EU lawmakers reach agreement on game changing new health innovation rules

The provisional agreement is said to pave the way for more transparent and coordinated approach on health technology assessment at EU level. [Gorodenkoff / SHUTTERSTOCK]

The European Parliament and Council reached on Tuesday (22 June) a provisional agreement on the health technology assessment (HTA), in a move to help member states take more “timely and evidence-based decisions on patient access” to their healthcare systems.

HTA regulation is aimed at helping EU countries determine the effectiveness and value of new technologies and deciding on pricing and reimbursement by health insurers or health systems.

Health technology covers medicines, medical devices, diagnostic tools, and surgical procedures, as well as measures for disease prevention, diagnosis and treatment.

The provisional agreement is said to strengthen the cooperation on HTA among the 27 member states, improve the availability of innovative health technologies such as innovative medicines and certain medical devices for EU patients, ensure efficient use of resources and strengthen the quality of HTA across the EU.

Parliament’s rapporteur, German socialist Tiemo Wölken, said that “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”.

He added that parliament had “fought for stronger provisions with regards to the uptake of joint clinical assessments” and had “secured safeguards to ensure that joint assessments cannot be ignored”.

New EU health innovation rules edge closer

After three years, the game-changing health technology assessment, which determines the effectiveness and value of new technologies, has finally reached interinstitutional negotiations, but a number of challenges remain.

Launching a member state coordination group

The long-awaited political agreement was welcomed by the EU’s Health Commissioner, Stella Kyriakides.

“Such high-quality scientific assessments will help the member states take more timely and evidence-based decisions on patient access to their healthcare systems,” she said.

The new regulation, Kyriakides added, will be crucial for the objectives of the EU’s pharmaceutical strategy and Europe’s Beating Cancer Plan, as it covers innovative medicines and addressing unmet medical needs.

The regulation establishes a new member state coordination group which will include representatives and experts from each EU country, who are not permitted to have any interests in the health technology developers’ industry that could affect their independence or impartiality.

The coordination group will be expected to engage and consult widely with relevant stakeholders, including organisations representing patients, healthcare professionals, clinical experts, HTA developers, and consumers to ensure inclusiveness and transparency.

The regulation sets safeguards on the uptake of joint clinical assessments to ensure that they are annexed to national assessments and that member states must report on their use in national HTAs. It will also shorten the timeline for the full implementation of the scope of health technologies.

Long awaited agreement

Wölken highlighted the importance of the timing of the agreement. “Especially now, faced with a health crisis, it is increasingly important that we, as a Union, pool our expertise and resources to ensure good quality joint assessments whilst contributing to timely access of innovative health technologies,” he said.

The HTA process is currently fragmented, performed by about 50 European HTA agencies across the bloc. Different systems are being used across member states to evaluate new treatments and their prices.

The legislative initiative to overhaul the current HTA system was put forward by the previous EU executive in January 2018.

The European Parliament closed its first reading in February 2019, while discussions in Council lasted over three years until the EU health ministers agreed on their mandate.

Regulation on HTA is a top priority of the Portuguese presidency, which was pushing for an agreement before the dossier falls into the hands of the Slovenian presidency in July 2021.

“This result was a major achievement for EU cooperation and I am looking forward to a swift adoption by both institutions in the coming months,” said Kyriakides.

The regulation still needs to be formally adopted by the Council and the European Parliament before it comes into force.

[Edited by Zoran Radosavljevic]


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