Adapting Regulations Post-Brexit

On 1 Jan. 2021, the United Kingdom formally left the European Union to become a third country and no longer a member of the Union’s single market and customs union. But what the country has lost after more than 40 years of membership, the UK government believes it can make up—at least in life sciences—with the increased competitiveness generated by the country being able to develop its own regulations and drug evaluation methods.

A key objective of the UK government is to use the country’s clout as one of Europe’s biggest research centres for pharmaceuticals and related products to speed up the development and approval of new medicines so that they reach patients more quickly. Giving patients quicker access to innovative drugs is also a key priority for the EU over the next several years.

Trade agreement in principle

On 24 Dec. 2020, a few days before the Brexit deadline, the UK and EU agreed to a 1000-page EU-UK Trade Co-operation Agreement, which effectively eliminated tariffs and quotas on their goods. But in principle, it allowed the UK to erect its own non-tariff barriers, although the EU reserved the right to retaliate with its own measures if it considered that the UK was threatening its competitiveness.

The UK has, for example, decided to draw up its own version of the EU chemicals legislation—called REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals)—which sets technical standards for chemical ingredients for medicines (1).

Because the UK is a separate legal entity—a third country—the UK’s excipient producers and their raw material suppliers have started to be concerned about procedures like customs declarations and rules of origin.

An unusual feature of the trade deal, covering the four nations of England, Wales, Scotland, and Northern Ireland on the UK side, was the creation of a customs border within the UK’s boundaries (2). This runs through the Irish Sea to avoid the necessity for a ‘hard’ border between the Irish Republic, an EU member, and Northern Ireland.

Under the agreement, Northern Ireland has to have its own EU-UK border, because it is subject to EU single market and customs union rules, unlike the rest of the UK. By late February 2021, the arrangement was having to be re-negotiated with the EU accused of being ‘legalistic’ in ways the border was being applied. Other sections of the agreement were also already looking likely candidates for re-negotiations as well.

In the first two months of the year, medicines and related products seemed to flow without much disruption between the UK and the EU. This could have been due to the setting up of protected shipping and freight routes for pharmaceuticals and other essential products (3).

Also, the EU-UK trade deal managed to avoid the setting up of major technical barriers to medicinal products (4). There has been, for example, mutual recognition of each other’s good manufacturing practice (GMP) inspections (4).

Boosting UK pharma

Meanwhile, UK government officials have been working on a strategy aimed at boosting the competitiveness of its pharmaceuticals sector by making the country a focal point for investment in drug development within Europe.

One means of boosting competitiveness has been ensuring that the country’s regulatory system and drug evaluation procedures provide relatively rapid pathways to the market. This regulatory change is being implemented despite the handicap of no longer being part of the EU’s medicines licensing network with the European Medicines Agency’s (EMA) centralized system for EU-wide authorizations and the decentralized procedure for national approvals. The UK tactic seems to be to exploit gaps and loopholes in existing EU legislation.

Even before the UK formally left the EU when it was obliged to obey EU legislation, the country demonstrated some success with this approach when it surged ahead of its European rivals in the roll-out of the two main COVID-19 vaccines launched by Pfizer and AstraZeneca.

During a transition period ending with Brexit on 1 Jan. 2021, the UK was obliged to obey EU legislation but not non-regulatory initiatives. When the remaining 27 member states voluntarily agreed in June 2020 on a collective arrangement for the joint procurement and approval through EMA of the new COVID-19 vaccines, the UK opted out.

Both regions approved the vaccines under a 2010 EU directive (5), but while the EU-27 chose the longer route of a conditional authorization, the UK selected the quicker alternative of a temporary approval. As a result, by 18 Feb. 2021 the UK had vaccinated 26% of its population versus 8% in Denmark—the leading EU country for vaccines availability—6% in Germany, and 5% in France (6).

Areas being prioritized by the UK government in its post-Brexit plans are those where the country has research advantages and opportunities to adjust its regulations so that they are more in line with the needs of the market. With the continuous manufacturing of pharmaceuticals, for example, the EU and the rest of Europe has been making slow progress on the approval of continuous production processes. This slow progress stems partly from a lack of agreement on issues like the definition of ‘continuous’ and ‘quality management standards’, which will have to be consistent with those for batch processing.

