Pharmaceutical industry sets out its vision for the future UK medicines regulation

• New report says post-Brexit Britain’s medicine regulation system has the potential to be faster and nimbler for emerging technologies. 
• But authors warn that introducing friction and diverging from established medicine rules for the sake of it risks undermining the future attractiveness of the UK as a launch market.

Britain should work with its ‘science allies’ abroad and develop medicines regulation for emerging technologies at home to build a globally attractive life sciences sector fit for the 2020s, or it risks being left behind.

A new report from the Association of the British Pharmaceutical Industry sets out recommendations for how to boost attractiveness for global investment for life sciences and make the UK a go-to destination for innovations coming down the pipeline. 

LINK: ABPI Vision Paper: UK medicines regulatory policy and global influence in a post-pandemic world

After a global pandemic that has seen the UK lead the way in approving new medicines and treatments, being one of the first countries in the world to approve a COVID-19 vaccine, and with the MHRA restructuring to work in “new areas of regulation and science,” the report says there has never been a better time to look at the future of UK medicines regulation.

The report points to significant opportunities in areas such as innovation passports, Advanced Therapy Medicinal Products – a brand new type of treatment that includes cures – and digitisation of regulatory approvals, where the UK can potentially work faster than its international counterparts.

It says the UK should work with like-minded ‘science allies’ including the United States, Canada, Australia, Singapore and Switzerland to build a coalition of forward-thinking future regulatory leaders and be at the table for setting the rules about the next generation of breakthroughs.

But the authors also send a warning that, as only 2.4% of the global market, the UK cannot afford to substantially differentiate its regulatory regime for pharmaceuticals to the point that it creates friction for global manufacturers and must stay in sync with existing international regulatory science if it is to continue being attractive for global investment.

Colette Goldrick, Executive Director, Strategy and Partnerships for the Association, said: 

"As the government begins to set out what Britain being a science superpower outside of the EU means, this is the perfect time to look at the important policies which attract companies to launch their products here in the UK. 

"There are opportunities and pitfalls: we have seen what friction does to global supply chains and the same principle applies to regulation. Diverging from global medicines standards for the sake of it would be destructive and undermine the attractiveness of the UK. 

"That’s why we want ministers to instead look at areas where we can do things faster and set the agenda for new types of medicines and vaccines, so that NHS patients can be some of the first in the world to benefit."

The report – UK medicines regulatory policy and global influence in a post-pandemic world – sets out recommendations for policymakers to focus on two key areas:

1. An internationally competitive regulatory framework at home that means NHS patients are some of the first in the work to get new breakthroughs and makes Britain an attractive destination for investment, by:

• Expanding ‘Innovation Passports’ for medicines that show promise during pre-clinical research, helping fast-track these through the regulatory system.
   
• Winning the race for regulatory expertise in a new type of treatment – Advanced Therapy Medicinal Products – so that the UK offers companies a ‘single front door’ for clinical trials and approvals.
   
• Adequate and stable funding for the MHRA, allowing it to fully deliver on the ambition to expand its Early Advice Service and the Innovative Licensing and Access Pathway (ILAP), to improve the UK’s competitiveness in clinical research.
   
• Upgrades for the MHRA’s IT infrastructure to speed up approvals and protect against future cyberattacks, with cloud-based data submissions and iterative, real-time reviews, speeding up medicines reviews and making it easier for companies to engage.
   
• Digitisation of the regulatory system, reducing paper waste and shifting to electronic product information in packs of medicines – eliminating waste and helping to decarbonise the system.

2. Influence international regulatory policy and work with our ‘scientific allies’ like the United States, Australia, Canada, Singapore and Switzerland to set global standards and speed up the development and launch of new medicines.

This year’s G7 and the launch of the new Pandemic Preparedness Partnership (PPP) shows that the UK can lead the way on health-related international policy and should go further by:

• Using new trade deals to secure commitments that the medicines regulators on both sides will work together on future technologies and look to secure Mutual Recognition Agreements to secure the MHRA’s position as a ‘gold standard’ global regulator.
   
• Build on and fund greater engagement in multi-country collaborations that speed up medicines approval such as the Access Consortium (Australia, Canada, Singapore, Switzerland) and Project Orbis (United States, Canada, Australia, Switzerland, Singapore, Brazil).
   
• Make sure the MHRA remains an active and strategic member of international forums (such as (ICH, ICMRA, PIC/S) that set global medicines policy so that the UK is not only shaping the agenda for future emerging tech but also harmonising its approach to existing rules with other countries to reduce friction and speed up access. 

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