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#EAPM - Ongoing #HTA debate sees upcoming key meeting in European Parliament

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The European Alliance for Personalised Medicine (EAPM) is to host a meeting on the ongoing issue of HTA  in the Brussels European Parliament on 26 September (12h30-14h),
writes EAPM Executive Director Denis Horgan.

The round table, entitled Aligning the priorities between the health-care community and the European Parliament: 'Where we are now and the necessary next steps for a regulatory framework for HTA', comes in the wake of a successful round table held in June, as well as a meeting held with MEPs and political groups in July.  Please see the following link for the agenda.The background to the meetings is that, in June, France and Germany published their views on the European Commission’s controversial proposals for mandatory joint clinical assessment (JCA) on HTA.

The two big nations disagree with the mandatory option, although they said that, in principle, they support a more profound, voluntary cooperation at EU level in the area of Health Technology Assessment.

They added that “well-organized and high-quality cooperation can assist member states in preparing their health-care decisions, in particular regarding pricing and reimbursement”.

Several member states complained that the Commission is over-stepping its remit in its bid for a mandatory solution to improve HTA coordination, given that health is a member state competence. As well as Germany and France, these included Denmark, the Czech Republic, Poland, the UK, Italy and Spain.

France and Germany said that conditions must be right and retain the room for manoeuvre at national level, in implementing health care decisions, as well as in pricing and reimbursement.

“It should only be required that EU-level clinical assessments be taken into consideration at national level, instead of having them obligatorily applied”, the two countries said.

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In response to the Assemblée nationale, the Commission wrote that “the proposal is based on 20 years of voluntary cooperation in the area of Heath Technology Assessment. Despite this long-standing co-operation, the Commission notes that the uptake of joint work continues to be low. It therefore believes that it is time to increase member states’ commitment, further pooling resources and exchanging expertise, which would in particular be beneficial to smaller member states with less capacity to carry out Heath Technology Assessments”.

The EU Executive wrote that it “takes seriously the concerns expressed by the Assemblée Nationale as regards the proposal’s compliance with the principles of subsidiarity and proportionality and, more specifically as regards the choice of legal basis and division of competences between the Union and its member states in the field of health”.

The Commission stressed that “medicines and medical devices are products which benefit from the principle of free movement of goods within the internal market. The currently existing diversity of national rules regarding health technology assessment contributes to distorted market access for health technologies and a delayed access for patients”.

It adds: “Against that background, the proposal aims to ensure a better functioning of the internal market while contributing to a high level of human health protection. This is to be achieved by improving patientsʼ access to the most innovative health technologies in a more timely and equitable manner across the Union.”

And, crucially, it states; “The Commission does not share the view that the proposed Regulation would encroach upon member statesʼ rights and obligations under Article 168(7) TFEU. The proposal provides that the clinical assessment part of the health technology assessments, in cases covered by the proposal, would be carried out at Union level ˗ not by the Commission but by member statesʼ health technology assessment bodies working together within the Co-ordination Group. Member states would remain free to add context-specific information and continue to carry out the non-clinical assessment part.

“The proposal does not oblige member states to carry out a health technology assessment on health technologies which are the subject of joint clinical assessments.”

The Commission goes on to say that “there is an important link between the quality of the assessments and the mandatory nature of both submissions from health technology developers and the use of the assessment report at member-state level”.

There is clearly a major debate in full swing and the EAPM workshop will address compromises that have been proposed in consultation with MEPs as well as with a cross-section of stakeholders.

It will provide a forum for MEPs within the health-care community to discuss the compromise amendments and receive feedback from experts, while wishing to support the goals of the Commission’s HTA proposal.

The overall aim is to give MEPs an understanding of the pros and cons of the current amendments and compromise amendments seen from different stakeholders’ groups.

The meeting will comprise two sessions with expert contributors focused on providing their perspective to MEPs on the impact of the compromises on the “real world” of HTA and the relevance of EU-level HTA for health care decision makers.

Representatives from key stakeholders groups will be asked to set out their three priorities for the HTA proposal and the proposed compromised amendments will be reviewed based on these criteria/priorities.

Each session will comprise panel discussions as well as Q&A sessions to allow best possible involvement of all participants to be focused on the amendments.

Among the participants will be Peter Liese MEP, Ansgar Hebborn, head of Global HTA & Payment Policy at Roche, Menno Aarnout, executive director, International Association of Mutual Benefit Societies (AIM), Marcus Guardian, COO, EUnethHTA, and Matteo Scarabelli, patient engagement manager, HTA, of EURORDIS.

They will be joined by Ioana Siska, policy officer, Health technology Assessment, Unit B4 – Medical Products: safety, quality, innovation at DG SANTE, Valentina Strammiello, European Patient Forum, Tanja Valentin, Director External Affairs, MedTech Europe and EAPM Executive Director Denis Horgan.

Members and stakeholders are invited to register their attendance to join in the discussion on this vital topic by emailing Chiara Bernni at the following address: Chiara BERNINI EAPM [email protected]

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