ABEP Quarterly Meeting Report – 26 March 2025.

ABEP (AIPM and Patient Organisations Collaboration Platform) aims to promote transparent, ethical and effective collaboration between the innovative pharmaceutical industry and patient organisations. Their aim is to involve patients in all steps of the medicines lifecycle, including research and development and health policy discussions. The current meeting covered several important topics.
Batthyány-Strattmann Foundation
One of the main topics of the meeting was the newly established László Batthyány-Strattmann Foundation, which deals with the management of equity-based medicines claims. Under the current rules, applications are sent to the NEAK, which decides whether to process the application in the traditional way or to transfer it to the Foundation. During the meeting, there was a discussion on how patient organisations could be involved in the operation of the Foundation. Finally, a proposal was made to consult the decision-makers by joint letter.
AIPM Patient Organisation Strategy

The Association of Innovative Pharmaceutical Manufacturers (AIPM) has the strategic goal of promoting collaboration between patient organisations and the pharmaceutical industry. During the meeting, it was reaffirmed that the involvement of patient organisations remains a priority in the process of developing and making available medicines. It was stressed that the pharmaceutical industry cannot directly support patient organisations, but that this is possible for global organisations. The need for a legal definition of patient organisations in law was raised during the meeting and proposed to be submitted to the Parliament.
Advocacy Research
The results of the research on the use of support taxes, i.e. nurses, were presented. The rapporteur stressed that the role of caregivers is extremely important, especially for seriously ill patients. Participants in the session highlighted that these people are often exhausted themselves, which requires even more attention to support them. The presentation emphasised that the burden on carers is often underestimated and that they need additional support.

HTA Process: Health Technology Assessment
At the end of the meeting, the European Union’s new HTA (Health Technology Assessment) regulation was presented, which aims to give patients faster access to innovative health technologies such as new medicines and medical devices. The HTA process will come into force from 2025 and will apply first to cancer medicines, but may later also cover cardiovascular diseases. The new system aims to increase transparency and involve patients in clinical assessments.

Information for members of the National HeartSN Patient Association on joint clinical evaluation of health technologies
From 12 January 2025, the European Union has introduced a new regulation on Health Technology Assessment (HTA), which aims to facilitate faster and wider access to innovative and effective health technologies, such as medicines and medical devices, for patients in the EU.
What is Health Technology Assessment (HTA)?
HTA is a scientific, evidence-based process that examines the medical, social, economic and ethical issues related to the use of health technologies such as medicines, diagnostics and treatment tools.
Joint Clinical Assessments (JCA)

A key element of the regulation is the introduction of joint clinical assessments, where EU countries work together to evaluate the clinical impact of new health technologies.
The process of joint clinical assessments
1.
2. Evaluation process:
a. Manufacturers are required to share product characteristics and clinical data with the HTA Secretariat when submitting a marketing authorisation application.
b. The European Medicines Agency (EMA) notifies the HTA Secretariat of the submission of the application.
c. The joint clinical evaluation formally starts with the appointment of the evaluator and co-evaluator.
Benefits for patients
– Faster access: the new rules will give patients faster access to innovative and effective treatments as the evaluation processes are harmonised and accelerated at EU level.
– Transparency and involvement: Patients and clinical experts can be regularly consulted during the evaluation process, ensuring that the process is transparent and that patients’ needs are taken into account.
Impact on heart patients
Although the joint clinical evaluations will initially focus on oncology medicines and ATMPs, they are expected to be extended to other therapeutic areas in the future. This means that heart patients will also have faster and more equal access to new, effective treatments in the EU.

Closing words
During the meeting, the role of patient organisations in health decision-making was underlined and further efforts are needed to represent patients’ interests. Continued cooperation and facilitation of dialogue can benefit both parties in future health care developments.