Shortages of essential cancer medicines have a direct impact on patient care across Europe.
To ensure that this issue remains a top priority on the EU policy agenda, ESMO collaborated with the European Parliament to organise a cross-partisan event entitled “Shortages of Inexpensive, Essential Medicines: Calling for Tangible Political Commitments in the EU”.1
Shortages of inexpensive essential medicines have complex and multifactorial causes. In Europe, these often involve quality and manufacturing issues, including low profitability of inexpensive medicines and poor reporting mechanisms. In oncology, in particular, where there are often no alternatives to these medicines, shortages pose a threat to patient safety as they reduce adherence to therapy and limit the ability of physicians to provide effective treatment regimens.
Recognising that this issue cannot be addressed by any single country on its own, ESMO organised the meeting in Brussels to bring together Europe’s prominent stakeholders on the topic and drive concerted and collaborative action at EU level.
Vlad Voiculescu, Chair of the ESMO Patient Advocates Working Group as well as former Minister of Health of Romania, delivered the keynote speech at the event. A statement from the European Commission and a discussion with Member State representatives followed, with questions from the audience and an outlook on the next parliamentary legislature to conclude the working session. The meeting served also to launch a call to action1 with recommendations for the 2019-2024 legislative cycle.
- Introduce legislation for early notification requirements for medicines shortages
- Establish European strategic plans for medicines shortages
- Introduce incentives for production infrastructure improvements, including financial incentives to address the economic causes of manufacturing issues. Incentives for suppliers to remain in these markets should also be considered
- Develop catalogues of shortages based on a common minimum set of data requirements, including a common EU definition of medicines shortages
- Develop national essential medicines lists based on the WHO’s Model List of Essential Medicines
- Establish procurement models designed to prevent medicines shortages, including tender-cycle harmonisation
ESMO President Josep Tabernero commented: “Shortages negatively impact both the health of European citizens and the sustainability of the healthcare systems. The situation is dramatically impacting on cancer patients, as the medicines affected by shortages have few proven effective alternatives or no alternative at all. That’s why ESMO is proposing a course of action with key steps to be taken in the near future.”
Among other measures, ESMO recommends that a common European definition of medicine shortages be created and that EU-level strategic plans and actions be introduced to respond to such shortages. The Society will also advocate that, as a first important step, an EU-wide study be developed on the issue and its overarching impact on the European Union.
“This is a public health emergency,” Tabernero emphasised. “The European Union has the competence to address market failures in this area, and ESMO can be a strong partner in developing practical solutions to prevent shortages going forward. I am confident that the discussions in Brussels will help to position inexpensive essential medicines as a key political priority for the EU legislature of the next five years.”