|Pharma industry steels itself for no-deal Brexit
Financial Times, Sarah Neville, 26 February 2019
Within days of the UK’s 2016 vote to leave the EU, pharmaceutical companies began planning for a worst-case scenario — well ahead of many other sectors.
But, with barely a month to go before Britain’s scheduled departure, industry anxiety is mounting over a no-deal Brexit’s impact on the supply of drugs, as well as on the UK’s outsized share of global life sciences investment.
“We’ve all worked very, very hard to be ready for whatever happens,” Pascal Soriot, chief executive of AstraZeneca, the Anglo-Swedish drugmaker, told the FT. “But it’s not optimal because there’s a lot of things we have no idea about.”
Despite all the industry’s planning, many potential problems are beyond its control — such as congestion at ports and the regulatory regime on both sides of the English Channel. Both could affect whether there are sufficient supplies of vital drugs.
Moreover, both the UK government and business have recognised that investment in the sector could be dented, because Brexit implies extra costs for pharmaceutical companies, which in turn could affect patients’ access to medicines.
David Jefferys, an executive at Eisai, the Japanese pharma company, who has the regulation brief at the Association of the British Pharmaceutical Industry, said companies could not eliminate the possibility of patients facing drug shortages in the event of no-deal.
“We aren’t controlling the whole supply chain,” he said. “We can do our bit, but we don’t control the ports, we don’t control the airports.”
Eisai has stockpiled around four months’ worth of medicines, considerably more than the six weeks that the UK health department has instructed companies to keep.
But the industry is also facing a more bureaucratic but equally serious problem: how to ensure medicines licensed in another European country can continue to be sold in the UK.
The Medicines and Healthcare Products Regulatory Agency, the UK drugs regulator, has agreed in principle to recognise approvals already granted in one of the 27 remaining member states. But these licences now have to be translated into the British system, so that, in Mr Jefferys’ words, “they’ll have currency in the UK on March 30 as they did on March 29”.
Dossiers covering each medicine, including safety information, will have to be deposited into a new agency database because the EU will not permit data to be transferred directly from its computer systems.
“This is a big database to build and they’ve got less than a month to build, test and validate it,” Mr Jefferys warned.
Many in the industry also fear the UK will find itself excluded from European clinical trials, which not only generate significant income but can give participating patients the chance of a life-saving or life-enhancing treatment.
To minimise the disruption caused by no-deal, the UK government is pushing through so-called “statutory instruments” — amendments to primary legislation — covering areas from medicines approvals to clinical trials regulation.
But some in the industry are privately complaining the measures are being rushed through with too little consultation.
An official “impact assessment”, published in January to help establish the MHRA as a standalone regulator, made clear the risk that additional bureaucracy and cost may lead companies to decide against launching a medicine in Britain.
It acknowledged “a possibility that some medicines that would have been authorised in the UK” when the country was part of the European Medicines Agency — the EU body previously based at Canary Wharf — “will not be submitted to the MHRA due to business decisions”. It added: “This could have an impact on access to certain medicines and therefore to public health.”
Life sciences is one of the UK’s most important industries, generating more than £70bn a year and employing nearly 241,000 people.
The size of the sector is out of proportion with the domestic market, highlighting Britain’s role as a platform for the international pharmaceutical business. The UK accounts for 3.5 per cent of global life sciences investment, the highest share in Europe if exchange rate effects are excluded, but its share of global sales is only around 2.6 per cent.
But now the costs of the British sector are going up, largely because of Brexit contingency spending and duplication.
Eisai has spent around £10m on transferring licences for about 60 medicines to Germany as well as on its stockpiling.
Larger companies have spent much more. GlaxoSmithKline last year estimated the cost to the company of the duplication of facilities at around £70m, while AstraZeneca last week said it anticipated spending between £40m and £50m.
While the Anglo-Swedish group is pouring £500m into a new life sciences campus in Cambridge, it is holding off on a potential further investment into a manufacturing facility it owns in Macclesfield, Cheshire, due to Brexit uncertainties. It invested £220m in the plant between 2015 and 2018 before calling a halt.
Asked what would determine his ultimate decision about whether to resume investment, Mr Soriot told the FT he needed “simply clarity” about how medicines were to be moved across borders post-Brexit.
“We just need to know what [the future trading environment] is . . . because if we have a manufacturing activity here, we have to export our products,” he added.
“Are we [on World Trade Organization] terms . . . or are we in a different place? How do we get our drugs approved? How do we manage safety around our products? What’s the role of the EMA? What’s the role of the UK agencies? All these things need to be clarified.”
It should be doctors, not ministers, who decide on medicines
The Times, Jon Ashworth, 26 February 2019
The Leavers with their red bus told us Brexit would be a boon for the NHS. Yet today confirms that a no-deal would be an utter disaster for the health service and patients.
