The UK’s exit from the European Union (EU) has left the pharmaceutical industry with increased trade barriers and costs and has reduced opportunities to collaborate with other countries, a new report has suggested.
And while Brexit could provide opportunities for innovation in product development and patient safety, the report by the Independent Commission on UK-EU Relations also suggested it could also detrimentally impact Britain’s involvement in clinical trials.
Tamara Hervey, Jean Monnet Professor of EU Law, City, University of London, who introduced the report, called for ‘regulatory consistency and clarity’ around post-Brexit trade.
And she suggested that Britain’s European neighbours remain the ‘most obvious partners’ with which to forge alliances to support healthcare.
Medicines costs could increase up to 5%
Drawing on research and a roundtable with health leaders, the report explores the effects of Brexit on the NHS and healthcare since 2016.
Citing ‘research based on the experience of other free trade agreements’, the report warned that the cost of pharmaceuticals could increase by 5%.
It added that the ‘end of mutual recognition of multiple aspects of medical products regulation’ since Brexit, has meant ‘higher costs and a greater burden on researchers, producers and importers’ within healthcare.
‘The need to go through a different process for access to the UK market, because different bodies are responsible, makes the UK less attractive as a market and a smaller global player,’ the report added.
Roundtable participants told those behind the report that the pharmaceutical and healthcare industry had seen ‘increased trade barriers, reduced access to required labour and skills, increased costs, and reduced opportunities to collaborate with peers in the EU’ following Brexit.
And the report called for mutual recognition of batch testing between the UK and the EU to reduce barriers to collaborative research and innovation.
Speaking to The Independent about the report, Community Pharmacy England chief executive Janet Morrison said that medicine shortages and market instability ‘appear to be as bad as they have ever been and are making life incredibly difficult for community pharmacies and their patients’.
But she said that supply issues ‘can be caused by many factors’.
In addition to Brexit, Ms Morrison said that the war in Ukraine, the impact of the Covid-19 pandemic and broader economic instability had ‘put extra stress on the medicines supply chain, stretching community pharmacies financially and often causing unavoidable delays in patient care’.
And she called for the government and the NHS to ‘step in and do more to help protect community pharmacies and their patients from these ongoing supply chain shocks and issues’.
‘We would like to see them strategically reviewing medicines supply and giving more powers to pharmacists to help them to better manage their patients’ medicines when shortages do occur,’ Ms Morrison added.
And a Department of Health and Social Care (DHSC) spokesperson told The Pharmacist that it did not accept that Brexit red tape has caused medicine shortages 'and it would be wrong to be so definitive, when global supply changes continue to rebound from the pandemic and shocks such as the war in Ukraine continues to impact a range of areas and markets.'
They added: 'There are numerous reasons that a limited number of medicines may be unavailable, such as manufacturing difficulties, supply of raw materials, or sudden demand spikes or distribution.
'We have well-established procedures to deal with such issues and works closely with industry, the NHS and others to prevent shortages and resolve any issues as soon as they arise – if they arise.
'This includes routine information sharing directly with the NHS, so if needed, it can put in place plans to mitigate the risk of the shortage impacting patients.'
‘Significant ramifications’ for NI medicines supply
The report also highlighted issues of medicines supply to Northern Ireland. It warned of ‘significant ramifications’ of the shift towards UK regulation which is now underway.
‘Before the Windsor Framework, Northern Ireland was much closer to the EU system of medicine regulation than the UK one. This was a significant problem given that Northern Ireland relied on Great Britain for 80% of its medicines,’ the report said.
But the Windsor Framework that was agreed in February enabled the same medicines, in the same packs, with the same labels, to be available across the UK – a move which was welcomed by the community pharmacy sector.
However, the Independent Commission on UK-EU Relations report noted that ‘whilst there are clearly positives to this it does mean that Northern Ireland will lose access to medicines approved by the EU’.
Britain ‘less attractive’ for clinical trials and policy
Meanwhile, roundtable participants also ‘expressed concern that post-Brexit regulatory divergence may leave the sector without a competitive regulatory framework and without influence in international policy’.
And they suggested that ‘the more the UK moves away from EU institutions and formal frameworks the less attractive it will be as a place for global clinical trials to take place, with consequent reduced funding and research clout’.
But the chief executive of the Centre for Research Equity at Oxford University, Professor Mahendra Patel, told The Pharmacist that there may be other ways for the UK to become an attractive location for clinical research.
In particular, he suggested that the UK could become known for having the infrastructure to run clinical trials that reach diverse populations, including diverse ethnicities, socioeconomic groups, and isolated communities like those in rural or coastal areas.
‘A lot of research that is carried on doesn't include a representative sample of the national diaspora, which then means that you potentially could increase inequalities,’ he said.
But he said that inclusive, representative research would be ‘more robust and accurate’.
Community pharmacies could have a key role to play in reaching people within their own communities, making the UK ‘a very attractive place for pharma companies to come in’, he added.
Because community pharmacies have good knowledge of and trust within their local communities, they could also help people become better informed and more confident in taking part in clinical trials, Professor Patel suggested.
According to Professor Patel, research has historically had issues around ‘culture, behaviour, practice, knowledge, communication, trust’, resulting in some communities being ‘left behind’. But these were things ‘that community pharmacy can provide and strengthen’, he added.
He also suggested that pharmacists could get involved with NHS England’s inclusive pharmacy practice to help them ‘understand with greater cultural engagement, which can then lead to engaging better with the communities which can then ultimately lead to improving health inequalities’.
But while he said that community pharmacy could ‘change the dial hugely’ in terms of reaching communities that had historically been excluded from research, Professor Patel said that the sector needed the resources, space and time to be able to build upon and utilise the relationship they have with their patients.
‘We’re not using that resource as effectively as we could,’ he said.