What leaving the EU means for NHS regulations

European working time directive

The European working time directive limits working hours to NHS staff to 48 hours per week, calculated over a period of 26 weeks, though doctors are allowed to opt out and work additional hours if they wish.

According to the Royal College of Surgeons if a post-Brexit UK did not join the internal market, the working time directive would likely not apply.

However, the working hours cap is part of the draft junior doctors’ contract and there will be pressure to put it in a deal for Agenda for Change staff too.

Procurement and competition law

Public authorities including the NHS must respect a number of EU treaty principles when they award procurement contracts, along with a new directive that was approved in 2014 and implemented via the Public Contracts Regulations 2015. This requires the health service to advertise all contracts worth over €750,000 and ensure principles such as anti-discrimination are respected.

The law firm Hempsons has emphasised that the law applied immediately before the announcement of the referendum result will continue to apply and should be observed by public bodies.

According to Andrew Taylor, a competition expert at Aldwych Partners, requirements around procurement could form part of Britain’s trade negotiations with Europe.

Bilateral trade deals currently under negotiation, such as the Transatlantic Trade and Investment Partnership deal between the US and the EU, give an example of the terms likely be available, and requires the introduction of domestic procurement rules very similar to current EU law.

Mr Taylor said it was likely the NHS would retain procurement rules because the health service would still have an interest in “fair, open and transparent” procurement.

On competition, Mr Taylor said that the UK operated a “parallel regime” to EU competition law, meaning it would still be likely to apply after leaving the union.

Sharon Lamb, a partner at law firm Capsticks, said the one exception could be EU state aid legislation, which has been seen as a barrier to funding some UK healthcare services in the past.

“That is one area that has not been enacted into UK law and where legal recourse must be sought in European courts,” she said.

Pharmaceuticals industry

According to PwC, the pharmaceutical industry now faces a “daunting challenge” in terms of regulations for drug development and approvals, intellectual property and investment.

Jo Pisani, a PwC partner, said when it comes to drug development and approvals “the UK’s impact on EU regulation is now likely to diminish, making any UK involvement both more complex and costly”.

While the UK continues to be regulated by the Medicines and Healthcare Regulatory Agency, Ms Pisani said “extra pressure” on the organisation would “potentially slow UK patient access to medicines”.

The UK’s pharmaceuticals industry will also lose access to various EU funds, such as the European Investment Fund.

Years of uncertainty

Ms Lamb also warned: “The only thing that is certain now is that years of legal uncertainty lie ahead.

“Thankfully, things will stay the same for the two year notice period and it will probably take longer than that to implement the changes that might necessary.”