European Council health care recommendations are step in right direction

| December 2, 2014 | 0 Comments

1398118700957By European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan

With the publication this week of the European Council recommendations, the European Alliance for Personalised Medicine (EAPM) is pleased to note that several of its own recommendations are included.

These have been put forward as part of ongoing dialogue with the presidency of the EU and are geared, ultimately, towards realizing the potential of personalised medicine for all of the EU’s 500 million citizens across 28 member states.

As far as EAPM is concerned, some of the language in the recommendations is not as direct as it could be (although this is normal) – with plenty of ‘recalls’, ‘recognises’ and ‘takes note’ throughout the text, but it is fair to say that progress is being made in the arena of health and, specifically, personalised medicine as one rotating presidency is replaced by the next.

For example, the Council: “Recognizes that innovations in health care can contribute to health and well-being of citizens and patients through access to innovative products, services and treatments that have added value…”

EAPM’s manifesto quite clearly states the above ideals on innovation and came about as a result of intensive dialogue with all stakeholders which, of course, include patients.

The Council also: “Takes note that in order to stimulate development, there is a need to facilitate the translation of scientific advances into innovative medicinal products that meet regulatory standards, accelerate patients’ access to innovative therapies with added value for patients and are affordable to the member states’ health systems.”

The above are core to the EAPM messages regarding what is required to deliver the right treatment to the right patient at the right time and EAPM is pleased to note that the Council also

Recalls that the new Clinical Trials Regulation aims to increase the EU’s competitiveness in clinical research and the development of new and innovative treatments.”

Meanwhile it: “…recognizes that early dialogue between technology developers, regulatory, health technology assessment and, where relevant, pricing bodies may promote innovation and quicker access to medicines at affordable prices, to the benefit of patients.”

EAPM is also pleased to see that the Council also underlines previous conclusions, especially those on the reflection process on modern, responsive and sustainable health systems, adopted on 10 December 2013, as well as those on the economic crisis and health care, adopted on 20 June 2014.

The latter advocates the need for “cooperation, while fully respecting areas of member states’ competence, on strategies to effectively manage expenditure on pharmaceuticals and medical devices, while ensuring equitable access to effective medicines within sustainable national health-care systems”.

Finally, for the purposes of this article, the Council: “Recalls the discussion at the Informal Meeting of Ministers of Health in Milan on 22-23 September 2014 on ‘innovation in health care for the benefit of patients’, which highlighted the need to support innovation for the benefit of patients with better use of the existing regulatory tools for marketing authorisation procedures and which highlighted the potential risks to the sustainability of some national health systems linked to very high cost pressures arising from some innovative products.”

EAPM has four Working Groups, plus a Regulatory Affairs Group, tasked with realising all of the above goals and covering Big Data, Education and Training of Health Care Professionals, Early Access and Better Decision Making, plus a Research Road Map for Personalised Medicine. These are all geared towards providing timely access to the best health care for Europe’s patients.

And when it comes to rational use of resources across member states, EAPM will be following the new EU Semester process closely and making its own regular recommendations.

As noted earlier, the Council recommendations represent key steps in the right direction, although EAPM strongly believes that more concrete actions are needed on these topics if barriers are to be overcome and goals are to be reached.

As part of its conclusions, the Council does go a step further by inviting member states to: “Explore opportunities for cooperation on exchange of information between competent bodies in relation to a ‘life cycle approach’ for innovative medicinal products.”

These, it says, should include where appropriate, early dialogue and scientific advice; pricing and reimbursement models; registries for monitoring the effectiveness of therapies and technologies; appropriate re-assessments, and; post-authorisation studies.

Also, the Council invites member states and the European Commission to: “Discuss national initiatives for early patient access to innovative medicines and the possibility of increased information-sharing and cooperation in relation to compassionate use, so as to maximise the opportunities of patients across the EU to be supplied with innovative medicines.”

It also calls for further discussion on whether criteria are needed to take account of the added therapeutic value of new medicinal products in comparison with the existing ones for placing them on the market – something that EAPM has strongly supported.

The conclusions also refer to continuing the dialogue between stakeholders and competent authorities, including pricing and reimbursement authorities, and examining opportunities for potential cooperation on a voluntary basis in the field of pricing and reimbursement and facilitate the launching of pilot projects in that field.

Again, these are topics that EAPM has discussed many times among all of its stakeholders and during meetings with the Commission, the presidency of the EU and the European Parliament. This will continue as EAPM follows up prior discussions through the efforts of its Working Groups who, in 2015 and beyond, will continue to strive for better health care for all of Europe’s patients, regardless of who or where they are.

There is certainly a dire need for improvement, especially given that we have a pan-European population that is living longer and will all require health care at some stage.

Unfortunately, access to the highest-quality health care is unbalanced in the EU at present, with different levels of access, inequality in standards of care and imbalances in reimbursement procedures, to name but a few issues.

For example, EAPM knows of Aga, a Polish woman of 49, who needed specialist treatment for a rare cancer. Aga eventually sought relatively expensive treatment in another, richer, EU Member State but struggled financially due to the reimbursement levels in her own country.

Meanwhile George, a 58-year-old UK citizen, could not afford the private costs of cataract operations on both eyes and found that the NHS waiting list was too long in his area. He was finally treated at a hospital near Paris quickly and at a much more affordable cost than at a private clinic in England, but the lengths he had to go to should surely be unnecessary in modern-day Europe.

And in Sweden, 25-year-old Frieda, also suffering from a rare cancer, was not only unaware of any clinical trials for such a small group of patients, but she would not have been able to access them anyway given her isolated location.

Such situations as those above are commonplace across the EU and occur on a daily basis. Meanwhile, winter is here and more and more expensive hospital beds will be filled with patients, stretching the national health-care systems. Beds will be at a premium but, were there an EU-wide strategy that integrates personalized medicine into daily practice, more preventative measures and innovative treatments minimizing hospital time would help to ease the burden.

EAPM therefore, while backing the European Council, firmly believes that it needs to better recognise the current issues in access – and more – and push for stronger measures than this week’s recommendations actually provide for.


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Category: A Frontpage, Demographics, Economy, EU, EU, European Alliance for Personalised Medicine, Health, Health care, Personalised medicine

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