about to propose an upgrade to the EU rules on in vitro diagnostic medical devices, “to bring the clarity and legal certainty necessary to pave the way for innovation in this field.” He also said he was “confident that the commission's recent proposal on clinical trials will also contribute to the development of personalized medicines.”

Dalli’s biggest ‘but’ was reserved for the funding implications of widespread use of personalized medicine. “There are critical economic issues which could negatively affect availability”, he cautioned. “With unit costs predicted by some to be prohibitively high for many, the possibility of a widening impact on health inequalities is a worrying prospect”.

The commissioner’s enthusiasm was, to say the least, rather ambivalent. “Whilst we hope that the potentially high costs of personalized medicine could be compensated by efficiency gains for public health budgets, such hopes might not be enough,” he announced.   

In addition, Dalli confirmed that an assessment of the scope and potential of personalized medicine that he had promised for mid-2012 will not appear on schedule. “The Commission will contribute to the necessary on-going discussion with a report on personalized medicine next year”, he said.

The ambivalence of his remarks was all the more remarkable since he was speaking as the celebrity guest at the launch of a manifesto by the European Alliance for Personalised Medicine. This recently-launched initiative brings together health professionals, academics, industry, patient organizations and officials in a bid to promote the interdisciplinary collaboration that progress in this field is going to demand.

To judge from the mitigated support of Dalli on this auspicious occasion, one of the first areas that should be targeted for fuller collaboration is the European Commission itself!

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