Landmark personalised medicine conference under Luxembourg presidency

By European Alliance for Personalised Medicine Executive Director (EAPM) Denis Horgan

Last week, on the first of July, Luxembourg took over the rotating presidency of the European Union. On 8 July, a landmark high-level conference will take place on personalised medicine. This is one of the key elements of the presidency, which runs until 31 December.

Brussels-based EAPM (the European Alliance for Personalised Medicine) has been instrumental in putting personalised medicine on the political map and the results of the conference will eventually feed in to Luxembourg’s Council Conclusions in December this year.

It ties in perfectly with EAPM’s ‘SMART’ agenda, which stands for Smaller Member States And Regions Together, and it is clear that Europe’s smaller nations have a disproportionately large part to play in the facilitation of personalised medicine, not least because they are more likely to co-operate to pool resources.

Luxembourg’s Health Minister Lydia Mutsch, who will attend the meeting, said at EAPM’s conference in June that: “The exciting field of personalised medicine is, and should be, all about the patients. It offers the opportunity for them to be seen not merely as passive recipients of care but as participants, partners and even guides in their own health care.

“Involving patients in treatment-related decision making is in line with the increasing acknowledgement of their right to autonomy and self-determination. For personalised medicine to reach its full potential, among many things it needs engaged and informed patients who are encouraged to discuss various treatment options, the possible consequences of those options, and then to arrive at an informed determination about the best action.”

The minister pointed out that success for personalised medicine as a whole will require higher levels of health literacy among patients and the wider population.

There is also a clear need for readiness and updated skills among health-care professionals, she said. This will allow front-line professionals to engage more closely with patients over treatment issues and options.

Both Luxembourg and EAPM believe that it is necessary to formulate a strategy, with patients at the centre and involving EU decision makers in the arena of public health, to enable the EU and member states to contribute to integrating personalised medicine into clinical practice while enabling much-greater access for patients.

The 8 July conference, in Luxembourg City, aims to assess and address obstacles to the integration of personalised medicine into Europe’s healthcare systems, identify best practices and the added value that such an approach can deliver, and outline the potential benefits that a personalised medicine approach could have on public health and its impact on policymaking in the EU.

It is clear that personalised medicine has a great potential for improving the health of many patients and in ensuring better outcomes. Yet, currently, its integration into clinical practice is proving difficult given the many barriers that exist.

On the basis that this exciting new form of treatment is in line with the EU principle of universal and equal access to high quality health care, then clearly it must be made available to many more citizens than it is now.

Personalised medicine is at the heart of societal debate. Recent initiatives in the UK and US have put this innovative method of diagnosing and treating patients in the spotlight while demonstrating that it is necessary to build frameworks that allow the delivery of the right treatment to the right patient at the right time.

Moreover, facilitating better-targeted and more cost-efficient treatment - to a potential 500 million patients in 28 member states - is in line with the Horizon 2020 strategy and the aims of the Juncker Commission.

There is no denying that science has led to major advances in the understanding of the role of genomics in diseases, in the discovery of biomarkers, in the development of new statistical methods and in the invention of dynamic tools for collecting real-world effectiveness and safety data. The Brussels-based Alliance has worked hard to bring stakeholders together to find a way through the legislative labyrinth that surrounds these issues.

Luxembourg, and EAPM believe that it is time that clear, harmonised rules applied across the European Union, imposing more rigorous review, but with standards of clinical evidence that balance the risk-benefit profile with the degree of innovation.

Also, greater collaboration is needed between pharmaceutical and diagnostic manufacturers. This must be based on deeper mutual understanding of the differing development timelines and life-cycles, regulatory and reimbursement pathways, and markets and customers.

Meanwhile, more-and-more rare diseases are being discovered and the patients who have them should have as much entitlement to new drugs and high-quality treatment as anyone else.

The development of personalised medicine therefore requires complex international clinical trials involving highly selected patient populations, the collection of human biological material and the use of large databases for bioinformatics.

Europe’s researchers would benefit from research infrastructures able to support large screening platforms to identify the target population, as well as relevant IT tools such as simulation or computer assisted decisions.

And let us not forget the difficulties many patients have in taking part in clinical trials of any size. A great deal suffer issues with transport and cost - not just cross-border but often within a Member State - that’s if they even actually learn that they are eligible in the first place.

Elsewhere, the future of personalised medicines requires developments in health technology assessment that will support timely patient access – because it’s all about the patient.

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