A fit Pharmaceutical Legislation to benefit EU citizens and health systems
AESGP has submitted its response to the European Commission’s Combined Evaluation Roadmap / Inception Impact Assessment on the Evaluation and revision of the general pharmaceutical legislation.
AESGP welcomes the European Commission’s combined Evaluation Roadmap and Inception Impact Assessment to provide sound information that can support the establishment of a Pharmaceutical Strategy for Europe, that follows plans set on the Industrial Strategy, and under the continued efforts to build a stronger European Health Union.
AESGP supports a pragmatic and risk-based regulatory framework that fosters a stronger role for self-care and prevention. The current structure is overall fit for purpose although some issues may arise from divergent interpretation, disharmonised application and addition of gold plating or administrative elements. These can be tackled through non-legislative initiatives.
AESGP fully supports the ‘targeted approach’ pursued by the Commission for this exercise based on the recognition of the well-established dual marketing authorisation system in the EU. For the sake of legal certainty and regulatory efficiency, keeping the existing legal instruments fits best the objective of this targeted approach. Updates to existing policy and guidance documents must be considered as valid instruments to deliver on the objectives.
We believe that a solid analysis of the existing regulatory framework and impacts of the proposed measures under each of the considered policy options is critical to achieve a proportional legal proposal. AESGP is committed to engaging in an open dialogue with all the involved stakeholder groups to achieve the common objectives of this initiative. In carrying out this analysis, the interconnection of the pharmaceutical legislation with the ongoing proposals for the reinforced role of EMA, the creation of HERA, the ongoing implementation of the Medical Devices Regulation must be taken into account so as to avoid unnecessary duplication of initiatives.
AESGP would also like to highlight some of the policy areas identified by the European Commission and some important considerations:
- Legislative instruments are fit for a stable, integrated, predictable, coherent and proportional regulatory and administrative framework
- Opportunities to improve health outcomes and sustainability of health systems
- Incentives for safe switches of medicines from prescription to non-prescription
- An agile variations system allows for quicker adaption to health needs
- Learnings of COVID-19 have shown the way to ease regulatory burden
- Global supply chain robustness gives more options to availability and affordability
- Digital tools allow supple procedures, better medicine use and more patient safety
- Scientific-based environmental concerns help to drive risk-pondered solutions that ensure medicines accessibility
- Health literacy helps taking health decisions and the responsible use of medicines
AESGP is looking forward to the dialogue with the Commission, European Parliament, Member States and European Medicines Regulators on the proposed actions.
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