The status of the United Kingdom post-Brexit and how the life sciences industry might be affected is still up for debate.
When predicting what the United Kingdom’s pending European Union departure will look like, and how it might affect the life sciences industry, the straightforward answer is that no one knows for sure. However, the European Medicines Agency (EMA) – the regulator and monitor for medicines in the EU – has been consistent in its message: upon departure, the United Kingdom will be treated as a “third country” with no special access to the EU market.
Currently, the United Kingdom plays a critical role in the EU drug approval process, with the EMA headquartered in London since its establishment in 1995. But in March 2019, presuming Brexit officially occurs, the EMA will move to Amsterdam, along with more than 900 jobs. This will be a major loss for the United Kingdom, and a challenge for the EMA in terms of resource planning, staffing and administration, as 30 per cent the current EMA workforce may be lost during transition.
Questions about post-Brexit supply disruptions also abound, with the EMA warning of potential access problems for 39 medicines as of September 2018. Although an improvement compared to July, when it was above 100, it’s unlikely the number will reach zero by March 2019. Some actions being taken, such as stockpiling UK product in the European Union, and vice versa, might help prevent disruption immediately after Brexit. But longer-term planning requires certainty of what the post-Brexit landscape looks like.
Britain’s domestic regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has stated: “What is needed to ensure the supply of medicines to British patients is an agreement between the [UK] and the EU27 to allow the free flow of medicines and their components.” While this might seem the best outcome for patients and the industry, it’s important to remind ourselves of the deal the UK government is trying to negotiate, namely one that’s acceptable to its own and supporting Members of Parliament, the voting public, and the European Union.
While questions remain, there are some post-Brexit implications of which we are reasonably sure.
> One License May Not Fit All
Over the last decade, a large proportion of drugs have been approved via the “Centralised Procedure”. Here, the applying pharmaceutical company is granted a single European Union approval, permitting EU-wide product sales. Brexit will change that. Firstly, if the entity that originally applied for and was granted the centralised approval is UK-based, that authorization will need to be transferred to an EU-based entity, since EU-wide approval must be held by an entity established in the European Union. Secondly, if the United Kingdom is no longer part of the European Union, the centralised approval cannot, as far as we know today, be applicable. Although UK approval could possibly be divisible from the centralised approval process, fundamentally two approvals will be needed: one for the United Kingdom and one for the European Union.
> Qualified Persons Must Be in the Right Place
Before drugs can be sold in the European Union, their compliance with quality standards for release into the market must be legally certified by a Qualified Person (QP): an individual qualified to assess that quality compliance. To release product into the European Union, the QP must actually live there. Post-Brexit, companies with QPs residing in the United Kingdom will need to either relocate them to EU countries or replace them with individuals residing in the European Union.
> Prepare for Import/Export Shifts
UK drug companies will need to prepare for a different approach to how products and components enter and leave the country, particularly items crossing several borders within the supply chain. For instance, an active pharmaceutical ingredient (API) might be produced in Germany, but the finished product is manufactured in the United Kingdom. This would require a protocol for importing that API into the United Kingdom. This is doable, as many APIs are currently manufactured outside the European Union and imported for incorporation into finished products. But those imports are based on existing regulations accounting for this, with the EMA approving the non-EU facilities. So to achieve this, there must be certainty about what regulations govern imports into the United Kingdom, and what is acceptable to the European Union for re-exporting finished products.
In the end, though the United Kingdom may be able to replicate every EU protocol, procedure and process for approving, manufacturing and delivering product, this doesn’t mean the European Union needs to accept those products. It all depends on the deal. Ideally, the MHRA wants the United Kingdom to remain part of the European medicines regulatory environment, or for a mutual agreement to be agreed to quickly. But with a potential “hard” or no-deal Brexit on the horizon, the United Kingdom must hope for the best but plan for the worst.