Brexit forecasts and preparations for UK medical writers, 2017–2019
Preparations for Brexit raised questions about UK medical writers’ regulatory work, access to clients and colleagues, and the pharmaceutical research supporting their market.
The uncertainty before departure
In December 2017, Brexit forecasts faced an unprecedented withdrawal: no nation had previously left the EU, there were no comparable data, and the terms remained unknown. By December 2018 the expected departure was midnight on 29 March 2019, but the immediate effects remained impossible to predict and might become visible only through the longer-term impacts of separation.
Three December 2018 scenarios ranged from a mild deal with little disruption, through a no-deal “doomsday” decline, to a severe intermediate outcome. The severe scenario was considered most likely: a moderate settlement with limited regulatory divergence, potential loss of EU funding and reduced productivity, depending on the UK’s position within the single market. The UK was Europe’s sixth-largest pharmaceutical producer in 2014, and its pharmaceutical exports to EU countries were valued at £15 billion in 2015. In 2018, separation was expected to harm the industry through long-term restrictions on information flow, business and trade agreements, and workforce movement. The European Federation of Pharmaceutical Industries and Associations expected restrictions on free movement to harm both UK and EU academic research and small and medium-sized enterprises; earlier clarity about withdrawal plans could provide stability.
The European Medicines Agency’s relocation
In June 2017, keeping the European Medicines Agency (EMA) in London appeared untenable even under a soft Brexit, and relocation was a public-health concern. Its 2017 budget was €322 million, much of it spent in the UK, with 900 permanent staff paying taxes and spending in central London and many visitors using the city’s hotels. Denmark, Ireland, Italy and Sweden had launched candidacies, while Spain, Portugal and Croatia were possible contenders. Travel connections, hotel capacity and somewhere staff wanted to live were expected to matter, but political considerations might exclude countries already hosting a major agency or favour an eastern European location. Reports of low morale and senior departures made a rapid decision desirable to limit further expertise loss and damage to the agency’s work.
In December 2017 the EMA declined to speculate about its future seat and operations while the UK’s future relationship with the EU remained unknown. By December 2018, its move from London to Amsterdam was removing the competitive advantage of proximity for UK regulatory-affairs officials and Medicines and Healthcare products Regulatory Agency (MHRA) staff. The ending of the EU contract with the MHRA for medicines evaluation was also reported in December 2018. By September 2019, the EMA had maintained its core public-health work and evaluation and supervision of medicines from Amsterdam while temporarily scaling back guidance development and transparency initiatives.
Regulatory routes and clinical trials
The December 2017 expectation was that the UK market’s regulatory authority would change from the EMA to the MHRA, with disruption despite their close alignment, especially if European marketing authorisations ceased to be automatically valid. Medical writers’ role in marketing applications made such disruption relevant to their work.
By December 2018, the European Commission had set out requirements for a European-based Qualified Person and treatment of the UK as a third country for clinical studies from the withdrawal date. The EMA then assumed that the UK would be outside the European Economic Area, but a Norway-type arrangement was expected to avoid significant disruption; most mild scenarios anticipated largely maintained regulatory frameworks and little industry impact beyond reduced European influence. Even the mild scenario anticipated loss of rapporteur status and MHRA participation in EMA decision-making, while the obligation to follow EMA rules remained. The Commission’s notice of 6 September 2018 identified three main consequences for clinical trials:
- Supply of investigational medicinal products.
- Establishment requirements for the sponsor or legal representative.
- Submission of clinical trial information.
In 2018, the UK Business, Energy and Industrial Strategy Committee saw no benefits in regulatory divergence. A government white paper suggested an association agreement under which the UK would pay a fee to remain under EMA jurisdiction and retain eligibility to apply for EU funding without influencing the programmes’ direction. Policy on the Clinical Trial Directive, then due to become the Clinical Trials Regulation, remained unclear; withdrawal from a directive perceived as overly bureaucratic was considered possible. A PricewaterhouseCoopers report suggested that this could lead companies to exclude the UK from clinical study design or include it only at a later development stage. In September 2019, proactive preparation included allowing for slightly different regulatory-document sets for the EMA and MHRA when they parted ways.
