“You can expand the shelf life of salad, but you can’t do that with medicines — which are unique and vulnerable.”
So says Ash Soni, president of the Royal Pharmaceutical Society, arguing that the fragility of the UK medicines supply chain in the event of a no-deal Brexit is not something that is widely understood.
Fears of a no-deal Brexit impacting the UK’s drugs supply have been growing for some time, since Jeremy Hunt, the then health and social care secretary, admitted in January 2018 that the supply of some cancer drugs could be disrupted if the UK leaves the EU at the end of March 2019 with no agreement on a future relationship in place.
The parallel drug importers’ trade association has told The Pharmaceutical Journal it has been asked by the Department of Health and Social Care (DHSC) whether its members have extra storage space in their warehouses for refrigerated products; and the major pharmaceutical firms are taking steps to create “additional buffer stocks” of drugs that could run short after Brexit.
The Company Chemists’ Association (CCA), which represents the big high street pharmacy chains, says it is working within the community pharmacy sector to ensure ’business as usual’ for access to medicines.
But despite these efforts, there is a feeling that pharmacy has yet to be properly involved as part of the effort to ensure a continuous and uninterrupted medicines supply.
Hunt’s successor, Matt Hancock, told MPs on the House of Commons Health Select Committee on 24 July 2018 that the government was starting to take steps to stockpile drugs in the event of no-deal Brexit. He said the DHSC was also focusing on the “importance of a continuous supply of medicines that have a short shelf life — so some of the medicines most difficult to provide in a no-deal scenario, where there is difficult access through ports, will need to be flown in.”
And Sir Michael Rawlins, chair of the Medicines and Healthcare products Regulatory Agency, the UK drugs safety watchdog, told The Pharmaceutical Journal in an exclusive interview that millions of patients — especially those who rely on insulin which is barely manufactured in the UK — were at risk, too.
Disruption to the supply chain is one of the ways that patients could be seriously disadvantaged
“Disruption to the supply chain is one of the ways that patients could be seriously disadvantaged,” he said. “It could be a reality if we don’t get our act together. We can’t suddenly start manufacturing insulin — it’s got to be sorted, no question.”
Source: Jon Barlow
The Pharmaceutical Services Negotiating Committee, which negotiates on behalf of community pharmacy, has responded to these concerns by creating a Community Pharmacy Brexit Forum, made up of pharmacy organisations to liaise with the government, share advice and information about any medicines shortages and to keep the supply chain going. It is due to hold its first meeting in September 2018, just six months before the UK’s planned exit from the EU.
Manufacturers, wholesalers and distributors have also taken things into their own hands in recent weeks. The Healthcare Distribution Association, which represents businesses that supply medicines, medical devices and healthcare services, revealed it is in talks with the government about building up a “buffer stock” if there is no deal. And Mike Thompson, chief executive officer of the Association of the British Pharmaceutical Industry, which represents research-based biopharmaceutical companies in the UK, says drug manufacturers have taken similar steps to create “in excess of buffer stocks”.
“We are working with our members to understand where the pressure points are and to make sure that we do everything we can to continue to supply medicines to patients across the whole of Europe,” he says.
Drug manufacturers have also said they are taking action, with Sanofi announcing that it is increasing its UK stocks by an extra 4 weeks’ worth, allowing for a 14-week supply of medicines based on its own “internal assumptions of potential delays around a no-deal scenario”.
While many may feel reassured that protecting the medicines supply chain — especially in the UK — is finally getting the attention it deserves, there is an undercurrent of alarm and nervousness, particularly in community pharmacy, about being caught up in a race against time and the potential disaster a no-deal Brexit could be for their business and their patients.
Soni says: “I have been quite shocked that there has been no discussion about the potential impact of a no-deal on the supply chain. There’s been no consultation with community pharmacy. I was talking about six weeks ago to the president of the Faculty of Pharmaceutical Medicine — who sits on the Brexit group which is looking at supply issues — who told me they had been looking at supply from the perspective of what happens if a patient can’t get their normal medicine — what could I prescribe instead? They were looking at it through the wrong lens. It’s only now that the issue is being given the urgency it deserves.”
Despite the looming crisis, there is a reluctance from some community pharmacy organisations to speak out
Despite the looming crisis, there is a reluctance from some community pharmacy organisations to speak out, possibly worried about fuelling patient anxiety. This could, in turn, trigger individuals stockpiling drugs — which would then create artificial shortages. Perhaps there are other concerns that they could be accused of being part of the much-reported ‘project fear’.
Helga Mangion is policy manager at the National Pharmacy Association — the membership group for community pharmacists. She told The Pharmaceutical Journal: “We think it’s unhelpful to speculate where there are so many uncertainties around Brexit and we are working to get an ideal scenario for our members in order to ensure a timely supply of medicines to patients.
“Community pharmacists, and everyone in the medicines supply chain, need certainty as soon as possible in order to prepare appropriately to meet patient need. The onus is now on the government to achieve that certainty. Whatever the scenario that finally emerges, pharmacists will put the needs of patients first, as they always do.”
Source: National Pharmacy Association (NPA)
The CCA says it is not in a position to discuss specific contingency plans, but Malcolm Harrison, chief executive of the CCA, adds: “Access to medicines is of critical importance to the UK: we encourage all parties to do all they can so that [the public feels that] a ‘business as usual’ approach is being taken. The CCA is working with partners within the community pharmacy sector so that we can play our part in achieving this.”
Celesio, parent company of LloydsPharmacy, gave a similar response when asked what its contingency plans were in case of a no-deal Brexit: “Whilst negotiations continue, the effects of Brexit are not clear, but we are monitoring developments and planning for a number of different scenarios. Regardless of the outcome, we will help our customers to deal with the transition and work with the NHS and other partners to ensure that patients are not negatively impacted.”
