Medicinal products for human use
EC Report highlights the potential of Personalised Medicine
On 31 October 2013, the Commission published a report that takes stock of the progress made in personalised medicine, and the opportunities and challenges it presents for healthcare systems.
The report focuses on:
- the potential for, and issues with, the use of '-omics' technologies in personalised medicine, and the related EU research funding;
- recent developments in EU legislation for placing medicinal products and devices on the market; and
- factors affecting the uptake of personalised medicine in health care systems.
The report concludes that personalised medicine has the potential to offer new treatment opportunities for the benefit of patients, including better targeted treatment, avoiding medical errors and reducing adverse reactions to medicines. It also recognises the challenges (e.g. in research) to its successful incorporation into healthcare systems.
What is personalised medicine?
Although no official definition of personalised medicine exists, it can best be explained as a medical approach which is tailored to the patient or a group of patients – for prevention, prediction and treatment. In other words, it moves away from the common "one size fits all" medical model.
How does the EU support personalised medicine?
Since 2007 the EU has committed over €1 billion of health research funding underpinning the development of personalised medicine through its Seventh Framework Program for Research and Technological Innovation. Going forward, funding under Horizon 2020, the EU's new framework program to be launched at the end of this year, will continue to support this field.
A constructive legal framework has also contributed to the development of personalised medicine. The regulatory framework for pharmaceuticals offers a number of tools and procedures to ensure that medicines placed on the market are of high quality, safety and efficacy. These tools, complemented by scientific guidelines and expert evaluation, have already worked well for innovative products including therapies relevant to personalised medicine.
The ongoing revisions of important pieces of legislation address certain challenges identified in the development of these therapies. The revision of the medical devices legislation will strengthen the legal framework of in vitro diagnostics and introduce a better consultation process for companion diagnostics to assess patient eligibility for treatment with a specific medicinal product. The revision of the Clinical Trials Directive is expected to simplify the conduct of clinical trials and consequently facilitate research in therapies using personalised medicine.
Finally, EU-level cooperation on Health Technology Assessment can help Member States assess the value of using personalised medicine in their health systems, i.e. judge whether their benefits will offset their costs through efficiency gains.
Personalised Medicine should be seen as an evolution of medicine, rather than a revolution, and the report recognises the challenges (e.g. in research) associated with its successful entry in healthcare systems. The European Commission will continue to monitor the developments of personalised medicine in the coming years and maintain a fruitful dialogue with stakeholders.