Workforce movement, investment and research funding
The December 2017 concern about foreign investment was particularly relevant to knowledge-based outsourced services, whose investors seek large pools of talent and technical expertise. English-language working and access to European talent were UK advantages, and ending free movement was considered a serious threat to its attractiveness for foreign direct investment. Recruiters consulted in 2017 described English as the language of choice and much European medical-writing talent as UK-based, but stressed that significant regulatory and life-sciences talent came from elsewhere in Europe and that the sector could not afford to lose free movement.
In December 2018, uncertainty over free movement threatened future worker shortages and further foreign investment. The government had stated that free movement would end and immigration rules would be determined by government and parliament, but little was known about those rules; uncertainty about EU nationals’ status had already prompted some professionals to leave. An inability to attract the best EU talent would reduce the UK’s appeal to foreign investors. The UK had been the EU’s largest recipient of foreign direct investment, much of it dependent on access to the EU market and the best people.
The December 2018 no-deal scenario anticipated a short-term halt in skilled workers’ free movement despite promises of prioritised entry, visa delays affecting meetings, missing personnel and interruptions to goods and services. Larger enterprises were thought more likely to survive, while smaller ones could lack the workforce needed to remain financially viable, with possible mass migration of industry personnel to EU member states.
In December 2017, healthcare spending was considered relatively protected during economic difficulty, but drug innovation and the medicines the NHS could afford remained vulnerable to cuts. The UK was described as Europe’s foremost destination for phase I trials, with loss of EU grants and participation in EU-wide projects forecast after departure. In December 2018, the UK received more EU scientific research and development funding than it contributed; the Treasury had committed to underwrite projects applied for before departure, but their subsequent status remained unclear. Even an association agreement preserving eligibility to apply was considered unlikely to preserve that favourable surplus, and some loss of research funding appeared inevitable. The UK Business, Energy and Industrial Strategy Committee considered that the government could not match the EU pharmaceutical-research funding from which the UK had disproportionately benefited, particularly under no-deal financial strain. Loss of research momentum and of the UK’s contribution to European research were further no-deal concerns.
Trade and supply chains
In December 2017, a falling pound was expected to benefit exports but make imports more expensive and harm the UK economy; uncertainty could deter or reverse foreign investment. Departure could bring tariffs, red tape and new regulatory challenges. One contemporaneous forecast doubted that EU free-trade arrangements would continue and anticipated individual negotiations with EU states as well as other countries, affecting globally focused businesses including medical writing. Possible benefits envisaged in 2017 included freedom to trade with countries such as the US and China, removal of some EU regulations and tariffs, lower costs and faster or more efficient work, and new non-EU investment attracted by the lower pound.
In December 2018, a Norway-type European Free Trade Association and European Economic Area arrangement was considered the least damaging option, preserving similar free trade without renegotiating all existing deals while allowing other agreements, although it might already have been excluded from negotiations. Under the severe scenario, a common rulebook appeared likely given the government’s commitment to frictionless trade, but the EU had rejected the proposal to apply EU tariffs to goods entering the UK for onward movement to the EU. The anticipated choice was between losing EU-negotiated free-trade agreements, including those with Israel and South Korea, to negotiate new ones, or retaining existing agreements without the ability to make independent ones. AstraZeneca had begun stockpiling medicines, and immediate supply-chain disturbance appeared inevitable. Reduced investment and funding and higher costs from disrupted supply chains were anticipated, although new supply chains and possibly more favourable trade agreements might mitigate some effects over time.
