The implementation plan published in May 2023 follows an in-depth review of how pro-innovation regulation can support the life sciences sector. This forms part of a wider initiative to explore how the UK can better regulate emerging technologies, enabling their rapid and safe introduction.
The review focuses on specific regulatory challenges and opportunities identified for action within the next 12 to 18 months and forms part of a major series of reviews including programmes for Digital Technologies and Green Industries. The Life Sciences review addresses two areas: Human Health Application of Life Sciences and Life Sciences beyond Human Health.
The report issued by the Chief Scientific Adviser, Professor Dame Angela McLean, sets out twelve practical recommendations. These focus on:
- common regulatory challenges that impact innovation and growth across multiple areas of life sciences
- regulation of medicines, advanced therapeutics, and medical devices in the UK
- opportunities for better regulation in the life sciences beyond human health
We consider the key points of action that the Government has committed to implement in each area of focus.
Common challenges
The review shows that regulators face issues in attracting skills and talent in competition with the private sector. The Government is committing to look at secondment programmes from the private sector and across UK academia to promote regulatory research and innovation. It will also look to convene a network of expertise similar to the CERSI model, which has proved effective in the United States, to build a sustainable pipeline of talent.
Another issue highlighted by the review is that technological innovations and their applications in life sciences often cross multiple regulatory remits which lead to overlaps, duplications and inconsistencies in implementation, leaving start-ups and SMEs facing acute challenges.
To address this issue, the Government will ensure data sharing between the different parts of the regulatory system and consider the underpinning infrastructure. The Government agrees in principle to enable a consent-based approach of sharing industry data between regulatory bodies and will look to change the information-sharing restrictions in legislation.
Regular reviews of regulators’ funding models will also be carried out to ensure each organisation is appropriately resourced and funded. Reductions in timescales will be achieved through targeted pathways for specific products and the Government will consider how data can be collected, monitored and published with regard to different organisations meeting their published timelines. Existing pathways such as the Innovative Licensing and Access Pathway (ILAP), which leave applicants with a number of challenges, will be further reviewed to ensure improvements are made ahead of future relaunch.
Targeted recommendations are made by the Chief Scientific Adviser for improving processes of specific entities such as UK medicines regulator, the MHRA and health and care assessment body, NICE.
Cell and tissue therapies
Advanced Therapy Medicinal Product (ATMP) developers, both UK-based and international, have pointed to a lack of consistency between the legislation covering tissue and cells, and that for medicines, and their application to the different stages of advanced therapies development. The review calls for the MHRA, and the Human Tissue Authority (HTA) to work together on the review of regulatory oversight for the use of human cells or tissues collected for the specific purpose of manufacturing ATMP.
Engineering biology
Applicants to regulatory bodies in this field have reported a lack of consistency, support and streamlined process. To address this, the Government will set up an Engineering Biology Regulatory Network (EBRN) to enable collaboration and share capacity between regulators, and create clear product taxonomies, regulatory pathways and streamlined timelines for new engineering biology products.
The Government also supports the creation of regulatory sandboxes to provide focused support for promising technologies. The Digital Technologies paper describes a regulatory sandbox as “a live testing environment, with a well-defined relaxation of rules, to allow innovators and entrepreneurs to experiment with new products or services under enhanced regulatory supervision without the risk of fines or liability.” The report singles out cell-free systems, or "programmable liquids", as a possible application for this approach.
Novel foods
The Chief Scientific Adviser calls for increased support for the Food Standards Agency (FSA) and acceleration of plans to reform the approval process for Novel Foods. The Government recognises the need for additional resourcing for the FSA and exploration of further reform opportunities.
Waste valorisation
In this field, an update to the current DEFRA waste hierarchy is proposed, to include waste valorisation whereby waste materials are converted into higher value products. Biorefining processes aim to transform bio-based feedstocks into useful products, using microbial fermentation for example. The UK already has set a legally binding target via the Environment Act 2021 to effectively halve residual waste by 2042 relative to 2019 levels. The Government agrees that there is potential for greater innovation to get more value out of the end-of-life treatment of biological residual waste innovation but emphasises the need to avoid diverting recyclable materials to residual waste treatment.
Overall, the report presents a practical and pro-innovation package of measures. Implementing these will not be easy, and will require cooperation and collaborative work across Government and beyond. The positive response to the proposals is to be welcomed.
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