Following negotiations with the Council of the European Union on proposed regulations on health technology assessments, the European Parliament has conceded its position that joint clinical assessments should be mandatory for member states carrying out HTAs on medicines and medical devices. However, industry representatives doubt that safeguards secured by the parliament to prevent a bigger burden on companies go far enough.
“While the European Commission's original legislative proposal was certainly a step into the right direction, last night’s agreement falls short of addressing the main issue of duplication of clinical assessments, EUCOPE, the European
The Background To The Regulations
The commission published its proposal for a Regulation on health technology assessment (HTA) and amending Directive 2011/24/EU on patients' rights in cross-border healthcare in January 2018.(Also see "Industry Welcomes Mandatory EU Joint Clinical Assessments For HTA" - Pink Sheet, 1 February, 2018.)
The proposal recognized that numerous HTA procedures across the EU lead to delays in access to medicines for patients, duplication of work and inefficient use of resources for the numerous national and regional HTA bodies, as well as a lack of predictability and higher costs for industry. The commission’s aim was to improve the situation by ensuring greater cooperation across Europe on joint clinical assessments, joint scientific consultations, joint horizon scanning and voluntary cooperation in other areas
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