Question to the Department of Health and Social Care:

To ask His Majesty's Government how many fines they have issued in the past year for failure to report medicines shortages.

Suppliers are legally responsible for reporting disruptions and discontinuations through the Health Service Products (Provision and Disclosure of Information) Regulations 2018 (the ‘Information Regulations’), this includes a provision that allows the Department to fine a company if they fail to report. To date the Department has not issued any fines.

Reporting of potential supply issues is critical, enabling the Department to complete a thorough risk assessment of the severity of the issue. Alongside legal requirements, the Department also has an online reporting tool, known as the Discontinuations and Shortages portal, launched in October 2020, which suppliers can use to notify the Department. When reporting issues are identified we work with companies to understand how we can help enable them to inform the Department of any future supply issues. While the majority of suppliers report disruption in a timely manner, not all do so, and this can impede our ability to mitigate patient risk. As part of our obligations under the ‘Information Regulations’, we regularly review and consider the need to amend provisions. We plan to consult on how to ensure we receive sufficient information to put in place effective mitigations for supply issues, and we will also be reviewing the penalties for not complying with legal reporting requirements to ensure that these support the timely reporting of supply issues.