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Assessing health technology: EU Commission to boost cooperation among member states

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Different HTA processes and methodologies across EU countries and regions have urged the European Commission to come up with a framework for more joint clinical assessment among member states. (Photograph: roibu/Shutterstock)
Dental Tribune International, Kasper Mussche

By Dental Tribune International, Kasper Mussche

Wed. 2. May 2018

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BRUSSELS, Belgium: Health Technology Assessment (HTA) is an independent, objective and evidence-based system used to measure the added value of new health technologies. Joint assessments at EU-level covering clinical, but in some cases also social, economic and ethical issues, have been ongoing since the 1980s. However, a series of shortcomings in the current cooperation model has necessitated that the European Commission put forward a new proposal enabling a sustainable and more effective European cooperation on HTA.

The aims of HTA
To begin with, it is important to note that when talking about HTA, the term "health technology” is to be understood in the broad sense, comprising the different elements that constitute healthcare, namely innovative drugs, medical devices and procedures, as well as measures for disease prevention, diagnosis and treatment. “HTA assessments can help policy makers select new effective technologies and reject those that do not provide added value. As such, HTA can help decision makers formulate safe and effective health policies that are patient-focused,” says Anca Paduraru, the Commission’s Spokesperson for Health, Food Safety and Energy Union projects.

HTA is also important for the individual member states, as it ensures the sustainability of their health systems, and stimulates innovation. However, a series of shortcomings has prevented the current cooperation model from reaching its full potential.

The need for more cooperation
The current European cooperation on HTA suffers from short-term funding that has to be renegotiated every financial cycle, making effective cooperation impossible in the long run and not very efficient in the short to medium term. According to Paduraru, “Differing HTA processes and methodologies across EU countries and regions have contributed to lack of business predictability, higher costs for industry, delays in access to technologies, and negative effects on innovation. Other shortcomings include duplication of work for national HTA bodies, inefficient use of resources and limited transparency for patients. EU countries have cooperated on HTA on a voluntary basis for more than 20 years, however the issues mentioned cannot be addressed by the purely voluntary approach on joint work taken to date. We need to reinforce our cooperation to reap full benefits for patients and national authorities and for innovation and competitiveness in the EU.”

A new proposal
On 31 January 2018, the European Commission adopted the Regulation on Health Technology Assessment - a proposal to boost sustainable and effective cooperation at EU-level. “At the heart of the proposal is the ability to use common HTA tools, methodologies and procedures across the EU, working together on joint clinical assessments, joint scientific consultations, identification of emerging health technologies, or 'horizon-scanning', as well as continuing voluntary cooperation in areas outside the scope of the proposal,” says Paduraru.

By carrying out joint clinical assessments and focusing on the most innovative technologies with the highest impact for patients (i.e. medicines with central marketing authorisation and some high-risk medical devices), HTA bodies will be able to assess promising health technologies early which will enable timely delivery of the high quality reports to national decision makers. The assessments will not include aspects which are more context specific such as social, ethical and economical aspects, as these will remain for individual member states to assess as part of their decision making process. In this process, member states will also be able to make sure that the clinical assessment done jointly can be contextualised in national and, in several cases, regional settings. It is also very clear from the proposed approach that pricing and reimbursement decisions remain a national prerogative.

Secondly, HTA authorities will be able to hold joint consultations with health technology developers, ensuring that the way they conceive clinical trials and collect data is relevant for both regulators and HTA bodies, with good potential to speed up patients' access once the technology receives market authorisation. Lastly, member states will be able to continue voluntary cooperation on other health technologies of mutual interest, such as medical and surgical procedures or complex interventions.

As for now, the proposal has been sent to the European Parliament and Council for a first reading. If adopted, member states will benefit from high quality and timely information to be used in their decision making process and to ultimately support them in the challenging task of ensuring high quality sustainable healthcare systems. Moreover, the proposal would contribute to public health by ensuring transparent information regarding the added value of health technology. Finally, manufacturers would no longer have to adapt to different national procedures, facilitating the introduction of innovative health technologies to internal markets and ultimately to a larger number of EU patients. Considering that this is a time in which European countries are experiencing ageing populations and a rise in chronic disease prevalence, the proposal strikes a chord.

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