The UK is set to start the process of leaving the European Union (EU) from 11pm on the 29 March 2019. One of the major concerns of Brexit is the potential impact on the supply of medicines and the regulation of medical and in vitro diagnostic devices.
Medicines and medical technologies are regulated by EU-wide systems under the single market. The scale of trade and supply between the UK and EU is substantial and involves complex chains for product development and delivery. Once the UK leaves the EU, they will no longer be part of this regulatory process. The concern is that without an agreement and continued cooperation between the UK and EU, there would be a detrimental impact on the public.
The EU has developed a set of standards and regulations that determine what medicines are sold within the EU. As it stands, regulation of medicines and medical technology require assessment to ensure a safe, efficacious, high standard of products is placed on the market. Furthermore, processes ensure medicines and medical devices are then strictly monitored to confirm they continue to be safe, effective and fit for purpose. This vigilance is provided under a European-wide framework. For example, the surveillance of medicines under the Pharmacovigilance Risk Assessment Committee can make recommendations on the optimal use of medicines and their restrictions, provide timely decisions and conduct major public health reviews on medicines.
A lack of agreement between the UK and Europe has the potential to lead to duplication of regulatory processes. This could slow the process of development and delivery of medicines and medical devices to a point that could lead to shortages, therefore slowing down access to treatment. In particular, analogue insulins and plasma products, which are mostly imported and biological medicines are vulnerable to shortages and would require cold storage which would need to be prearranged to accommodate any delays en-route.
It is estimated that around half of the assessment work for the regulation of medical devices to be authorised on the EU market occurs in the UK. Capacity for this work across Europe is limited and thus any reduction in this assessment work could limit the availability of those medical devices in healthcare facilities.
Another impact outside of the EU is a delay in the access to new treatments. As an example, Switzerland, which is not a member of the European Medicines Agency (EMA), despite a number of bilateral trade agreements with the EU, experiences on average a delay of 157 days to new treatments compared with the EU. Interestingly, compared with the EU and USA, Australia and Canada experience a delay of around 6 months for access to new medicines.
Collaboration between the UK and EU is important, as the development and distribution of medicines involves many stages with different parts of that process often carried out in different locations/countries. Conversely, in examples where a medicine is developed, manufactured and quality assured in the same country, it is still distributed to multiple countries. A prostate cancer treatment, for example, is developed and manufactured in the UK, but distributed to over 80 other markets worldwide. This involves a number of processing and packing stages before the product is ready for the market.
Trauma packs, required to treat those critically injured, are not always stockpiled due to the contents running past their shelf life when not used. However, from the time of order, these can be flown from the EU to the UK within a very short time frame (hours). Potential customs checks post-Brexit could have an impact that will delay delivery of these trauma packs. This could easily have adverse effects for the treatment of acutely and critically injured patients, particularly in scenarios whereby a large number of people have been injured.
Eisai, which produces anti-epileptic and chemotherapy treatment in Hatfield, Hertfordshire, imports a number of ingredients which are processed in other countries, for completion in the UK. In order to mitigate delays in production due to difficulties or a breakdown in the supply chain, companies may look to relocate outside of the UK in order to facilitate continued production.
These examples highlight the integration and collaboration of production and supply across Europe, the UK and further. The continued availability of medicines relies on the continued cooperation between the UK and EU. To provide some idea of this cooperation and trade, around 37 million patient medication packs are supplied from the UK to the EU every month and conversely 45 million from the EU to the UK. Any change in the complex production and delivery chains will put the supply at risk. This concern over medication shortages leads to concerns over stockpiling.
According to the Pharmaceutical Services Negotiating Committee (PSNC), an increasing number of medications in the UK are in short supply for a variety of possible reasons (e.g. increased cost of raw ingredients, increased demand, fluctuations in exchange rates). This has been a fluctuating problem for a number of years.
There is apprehension that this shortage in supply may be compounded as a result of people stockpiling medication in preparation for Brexit, worried that there will be a negative impact on the supply chain which will delay access to medication.
