Medicines legislation review

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched an informal consultation about future provision for the exemptions to the Medicines Act that allow health professionals, and also others, to sell, supply and administrate medicines. The deadline for responses is 1 November.

The MHRA is considering a major simplification of the current processes, in addition to its specific proposals for each of the current legal provisions. At present, for health professionals, the current mechanism is that changes to specific lists of medicines covered by the exemptions must be made by legislation following consultation. This can be a lengthy process that does not respond quickly to changes in professional practice, which can mean treatment delays for patients. The MHRA is suggesting that instead of the law specifying lists of medicines, and any attached conditions, it would specify the health professionals that are allowed to sell, supply or administer medicines. What they are allowed to sell, supply or administer would be determined by the “relevant statutory regulatory body” – so the current consultative and legislative processes would not be required. The MHRA says this is an idea that needs further discussion and exploration, and is seeking views on it now.

Among the specific proposals is one concerning the administration of a specified list of medicines by anyone – not necessarily a health professional – for the purpose of saving life in an emergency. The MHRA intends to retain the list but is asking for views on possible changes, perhaps including medicines used in cardiac arrest. It is also asking for views on whether there should be a separate provision allowing people who hold the Resuscitation Council’s Advanced Life Support to administer these medicines in emergencies involving cardiac arrest.