Brexit: the impact on pharma

Brexit: the impact on pharma

The Government will hold a referendum on Britain’s membership of the EU on 23 June. With the National Centre for Social Research’s latest poll of polls showing a narrow lead for the Remain campaign, a Brexit is still very much a possibility.

Health in the Brexit spotlight

Much of the sparring between the Remain and Leave campaigns has focused on the long term impacts of EU membership on security, sovereignty, immigration, and of course economic prosperity. However, in recent weeks, the confrontation has spread to another politically charged area: the NHS.

In between tussles with junior doctors, the Health Secretary, Jeremy Hunt, has declared the NHS will face budget cuts, falling standards and an exodus of overseas doctors and nurses if the UK votes for Brexit. The Trades Union Congress (TUC) also argues that Brexit would block skilled workers coming into the NHS, increase cross-border healthcare costs and complexity, and reduce scientific collaboration, funding and innovation.

The Leave campaign has countered with arguments that a Brexit would actually enable the UK to spend more money on the NHS, by redirecting money previously spent on EU financial contributions; enabling the Government to be more generous with the new junior doctors contract and invest more money in hospitals. Former health secretary, Lord Owen, has also backed Brexit because he thinks the proposed US-EU trade deal, known as the Transatlantic Trade and Investment Partnership, will eventually lead to permanent privatisation of the NHS.

With such disparate views being expressed by our politicians about the likely impacts of Brexit on the NHS it is difficult to know who to believe. Although there is probably a grain of truth to all of these arguments.

The impact on UK pharma

According to the Office of National Statistics, the UK’s pharmaceutical sector is worth over £13 billion of gross value added (GVA), or around 9% of the country’s manufacturing economy. Analysts therefore suggest a Brexit would have serious consequences for the UK and for the industry itself. Here are some of the more widely cited arguments:

  • A Brexit would cause UK researchers in the sector to lose access to facilities and valuable public/private partnerships, such as the EU’s Innovative Medicines Initiative.
  • The EU is introducing new Clinical Trials Regulations and a portal to make it easier for companies to conduct multi-site clinical trials. If the UK votes to leave, it would miss out; making the UK a less attractive place for companies to conduct their trials.
  • UK companies would no longer benefit from Single Marketing Authorisations, which are granted by the European Medicines Agency, and enable them, in one go, to market and make their medicines available across all Member States. The UK may instead have to create its own process.
  • The EMA itself is based in London and would have to relocate, causing disruption to companies whose drugs are undergoing assessment at that time. The pharmaceutical division of the Unified Patent Court, which will make rulings on disputes, is also supposed to be housed in London when it launches next year. But this would also have to be relocated.
  • Finally, Brexit would alter residency status for some EU pharmaceutical staff and reduce the size of the available talent pool for UK companies – damaging the UK’s long term competitiveness.

The industry’s response

The pharmaceutical industry has taken its time to publicly respond to the threat of Brexit. The first real rumblings occurred over a year after Cameron’s speech on the issue, leading to a few pieces dripping out in the media about the subject. However, fast-forward to 2016 and the drip has become more of a steady stream.

Earlier this year, the BioIndustry Association penned an open letter in the Financial Times, signed by 55 executives, in favour of Remain. Eli Lilley’s CEO and the Head of R&D at Merck in the US have also both said withdrawal would be challenging for their scientists. While the European Federation of Pharmaceutical Industries and Associations (EFPIA), unsurprisingly, thinks the UK’s departure from the EU would threaten scientific research and jeopardise the Member States’ system of drug regulation.

The newly created British Biosimilars Association, has also said Brexit would bring significant uncertainty to approvals and launches of biosimilars for manufacturers and deny jobs to companies that want to compete in the biosimilars market.

And in the latest intervention, Sir Andrew Witty, CEO of GSK (plus 92 other leading life sciences figures), has published an open letter in the Observer articulating the ‘significant advantages’ of EU membership for the life sciences sector and the UK. In addition to putting forward conventional arguments about inward investment and jobs, there was a more overt reference to how UK and EU patients benefit from getting access to medicines more quickly, because of the harmonised EU regulatory approval system that aids faster dissemination.

The elephant in the room

This last point is worth reflecting on, because while pharmaceutical companies and industry groups have been quick to hammer home messages about the economic and scientific impacts, they are only now just beginning to talk about the knock-on effects for patients.

If the UK does leave the EU completely (and fails to negotiate an EU non-member deal to stay in the EMA), it would miss out on access to other pan-EU projects designed to speed up patient access to innovation, including collaboration on health technology assessments.

Slower access

At the same time, because pharma companies would then have to undergo a duplicative process for authorisation of their drugs in the UK, it may force them into a binary decision about where to launch their medicines first.

Since the EU would still be a larger marketplace than the UK, companies may legitimately decide to launch their drugs there first, meaning that UK patients end up waiting longer to get hold of cutting edge medicines.

Higher prices

There is one other nasty side effect. An adjustment in the launch sequencing for medicines in favour of the EU could lead to a consequent erosion of the UK’s status as a global reference price, reducing the UK’s ability to obtain discounted prices (e.g. The Lancet Oncology recently concluded that the UK pays less for cancer drugs than most other EU countries) and leading to a refactoring of global prices in general.

So, in layman’s terms, if the UK does vote for Brexit the cost of our medicines could go up and it could take longer for us to get access to new medicines.

This is a hugely contentious issue. After all, no company wants to be seen to be placing commercial interests above those of patients. Nevertheless, it is a potential consequence of the domino effect and one that the public deserves to be made aware of.

Written By

Jamie Hewitt