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Title: Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU
Author: [European Commission]
Series/Date: COM (2018) 51 final
Source Origin: EU
Source Type: Policy-making
Notes: The European Commission adopted on 31 January 2018 a proposal aiming to boost cooperation amongst EU Member States for assessing health technology.
Source URL: http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2018:051:FIN
Related URL:
Keywords: Health Technology Assessment | HTA - Directive 2011/24/EU - COM / 2018 / 51
Subjects:  9.9 - Health
Geographic Indicators:  European Union
Further information:

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 would 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;
4) on continuing voluntary cooperation in other areas.

Background information:

Health technology assessment (HTA) is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased and robust manner. Its aim is to inform the formulation of safe and effective health policies that are patient focused and seek to achieve best value.

At EU level, cooperation on HTA has been ongoing since the 1980s. Two Joint Actions (EUnetHTA JA) were carried out together with a number of projects. A third Joint Action (EUnetHTA Joint Action 3) was launched in June 2016 and runs until 2020 with a total budget of €20 million. In addition, following the adoption of the Cross-Border Healthcare Directive (Directive 2011/24/EU), the HTA Network was established in 2013 to provide strategic and political guidance to the scientific and technical cooperation at Union-level.

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