What does ‘no-deal’ mean for the supply of medicines?

Following today’s defeat of the Prime Minister’s Brexit deal, many thousands of people up and down the UK will be extremely worried. Not because of the economic or political implications, but because their wellbeing and potentially even their life is dependent on a consistent supply of medicine.

So is it fear mongering to suggest a no-deal Brexit could threaten the supply of critical medicines in the UK?

Well the problem seems to be that nobody really knows, and faced with uncertainty of any kind, nervousness is understandable when it comes to medicine.

Stockpiles: 6-weeks or 6-months?

Illustrating the scale of confusion are conflicting messages from the Department of Health. Since Q3 and Q4 2018, the Department issued official guidance to all pharmaceutical companies in the UK, indicating that they should stockpile an additional 6-weeks of each of their medicines above and beyond their planned allocations for 2019. This gave companies time to adjust and do their best to act on the government’s guidance. But further confusion was created last month by the Health Secretary himself, Matt Hancock, who suggested that the movement of medicines between Dover and Calais could be “significantly reduced” for up to 6-months. This leaves pharmaceutical companies with an unenviable tightrope to walk… 6-weeks, 6-months or somewhere in-between?

In this scenario, each company is essentially faced with three possible outcomes with regards to supply. Firstly, they get it right, they stockpile enough medicine to smooth out any supply inconsistencies until things return to normal. Secondly, they oversupply, they stockpile too much medicine and much of the product remains unused. Thirdly, they undersupply, the company doesn’t have a large enough stockpile to smooth out supply inconsistencies and the people who rely on their medicines turn to alternative companies (if possible) or, in the worst case scenario, go without their medicine.

An unenviable tightrope

Both the second (oversupply) and third (undersupply) scenarios are extremely concerning for pharmaceutical companies. As with any company that provides a physical product, that product represents an investment. The industry is constantly trying to balance supply versus demand, as unused medicines that exceed their use by date must be disposed of. With many modern medicines, a single months supply for a single person can represent an investment of thousands of pounds – when you scale this up you get a sense of the commercial challenge this represents. If, however, companies under supply critical medicines, people’s health could be at risk – and no company in the UK wants to be complicit in that scenario.

“It is more accurate to say that monoclonal antibodies are ‘grown’ than ‘made’ as they are biological molecules which are produced in highly specialised laboratory environments.”

In the context of this issue, it is important to recognise that the production of many modern medicines is far more complex than most people assume. Let’s take human monoclonal antibodies as an example. This is a class of medicines that end with the suffix -umab and are used to treat cancer and autoimmune diseases such as rheumatoid arthritis, Crohn’s and ulcerative colitis, to name a few. It is more accurate to say that monoclonal antibodies are ‘grown’ than ‘made’ as they are biological molecules which are produced in highly specialised laboratory environments. This means they usually take several months to manufacture and as such it is extremely difficult for companies making these medicines to react to short-term political environments and unpredictable demands.

The reality of the current situation is that while a shortage of critical medicines is unlikely, a consistent supply is far from guaranteed and for people whose lives depend on that consistent supply, nervousness is justified.

Official information on the UK pharmaceutical industries position on Brexit can be found via The Association of British Pharmaceutical Industry (ABPI) – http://abpi.org.uk