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January 2019

Brexit news: New powers for pharmacists, new drug licensing plans

Plans initially intended to cope with medicines shortages in the event of a no deal Brexit could see prescribers’ decisions altered without discussion

Proposals to allow pharmacists to alter or block prescriptions to avoid drug shortages in the event of a no-deal Brexit are now likely to be brought into law regardless of the state of negotiations over leaving the EU.

Legislation has been laid before Parliament and are expected to come into effect next month, on 9 February.

The serious shortage protocols (SSPs) would allow a pharmacist to alter a prescription and dispense an alternative quantity, strength or pharmaceutical form or a generic equivalent of medicines in short supply, without having to discuss it first with the original prescriber. The BMA has warned that this would constitute a new prescription, and without knowing the patient’s history or access to their medical records, could put patients at risk of harm.

It is expected that the powers will only be used in exceptional circumstances, but the health department says: 'Regardless of whether a shortage of a medicine is caused by a “no deal” EU exit or something else, a serious shortage protocol can be a useful tool for managing any mitigating any impact on patients’.

UK to grant automatic drug licenses on Brexit day

Any medicine with a current European Medicines Agency license will automatically be authorised for use in the UK market after Brexit, according to new guidance from the Medicines and Healthcare Products Regulatory Agency (MHRA).

The agency says most human medicines on the UK market already have a UK marketing authorisation and this will be unaffected by Brexit. However, most novel medicines and biosimilars, and some generics, come to market via the EMA’s centralised authorisation route.

To ensure such medicines will continue to be authorised for use in the United Kingdom, all medicines that have been centrally authorised in Europe will automatically be granted UK marketing authorisation on exit day.

If there’s no deal, the UK’s participation in the EU medicines regulatory network (EMRN) would cease and the MHRA would take on the functions currently undertaken by the EU for human medicines on the UK market. The MHRA will have oversight of all pharmacovigilance activities. Currently, risk management plans, reports of suspected adverse drug reactions from the pharmaceutical industry, the majority of periodic safety update reports (PSURs) and post-authorisation safety studies (PASS) are submitted and assessed at EU-level. After Brexit, these will need to be submitted to and assessed by the MHRA.

The MHRA says there will be ‘targeted assessment’ of applications for products containing new active substances or biosimilars which have been submitted to the EMA but have not yet received final approval.

For medical devices, there will be a time-limited period during which devices that have a CE mark from a notified body based in the UK or an EU country will continue to be allowed to be marketed in the UK.

Meanwhile, the Government has advised the pharmaceutical industry to stockpile 6 weeks’ supply of medicines as part of its no-deal planning, and has purchased ‘extra refrigeration capacity’ for medicines that have to be held under cold-chain conditions. Contingency plans also include chartering aircraft to avoid delays at Channel ports.