Richard Freudenberg is chief executive of the European Association of Euro-Pharmaceutical Companies, the membership organisation that represents parallel importers. Its members trade in medicines across the EU and European Economic Area. Freudenberg says the organisation has already been asked by the DHSC to see if it can help with its contingency plans. It has been asked whether its members have any excess warehouse space or storage space in licensed premises for refrigerated products, and if there is any chance they can increase their buying capacity now to build up stock.
“We are happy to help, but we can only buy in the single market — so that’s the 27 member states and members of the EEA; we can only buy what excess product is available,” he says.
“I can’t tell you any of the details because I am now consulting our members and I have promised the Department to get to them by the end of summer, sometime in September 2018.”
More than 37 million medicine packs are imported into the UK from the rest of the EU every month, while 45 million packs are exported.
So what is the size of the drugs market between the UK and the rest of the EU, and which drugs are at risk of being in short supply?
According to figures from the European Federation of Pharmaceutical Industries and Associations, which represents 33 national pharmacy associations and 40 leading pharmaceutical companies, more than 37 million medicine packs are imported into the UK from the rest of the EU each month, while 45 million packs are exported.
Insulin is clearly at risk, as Rawlins told The Pharmaceutical Journal, because so little is manufactured in the UK. The Brexit Health Alliance, which includes the Academy of Medical Royal Colleges, the NHS Confederation and many other health-related organisations, believes patient access to a prostate cancer medicine, which it has not named, is another drug likely to be at high risk of shortages.
Soni says you could add to the list any drugs that need to be refrigerated, which would include vaccines, inhalers that need to be kept temperature-controlled, eye drops and controlled drugs. “There are a raft of different medicines,” he says. “I’ve never known so many fridge lines — my two fridges are rammed with stock now just to keep up with day-to-day stock.”
Source: Simon Wright Photography / The Pharmaceutical Journal
The CCA predicts that any drug with “complex storage needs and high-volume usage” would be vulnerable.
Freudenberg is confident, however, that irrespective of how many drugs are at risk of shortages, if the government’s contingency plans are put in place, the supply chain should remain intact and there will be no impact on community pharmacy in the UK. He says: “I don’t see what community pharmacists can do. Most are supplied by a single wholesaler and more than three-quarters are supplied by the ‘direct to pharmacy’ model. So I can’t see there is any way that a community pharmacist will be able to move more product than they normally get.
They do have the option to buy more product on the grey market — buying from a source other than the manufacturer. And there are about 2,000 wholesalers working in the grey market and that is the only way that pharmacists can increase their stock, but I don’t see that being the solution because there isn’t the volume of product available from that source. Then there are issues with storage and cash flow.”
Historically, we get paid once drugs are dispensed — if they apply the same principle to drugs which we stockpile, they will bust the system
Soni sees things from a different perspective, suggesting community pharmacies could help with extra storage space and easily clear a shelf in store to stockpile medicines if called upon, but the crucial issue is cost.
“The government might say ‘pharmacy will hold the drugs for us’, but that only works if they pay us for the medicines,” he says. “Historically, we get paid once drugs are dispensed — if they apply the same principle to drugs which we stockpile, they will bust the system.”
Whatever contingency plans are put in place by the central government, community pharmacists will be at the sharp end if stock shortages mean they are unable to dispense certain medicines to patients after the end of March 2019.
“At the moment, we are used to dealing with shortages, but they are a small number and for a limited amount of time. But what we are talking about here is on a scale which is unprecedented,” says Soni.
“For the time being there is nothing we can do. It’s about keeping your eyes and ears open, and as we get closer to Brexit there is likely to be more information and greater clarity. Pharmacists have got to hold their nerve, and more importantly, they have to persuade the public to hold their nerve too.”
This article was amended on 22 August 2018 to reflect the fact that the CCA has not said it has held discussions with government to ensure provision of medicines after Brexit.
Panel 1: What else could be at risk from a no-deal Brexit?
Medicines regulation: MPs instructed the government in July 2018 to make the UK’s participation in the European medicines regulatory network a negotiating priority when the UK leaves the EU. The government said early in the Brexit negotiation process that it would seek continued membership of the European Medicines Agency (EMA), and that it would be prepared to pay to do so, but without a deal this could all come to nothing. The EMA has already shifted the responsibility for evaluating 370 medicines away from The Medicines and Healthcare products Regulatory Agency.
Pharmacy workforce: Malcolm Harrison has warned that Brexit could play a part in a shortage of pharmacists in the near future. He highlighted figures from the General Pharmaceutical Council that showed an 80% fall in the number of pharmacists from the European Economic Area registering with the Council. Exiting the EU without any agreement may be a further disincentive for EU pharmacists to practise in the UK.
A proposal to continue cross-border recognition of seven professional groups, including pharmacists, included in the government’s white paper on Brexit, could fall away if there is no deal on leaving.
Falsified medicines: The Falsified Medicines Directive (FMD) comes into force just six weeks before the planned date of the UK’s departure from the EU. The chair of the UK FMD working group for community pharmacy has already warned that community pharmacies should proceed to implementation “with caution”, in part at least because of uncertainty over “how long the FMD system will be needed”.
The UK could lose access to all EU networks, including the European Medicines Verification System, after Brexit.
Research cooperation: Research could also be affected, with a senior figure at pharmaceutical firm AstraZeneca telling the House of Lords Science and Technology Committee that the UK’s population was too small to produce the scientific talent needed to maintain the country’s eminent position in pharmaceutical innovation, but that scientists were reluctant to take jobs here because of the uncertainty surrounding Brexit.