Post-Brexit medicines regulation must have international scope

Post-pandemic, post-Brexit Britain must create a regulatory framework that both defines and aligns with international standards, or risk being left behind.

If the UK creates regulatory frameworks that drastically diverge from those of its “science allies”, it could become a late – or even no – launch market for new treatments.

The need for companies to make multiple dossiers and submissions could lead to “profound implications for UK patients needing access to innovative and novel therapies”, says a new Association of the British Pharmaceutical Industry (ABPI) vison paper.

Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends.

“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,” said Colette Goldrick, the ABPI’s Executive Director, Strategy and Partnerships.

The decoupling of the Medicines and Healthcare Products Regulatory Agency (MRHA) from much of Europe’s regulatory architecture has allowed the UK to independently shape its own policies.

However, this needs to be done in a way that maintains international competitiveness, argues the report, UK Medicines Regulatory Policy and Global Influence in a Post-Pandemic World.

Opportunities and pitfalls

Goldrick said that there were “opportunities and pitfalls” to this new landscape. The UK can, for example, now shape polices that place the MHRA at the forefront of developing ‘gold standard’ regulatory frameworks and innovative practices for new technologies.

However, this must be done in a way that ensures the country remains internationally competitive – drastically diverging from the international direction of travel could have negative consequences, said the report.

The COVID-19 pandemic, Goldrick said, had demonstrated what friction could do to global supply chains.

“The same principle applies to regulation,” she went on. “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.”

Prerequisites for global competitiveness

The vision paper focuses on how to boost the “global competitiveness” of the UK’s life sciences, and make it a “go-to destination for innovation”.

“The ABPI believes that there are several ways in which the UK can progress towards an internationally competitive regulatory framework. The key elements to achieve this rely on being patient-focused, innovation-focused, and forward-looking,” said the authors, adding that Britain must remain an “effective player on the main stage”.

“The MHRA is in a position to capitalise on the UK’s unique capabilities to help define and set international standards and rules, contributing to the reputational strength of the UK life sciences sector, and supporting the export of UK innovation to major trading partners.”

To achieve this vision, the sector must have the right resources and funding, as well as an open dialogue with stakeholders from across the regulatory and life sciences ecosystem.

“The industry stands ready to partner with government to ensure the success and international recognition of this agenda.”

Recommendations

The paper, which was compiled following a series of interviews and workshops with ABPI members and representatives from organisations including the MHRA, NICE, and UK Research and Innovation (UKRI), makes a range of recommendations.

They include strengthening processes and partnerships that allow for the inclusion of the patient voice in policy development.

It recommends, for example, that the MHRA publish an annual report outlining how patient and public engagement has been embedded in regulatory processes, and work with the International Conference on Harmonisation (ICH) to develop guidelines on measuring patient-reported outcomes in clinical trials.

To help create a fit-for-the-future landscape, the MRHA could also develop regulation to enable more environmentally sustainable processes, and work with NHS Digital and NHSX to integrate digital approaches into clinical research.

In terms of trade policy, the UK should “pursue opportunities for regulatory cooperation with key trading partners” to “secure the position of the MHRA as a gold-standard regulator”.

A recurring theme in the report is the importance of maintaining, nurturing, and deepening international relationships.

For instance, it recommends the MRHA remain an “active and strategic” member of international forums, such as the ICH and the International Coalition of Medicines Regulatory Authorities (ICMRA).

“UK regulators should seek to be leading voices in World Health Organisation (WHO) networks, including through being full and active members of the WHO’s Coalition of Interested Parties Network for Regulatory Systems Strengthening, sharing its expertise to improve global health and health security,” it said.

Underpinning these recommendations is the need for the resources, funding, and engagement channels the MRHA needs to make this vision a reality, said the authors.

Life sciences future

The UK’s life sciences sector, which employs more than 250,000 people, makes an important contribution to the country’s economic growth, while also underpinning the health and resilience of the population. But it also has a role in leading international regulatory policy.

Strong regulatory frameworks which define gold standards while also aligning to the international direction of travel are essential to maintaining both functions.

“Oversight by effective, independent regulators not only gives patients and clinicians confidence that medicines are safe, high-quality, and effective, but will also contribute to the international competitiveness of the UK relative to other countries,” said the paper.