Improving the availability, accessibility and affordability of innovative medicines for cancer patients
In April 2023, the European Commission (EC) published its proposals, the first major overhaul to the EU’s medicines regulations in 20 years, to revise the following EU pharmaceuticals legislation:
- Regulation 726/2004 - authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (EMA);
- Regulation 141/2000 on Orphan Medicinal Products (OMPs) laying down criteria for designating certain medicinal products as orphan drugs;
- Regulation 1901/2006 on medicinal products for paediatric use;
- Regulation 1394/2007 on Advanced Therapy Medicinal Products (ATMPs);
- Regulation 536/2014 on clinical trials on medicinal products for human use;
- Directive 2001/83 on the Union code relating to medicinal products for human use.
The EC’s legislative proposal has an overarching goal of so-called ‘3 As’ - Affordability, Accessibility, Availability - and it includes, amongst others, the following objectives:
- Putting patients in the centre - equal access and security of supply for patients across the EU;
- Driving innovation for the pharmaceutical industry through a number of incentives related to market exclusivity;
- Developing the criterion-based definition of unmet medical need (UMN) and scientific guidelines on the category of ‘orphan medicinal products’ addressing high unmet medical need (HUMN);
- Introducing structural changes to the European Medicines Agency (EMA), which includes greater representation of patients and healthcare professionals;
- Adopting a list of critical medicines that require coordinated EU-level action to prevent medicines shortages;
- Repurposing off-patent medicines;
- Greater transparency in public funding for research and development of medicines.
The proposal has now been sent to the European Parliament (EP) and European Council for consideration and adoption of their negotiation positions ahead of Trilogue negotiations with the Commission to try and agree on the final text of this legislation, ahead of next year’s (6-9 June) elections to the EP.
As the new Parliamentary term will significantly delay the legislative process, the final text is not expected to be adopted until late 2026 or mid-2027.
ESMO published its statement on the European Commission’s proposal welcoming the general objectives of the proposal and highlighting the need for patients’ and healthcare professionals’ involvement in the development of definitions of UMN and HUMN.
ESMO is currently developing its official position on the proposal which will also serve to form an ESMO response to the ongoing public consultation on the European Commission’s legislative proposal (deadline 8 November 2023).
Given the current scourge - an estimated 2.7 million new cases and 1.3 million deaths in the EU in 2020 - of cancer and the increasing threat - lives lost to cancer in the EU are set to increase by more than 24% by 2035, making it the leading cause of death in the EU - that it poses to Europe’s patients, their families and friends, ESMO is committed to working with the EU institutions to ensure that this revision is completed in a timely fashion and delivers improved health outcomes to patients through the timely delivery of innovative cancer medicines.