HTA close to be adopted by the Parliament and the Council

22/06/2021 68 Views
HTA close to be adopted by the Parliament and the Council

Early on June 22, the European Parliament and the Council negotiators reached a provisional agreement on the increased cooperation of member states on health technology assessment (HTA) at EU level. After years of ongoing discussions, the co-legislators struck a political deal on a legislative proposal concerning joint work on HTA.

“We have reached a decisive breakthrough on a new law which will benefit patients, manufacturers of health technologies and member states’ health systems. We will all stand to gain when innovative, safe and effective health technologies can reach the market more quickly. EU-level cooperation is the way forward to make this happen”, said Marta Temido, Minister of Health of Portugal.

Enhanced coordination, transparency and impartiality

The regulation establishes a new “Member State Coordination Group” – each EU country will designate its representatives in the Coordination Group as well as in various subgroups. The agreed text underlines that all representatives and experts must not have any interests in the health technology developers’ industry which could affect their independence or impartiality. Parliament negotiators ensured that a clear voting mechanism for the Coordination Group is in place regarding political strategic issues and scientific technical issues.

“The regulation will dramatically reduce duplications of clinical assessments, ensure sustainable cooperation on HTA and provide us with a framework to better face health issues, such as rare diseases, personal medicine and orphan medicines. Parliament fought for stronger provisions with regards to the uptake of joint clinical assessments. We secured safeguards to ensure that joint assessments cannot be ignored”, said MEP Tiemo Wölken.

Next steps

The presidency will submit the outcome of the negotiations to the Council’s Permanent Representatives Committee (Coreper) for endorsement. This will be followed by adoption by the Council and then the Parliament.

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