Brexit negotiations are underway and while trade and immigration remain dominant concerns, there is one significant issue that has not made headlines.
Read more: On the anniversary of the EU vote, here are eight ways Brexit has hit science, tech and design
It is entirely possible that when the UK leaves Europe on 30 March 2019, it will also leave the European Medicines Agency (EMA), a collaborative venture between all of Europe’s regulatory bodies that speeds up the approval of new drugs. Any drug approved in any of the 28 member states can then be sold across all 28 markets. Without the EMA, there is a real danger the UK could end up at the end of the pecking order, an unattractive single market that drugs manufacturers will never go to first before the world’s biggest markets: the US, Europe, Japan, Canada, Australia. The knock-on effects to the cost of drugs in the UK, to access to cutting-edge medicines, and to UK research efforts, could be devastating.
“Pharmaceutical companies will go to the Americans first because they pay the most and uptake is fast there; then Europe because it’s one submission for 28 countries, then they tend to go to Japan because there are 128 million people and it has a high GDP,” Anthony Hatswell from independent health economics consultancy BresMed and University College London PhD, tells WIRED. “If you look at it commercially or ethically, 128 million people compared to our 65 million, you go to the 128 million first. Regulators ask a lot of questions and put the drug companies through the ringer, and all regulators ask different things. So they have to prioritise...the claim of UK patients having to wait for two to three years for access to novel treatments does not sound unreasonable.”
Hatswell has penned an article in the journal ecancermedicalscience, out today, which explores these themes and implores regulators, drug companies and politicians to take heed of this potentially damaging path.
Currently, the EMA helps distribute and share an otherwise enormous workload. Each new drug submission leads to the appointment of a ‘rapporteur’ from one of the member state's own regulatory bodies, who assesses the medicine, looking at efficacy, data results, manufacturing standards, adverse effects and more. Hatswell is concerned that because there are not many researchers working in this field, where regulation, commercial sales, and market access intersect, the issue has not been given due focus.
“I read all the (political) manifestos, and not one said anything about it. The Brexit stuff was very short on detail. No one picked up how much of big deal this is and I don’t think they realise how much they could royally screw things up.”
If the UK reverts to relying solely on its own regulatory body, not only does it face the cost burden of taking on all the regulatory work, it also has a history of being overly cautious when it comes to regulating new drugs and this fact could be exasperated. The National Institute For Health and Clinical Excellence (NICE), part of the Department of Health, is tasked with approving drugs for the NHS that are cost effective and have value for money. The result is that the UK has to take a pragmatic approach to some drugs that might only add four to five weeks to life, says Hatswell. “The UK can be stingy in paying for drugs. If a drug adds a small time to life, the UK is generally not prepared to pay for it, and I don’t disagree. But you may run into problems ten years down the line.”
This is because if we fail to license a drug, by the time it becomes the standard of care ten years later we won’t have access to the original, cheaper generic version. On top of taking over the EMA’s work, carrying out all the regulatory work by ourselves and inspecting manufacturers, we might also be burdened with the cost of higher priced drugs later down the line. Hatswell gives the example of emflaza, a steroid for muscular dystrophy that has been licensed in Europe for 40 years. Today, it is off-patent and the standard of care. However, it wasn’t made available and licensed in the US at that time. A drugs company that got the same drug type licensed in the US and received exclusivity over sales there proceeded to “jack up the price 89-fold,” says Hatswell. “Leaving the EMA could leave us open to that kind of exploitation.”
As well as potentially being stuck with more expensive drugs, we will also lack the basic foundations for research that will put us behind the rest of the world, argues Hatswell. When it comes to carrying out clinical trials, UK patients will present a different research base from every other nation where the drugs were available years earlier. Candidates will have experienced different first line treatment from the modern standard of care.
Leaving the EMA could mean the UK has to lobby drug companies to apply for UK licensing; we may also be forced to accept higher prices to make the UK a more attractive market.
Hatswell concludes in his paper: “If the vital area of pharmaceutical regulation is neglected, irreparable harm could be done to the health of the UK population for generations to come.”
There is a chance of ensuring a better path forward, though. The UK already carries out about a third of EMA’s workload, making us an attractive partner to maintain. EMA’s headquarters is currently based in London. If we could stay in the EMA but potentially retain an independence that is beneficial to us, we could end up with an even better regulatory stance.
“It seems we are going to have Brexit, but how can we leave it in a not terrible way. If this is about having more freedom, let’s make the most of it and stay part of EMA but give our regulator additional freedoms. If we think the US has done a good job, why not take the FDA’s recommendations up?”
There tends to be a great deal of agreement between regulators, he argues, so why wait for our own body to authorise something if we agree with and trust the Food and Drug Administration’s (FDA) finding. The UK can also remain a member of the EMA but, as Hatswell points out in his article, “accept the decisions with political oversight oversight (as currently happens with the European Commission)”. Having the European Commission, a purely political, non-scientific entity, approve an EMA decision adds more than two months to the drug regulation procedure. Bypassing this is an attractive benefit. “Such an arrangement would put the UK in a better position than the good position it is in currently. This would give patients (both now and in the future) the best access to treatment possible, and promote/attract an industry which employs (directly and indirectly) 500,000 jobs.”
Brexit campaigner Michael Gove might have famously said “people in this country have had enough of experts” when asked to provide just one example of an economist that backed an exit but Hatswell says now is the time to let the experts get on with what they do best, and continue a collaboration with our European partners that has proved fundamentally beneficial to every UK citizen receiving free healthcare, to date.
“What is needed to avoid disaster is for the case for collaboration to be made clearly by all stakeholders,” Hatswell writes in ecancermedicalscience. “Rather than treating the topic as a chip in trade negotiations, politicians need to give freedom to and empower the highly skilled staff at the MHRA and EMA to work together to find the best solution. Ideology should not trump the benefits of cooperation, beneficial to both parties, and whilst it will be sad to see the EMA leave the UK, this should not be the end of a productive relationship that has done great things for patients across Europe. If the situation is handled with the necessary respect and delicacy, it can continue to do so.”
This article was originally published by WIRED UK
