Personalised Medicine

Personalised medicine aims to deliver the right medicine to the right patient at the right time.
Although there is no universally accepted definition, the Horizon 2020 Advisory Group has defined personalised medicine as “a medical model using characterization of individuals’ phenotypes and genotypes (e.g. molecular profiling, medical imaging, lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time, and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention”. The EU Health Ministers also used this definition in their Council conclusions on personalised medicine for patients, published in December 2015.

Personalised medicine is a therapeutic strategy that departs from the traditional “one-size-fits-all” approach. It addresses the common observation that patients with apparently the same clinical diagnosis or symptoms often show different responses to the same treatment. Thanks to personalised medicine, based on an increased understanding of the molecular mechanism of diseases, we are now better able to sort patients into different groups that will benefit from a different and appropriate treatment.

Personalised medicine has enormous potential to make treatments both more clinically and cost effective. This is especially the case in the area of complex diseases, such as cancer or inflammatory diseases, where only 30 to 50% of patients who were given the treatment benefited from it. Based on the analysis of the molecular mechanism of each patient, personalised medicine helps identify the ones likely to react positively to a treatment and the ones at high risk of severe reactions. Overall, the personalised medicine approach improves safety and reduces the financial burden for healthcare systems.

In 2010, EBE established a Working Group on Personalised Medicine; since mid 2015 it is a joint group with EFPIA. The activities of the Working Group include:

Regulatory input

The Personalised Medicine Working Group develops stakeholder input during the implementation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices, adopted on 5 April 2017. This Regulation has significant impact on the field of personalised medicine through its provisions on companion diagnostics. A companion diagnostic is a key element in the paradigm of personalised medicine – it is the mean that enables the distinction between patients, and supports healthcare professionals in their decision making to tailor the treatment to the patient.

Benefit of personalised medicines to patients, society and healthcare systems

In 2017, the EBE-EFPIA Personalised Medicine Working Group  developed a Manifesto setting out policy elements considered essential to ensure that personalised medicines and their paired diagnostic tests, also called companion diagnostics, successfully reach patients.

Registries and biobanks

The Personalised Medicine Working Group ensures that the European Union is based on a landscape of standardized, well coordinated and connected European registries and biobanks embracing genomics and clinical data with high quality e-health record systems.