In June 2021, representatives of the European Parliament and the Council of European Union reached an agreement to boost cooperation amongst EU member States on HTA.
Since the 31st of January 2018, the European Commission has been working on a proposal to boost cooperation amongst EU Member States on Health Technology Assessment (HTA)1. On 22 June 2021, representatives of the European Parliament and the Council of the European Union reached an agreement2. Its adoption is expected in the coming days.
This common procedure aims to1:
- Facilitate the assessment of health technologies with clearer rules;
- Faster access for patients;
- Improve transparency;
- Foster innovation and improve the competitiveness of the medical industry;
- Make better use of available resources and pool expertise.
The proposal includes provisions for the use of common HTA tools, methodologies and procedures across the EU. It sets out four pillars for joint work of Member States at EU-level1,3,4.
- Joint clinical assessments focusing on the most innovative and potentially impactful health technologies for maximum EU-added value;
- Joint scientific consultations whereby developers of a health technology can seek the advice of HTA authorities on what type of data and evidence is likely to be required in the submission for HTA;
- Identification of emerging health technologies to help ensure that the most promising health technologies for patients and health systems are identified early and included in the joint work; and
- Voluntary cooperation in areas outside the scope of mandatory cooperation, for example on health technologies other than medicines and medical devices (e.g. surgical procedures), or on economic aspects of health technologies.
The proposal establishes a Member State Coordination Group on HTA composed of representatives from national HTA authorities and bodies. It will take 5 years before the full application and the process will start with anti-cancer treatments, orphan drugs and 5 fully approved products. Member States’ HTA authorities will use the reports of joint clinical assessments conducted at EU-level as part of their national or regional HTA processes and complement it with assessment of non-clinical HTA aspects (economic, social, ethical). Member States will also continue to draw conclusions on the overall added value of a health technology and take related decisions for their health systems (e.g. on pricing and reimbursement)3,4.
“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.” Marta Temido, Minister of Health of Portugal, the current chair of the EU Council on health issues2.
At ICON, we are ready to support pharmaceutical companies by providing a full range of services, from strategic analysis, pricing strategy, development of economic models, drafting of the pricing and reimbursement application, per these new EUROPEAN requirements.
To learn more, visit ICONplc.com/HEOR or contact us.