Ahead of the plenary vote in the European Parliament (EP), held on 10 April 2024, ESMO wrote to the Political Groups Coordinators on the EP’s Committee on the Environment, Public Health and Food Safety (ENVI) to welcome its reports as a positive step towards reforming the European Union’s general pharmaceutical legislation, as it provides a once in a generation opportunity to improve the availability, accessibility and affordability of medicines for both cancer and rare cancer patients in the EU. Accordingly, ESMO invited all the EP’s Political Groups to vote in favour of adopting both the reports, on the Directive and on the Regulation, as this would be a significant step towards creating a regulatory environment which places the patients at its center while securing the timely delivery of innovative and affordable medicines to patients with cancer across the EU.
ESMO particularly welcomed the EP’s proposal introducing stronger wording to Article 162 of the draft Regulation, which reflects the society’s recommendation, that the European Medicines Agency (EMA) shall establish a consultation process with relevant stakeholders, including healthcare professionals and patients, on general issues of a scientific or technical nature related to the tasks of the EMA, in particular guidelines on unmet medical needs (UMN) and the design of clinical trials. ESMO reiterated its support for plans to establish a criteria-based definition of UMN and scientific guidelines on the category of orphan medicinal products addressing high unmet medical needs (HUMN) and advised that further clarification will be required to explain how those criteria and scientific guidelines will be quantified/defined to ensure that they reflect the latest scientific developments. However, ESMO expressed its disappointment that the EP’s initial amendments the definition of UMN, notably referring to quality of life, have not been included in the final version adopted in the ENVI Committee on 19 March 2024.
Noting ESMO’s recommendation, previously communicated to European Commission (EC) and the EP to establish a European network for adult rare cancers, ESMO also welcomes the EP’s proposal that the EC establish a European Framework for Rare Diseases to better meet the unmet needs of people living with rare diseases, and their carers as such a network - of patients’ representatives, academics, medicines developers and investigators – will act as an invaluable advisory mechanism on specific rare cancer types and, ultimately, result in the improved treatment of patients with rare cancer.
On medicines shortages, ESMO supports the proposal that the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) will develop a list of critical medicines and, as only a supranational EU solution can mitigate shortages of inexpensive and essential medicines, that market authorisation holders be obliged to provide shortage prevention plans. ESMO also calls for rare cancers medicines to be considered as critical medicines and included in shortage prevention plans – including but not limited to the proposed European list of critical medicines, WHO Essential Medicines List (EML) cancer drugs, cancer drugs covering UMN and rare cancer drugs. In addition, ESMO believes that the future EU pharmaceutical legislation should include adequate measures to encourage production of key medicines and active pharmaceutical ingredients (APIs) within the EU.
As part of ESMO’s efforts to prevent medicines shortages, ESMO Chair of Cancer Medicines Committee (CMC), Dr Dario Trapani recently gave an interview on medicines shortages to the Financial Times advising that in the past six months ESMO members have reported shortages in inexpensive drugs which are being used every day across the continent.
With cancer incidence in Europe set to increase from 4.4 million in 2022 to 5.32 million in 2040, ESMO is committed to working with decision-makers post-EU elections to ensure that this revision is completed both in a timely fashion, and with tangible provisions which will deliver improved health outcomes to patients with cancer.