New EBE-EFPIA study demonstrates benefits of personalised medicine for patients, society and healthcare systems and makes recommendations for equitable access for patients in Europe
The European Biopharmaceutical Enterprises (EBE) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) released today the outcome of the evidence-based analysis on personalised medicine carried out by Charles River Associates on their behalf.
Personalised medicine is defined as “a medical model using characterisation 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 report aggregates considerable evidence on the benefits of a personalised medicine approach. It gives concrete examples of, among others, improved efficacy of medicinal treatments, better prevention and prediction of diseases, reduced hospitalisation, and more effective and ethical clinical trials.
Based on the analysis of the available evidence, the report makes five policy recommendations which ask for:
- A coherent prioritisation of personalised medicine that goes hand in hand with existing health strategic plans;
- A continued emphasis on better management of care, coordination of expertise and resources to ensure an adequate “personalisation of care”;
- A continued investment and cooperation in next generation testing infrastructure (such as molecular genetic laboratories) as well as developing dedicated funding pathways to ensure access to diagnostics;
- A consistent diagnostic testing infrastructure throughout Europe;
- Better alignment of data requirements between regulators and health technology assessment (HTA) bodies to improve evidence development and facilitate the value assessment process.
“Despite its well known benefits, personalised medicine in Europe still faces a wide range of challenges that are highlighted in our report,” says Barbara Freischem, EBE Executive Director. She added: “The five policy recommendations that we have identified are critical for personalised medicine to thrive in Europe”.
Nathalie Moll, EFPIA Director General, highlighted that “implementing the policy recommendations identified in the report is essential to ensure an equitable access for patients to such innovative medicines”. She concluded by saying that “the pharmaceutical industry stands ready to support Member States and the European authorities in their strategy for an improved ‘personalisation of care’ for the benefit of patients in Europe”.
The report is available HERE.
The accompanying slide deck is available HERE.
The report was funded by voluntary contributions of the 10 following members of EBE and EFPIA: Association Innovative Medicines (National pharmaceutical industry association of the Netherlands), AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Genomic Health, Merck KGaA, Novartis, Roche, Roche Diagnostics.
The European Biopharmaceutical Enterprises (EBE) represents the voice of biopharmaceutical companies of all sizes in Europe and is a specialised group within the European Federation of Pharmaceutical Industries and Associations (EFPIA). Established in 2000, EBE is recognised as the leading biopharmaceutical association in Europe. To learn more about EBE, visit www.ebe-biopharma.eu
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world. To learn more about EFPIA, visit: www.efpia.eu
Barbara Freischem, Executive Director
European Biopharmaceutical Enterprises – EBE
Tel: +32 2 626 25 64
 Council conclusions on personalised medicine for patients published in December 2015.