The UK Bioindustry Association (or BIA) has recently launched a briefing paper on Advanced Therapy Medicinal Products (ATMPs) following its continuous engagement with regulatory bodies on behalf of patients and companies. The paper, which can be downloaded here, is a concise review that summarises very well the main points of the regulatory framework for the development of ATMPs in Europe.
BIA has always engaged with regulatory agencies in order to facilitate strategies for making the development of ATMPs profitable for member companies while addressing yet unmet clinical needs. In the past decade, it has advocated that the European Commission prioritises areas of work which will help ATMP developers to overcome the key commercial challenge of fitting into the modern healthcare market while getting therapies reimbursed.
The purpose of the paper is to provide guidance to stakeholders and to review the current state of ATMP development. It highlights the UK strength in the field and spotlights the key contribution of IUK-funded Cell Therapy Catapult in the commercialisation of ATMPs and of its Cell Therapy Catapult Manufacturing Centre, expected to open in 2017 with the capability of manufacture multi late-stage clinical trial and commercial-scale products. The paper also covers the European Medicines Agency’s (EMA) regulatory framework for ATMPs, the central role of the Committee for Advanced therapies (CAT), the EU R&D activity in ATMPs and the application of the ATMP regulation, which has already allowed five marketing authorisations to be granted across the European market space. The paper clearly emphasises the symmetric relationship that needs to exist between a product’s quality, safety and efficacy and its early access authorisation and mention the EU strategies and conditions to facilitate the clinical adoption of ATMPs whilst still generating commercial opportunities.
Finally, the paper discusses the link between health technology assessment and market access and explains the fundamental role of dialogue with bodies such as the European Commission Expert Group on Safe and Timely Access to Medicines for patients (STAMP) and the UK National Institute for health and Care Excellence (NICE) in providing understanding for assessment, pricing and reimbursement decisions.
Of note, BIA CEO Steve Bates said: “It’s vital that the UK becomes not just a great laboratory for ATMPs but a great place for them to be commercialised. In this the UK faces stiff competition from Japan where the possibility to gain reimbursement after conditional approval is making it an attractive market for the development of ATMPs”.
Author: Giulia Detela