Will Brexit affect access to medicines?

Chris Gould, managing director at Active Pharma Ideas Ltd, examines the “Brexit balancing act” between patient access to medicines, industry’s concerns and the complexities facing those undertaking the negotiations.

As recently as November, there were apparently opinions still held by some in the pharmaceutical industry that “Brexit is going to be what it is and we’re not going to worry about it”. While such stoicism has a touch of the Einstein about it (“I never think of the future; it comes soon enough”), it would be worrying if this truly represented preparations for a post-Brexit landscape. It is worth repeating just some of the key areas expected to be impacted: cross-border controls delaying access to medicines, exclusion from EU pharmacovigilance data-sharing (EudraVigilance), reduced later-phase UK clinical trial activity, confusion over product licence reviews and timetabling, increased costs for EU batch release, tariffs, re-classification of the UK as a “third country” for Good Manufacturing Practice (GMP) and second-tier ranking regarding access to new medicines. It is quite a list and something entirely appropriate to be worried about.

The EMA and BEIS Committee

It was perhaps an appropriate coincidence that, also in November, the European Medicines Agency (EMA) issued “Practical Guidance” on the legal consequences for medicinal products following a UK withdrawal from the EU; thirteen critical questions and answers and a further example of value provided by the (UK-based) EMA. It would perhaps not be amiss to survey industry regarding awareness of the guidance and any plans put in place, if nothing else to reassure those relying on access to medicines that a “wait and see” approach was no longer holding sway.

By way of offering some encouragement, industry’s proactivity was in evidence at the House of Commons’ Business, Energy and Industrial Strategy (BEIS) Committee: Leaving the EU: Implications for the Pharmaceutical Industry (December 2017). Key industry representatives included Mike Thompson (chief executive, Association of the British Pharmaceutical Industry (ABPI)); John Smith, (chief executive, Proprietary Association of Great Britain); Paul Fleming, (technical director, British Generic Manufacturers Association) and their clearly-stated overriding concern was “to continue to supply medicines to patients across Europe.” Who would disagree with that? If industry does not have as a paramount concern patient access to medicines (and that means quality, efficacy and pricing as well as availability), then that is certainly something we should all “worry about”.

While evidence to the BEIS Committee demonstrated an industry fully aware of the issues, it was also a fascinating (but at times worrying) insight into an apparent gulf between pharmaceutical industry’s concerns and levels of understanding displayed by the Committee. Whether in Committee members’ apparent misunderstanding that animal testing is not part of batch release testing, or in proposing that production of the UK’s drug requirements be undertaken domestically, or an unawareness of the extent to which drug manufacture has exited the UK, or suggesting lost UK pharmaceutical sales to the EU could be replaced by business to other regions, then it would perhaps not be a surprise were observers to be concerned when it comes down to the specific and detailed Brexit negotiations themselves. Mike Thompson put his finger on it: “Sometimes you can see that the scale of [the] challenge that is facing those who are negotiating arrangements is such that somehow these things could get missed, the officials cannot cope with it”.

Potential impact to consider

To be clear, fundamentally we have a lose-lose situation across Europe. Mike Thompson says “people need to understand that this is not an issue about UK patients versus EU patients. This is about patients across the whole of Europe”. On a monthly basis, 45 million patient packs of medicines produced in Europe and covering approximately 2,200 final products enter the UK while 37 million packs manufactured in the UK (approximately 2,600 final products) are exported to the EU. Consider also UK legal entities and the numbers of EU marketing authorisations they hold: around 400 (approximately 45%) centrally authorised products and almost 6,000 (approximately 10%) covered by decentralised and mutual recognition procedures. Whether in finding ways to remain compliant to current regulations or in adhering to new arrangements, it would be no surprise were the inevitable costs ultimately to be passed on to the public.

"This is not an issue about UK patients versus EU patients. This is about patients across the whole of Europe"

Those in the pharmaceutical industry are well aware that it is the mountain of day-to-day compliance and the myriad of processes, regulations and guidelines that can ultimately dictate the availability of medicines. Therefore, while the BEIS Committee (not unreasonably) is asking whether UK the pharmaceutical industry will remain a centre for innovation or has access to an appropriate talent pool, in fairness, what pre-occupies patients today, and rightly so, is “will I still get my medicines tomorrow?” When the likes of Johnson & Johnson state that tariffs with the EU would make it “extremely challenging … to continue to prioritise the UK in any future supply-chain planning”, no clearer message is needed. The pharmaceutical industry will face an enormous struggle to ensure continued patient access to medicines and, for the moment, getting Brexit negotiators to grasp what is at stake still appears to be part of that effort.

To discuss this article, Chris Gould can be contacted at [email protected]