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Regulatory Focus™ > News Articles > 2019 > 10 > With Drug Shortages in Mind, UK Looks to Block Some Parallel Exports

With Drug Shortages in Mind, UK Looks to Block Some Parallel Exports

Posted 03 October 2019 | By Zachary Brennan 

With Drug Shortages in Mind, UK Looks to Block Some Parallel Exports

As part of efforts to prevent drug shortages ahead of a possible no-deal Brexit, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday published a list of 24 medicines that cannot be parallel exported from the UK.

The list includes drugs like the hormone therapies estradiol and levonorgestrel, the antiviral oseltamivir, adrenaline, the blood thinner rivaroxaban and the high blood pressure medicine prazosin, among others.
The reason why the UK has decided to restrict these medicines from parallel export is that the practice can create or worsen supply shortages.

“Parallel export is the practice of buying medicines already placed on the market in the UK in order to sell them in another country in the European Economic Area (EEA) where they are repackaged and relabelled in accordance with the requirements of the importing country,” Steve Oldfield, chief commercial officer of the UK’s Department of Health and Social Care explains in a letter sent Thursday to wholesalers.

“Anyone holding a wholesale dealer licence can parallel export a medicine but in practice parallel export is undertaken by a small group of licence holders. Sometimes the parallel export of a medicine can lead to or exacerbate supply shortages in the exporting country. Shortages of medicines can pose serious risks to patients and lead to increased difficulty of sourcing medicines and mitigating risks to patients,” he adds.

If wholesale license holders supply one of the listed medicines for parallel export, the letter explains that they would be in breach of regulation 43(2), which may lead to regulatory action by the MHRA.

“This could include (i) an immediate suspension of the licence or suspension of the supply of certain products under the licence and/or (ii) a 28-day notice proposing to vary the licence to restrict or prevent export activity as necessary,” the letter says.

The letter also notes that any stocks of medicines included in the parallel export restriction may also not be “withheld or ‘hoarded’ and doing so may similarly lead to regulatory action being taken.”

The Association of the British Pharmaceutical Industry praised the move. Director Rick Greville said: “The decision to take precautionary measures to protect medicines supplies will 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 patients for which they were intended.”

Medicines that cannot be parallel exported from the UK
 

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