Luxembourg pushes personalised medicine agenda

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

Today, the first of July, Luxembourg takes over the rotating presidency of the European Union. The Duchy was one of the six founding member states of the organization that eventually became the 28-country EU that we know today.

As it turns out, current European Commission President, Jean-Claude Juncker, spent many years as Luxembourg’s prime minister and, thus, has been involved at European Council level for a great deal of time.  One of the key elements – a thematic focus – of this presidency, which runs until 31 December, is the exciting new world of personalised medicine, and EAPM (the European Alliance for Personalised Medicine) has been instrumental in putting personalised medicine on the EU map and will be actively participating in the high-level conference taking place in the Duchy’s capital next week (8 July). 

The results of this meeting will eventually feed in to Luxembourg’s Council Conclusions in December this year and this ties in perfectly with EAPM’s ‘SMART’ agenda. SMART 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 cooperate to pool resources. 

At EAPM’s recent third annual conference in Brussels, Luxembourg’s health minister, Lydia Mutsch, told a room full of stakeholders 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 healthcare.  “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 healthcare professionals, she said. This will allow front-line professionals to engage more closely with patients over treatment issues and options.  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, harmonized 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.  The subject of clinical trials, meanwhile, is a difficult one. More-and-more rare diseases are being discovered and the patients who have them should have as much entitlement for new drugs and high-quality treatment as anyone else.  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. 

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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 development of personalised medicines requires developments in health technology assessment that will support timely patient access. And it’s all about the patient, remember…  At EAPM’s SMART conference, the minister also said that it is Luxembourg’s view that public-private partnerships, such as IMI, are vital in supporting pioneering research. 

The minister is correct, as identifying different and distinct diseases and developing the appropriate tests to diagnose them, as well as the treatments to tackle them, requires a large-scale research and innovation effort involving all key players in drug development.  Public-private partnerships can drive forward personalised medicine research, benefiting from wide expertise and input, and knowledge that can be rapidly exploited by all key groups. 

IMI has more than 40 projects that are delivering results with an impact on all aspects of the drug development procedure, from adding to understanding of the underlying biology of diseases, through the identification of potential drugs and testing for safety and efficacy, to the design of clinical trials.  The future has arrived. Personalised medicine is here to stay. EAPM congratulates the Luxembourg Presidency on its commitment to a new form of diagnosing, medicating and treating, that will give the right treatment to the right patient at the right time.

This in turn will bring benefit to the EU’s 500 million potential patients now and into the future.

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