Medicinal products for human use
Personalised medicine is a medical model that aims to provide tailor-made prevention and treatment strategies for defined groups of individuals. While there is no universally accepted definition, the EU Health Ministers in their Council conclusions on personalised medicine for patients, published in December 2015, 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.
Personalised Medicine should be seen as an evolution of medicine, rather than a revolution, and many challenges remain before its successful application across healthcare systems.
New genetic technologies such as pharmacogenomics, often summarised under the term -'Omics' enable scientists to use patients' genetic information to better determine the right active substance, dose and time. The emergence of these technologies marks a step closer to personalised medicine.
The EU 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 worked well for innovative products including therapies relevant to personalised medicine.
There are a number of additional EU instruments that support the development of personalised medicine.
- The in vitro diagnostics and medical device legislation aims adapting the EU legislation to the technological and scientific progress in this sector and introduce a better consultation process for companion diagnostics
- The general data protection regulation aims to make the EU legal framework in this area fit for new scientific concepts
- The clinical trials regulation aims to simplify the conduct of clinical trials and consequently to facilitate research in therapies using personalised medicine.