TRANSFORM Position on the EU Pharmaceutical Package
TRANSFORM Alliance Members’ consensus positions in response the European Commission’s legislative proposals on the Pharmaceutical Package. These positions aim to drive positive change across the full lifecycle of ATMPs, hence they are listed according to their place in the lifecycle of a therapy, from research through to patient access, and must be viewed holistically.
TRANSFORM MEP Charter with Solutions to Enable Safe and Timely Patient Access to Advanced Therapies in Europe
On 13 October, the European Alliance for Transformative Therapies launched its MEP Charter with Solutions to Enable Safe and Timely Patient Access to Advanced Therapies in Europe, developed collaboratively with expert stakeholders. The Charter will serve as a guide for TRANSFORM’s action in the coming years, including for the MEPs to prepare the discussion of expected legislative files such as SoHO legislation, the General Pharmaceuticals legislations, the EHDS, among others.
TRANSFORM: Multi-stakeholder approach to gene and cell therapies
TRANSFORM is a multi-stakeholder alliance composed of patient groups, medical experts and associations, healthcare and non-healthcare specialists, scientists, researchers, industry actors and other relevant stakeholders. We advocate for improving the regulatory and legislative systems with the intention to realise the promise of transformative therapies for severe, disabling or life-limiting conditions.
Policy Asks on the Regulatory Framework for ATMPs
The European Alliance for Transformative Therapies’ (TRANSFORM) Policy Asks advocate for a regulatory framework that enables safe and timely patient access to transformative therapies, building on the 2021 TRANSFORM Recommendations for Action.
Policy Asks on Access to Authorised ATMPs
The European Alliance for Transformative Therapies’ (TRANSFORM) Policy Asks advocate for changes that offer potential solutions to unlock safe and timely patient access to authorised ATMPs in Europe, building on the 2021 TRANSFORM Recommendations for Action.
5 Policy Asks to Optimize Cross-border Patient Access to Transformative Therapies
The TRANSFORM MEP Interest Group launched 5 Policy Asks on how to optimize cross-border patient access to transformative therapies at their online event on 10 November 2021.
The current mandate of the European Parliament is ending, with elections in June 2024. This gives MEPs little more than six months to work on outstanding files. The Parliament is currently reviewing several health legislative proposals that will impact the ATMP ecosystem, including: the Regulation on Substances of Human Origin (SoHO), crucial for products derived from human substances; the European Health Data Space (EHDS), a cornerstone of a new era of digital health, interoperability and innovation; and the proposed Pharmaceutical Package, which contains rules that impact every stage of product development, from R&D to access. Together, they present an opportunity to future-proof healthcare systems and strengthen patients’ access to care by ensuring the EU is attractive for R&D and, therefore, new therapies. The TRANSFORM MEP Interest Group is pleased to host this timely event, together with the TRANSFORM multi-stakeholder Alliance, to explore how policymakers can ensure innovative therapies are a cornerstone of EU healthcare for the future. Registration is subject to approval by the TRANSFORM Secretariat due to limited spaces.