Brexit

Post-Brexit medicine approvals: what we know

Matthias Hofer — Fri, 10 Mar 2023 10:43:14 +0000

Post-Brexit medicine approvals: what we know

Matthias Hofer Fri, 10/03/2023 - 10:43

13 March 2023

Has the UK fulfilled its ambition to break free from Brussels and give patients faster access to new drugs as they emerge? Or has Brexit only increased red tape and made the UK a less attractive market for innovation?

While the UK has been slower than the EU to approve some novel medicines, and still relies heavily on EU decision-making, there have also been encouraging results from the early steps made to fast-track new drugs.

In our research, we’ve investigated official records of drug approvals and drawn comparisons between the performance of the UK regulatory body, Medicine and Healthcare products Regulatory Agency (MHRA), and its international counterparts in the EU, US and Switzerland.

Our review reveals that fewer novel drugs were authorised by the MHRA in 2021 – its first year of independence – than by the European Medicines Agency, with 35 approved in the UK, compared to 40 in Europe and 52 in the US.

Of five new drugs that were approved in Europe but not the UK in 2021, two were given the UK’s green light in spring and early summer of 2022, while three have yet to be approved.

International recognition framework

The number of UK approvals of new drugs appears in line with those of Switzerland, which acts independently of EU regulations, and also approved 35 in the same year. But these figures mask a relative lack of independence; nearly 70 per cent of new drugs authorised by UK authorities relied upon the EU’s approval process, despite a post-Brexit vision of sovereignty.

In 2021, the MHRA stipulated it would rely on EU medicine approval procedures for two years in order to maintain stability and continuity. The UK extended this in January 2023, with the aim of introducing a new international recognition framework in 2024, taking into account EU regulatory decisions, as well as those of other international regulatory bodies.

The reasons for these delays and lack of approvals since Brexit aren’t entirely clear at this stage. The UK is now slightly behind Europe in the queue to get medicines approved, and both Europe and the UK are behind the US, where drug markets function differently with faster access to innovation.

The number UK approvals of new drugs appear in line with those of Switzerland

But we lack more detailed information. For example, we don’t yet know enough about what’s going on behind the scenes at the MHRA to assess the cause of the delays. There might also be other factors at play like hitches in manufacturing or different marketing strategies.

Nor do all regulatory decisions follow international trends. One drug not yet approved in the UK is Vorositide, a treatment for achondroplasia, the most common form of dwarfism. Although it’s already in use in the US and parts of Europe, the jury is still out – amid doubts expressed by experts and people with dwarfism alike – about its impact and benefits. Even if a drug is licensed in the UK by the MHRA, it still has to jump the hurdle of approval by the National Institute for Health & Care Excellence to ensure use within the UK's National Health Service (NHS).

More troubling are suggestions that pharmaceutical companies may judge it not to be worth the effort to seek UK approval, given the size of the national market and doubts over approval and NHS commitment. After all, the UK has a relatively small share of the global pharmaceutical market (2.4 per cent).

Is Brexit an opportunity for innovation?

But Brexit was also hailed as an opportunity for the UK to innovate alongside international partners, and here the UK has made progress. A number of schemes to fast-track promising drugs have borne fruit: in 2021, four innovative new cancer drugs were approved in the UK via an international scheme, Project Orbis, coordinated in the US with other non-EU partners. Additionally, the national Early Access to Medicines Scheme, which allows UK medics to prescribe before formal MHRA approval, saw another four medicines fast tracked for patients.

Nearly 70 per cent of new drugs authorised by UK authorities relied upon the EU’s approval process

We’ve excluded COVID-19 vaccines and medicines from our research and, here, UK authorities were faster than the EU to approve two leading vaccines in late 2020. While this is often cited as proof that Brexit has allowed greater independence and speed over national health matters, these decisions were in fact made while the UK was still under EU jurisdiction – they were allowed thanks to a legal clause in EU law that permits exceptional use in response to disease.

So, it is a mixed report for the UK authorities’ first year of independence: the MHRA is weathering a stormy transition amid political and institutional changes but has made a start on innovating with international partners.

This article draws on findings from "Regulatory Policy and Pharmaceutical Innovation in the United Kingdom After Brexit: Initial Insights" by 91��ɫ London's Matthias P. Hofer, Paola Criscuolo, Nilay Shah , Anne L. J. ter Wal and James Barlow.

Healthcare management and policy

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"It's a small drop in the ocean": Politico interviews Professor Tommaso Valletti on the UK's tech strategy

Evie Burrows-Taylor — Tue, 07 Mar 2023 11:52:45 +0000

"It's a small drop in the ocean": Politico interviews Professor Tommaso Valletti on the UK's tech strategy Evie Burrows-Taylor Tue, 07/03/2023 - 11:52

2 March 2023

Digital transformation

Technology

Brexit

Economic impact of coronavirus much larger than Brexit, Professor David Miles tells Business School alumni

Evie Burrows-Taylor — Tue, 25 Aug 2020 11:26:27 +0000

Economic impact of coronavirus much larger than Brexit, Professor David Miles tells Business School alumni Evie Burrows-Taylor Tue, 25/08/2020 - 11:26

Leading UK economist David Miles gave his take on the economic impact of coronavirus (COVID-19) and Brexit at a virtual event for Business School alumni

Professor David Miles, Professor of Financial Economics at 91��ɫ Business School, explored the different effects of COVID-19 and Brexit on the UK economy at the event entitled “COVID-19 and Brexit – the journey through troubled waters”.

