Drug companies could face duplication of work and added financial and administrative burden if proposals from the Council of the EU are adopted to weaken draft legislation on EU-level mandatory clinical assessments, warns EUCOPE, the European Confederation of Pharmaceutical Entrepreneurs.
Although some matters are yet to be agreed upon, the Portuguese presidency of the Council of the EU said this week that it hopes to start trialogues soon with the European Commission and the European Parliament on the commission’s
The Proposals
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 recognizes that numerous health technology assessment (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
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