In a multi-part series juniordoctorblog.com looks at the No Deal Brexit scenario and its direct and indirect impact on the National Health Service.
Informed consent is the bedrock of medical ethics. It means I cannot legally do anything to you without your express permission, and for anything you do allow, or “consent to”, you have to know why you need it, the risks, benefits and all the alternatives. Such are the legal ramifications of this, if I were to perform a procedure without properly informed consent I could be jailed for the crime of battery.
The absolute irony of the EU referendum, arguably the most important vote in a generation, was the completely backward approach to the decision. The further from the time of “consent” the more informed the conversation has become. In this first part juniordoctorblog.com asks, how will a No Deal scenario affect our supply of drugs and medicines?
Will we still be able to import medicine?
Short answer: Yes, but costs will likely rise, and some supply chains will be threatened or may breakdown entirely.
Currently there are no tariffs or border checks within the EU for medicines. Tariffs are additional duties charged at the border for moving medicines between countries.
In the event of No Deal we would leave the EU and become an individual state within the World Trade Organisation, an internationally agreed baseline for trading.
The WTO has its own issues:
1. Although we are currently members our membership is within the EU bloc. We don’t have individual membership yet.
2. The WTO court for settling disputes is currently non-functioning due to a dispute with the USA. If any aspect of our joining or terms is disputed, there isn’t currently a way to settle it within the WTO.
Specifically in regards to moving medicines back and forth between the EU from the WTO, the EU is signed up to the Pharmaceutical Tariff Elimination Agreement, an Agreement to eliminate tariffs on a set list of medications with other WTO countries. We could continue to import tariff free medicines on this list from the EU under this agreement. However, this list hasn’t been updated since 2010- the US are again disputing it and holding up a revision. This leaves many new medicines off, meaning we would have to pay new tariffs on importing those from the EU. Which is a lot. We import 37 million packets of medicines every MONTH from the EU worth £18.3billion. The EU are our largest source of medicines (73% of all our imports), likely due to the frictionless movement and lack of tariffs. Estimated WTO tariff rates would add 5-6% of cost to these medicines. We also leave all the EU-WTO countries Free Trade Agreements we also had access to, e.g Japan, and any agreed medicines tariff reductions included in them.
Worse, UK based companies produce medicines in supply chains that often cross borders multiple times – each import potentially adding an additional tariff without an agreement. This will add significantly to the current £16bn medicines bill for the NHS.
That’s just the additional taxes. The costs and practicalities of physically moving medicines across customs borders will be a huge barrier to importing medicines, so-called “non-tariff barriers”. These govern how medicine is checked, regulated and transported – essentially guaranteeing the drug that’s injected to you has for example been refrigerated across the entire supply chain so it remains safe. Or is actually the drug on the bottle and not a knock-off imported elsewhere.
If we leave with No Deal we also leave the Customs Union, meaning we will require infrastructure at our border and at every exporting countries border to facilitate movement of medicines between our countries.
Not only will this disrupt and delay the import of finished medicines to our hospitals, it will also disrupt our ability to make medicine in U.K. based pharmaceutical companies like AstraZeneca and GSK. Many of these supply chains are time and temperature sensitive. Delays at borders may break the chain entirely and strategies to circumvent these issues, such as building additional storage space, additional supply routes or moving manufacturers, will only add to the final cost of the medicines passed on to the NHS.
Many drugs we also can’t stockpile for very long to prepare for a No Deal scenario. Insulin is a good example. We only make 1-2000 patients worth of insulin in the U.K. each year, while the national need for the medicine is 400,000 patients, the vast majority imported from Europe. We can’t stockpile insulin for very long, and it requires refrigeration and very careful regulated transport.
So, back to our short answer, availability of medicines will be reduced due to customs delays and supply chain issues, while the cost of these new barriers will be added to the medicines alongside any new tariffs for medicines off the list of WTO traded drugs. If this adds even a conservative 8% to the cost of medicines, that means an additional cost to the U.K. of £1.4bn every year.
What about importing future medicines?
