- Government introduces ban on the “parallel exporting” of certain drugs, starting with 24 medicines
- Move follows industry concerns no-deal Brexit could spark sell-off of stockpiled drugs
- DHSC however insisted move was “unrelated to Brexit”
Ministers have confirmed plans for a ban on the export of certain medicines, starting with a group of 24 drugs including 19 hormone replacement therapy treatments, ahead of the no-deal Brexit deadline at the end of this month.
The move, just 28 days before the October 31 deadline, follows sustained lobbying by drug chiefs who warned a no-deal Brexit could trigger a sell-off of stockpiled drugs by wholesalers looking to profit if the value of the pound drops by so-called “parallel exporting”.
Parallel exporting is a legal practice where wholesalers import medicines for one market, in this case the UK, but then export them for a higher price to another EU market, often to take advantage of currency and price fluctuations.
The Department of Health and Social Care however insisted the new restrictions on so-called parallel exports were “unrelated to Brexit”, because, it said, “there [was] currently no evidence of any supply constraints related to the UK leaving the European Union”.
A senior DHSC official, however, drew a connection between the ban and the stockpiling preparations for a no-deal Brexit yesterday afternoon, although he also insisted it was part of a “business as usual” strategy.
DHSC commercial director Steve Oldfield told the public accounts committee: “[A temporary ban on parallel exports] is something that we have been looking at with industry for quite some time now [because] having gone to these enormous efforts… to build stockpiles and put in place re-routing plans [ahead of the Brexit deadline] the last thing we would want in any circumstances, independent of the Brexit situation, is for products intended for the UK market to be needlessly shipped abroad in the name of arbitrage and profit making.”
Mr Oldfield added a list of affected drugs would be “updated weekly” depending on overall supply, and if “there are actual [parallel] exports taking place or, financially, it looks like it’s very viable to do so”.
The Association of British Pharmaceutical Industry also specifically referenced the benefits for stockpiled drugs when it welcomed the move.
It said: “[The move] means that these stockpiles of medicines which companies have built over previous months are better protected and available for use only by the NHS patients for which they were intended”.
HSJ exclusively revealed on Monday that plans for a parallel exporting ban had been drawn up specifically with a potential no-deal Brexit in mind, but senior figures said officials were mindful to take a “watchful waiting” approach to prevent unintended consequences.
However, the DHSC today has gone a step further, announcing the introduction of new restrictions concerning 24 medicines 19 HRT drugs, as well as all adrenaline auto-injectors and Hepatitis B vaccines.
A DHSC statement said: “[The 19] HRT drugs will be subject to export restrictions to ensure that sufficient alternatives remain available for the HRT drugs that are in short supply. Similar measures are in place in other European countries including France and Spain.
“The [DHSC] has today written to holders of wholesale dealer licences to inform them that the government will exercise its powers to stop parallel exporting of medicines that are needed for UK patients.
“New restrictions for a further five medicines, including all adrenaline auto-injectors and Hepatitis B vaccines, have come into force to safeguard these products for patients.”
Companies which “flout the rules could face stringent action from the Medicines and Healthcare products Regulatory Agency,” the department said, which includes having “their licenses suspended immediately”.
The department has also announced it has also introduced “serious shortage protocols”, a newly introduced practice which allows pharmacists to substitute or restrict prescriptions of certain drugs, for example antidepressant Fluoxetine.
It said: “Fluoxetine 10mg, 30mg and 40mg capsules are currently out of stock but 20mg capsules, tablets and oral solutions remain available in sufficient quantities to mitigate this supply issue during the affected period.
“Therefore, serious shortage protocols have been issued for Fluoxetine 10mg, 30mg and 40mg, allowing pharmacists to switch to another strength or pharmaceutical form of Fluoxetine.”
Patients have the right to refuse the alternative and instead go to their GP to discuss alternative treatments.
There are currently around 360,000 prescriptions of HRT dispensed a month to relieve symptoms of menopause, the department said.
“Currently, some HRT drugs are being parallel exported and the measures announced today will end this practice to protect UK patients and ensure people can continue to access the medicines they need.”
Health and social care secretary Matt Hancock said: “I know how distressing medicine shortages can be for those who rely on drugs like HRT and it’s absolutely crucial patients can always access safe and effective treatments through the NHS.
“The new measures we’re introducing today will help us ensure patients get the medicines they need and the high quality care they deserve.
“Helping the NHS is a priority for this government, and people should be fully reassured that we will always act to ensure that there is an adequate supply of the medicine you need.”
PAC hearing, information obtained by HSJ