European Cancer Patient Coalition
ECPC
ECPC works for a Europe of equality, where all European cancer patients have timely and affordable access to the best treatment and care available.
ID: 782811248337-11
Lobbying Activity
Response to Evaluation and revision of the general pharmaceutical legislation
7 Nov 2023
Regulatory Aspects ECPC welcomes the proposal to involve patients in the regulatory cycle of medicines, such as in the Committee for Medicinal Products for Human Use within the EMA. However, we recommend that the new EMA governance structure considers patient involvement throughout the whole development and evaluation cycle of new medicines in order to improve the outcomes and the implementation of the regulatory decisions. ECPC believes that no matter the circumstances, patients must have timely access to the medicines they need. The EU Commission is best positioned to support Member States (MS) throughout the approval process. However, MS must consider involving patients in the approval process, as full members of the coordination group. This will give patients the opportunity to express their position on the approval/rejection of a medicine. At the same time, the EU Commission should support MS to involve patient organisations in the health legislative process at the national level. Marketing Authorisation The need to improve the efficiency of the European Medicines Agencys marketing authorisation process, e.g., through adaptive licensing and streamlined, accelerated pathways for new technologies with the suggested measures for greater involvement of patient representatives in the consultation process. Since the adaptive licensing allows the patients to decide about the risk they want to take depending on their disease progression, ECPC considers that the EC should propose a harmonised framework to allow patients across Europe to have early access to the adaptive licensing in each MS. We welcome the proposed measures for a more competitive market across Europe and would like to point out the importance for the regulation to ensure the high-quality and safety standards that will benefit patients needs. Regulatory protection and incentives ECPC supports the idea of implementing a system that stimulates innovation and would like to recommend the following: Strengthening the incentives for faster launch and early access to medicines for patients is key. The close cooperation between industry and Member States in meeting their responsibilities of ensuring the availability of and access to medicines for patients is crucial. A step-by-step approach in this sense and best practice sharing will be key in ensuring that there will be no disruptions in ensuring timely access for patients to their critical medicines. ECPC believes that an incentive system should also be defined for academic research institutes and non-for-profit entities that are also key players in innovation. A measure as such would further support the development of new therapies in disease areas that are currently lacking behind, such as rare and ultra-rare cancers. Medicinal products addressing an unmet medical need (UMN) ECPC endorses the need to define the concept of UMN based on scientific and technological developments and current knowledge in disease areas that are underserved. The criteria for the UMN should not focus solely on aspects related to high morbidity or mortality. Patients should be involved in defining the UMN and that this definition should be broad enough to include aspects that are meaningful to them, such as quality of life. At the same time, patient advocates should also be involved in developing the proposed awareness card for patients with information on AMR. It is key that all relevant stakeholders, including patients and disease-communities, academia, health professional organisations and representatives of the European Reference Networks (ERNs), engage in dialogue and cooperation to ensure that the definition of unmet medical need meets patients needs and values and improves access and availability of medicines throughout the whole pathway of care.
Read full response