A medical device company has been fined £2.2m after admitting that it sold medical equipment to the NHS without proper approval.
The UK’s Independent Medical Journal (IMJ) reported that The Medicines and Healthcare Products Regulatory Agency (MHRA) had ruled that The Thermo Fisher Scientific Company breached rules by failing to register its sales to the Royal Free NHS Trust, and also that it breached its duty of care by failing “to take reasonable steps to ensure that the company’s products meet the requirements of the regulatory regime”.
The MHRA had previously found that the firm failed to inform customers that it did not need to register with the regulator, despite its claim that it had done so.
The company’s chief executive, Ian Simpson, was given a 10-month prison sentence for failing to take reasonable measures to ensure the safety of its products.
Mr Simpson, who also pleaded guilty to two other charges, said he regretted his actions.
The case came to light after the IJM asked for an investigation into the company, and received a letter from the MHRA.
The letter said that The Pharma-Rights Alliance had “found the company to be in breach of regulatory requirements in respect of the sale of medical devices to the public health service.”
The MHRC said that it was unable to comment on individual cases, but said that its regulator, the Health Protection Agency, was investigating.
A spokesperson for The Pharma Rights Alliance said that the organisation would be appealing the decision.
In a statement, the Medicines, Healthcare Products and Cosmetics Association (MHPCA), said: “We have been in contact with the MHRC and will be appealing to the courts to overturn this judgement.”
The MHQA is a regulatory body that sets standards for health and safety in the supply of medical products to the general public and is committed to upholding those standards.
“The Medicines & Healthcare Products Association ( MHPA ), a trade body for medical devices, said that although it had a number of members, “most of the members are registered and approved by the MHQAs regulatory framework, and all the members abide by its rules and regulations”.
It said that MHQAS had a “zero tolerance” policy for “illegal, unethical or misleading” business practices.
A spokeswoman for the MHSA said:”We are deeply concerned that a company like The Pharma Rights Alliance may have broken a number safety and regulatory requirements that are already in place.
We will be consulting with the company and taking the necessary steps to get it back in line.
“Mr Simpson is due to appear at the Old Bailey on Monday.