This week, a group that represents U.K. hospitals and ambulance services has said that its members may run out of drugs if Britain leaves the European Union without an agreement on future relations.
Pharma Logistics IQ wanted to dig deeper into those claims, so we spoke to Elisabethann Wright, Partner at Hogan Lovells and Jane Summerfield Counsel at Hogan Lovells. Both are experts in regulatory issues on EU Life Sciences Law. Here is what Elisabethann and Jane had to say:
You may remember reading Elisabethann's and Jane's article about the extent to which a "no-deal" will lead to immediate shortages. Now, they're back again to answer the following:
- Are suggestions of drug shortages over exaggerated?
- How long will stockpile efforts alleviate drug shortages?
- What kind of patients will be the most at risk?
In terms of broader supply chain issues, the supply chain for many medicines involves moving products or ingredients across the UK-EU border at one or more stages in the manufacturing process. Any increase in tariffs or non-tariff barriers, such as additional paperwork or delays, could disrupt the supply chain and potentially lead to shortages (even if the product meets all regulatory requirements). This risk is particularly acute for the pharmaceutical sector given the complex and time-critical supply chains and the need for many medicines to be kept in cold storage during transport and storage.
Shortages of supply are most likely to occur in relation to those products with a centralised marketing authorisation held by a UK company or authorisation based on mutual recognition involving a UK entity or authorisation. Although this may represent a substantial number of products, in practice, the immediate shortage is more likely to occur in relation to those products with a short shelf life or cold chain requirements.
Are suggestions of Brexit drug shortages over exaggerated?
Given the regulatory procedure that governs marketing authorisation and release of medicinal products in the EU and the potential impacts on the supply chain, shortages of supply of products in the UK in the event of a hard Brexit cannot be excluded. Medicinal products for which marketing authorisation is held in one of the 27 EU Member States may not be so greatly impacted. This is because, unlike products for which a marketing authorisation is currently held in the UK, these will continue to be freely supplied in the EU after Brexit. The potential exception to this would be in relation to products manufactured in the UK for the EU market.
Related: Survey indicates that some companies need to step up efforts to ensure medicine supply in the EU
Equally, from a UK perspective, while the UK is likely to set up a process for issuing national authorisations based on the existing EU authorisation and recognise EU release, there may be practical difficulties in moving products across the border from the EU into the UK.
How long will stockpiling efforts alleviate drug shortages?
If stockpiling proves to be necessary, its effectiveness will depend on the shelf life of the related product and the nature of the issue triggering the shortage. The longer the shelf life of the product the longer the product can be stored. Where the issue is a matter of transferring the marketing authorisation to another company in the EU, stockpiling may be sufficient to cover supplies in the interim period.
Where the issue is transferring manufacturing steps taking place in the UK, such as batch release, stockpiling may not be sufficient to tide companies over until batch release has been moved to an EU site as this is not a quick process. Stockpiling is also not without its challenges as the warehousing facilities used must meet certain regulatory standards. This creates potential cash flow issues given that companies often have to pay suppliers before they have received payment for the product from customers.
What will patients be the most at risk?
Patients who rely on products in relation to which the centralised marketing authorisation is held in the UK, which have a short shelf life or require cold chain storage, and for which there is no alternative treatment authorised in the 27 EU Member States could, potentially, be at most risk.