It's getting serious
Last month I said “forget Brexit”. Since then, I think the only way I could have forgotten Brexit would be to have emigrated, or at least gone on a very long holiday. The on/off voting in Parliament, entrenched positions, the backstop, the preface “let me be perfectly clear”, which signals that what will follow will be anything but. Deal or no deal, bring back Noel Edmonds.
I’m not an expert, and apparently we’ve had enough of them anyway, but it seems to me that the UK is a significantly important manufacturing base for pharmaceuticals, as well as being a supply hub for 60 million people. So this is what concerns me, particularly about the lack of clarity of what is actually going to happen when we leave, and I’m not just thinking about import/export here.
For the long term, the bigger impact than delays at the UK border to trucks carrying medicines, will come from the UK finding itself, by accident or design, outside the European medicines regulatory processes. This could create risks for patients in terms of delays to approvals for new and existing medicines if this results in additional bureaucratic burdens. The inclusion and alignment of the UK within the manufacturing, regulatory testing and release of drugs mechanisms of the EU, as moderated by the European Medicines Agency (EMA), has avoided duplication here of processes which have taken place there. If we now find ourselves outside, this is likely to add significant cost, and time through the administrative impact, furthering risking supply issues to the UK market. And that’s if the choice of a market of 400 million people, regulated by the EMA, versus a 60 million people UK market, regulated by a revamped MHRA, does not push us down the queue for manufacturers seeking regulatory approval for their new products in the first place.
I hope the UK Government recognises the need for a cooperative and inclusive approach, which we have been instrumental in building over the past 40 years – and the EMA was based here, in Canary Wharf, until it upped sticks for Amsterdam the other day – is vital to ensure continued engagement and investment by manufacturers in the UK market, and the flow of innovative medicines into the NHS for patients.
Of course, the border issues are going to be important in maintaining supply and access to medicines, and does need to be addressed rapidly to ensure certainty and enable planning for any adverse eventualities that may occur. Logistics are one thing, but the tariffs that may result from the negotiations (or non-negotiations) could also delay access too. If that were not bad enough, the impact of over-onerous customs procedures could deter and disincentivise further investment. Of particular concern for me would be access to short-dated products for use in emergency situations such as a public health crisis.
Also, and again for the longer term, the UK currently supports innovation and rapid access to new medicines through its intellectual property regime and special national drug funds. It is vital that the UK continues to act as a base for research and development, which supports NHS access to the medicines patients need. Ensuring that the UK can continue to attract the expertise and skills we need from other parts of the world to support vital research is a must. The industry stands on the brink of major advances in genomic medicines, personalised healthcare and novel drug delivery system design. UKplc cannot miss out on the opportunities continued investment could mean for the UK-based industry.
Lastly, while there have been no major announcements to date, unless I’ve missed them (like you, I’m busy trying to keep the show on the road, and I did despite shortages last month), given that the European market is much larger than the UK, there is a danger that manufacturers will prioritise EU sites, inside the single market, over possible UK sites outside it, when they are looking and investment, and they are already putting millions into mitigating the current uncertainties.
All of these are massive risks, for access to medicines. It is vital that the development, manufacturing and regulation of pharmaceuticals maintains a high level of cooperation with the EU and its existing structures, wherever we sit after the end of March, for the sake of the safe and timely provision of medicines to patients in the future.
Maybe this time next month we’ll know. But I wouldn’t bet on it.
Outsider is a community pharmacist
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