Think back to June 2016, when the UK voted to leave the European Union (EU). What did you imagine would be the greatest changes to come from Brexit? That Britain would be able to ‘take back control’ from European bureaucracy? That holidays on the continent might become more expensive? That the value of the pound was at risk?
It may not have been the first consequence to spring to mind, but Brexit could have a profound impact on the UK’s crucial stock of medicines.
The trade and supply of drugs between the UK and the EU is significant. The European Federation of Pharmaceutical Industries and Associations (EPFIA) estimates that the UK supplies 45 million medicine packs to the EU every month, while 37 million travel in the opposite direction to enter the country.
As a member of the EU – although not for much longer – the UK is part of the single market, a series of trading arrangements that offer free movement of goods, services, people and capital. Once the UK leaves the EU in March 2019, it is likely to lose these benefits.
While the negotiations between EU and UK leaders are still ongoing, many fear
a no-deal Brexit could be catastrophic for the UK supply chain, pharmacists and patients alike.
Impact on the supply chain
The UK heavily relies on the EU for its medicine supplies. In the absence of a favourable, or indeed any, Brexit deal, the supply chain could be severely disrupted, with reduced access to pharmaceutical products.
Generic medicines alone make up 75% of the NHS’s daily medicine use, of which around 80-90% are imported, according to a House of Commons report published in May. In 2016, the UK imported £24.8bn of pharmaceutical products, of which 73% (£18.2bn) were from the EU.
According to Christopher Vowels, head of medical valuation at commercial real estate agency Christie & Co, the UK has benefited from sourcing medicines from Europe due to ‘lower’ prices.
Therefore, crashing out of the EU without a deal could increase the cost of medicines for contractors.
He says: ‘Without a free trade agreement, this could have an impact on drug prices resulting in price increases and reduced gross margins. Fluctuations in [the value of] sterling will also potentially increase the cost of imports, resulting in higher cost pressures on drug suppliers and ultimately retail pharmacies.’
In 2016, the British Government held a referendum that offered people the choice for the country to leave or remain in the EU.
The outcome saw 52% voting for what became known as ‘Brexit’ against 48% wanting to stay.
Britain is set to exit the EU in March 2019, followed by a 21-month transition period provided a deal is reached.
The changeover will see British MPs leave the European Parliament and enable the UK to negotiate its own trade deals and settle the terms of its departure.
For the past two years, UK and EU leaders have tried to reach a deal – with little success thus far.
The four possible Brexit scenarios are:
1 No deal. If the UK does not reach a deal with the EU before the March deadline, it will leave the EU without a transition period and no guarantee that EU citizens’ rights will be protected. The UK will be subject to the same customs rules and commercial taxes as non-EU countries.
2 Hard Brexit. The UK will lose access to the single market, the European court of justice and the customs union. However, the UK might still be able to negotiate some deals, including the free movement of people.
3 Soft Brexit. Under this deal, not many things change, with the UK potentially staying in the single market and customs union.
4 Chequers plan. In September, Prime Minister Theresa May came up with a plan under which the UK stays close to the EU while having more freedom to strike worldwide deals with other countries and being able to end the free movement of people.
Potential harm to patients
Introducing customs barriers in a post-Brexit UK could create a significant challenge for patients, as they might be forced to wait for their medicines to become available. Moreover, any time or temperature sensitive drugs – such as insulin, which must be kept in a fridge between 2°C and 8°C – become unusable when not stored properly or used within an allotted time.
Naturally, this poses a threat for patients who urgently need access to life-saving medicines.
Royal Pharmaceutical Society (RPS) president Ash Soni tells The Pharmacist: ‘If we have a hard Brexit and people need to go through customs or there are issues about where the product is supplied to, we may face greater problems in terms of access [to drugs].
‘That may create a situation where we have greater shortages, with the likelihood that they have an impact on patient care.
‘From the pharmacist point of view, the risk is that people blame us for the problem when we’re obviously not responsible.’
Another difficulty could arise when new European medicines enter the country. Following the Brexit vote, the European Medicines Agency (EMA) – which approves the use of most new medicines sold across the bloc – relocated its London headquarters to Amsterdam.
