With less than 200 days until the UK leaves the European Union, the government is in talks with pharmaceutical companies to stockpile medicine in the event of a no-deal Brexit.
The pharmaceutical industry had already taken a blow, with the European Medicines Agency (EMA) set to move out of London to Amsterdam in March 2019. Some 30% of staff are expected to be lost in the move.
Currently, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) can bid for contracts from the EMA to evaluate drugs, but will no longer be able to do this after Brexit.
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Health Secretary Matt Hancock said on Thursday: “The medicine delivery to the hospitals should continue unhindered. Their existing contracts need to be fulfilled. The task is for the pharmaceutical companies to ensure that enough supplies are available to ensure that can happen.
“That means stockpiling in the case of medicines that come over the land border but it also means, in some cases, being prepared, if necessary to switch the supply from land to air, so that we can fly in, for instance, the very short shelf-life medicines.
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"We are talking to pharmaceutical industry about what extra costs the government will cover.”
In 2016, 48% of the UK's pharmaceutical exports went to the EU, and 73% of its imports came from the EU.
But what noticeable effects of a no-deal Brexit have on medicine, and the people that need to take it? And how much are companies really stockpiling?
Mike Thompson, the Chief Executive of the Association of the British Pharmaceutical Industry answers some common questions.
How does the UK currently work with the EU on medicines?
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“If you look at the [Chequers] White Paper, the UK has said that they would like to have continued cooperation with Europe on medicines. We would like the Medicines and Healthcare Products Regulatory Agency to stay part of the European Medicine Agency, even though that agency is moving to Amsterdam," says Thompson.
“It makes a lot of sense to stay together. In terms of safety, there is an early warning system that alerts companies to side effects which doctors pick up. At the moment we have one single database with Europe, which really helps particularly for rare diseases - there is a small number of patients, therefore the bigger the scale of the survey the more effective it would be.
“Secondly, if we look at things like infection and disease control, we have one early warning database that we all use so in the event of the next Zika-type virus that comes through, it is much better if we all work together.
“Again, particularly from Europe’s perspective, a lot of people come to Europe through Heathrow so it doesn’t make any sense for the UK to have a separate database which is not connected to the current European database.
"Hats off to the UK government who looked at all of this and said ‘we can see that in medicines it is actually better for patients and public health if we continue to work together and that is our offer'.”
Why is medicine being stockpiled?
“We have been working closely with the UK Government for a long time and we advise building stocks. We would call it buffer stocks. All companies have buffer stocks because we cannot afford to run out of medicine," Thompson explains.
“This is pretty standard practice for us. The question is, what sort of additional stocks do we need to transfer our medicines over the border? Nobody seems to know what that would be and the UK Government have helpfully issued guidance.
“They think an additional six weeks of stocks should do it and we are taking that into account, and asking every company to work through their supply chain and ensure the stock they are holding would give them enough stock to manage a delay through a border of up to six weeks.”
How much medicine could be affected?
“There are 45 million packs of medicines a month manufactured in the UK which are delivered to the continent of Europe - that gives you an idea of the scale of what we are talking about. This is as much an issue for patients in Europe as it is for patients in the UK.
We have a very integrated supply chain across Europe - I think the UK government came to the right conclusion which is actually in this sector, it makes sense for us to continue to work together.
“One company told me they had to check over 15,000 supply lines so that they can continue to manufacture effectively. There are some medicines that are more complex and we are looking to focus on those; we have a plan B which would then be to airlift medicines where necessary.
“We are used to airlifting things if we have a problem in our supply chain. For clinical trials we do a lot of airlifting, because there is a very short time between agreement for a patient to go on a trial and getting those materials to them.
What would happen in a no-deal Brexit?
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“Our focus in the first instance is always on the supply of medicines. In a no-deal situation, the UK will not be part of the EMA, it will be a stand-alone regulator and that starts to have all other sorts of consequences which I think are not helpful.
“It means we won’t participate in some of the research programmes - Horizon 2020 is a good example of a research programme in which UK institutions have done very well in terms of participation. We won’t be participating in that in short term, it will have to be renegotiated.
“We need to work hard to make sure that medicines will come to the UK as well as going to the EU, even though that may be later. Companies will look to licence their new medicine in a market of 500 million [in the EU] before they look to market it in a market of 60 million [in the UK]. There are some challenges in UK patients getting access to new medicines in comparison to their counterparts in Europe.
“That is the challenge that we have to overcome - I think all the no-deal stuff really emphasises why we want a deal. Medicine cooperation is in the best interest of patients and public health across Europe.”
What are the extra costs and who will be paying for them?
“There are significant costs. Pfizer published in their quarterly reports that they've made a provision of a $100 million to cover their Brexit costs. That is just one company. We estimate that the cost of an extra six weeks [of medicine] across the industry is hundreds of millions of pounds.
“What we are asking the government to do, is not to cover that cost, but the cost of some additional warehouse space. That is a much smaller amount of money and we are in discussions for that. I think it is in their interests to do that; it will reduce the risk because there are some manufacturers who work on very tight budgets for whom this is a huge challenge.
“It is in the interests of the Department of Health to ensure that they have played their part in helping to make that warehousing available so that we don’t have issues anywhere across the supply of medicines.”