Health and Social Care Bill

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.