By Dr. Jonathan Trethowan, Vice President Regulatory and Scientific Policy at PharmaLex
Every month, there are 45 million patient packs of medicines transported from the UK to the EU, and 37 million patient packs transported from the EU to the UK. These products are moved in complex supply chains, but in the case of a ‘no-deal’ Brexit, how can pharma companies ensure this chain remains intact? The European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) have both shared guidance for pharma companies describing systems which can help ensure vital medicines are not stuck at the borders, if there are no transitional arrangements in force to prevent an aftermath post-Brexit, but will they be enough?
On 23 August 2018, the Department of Health and Social Care shared information on a new scheme to ensure a sufficient and seamless supply of medicines in the UK in the event of a no-deal Brexit. The UK government has since taken steps to ensure that an additional six-weeks’ supply of medicines will be available in the UK, on top of the company’s own normal stock levels. But this is posing a considerable challenge for many companies; the sheer amount of storage needed for so much additional stock, particularly for medicines that need refrigeration, is overwhelming for companies with limited available resources to hold such a volume of supply. For the more complex medicines, or those that have a short shelf-life, it might not even be possible to get hold of that volume of supply.
For medicines that require significant travel to reach the UK end-user, the solution relies on the supply chain mechanics. Companies have to consider setting up duplicate sites, possibly liaising with other UK sites to ensure supplies are met. However, many aspects of pharma have not been quick to replicate, and new storage sites and testing labs simply cannot be built overnight.[bctt tweet=”According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the pharma industry has spent millions of pounds to ensure that the supply of medicines post-Brexit is seamless.” username=”pharmamktnet”] The trend for larger pharma companies has been to spend to ensure that the medicine supply chain will not break, setting up internal task forces, often more than two years ago, to manage the challenges internally. However, smaller pharma companies do not have the luxury of the resources needed to create additional teams and are largely waiting until some form of deal is announced.
It remains a top priority for the UK government to reach an agreement with the EU. However, should the UK leave the EU on the 29th March without a ‘deal’, contingency legislation subject to approval by parliament were laid at the end of January. These Regulations set out a comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; for pharmacovigilance; and for clinical trials. So as soon as any clarity comes on the type of deal the UK will have post March 2019, if any, it is expected that many small pharma companies will be looking for solutions.
Changes to the Brexit plans are constant and very fast, making managing the plans a full-time job. Following the advice of the regulators and taking steps to ensure Brexit preparedness, as well as keeping in touch with the political landscape as we head towards March 2019 and into any transition period, will promote the best prospects of being able to maintain a functioning supply chain. However, the outcome of all this to patients is still unclear. Will patients be left without vital medicines, such as insulin and cancer therapies? We will have to wait and see, and hope the worst-case scenario is not the reality.