The Lancet’s analysis outlines how Brexit, especially no-deal, will effect “the health care workforce, NHS financing, availability of medicines and vaccines, sharing of information and medical research”.
This follows Diabetes UK’s shocking revelation that “despite reaching out directly to the Department of Health and Social Care in December, we still have not seen the concrete detail needed to reassure us — or people with diabetes — that the UK Government’s plans are robust enough to guarantee no impact on insulin and medicine supplies in the event of a no-deal Brexit”.
It was a similar story from the epilepsy bodies, who said: “We do not have confidence in the current arrangements to ensure the continuity of life-saving medications for people with epilepsy.”
Last week the Royal College of Radiologists issued staggering concerns about the supply of medical isotopes, spelling out how the expected disruption would force clinicians to alter treatment plans and mean the prioritisation of some cancer patients over others.
In response Matt Hancock, the health secretary, glibly told the Commons health select committee that he would prioritise medicine over food and that everything would be just fine. Yet his own departmental impact assessments of the emergency legislation warns that under a no-deal scenario the NHS will pay more for drugs, UK firms will face duplicative red tape and we’ll be at the back of the queue for medical research innovations.
Perhaps the most far-reaching and contentious of his changes is the Serious Shortage Protocol — an extraordinary power grab whereby ministers grant themselves authority to instruct local pharmacists to ration drugs, overrule a GP’s prescription and dispense therapeutic, generic equivalents or reduced dosages in the event of a medicines shortage.
Once it was doctors who told you what medicines to take. Now it will be ministers.
The emergency measures have rightly caused alarm: the National Aids Trust has said that the “only person qualified to safely alter the medication prescribed to a person living with HIV is that person’s HIV consultant”.
On behalf of the official opposition I have laid a “prayer” motion against the changes and today we expect judicial review proceedings to be launched in the High Court led by the Good Law Project and supported by crowdfunding.
I talk and listen to frontline NHS staff all the time and I know there is well-founded fear and trepidation about the implications a no-deal Brexit will have for hundreds of thousands in need of life-saving medicines. It’s the height of shameful irresponsibility for Theresa May and her cabinet ministers to refuse to take no-deal off the table.
This week parliament faces a choice: it must vote to safeguard the NHS and patients by saying no to no-deal.
THE LANCET: Brexit will cause significant harm to the NHS, but No-Deal Brexit presents by far the worst option
The Lancet, Press Release, 25 February 2019
All forms of Brexit will negatively impact the UK National Health Service (NHS), but the prospect of a No-Deal Brexit presents by far the worst scenario, with negative effects on the health care workforce, NHS financing, availability of medicines and vaccines, sharing of information and medical research, according to a new Health Policy review published in The Lancet.
While the Withdrawal Agreement negotiated between the UK Government and the EU (but not agreed by Parliament) offers a more positive scenario compared to a No-Deal Brexit, there are serious concerns about the negative impact of Brexit on the NHS beyond the transition period, when the Backstop or arrangements envisaged in the Political Declaration on the Future Relationship would come into force.
Under either the Backstop or Political Declaration scenarios, the impact of Brexit on the NHS is only slightly less harmful than the No-Deal scenario, though the exact impacts vary.
In the new analysis, the authors, who are leading experts in public health and law, use the available legal and political texts on four Brexit scenarios to assess the likely impact on fifteen specific aspects of the UK health service.
The four scenarios are a No-Deal Brexit under which the UK leaves the EU on March 29, 2019 without any formal agreement on the terms of the withdrawal, the Withdrawal Agreement including a transition agreement until the end of 2020, the Northern Ireland Protocol’s Backstop, and the Political Declaration on the Future Relationship between the UK and EU, which are possible scenarios after the end of the transition period.
Remaining in the EU was not included in the analysis but is better overall for health than any form of Brexit, as was outlined in a previous paper by the same authors in 2017, also published in The Lancet .
The authors warn that little evidence exists that the UK is prepared for any of the eventualities set out in their analysis. For instance, the recently published NHS ten-year plan ran to 136 pages, with only two mentions of Brexit, neither of which offered any detail about what it might mean, or how any threats would be addressed.
Professor Martin Mc Kee, co-author from the London School of Hygiene & Tropical Medicine (UK) says: “Some people will dismiss our analysis as “Project Fear”. But with just over a month to go to Brexit, we need to move beyond slogans. We have set out the problems in detail, based on the best available evidence. If others disagree, then they owe it to the British people to say why. It just isn’t good enough to keep saying that “something will work out” without any details of exactly how.” 
Recruitment and retention to the health care workforce represents a major challenge post Brexit. The Withdrawal Agreement provides reciprocal arrangements and mutual recognition of professional qualifications up to 2020. But, no provisions for health care workers have been made in the Backstop or Political Declaration. And, under a No-Deal Brexit, the Immigration White Paper proposes a minimum salary threshold of £30,000 per year which could seriously limit immigration of many health workers to the UK.
