Update on Brexit threat: gaps in the medicines stored, and stockpiling itself causing disruption

Update: We have been posting regularly on medicines supplies as part of the MHRA’s guidance on minimising the risks and dangers of medicines and medical supply stockpiling in the event of a no-deal Brexit and the “Serious Shortage Protocol” (SSP) (e.g. here) and the Department of Health’s contingency plans for a no-deal Brexit (e.g. here), and the fact that the ABPI is concerned that stockpiled products are at risk of being exported to the EU by wholesalers given the drop in the value of sterling (here).

Possible medicine shortages following a no-deal Brexit remains a critical issue.  Two points to raise here are as follows:

  1. Some medicines “cannot be stockpiled”

On 3 April, BBC’s Newsnight highlighted discrepancies between the views of the Department of Health and NHS England on the levels of medication stockpiled. Health Secretary Matthew Hancock has said in parliament that medical suppliers had been asked to stockpile an extra six-weeks’ worth of medicines.  However, a confidential document was shared with Newsnight by NHS England that lists medicines that “cannot be stockpiled” for various reasons, citing capacity problems and “disruption in production” (and presumably shelf-life), but the document has not been made public. Newsnight interviewed consultant neurologist David Nicholl and epilepsy-sufferer Gillian Marshall, who voiced their concerns about the situation, and Mr Nicholl told Newsnight that the problems could have been more easily solved if the Department of Health was more open and transparent about the issue.

The Department of Health since wrote to Newsnight bosses, accusing them of Brexit scaremongering that “could needlessly cause substantial worry to anyone reliant on epilepsy medication”.  Mr Nichol and Ms Marshall then co-wrote a letter to the Guardian stating that they “profoundly disagree” with the accusation of Brexit scaremongering.

Epilepsy Action’s chief executive Philip Lee and the chair of the All Party Parliamentary Group (APPG) on epilepsy, Paula Sherriff, have written to the Health Secretary to demand the sharing of the NHS list, and to know what is being done to protect the people affected.

  1. Is stockpiling in itself causing shortages?

With the ongoing UK parliamentary deadlock and delay to Brexit, anxiety around the risk of supply disruption, and the contingency stockpiling being imposed by the government, it appears that in fact patients are facing shortages already, even ahead of the UK’s departure from the EU.

The Guardian has reported that the stockpiling of medicines has already caused shortages around pharmacies in England.  As a consequence of Brexit, anxiety over drugs shortages has become an issue of critical concern, not least to patients who rely on regular lifesaving drugs being available, such as those suffering from epilepsy or cancer.

Supply issues have caused an official list of “concession” priced medicines (drugs which the NHS will consequently need to pay higher tariffs for) to reach its longest ever, since first being introduced in 2014. The Pharmaceutical Services Negotiating Committee (PSNC), who is responsible for the list, noted that it was a mix of Brexit contingency planning and EU manufacturers’ views of the country as a ‘less attractive market’ behind these problems. Thus, it is community pharmacies that are now exposed to these increasing issues of sourcing generic medicines for patients. This is despite controversial government plans such as the “SSP” that is designed to allow pharmacists to supply different quantities or branded medicines.

The chief executive of PSNC, Simon Dukes, commented: “Community pharmacy teams are continuing to work hard to ensure that all patients receive the medicines they need when they need them, but we are becoming increasingly concerned about the impact that this is having on already busy pharmacy teams”.

Similarly, the Epilepsy Society has reported a significant increase in calls to its helpline in relation to drug shortage queries. Meanwhile, the society is advising patients not to stockpile so as not to inadvertently cause further disruptions to supply levels.

Author

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

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