UK’s ‘Pro-innovation Regulation of Technologies Review – Life Sciences’ report outlines regulatory opportunities to speed market access 7 Jun 2023

The ‘Pro-innovation Regulation of Technologies Review – Life Sciences’, published at the end of May 2023, highlights areas where improvements can be made to the UK’s regulatory environment to further enable innovation and a thriving life sciences sector. It presents ambitious ideas on developing innovation pathways and ways to support and retain talent in the regulatory organisations to ensure speed to market for new products.

The report was led by Government Chief Scientific Adviser, Professor Dame Angela McLean, after Sir Patrick Vallance stepped down from the role, and is one of several under this Pro-innovation Regulation of Technologies Review banner, with others investigating digital technologies and green industries.

It is one strand of the government’s overarching 10-year Life Sciences Vision strategy, published in July 2021, which sets out its ambition to ‘make the UK the leading global centre for innovative research design and delivery’.

This latest document stresses the importance of regulatory frameworks and regulators keeping pace with novel technologies, such as AI and digital tools, or the rapid development of nucleic acid based therapies (gene therapy, gene editing, RNA based therapies). It states that if the UK provides the most scientifically capable and supportive regulatory system, this will encourage innovators to engage early with the UK regulatory process, helping to bolster the biopharma and medtech industries and the country’s economic growth.

Following consultation with stakeholders, including government, regulators, industry and academic experts, the report identifies regulatory opportunities that can be actioned within 12-18 months. The focus is on the barriers to new technologies faced by regulators and those affected by regulation in the life sciences sector, and outlines plans to overcome them.

Along with recommendations on common regulatory challenges impacting innovation and growth across the life sciences, there are more specific suggestions regarding regulation of medicines, advanced therapeutics and medical devices. These include proposals related to the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE). There is also a section on life sciences beyond human health.

The review highlights a series of cross-cutting challenges that impede regulators from making timely decisions and, as a result, slow innovation and growth. These concern skills shortages, fragmentation where innovations cross regulatory remits, and having capacity for regulators to support innovation programmes while maintaining day-to-day activities.

Skills

To address the skills shortage, the report recommends creating a skills pipeline, using industry secondments, Centres of Excellence in Regulatory Science and Innovation (CERSIs) and flexibility on pay scales to improve recruitment and retention.

Fragmentation

In order to reduce the regulatory complexity when innovations have applications in several regulatory fields – which leads to overlaps, duplication and inconsistencies in implementation – the report recommends data sharing between different parts of the regulatory system. To this end, it suggests that the government invests in integrating cloud-based platforms in the regulatory application system. This should be dynamic and enable different regulators to access the information as needed for decision making.

Capacity

While programmes like sandboxes and innovation hubs are recognised as having a positive impact on supporting new technologies, extra help is needed to ensure regulators have sufficient funding, capacity and capability to deliver them alongside usual work commitments. Greater support should enable redeployment and an increase in headcount as necessary to deliver flexibility to address the regulatory needs of upcoming technologies. Teams should be supported to fill acknowledged gaps in regulatory expertise.

A further recommendation is that regulators set approval timelines that meet international best practice to ensure the UK remains globally competitive. A proportionate approach should be taken at different stages of the regulatory pathway. Industry should be kept up to date with regulators’ expected response timelines, as speed and transparency are important. The challenge here is demonstrated by the fact that the average time for a new medicine or medical technology to go from central approval to availability to patients is 329 days in England (excluding products under the MHRA’s Early Access to Medicines Scheme).

Beyond the key challenges and cross-cutting issues noted, the human health applications of life sciences section of the report makes recommendations on improved routes to market through innovative pathways for therapeutics and devices, pathway acceleration, data and cell biotechnologies.

While innovation pathways already exist, industry cautions that too many products are being assigned to the Innovative Licensing and Access Pathway (ILAP), overwhelming regulator capacity and slowing processes. The report recommends that the MHRA is supported to ensure that domestic routes for approval of medicines and devices, including AI, are predictable, transparent and proportionate. It suggests regulatory organisations work together to agree what products take innovative licensing routes and create a more effective ILAP pathway. Learnings from this process should be applied to the development of the Innovative Devices Access Pathway (IDAP).

In addition, it recommends a new and strengthened partnership between the MHRA and the UK Approved Bodies. The Approved Bodies are designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements of the Medical Devices Regulations 2002. Their experience and skill should be applied to domestic market access decisions. MHRA, with new powers to issue market access (UK Conformity Assessed mark), should work alongside the Approved Bodies to ensure efficiency.

Further, there should be an early market access system for MedTech where there is an unmet need or significant benefit to patients.

Overall, the route to market for innovative products through the wider regulatory system should be accelerated by improving efficiency and enabling quicker decision making on NICE approvals. NICE should consider how it can enable this, review its use of committee processes and consider novel ways of working.

The report also recommends enabling a consent-based approach to sharing industry data between different bodies within the regulatory system to enable access to accelerated progress of applications through different regulators. The current cautious interpretations of rules on data disclosure are creating barriers here, but legislative change in the short- to medium-term could help to overcome them.

Regarding development of cell biotechnologies, the review notes inconsistencies between tissues and cell regulation. It recommends that the MHRA and Human Tissue Authority (HTA) work together to review regulatory oversight for the use of human cells or tissues collected for the specific purpose of manufacturing advanced therapy medicinal products (ATMP), with the aim of clarifying and simplifying the regulatory pathway.

Read the full Pro-innovation Regulation of Technologies Review – Life Sciences report via this link.

Following the publication of the report, the government stated that it accepted all the recommendations and the details of its response can be read here.

For anyone wondering how to navigate the fast-changing regulatory environment and latest government-backed initiatives, PharmaMedic Consultancy has the experience and expertise to guide you through to a successful outcome. Please get in touch to discuss how we can help you via Tel: +44 (0) 208 168 1668 or Email: hello@pharmamedic.co