Under the Withdrawal Agreement, reciprocal health care arrangements (eg via the European Health Insurance Card, EHIC) would remain but only until 2020 as there is no mechanism to continue them subsequently, although some limited bilateral agreements may be possible with time. All reciprocal health care arrangements would cease in 2019 under a No-Deal scenario. This would be particularly harmful to older UK residents and people with pre-existing conditions for whom health insurance cover in the EU would be particularly expensive.
Access to capital financing for NHS infrastructure via the European Investment Bank would be negatively impacted in all scenarios. As one of the largest areas of public expenditure, any negative impact in the UK economy will put additional pressure on NHS financing, and the UK has already seen a slower rate of economic growth than if it had remained in the EU. The idea that Brexit will bring a “deal dividend” has been described as not credible by the Treasury Select Committee.
Given looming crises in several other sectors, including welfare and the criminal justice system, the authors note that concerns about whether the Government can maintain its funding commitments for the NHS are warranted.
Under the Withdrawal Agreement, the continuity of legal provisions will secure supply chains for medicines, vaccines, medical devices and equipment until 2020. Under a No-Deal Brexit, the absence of a legal framework for imports and exports would have an immediate and drastic effect on supply chains. Despite Government reassurance of contingency plans in place, shortages are likely because stockpiling arrangements cannot cope more than a few weeks, proposals that doctors offer “best alternative medication” can be distressing for patients, and some products (such as radioisotopes) cannot be stockpiled.
Under any form of Brexit, the UK will no longer be part of the European Medicines Agency, and while the UK’s Medicines and Health products Regulatory Agency will continue to licence medicines, without laws in place to secure regulatory alignment, the UK would become less attractive for global pharma to launch new medicines, potentially meaning launch dates up to 24 months later.
Professor Tamara Hervey, co-author from the School of Law, University of Sheffield (UK) says: “It’s critical to be clear about the practical effects of disentangling over 40 years of legal integration. This is not something that can be done hastily without potentially jeopardising people’s health. Future legal relations will have quite different effects on the NHS: these should be taken into account when the UK Government, advised by Parliament, makes its post-Brexit choices.”
Any form of Brexit will also harm the UK’s European and global leadership role in health. Membership of the European Centre for Disease Control is not mentioned in the Withdrawal Agreement, and while the Political Declaration mentions global collaboration on public health, it does not reference European collaboration. UK laws on air pollution, workplace health and safety, and tobacco trade derive from EU law. With the UK having failed to meet standards on air quality, there is concern that the UK might use Brexit to roll back some of these measures.
Dr Nick Fahy, co-author from the Department of Primary Care, University of Oxford (UK), says: “The NHS is at the heart of our national life; it is vital to understand the impact Brexit will have on it. Patients and the people who care for them are facing ever-growing uncertainty and potential disruption to healthcare. The NHS urgently needs clarity and certainty about Brexit.”
Finally, Brexit has required the mobilisation of hundreds of civil servants, but the task ahead is immense, requiring Government and Parliament to pass several major pieces of legislation and up to 600 statutory instruments within a month. Meanwhile important legislation, such as social care, has suffered prolonged delays.
The authors note that their analysis is based on the most up to date available legal texts, but is inherently limited by the lack of transparency about the Governments’ preparations, the lack of detail in the Political Declaration, and the unprecedented nature of a member state leaving the EU after more than 40 years of membership for which no comparable situation exists.
Hub in Belgium to keep NHS supplied in event of no-deal Brexit
The Guardian, Denis Campbell, 25 February 2019
The government has created a logistics hub in Belgium where vital medical supplies will be stockpiled to stop the NHS running short of equipment if there is a no-deal Brexit.
Stents, implants and other products needed to ensure that patient care is not disrupted will be stored at the hub, the exact location of which has not been disclosed.
The Department of Health and Social Care has also arranged to get NHS supplies – including drugs – into Britain using seven new ferry routes, to bypass the chaos that is widely expected in and around Dover in the event of no deal.
The Department for Transport has agreed to pay two companies, Brittany Ferries and the Danish firm DFDS, £88.8m to transport products from the hub across the Channel over the next six months. Suppliers, including pharmaceutical companies which will store their products elsewhere, will be given priority access to the ferries.
The shortest route, Cherbourg in France to Poole in Dorset, will take four and a half hours while the longest, from Cuxhaven in Germany to Immingham in Lincolnshire, will be 16 hours.
The other routes will be Le Havre to Portsmouth, Roscoff to Plymouth, Caen to Plymouth, Vlaardingen in the Netherlands to Immingham and Vlaardingen to Felixstowe.
