According to Lynne Byers, executive director at NSF International, both the UK and European Union (EU) sides of the pharmaceutical industry stand to lose if no deal can be agreed during Brexit discussions.
The scale of trade occurring between the UK and the EU means that many of the larger pharma companies have moved quickly to create a surplus of medicines in the UK, as well as investing significant sums – £40m ($52m) in the case of AstraZeneca – to ensure a smooth transition.
Byers highlighted just how significant the trade occurring between the UK and the EU is: “There are 45 million packs that go from the UK to the EU and there are 37 million that come the other way, every month. [There’s] a massive question as to how that trade will keep flowing," Byers told delegates at CPhI Worldwide this month.
As can be seen from these figures, the balance of the trade is skewed towards the UK supplying the EU with more packs of medicine. Due to these circumstances, Byers suggested that EU industry faces just as much uncertainty as those companies based in the UK.
The potential for this trade to suddenly cease is actually far more probable than may have been considered by the industry and the reason why hinges on the ‘transition period’, Byers explained
The agreed transition period onto 2020 allows industry breathing space to adapt to the changes of a post-Brexit trading environment by keeping existing regulation until the end of this period.
However, Byers observed a crucial detail of this transition deal: “Most importantly, and this is something many companies have missed, everyone is assuming this transition period will happen, but it will only happen if a deal is done – if there's no deal, there's no transition period. This would have some serious implications for the pharmaceutical industry.”
This potentiality has led to the UK government arriving at drastic solutions to plug potential medicine gaps, such as using airfreight to transport products with short shelf lives.
Leaving little time
If no deal is agreed in the coming months, the UK will have to act rapidly to create and support infrastructure that the pharma industry relies on to ensure the safety of medicines – with Byers providing the examples of the implementation of serialization regulation and ensuring there is a functional pharmacovigilance system.
“EudraVigilance is the system that captures all of the adverse events in Europe and the UK will no longer have access to once it leaves the EU. What the UK has said is that by March of next year, it is going to develop its own system – which, in that timeframe, is a real challenge”, Byers cautioned.
When Byers was asked what the expectations are for the timeline of Brexit negotiations, she suggested that the “mood music” surrounding the discussions pointed towards a conclusion by November, but added that this could extend into December.
Even on the building blocks of medicines, active pharmaceutical ingredients (APIs), there is a degree of uncertainty for UK manufacturers, we were told.
“In Europe, if [APIs are] coming from outside of Europe, then there's a 'white list' that some countries are on. The question is whether the EU is going to put the UK on this list?
“Hopefully yes, but this could also take some time to arrange. Maybe no, in which case then there'll have to be special certification for every batch of APIs coming from the UK,” said Byers.
Time is a significant factor to allow industry to prepare for post-Brexit changes; however, Byers warned that a deal being agree does not mean that it will be enacted immediately – both the EU and the UK parliaments will have to ratify the agreement, which will take time.
The European Medicines Agency did find during its own investigation that an increasing number of pharma companies are prepared for the various post-Brexit eventualities but there are still 39 medicines for which future supply remains a question mark.
As negotiations slip later into the year, Byers noted that this may make finalising any deal ahead of the March deadline extremely difficult, and means the urgency for such medicines to be secured becomes ever greater.
