«Better quality, innovative healthcare for the benefit of patients, especially those with unmet medical needs» this is the main goal of the proposal for strenghtening cooperation within the European Union on the assessment of health technology, in the words of EU Commissioner for Health and Food Safety, Vytenis Andriukaitis.
The new regulation on health technology assessment (HTA) put forward by the Commission covers new medicines and certain new medical devices (including in vitro diagnostic medical devices), and wants to establish «permanent and sustainable cooperation» in the European Union for joint clinical assessments in these areas.
Member States will be able to use common HTA tools, methodologies and procedures across the EU, working together the clinical assessments focusing on the most innovative health technologies, particularly those with the most potential impact for patients, scientific consultations allowing developers to seek advice from HTA authorities, and early identification of promising emerging health technologies within a wider framework of continuing voluntary cooperation.
Individual EU countries will continue to be responsible for assessing non-clinical aspects of health technology, such as economic, social and ethical aspects, and for pricing and reimbursement.
«Reinforcing health technology assessment co-operation at EU level boosts innovation and improves competitiveness of the medical industry. The healthcare sector is a crucial part of our economy, it accounts for approximately 10% of the EU’s GDP» commented Vice-President of the European Commission Jyrki Katainen. «We are proposing a regulatory framework that will bring benefits to patients all over Europe, whilst encouraging innovation, helping the take-up of high-quality medtech innovations and improving the sustainability of health systems across the EU».
This cooperation should ensure that all EU countries can benefit from the efficiency gains, with better use of available resources and improvements of business predictability, applying common methodologies and procedures and making sure that joint clinical assessments are not repeated at national level, thereby avoiding duplication and discrepancies.
If the proposal will be approved by the European Parliament and the Council of Ministers, application will take three years, and a further three-year period is envisaged to allow for a phase-in approach for Member States to adapt to the new system.