Many medicines do not work effectively for a large number of the patients they are supposed to treat. A considerable proportion of the differences in individual response may be due to genetics. Personalised medicine uses a person’s individual genetic and other characteristics to arrive at “the right diagnosis, the right treatment, at the right dose, to the right patient, at the right time”. Ultimately, personalised medicine represents a shift from reactive to proactive, pre-emptive, and preventive care (Source).
Personalised medicine has emerged in recent years as a topic of interest at EU level. EPF initiated background work in this area in 2010, based on discussions within the Policy Advisory Group, and following EPF’s involvement in a workshop on the topic organised by the European Commission’s Directorate-General for Research and Innovation.
EPF’s key message is that patients need to be fully engaged from the very start of the process of developing innovative treatments in order to be able to identify real unmet needs. Moreover, innovative treatments should be available to all on an equitable basis. A number of issues need to be solved when it comes to translating scientific developments into clinical practice and patient care: these are legal, ethical, political and economic in nature and require wide public debate.
A clear regulatory framework is needed at national and EU level in order to ensure timely and equitable access for patients to personalised therapies; avoid discrimination of patients on the basis of genetic information; and monitor and regulate any commercial use of genetic/genomic information. The involvement of patient groups will be key in developing a patient-centred future regulatory framework.
In 2011, EPF developed this topic further through background research and participation in various events.