The EU Regulation on Health Technology Assessment: investing in the healthcare of the future

What does Health Technology Assessment involve?  

Let’s first look at what health technology is before talking about the need to assess it. Health technology is an exciting and very diverse field covering for example medicines like new cancer drugs, medical devices like artificial hips and heart valves and other health interventions like new surgical procedures. New health technologies are often complex and expensive, which is why it’s important to be able to make informed decisions before investing in them.  

This is what Health Technology Assessment (HTA) does. It summarises information about clinical, economic, social and ethical issues related to the use of a health technology in order to help Member States make decisions based on evidence.  In doing so, it also helps ensure that health care is accessible, sustainable and of high quality. HTA helps answers clinical questions like ‘How well does the new technology work compared with existing alternative health technologies?’ and financial questions like ‘What costs are entailed for the health system?’ 

What does the new HTA Regulation cover?

The HTA Regulation focuses on clinical aspects of HTA. It can, for example, compare new and existing technologies, looking at their relative clinical effectiveness and relative clinical safety.  Under the new Regulation, Member States HTA bodies will conduct Joint Clinical Assessments of new medicines and certain high-risk medical devices. 

They will also take part in Joint Scientific Consultations, to advise technology developers on clinical study designs that generate evidence for decision-making. In addition, “horizon scanning” exercises will identify promising health technologies early, to help health systems prepare for them. This is the mandatory scope of the Regulation, but Member States may also cooperate further voluntarily, for example on health technologies other than medicines and medical devices, or on economic aspects of HTA. 

Who will benefit from the new Regulation?

Member States will be able to pool their HTA resources and expertise. Joint Clinical Assessments will be high quality, timely scientific reports that Member States will take into consideration in their national HTA processes. In this way, the Regulation will support Member States in taking more evidence-based and timely decisions on patient access to new medicines and medical devices. 

Patients will be empowered and clinicians better informed by having access to Joint Clinical Assessment reports that are of high scientific quality, transparent and accessible to the public. Developers in the pharmaceutical and medical device industries will have more clarity and predictability concerning the clinical evidence requirements for HTA. Industry will also benefit from efficiency gains when submitting clinical evidence for HTA, since there will be only a single EU-level submission file for Joint Clinical Assessments (rather than, as in the past, multiple parallel submissions to the different national HTA systems).

How will the cooperation work in practice?

The Regulation establishes a Coordination Group including representative HTA authorities by all Member States that will oversee the joint technical work carried out by subgroups of national representatives for specific types of work (e.g. Joint Clinical Assessments). External experts, including clinicians and patients, will also be able to provide their input. The European Commission will serve as secretariat to the cooperation, making sure that procedures are followed and that joint work is produced in a timely and transparent way. The Commission will also facilitate the exchange of information with other relevant EU agencies like the European Medicines Agency as well as with stakeholder organisations.

After many years of preparatory work, the HTA Regulation should be adopted by the end of the year. A three-year preparatory phase will then start, to set up the governance and operational structures and complete the development of procedures and scientific methodology for assessing health technologies.  Only then will the Regulation be applied. It’s worth the wait – it will indeed benefit clinicians, technology developers and HTA authorities, but ultimately, it will benefit people across the EU by making sure that the most valuable advances in health technology are available to them.

For more information on Health Technology Assessment, please visit Health Technology Assessment online