On Tuesday 30 March, the European Commission began consultations on the review of medicines legislation, as it committed to do in its November 2020 pharmaceutical strategy (see EUROPE 12609/10). Stakeholders can comment on its initial impact assessment until 27 April.
The consultation focuses on Directive 2001/83/EC and Regulation 726/2004. In particular, the Commission wants to know whether this framework responds to the problems identified by the Pharmaceutical Strategy, whether it is coherent and complementary to other European initiatives, and whether it keeps pace with technological developments. The evaluation covers the period from 2005 to the present.
On this occasion, Health Commissioner Stella Kyriakides said: “To ensure that all patients have access to safe, high-quality, and affordable medicines, we need pharmaceutical legislation that is relevant to today’s world. This is an opportunity for all of us, citizens and stakeholders, to participate in this ambitious reform and help us reshape and strengthen our legislation”.
Among the objectives, the Commission wants to reach a common understanding of the notion of ‘unmet medical needs’. It also wants to revise the incentive system (options will explore new incentives that “complement, replace or adjust market protection while taking into account the relationship with intellectual property rights”) and examine the creation of specific incentives to promote the development of a new class of antimicrobials. It also wants to look at ways to increase support and speed up product development and authorisation in the area of unmet need, as well as to improve competition provisions, in particular with regard to generics and biosimilar medicines.
This “comment” period will be followed by a public consultation in the second half of 2021, and then by a legislative proposal in the fourth quarter of 2022.
Link: https://bit.ly/3uaWiWG (Original version in French by Sophie Petitjean)