Update: Where does Brexit leave European pharma, now that the EU has excluded the UK from drug approvals?

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A European decision to exclude Britain from the EU’s drug approval system from beginning 30, 2019–the day after Brexit–has raised alarm among drugmakers, who fear the abrupt change could disrupt the flow of needed medicines to patients. The move bewilders hopes for continued joint cooperation via the European Medicines Agency (EMA), at least during a transition or implementation period until the end of 2020 when the UK will remain closely tied to the European Union, says a Reuters report.

Prime Minister Theresa May had said in a speech on March 2 that London wanted to explore ways to keep Britain a part of EU agencies, such as the EMA. But the highly regulated drugs industry is particularly susceptible to Brexit, given the EU’s centralized system for approving and monitoring medicines. Brexit is already forcing the EMA to relocate from London to Amsterdam.

Now, the EMA has appointed experts from other European countries to take over work currently undertaken by Britain’s Medicines and Healthcare products Regulatory Authority (MHRA) from next March. Since the MHRA assesses around a fifth of EU medicines, drug industry leaders fear this sudden handover will cause disruption.

“Removing key expertise and reallocating work to other agencies who are not yet able to take on the work and expecting them to increase their capability overnight is an increasingly reckless course of action proposed by the (European) Commission,” said BioIndustry Association (BIA) chief exec Steve Bates. “In the interests of patients on both sides of the Channel, it is important that the EU retains access to UK expertise in a post Brexit medicines regulatory framework and that regulatory alignment is maintained to ensure continuity of medicines supply.”

Maintaining timely approvals for new drugs is crucial for pharmaceutical and biotechnology companies, which have dozens of experimental medicines due to be assessed by the EU regulator in the next couple of years. Global drug companies, including UK-based GlaxoSmithKline and AstraZeneca have been vocal in calling for continued close EU-UK ties after Brexit. The issue is also important to many Japanese drugmakers that have made Britain their European base.

The MHRA confirmed it would no longer act as a so-called “rapporteur” for EU drug licensing or safety monitoring, although there has been no decision on long-term relations.

“It is important to note this only applies to the implementation period and there is no decision yet on the future relationship,” a spokesperson said. “The UK’s position on medicines regulation remains clear. We want to retain a close working partnership with the EU.”

The Association of the British Pharmaceutical Industry (ABPI) said it was clearly in the EMA’s interest to continue to draw on the expertise of the MHRA and it urged London and Brussels to come to an early agreement “in the interest of patients and public health.”

Steve’s Take:

“Brexit means Brexit.” These three guileless words that commenced Theresa May’s leadership campaign in the aftermath of the EU referendum were originally described as firm and unambiguous.

But almost two years after the UK voted to leave the European Union, their meaning remains as unclear today as it was in July 2016. In the intervening months, Brexit has dominated both news and business agendas–and become a topic to be avoided at family barbeques, says Chris Ross for PMLive. Yet in the sphere of healthcare, Brexit is much more than a political ideology or a three-word soundbite; it affects patients and it affects lives.

Brexit may indeed mean Brexit–but for the European pharmaceutical industry, knowing what it really means is hugely important. The final outcome will lead pharma–and the patients it serves–to one of two extremely different destinations.

With this date now just 10 months away, companies, organizations and individuals all over the world have speculated about how Brexit might impact them.

According to Prime Minister May back in 2016: “It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry.”

With under a year to go until Brexit kicks in, its consequences are already evident in this crucial industry, says a report by Labiotech.

A number of EU academics were reported to have already pulled out of the UK by last summer, and as of June 2017, the number of EU staff departing the UK was up 30% compared with 2 years previous, according to data released by universities under the Freedom of Information Act.

Unfortunately, these consequences are only a taste of what it is to come, and as recently as January 2018, European Pharmaceutical Review reported challenges for UK life sciences companies in filling senior positions, with applications from non-UK nationals plummeting from around 40% to just 15% on average.

The relocation of the EMA from its historical home in London to Amsterdam is arguably one of the biggest consequences of Brexit to the life sciences sector. The EMA was established in 1995 with financial support from the EU, the pharmaceutical industry and member states, with the goal to streamline and simplify the work of the existing national regulatory bodies.

The replacement of 28 individual marketing authorization (MA) systems (1 for each member state) with 1 European-wide MA system was huge. The EMA’s relocation to Amsterdam by the time Brexit comes into force will mean breaking up this well-established system that will take huge efforts to rebuild.

Once the Brexit process is complete, the UK will regulate its own life science industry and will no longer contribute to the regulatory framework of the EMA.

According to Thomas Lönngren, former executive director of the EMA (2001-2010), at the BIO-Europe meeting in Amsterdam in March, “It’s a very sad decision to have to move the EMA from London. It destroys a lot of the hard work that was put into it, as it has consequences for the performance of the EU regulatory system.”

So, where stands European pharma today? For a subject that polarizes opinion and sparks heated debate, Brexit has found a rare consensus in pharma. In the UK, the ABPI has outlined five priorities. These include securing a single-step transition period, regulatory alignment between the EU and UK and “frictionless” movement of medicines across borders.

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In addition, it wants an immigration system that allows pharma to attract talent from around the world as well as “predictable access” to funding and collaboration for scientific research. These common-sense ambitions are broadly aligned with those of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and pharmaceutical companies across Europe. Mercifully, they also reflect the position of the UK Government.

In her speech in March at the official residence of the Lord Mayor of London (the Mansion House), Prime Minister May called for a comprehensive system of “mutual recognition” (distinct connotations of working together) where products only need to undergo one series of approvals, in one country, to show that they meet the required regulatory standards.

The Prime Minister specifically cited the importance of regulatory alignment for the pharmaceutical industry, indicating a determination to explore how the UK can remain a member of the EMA. Maintaining membership would, she said, assure a continuation of investment in innovative medicines in the UK.

May’s Mansion House statement was welcomed by the ABPI.

Its CEO, Mike Thompson, said: “Every month, 45 million packs of medicines move from the UK to the EU–and 37 million come the other way. That is why the Prime Minister’s commitment to seek cooperation on medicines regulation would be the best outcome for patients, not just in the UK but across Europe.” However, close cooperation on regulation is, he said, only one part of the challenge. “Making sure the supply of medicines is uninterrupted is essential to ensure patients in the UK and EU can get the medicines they need from day one of Brexit.”

As highlighted by the ABPI, one of the biggest risks of a failure to achieve the industry’s preferred outcome is in the crucial arena of supply chains.

“As we know, any changes in regulation that affect the movement of goods across Europe will have significant implications–not just for businesses, but also for healthcare consumers,” says Jonathan Trethowan, VP, Regulatory and Scientific Policy, PharmaLex.

Bottom Line:

Many of the professionals that populate the EMA’s expert committee–for example the CHMP (Committee for Medicinal Products for Human Use)–will leave the EMA before it relocates to Amsterdam, leading to a loss of expertise in the EMA that will require time and financial efforts to compensate. With British citizens estimated to make up 20-30% of the EMA’s 900-strong workforce, this loss of expertise is expected to be significant.

In an uncertain environment where “Brexit means Brexit,” but no-one truly knows what the final deal will mean, the industry’s future may still depend on those three little words, Ross asserts. Many specialists involved in the industry don’t want to see political borders in the work that they are doing and are in favor of the UK continuing its involvement in the EMA to some extent. But right now, it’s anyone’s guess whether the EU will permit that.

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