Circle Health Group Limited (Formerly BMI Healthcare) has been fined £100,000 for unauthorised storage of human tissue at an unlicensed premises, contrary to the Human Tissue Act 2004.
The London-based company was handed the fine today, Monday 23 October 2023, at Worcester Crown Court, after pleading guilty to the offences in July.
The conviction follows a lengthy and detailed investigation by the Human Tissue Authority, West Mercia Police and West Midlands Police.
The investigation identified that BMI Edgbaston illegally stored human tissue samples over a period of at least 11 years, collected under the direction of a surgeon working at the hospital, without holding an appropriate Human Tissue Authority licence.
The hospital subsequently allowed the human tissue to be removed from the hospital, again under the direction of the surgeon, to a private address which was also not covered by an appropriate licence.
The group failed to make any reasonable enquiries whether such a licence existed. The inappropriate storage of human tissue at the hospital was previously highlighted in both 2015 and 2019 following an internal audit but the response by management at the hospital was found to be wholly inadequate in addressing failings and it was evident there was a poor understanding and interpretation of the Human Tissue Act.
Following the investigation, the Crown Prosecution Service authorised West Mercia Police to charge the group in April 2023.
Detective Inspector Mark Walters, senior investigating officer for West Mercia Police, said: “This is an unusual case and prosecutions under the Human Tissue Act are rare which indicates the severity of the failings by the Circle Health Group in this matter.
“The Human Tissue Act 2004 is in place to provide safeguards and standards as to how institutions retain, store and dispose of an individual’s human tissue. It is essential that the requirements of the act are adhered to by everyone at all times. The serious breach of the licencing requirements by the Circle Health Group over a prolonged period of time undermines the trust placed in the hospital by patients and their families that their human tissue would be dealt with appropriately, ethically and in accordance with the law.
“I am pleased with today’s outcome and hope that this case will act as a reminder to all those involved in the storage, retention and disposal of human tissue of the importance of adhering to the standards and requirements of the Human Tissue Act.”
Dr Colin Sullivan, Chief Executive of the Human Tissue Authority added: “I welcome the conclusion of this case and the successful prosecution of Circle Health Group Limited. This sends a strong message to anyone wanting to use human tissue that they must follow the law.
“The Human Tissue Act 2004 has been in place for nearly 20 years and must be followed. We advise anyone who wants to use human tissue to check our website (hta.gov.uk) and contact us if they are not clear about what they need to do.”
