Under the Pharmaceutical Strategy for Europe, presented in November 2020, the European Commission announced the future revisions of the EU general pharmaceutical legislation as well as of the Regulations on medicines for rare and paediatric diseases. The related legislative proposals are expected by the end of 2022.
ESIP recently discussed the need to revise the general pharmaceutical legislation, with view to increasing affordability by strengthening fair competition and revising the framework for incentives.
The context:
The current system has allowed medicines to come to the market often with high/unsustainable prices, coupled with lack of transparency of costs borne by producers as well as unsatisfactory levels of evidence. At the same time, R&D tend to cluster in areas of greater profitability rather than greater patient/societal needs.
While the legislation allowed for the timely development, scientific evaluation and authorisation of medicines both in crisis and normal times, more should be done to steer research towards areas of unmet medical/societal needs, improve the competitive functioning of the market and ensure availability of products across the EU.
The call:
Against this background, ESIP calls to ensure that patient across the EU can access affordable medicines, while maintaining healthcare systems sustainable.
Find the full ESIP response to the public consultation on the revision of the EU general pharmaceutical legislation here.