Brexit, particularly a no-deal Brexit, has potentially serious consequences for the supply of medicines in the UK. However, medicine shortages are already widespread in the UK and the EU due to long-standing structural problems in the medicines supply chain. These latter issues may overshadow any problems caused by Brexit.
The past few years have seen increasing concern about drug shortages. A globalised procurement process focussed on reducing costs has led to the manufacture of many drugs outside Europe, mainly China and India. This has made the medicines supply chain more fragile, and production problems, contamination of medicines, a lack of local market responsiveness, and over-concentration of production of raw materials in a small number of medicine manufacturers have all contributed.
This fragility is well illustrated by a 2017 explosion at a Chinese factory, which left only one other global supplier of an important antibiotic (piperacillin-tazobactam). There is concern over other current shortages include hormone replacement therapy, anti-epileptic drugs, statins, anti-psychotics, eye-drops, and anti-depressants. UK pharmacists have reported shortages of drugs across most major therapeutic areas.
Increasing the local production of medicines is one proposed solution. For example, France has argued for the creation of public drug manufacturers to supply the EU. Germany has been discussing the repatriation of antibiotic production. Restrictions on parallel trading of medicines within the EU have been seen as another way of preventing shortages within individual states, and the UK has already restricted the export of some medicines with known shortages. This previously happened in Greece during the financial crisis.
The UK government has also introduced a “Serious Shortage Protocol” for drugs with known supply problems. The protocol enables pharmacists to supply alternate forms and strengths of medicines without the need to contact the prescriber. The first such protocol was issued on 3rd October to alleviate the shortages of fluoxetine capsules, unrelated to Brexit; it allows pharmacists to dispense different forms and strengths to fill patients’ prescriptions.
A no-deal Brexit complicates the existing drug shortage problem, with potential border delays. In the short-term this disruption at ports could be serious. A no deal Brexit is predicted to disrupt ferry ports for at least six months, with capacity halved initially.
Brexit has therefore led to further mitigation polices. Wholesalers have been asked to keep rolling six-week stockpiles in case of a no-deal Brexit, and additional warehousing has been bought. Regulatory requirements have been communicated to companies to ensure they can still sell their medicines in the UK in the event of a no deal Brexit, and support has been given to companies to ensure they can meet new custom and border requirements. A £25 million express freight service, using both air and road, has also been created, allowing next-day delivery for small consignments, including temperature-controlled or hazardous products, 48 hr deliveries for large orders, and specialist hand deliver if required.
At a local patient level, further “Serious Shortage Protocols” could be introduced to deal with Brexit-related shortages, including substitution of alternate medicines. Pharmacists are also legally allowed to share medicine stocks between pharmacies, which would help them to manage local stock imbalances.
Despite this, there have been concerns that there is no guarantee that loss of life due to lack of access to medicines will be avoided if there is a no-deal Brexit. The Government’s use of non-disclosure agreements in discussions with some pharmaceutical bodies, to enable honest discussions, has led to concerns about a lack of transparency. Pharmacists seem divided on whether enough has been done to mitigate Brexit-related medicine shortages.
Although the UK media focus has been on the effects in the UK, there are concerns that Brexit may worsen medicine shortages in other member states; for example, in Ireland, where the majority of medicines come from or through the UK. In the event of a no deal Brexit, the political will to ensure the continued movement of medicines into, out of, and across the UK should exist.
As well as the short to medium term logistical and market issues related to Brexit, there are longer term concerns. The European Medicines Evaluation Agency, responsible for the licencing of medicines and continued monitoring of their safety after licensing, has already moved from London to Amsterdam. If manufacturers decide to focus on the EU market, the UK may have reduced access to new innovative medicines. The recent Queen’s speech had proposals to try to maintain access to innovative medicines for patients and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) plans for a no-deal Brexit are in the public domain.
The effects of Brexit, and consequences of attempts to mitigate those effects, are difficult to predict. Any evaluation is complicated by the baseline rates of drug shortages caused by other factors. Media reports of medicine shortages and their causes in the aftermath of Brexit may be influenced by the polarisation seen in the wider Brexit debate. What is clear though, is that even if government attempts to avoid medicine shortages are entirely successful, and supply chains adapt rapidly to post-Brexit changes, the underlying structural causes of medicine shortages will affect the supply of medicines for years to come.