Professor Miles, who was a member of the Bank of England’s Monetary Policy Committee for six years from 2009 in the aftermath of the financial crash, gave a talk and was interviewed by Professor Nelson Phillips in front of 91��ɫ Business School alumni based across the globe.

At the event Professor Miles compared COVID-19, which the UK “has in common with pretty much every country in the world” and “the more parochial and specific” Brexit phenomenon.

Brexit is a significantly less important economic, social and political event than the virus

Professor Miles argued that the economic impact of COVID-19 – at least in the near-term – was likely to be much greater than that of Brexit, which he said was less predictable.

“Some people see potential upsides of Brexit, but I don’t think anybody in their right mind sees any particular upsides to COVID-19,” he said.

“Brexit is somewhat ambiguous and somewhat negative, but in terms of magnitude it is a significantly less important economic, social and political event than the virus.”

Widespread costs of lockdown

Professor Miles also said the reaction from the UK government to the pandemic had been “enormous”, noting the economic lockdown and the furlough scheme, adding that despite this effort, the response had not been particularly successful.

Professor Miles recently wrote a paper, warning of the “widespread costs of lockdown”. Published in the National Institute Economic Review, the paper suggests that the losses from continuing severe restrictions in the UK are large relative to the likely gains.

It’s human welfare on both sides of this balance sheet

“It’s not as crude and simple as lives on the one hand and money on the other, it’s human welfare on both sides of this balance sheet,” he said at the event.

Professor Miles argued the different kinds of costs associated with coronavirus, such as a significant rise in unemployment, and Brexit, such as new barriers to trading goods and services, were so different that there was not a lot of interaction between them.

“These are additive factors and unlikely to interact with each other.”

25 August 2020

Entrepreneurship

Brexit

David Miles speaks at House of Lords committee on financial services post-Brexit

Evie Burrows-Taylor — Wed, 29 Jan 2020 15:51:44 +0000

David Miles speaks at House of Lords committee on financial services post-Brexit Evie Burrows-Taylor Wed, 29/01/2020 - 15:51

David Miles, Professor of Financial Economics at 91��ɫ Business School, spoke at the House of Lords EU Financial Affairs Sub-Committee on 29 January.

The Committee put questions to David and Professor Niamh Moloney from the London School of Economics on the potential impact of Brexit on the financial services sector.

Examining the effects from both the perspective of the UK and the European Union (EU), the discussion explored to what extent the EU relies on the UK financial services sector, how this relationship may change after Brexit and what effect this could have on UK GDP.

"I think in some areas the EU relies very heavily on UK financial services. For example, probably 60-70 per cent of foreign exchange transactions that are relevant to the euro come through London," said David, adding that a "very high percentage" of European transactions in certain types of derivatives also go through London.

He noted the size of net exports of financial services from the UK to the EU alone is in the region of £30 billion, equivalent to 1.5 per cent of UK GDP.

David also explained his concerns over the potential pressure to conform to EU regulations under the proposed "equivalence" system, as well as the possibility that financial centres in the EU may use Brexit as an opportunity to wrangle some financial activity away from London, which could have a knock-on effect on other industries.

"If there were to be another European centre where most of the activity does end up and it doesn't get fragmented across lots of different places, maybe the economies of scale that generates means that it really becomes a much more efficient place to do all kinds of business," he said.

However he stressed that the situation should not be overplayed.

"I think it's sometimes easy to exaggerate how significant all this is, economically," he said. "My guess is the situation will be lose-lose for both the EU and the UK.

"The UK will lose a little bit... say £3-5 billion a year - not good - but it's not a huge loss."

Watch the full discussion.

Find out more about David Miles.

Media coverage

Brexit could mean 5 billion pound tax loss from finance - academic (Reuters)

29 January 2020

Finance and institutional resilience

Brexit

91��ɫ's David Miles discusses Brexit with alumni in Hong Kong and Singapore

Anonymous — Wed, 05 Jun 2019 16:46:27 +0000

91��ɫ's David Miles discusses Brexit with alumni in Hong Kong and Singapore Anonymous (not verified) Wed, 05/06/2019 - 16:46

29 May 2019

Brexit

Brexit

Post-Brexit medicine approvals: what we know

Has the UK fulfilled its ambition to break free from Brussels and give patients faster access to new drugs as they emerge? Or has Brexit only increased red tape and made the UK a less attractive market for innovation?

International recognition framework

Is Brexit an opportunity for innovation?

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"It's a small drop in the ocean": Politico interviews Professor Tommaso Valletti on the UK's tech strategy

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Economic impact of coronavirus much larger than Brexit, Professor David Miles tells Business School alumni

Leading UK economist David Miles gave his take on the economic impact of coronavirus (COVID-19) and Brexit at a virtual event for Business School alumni

Widespread costs of lockdown

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David Miles speaks at House of Lords committee on financial services post-Brexit

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91��ɫ's David Miles discusses Brexit with alumni in Hong Kong and Singapore

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