Personalised medicine — challenges of authorisation and reimbursement

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Personalised medicine is a very promising and cutting-edge approach that Taylor Wessing recently discussed from a patent law perspective in its Synapse October edition.

In principle, personalised medicine refers to a classification of individuals into sub-populations that differ in their susceptibility to a particular disease or their response to a specific treatment. Preventive, diagnostic or therapeutic interventions can then be tailored to the individual characteristics of patients who will benefit, sparing expense and side effects to those who will not.

A predictive biomarker — such as a particular genetic characteristic, which is causally linked to the disease — can play a crucial role in classifying patients in sub-populations. As regards the suitable therapy with a medicinal product or a range of medicinal products, so-called companion diagnostics are essential to and specifically intended for the selection of patients with a previously diagnosed condition or predisposition. To date, more than 30 ‘personalised’ medicinal products are sold on the German market for which a prior diagnostic test is either mandatory or recommended…

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