The following is an extract from Hansard from the Lords’ debate on the decriminalisation of dispensing errors.
Amendment 297
Moved by ; Lord Clement-Jones
After Clause 294, insert the following new Clause-
“Contravention of section 64 of the Medicines Act 1968: due diligence defence
In section 67 of the Medicines Act 1968 (offences under Part 3), after subsection (2) insert-
“(2A) But it is a defence for a person charged with an offence under subsection (2) in respect of a contravention of section 64 to show that the person exercised all due diligence to avoid committing the offence.””
Lord Clement-Jones:
My Lords, in moving Amendment 297, I shall speak also to Amendment 301. First, I declare an interest as chairman of the council of the School of Pharmacy, University of London. For the avoidance of doubt from the outset, I will not press these amendments.
In Committee, I moved an amendment to provide a due diligence defence to the currently strict liability criminal offence committed under Section 64 of the Medicines Act 1968. This has the potential to operate very harshly on those making single errors dispensing medicines, whether in retail or hospital pharmacies. The intent of the original amendment was to remove the injustice that pharmacists and some others among healthcare professionals face criminalisation through single dispensing errors.
It was also very importantly designed to increase patient safety by removing barriers to a learning culture within the pharmacy profession and to ensure that pharmacists who wish to declare a dispensing error in the interests of patient safety are not penalised. The formulation of a defence, which gains universal acceptance among the pharmacy profession, has however proved more difficult than originally anticipated. Although the regulator, the General Pharmaceutical Council, has been supportive of the proposed amendment, there is as yet no consensus with the pharmacy professional bodies as to the best way legally of formulating a defence that meets these objectives.
There is, however, a unanimous view among professional pharmacy bodies that it would be better not to amend the Act at this juncture in this way but to wait for the full review of offences under the Medicines Act due to be carried out by the Medicines and Healthcare products Regulatory Agency, the MHRA. There have of course been helpful discussions to this effect with the chief pharmacist and his colleagues at the department, and agreement, as I understand it, that we should go forward on this basis.
In this context, it would extremely helpful for all concerned if the Minister could confirm the timetable for the scoping of the sanctions and penalties in medicines legislation review to be carried out by the MHRA and any other details of the review that he can give at the present time, such as the procedure, the timetable, and the involvement of the regulator-the GPhC-and professional bodies.
Although this is not directly within the gift of the Minister, it would be extremely helpful if he could also indicate that the department will engage with the DPP and the Crown Prosecution Service to encourage them in the mean time to engage with the profession and the regulator in reviewing the prosecution guidelines for offences under the Medicines Act. That would be extremely welcome to all those concerned in the profession. I beg to move.
Lord Hunt of Kings Heath:
I must say that I am surprised that the noble Lord moved this amendment. He told me yesterday that he was not going to and did not have the courtesy to tell me that today he is. The amendment raises a very interesting question. No doubt we will be very interested to hear the response of the noble Earl, Lord Howe. He might perhaps add the membership of the review team to the details of the review.
Earl Howe:
My Lords, I am very grateful to my noble friend, to whom I should like to pay a particular tribute for his work to bring interested parties together on this important issue to see whether a common view could be found on a practical way forward.
Both I and my ministerial colleagues are determined to ensure that we address the concerns of pharmacists and registered pharmacy technicians about the risk of prosecution for inadvertent as opposed to wilful or reckless dispensing errors. We and the profession want to see a learning culture that encourages the reporting of dispensing errors so that any helpful lessons can be learnt. Equally, we must make sure that any changes we introduce continue to give patients protection under the law and do not in any way compromise patient safety. It was therefore disappointing to me that, after a great deal of dialogue in recent months, there has not been a sufficient measure of agreement to proceed on a specific legislative change at this time. I have to accept the reality of that, despite everyone’s best efforts.
I turn to the next steps in resolving this issue. The Medicines and Healthcare products Regulatory Agency intends to carry out a review of sanctions and penalties in medicines legislation. This will extend well beyond issues that have arisen in dispensing errors, but the review will look at the respective roles of medicines legislation and professional regulation in this area. It will also enable other important stakeholders, such as patients and the public, to contribute. Indeed, I have no doubt that the MHRA will encourage all interested parties to have their say. The possible role of a due diligence defence will remain on the table for consideration in the wider context of this review. It is worth stressing this point as due diligence defences have a well established usage in association with strict liability offences in many areas of legislation, including medicines legislation.
This will be a significant and wide-ranging review, and it is important to ensure that it covers the right ground. The MHRA would aim to scope the coverage, conduct and timetable of the review by September 2012. I will just say to the noble Lord, Lord Hunt, that membership of the review team will be established as part of the scoping work. As part of that scoping, we will look at the feasibility of including an independent element to the conduct of the review as it relates to the challenging task of achieving a suitable balance between the roles of medicines legislation and professional regulation.
In the mean time, we are encouraged by the guidance to government prosecutors in England and Wales issued by the Crown Prosecution Service in June 2010 and by more recent dialogue. It is clear from this that the CPS takes very seriously the issue of judging the question of whether there is a public interest in mounting a prosecution. I am sure, too, that the Director of Public Prosecutions will read tonight’s debate and consider very carefully the comments that have been made. We will certainly look to encourage any opportunity for further constructive dialogue on the issue.
It is important to emphasise that all parties have their part to play in developing a solution and a culture that protects the public while encouraging and supporting pharmacists and pharmacy technicians to report, and learn from, mistakes-which in turn improves patient safety. In this regard, we see the role of the professional leadership bodies for pharmacists and pharmacy technicians as critical; and we would encourage pharmacists and pharmacy technicians to ensure that they are well placed to respond to the professional regulator in a manner that makes the public’s interest central to any future discussion.
In conclusion, I reiterate my thanks to my noble friend for enabling this afternoon’s debate on the issue. I hope he will be reassured by the undertakings I have given that, despite the current lack of consensus, we will continue to work with interested parties on a way forward.
Lord Clement-Jones:
My Lords, I thank the Minister for that reply. First, let me say to the noble Lord, Lord Hunt, that no discourtesy at all was intended. We may have misunderstood each other. I never intended to press the amendment, but of course wished to raise the issue in order to get a response from the Minister about the way forward in the absence of this amendment being incorporated in the Bill. I apologise if I inadvertently misled the noble Lord.
We all have the same purpose, which is, as the Minister said, to encourage a learning culture within the profession so that it no longer has hanging over it a lack of a defence to the absolute liability in Section 64 of the Medicines Act; and, it may well be, other aspects of the Act as well, which no doubt will be uncovered as the MHRA carries on its work. I, too, share the Minister’s disappointment that we were not able to agree a suitable solution between the department, the regulator and the pharmacy profession.
I thank the Minister for showing us the way forward with the MHRA review of the scoping that will be done by September 2012. I very much hope that, as he said, the DPP will consider this debate very carefully, and that he will respond favourably and engage in a review of the guidelines. I also reiterate the Minister’s wish and hope that the profession will engage very closely with the MHRA in this review and in any review of the guidelines by the Crown Prosecution Service. In the mean time, I beg leave to withdraw the amendment.