Medicines regulation after Brexit: compromise the key

The UK’s departure from the EU has been the topic of much sparring and speculation since the controversial vote in June 2016, but one important implication of Brexit has been little discussed in the mainstream news: medicines regulation.

Brexit’s impact on the UK life sciences industry is likely to be significant, and the ultimate extent to which researchers, manufacturers and the general public are affected will depend on the terms governing the EU-UK relationship post-Brexit, says Roberto Valenti, partner in DLA Piper’s Milan office.

The European Medicines Agency (EMA) is the EU regulator for human and veterinary medicines, although the regulatory bodies of national member states have some flexibility in how they implement the relevant framework.

Across all member states, medicines are regulated by Directive 2001/83/EC and Regulation (EC) no. 726/2004, while medical devices are governed by the framework of Directive 93/42/EEC.

“The regulatory framework for pharmaceutical products and medical devices is, for the most part, harmonised at EU level,” explains Gregory Bacon, partner in Bristows’ London office.

For member states, being a party to the EU’s harmonised regulatory regime ensures that products are of suitable quality, safety, and efficacy while also providing a more straightforward path to market access across the EU, Bacon adds.

Under EU regulations, a pharmaceutical company can simultaneously apply for a medicinal product authorisation in multiple member states after having completed the EU’s decentralised procedure, Valenti says.

It enables applicants to benefit from a single scientific review which is led by one member state, the conclusion of which is recognised by other member states.

“This is simpler for a company than having to seek multiple independent national authorisations,” Valenti adds.

Similarly, the medical devices directive harmonises the rules for placing medical devices on the market in the EU, which saves companies time and money.

The UK’s withdrawal from the union will be effective from March 29, 2019, at which point it will become a non-EU country and will cease to be a part of the EMA. Subsequently, the UK will be responsible for regulating its own life sciences industry and will not contribute to, or be governed by, the regulatory framework of the EMA.

Deal or no deal?

The Draft Withdrawal Agreement released in March, suggests that certain arrangements between the UK and EU may be extended until the end of 2020, but the deal has yet to be finalised and many uncertainties remain.

Bacon explains that it is so far “unclear” whether companies seeking regulatory approval will have to abide by the March 2019 deadline, or whether the extended relationship between the UK and EU will give them more time.

One change engendered by Brexit is the EMA’s move from London to Amsterdam before March 29, 2019, on the grounds that an EU agency should be situated within the EU, Valenti explains.

Bacon says another change will centre on how medicinal products are marketed, as EU law currently requires that marketing authorisation owners are based in the EU or the European Economic Area (EEA).

In practice this means that, subject to any agreement reached between the UK and EU governments, owners of marketing authorisations within the EU will not be able to be based in the UK, Bacon says.

“The open question is to what extent the UK will remain ‘part’ of the EU regulatory system for medicines and medical devices or to what extent, to the contrary, it will build a separate and autonomous regulatory system,” says Valenti.

He explains that the life sciences industry has taken the position that the UK should remain as aligned as possible to the EU regulatory system, and the EMA has consulted a range of UK-based pharmaceutical companies on Brexit for an industry insight.

“The UK certainly remains an attractive environment for the innovative life sciences industry, but risks arising from Brexit could prove problematic,” he adds.

Regulatory picture

Nonetheless, the main implications of Brexit on those in the life sciences in the UK and the EU will depend on the regulatory regime the UK adopts, Bacon believes.

“It is possible, and indeed probable, that the government will seek to align national requirements with those under the current (and future) EU regime to some degree, in order to avoid companies being faced with two divergent systems for gaining regulatory approval for their products,” he says.

However, it is also possible that Brexit could trigger UK regulations which are vastly different from the existing EU regime; this could make research and development (R&D) more costly and burdensome for UK companies, or for research conducted in the UK, Valenti notes.

He adds that this may motivate businesses to relocate to the EU in order to have access to a broader market and R&D pool.

Bacon agrees. “The UK represents only a part of the EU market for life sciences products by value, so priority is likely to be placed by companies on securing EU approval over that in the UK,” he says.

That said, “the UK is trying to minimise the negative impact of Brexit,” according to Valenti.

He suggests that the impact of Brexit on the life sciences will rest on the ability of UK workers (such as researchers and inventors) to move freely around Europe, and vice versa, as well as the accessibility and eligibility of UK-based researchers to funding schemes.

“Access to finance, availability of skilled employees, strength of and links with academic institutions, and ease of establishment are all factors that in the past have helped to boost the UK life sciences sector,” Bacon adds.

A further concern is that the cost of medicine in the UK will increase once the UK leaves the EU because the UK will no longer be part of the single market, which requires free movement of goods.

Bacon explains that medicines from other member states are sometimes cheaper than their equivalents in the UK and, after Brexit, the trade of medicines from the EU to the UK may well be curtailed, resulting in people paying a higher price for their medication.

Although there is still much uncertainty surrounding Brexit, the UK has demonstrated its dedication to maintaining and sustaining the life sciences industry.

For example, Bacon notes, Baroness Goldie, the UK government’s representative for life sciences, confirmed the UK’s commitment to implement the EU Clinical Trials Regulation 534/2014 into UK law after Brexit. The regulation is currently expected to be applied in the EU from March 2020.

“The new regulation is intended to introduce a single, harmonised regulatory regime that will apply to clinical trials conducted in the EU,” says Valenti.

“It should reduce different approaches among different member states and, accordingly, uncertainty for clinical trials sponsors and other actors,” he explains.

Bacon adds that it will lead to a streamlined application procedure and simplify the authorisation procedure for clinical trials in the EU, which will benefit patients, as well as simplifying the clinical trials process for pharmaceutical companies.

National efforts

The UK government and national authorities have made a variety of other efforts to ensure the UK life sciences industry does not suffer as a result of Brexit.

In August last year the UK government committed £160 million ($280.2 million) in funding to the life sciences after a review of the industry showed it to be one of the UK’s five leading sectors.

Also last year the House of Lords Science and Technology Committee invited the thoughts of pharmaceutical companies and regulators (including GSK, AstraZeneca, and the Medicines and Healthcare Products Regulatory Authority [MHRA]) in efforts to inform regulations post-Brexit.

Prime Minister Theresa May delivered a speech in March in which she said the UK sought to explore the “terms on which the UK could remain part of EU agencies such as those critical for the chemicals, medicines, and aerospace industries”, suggesting that “associate membership” of the EMA is desirable.

However, in the Draft Withdrawal Agreement, the European Commission seemed to rule out UK membership of EU regulatory bodies as there can be “no sector cherry-picking”.

Most recently, in April, the MHRA unveiled its five-year plan which included the recommendation that an “active regulatory partnership” be formed between the UK and EU.

Although there is “increased uncertainty” around Brexit, the plan suggested, “clear precedents” for regulatory collaborations are already in place through the relationship with the EU and non-EU territories, such as Switzerland.

“All regulatory agencies across the world, including the EMA and the MHRA, should pursue cooperation and collaboration in the interests of protecting the safety of the patients and at the same time ensuring a quick access to innovative products,” Valenti says.

Similarly, Bacon advocates regulations that are “driven by science and medicine, which should lead to increased global harmonisation” and, ultimately, more advanced innovation and improved public health.

EMA fact file