The hub will act as a warehouse for the wide range of supplies that hospitals, GP clinics and pharmacies will need in the event of no deal.
In a written ministerial statement on Tuesday, the health minister Stephen Hammond sought to reassure MPs that the in-depth nature of government planning should mean medical supplies would not be not affected.
The extensive preparations also include extra warehouse capacity in Britain to store medical supplies, drug firms stockpiling an extra six weeks of products, and daily flights from Maastricht in the Netherlands to Birmingham to bring in items that the NHS needs.
Hammond said: “While we never give guarantees, we are confident that if everyone – including suppliers, freight companies, international partners and the health and care system – does what they need to do, the supply of medicines and medical products should be uninterrupted in the event of exiting the EU without a deal.
“There is cross-government agreement that all medicines and medical products will be prioritised on these alternative routes to ensure the flow of all these products may continue unimpeded.”
However, the minister raised the possibility that some of the 500 over-the-counter medicines that come into the UK from the EU may become hard to obtain if there is no deal.
“For general sales list medicines, also known as over-the-counter products, 500 of which have an EU touchpoint, we have worked with NHS England to identify which are important for the management of specific health conditions, and are working with suppliers to assure contingency plans for those products,” he said.
Firms that supply drugs or medical goods would be offered the option of buying tickets on the ferry routes, Hammond confirmed. However, a leaked letter to suppliers last week from Steve Oldfield, the DHSC’s chief commercial officer, made clear that the department was “unable to guarantee access to any particular route at this stage” under the scheme.
The DHSC is referring to the arrangement as the “dedicated NHS shipment channel”. An official said the hub was “one small part of the preparations we are making”.
Niall Dickson, the co-chair of the Brexit Health Alliance and chief executive of the NHS Confederation, said: “Today’s detail about additional freight capacity, airplane use, buffer stocks and extra warehouse space will help to support local preparations. This is vital because around three-quarters of the medicines and over half the clinical consumables we use come from, or via, the European Union.”
Update on medicines and medical products supply as we exit the EU
Department for Health and Social Care, 25 February 2019
Leaving the EU with a deal remains the government’s top priority and would give businesses the stability and certainty to prepare for our new relationship after EU Exit. However, the government must plan for every possible outcome, including no deal.
The Department of Health and Social Care (DHSC) is working closely with trade bodies, product suppliers, the health and care system in England, the devolved administrations and crown dependencies (the Isle of Man, Jersey and Guernsey) to make detailed plans to ensure the continued supply of medical products to the UK in the event of a no-deal EU Exit.
Together with industry and the health and care system, DHSC has analysed:
the supply chains of 12,300 medicines
almost half a million product lines of medical devices and clinical consumables
vaccines used in national and local programmes
essential non-clinical goods on which the health and care system relies, such as linen, scrubs and food
Around three-quarters of the medicines and over half of the clinical consumables we use come from or via the EU. The main risk to supply is reduced traffic flow between the ports of Calais and Dover or Folkestone.
DHSC also has responsibility to ensure medicines supply on behalf of the devolved administrations and crown dependencies, and they have accepted the department’s offer to manage the supply on their behalf. All supply arrangements therefore take into account the requirements for the whole of the UK. There has been excellent engagement from all parties, and preparation plans are well advanced as a result.
Following this analysis, DHSC has put in place a multi-layered approach to minimise any supply disruption, including:
securing, via the Department for Transport, additional roll-on, roll-off freight capacity away from Dover and Folkestone for goods to continue to come into the UK from 29 March.
buffer stocks and stockpiling, where this is practical, or asking industry or NHS Supply Chain to build up buffer stocks in the UK before 29 March
buying extra warehouse space to hold additional stock
booking space on aeroplanes for products that require an immediate shipment due to short shelf-life or specific storage conditions
making changes to, or clarifications of, regulatory requirements so companies can continue to sell their products in the UK even if we have no deal
strengthening the processes and resources used to deal with shortages in the event that they do occur despite everyone’s efforts
A combination of securing freight, buffer stocks, stockpiling and warehousing, and regulatory flexibility will be required help to ensure the continuation of medical supplies.
By securing additional freight capacity to ensure a continued flow of products, stockpiling and providing warehouse storage capacity as a further contingency, and removing regulatory barriers, medicines and medical products should continue to be available for the NHS, other healthcare providers and the public in the event of a no-deal EU exit.
Local stockpiling is unnecessary and could cause shortages in other areas, which could put patient care at risk. It is important that patients order their repeat prescriptions as normal and keep taking their medicines as normal.
While we never give guarantees, we are confident that, if everyone – including suppliers, freight companies, our international partners, and the health and care system – does what they need to do, the supply of medicines and medical products should be uninterrupted in the event of exiting the EU without a deal.