EU pharmaceutical legislation
ESOP Global: response to the new EU pharmaceutical legislation proposal (2023)
The members of ESOP Global, who represent health care professionals from 67 countries worldwide including all countries inside the European Union, applaud the presented proposals for the new legislative pharmaceutical framework.
The needs of our patients have been placed at the center of the revision. Moreover, the concerns expressed by us as oncology pharmacists have been addressed throughout the legal text. We fully support the committees’ endeavors
- to tackle the problem of antimicrobial resistance,
- to work towards equal access of all citizens across all member states to innovative treatment modalities, where in-hospital production can also play an important role, and
- to highlight unmet medical needs in both adult as well as pediatric patients.
Furthermore, we are supportive of the proposed changes to make the pharmaceutical field more environmentally sustainable and to provide greater transparency to the public regarding public funding of medicine development and regarding drug shortages.
Realizing that the extended mandate with respect to shortages to the European Medicines Agency (EMA) has not been in place for long, we are eager to collaborate with EMA to address drug shortages at their root causes. Especially regarding drug shortages, we need measures to be implemented with great urgency, as we continue to face unavailability of essential medicines that severely hamper the delivery of our care.
Therefore, we assume the inclusion of the following bases for action:
- Guaranteeing a seamless supply. Ultimately, this can only be ensured through European production facilities in which supply chains are made shorter and supply bottlenecks are minimized.
- Ensuring social responsibility for our countries by maintaining or creating jobs in the broader field of healthcare and contributing to the protection of the population
- The protection of the environment is not divisible; clean water and clean air cannot be limited to certain regions of the world, but must be guaranteed everywhere.
- Socially acceptable pricing must be achieved through regulatory measures in relation to the markets.
Finally, we are calling on the involved stakeholders who will work on the implementation of the new legal texts to involve patient representatives and health care professionals for assessing unmet medical needs. Only with the voices of patients and with the voices of those professionals who strive to provide these patients with optimal care on a daily basis, the highest unmet medical needs can be identified and defined. All the while the highest level of safety of patients should and will be guaranteed.
We are committed to helping the European Union in the near future to ensure that the ambitions of the proposal will be upheld during the negotiation process that will follow and to provide input and insight in those areas where further work will be needed.