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The health technology regulation up for debate in the European Parliament

Marta Pacheco by Marta Pacheco
10 September 2020
in EU Institutions News, European Parliament News
Launch,of,the new European-Parliament,logo

Today (September 9th), the S&D MEP Tiemo Wölken, rapporteur for the Health Technology Assessment (HTA) file at the European Parliament, will express his views about the potentials of HTA as well as its legal deadlock, during the webinar “Lessons learnt from the COVID-19 pandemic and future of HTA collaboration at EU level” from 15h until 17h.

The panel will count with the European Patients’ Forum (EPF) and EURORDIS – The Voice of Rare Disease Patients in Europe in a bid to re-launch a constructive debate and boost HTA cooperation at European level.

While the second wave of COVID-19 seems to be gaining track, patients’ organizations defend the urgency in effectively responding to the needs of national health systems and patients across Europe.

The European Union is considering a more ambitious health policy than previously foreseen for the upcoming Multiannual Financial Framework (MFF), through the EU4Health programme and other initiatives. In this context, the Proposal for a Regulation on European Cooperation in HTA is very timely: European patients and citizens count on a transparent, high quality and effective EU cooperation. In that sense, an agreement on the HTA regulation is not just only urgent, but also possible.

What is Health Technology Assessment (HTA)?

On 31 January 2018, the European Commission proposed a regulation on health technology assessment (HTA).

HTA is a research-based tool that supports decision-making in healthcare by assessing the added value of a given health technology compared to others. The proposal would provide the basis for permanent EU-level cooperation in four areas:

  • Joint clinical assessments focusing on the most innovative health technologies with the most potential impact for patients;
  • Joint scientific consultations, whereby health technology developers (i.e. the pharmaceutical industry and medical-device manufacturers) can seek advice from HTA authorities;
  • Identification of emerging health technologies (‘horizon scanning’), with a view to identifying promising health technologies at an early stage;
  • Continuing voluntary cooperation on other aspects of HTA.

Member States would still be responsible for assessing the non-clinical (economic, ethical, social, etc.) aspects of health technology, pricing and reimbursement. While Member States could choose to delay participation in the joint work until three years after the rules enter into force, it would become mandatory after six years. Stakeholders have broadly welcomed the proposal whereas national parliaments are divided on the question.

In the Council, work is continuing under the ongoing German Presidency. In its June 2020 progress report, the Croatian Presidency concluded that the outbreak of the pandemic emphasised the importance of having a legally sound and functioning HTA system in place.

@woelken

@eupatientsforum

@eurordis

@EU_Commission

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