Assessing Health Technology in the EU: Commission Proposes to Reinforce Cooperation Amongst Member States

European CommissionEuropean Commission has put forward a proposal to boost cooperation amongst EU Member States for assessing health technology. Greater transparency will empower patients, by ensuring their access to information on the added clinical value of new technology that could potentially benefit them. More assessments could lead to effective, innovative health tools reaching patients faster. For national authorities it means being able to formulate policies for their health systems based on more robust evidence. Furthermore, manufacturers will no longer have to adapt to different national procedures.

Vice-President Katainen said: "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. 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."

Commissioner for Health and Food Safety, Vytenis Andriukaitis, added: "Today, the Commission has put the wheels in motion for better quality, innovative healthcare for the benefit of patients, especially those with unmet medical needs. I also expect this initiative to result in a more efficient use of resources by Member States through the pooling of resources and exchanges of expertise, thereby avoiding duplications in the assessment of the identical products."

The proposed Regulation on Health Technology Assessment (HTA) covers new medicines and certain new medical devices, providing the basis for permanent and sustainable cooperation at the EU level 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 in four main areas: 1) on joint clinical assessments focusing on the most innovative health technologies with the most potential impact for patients; 2) on joint scientific consultations whereby developers can seek advice from HTA authorities; 3) on identification of emerging health technologies to identify promising technologies early; and 4) on continuing voluntary cooperation in other areas.

Individual EU countries will continue to be responsible for assessing non-clinical (e.g. economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement.

Next steps

The proposal will now be discussed by the European Parliament and the Council of Ministers. It is expected that once it is adopted and enters into force, it will become applicable three years later. Following the date of application, a further three-year period is envisaged to allow for a phase-in approach for Member States to adapt to the new system.

The proposal comes after more than 20 years of voluntary cooperation in this area. Following the adoption of the Cross-border Healthcare Directive (2011/24/EU), a voluntary EU-wide network on HTA composed of national HTA bodies or agencies was established in 2013 to provide strategic and political guidance to the scientific and technical cooperation at EU level. This work, complemented by three consecutive Joint Actions[1] on HTA, has enabled the Commission and Member States to build a solid knowledge base on methodologies and information exchange with regards to the assessment of health technology.

Cooperating on HTA on a sustainable basis at EU level should ensure that all EU countries can benefit from the efficiency gains, maximising EU-added value. Strengthened EU-cooperation in this area is widely supported by stakeholders interested in patients' timely access to innovation. Stakeholders and citizens who responded to the Commission's public consultation showed overwhelming support, with almost all (98%) acknowledging the usefulness of HTA and 87% agreeing that EU cooperation on HTA should continue beyond 2020.

1. EUnetHTA Joint Action 1, 2010-2012,) EUnetHTA Joint Action 2, 2012-2015 and EUnetHTA Joint Action 3, 2016-2019: http://www.eunethta.eu

Most Popular Now

Philips Foundation 2024 Annual Report: E…

Marking its tenth anniversary, Philips Foundation released its 2024 Annual Report, highlighting a year in which the Philips Foundation helped provide access to quality healthcare for 46.5 million people around...

Giving Doctors an AI-Powered Head Start …

Detection of melanoma and a range of other skin diseases will be faster and more accurate with a new artificial intelligence (AI) powered tool that analyses multiple imaging types simultaneously...

Scientists Argue for More FDA Oversight …

An agile, transparent, and ethics-driven oversight system is needed for the U.S. Food and Drug Administration (FDA) to balance innovation with patient safety when it comes to artificial intelligence-driven medical...

New AI Transforms Radiology with Speed, …

A first-of-its-kind generative AI system, developed in-house at Northwestern Medicine, is revolutionizing radiology - boosting productivity, identifying life-threatening conditions in milliseconds and offering a breakthrough solution to the global radiologist...

AI Agents for Oncology

Clinical decision-making in oncology is challenging and requires the analysis of various data types - from medical imaging and genetic information to patient records and treatment guidelines. To effectively support...

New Research Finds Specific Learning Str…

If data used to train artificial intelligence models for medical applications, such as hospitals across the Greater Toronto Area, differs from the real-world data, it could lead to patient harm...

Start-ups in the Spotlight at MEDICA 202…

17 - 20 November 2025, Düsseldorf, Germany. MEDICA, the leading international trade fair and platform for healthcare innovations, will once again confirm its position as the world's number one hotspot for...

AI Medical Receptionist Modernizing Doct…

A virtual medical receptionist named "Cassie," developed through research at Texas A&M University, is transforming the way patients interact with health care providers. Cassie is a digital-human assistant created by Humanate...

AI Detects Hidden Heart Disease Using Ex…

Mass General Brigham researchers have developed a new AI tool in collaboration with the United States Department of Veterans Affairs (VA) to probe through previously collected CT scans and identify...

MHP-Net: A Revolutionary AI Model for Ac…

Liver cancer is the sixth most common cancer globally and a leading cause of cancer-related deaths. Accurate segmentation of liver tumors is a crucial step for the management of the...

AI Tool Set to Transform Characterisatio…

A multinational team of researchers, co-led by the Garvan Institute of Medical Research, has developed and tested a new AI tool to better characterise the diversity of individual cells within...

Highland Marketing Announced as Official…

Highland Marketing has been named, for the second year running, the official communications partner for HETT Show 2025, the UK's leading digital health conference and exhibition. Taking place 7-8 October...