Under a centralised procedure, new medicines such as gene therapies and cancer treatments are authorised in all EU countries at the same time to ensure that no individual country is left out.
After leaving the EU, Britain might have to submit a marketing authorisation for a new medicine to the EU first and then to UK drug regulator the Medicines and Healthcare products Regulatory Agency (MHRA). This new process could create substantial workload for the MHRA and reduce the number of authorisations it is capable of granting. This in turn could result in extra costs.
‘As a highly regulated industry, the prospect of regulatory divergence from the EMA is the deepest concern for the industry,’ the House of Commons report reads.
‘A divergent regime could see extra costs of £45,000 for each new medicine released in the UK, making the UK an unattractive small market for specialised medicines and risking the loss of access entirely to some products.’
Government stockpiling plans
According to NHS Digital, community pharmacies dispense more than one billion items a year, accounting for more than £17.4bn in spending.
In August, the Government unveiled plans to maintain a ‘sufficient and seamless supply of medicines’ in the UK in the event of a no-deal Brexit. In a letter, health and social care secretary Matt Hancock asked pharmaceutical companies to hold an additional six weeks’ worth of medicines on the top of their usual buffer stocks.
Although the initiative sounds sensible on the surface, pharmacy leaders believe it might not be ambitious enough to meet the UK’s demand. Mr Soni argues that the plan could create concern among the public, who could then start to stockpile medicines.
He says: ‘It’s a good thing that somebody is thinking about what needs to be done to make sure we have sufficient stock for the UK market.
‘But one of the things that happens when you do that is that you create a whole emphasis for panic, and if you create panic it’s likely that what you’re talking about as being a potential becomes reality.
‘That will have real implications on how long the stock will last. It’s all very well to
say you need to have stocks for six weeks. But if you were in a position where the public is concerned they may start to look at increasing what they’re holding. [Then] that [stockpile] doesn’t last six weeks, but four.’
Echoing his comments, the National Pharmacy Association’s (NPA) public affairs manager Gareth Jones adds that we might start seeing ‘significant pressures on pharmacy and demands for prescriptions from GPs’.
He tells The Pharmacist: ‘A six-week stockpile is a positive start but there are further scenarios we need to consider that may occur over the next six months.
‘It’s not [exclusively] about what the manufacturers and wholesalers can do – there is a human element on the front line that we have to deal with. We may need more than simply a six-week stockpile [plan] to deal with that’.
Responding to those concerns, the Department of Health and Social Care (DHSC) says that it will work with stakeholder companies, including those in the supply chain, to ensure stockpiles of drugs in the UK are ‘appropriate to cope with delays that may arise at the border in a post-Brexit UK’.
Rise in prices
The price of generic medicines is affected by the law of supply and demand. When there are more products than demand, the price tends to fall. Likewise, when the demand for a product is high and the supply low, the price increases.
Mike Hewitson, superintendent pharmacist at Bedminster Pharmacy in Dorset, believes that if patients start to buy more medicines, there will be price hikes come the autumn.
‘We’ve seen news footage of patients with diabetes being concerned about insulin supplies and consequently we might start seeing patient behaviour change, which means they could start to order an excess of medicines,’ he says.
‘My concern is that through the autumn, we’ll start to see prices increase and sporadic stock shortages on particular products.’
Over the past few years, community pharmacists have faced various obstacles including stock shortages, the funding cuts and category M clawbacks, leaving some on the brink of collapse.
‘In the midst of uncertainty, we really need clear guidance, flexibility and better staging,’ says Ade Williams, superintendent pharmacist at Bedminster Pharmacy in Bristol.
‘To think about where we are now, with the time scale ahead of us, it begs the questions: how are we going to make sure that the care we provide to patients won’t be impeded while we’re trying to navigate around all these things? Can the system and the sector take on all those things without the financial and administrative assistance to cope with them?’
So far, the sector has managed to adapt to change. But with the effects of Brexit yet to be seen, another question needs to be asked: Do pharmacists have another trick up their sleeves to survive this next difficulty?