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30 June 2021
CARE, - Healthcare

In June, the EU reached an agreement on harmonising the Health Technology Assessment process in Member Statesa process that evaluates the efficiency of medical technology. Once implemented, the Regulation will improve patient access to best quality care and technology across the EU.

The Health Technology Assessment (HTA) is a process to evaluate the efficiency of existing or new technology in the field of public health. The assessment applies to medical equipment procedures and operations, medicinal products, and patient centric diagnostic and prevention methods. This process is important for all patients including those living with allergy, asthma and chronic obstructive pulmonary disease (COPD), as it sets out to improve scientific cooperation.

Currently, all EU Member States have their own processes in place to evaluate any existing and future technological offers. However, due the challenges rising for the technical landscape of the various systems in place, in 2017 the European Commission started working on an initiative to strengthen the cooperation and harmonise the process between EU Member States.

The Commission proposed Regulation in 2018 to the European Parliament and Council of EU with the aim to adopt it by 2019 following the co-legislative process. The negotiations were not successful until January 2021, where the topic appeared high on the agenda of the EU’s response to the COVID-19 pandemic, and the Portuguese Presidency’s portfolio.

In March 2021, Portugal began the work to reach an agreement and the EU trilogues started (negotiations between the European Parliament and the Council).

Reaching an agreement for HTA

On 22nd June 2021, the European Parliament and the Council of the EU announced that a political agreement has been reached between the two parties, unblocking the process held since 2019.

The Regulation offers improved and accessible innovative health systems, access to higher quality health technology assessment practices, harmonised HTA tools, procedures and methodologies, joint clinical assessments and scientific consultations as well as faster identification of new and advance medical technologies.

Entering into force and next steps

This new law is a major step for the benefit of patients as it will improve patient access to medicinal products and medical devices.

In addition, policymakers will have accurate and evidence-based information allowing them to introduce patient centric, cost efficient, safe, and modern policies on public health. National authorities will be able to better identify which health technology options will be reimbursed under national schemes.

For the new regulation to come into force, both the European Parliament and the Council of the EU need to formally approve the text (timeline is not yet available).

After its adoption and publication in the Official Journal of the EU, the Regulation will become binding for all EU Member States. Its provisions will become gradually applicable three years from the entry into force.

EFA will continue following and information about this important Regulation affecting patients. EFA is part of the European Commission Stakeholder Network on HTA since it was created in 2017, and has been advocating since for a regulation that responds to patients’ needs.