NEWSLETTER
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Stay updated on ATMP innovation and rare disease care across Europe
CREATIC LabtoP Talks ~ From Lab to Patient continue this autumn
Since the first CREATIC LabtoP Talk in November 2024, the series has developed into a regular platform for expert dialogue on how Advanced Therapy Medicinal Products (ATMPs) move from the laboratory toward clinical practice and patient access.
The talks address scientific, regulatory and practical questions shaping the future of advanced therapies: from hospital exemption and clinical trial pathways to rare disease genomics, disease modelling, cell-based immunotherapies and coordinated approaches to patient access.
About ATMP Newsletter
The CREATIC ATMP Newsletter is a joint effort by Masaryk University and the University of Copenhagen. MUNI | CREATIC (Masaryk University) has established a partnership with the University of Copenhagen, Leipzig University, and the Fraunhofer Institute for Cell Therapy and Immunology IZI to build a center of excellence in research and development focused on Advanced Therapy Medicinal Products (ATMPs). This Czech‑Danish collaboration behind the newsletter brings key updates, expert perspectives, and relevant regulatory developments in the ATMP and rare disease ecosystem, with a focus on Central Europe.
Highlights from the Latest Issue
Who Gets to Decide? Normative Judgements in Health Technology Assessment
By Zainab Afshan Sheikh, Assistant Professor, CeBIL, and Jakob Wested, Associate Professor of Pharmaceutical Law, CeBIL
Are decisions about access to advanced therapies purely scientific, or are they also political and ethical choices?
The growing use of ATMPs and other innovative therapies is putting pressure on health technology assessment (HTA) systems across Europe. These therapies often reach decision-makers with promising, but still uncertain, evidence. This raises an urgent question: how should healthcare systems weigh uncertainty, unmet need, severity of disease, costs and fairness when deciding who gets access?
Focusing on recent debates in Denmark, this article shows that HTA is not only a technical process of evaluating data and costs. It is also a process of prioritization, where ethical and normative judgements are unavoidable.
The article explores why transparency, legal basis, public accountability and the composition of HTA bodies matter — especially when decisions concern therapies where long-term evidence may take years to establish, but patients need answers now.
The conundrum of Europe's East–West healthcare divide
How Ireland built an ecosystem for advanced therapy manufacturing
The Danish Medicines Council calls for more risk-sharing agreements for ATMP medicines
In this seventh edition of the CREATIC ATMP Newsletter, we turn to a difficult but unavoidable question: who gets to decide how, when and for whom advanced therapies become accessible?
As ATMPs move further from experimental promise toward clinical and regulatory reality, decision-makers across Europe are facing growing pressure to act under conditions of uncertainty. Evidence may still be incomplete, long-term outcomes may take years to establish, and treatment costs remain high. Yet for patients with limited options, delayed access is not an abstract policy issue.
This issue examines how these tensions are playing out across the European ATMP landscape. It brings together perspectives on health technology assessment, ethical and normative judgement, risk-sharing, unequal access to innovation, pharmaceutical reform, manufacturing ecosystems, clinical trials, logistics, education and patient experience.
Together, the contributions show that the future of ATMPs will not depend on science alone. It will also depend on whether Europe can design systems that are transparent, fair and capable of balancing innovation, uncertainty, sustainability and patient need.
ATMP Newsletter Archive
Browse previous editions of the CREATIC ATMP Newsletter and stay informed about key developments in advanced therapies.
Issue #1 (online) | DOWNLOAD .pdf | Issue #2 (online) | DOWNLOAD .pdf | Issue #3 (online) | DOWNLOAD .pdf
Issue #4 (online) | DOWNLOAD.pdf | Issue #5 (online) | DOWNLOAD.pdf | Issue #6 (online) | DOWNLOAD .pdf
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