EFPIA statement on tomorrow's meeting of EU Health MinistersEFPIA welcomes the proposals from the the Slovenian Presidency of the Council of the EU presented in the draft Council Conclusions to strengthen a European Health Union.
Tomorrow (12 October 2021), EU Health Ministers will gather for an informal meeting in Slovenia, which will also be attended by Stella Kyriakides, Commissioner for Health and Food Safety. The agenda will focus on the following topics, amongst others: availability and accessibility of medicines, the response and preparedness to cross-border health threats, and resilient health systems.
EFPIA welcomes the proposals from the the Slovenian Presidency of the Council of the EU presented in the draft Council Conclusions to strengthen a European Health Union.
We welcome the draft Council Conclusion’s invitation to Member States and the Commission to pay due attention to finding ways to improve the accessibility and the availability of medicinal products, notably of antimicrobials. In regard to the fight against Anti-Microbial Resistance (AMR), a comprehensive set of policies is required including better awareness, stewardship and surveillance programmes. We also need to urgently address the failure of the current economic framework for anti-microbials to drive sustained research and development (R&D) investments in this critical field. To achieve this objective, we call for the development of a new incentive at the European level in the form of a transferable exclusivity extension (TEE) which is pro-stewardship and respects prudent use by delinking financial reward from the volume of prescriptions. Rewarding successful innovation at a level sufficient to increase anti-microbial R&D is required to overcome the commercial challenges associated with appropriate use of anti-microbials, whilst ensuring a sustainable pipeline of innovative antimicrobial medicines to meet future AMR threats as well as patient access to these medicines when needed.
In light of the inclusion of repurposing in the draft Council Conclusions and likely discussion at tomorrow’s meeting, EFPIA wishes to highlight that together with other trade associations, patient groups and regulators from around Europe, we have been working with the European Commission on a repurposing pilot project with the Commission's Expert Group on Safe and Timely Access to Medicines for Patients (STAMP)1. Results of the pilot are likely to be launched later this month and should inform further policy decisions. Commenting on the draft Council Conclusions, EFPIA Director General, Nathalie Moll said, “As seen in the case of multiple myeloma, repurposing existing on-patent or off-patent products can also be an effective means of addressing orphan and paediatric health needs. However, the consent of the Marketing Authorisation Holder(s) for such repurposing is important. To regard repurposing as one viable way to address unmet needs in rare disease, we have to acknowledge the merits of incentives."
1The STAMP expert group is set up to provide advice and expertise to the Commission services in relation to the implementation of the EU Pharmaceutical legislation, as well as programmes and policies in this field.