| Author (Corporate) | Council of the European Union, European Parliament |
|---|---|
| Series Title | Official Journal of the European Union |
| Series Details | L 458, Pages 1-32 |
| Publication Date | 22/12/2021 |
| Content Type | Blog & Commentary, Legislation, News, Policy-making |
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Summary: Regulation (EU) 2021/2282 - adopted by the European Union on 15 December 2021 - setting out an EU-wide framework for health technology assessment. This is a text with EEA relevance. Further 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. This Regulation establishes a support framework and procedures for cooperation of Member States on health technologies at an EU level. It introduces a mechanism whereby any information, data, analyses and other evidence required for the joint clinical assessment of health technologies is submitted by the health technology developer only once at EU level. It also lays out common rules and methodologies for the joint clinical assessment of health technologies. Cooperation on HTA at EU-level was launched in the 1980s. Three Joint Actions (EUnetHTA JA) were carried out comprising a number of projects. Directive 2011/24/EU - also known as the Cross-Border Healthcare Directive - established the HTA Network in 2013 to provide strategic and political guidance to the scientific and technical cooperation at EU-level. The draft law for this Regulation was tabled by the European Commission on 31 January 2018. The aim was to improve cooperation among EU Member States and thus to introduce amendments to the Cross-Border Healthcare Directive. The proposed Regulation covered 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. The plenary of the European Parliament adopted a negotiating position on 14 February 2019, followed by the Council of the European Union on 24 March 2021. An informal agreement between the co-legislators on a compromise text for this draft law was reached on 22 June. This was formally endorsed by the Council on 9 November, followed by the Parliament in its December session. The Act was signed by the co-legislators on 15 December 2021 and published in the Official Journal on 22 December 2021. |
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| Source Link | http://data.europa.eu/eli/reg/2021/2282/oj |
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| Subject Categories | Health |
| Subject Tags | Medicines | Medical Devices, Public Health |
| Keywords | Health Services | Healthcare |
| International Organisations | European Union [EU] |
