New EU health innovation rules edge closer

Regulation on health technology assessment is said to ensure better cooperation across the member states. [EPA-EFE/MARCIN BIELECKI]

Three years after the original proposal, the EU’s game-changing Health Technology Assessment (HTA) dossier has at last reached interinstitutional negotiations, but a number of challenges remain.

This important piece of legislation 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 and diagnostic tools, surgical procedures, as well as measures for disease prevention, diagnosis or treatment. 

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.

To address this, a legislative initiative to overhaul the current HTA system was put forward by the previous EU executive in January 2018.

According to the Commission, stronger cooperation between member states for assessing health technologies would lead to a faster access to innovative health tools, boosting at the same time innovation and improve the competitiveness of the European healthcare sector, which accounts for 10% of the EU’s GDP. 

The proposal would provide for joint work in four areas, including joint clinical assessment, joint scientific consultation, identification of emerging health technologies and voluntary cooperation on other aspects of HTA.

It took a few months for the European Parliament to agree on their position but it took over three years for the EU health ministers to agree on their mandate.

On 24 March, the Council finally reached an agreement considered an important milestone by  Portuguese Health Minister Marta Temido, the current chair of the EU Council on health issues.

She added that once adopted it will be a major step forward in the field of health. “It will constitute a robust framework for cooperation for the benefit of member states, industry and, above all, patients,” Temido said.

The Parliament’s rapporteur on the file, the socialist MEP Tiemo Wölken told EURACTIV that the proposal on HTA “addresses the shortcomings of the current model of EU cooperation on HTA, which is purely voluntary, and leads to impeded and distorted market access for health technologies”.


Portugal gets mandate to negotiate health technology assessment law

The Portuguese presidency of the Council of the European Union on Wednesday obtained a mandate from the member states to start negotiations with the European Parliament on a legislative proposal on Health Technology Assessment (HTA).


“A European approach on joint clinical assessments would not only combine national strengths but give companies a predictable and harmonised assessment process at EU level,” Wölken said, adding that it will also contribute to the goal of the pharmaceutical strategy to ensure sustainable innovation.

“HTA will speed up and improve access to new medicines and medical devices for patients across Europe and, hence, make access across the EU more equal,” he added.

Top priority for Portuguese presidency

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

Now, the second trilogue on HTA is set to be held on Monday (31 May), but a number of issues remain before a deal on the dossier can be reached.

One of the sticking points in the discussions will be the question of whether joint clinical assessments should be binding, as initially proposed by the Commission and supported by Parliament, or, following the Council’s view, merely be given ‘due consideration’, Parliament’s shadow rapporteur Véronique Trillet-Lenoir told EURACTIV.

Another potential clash is voting modalities for adopting a decision in the coordination group, the liberal MEP added.

For me, the unanimity rule should not be an option and we need to ensure that the work of the coordination group is transparent,” she said.

She also highlighted that regulation should be implemented progressively through different therapeutic areas.

As an oncologist, I fully support starting joint clinical assessment with the cancer treatment, but the assessment of other medicines should follow smoothly”, she explained.

Another point is including patient’s organisations and health professionals in the stakeholders’ network. The stakeholder network would be set to support the work of the Coordination Group and its subgroups upon request.

“The cross-border dimension of the clinical assessment and the role given to regional authorities in charge of HTA should be reinforced as suggested by the EP,” said Trillet-Lenoir.

She added that voluntary cooperation between the member states on measures relating to compassionate use in clinical practice and on the disinvestment in obsolete technologies should be also promoted.

[Edited by Josie Le Blond]


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