Some manufacturing companies have made provisions to stockpile certain medicines in order to mitigate any potential delay in delivery of those medicines. In the UK, 1.14 million people require insulin to help control their blood sugars. One UK company produces a specialised form of insulin that only a small group of diabetic patients use. Consequently, the bulk of supply is provided by three main manufacturers; Lilly, Novo Nordisk and Sanofi. According to the British Medical Journal, UK stocks from Novo Nordisk will increase to around 16 weeks, from Sanofi to 14 weeks and Lilly has also confirmed they are making provisions, although further details were not revealed.
It is not possible to stockpile all medicines, such as those with a short half-life which decay rapidly, e.g. radioactive drugs. The supply of radioisotopes are particularly important for diagnosing disease through imaging techniques, treatment of cancers in radiotherapy, pain relief in palliative care and some biochemical analysis. Furthermore, some isotope treatments for cancer, (e.g. iodine-131 used in the treatment of thyroid cancer), rely on a continuous supply of the isotope from Europe, as these products are produced from reactors at designated locations on the continent.
The EU’s Euratom programme, of which the UK has been a member, governs the use and transport of radioactive material and oversees nuclear research. Euratom is legally separate from Europe, but comes under the European Court of Justice. To be a full member requires first being a member of the EU. The UK has stated its intention to leave Euratom and will be replaced with a new agreement with the International Atomic Energy Agency. However, there are concerns surrounding the vulnerability of the supply chain, which could reduce timely access to radioisotopes for medical treatment and restrictions over sharing expertise and weakening collaborations between the EU and UK.
Other Healthcare Considerations
As well as the medical supply and regulation issues and concerns discussed above, there are also other healthcare concerns such as reciprocal healthcare. Under EU law EU citizens visiting or residing in the UK are entitled to healthcare and this also stands for those UK citizens residing in and visiting other EU countries. An example of this is with patients who suffer with chronic kidney disease and require dialysis.
In the UK there are around 29,000 patients who require dialysis three times weekly, which is a process that can take around 4-5 hours each time. Were they to choose to go on holiday to Europe or work there, they could book into a specialist renal unit nearby for dialysis. This arrangement is reciprocal and is covered by the European Health Insurance Card (EHIC). Without this arrangement, travel may be unlikely. With a ‘no-deal’ Brexit, UK citizens may be treated as third country nationals. Dialysis patients may then need to pay for their dialysis which can be around €1000 per week.
Availability of healthcare at the patient side relies on highly skilled healthcare professionals. As in many other industries, staff shortages may become apparent as healthcare trusts may lose some of their EU staff if new restrictions come into play. The UK government has partially accepted a recommendation from the Migration Advisory Committee to set a minimum earning threshold of £30,000 for skilled EU migrants coming to work in the UK. For junior healthcare staff, wages often fall below this (starting salary for healthcare assistants £17,000, nurses, midwives and paramedics £23,000 and junior doctors £27,000).
Research and development is a huge part of healthcare and allows for development in technologies and treatments. This requires a significant amount of collaboration and funding, both of which may be adversely affected if no deal is forged between the EU and UK. These collaborations are also important for multi-disciplinary clinical partnerships in order to share knowledge regarding complex and rare conditions. The European Reference Networks (ERNs) is an example of this, which links many thousands of healthcare professionals across multiple healthcare units, hospitals and countries. The UK is heavily involved in either leading or contributing in these multi-national collaborations.
Due to a lack of deal currently, it is very difficult for healthcare providers and those manufacturers and suppliers of healthcare products to be able to plan effectively for an outcome.
Certain changes have already been implemented to help mitigate any future difficulties, such as the relocation of The European Medicines Agency (EMA) to Amsterdam from Canary Wharf in London, UK. The EMA are responsible for facilitating the development and access to medicines and determines whether medicines can be marketed within the EU. However, it is not clear whether there will be duplication of regulation in the UK.
Ultimately, the extensive integration of the processes that underpin the research, development, marketing and monitoring of medicines and medical products between the EU and UK are incredibly complex, not unlike an ecosystem. It would require an agreement between the EU and UK to facilitate cooperation that allows continued supply and regulation of medicines and medical devices.