New Clause 11
Health Bill [Lords]
3:45 pm
Mike O'Brien (Minister of State (Health Services), Department of Health; North Warwickshire, Labour)
There is a problem, but the clause is not the place to resolve it. The Government recognise the concerns that the provision in the Medicines Act 1968 could lead to the criminal prosecution of pharmacists who make a single error in dispensing medicine to a patient, and I know that the issue has caused concerns to pharmacy professional bodies.
There are, however, circumstances in which sanctions should be available when the requirement to sell only medicines that are
“of the nature or quality demanded by the purchaser”
is seriously and knowingly contravened. The sanction may, for example, be used to protect against the sale of medicines to the public that are clearly counterfeit or have been adulterated. We must ensure that the Act provides sufficient enforcement powers and sanctions to deal with such serious risks to public health, so I cannot accept the new clause.
However, some change to the law is necessary to ensure that cases of genuine clinical error, such as dispensing the wrong medicine without a degree of culpability, are dealt with proportionately. A full review of the Medicines Act 1968 is already under way by the Medicines and Healthcare products Regulatory Agency, the Department of Health agency responsible for medicines regulation. The review will include consideration of possible changes to the law to clarify the issue. The MHRA is working closely with the Royal Pharmaceutical Society and other stakeholders to ensure that the law provides the necessary safeguards for the public while being proportionate in dealing with instances of clinical error.
The chief pharmacist appeared before the all-party pharmacy group on 16 June to discuss that very issue, as did the presidents of the Royal Pharmaceutical Society, the Pharmacists’ Defence Association and the National Pharmacy Association. They all agreed that a detailed examination of the legislation was needed, coupled with an exploration with the Crown Prosecution Service whether guidance could be issued in the interim on how to proceed with potential cases. Indeed, the president of the Royal Pharmaceutical Society said that
“we should not rush to replace poor regulation with on-the-hoof regulation”.
The review of the Medicines Act 1968 provides the opportunity to work with the full range of stakeholders affected by the provision and to create a legislative framework that is comprehensive, comprehensible and fit for current purpose.