European Commission Starts Revising Pharmaceutical Legislation and Publishes Evaluation Roadmap and Inception Impact Assessment
Earlier this week, the European Commission (the Commission) started the process of revising the general pharmaceutical legislation – Directive 2001/83/EC and Regulation (EC) 726/2004 - which it labels as one of the flagships of the Pharmaceutical Strategy for Europe (PSE) (see, Van Bael Bellis Life Sciences News Alert of 26 November 2020). Both the general public and the stakeholders are invited to submit their views on the “Combined Evaluation Roadmap/Inception Impact Assessment” (see, attachment).
The Commission is seeking contributions on the broad range of issues covered by the PSE such as (i) unmet medical needs in areas outside the scope of the rules governing rare diseases and paediatric medicines; (ii) unequal access to affordable medicines; (iii) new technologies, including genomic sequencing, genome editing, artificial intelligence and medication based on genetically modified organisms; (iv) simplification of applicable rules and procedures; (v) vulnerable supply chains, security of supply and shortages; (vi) competition issues, including the role played by generics and biosimilar products; (vii) incentives designed to stimulate innovation; and (viii) antimicrobials.
This initial public assessment started on 30 March 2021 and will end on 27 April 2021. A more thorough public consultation featuring targeted questions will be held in the fourth quarter of 2021. The Commission plans to propose draft legislation one year later in the fourth quarter of 2022.
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