By Fisentzos Stylianou, PhD; Senior Analyst
The UK will be the first country to introduce a regulatory framework for innovative medicines manufactured at the point of care (POC), according to the Medicines and Healthcare products Regulatory Agency (MHRA) [1].
The new framework will allow for new medicines with short shelf-lives and highly personalised medicines to be made in or near a hospital or ambulance setting and reach patients more quickly. The framework “will ensure there are no regulatory barriers to innovative manufacturing and that products made via such routes have the same assurances of safety, quality, and effectiveness as those for conventional medicinal products.” The MHRA will collaborate with relevant parties to create accompanying guidance for the new framework, which will be released in due course.
The development of a new POC framework is particularly significant for manufacturers of autologous cell therapies such as CAR-T’s, as it has implications for both the public and commercial sectors. In the public healthcare system, reducing regulatory barriers and increasing the potential for POC manufacturing may be a show of support for publicly developed medicines, such as therapies developed under hospital exemption (HE; see P4A white paper for trends in HE [2]). This is particularly important as healthcare budgets are currently strained and there is a growing appetite for increased funding and support for advanced therapy medicinal products (ATMPs) developed by the public sector, given their cost-effectiveness when compared to commercial ATMPs.
Several industry organisations, including the Alliance for Regenerative Medicine, have recently voiced their concerns about the implementation of HE, stating that HE legislation in the EU is not strict enough and that there are “great variations in the interpretation of the HE across the EU”, which could stifle competition and innovation [3]. As support for HE-developed therapies continues to gain momentum in the UK, these concerns may also continue to grow. However, it’s crucial to recognize that there are ample opportunities for pharmaceutical companies to embrace the new regulations and technologies. This holds the potential to not only reduce costs, but also enhance affordability and competitiveness, leading to increased collaboration between the pharmaceutical industry and public healthcare system. By actively exploring these opportunities and adapting their business models accordingly, pharmaceutical companies can ensure their continued competitiveness in the rapidly-evolving world of autologous cell therapy.
To gain a deeper understanding of these new regulations and how to adapt your business models accordingly, we invite you to reach out to P4A. Our team would be happy to share our expertise and discuss how our offerings can assist you in your journey to driving patient access for your therapies.
[2] https://partners4access.com/whitepapers/hospital-exemptions-friend-or-foe-to-pharma/
[3] http://alliancerm.org/wp-content/uploads/2022/11/ARM-Call-to-Action-FINAL.pdf
