Personalized Medicine: Experts Present New Recommendations
Personalized medicine (PM) offers up the possibilities of a world where treatments are tailored-made to suit each individual patient according to his or her genetic make-up. But there are legal and ethical conundrums to solve as well, such as the ownership of medical data or the question of individual vs. state responsibility for health care.
European recommendations presented at the European Health Forum Gastein include developing suitable models for research to increase the understanding of the biology involved in PM and supporting new methods for the pre-clinical and clinical development phase of a treatment. A coordinated European research approach would guarantee that the potential benefits of PM can be rolled out to citizens regardless in which EU country they live, experts said.
Personalized Medicine Is Up and Coming
2004 saw the publishing of a mere 38 articles on this topic, compared to more than 800 in 2013, Prof. Dr. Angela Brand, Institute for Public Health Genomics (IPHG) at Maastricht University told the European Health Forum Gastein (EHFG). Personalised medicine refers to a concept that uses molecular profiling for several purposes: "To tailor the right therapeutic strategy for the right person at the right time; to determine the predisposition to disease; and to deliver timely and targeted prevention." The advantages of such an individualised approach are easy to see: chance of early diagnosis, fewer adverse drug reactions, increasing therapeutic efficiency that may result in cost savings, to name but a few. "Personalized medicine can also be seen as encouragement of patients to be more active in their health management und feel greater ownership in the responsibility of their health", according to Prof. Brand.
However, "we are still only at the beginning", cautioned the expert. For instance, one large stumbling block is the "inherited fragmentation between EU member states, inadequate communication and lack of common vision on the solution. Appropriate governance levels are required to solve these challenges", said Prof.
Brand. "As no European country can develop PM alone, we have the chance here to show the benefit of a European research approach to our fellow citizens. By joining the European research capacities, we could prepare Europe for leading the global way. When it comes to applying the results of this research to health and care, this could also develop into a unique European business model in which small and large European countries and their citizens can participate equally."
Coordination & Support Action
This is where the Coordination & Support Action (CSA) PerMed comes in, CSA-coordinators Dr. Ulrike Bußhoff and Dr. Wolfgang Ballensiefen explained at the EHFG. "PerMed was initiated to step up coordination efforts between European key stakeholders in order to allow synergies and avoid duplication or competition," Dr. Bußhoff explained. PerMed developed a broad range of recommendations to overcome hurdles and to foster PM at the European level. "They include, inter alia, developing suitable models for research to increase the understanding of the biology as the basis for PM, promoting models for the individual ownership of personal health data and supporting research for adequate regulatory pathways", said Dr. Ballensiefen. Other suggestions involve supporting new methods for the pre-clinical and clinical development phase of a treatment, e.g. tools that allow translation into humans with more predictability and accuracy.
The question of data ownership also encompasses the ethical dilemmas to be solved, Dr. Effy Vayena, Institute of Biomedical Ethics at the University of Zurich, told the EHFG. "Currently, we are clearly operating in a grey area concerning the consent, ownership and secondary usage of medical data." The expert suggested utilising human rights as framework to address these issues.
"Electing Health - The Europe We Want" is the motto for this year's EHFG. Around 600 participants from more than 50 countries are attending the most important health policy conference in the EU to exchange view on key issues affecting European health systems. The future direction of European health policy is the key topic on the conference agenda.