#Health: Personalised medicine advocates reach out to Poland and Italy 

The European Alliance for Personalised Medicine’s (EAPM) latest SMART Outreach meetings are taking shape to set up an Alliance presence nationally, writes EAPM Executive Director Denis Horgan.

The Alliance’s June 2015 conference introduced the ‘*SMART*’ concept, which stands for *S*maller *M*ember states *A*nd *R*egions *T*ogether, and EAPM has been expanding this by taking its message directly to EU countries.

All outreach events follow on from EAPM’s original *STEPs* campaign - *S*pecialised *T*reatment for *E*urope’s *P*atients - which calls for the EU to commit to:

• STEP 1: Ensuring a regulatory environment that allows early patient access to novel and efficacious personalised medicine
• STEP 2: Increasing R&D for personalised medicine, while also recognising its value
• STEP 3: Improving the education and training of health care professionals
• STEP 4: Supporting new approaches to reimbursement and HTA, required for patient access to personalised medicine
• STEP 5: Increasing awareness and understanding of personalised medicine.

Successful outreach events have already been held in Poland, Austria and Bulgaria with two more coming up shortly - Poland, for a second time (1-2 March in Warsaw), and Italy (7 March in Milan).

Click here for the agendas for Italy and here for the Agenda for Poland.

These agendas reflect the barriers to fully integrating personalised medicine into EU healthcare systems, not least of which is patient access.

Speakers in Milan will include Gianluca Vago, Rector of University of Milan, Beatrice Lorenzin, Italian Ministry of Health, Mario Melazzini, President of Italian Medicine Agency, and David Byrne, former European Commission for Health and EAPM Co-Chair.

Speakers in Warsaw include Prof. Zbigniew Gaciong, Chair, Polish Association for Personalised Medicine, Prof. Jacek Fijuth, Chair of the Polish Oncology Association and a member of Polish Alliance for Personalised Medicine, and Jacek Graliński, Public Affairs Director, AstraZeneca Poland.

Although Brussels-based – which helps to better engage with the European Commission, EU permanent representations and the European Parliament in the ‘Capital of Europe’ – EAPM believes it is time to place its feet firmly on the ground in more EU countries, in order to expand its work with the multi-stakeholder groups, and nations, that form its membership.

Last year, the European Union had two of the smaller member states as its rotating presidencies - Latvia and Luxembourg (which published landmark Council Conclusions on personalised medicine in December 2015) - and now a third smaller country, The Netherlands, is at the helm.

Europe’s health policies need to recognise and tackle the inherent health system vulnerabilities faced, specifically, by smaller countries and in the regions of the larger ones. EAPM therefore calls for adoption of its SMART approach.

Already the idea has been a great success, involving medicines bodies, national health ministers and cross-sectional stakeholders, all working with EAPM to move personalised medicine to the next.

The SMART Outreach programme aims to establish the direction required to facilitate an environment for personalised medicine at national level. This includes (but is not exclusive to):

• Implementation of EU regulatory instruments at the national level (data protection, clinical trials and the future in-vitro diagnostics)
• Harmonisation of research between Member States
• Better and common guidelines on various diseases
• Patient empowerment and health literacy
• Genomics in the health arena
• National Cancer Plans/biomarkers.

Already, due in part to the consultation with the Alliance and other stakeholders, the European Commission, Parliament and Council have combined to move new legislation along nicely and great progress has been made in the huge areas of the Clinical Trials Directive, Data Protection Regulation (DPR), Big Data issues, and the legislation on In Vitro Diagnostics.

Meanwhile, Horizon 2020 rolls on, the Innovative Medicines Initiative second phase (IMI II) is now under way and even the Commission’s relatively new Semester process could aid health care systems if used wisely and in a forward-thinking manner, allowing opportunities for investment, training, research and focusing on sustainability.

With personalised medicine, the world is on the cusp of a revolution in healthcare. But not to be forgotten is the fact that, in the changing world of health care in Europe, a key element is the education of health-care professionals.

The true potential of all of the new science, built around genetic profiling and individual DNA, will never be fully realised unless the front-line clinicians have the knowledge and understanding to exploit it.

The EU needs to make moves in this sphere and the Alliance has called for urgent action.

EAPM will hold its first Summer School in early July (Portugal) and will play its part in helping to address this.

Generally speaking, in the world of health care, personalised medicine is gaining ground at a grass-roots level among health-care providers and, indeed, among patients too. But there are still plenty of barriers, or ‘tensions’.

These include guideline issues, patient power (or lack thereof), end-of-life care (much more matched to what the patient actually wants), and policy engagement (there needs to be a great deal more, which ultimately means getting politicians and civil servants to understand the value and  societal benefits of personalised medicine in an EU of 28 Member States and an ageing population of 500 million).

With all of the above in place, the goal of a healthier and, thus, wealthier Europe will be easier to reach. And that will only be good news for the EU’s patients and potential patients now and well into the future.

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