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 Imperial London's Matthias P. Hofer, Paola Criscuolo, Nilay Shah , Anne L. J. ter Wal and James Barlow.

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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

Brexit and Trump will not diminish London as a leader in business education

Nelson Phillips — Mon, 18 Jan 2021 09:36:32 +0000

Brexit and Trump will not diminish London as a leader in business education

Nelson Phillips Mon, 18/01/2021 - 09:36

14 February 2017

Professor Nelson Phillips, Acting Dean of Imperial Business School, argues London’s reputation as a global centre for research and learning will continue to attract the most talented ��ý and academics.

Students must “think and act internationally” to succeed in their careers and personal life. These were the words of advice given by Imperial London’s President, Alice P Gast to the latest graduates at last October’s Commemoration Day. Whether these graduates go on to forge careers in London or elsewhere, the need to adopt a global perspective has never been more important for anyone who wants to succeed in the interconnected worlds of business and innovation.

‘Globalisation’ has long been one of the hallmarks of business schools around the world. Following Britain’s vote to leave the European Union, it’s not surprising schools have been keen to reassure existing and potential ��ý and academics of the creative, entrepreneurial and academic excellence they bring to the higher education community.

Indeed, President Gast has stressed how political changes will not hold Imperial back from delivering excellence in research and education for the benefit of global society.

Seeking global talent

We don’t yet know what the outcome will be for higher education in a post-Brexit Britain. But institutions such as Imperial are well positioned to thrive as London continues to seek out global talent to contribute to its thriving ‘powerhouse’ of entrepreneurship and innovation.

London’s dynamic startup scene is the biggest in Europe and continues to grow, making the capital one of the most innovative cities in the world. The capital’s burgeoning technology scene is rapidly producing companies with extraordinary growth potential. This makes London an attractive option for ��ý seeking careers in areas such as fintech, either with small to medium sized enterprises or multinational companies.

Choosing to study in another country has always been a risky decision for international ��ý, even before last summer’s EU referendum vote. For business ��ý, the high cost of an MBA degree, which often involves giving up a career for a year of studying, is a calculated risk.

I believe the ��ý London-based schools seek to attract, the natural risk-takers, will continue to take a gamble on London and take advantage of the excellent educational experiences available, as well as the wealth of links between London-based schools and industry in the capital.

London is now flourishing in a number of traditional and new markets, from finance to big data, healthcare and even climate change. Companies such as Accenture, Deloitte and McKinsey have long reached out to Imperial for outstanding business graduates and will still do so as long as London, in Mayor Sadiq Khan’s pledge, remains “open for business” and continues to seek out the best talent from around the world.

London-based firms will always want the people who are the best fit for their business, which means employment prospects for new graduates shouldn’t change, certainly not in the short term.

A new visa pilot scheme that allows ��ý studying on the Business School’s one-year Master’s programmes to stay in London for up to six months after graduation will be another incentive for international ��ý outside the EU to study in London.

Capitalising on the Trump effect

But does anything change, now Donald Trump has become President of the United States ? What will this mean for London-based business schools trying to attract the best talent from around the world, in light of his pledges to ban people from certain countries and religious backgrounds from entering the US?

Trump’s presidency has created real uncertainty for ��ý and academics who would ordinarily have looked to US business schools for their next career move. However, the current climate represents a huge opportunity for UK business schools to show our international values by welcoming more ��ý from Trump’s black-listed countries, as well as other Muslim countries such as Saudi Arabia and the UAE.

In the past, the Gulf countries have sent many thousands of ��ý to the US and as a result they have extensive ties with major US business schools. But ��ý from the Gulf may now be deterred from studying in the US by some of Mr Trump’s controversial pledges, such as a plan to create a register of Muslims. These ��ý will want to go abroad and study in English, creating an opportunity for UK business schools.

Offering greater value for money

At the same time, US citizens have long been attracted to studying in London and the current drop in the pound has just made this even more attractive. This means international ��ý can now obtain an MBA degree from a prestigious business school for a much lower price in the UK.

But will ��ý be put off from coming to London following Theresa May’s pledge to take Britain out of the single market? And what about the threats from multinationals to withdraw their offices from London if this happens?

I believe big corporates and companies with an international outlook will continue to seek out the best graduates, whether they are based in London or elsewhere. Technology is making this even easier by increasing opportunities for employees to work remotely from wherever they are based in the world. This further breaks down barriers between countries, cultures and nationalities.

The spirit of partnership and bringing together great minds from across the world is what drives the world’s best universities and businesses. At Imperial, I see many examples of how ��ý are working together to create exciting new business ideas.

Take Phillip Jarman, an MBA student who collaborated with ��ý in Imperial to help create a customisable smartwatch that allows people to keep track of their health and lifestyle. The project raised over $1 million through crowdfunding and has attracted high-profile publicity.

The prospect of being part of a thriving, entrepreneurial community that contributes to the UK and global economy will make London-based schools like Imperial attractive places to work and study.

