A Channel 4 documentary aired on Monday (June 17) claimed that thousands of stolen prescription medicines entered the UK supply chain between 2011 and 2014.
The TV programme showed that prescription medicines stolen from hospitals in Italy ended up in unlicensed storage facilities in Eastern Europe before making their way into the UK via parallel imports.
‘Dispatches’ alleged that McKesson Corporation, the owner of Lloyd’s Pharmacy, was “one of the pharmaceutical companies caught up in this illegal trade.”
However, the British Association of European Pharmaceutical Distributors (BAEPD) condemned the ‘Dispatches’ investigation by saying that “the parallel import sector is completely safe and there have been no safety concerns at all since the 2015 investigation referred to in the programme.”
The BAEPD also questioned why the makers of the programme “felt it necessary or relevant to choose to highlight in June 2019 something that happened as a result of the work of organised criminals in 2015 in Italy.”
The documentary also overlooked the fact that since the enforcement of Falsified Medicines Directive in February 2019, all new packs of prescription medicines placed on the market in Europe have been going through stringent safety measures. These include two safety features: a unique barcode and an anti-tamper device.
Responding to a question from Pharmacy Business, McKesson Corporation said: “In 2014 end to end supply chain traceability was much more difficult than it is today and given what we now understand to have happened we would not have been able to have visibility of which packs in each batch might have been part of the stolen consignment.
“Therefore, despite our rigorous processes, we could not have known if we were victims of fraud, but product was quarantined pending the investigation of the MHRA. New measures introduced across the industry this year (FMD) have reduced the risk of fraud significantly and we will continue to support the authorities in finding and prosecuting criminals.”
According to ‘Dispatches’, the Italian medicines regulator, AIFA, investigated a succession of thefts between 2011 and 2014 and found that thousands of critical medicines infiltrated official medical supply chains across Europe including the UK.
The first indication of the UK medical supply chain’s involvement was revealed in March 2014 when tests by a German pharmaceutical wholesaler found that a suspicious batch of Herceptin (a breast cancer drug) was tampered with and had been ineffective. The German firm said a wholesaler in the UK had supplied the medicine.
Channel 4 showed a full list of those stolen medicines bought by UK drug firms licensed to supply the NHS.
“It totals 25 different treatments including the epilepsy drug, Lyrica, as well as other critical medicines for diseases such as prostate cancer, Multiple Sclerosis, arthritis and asthma. More than 10 thousand units of stolen drugs had arrived in Britain by 2014,” a Channel 4 statement said.
‘Dispatches’ sent a Freedom of Information request to the Medicines and Healthcare Products Regulatory Agency (MHRA) asking if any of those drugs were sold to UK pharmacies and dispensed to patients in that period.
According to the programme, the MHRA admitted that “they had no idea what happened to numerous other falsified medicines that were imported into the UK. They simply said they had ‘no trace’ of them. This means they could have been exported back out of the UK but could also have been given to NHS patients.”
After repeated request for a response, the programme claimed, the MHRA Chief Executive, Ian Hudson, told Channel 4: “I take our responsibility very seriously and that is why I have ordered an internal review… to make sure that if there are any areas that need strengthening we address these as a priority.”
Channel 4 said a ‘Dispatches’ source provided names of the licensed wholesalers in the UK who have imported these unsafe medicines.
“And by far the largest purchaser of these falsified drugs is a company called Trident Pharmaceuticals… owned by the US firm that runs one of Britain’s best-known high street chemists, Lloyd’s Pharmacy.”
More than 4,000 units of epilepsy drug, Lyrica, were sold by a Spanish company to Trident in 2014, the programme claimed.
In a statement, the MHRA told Pharmacy Business: “Making sure the medicines people and their families take are acceptably safe and effective is the primary role of the MHRA, and our highest priority.
“Instances where falsified medicines have penetrated the system are very rare and should be considered against the backdrop of more than 1 billion prescription items dispensed annually in England and Wales alone.
“In 2014, following reports of medicines being stolen in Italy and sold to the UK, we undertook an investigation and acted to make sure products on the UK market were safe. We received this information more than a year after the thefts occurred.
“It is important to note these were legitimate medicines, they remain stable at room temperature and the risk to patients was very low.
“In addition to this case, the MHRA has seized falsified medicines from the regulated supply chain only nine times in the last decade, and there is no evidence any of these medicines made it to patients.
The BAEPD, the professional organisation representing 16 licenced suppliers, said the business of parallel imports was “strongly opposed by major pharmaceutical companies.”