Medicines’ Legislation Review; PDA wants removal of Section 64 of Medicines Act

PDA tells MHRA that the current Section 64.1 of the Medicines Act is not 'fit for purpose' and was never intended to prosecute pharmacists for unintentional dispensing errors. It submits that it should be removed altogether when legislation is reviewed.

Wed 22nd December 2010 The PDA

In a recent Medicines’ Legislation Review informal consultation, the MHRA stated that its aim was to deliver  proportionate law enforcement when dealing with dispensing errors. The PDA has told the regulatory body that it is opposed to any criminal prosecution being applied for unintentional dispensing errors and that Section 64 which is currently being used by law enforcers for this purpose should be removed altogether. Read the PDA’s full response below.

The PDA provided the defence strategy and legal support for the case of Elizabeth Lee. This was the case which initially resulted in a suspended prison sentence being given to a pharmacist who made an unintentional dispensing error. This case raised serious concerns, both within the profession and even in parliament about inappropriate and outdated legislation. The defence strategy ultimately succeeded in getting the Royal Courts of Appeal to provide clarification on the construction of Section 85.5 of the Medicines Act and the conviction of Elizabeth Lee under section 85.5 was overturned. However, the Crown Prosecution Service succeeded in getting the 85.5 offence substituted with an offence under section 64.1 of the Medicines Act. This still left Elizabeth Lee with a conviction and a criminal record.

The effect of these developments is that pharmacy is still governed by outdated and inappropriate legislation and we believe that it is no longer fit for purpose. We contend that Section 64.1 in particular was never drafted to deal with unintentional dispensing errors; it was designed to deal with intentional adulteration of medicinal products usually for the purposes of profiteering.

The case of Elizabeth Lee has led to defensive practice emerging within the profession – especially in the community pharmacy setting – as many pharmacists have now come to contemplate the reality of what was thought up until now to be a remote risk of prosecution. At a time when the healthcare needs of the nation demand that practitioners deliver an ever wider range of services, such defensive practice is detrimental to both the patient’s and the profession’s interests.

The MHRA review seeks to deliver proportionate handling of dispensing errors through enforcement of legislation; however, we contend that the unintentional dispensing error should never be handled as a criminal matter but that instead it should be dealt with as a professional regulatory matter. The only time that the Crown Prosecution Service and the judicial system should be involved is if there is a case of gross negligence manslaughter or other similar case to answer.

This approach would leave pharmacy in a similar situation to that currently faced by other healthcare practitioners. If a doctor or nurse is associated with the death of a patient during their care, the Crown Prosecution Service investigates to establish whether criminal negligence manslaughter has been committed. If there is no such evidence, they refer the case to the professional regulator. However, this is not the case in pharmacy where the CPS continues with the prosecution albeit through Medicines Act legislation.

We therefore submit that legislation already exists to deal with serious cases of negligence especially if serious harm or death results. We conclude that Section 64.1 serves no useful purpose in respect of either an unintentional or even a negligent dispensing error.

Furthermore, we believe that even if there is a case involving criminal intent and fraud involving adulteration of medicines for the purposes of profiteering, then there are many appropriate legal mechanisms to prosecute such matters aside from the use of Section 64.1 of the Medicines Act. These would include the Consumer Protection Act and also General Products Safety legislation.


We have confined our response to this informal consultation by considering one specific aspect of the Medicines Act which currently still acts as a dangerous impediment to pharmacy practice. We argue that Section 64.1 should be dropped altogether from the Medicines Act as there is significant alternative legislation to protect the public interest which would more appropriately be used in the event of criminal negligence or intentional fraud.

We believe that the proper remedy for the commission of unintentional dispensing errors is that it should be handled as a professional regulatory matter.

The Pharmacists' Defence Association is a company limited by guarantee. Registered in England; Company No 4746656.

The Pharmacists' Defence Association is an appointed representative in respect of insurance mediation activities only of
The Pharmacy Insurance Agency Limited which is registered in England and Wales under company number 2591975
and is authorised and regulated by the Financial Conduct Authority (Register No 307063)

The PDA Union is recognised by the Certification Officer as an independent trade union.

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