The regulations – which are expected to “come into force later this summer” – “will ensure that the government obtains information from all manufacturers and importers” in relation to “special medicinal products”, health minister Lord O’Shaughnessy said in a written response in the House of Lords last month (May 22).

Lord O’Shaughnessy was responding to a written question from Baroness Masham of Ilton, who asked him what plans the government has in relation to remuneration of specials.

The health minister said the information obtained from manufacturers and importers “will make the reimbursement arrangements for the most commonly used special medicinal products more robust”.

“However, where there are concerns about an individual price, it will also enable us to request from suppliers information on the costs of supplying a product,” he added.

Boots and Alliance allegations

Last month, Walgreens Boots Alliance “firmly rejected” allegations that its companies Boots and Alliance Healthcare colluded to overcharge the NHS for a specific specials product. According to an investigation by The Times, between 2013 and 2017 Boots ordered cocaine mouthwash – used to treat patients with severe sores caused by chemotherapy – “at least five times” from Alliance Healthcare, charging between £1,843 and £3,220 on each occasion.

Responding to The Times investigation, the Department of Health and Social Care (DH) told C+D that the new regulations “will provide [the DH] with more transparency about prices and costs in the supply chain, to inform any further action”.

However, “it is for NHS England to progress action if it thinks fraud has been committed”.

As part of its consultation on the costs of branded medicines – which ran from August to October 2017 – the DH recognised “that there was a need for clarity on the treatment of unlicensed medicines and 'specials' (ie an unlicensed, named-patient medicine) and companies providing aseptic preparation services to the NHS (ie sterile, compounding services)” to avoid “double-charging”.