UK Bans Parallel Export Of 24 Drugs As Brexit Nears
The move should help protect industry’s no-deal stockpiles
Executive Summary
The UK government has drawn up a list of 24 medicines that must not be parallel exported to EU countries. The move is widely seen as a way of protecting stockpiles of drugs that have been built up to compensate for supply chain problems in the event of a no-deal Brexit.
In an unprecedented move, the UK government has warned pharmaceutical wholesalers not to parallel export 24 medicines, mainly hormone replacement therapy but also other products like adrenaline auto-injectors and hepatitis B vaccines, in an effort to tackle drug shortages as the Brexit date draws nearer. Companies flouting the rules could face "stringent action" from the UK regulator, the MHRA.
The Department of Health and Social Care said on 3 October that the restrictions would “stop some medicine wholesalers from taking advantage of the present circumstances by parallel exporting – where companies buy medicines meant for UK patients and sell on for a higher price in another country, potentially causing or aggravating supply problems.”
HRT and other products have been in short supply for various reasons, such as manufacturing problems, and the DHSC said that the list of products subject to the export ban was not related to Brexit.
But the drafting of the list at this time is widely seen as a response to industry concerns that the stockpiles of medicines built up in preparation for a no-deal exit could be vulnerable to parallel exporting to other EU countries in the run-up to the 31 October Brexit date.
Rick Greville, director of supply chain at the Association of the British Pharmaceutical Industry, said the decision to take precautionary measures to protect medicines supplies would be “very much welcomed by our members. It means that these stockpiles of medicines which companies have built over previous months are better protected and available for use only by the NHS [National Health Service] patients for which they were intended.”
He added that companies could now work with the department to identify any “problem areas.”
The British Medical Association also welcomed the move. Farah Jameel of the BMA's GP committee said: “It’s vital that patients are protected from medicine shortages as much as possible, particularly as we head into the winter months – when pressure on NHS services is most intense – and uncertainty grows around the fallout of a potential no-deal Brexit.”
This is the first time that the UK government has imposed a parallel export ban. In a letter to wholesalers, the DHSC said that several EU member states had implemented measures to prevent the parallel export of specific medicines "where this is necessary to meet the needs of patients in their country. Those measures are based on Article 81 of EU Directive 2001/83/EC which has been transposed into UK legislation in relation to wholesale dealers at regulation 43(2) of the Human Medicines Regulations 2012."
The list of medicines subject to the ban comprises 19 HRT products as well as hepatitis B vaccine, adrenaline auto-injector, oseltamivir, prazosin and rivaroxaban. The DHSC warned that any companies found to be parallel exporting a medicine on the list would be “in breach of the Human Medicines Regulations 2012, which may lead to regulatory action by the MHRA, including the possibility of having their license suspended immediately.”
Together with the export restrictions, the DHSC has also introduced “serious shortage protocols” (SSPs) for the antidepressant drug fluoxetine (originator Prozac), under which pharmacists can supply an alternative strength or form of the products to patients who are prescribed one of three strengths that are currently in short supply.
Brexit-Related Or Not?
The department said around 360,000 prescriptions of HRT are dispensed each month to relieve symptoms of the menopause, and that currently "some HRT drugs are being parallel exported. The new restrictions will end this practice to ensure people can still access the medicines they need."
It insisted the ban was "unrelated to Brexit, as there is currently no evidence of any supply constraints related to the UK leaving the EU.” It pointed out that the medicine supply chain was “complex and highly regulated, so problems can arise for a variety of reasons, including manufacturing issues or problems with raw ingredients.”
However, it added that the export restrictions and the SSPs “provide the Department with additional tools to our robust, multi-layered preparations for exiting the EU that can be utilised should there be any Brexit-related disruption.”
The department noted that medicines will be “added to the list if they are needed to meet the needs of UK patients,” if they are “being parallel exported or at risk of parallel export,” and if this results in or contributes to a shortage.
Stockpiles At Risk
Industry has been warning for some time that the additional six-week medicine stockpiles requested by the government as buffer stocks in the event of shortages due to a no-deal Brexit could themselves be at risk, and had been calling for a temporary ban on parallel exports.
In some cases stockpiles are held in companies’ own warehouses, but in other cases they will have been sold on to wholesalers and distributors.
The concern is that unscrupulous traders may take advantage of the fall in the value of the pound as Brexit approaches to sell stocks to other EU countries where prices are higher, a practice that is allowed under EU rules.
Products could presumably be added to the list of medicines subject to the ban if there was evidence they were being exported from stockpiles.
Fluoxetine Serious Shortage Protocols
SSPs are another tool that the government introduced ostensibly as a hedge against routine shortages but which was widely seen as a way to address potential shortages resulting from a no-deal Brexit. The protocols allow pharmacists to supply a different product than the one prescribed without having to check with the prescribing physician, thereby saving time and effort for the NHS.
Fluoxetine 10mg, 30mg and 40mg capsules are currently out of stock in the UK, but 20mg capsules, tablets and oral solutions remain available in sufficient quantities to mitigate the supply issue during the affected period, the DHSC said. “Therefore, SSPs have been issued for Fluoxetine 10mg, 30mg and 40mg, allowing pharmacists to switch to another strength or pharmaceutical form of Fluoxetine.”
Dispensers can only make the switch during the validity of the SSP, with the patient’s consent and where appropriate. They would also be advised in the SSP to supply one of the alternatives available as set out in each protocol.