The Alpha-1 Europe Alliance (A1EA) took another important step in representing the European Alpha-1 community. Our Vice President, Heinz Stutzenberger, attended the Annual Meeting of the Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Party (HCPWP) with Eligible Organisations, held at the headquarters of the European Medicines Agency (EMA) on 20 and 21 October, 2026.
From eligibility to a seat in the room
The invitation follows a milestone for the Alliance. A1EA was recently accepted by the EMA, the body at the centre of the authorisation of new medicines in Europe, as an eligible patients’ and consumers’ organisation. This formally recognises A1EA as a voice the Agency can consult on the patient perspective, helping ensure that patients are represented throughout the lifecycle of a medicine.
Heinz has also been registered in the EMA Experts Management tool, which means he can now be involved in EMA activities related to medicines and medical devices.
“I am curious to get this kind of information directly from the most relevant organisation for the authorisation of new medicines. I look forward to meeting in person the people from EMA who guided us through the application process, and the other patient representatives.”
For a young organisation, this is a clear sign that the Alpha-1 community has a credible, structured voice at European level.
Two days of dialogue
The programme, co-chaired by Juan Garcia Burgos (EMA) and Marco Greco (PCWP), brought together patient, consumer and healthcare professional organisations with members of both working parties. Around 35 topics were addressed, including:
- the new EU pharmaceutical legislation
- the Substances of Human Origin (SoHO) regulation
- the availability and supply of medicines
- regulatory science, innovation and competitiveness, including the ACT EU multistakeholder platform
- biosimilars
- the European Patients’ Academy on Therapeutic Innovation (EUPATI)
- committee feedback and the Members’ Voice session
Between sessions, there was plenty of time to meet EMA representatives, healthcare professionals and fellow patient representatives.
Why this matters for the Alpha-1 community
Several discussions touched directly on the priorities of our community.
- A faster, smarter authorisation process. The planned changes to EU pharmaceutical legislation aim to make the authorisation of medicines faster and more efficient, with stronger patient involvement. This is both an opportunity and a responsibility: patient organisations must be ready to contribute well-structured evidence and clear priorities. The Alliance has been discussing how to prepare, especially as many new medicines for AATD are in the development pipeline, and the meeting confirmed that this is the right focus.
- Plasma self-sufficiency. During the discussion on the SoHO regulation, Heinz drew attention to its stated goal of achieving a self-sufficient plasma supply in Europe and reducing dependence on imports from the United States. For people with Alpha-1 who rely on plasma-derived alpha-1 antitrypsin (AAT) augmentation therapy, a secure and sustainable supply is a practical necessity.
- Critical medicines. The EU list of critical medicines also came up. Intravenous AAT currently does not meet the quorum required to appear on the list, which is inclusion on 50% of national lists.
Looking ahead
Heinz returned from Amsterdam energised, with new contacts and a clearer view of how EMA processes are evolving. He will share these insights with the Alliance’s member organisations so that what is learned at the table reaches the community.
“Being accepted as an eligible organisation was an important step, and being in the room shows what it makes possible. We will keep contributing to the conversation on how medicines are evaluated, supplied and made available in Europe, with the Alpha-1 patient perspective at its heart.”
A1EA will continue to share updates on its work with the EMA and other European institutions.
