Statement on EU Pharma Legislation Revision

European Academy of Neurology's Perspective on the Revised EU Pharmaceutical Legislation: Balancing Innovation, Access and Patient Needs.

In response to the review of EU Pharmaceutical Legislation, the European Academy of Neurology (EAN) is aligned with the following key positions:

Equity, affordability and accessibility EAN is dealing with the largest part of European population with a disease: the neurological patients. For all of them EAN shares the main objective of EU Commission that, with its new Directive and new Regulation, a fully revised legislation, wants to guarantee that all patients across all European Countries have timely and equitable access to safe, effective, and affordable medicines

Balancing Patient Needs with Industry Development: EAN appreciates the patient-centred approach that seeks to increase access to affordable and effective treatments. We also believe that legislation must balance this with fostering a favourable environment for pharmaceutical innovation. This ensures the continued development of cutting-edge treatments for neurological conditions. We are well aware that authorisation does not automatically equate with availability.

Addressing Unmet Needs in Neurology: Recognising the complexity and high prevalence of neurological conditions in Europe, affecting 1 in 3 of the population, EAN urges for tailored incentives to stimulate research and development in this field, to address unmet medical needs, such as in rare neurological diseases, and advance treatment options.

Involving Patients in Decision-making: EAN supports the integration of patients and of patients’ organisations and representatives’ perspectives in decision-making processes. Patients' lived experiences and insights can significantly contribute to the relevance and quality of healthcare development and delivery.

Preserving Research Incentives: EAN emphasizes the need for preserving and refining incentives for research, especially for rare neurological diseases. This is key to encouraging the continued exploration of innovative treatments.

Promoting Transparency and Addressing Shortages: EAN supports the drive towards greater R&D cost transparency to inform pricing discussions and strategies. Additionally, we back measures to mitigate medicine shortages, ensure the availability of treatments, and improve patient information.

Ensuring a strong EU voice in the world EAN is committed to collaborative work with stakeholders, including pharmaceutical companies, regulatory authorities, and patient organizations, to advance the interests of neurology patients and the broader neuroscience community and believes that this new legislative framework will be able to promote a high level of quality, efficacy and safety standards, example for all other regions of the world.