(Source: Council of the EU and European Council)
The Council today gave its final go-ahead for the adoption of a regulation on health technology assessment. Thanks to the new rules, innovative, safe and effective health technologies will be more quickly available for patients. Producers of medicines and medical devices will benefit because submission procedures will be simplified.
Janez Poklukar, the Slovenian minister for health stated: ‘The adoption of this law is another demonstration of how EU countries, when acting together, can achieve very practical results for their citizens. This new law will benefit patients, producers of health technologies and our health systems.’
The new rules foresee that member states cooperate to conduct joint clinical assessments and joint scientific consultations. They will also join forces when it comes to the identification of emerging health technologies.
In order to reduce the administrative burden especially for smaller companies, developers of health technologies should only have to submit information, data and other evidence required for the joint clinical assessment once at EU-level.
Today’s vote means that the Council has adopted its position at first reading. The regulation still needs to be adopted by the European Parliament before it will be published in the EU Official Journal. It will start to apply three years after its entry into force (which happens on the twentieth day following its publication).
The Commission adopted a proposal for a regulation on health technology assessment on 31 January 2018. Council agreed on its position on 24 March 2021 and on 22 June 2021 struck a political deal with the European Parliament.
Health technology assessment is an evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing technologies. It focuses specifically on the added value of a health technology in comparison with other new or existing health technologies. Thanks to health technology assessment, national health authorities can take informed decisions on the pricing or reimbursement of health technologies.
When member states carry out joint scientific consultations they exchange information with health technology developers on their development plans for a given health technology. The goal of this collaboration is to facilitate the generation of evidence – by the developers – likely to meet the evidence requirements of a subsequent joint clinical assessment.
Health technologies include medicinal products, medical devices (for example pacemakers, dialysis equipment or infusion pumps) or medical and surgical procedures, as well as measures for disease prevention, diagnosis or treatment used in healthcare.
- Health technology assessment post 2020 (background information)
- Position of the Council at first reading with a view to the adoption of a regulation on health technology assessment