At Strathclyde University, Scotland, CMAC Future Manufacturing Research Hub, which is funded by the UK government and by international drug companies with operations in the country, aims to make personalized products through digitalized supply chains. In February 2021, it held an international conference to push for an integrated approach to the adoption of continuous manufacturing and other advanced manufacturing technologies (7).

“Continuous manufacturing needs to be recognized more as a simplified but sophisticated production technique for solving many of the quality issues with medicines production,” Paul Hodges, chairman of NiTech Solutions, told Pharmaceutical Technology Europe.

Medicines Manufacturing Industry Partnership (MMIP), representing international drug manufacturers with operations in the UK, has been working closely with government ministries and agencies, and the research-orientated Association of the British Pharmaceutical Industry (ABPI), to maintain the UK’s strong position in continuous production and digitalization (8). One of the agencies has been the drug authorization body Medicines and Healthcare products Regulatory Agency (MHRA).

“ABPI and MMIP are supportive of work that shows how advanced digital technologies and continuous manufacturing can improve efficiency in all types of medicines manufacturing, across traditional small molecules, biologics, and complex medicines including cell and gene therapies,” an ABPI spokesperson told Pharmaceutical Technology Europe. “These advances require close collaboration with regulators (i.e., MHRA in the UK) for smooth implementation.”

Other areas of importance—not just to the government but industry and academia as well—in UK research in the post-Brexit era will be genomics, artificial intelligence (AI), early-stage diagnostics, and big data.

NICE needs to change

Industry believes that the National Institute for Health and Care Excellence (NICE), the government’s health technology assessment (HTA) body, is being too restrictive with its evaluation of digitalization products, which ultimately sets the price paid by the government for them (9).

“Those medicines for rarer conditions—in fact, precisely the sort of medicines that are enabled by developments in genomics, AI, and big data happen to be the medicines that tend to systematically have a harder time getting through (the evaluation process) than many others,” Richard Torbett, ABPI’s chief executive, told a conference in November 2020 on a NICE review of its appraisal methods (9).

“We have to have a system that is fair across all disease areas, and we believe that there’s increasingly strong evidence to suggest that there are certain types of medicines that typically have a harder time than others,” he said. “(We have proposed) some modifications in the methods that will allow particularly rarer diseases to be on a level playing field with diseases in other therapeutic areas.”

In its own proposals for modifications to its appraisal methods, which are subject to consultation until 15 April 2021, NICE acknowledges the need for change (10). NICE has suggested that there should be more opportunities for patients to have access to promising new technologies despite deficiencies in clinical outcome data. These products would be available on the market on condition that their suppliers filled the evidence gaps within a fixed time period.

Linking HTAs with drug licensing procedures shows how Brexit has given a new flexibility to UK drug regulators and medicine evaluators. If the government’s ultimate aim of attracting new investment is successful, the UK’s approach may soon spread to other parts of Europe.

References

1. EU, Regulation Concerning the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (Brussels, 18 Dec. 2006).
2. EU and UK Gov., Agreement on the Withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (Brussels 31 Jan. 2020).
3. UK Department of Health & Social Care, “Letter to medicines and medical product suppliers,” gov.uk (London, 3 Aug. 2020).
4. EU and UK Gov., Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community of the One Part, and the United Kingdom and Northern Ireland of the Other Part (Brussels, 31 Dec. 2020).
5. EU, Directive 2010/84/EU Amending, as Regards Pharmacovigilance, Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use (Brussels, 15 Dec. 2010).
6. Our World in Data, “Cumulative COVID-19 Doses Administered per 100 People—Collected from Official Data” (University of Oxford, 22 Feb. 2021).
7. MIT and CMAC, International Symposium on Continuous Manufacturing of Pharmaceuticals 2021 (Glasgow, 18 Feb. 2021).
8. MMIP, “Representing Voice of Medicine Manufacturing in the UK” (London, 2020).
9. ABPI, “Global Science Superpower; Future of Medicines Valuation,” Presentation, 2 Nov. 2020.
10. NICE, “NICE’s Methods of Technology Evaluation—Presenting a Case for Change,” News Release, 6 Nov. 2020.

About the Author

Sean Milmo is a freelance writer based in Essex, UK.

Article Details

Pharmaceutical Technology Europe
Vol. 33, No. 3
March 2021
Pages: 7–8

Citation

When referring to this article, please cite it as S. Milmo, “Adapting Regulations Post-Brexit,” Pharmaceutical Technology Europe 33 (3) 2021.