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

Using Artificial Intelligence to Predict…

Thyroid nodules are small lumps that form within the thyroid gland and are quite common in the general population, with a prevalence as high as 67%. The great majority of...

NHS Health Tech Team of the Year Named

A pioneering NHS trust has been recognised at the 2019 HTN Awards for its innovative work using InterSystems technology to help enhance care for hundreds of thousands of patients. North...

Philips and Klinikum Stuttgart Hospital …

Royal Philips (NYSE:PHG, AEX:PHIA), a global leader in health technology, and German Klinikum Stuttgart hospital, the largest provider in the region, announced they have signed a comprehensive 10-year innovation partnership...

Personalised and Powerful: UK to Lead Ne…

The UK will be transformed into a global hub for radiotherapy research, pioneering the use of the latest techniques such as FLASH radiotherapy and artificial intelligence, with a new £56...

Innovations for Tomorrow's Healthcare - …

18 - 21 November 2019, Düsseldorf, Germany. Groundbreaking innovations shape tomorrow's medical progress. At this year's MEDICA, visitors can find out what these exemplary innovations will be like in the here...

SilverCloud Health Marks World Mental He…

More than 300,000 people suffering with mental health disorders such as anxiety and depression have now been treated through innovative digital therapy programmes developed as a result of a partnership...

Siemens Healthineers Launches ACUSON Red…

Siemens Healthineers has launched the ACUSON Redwood, a new ultrasound system built on the company's new platform architecture and features advanced applications for greater clinical confidence, AI-powered tools for smart...

AI Predicts which Pre-Malignant Breast L…

New research at Case Western Reserve University could help better determine which patients diagnosed with the pre-malignant breast cancer commonly as stage 0 are likely to progress to invasive breast...

Nuance and Microsoft Partner to Transfor…

Nuance Communications Inc. and Microsoft Corp. have joined forces to help transform healthcare delivery for a more sustainable future. Together, the companies will accelerate the delivery of ambient clinical intelligence...

MEDICA 2019 + COMPAMED 2019 Bring in ove…

18 - 21 November 2019, Düsseldorf, Germany. More dynamic, more digital and more networked than ever: the medical industry is taking strides into the future. If you want to be in...

Telehealth Effectively Diagnoses / Manag…

A recent study of 368 pregnant mothers, led by Bettina Cuneo, MD, director of perinatal cardiology and fetal cardiac telemedicine at Children's Hospital Colorado, found that fetal congenital heart disease...

Siemens Healthineers Closes ECG Manageme…

Siemens Healthineers AG has completed the acquisition of a majority stake in ECG Management Consultants, a leading U.S. healthcare advisory firm, with an effective date of November 1, 2019. The...