The December 2018 no-deal forecast assumed loss of EU zero-tariff agreements and reliance on the World Trade Organization’s pharmaceutical tariff elimination agreement, which prohibits tariffs on listed pharmaceutical products among signatories. Its product list had not been updated since 2010 despite provision for three-yearly updates, leaving more than 1,000 products awaiting inclusion; rapid revisions were considered necessary for the UK industry to survive on that basis. The predicted asymmetry was severe UK damage but only short-term EU damage, because EU member states could fill the resulting market gap.
No-deal preparations
By December 2018, newspaper scenarios across the political spectrum envisaged shortages of food, medicine and power within days of a no-deal departure because of just-in-time supply chains, with effects on travel, IT and personnel stretching contingency plans. The Bank of England governor had called no deal highly undesirable, while the pharmaceutical-industry scenario anticipated potential chaos in research, development and sales.
UK guidance published on 20 March 2019 addressed registration of trials of investigational medicinal products, publication of summary results and future requirements in the event of no deal. Until the departure date and manner were clear, this represented a preparedness position conditional on no deal. Further September 2019 guidance covered medicines, devices and clinical trials in a no-deal scenario, including trials of investigational medicinal products and an MHRA registration route for submissions.
Contracts and competitive position
In December 2017, Brexit was expected potentially to accelerate an existing trend towards cheaper outsourced medical writing, including in India; regulatory change and probable loss of talent could make the UK less attractive for outsourcing, with contracts previously assured for up to a year perhaps secured only for months. The near-term outlook was considered unfavourable, but greater foreign competition need not mean loss of market share if UK writers acquired a competitive advantage, most likely through superior service. At that time, plentiful work had allowed UK writers to turn down contracts; competition was regarded as a normal development rather than a catastrophe, although it would require more effort to maintain an advantage. A lower pound offered a short-term benefit for medical writing as an exported service. Native English, UK and EU regulatory experience and international EMWA networks were potential UK strengths, while restrictions on movement could weaken the advantage of attending study-team review meetings in person.
Writers’ contingency options
In December 2018, reliance on the global industry and demand for English-language regulatory writing alone was considered insufficient preparation; awareness of wider industry problems could help writers prepare and possibly help address them. Learning new UK regulations and writing to them as for other territories could position writers favourably under a mild outcome, while experience of shifting timelines, contingency plans and multidisciplinary teams could help under any outcome.
The December 2018 contingency analysis identified these threats to the industry:
- The EMA’s move from London to Amsterdam.
- Fewer UK study centres.
- UK companies ceasing to be global or European research and development headquarters.
- Delayed regulatory roadmaps for UK strategy.
- Teams or clients unavailable because of relocation and different time zones.
- More short-term, sporadic outsourcing.
- Additional UK regulatory documents for a separate territory.
- Supply problems affecting timelines.
- IT and communications disruption.
- Economic problems, including a falling pound, supply-chain difficulties and emergency cuts to skilled staff.
- Longer preparation of investigator’s brochures and clinical study reports because of workforce cuts and communications disruption, risking fines for delayed public disclosure.
- Intermittent clinic IT affecting electronic case report forms, data cleaning and statistical tables.
- A UK industry reduced to a local sales force, removing UK production of global regulatory documents.
The December 2018 opportunities and adaptations for UK medical writers were:
- No immediate impact on medical writers.
- Global teams whose working practices are unaffected by site location.
- Familiarity with restructuring, global regulatory arrangements and new teams.
- Adaptability and proactive work to meet ambitious timelines under pressure.
- Remote working, brokering agreements, handling unexpected project changes and adapting working hours to clients.
- Freelance clients on different continents, providing variety and wider experience.
- Greater work volume and job security for writers experienced with non-EU and non-US documentation.
- Adapting timelines and communicating with teams.
- Using all communication methods, with paper contingencies where needed.
- Cheaper contracts increasing global and local marketability.
- Flexible timelines and ingenuity.
- Adapting to available data and contingency measures.
- Transferable skills and home working for global companies; if UK industry folded, remote EU or US work, another industry or relocation abroad.