Drawing conclusions from Council Conclusions

By European Alliance for Personalised Medicine Executive Director Denis Horgan

As most readers will be aware, the presidency of the European Council rotates among EU member states every six months. 

The current incumbent is Luxembourg. The presidency is responsible for driving forward the Council's work on European Union legislation, while ensuring the continuity of the EU’s agenda, orderly legislative processes and cooperation among the 28 states.

Part of its job is to prepare Council Conclusions on various topics to be delivered at the end of its term in office - in Luxembourg’s case, December. Typically, a Council Conclusion invites member states and/or another EU institution (for example, the Commission) to take action on a specific topic.

These conclusions are often adopted in areas where the EU has the competency to support, coordinate and supplement, for example in the arena of health. The Luxembourg Presidency will publish its Council Conclusions on personalised medicine next month, on the back of a high-level conference held in July and several subsequent discussions.

The conference, entitled 'Making Access to Personalised Medicine a Reality for Patients', addressed obstacles to the integration of personalised medicine into EU health-care systems, identified best practices and their added value and outlined the potential benefits of personalised medicine for public health and its impact on policy-making in the EU.

The high-level meeting also underlined the need to define a patient-centred approach to personalised medicine at EU level, involving decision-makers and regulators in the area of public health, as well as a comprehensive approach integrating the different phases along the life cycle of personalised medicine products in such a way as to facilitate its integration into clinical practice.

The conference was deemed a great success by all participants and will clearly influence the final conclusions. This represents a major step forward for personalised medicine.

Proponents of this fast-moving science believe that the adoption of such conclusions could help to bring about a situation in Europe similar to that in the US, which saw President Obama’s unveiling of the Precision Medicine Initiative, which the White House described as “a bold new research effort to revolutionise how we improve health and treat disease”.

It was launched with a $215 million investment and seeks to “pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients”.

The White House explains: “Most medical treatments have been designed for the ‘average patient’. As a result of this ‘one-size-fits-all-approach’, treatments can be very successful for some patients but not for others. This is changing with the emergence of an innovative approach to disease prevention and treatment that takes into account individual differences in people’s genes, environments, and lifestyles.”

“Precision medicine gives clinicians tools to better understand the complex mechanisms underlying a patient’s health, disease, or condition, and to better predict which treatments will be most effective,” it adds.

As a multi-stakeholder platform representing patients, healthcare workers, scientists, academics, industry and more, the Brussels-based European Alliance for Personalised Medicine (EAPM) welcomed the Obama initiative and is campaigning for similar progress to be made across the EU’s 28 member states for the benefit of its 500 million potential patients.

The Alliance also played a major part in the Luxembourg Presidency’s summer conference, has given coordinated input into many policy matters ranging from data protection, to IVD and clinical trial regulations, and is awaiting the Council Conclusions with interest.

These Conclusions - on ‘Facilitating access to personalised medicine’ - are expected to ‘recall’ that, under Article 168 of the Treaty on the Functioning of the European Union, “a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities, and that Union action, which is to complement national policies shall be directed towards improving public health”.

Furthermore: “The Union shall encourage co-operation between the Member States in the field of public health and, if necessary, lend support to their action.”  The Conclusions are also expected to: “Recall… a set of operating principles shared across the European Union, especially regarding patient involvement and quality and safety of care, and which emphasise in particular that all EU health systems aim to be patient-centred.”

In all probability, they will also correctly state that personalised medicine refers to a medical model using characterization of individuals' phenotypes and genotypes for tailoring the right therapeutic strategy for the right person at the right time, and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention.

The final text is expected to include the understanding that personalised medicine relates to the broader concept of patient-centred care, which takes into account that, in general, healthcare systems need to better respond to patient needs.

And it is expected to state that, with the development of personalised medicine, individuals and health systems face new challenges, including balancing its risks and benefits while also considering its ethical, financial, social and legal implications, particularly regarding pricing and reimbursement, data protection and public interest in processing personal data.   Insiders believe the document will ‘note with concern’ that not all patients have access to innovative methods of better-targeted prevention, diagnosis and treatments’.

It will go on to note that ‘a significant challenge for member states consists in promoting appropriate uptake in healthcare systems, in order to ensure integration into clinical practice in line with the principles of solidarity and universal and equal access to high quality of care’.

Given that healthcare is an individual member state competence, the Conclusions are expected to ‘invite’ the EU-28 to ‘"enable appropriate access to clinically and financially sustainable cost-effective personalised medicine by developing patient-centred policies…and the integration of patient perspectives in the development of regulation processes".

Those close to the proceedings believe that the Conclusions will also invite member states to develop or strengthen, if necessary, public health communication strategies…to increase public awareness as regards both the benefits and risks of personalised medicine, as well as the citizens’ role and rights (e.g. sharing their data), thus supporting appropriate access to innovative diagnostic methods and better-targeted treatment.

The Conclusions are also expected to urge member states to: put in place information and education strategies for patients, based on relevant and understandable information; provide education, training and continuous professional development to health professionals, and; foster cooperation on the collection, sharing, management and appropriate standardisation of data necessary for effective research, in accordance with data protection legislation.

EAPM believes that the above are all highly welcome developments although it does have concerns about a section on Health Technology Assessment (HTA), which, sources say, may well be watered down and thus fail to address what actually constitutes ‘value’ - an important debate at the moment.

The Alliance believes that there is a solid argument that value should be determined by the customer, in this case the patient, and is worried that the final document will fail to recognise and underline this.

EAPM also fears that, while the original document looked set to invite Member States and the Commission to jointly ‘assess the cost-effectiveness, clinical validity and utility of innovative methods of diagnosis and of targeted medicinal products, based on their overall value’ and ‘to facilitate their evaluation with a view to healthcare use, in accordance with the HTA strategy’, the final document may have this phrasing replaced by  a simple call to ‘support HTA of personalised medicine in accordance with the HTA strategy’.

This is a much weaker statement.  If this text change does occur, says EAPM, it will mean that a real, credible and necessary discussion on value could end up being brushed under the carpet.

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