CRDG Co-chair, Professor Trevor Jones CBE FMed Sci, today sent the following letter to key government ministers in the Home Office and the Department for Science, Innovation and Technology, acknowledging the ongoing support for the UK Life Sciences and MedTech sector.
This letter also underscores the sector’s crucial role in advancing medical innovation and economic growth. We are urging the government to implement the ACMD’s recommendations from December 2023, as doing so would help boost economy activity and support the UK’s biotech industry.
Please read on for further details.
Professor Trevor Jones CBE FMed Sci
Co-chair, CRDG
7 August 2024
Minister of State (Minister for Policing, Fire and Crime Prevention), Home Office
Minister of State for Science, Research and Innovation, Department for Science, Innovation and Technology
Dear Rt Hon Dame Diana Johnson DBE MP and Lord Patrick Vallance,
RE: ACMD Consideration of Barriers to Research Part 2: Schedule 1 Controlled Drugs
The CRDG Group and I wanted to send our sincere congratulations on your appointment, which signals continued support for the UK Life Sciences and MedTech sector. This support is crucial for ongoing investment in UK medical innovation and NHS modernisation.
It is very encouraging to see such strong and consistent messaging from the Prime Minister, the Chancellor, and yourselves in key roles as the new government takes up the reins.
Despite some recent post-pandemic issues, the Life Sciences sector has benefited from strong cross-party support over the last 20 years. I’m copying this letter to George Freeman MP, your predecessor, who has been pivotal in this support and is now working across parties to support the sector in both Houses through various APPGs.
As the Government looks for some early delivery wins – I am writing to highlight one that would be easy to resolve and would make a huge impact on a key UK life science sector currently being unnecessarily held back.
After the success of GW Pharmaceuticals, which was sold to Jazz Pharmaceuticals for $7.2 billion in 2021, many UK biotech startups aspire to emulate this achievement. However, they are currently burdened in their clinical research into cannabinoid medicines by barriers outlined by the Advisory Council on the Misuse of Drugs (ACMD) to the Home Office in December 2023. The previous government’s delay in addressing the ACMD’s recommendations has hampered these startups but also presents a significant opportunity for the new government to support economic growth and innovation in the UK biotech sector by promptly taking the recommended actions.
We are pleased to enclose ACMD’s Barriers to Research Part 2 report, which has thoroughly examined the barriers to research involving Schedule 1 controlled drugs.
Implementing these recommendations is crucial for stimulating economic growth and maintaining the UK’s competitive edge in the global biotech landscape. However, despite the importance of these recommendations, it has now been over six months since they were made, and the ACMD have yet to receive a response from the Home Office. In the meantime, companies are moving their research activities out of the UK, resulting in the loss of potential economic benefits and hampering the UK’s position as a leader in biotech innovation.
Following ACMD’s previous advice on reducing barriers to research for controlled drugs in research and healthcare (2017) and further advice on synthetic cannabinoid receptor agonists (SCRAs) (2021), a dedicated working group was established to address issues surrounding Schedule 1 controlled drugs. This group conducted a public evidence gathering exercise, receiving responses from a diverse array of stakeholders including university researchers, pharmaceutical companies, scientific societies, non-profit organisations, UK contract research organisations (CROs), and individual stakeholders.
The ACMD’s report highlights several barriers faced by the research community, particularly those related to the current regulatory framework. These barriers are significant impediments to both the theoretical and practical aspects of drug research and development in the UK. The report also provides a spectrum of options aimed at reducing these barriers, tailored to various stages of research activities.
The key barriers identified include:
Time and Administrative Burdens
The lengthy and complex process of applying for, acquiring, and renewing domestic licences significantly delays research activities. The validity period for import/export licences is also insufficient for organising cross-border shipments, causing further delays.
Cost
The financial burden of obtaining licences, complying with safe custody requirements, and undergoing necessary checks is substantial, especially for academic researchers who rely on limited funding.
Lack of Understanding
There is considerable confusion and lack of clarity regarding the licensing process and the permissions granted under these licences. This results in delays and additional administrative burdens as researchers seek clarification from licensing authorities.
Given the above, the ACMD has recommended several measures to alleviate these barriers. Notably:
Exempting Research in Universities and Hospitals
Allow research using Schedule 1 controlled drugs in universities and hospitals to operate under the requirements of Schedule 2 controlled drugs, exempting them from the need to apply for a domestic licence.
Streamlining Clinical Studies
Exempt clinical studies with relevant HRA and MHRA approvals from the need to apply for a domestic licence, thus operating under Schedule 2 requirements.
Approved Research Organisations
Define and establish ‘approved research organisations’ that would be exempt from the need to apply for a domestic licence, benefiting both academia and industry across all stages of research.
Rescheduling Specific Drugs
Reschedule individual Schedule 1 controlled drugs to Schedule 2 to reduce licensing burdens and facilitate research.
These recommendations, if implemented, will significantly enhance the UK’s research capabilities, enabling a thriving biotech sector. The removal of unnecessary regulatory barriers will spur innovation, attract investment, and accelerate the development of new therapies. This is imperative for the UK to maintain its competitive edge in the global biotech landscape.
We urge the Home Office to carefully consider these recommendations and take swift action to implement them. The potential economic and scientific benefits are substantial, and the current regulatory landscape must evolve to support the burgeoning biotech industry in the UK.
We look forward to further discussions on these recommendations and are committed to supporting their implementation.
Yours sincerely,
Trevor Jones
Professor Trevor Jones CBE FMed Sci
CC: George Freeman MP, Former Minister for Life Science at DHSC & Minister of State, DSIT
Professor Sagnik Bhattacharyya, Professor of Translational Neuroscience and Psychiatry, Kings College London
Dr. Elisabeth Philipps Phd, Clinical Neuroscientist
CRDG Founding Members
