Stephen O'Brien (Shadow Minister, Health; Eddisbury, Conservative)

I beg to move, That the clause be read a Second time.

The new clause proposes to decriminalise pharmaceutical errors, so that single dispensing mistakes are treated in the same way as errors in other medical professions. It is grossly disproportionate that errors committed by pharmacists are automatically deemed criminal offences, when those of doctors and other medical professionals are not.

My reasons for moving this clause are twofold. First, the criminalisation of pharmaceutical errors stems from antiquated legislation that bears little relevance to modern pharmaceutical practices. The Medicines Act 1968 has not been adjusted to accommodate the progress made in pharmaceutical services over the past 40 or so years. Secondly, the legislation fits rather uncomfortably with the Government’s intention to expand the role of the pharmacist to include enhanced services such as smoking cessation clinics. If pharmacists are to take on increased responsibilities that extend their contact with patients, they should be entitled to the same safeguards as the medical profession.

I am sure that the Minister will be well aware of the history and background to all this—the representations to the Royal Pharmaceutical Society, in particular in the case of Elizabeth Lee who, despite doing all the right things in trying to atone for her mistake, none the less ended up with a prison sentence. Most dispensing will take place where humans have to make the final decisions about the counting and handing out of medications, so human error will be a factor.

Equally, the Minister will be aware that early-day motion 1561 has been tabled and has attracted a number of signatures. Therefore, in the context of the positive role of pharmacists, I hope that the Minister will be able to look favourably on this proposed clause. I think the Government are already signalling that they want to move in this direction, and we have long had the Medicines and Healthcare products Regulatory Agency. While the Government are consolidating and reviewing the legislation, this clause—with these positive signs of potential change—gives the Minister an opportunity to take prompt action. I hope that he will therefore support it.

Sandra Gidley (Romsey, Liberal Democrat)

I need to declare an interest, being a pharmacist by profession. This proposed new clause is well meant, and I do not envy the Minister having this issue on his desk. It is useful that so many Members have signed EDM 1561, showing general support for this. Elizabeth Lee now has a suspended sentence; she did not go to jail. She made a single error; the problem was not so much that it was catastrophic but, more fundamentally, that having discovered that she had made an error, she got in touch with the patient and found that they had been taken to hospital.

The court case found that there was absolutely no interrelationship between the dispensing error and the patient’s ultimate death. Nevertheless, due to existing legislation, the judge felt duty-bound to give the woman a suspended sentence. Not to put too fine a point on it, Elizabeth Lee has withdrawn from the pharmaceutical register and will never practise as a pharmacist again. Her career is in ruins.

However, at the heart of the matter is also a patient safety issue. When a mistake is made or nearly made, that mistake can be learned from. Mistakes are often  picked up before they do any harm or the patient takes the medicine, and most chemists have some mechanism for reporting such errors. I can recall working for a company that introduced error reporting. Everybody was suspicious at first, but it then became apparent that there were a couple of common errors that everybody was making, and changes were made that had a big impact on reducing the number of mistakes.

The problem with the case of Elizabeth Lee is that it has made every pharmacist frightened of admitting to an error, so we stand to lose such learning experiences. There may be occasions in future when products become mixed up. People in such situations are only human. If the current anomaly is allowed to continue, we will go back a stage, because people will not be open and honest. That is ultimately a bigger danger to the patient than the potential consequences of amending the legislation, despite the concerns in some quarters about doing so.

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.

Stephen O'Brien (Shadow Minister, Health; Eddisbury, Conservative)

I am grateful to the Minister for making it absolutely clear that a change in the law is needed. I take seriously the view that moving from poor legislation to on-the-hoof legislation could carry more risk. I am sure that the fact that he has made that commitment will be of some comfort to pharmaceutical professionals as well as those who represent them and those who signed early-day motion 1561. I would simply urge the Minister to proceed with speed in the area. I beg to ask leave to withdraw the clause.