Will a "no-deal" Brexit lead to drug shortages?
While supply fears across the UK may be overstated, negotiations will matter...
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The UK may be hit with immediate drug shortages within weeks of leaving the European Union (EU) if a no Brexit deal is reached. Shortages may occur as a result of the European Medicines Agency (EMA) – which oversees manufacturing, clinical trials and marketing authorisation of medicines in the EU – being forced to leave the UK after Brexit.
The EMA, which has been based in London for over two decades, will be relocated to Amsterdam in the wake of the Brexit decision.
According to the EMA, “the UK will become a third country as of 30 March 2019. As a consequence, the UK will no longer be able to engage as (co)-rapporteur for new marketing authorisation applications for which the centralised procedure would finish after 30 March 2019.”
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The UK may find it is in the second or third wave for submissions for new medicines if arrangements are not made. This means British patients may face long delays waiting for new medicine, putting their health at risk.
The EMA is regarded as a major asset by European nations, as it currently supplies medicines for 500 million Europeans overseas and is worth around £200 bn.
How will the UK pharmaceutical industry be affected?
One major way Brexit will affect the UK pharmaceutical industry is licensing. At the moment, the UK can supply pharmaceuticals to all EU member states under a single license. However, when the UK leaves the EU pharmaceutical companies will have to establish EU-based entries.
This will be one of the biggest challenges for pharmaceutical companies in the UK, as they will likely have to juggle between divergent regulatory schemes when trying to sell products in both the UK and the EU.
However, the EMA has a history of signing Mutual Recognition Agreements (MRAs) with non-member states in the past. MRAs aim to facilitate market access and encourage greater international harmonisation of compliance standards while protecting consumer safety.
In practice, MRAs primarily benefit pharmaceutical companies by reducing duplication of inspections and facilitating trade. It achieves this by facilitating cooperation on inspections, exchanging information, and coordinating maintenance activities. Ultimately, this means manufacturers won’t be burdened by excessive re-testing of products in individual EU nations and repeated inspections.
The EU has MRAs with Australia, Canada, Israel, Japan, New Zealand, Switzerland and the United States.
SEE ALSO: EU Clinical trial Regulation: Producing plain language summaries
The UK's position as one of the foremost pharmaceutical centres of innovation may also be at risk. One of the biggest worries for patients and companies alike is that drugs will reach other markets long before they hit British shores. The UK government has expressed it will work towards arrangements for the UK to continue to receive access to new medicines regulated by the EMA.
Other aspects of the pharmaceutical sector that will be affected include the UKs access to scientific funding and how clinical trials will be affected. It is likely that the cost of clinical trials and study times will inflate as a result of working in two disparate markets.
The UK is stockpiling medicines
In July, Secretary of State for Health Matt Hannock announced that the UK was stockpiling drugs in the event of a “no-deal” Brexit.
Mr Hancock said: "We are working right across government to ensure that the health sector and the industry are prepared and that people's health will be safeguarded in the event of a no-deal Brexit.
"This includes the chain of medical supplies, vaccines, medical devices, clinical consumables, blood products. And I have asked the department to work up options for stockpiling by industry. We are working with industry for the potential need for stockpiling in the event of a no-deal Brexit."
NHS England’s chief executive Simon Stevens echoed similar sentiments earlier in the month. He said, "there is immediate planning which the health department, with other parts of government, are undertaking, around securing medicine supply and equipment under different scenarios.
What drugs will be affected the most?
Sir Michael Rawlins, the chair of the Medicines and Healthcare products Regulatory Agency, told the pharmaceutical industry that patients suffering from diabetes will be hit particularly hard.
He said, “We make no insulin in the UK. We import every drop of it. You can’t transport insulin around ordinarily because it must be temperature-controlled. And there are 3.5 million people [with diabetes, some of whom] rely on insulin, not least the Prime Minister.”
Rawlins also said it was important for the UK to have “associate membership” in the EMA so it can have influence in decision making and help facilitate drug imports and exports to the EU.
While it is not completely true the UK produces no insulin, many overseas suppliers have stated that they don’t expect significant problems with supply in the event of a no-deal Brexit.
The future state of the UK pharmaceutical industry will largely rely on the government's ability to negotiate for bilateral trade agreements and RMAs. However, that doesn't always result in quick drug processing.
According to The Guardian, Switzerland starts receiving new drugs an estimated 157 days after its members. Meanwhile, Austrailia and Canada received new drugs between six and 12 months later than in the EU or the United States.
