Device links to diagnostics
In his draft report on the proposals on diagnostics, German physician and MEP Peter Liese has also urged particular attention
to companion diagnostics, and is insisting that they should comply with the new rules. He is also advocating further toughening
up of the rules, because in vitro diagnostics, far from being the poor relations of the medical sector, "may be the parents
of all therapies, including pharmaceutical products and surgery." Arguing that without a proper diagnostic there is no proper
treatment or prevention of diseases, he goes on to conclude that the proposed rules fall short in their coverage of clinical
testing—and to recommend further provisions on ethics assessment and on informed consent.
Liese also makes an explicit link with the aspect of these proposals that has the most significant implications for pharmaceutical
executives. With the recent progress in medical science, companion diagnostics represent a key tool in evaluating whether
a specific therapy will work in a specific patient, he says. And he points to "the huge opportunity of personalized and stratified
medicine" that this opens up. This "needs to be addressed properly," and while the commission proposal "is a good base," it
"needs to be further clarified."
The clarification Liese calls for is long awaited—and not just in relation to companion diagnostics, but in relation to personalized
medicine in general. But here pharmaceutical executives in Europe are still awaiting a crucial paper from the commission,
announced five years ago, but still not finalized. According to the latest draft, in vitro diagnostics represent one of the
principal hopes for promoting personalized medicine.
The paper, entitled "The Use of '-omics' Technologies in the Development of Personalized Medicine," suggests major new opportunities
for the treatment of patients in the European Union, with better targeted treatment, fewer medical errors, and reduced adverse
reactions. And it argues for greater attention to diagnostics, rather than merely focusing on therapies. "A better consultation
process for companion diagnostics intended to assess patient eligibility for treatment with a specific medicinal product will
improve coordination of regulation relating to pharmaceuticals and diagnostics," it says.
Meanwhile, without the benefit of the commission's final version of its strategy paper, the debates on devices, diagnostics,
and the future of the drugs industry roll onwards. And as they roll, they are likely to start rolling very soon across the
paths of many pharmaceutical executives too.
Reflector is Pharm Exec's anonymous columnist, a commentator so close to the action in Europe his identity must be kept secret.