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The New Drug Manufacturing Landscape Under Post-Brexit Trade Rules

The New EMA Building in Amsterdam's Zuidas District.

The New EMA Building in Amsterdam's Zuidas District.

New Regulations and Approvals

The pharmaceutical industry in the UK is subject to many regulations compared to other sectors. There are regulations regarding the approval of new drugs, research and development of new drugs, the drug supply chain, and the movement of drugs and drug precursors from Europe in and out of the UK.

These included the EU community code, the centralized marketing authorization (MA) and EU-wide pharmacovigilance networks. Any change in pharmaceutical regulations has much more significant consequences than in other industries if, for example, it results in consumers no longer having access to certain drugs.

The UK will have to make important choices regarding achieving a coherent regulatory policy within the next three to five years. There is a lot of debate about whether the UK should completely align with the EU or whether partial alignment may lower costs and provide a competitive advantage.

The UK government should also take heed of the level of risk acceptable for the public and the trade-offs that arise in the context of divergence for the UK’s internal markets and trade.

Let’s look at how Britain re-engineered its system for the approvals of medicines during this transition process and what changes are still pending.

The most significant change following exit negotiations was the country’s departure from relying on the European Medicines Agency (EMA) as its primary regulatory entity.

The EMA had overseen pan-European drug approvals since 1995 from its London headquarters in Canary Wharf. Since March 2019, the EMA now operates under a joint governance structure with the Netherlands in Amsterdam.

The responsibility of approving new products falls to the Medicines and Healthcare Products Regulatory Agency (MHRA), the UK’s new sole medicines regulator.

However, the UK will still follow EU rules on drug development and regulation and continue to adopt decisions taken by the European Commission on approving new MAs until 1 January 2023.

The Committee for Medicinal Products for Human Use (CHMP) has advised that companies should submit an identical application as the EMA application to the MHRA. The MHRA will then wait for and follow the European Commission (EC) decision on whether an MA has been granted.

The UK can also consider the decisions of other EU member states for licencing drugs that have followed mutual recognition procedures rather than the centralised procedure for all member states.

The 81 meter high EMA tower was designed by architect Fokke van Dijk of the Central Government Real Estate Agency (CGREA).

The 81 meter high EMA tower was designed by architect Fokke van Dijk of the Central Government Real Estate Agency (CGREA).

All centrally authorised products (CAPs) and national MAs held in the UK have been re-assigned and transferred to a legal entity in the EU.

In terms of quality control processes, Britain will accept batch testing performed in the EEA until January 2023. Then a consensus could be reached regarding mutual recognition of good manufacturing practice (GMP) inspections with the EU.

Until then, companies must arrange for a qualified person (QP) to re-test and certify their products exported from the UK into the EU and provide a manufacturing import authorisation (MIA). And active pharmaceutical ingredients (APIs) imported into the EU from the UK now require written confirmation of EU GMP compliance by the MHRA.

In the longer term, MHRA is looking to speed up regulatory access and the subsequent timing of market access and product launch.

A 2021 report from the Association of the British Pharmaceutical Industry (ABPI) says Britain’s post-Brexit medicine regulation system has room for improvement.

If the system capitalised on newer interoperable technologies and digitised regulatory approvals through the cloud to a greater extent, the UK could potentially work faster than its international counterparts.

MHRA is working on several fast-track pathways called ‘Innovation Passports,’ which could help bring promising pre-clinical drug candidates to market for rare disease patients and improve the UK’s competitiveness in clinical research.

Upgrades to the MHRA’s IT infrastructure are also underway to protect against possible future cyberattacks and give companies a forum to engage in medicines reviews.

It is paramount that the MHRA maintains effective communication with global regulatory agencies and organisations such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Coalition of Medicines Regulatory Authorities (ICMRA) and the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).

This type of coalition gives MHRA an edge in this new era of decentralised trials and cross-disciplinary research that requires major international collaboration and wide use of data.

The futuristic and clean lines of the EMA's new open-plan headquarters make for a remarkably peaceful place of work.

The futuristic and clean lines of the EMA's new open-plan headquarters make for a remarkably peaceful place of work.

Medicine Supply and Safety Monitoring

Much of the UK's precursors and raw materials for manufacturing drugs come from European countries. However, following Brexit trade rules, supply chains have had to straddle different jurisdictions, which affected the supply of medicines to countries that the UK exports to.

For example, Northern Ireland remains in the EU system but receives most of its medicines from suppliers in Great Britain. As part of the Northern Ireland (NI) Protocol element of the Brexit deal, NI remains fully covered by the EU's pharmaceutical regulations.

The UK wants to strike an interim agreement with the European Commission to cover customs paperwork, medicines supply and the role of the Court of Justice of the European Union (CJEU) to maintain a properly functioning single market and trading relation with NI.

Some concerns were expressed at the beginning of the transition period regarding the loss of the EMA's pharmacovigilance machinery and the ability of MHRA to cope if it couldn't share its workload with other EU countries.

Except for NI, the UK is no longer part of the Belgium-led Medicines Verification System (EMVS), an important safety feature of the EU Falsified Medicines Directive (FMD) for marketing-authorisation holders.

The EMVS used to be connected and work hand in hand with SecurMed UK, the UK Medicines Verification System, to flag falsified medicines and facilitate rapid access to warnings of dangers found in drugs.

Without being connected to the EMVS, the unique identifier on packs of medicines cannot be readily verified by UK's healthcare stakeholders. And with an estimated 82 million packs of medicines moving between the EU and UK monthly, stakes are high to ensure they can.

MHRA retains responsibility for pharmacovigilance across the UK, and EU pharmacovigilance requirements continue to apply in addition to UK requirements for products authorised in NI.

In addition, MHRA can take sovereign regulatory decisions to help evolve the UK legal regime to meet future needs. These decisions will apply in NI—as long as they don't conflict with EU decisions.

The UK's post-Brexit pharmacovigilance strategy will mirror EU Good Vigilance Practices (GVP) requirements, as with Schedule 12A of the UK Human Medicines Regulation. But the MHRA reserves the right to publish guidance notes on exceptions and modifications to the EU guidance as required.

As mentioned earlier, MHRA is increasing the versatility and interactiveness of its IT systems. Many functions of the MHRA Submissions Portal will resemble the Common European Submission Portal (CESP), including Periodic Drug Safety Update Reports.

Further guidance on changes in pharmacovigilance affecting UK drug manufacturers and updates can be found on the MHRA's products website.

This article is accurate and true to the best of the author’s knowledge. Content is for informational or entertainment purposes only and does not substitute for personal counsel or professional advice in business, financial, legal, or technical matters.

© 2022 Camille Bienvenu