Question to the Department of Health and Social Care:

To ask Her Majesty’s Government which organisation has responsibility for ensuring implementation and compliance with the Medicines and Healthcare products Regulatory Agency guidance, which states that biologic medicines should be prescribed by brand name and tracked by batch number.

In 2008, the Medicines and Healthcare products Regulatory Agency (MHRA) issued best practice guidance on the prescribing of biological products. This advised:

“All biosimilar products are prescription only medicines (POM). When prescribing biological products, it is good practice to use the brand name. This will ensure that automatic substitution of a biosimilar product does not occur when the medicine is dispensed by the pharmacist. Products (biosimilar and reference) that have the same international non-proprietary name (INN) are not to be presumed identical for the reasons given above.”

The MHRA does not have responsibility for monitoring the compliance of healthcare professionals with its prescribing guidance. The responsibility for prescribing rests with the practitioner who has clinical responsibility for their patient's care and we would expect practitioners to take any relevant guidance into account when making their prescribing decisions. Practitioner professional bodies also have a role in setting out best practice to their members.