In a time of political uncertainty, it’s never been more important for us to embrace the contribution of the world’s best ��ý, academics and researchers in enabling London to flourish.

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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 Imperial 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 Imperial 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

Brexit: why too much information leads to uncertainty and chaos

Savitar Sundaresan — Wed, 20 May 2020 08:23:00 +0000

Brexit: why too much information leads to uncertainty and chaos

Savitar Sundaresan Wed, 20/05/2020 - 08:23

3 July 2019

Noisy information prevents people from uniting around an objective truth

Today we can get our information from hundreds of different sources. Some are traditional media such as newspapers, radio, and TV, whereas others are online like Facebook’s newsfeed or Reddit. With so many sources of information, it’s not only possible that we will develop permanently polarised beliefs, but inevitable.

If we are to maintain the belief that a shortage of information is responsible for divisions in society, it should follow that an increased supply of information will lead to agreement. But instead we find the opposite.

Brexit divisions

For example, across the two main political parties in the UK there are differing opinions on how to deal with Brexit. With the constant stream of information from analysts and professional forecasters, there should be a consensus on what would happen, for example, in the aftermath of a hard Brexit.

However, despite receiving a vast amount of information, both sides of the Brexit debate appear further apart now than they were three years ago. Voters and politicians disagree vehemently, not just about issues without a clear answer, but also about those which should be resolvable.

When two people disagree, even slightly, they seek out sources that confirm their respective beliefs

Political polarisation has the potential to lead to uncertainty and chaos as we have already seen with Brexit. In the UK, currency fluctuations have become a nightmare for traders, retailers are struggling in the face of rising consumer caution, and productivity has taken a significant knock.

But, as we cannot blame polarisation on a shortage of information, another possible explanation is the lack of clear signals. Information is by its nature, noisy. If we had access to perfect information, i.e. information that is truly objective and unbiased, then all agents would receive signals that will cause them to gradually unite around an objective truth – in this case an optimal solution to Brexit.

However, news sources are rarely objective. Rather, they start from a particular position in the debate and the information they present is skewed by this lens, biasing most signals.

Confirmation and complacency effects

Furthermore, an abundance of available sources of information will cause disagreement to spread. With innumerable blogs, newspapers, podcasts, TV channels, and other sources to turn to, we have a staggering level of choice in how and where we get our information. When two people disagree, even slightly, they seek out sources that confirm their respective beliefs. This is termed the confirmation effect.

In the context of Brexit, it means someone who is cynical of the EU will lean towards news sources that have historically been negative about the bloc, and whose ongoing reporting is likely to be biased in favour of a hard Brexit. That person would have a radically different experience compared to a Remainer getting the same piece of news from a historically EU-positive source.

Disagreement becomes permanent when people become more certain of their beliefs. This causes them to pay less and less attention to new information, even if it’s coming from sources they agree with. As a result, those who disagree will either choose to look at completely uninformative sources or will choose to ignore what sources they do have access to. Their beliefs will cease to change, due to what is termed the complacency effect.

Disagreement becomes permanent when people become more certain of their beliefs

Individuals are aided in this complacency by social media algorithms that lead them into echo chambers of one-sided news. Eventually, the news they consume will have only a passing relationship with any actual informational content. In Brexit terms, it can be observed in a growing apathy among voters, which crucially has not translated into any sort of cross-divide agreement or softening of stances.

So how can polarisation be avoided? One possibility is to recognise our own behaviour traits and try to force ourselves to read less biased or oppositely biased sources from time to time. Failing that, regulation of information could be a possibility, where news sources are rated as credible or biased based on various metrics.

Social media could also help in showing our current preferences in information consumption, and how it compares to those we are connected with, and the public overall. Placing a greater emphasis on these aspects of our news consumption could help to stem polarisation in our beliefs.

This article draws on findings from “Inattention and Belief Polarisation” by Dr Kristoffer P Nimark (Cornell University) and Dr Savitar Sundaresan (Imperial Business School).

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Will Brexit increase the cost of electricity?

Richard Green — Tue, 19 May 2020 13:34:38 +0000

Will Brexit increase the cost of electricity?

Richard Green Tue, 19/05/2020 - 13:34

3 March 2020

If Brexit leads to a withdrawal from the European Union’s internal energy market, the UK’s unwillingness to cooperate with its neighbours will come at a very high price

With the UK now officially out of the European Union, an 11-month transition period has commenced. Amid the multitude of details that still need to be negotiated, the UK’s presumed exit from the European Union’s internal energy market is a particularly important one. Exiting this highly beneficial arrangement could come with an unnecessary increase in the cost of electricity and hinder the UK’s decarbonisation efforts.

Efforts to connect the EU’s many electrical grids have been underway since the 1990s. By 2015 a cross-border energy market, named the internal energy market, had largely been implemented. From a trading perspective, the internal energy market creates a lot of benefits for all involved by ensuring the most electricity possible is sent from lower-priced markets to higher priced ones. If it’s a sunny day in France and the country’s solar network is operating at maximum capacity, the UK can purchase excess power at a beneficial rate.