Short answer: Leaving the European Medicines Agency will add to the cost of introducing new medicines to the U.K., deprioritising the U.K. for new drugs and delaying the introduction of state of the art therapies, such as in cancer.
Even if we can secure the supply line for our existing medication, in the short to mid-term we will face difficulties bringing new medications to the U.K. We were previously a key member of the European Medicines Agency, an organisation governed by the European Court of Justice. This Government decided Brexit should include leaving the EMA as it’s under the jurisdiction of the ECJ, although passed a motion this summer to include negotiating to stay in the EMA as a non-member. Obviously in the event of No Deal we are out of this entirely.
Why does this matter?
The process to develop new drugs and medicines is unbelievably expensive and time consuming. New medicines have to first be synthesised, tested on cells, then animal models and then a dose and formulation needs to decided upon. That process alone can take a decade and often doesn’t go anywhere at all. Once a drug is stable and theoretically beneficial to humans it has to go through several phases of trials before it can be approved for routine use by any doctor for a patient. Firstly it’s tested for safety in healthy people- unforeseen severe side effects in humans sometimes occur, for example see the “Elephant Man” trial at Northwick Park Hospital in 2006, where six healthy adults took an experimental drug at this phase of testing and all become critically unwell. Once it passes this safety benchmark the drug is then tested in a small group of people who actually have the disease. This is to demonstrate benefit and look at side effects- again, in the real world this may not work at all. If it passes this stage a much larger trial is organised, usually testing the drug against a placebo or the current best treatment in the strictest conditions possible to avoid any possible corruption of the results. These large trials take years to organise and perform and then publish, cost millions of pounds and again, often don’t go anywhere at all. Even once a drug is in the market we have a phase 4, where data is continuously collected from reported side effects. Sometimes it takes two or more of these trials to prove something actually works.
You can see already what a time-consuming and data-heavy undertaking this is. The EMA’s job is essentially to check every stage of this process, to take into consideration of practicalities like how the drug is given and how much it costs, and then to approve and regulate the medicine for use in EU patients.
Without this function there would be no checks on the drug development process, a process already hugely driven by the need for pharmaceuticals to recoup the money they’ve spent on development.
The EMA streamlines this process for the U.K. by allowing a single member state to undertake the approvals process and then applying that approval to all other members. So a drug approved in France is then licensed for the U.K.
Our subdivision, the Medicines and Healthcare products Regulatory Agency, was a leading part of the EMA. EMA HQ was formerly in London, and employed 900 people, but has already moved away post-Brexit vote. Once we are out of the EMA we will have to approve and license every new drug ourselves. As a much smaller market for drug companies than the EU we will be deprioritised for new drug launches. State of the art developments for conditions like cancer will take longer to come here. This might seem a trivial concern; what possible difference could a year or two make for a single drug?
In the 1960s an accidental discovery created an entirely new cancer drug called Cisplatin. Based on platinum, Cisplatin was found to be revolutionary for the treatment of testicular cancer, a condition that was once fatal in nearly all patients, but is now cured in 90%.
Imagine you have been given a terminal diagnosis, perhaps a year to live, when a new game-changing medicine like Cisplatin is discovered. Those few years delay will make the difference between life or death for you. That’s the reality of the unforeseen consequences of such a colossal decision; the knock-on effects domino everywhere, and real people may actually die as a result.
So, leaving the EMA will add to our own development costs and time requirements to approve medicines and delay state of the art treatment in conditions like cancer, where time can make all the difference.
What about future medicines?
Short answer: We are pulling out of research funding and EU-wide scientific collaborations on health and medicine products, which may hamper potentially life saving medical advances.
The long answer:
In the mid to long term, threatening to pull out of the EU with No Deal has already dropped many U.K. applicants from the EU research fund, Horizon 2020. A half a billion pound fund backing health science and technology, we may never know what good that could’ve done, what avoidable harm will now happen as a result.
So a No Deal scenario will have far reaching and damaging effects across nearly every aspect of current and future medicines in the NHS?
Short answer: Yes
Long answer: Very much so. But it only get worse. See Brexit and the NHS Part 2: Going nuclear.