ESIP responds to the public consultation on the revision of EU rules on pharmaceuticals

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.

  • A common definition of unmet medical needs should be based on quantifiable criteria and cross-referenced in the EU legislation. This would serve to identify (high) unmet needs and accordingly define eligibility criteria for incentives and conditional approval pathways.
  • The existing framework for incentives should be revised, including through measures to avoid misuse of existing incentives, and through the introduction of alternative rather than additional incentives, other than the transferable exclusivity vouchers which we strongly oppose. For antimicrobial resistance, new and alternative non-volume related incentives should be considered, along with measures promoting prudent use.
  • A transparency clause on (publicly-funded) research & development costs should be introduced for both new and repurposed products, to support informed pricing & reimbursement decisions and ensure public return on public investment.
  • Another obligation should be introduced on placing products on the EU27 markets, within a limited period after centralised marketing authorisation, and should not be subject to additional incentives.
  • As higher levels of uncertainty are registered at time of market entry, especially for novel products, attention should be given to avoid shifting the assessment of safety, quality and efficacy from pre- to post- marketing authorisation and randomised control trials should remain the gold standard. (Post-launch) evidence requirements should be further enforced and payers’ requirements for P&R decisions should be considered from the outset.
  • While P&R decisions are a national competence, measures could be introduced at EU level foster affordability, namely promoting fair competition and honing the joint procurement system. The legislation should provide for facilitated access to a repurposing framework especially to generic and biosimilar producers; a database of patent and SPC expiries could also be established.
  • Finally, on security of supply, it is important to strengthen cooperation, by monitoring supply and demand at Member States’ level and establishing a common EU monitoring system for shortages, with reinforced reporting obligations for producers and sanctions in case of non-compliance.


Find the full ESIP response to the public consultation on the revision of the EU general pharmaceutical legislation here.

Photo: © European Union, 2019 Source: EC - Audiovisual Service