This system is successful thanks to the sharing of information. In coupled markets, such as the arrangement the British electricity market currently has with France, information about how much electricity costs in both regions, as well as how much networks are willing to pay for electricity, is released to energy traders at the same time. Traders make an informed decision as to whether to buy or sell, and computer algorithms automatically handle the shifting of power from lower to higher priced markets. The only limiting factor is the transmission infrastructure available.

Conservative ideas

France frequently generates electricity more cheaply than the UK, meaning the UK benefits quite a bit from this arrangement. However, thanks to Brexit, the UK’s ongoing participation in this scheme, as well as the planned construction of additional interconnectors between Britain and Europe, is very much in doubt. It’s not even clear if an agreement to remain in the internal energy market is even possible under an exit from the EU.

The alternative is how things were before the internal energy market. In uncoupled markets, where two markets are connected but trade takes place in an uncoordinated way, there is room for costly mistakes. Traders know the price of electricity generation and how much consumers are currently willing to pay for it in their own market, but don’t have a clear idea of how things are on the other side. As a result, they will sometimes “buy dear” and “sell cheap”, moving electricity to the country where it is less valuable. With significant differences in price possible, mistakes can be very costly. To reduce the risk of this, energy traders often make very conservative decisions around buying and selling electricity, leaving the interconnectors under-used.

British firms and households would pay more for their power – by €2.4 billion a year in our worst scenario

Our recently published research sought to estimate the additional costs that would accompany leaving the internal energy market – a “Hard Elecxit”. We based our calculations on trading behaviour from 2009, back when Britain and France’s electricity markets were decoupled, and the assumption of only a modest increase of interconnector capacity.

Compared to a “Soft Elecxit” (where the current system is maintained), we estimated the increase of inefficiencies would result in an increase in the cost of generation between the two countries of €692 million a year – two per cent of the wholesale market value – by the year 2030. This cannot be avoided by building more interconnectors, as an increase in capacity would only present more opportunities for traders to make mistakes.

Cost of Hard Elecxit

These costs are greater than past estimates of the internal energy market’s benefits, as changes to the composition of both the UK and France’s energy mixes due to decarbonisation and investment in renewables will also affect prices and supply. Wind and solar generation are far more variable supplies than gas or nuclear, making well-coordinated trade more valuable while also giving traders more opportunities to sustain losses.

The scale of the costs of a Hard Elecxit depends on what happens to the mix of power stations in each country. France might retain more of its low-variable-cost nuclear capacity, making low prices common. Trade then would be more valuable, making disrupting it even costlier. In this scenario, a Hard Elecxit would cost the two countries approximately €2.7 billion annually by 2030.

From a trading perspective, the internal energy market creates a lot of benefits for all involved

If the UK drastically slows its decarbonisation initiatives and abandons its carbon tax, British and French power prices would converge, making trade less valuable and disrupting it less expensive. But, in most of our scenarios, Britain is a net importer of electricity, and a Hard Elecxit means British firms and households would pay more for their power – by €2.4 billion a year in our worst scenario.

As renewable energy generation progresses, the benefits of shared energy infrastructure become increasingly apparent. After all, you can’t rely on perfect conditions for renewables everywhere. But should the UK leave the internal energy market, decades of progress towards controlling the cost and supply of power will be lost.

This article draws on findings from the paper "Elecxit: The Cost of Bilaterally Uncoupling British-EU Electricity Trade" by Joachim Geske (Imperial Business School), Richard Green (Imperial Business School) and Iain Staffell (Faculty of Natural Sciences, Imperial London).

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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 Imperial 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

Imperial's David Miles discusses Brexit with alumni in Hong Kong and Singapore

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

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

29 May 2019

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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

Brexit: why too much information leads to uncertainty and chaos

Noisy information prevents people from uniting around an objective truth

Brexit divisions

Confirmation and complacency effects

Will Brexit increase the cost of electricity?

If Brexit leads to a withdrawal from the European Union’s internal energy market, the UK’s unwillingness to cooperate with its neighbours will come at a very high price

Conservative ideas

Cost of Hard Elecxit

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

Imperial's David Miles discusses Brexit with alumni in Hong Kong and Singapore

Brexit

Top business school articles for ������ý 2024

From the soft skills that are needed in the age of AI to the surprising advantages of imitation, we present 10 of the most-read articles from the last 12 months on IB Knowledge

Monthly newsletter

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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Brexit: why too much information leads to uncertainty and chaos

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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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Brexit and Trump will not diminish London as a leader in business education

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Capitalising on the Trump effect

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What can established firms learn from startups?

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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Brexit: why too much information leads to uncertainty and chaos

Noisy information prevents people from uniting around an objective truth

Brexit divisions

Confirmation and complacency effects

Will Brexit increase the cost of electricity?

If Brexit leads to a withdrawal from the European Union’s internal energy market, the UK’s unwillingness to cooperate with its neighbours will come at a very high price

Conservative ideas

Cost of Hard Elecxit

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

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Imperial's David Miles discusses Brexit with alumni in Hong Kong and Singapore

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