Hansard

Thank you, convener. The statement on this instrument is slightly longer than the previous one. The Scottish Government and the health departments in the three other nations are committed to legislative change in healthcare regulation to enhance public protection. That is why changes are being made to the General Pharmaceutical Council’s legislation through the order, which is made under the Health Act 1999. The change is to ensure optimal design to provide safety for users of pharmacy services, while facilitating and reducing the barriers to responsible development of practice, innovation and a systematic approach to quality in pharmacy. The General Pharmaceutical Council was established in 2010 with the approval of both the Scottish and United Kingdom Parliaments. The order will make seven key amendments to the legislation governing the GPhC’s processes. The first is to remove the requirement for the GPhC standards for registered pharmacy premises to be set in rules. Those will now be set in a more proportionate and flexible way, without requiring the use of rules that must be formalised in legislation. As a consequence of moving the premises standards out of the rules, they will no longer be included in a statutory instrument that is subject to Privy Council approval and laid before both the UK and Scottish Parliaments. Standards for individual registrants are not subject to such procedures. However, the order does include an explicit and important requirement for the GPhC to consult Scottish ministers, as well as English and Welsh ministers, on changes to pharmacy premises standards. Secondly, the proposals will enable the GPhC to apply the standards to associated premises that are integral to provision of pharmaceutical services as well as to registered premises. That reflects the fact that, in some respects, the traditional model of pharmacy premises being entirely self-contained operations at which all aspects of the retail pharmacy business are carried on is outdated. For some businesses, integral parts of their business operations, such as electronic data storage, may be elsewhere. The third amendment sets out the registration sanctions that the GPhC may use where pharmacy owners breach the standards. The General Pharmaceutical Council already has powers to issue improvement notices where a pharmacy owner breaches the standards for pharmacy premises. The order will mean that breaches of premises standards will be dealt with as a disciplinary matter by the GPhC’s fitness-to-practise committee. Fourthly, the order will introduce the use of interim suspension orders by the GPhC when that is in the public interest, prior to a disqualification decision or a removal decision taking effect after a full hearing of a fitness-to-practise case. Those changes reflect the move to align better the disciplinary provisions for pharmacy owners in respect of breaches of pharmacy premises standards with those for individual registrants. As well as the changes to premises standards, the order makes some adjustments to the GPhC’s powers to set rules around information-gathering obligations. Should the GPhC exercise its amended powers to make rules on information obligations, those changes will be subject to further parliamentary scrutiny. The order provides for a new criminal offence to support enforcement of the rules on information obligations. That provides a backstop should a pharmacy business fail to comply with an improvement notice from the GPhC. The Crown Office and Procurator Fiscal Service has been consulted and has indicated that it is content with that. Fifthly, the order makes changes to the GPhC’s powers to gather information from pharmacy owners so that the regulator will be able to allocate resources proportionately by assessing the risk in a pharmacy. The order also clarifies when the GPhC can require pharmacy owners to provide such information through its rules, and the type of information that is covered. The sixth amendment clarifies what information the GPhC may publish in reports of pharmacy premises inspections and makes it clear that if a report includes personal data it is assumed, for the purposes of data protection requirements, that such information can be published. Finally, the order will make a correction to terminology used in the General Pharmaceutical Council’s procedure on the notification of the death of a pharmacist or pharmacy technician in Scotland. The legislation is changed to refer to a district registrar, rather than the Registrar General, as is currently the case. The Scottish Government considers that the best way to improve consistency, create greater efficiency and simplify professional healthcare regulation would be to introduce a single UK bill covering all professional groups, which would build on the work of the Law Commissions. I understand that the Department of Health has now confirmed that there will not be such a bill in the near future. Instead, the department has proposed a consultation leading to a policy paper on future regulatory policy. The Scottish Government is disappointed at the lack of a bill, but is currently working with the Department of Health to understand the nature and extent of the new proposals. The order will make important changes to allow for optimal design to provide safety for users of pharmacy services, while facilitating and reducing the barriers to the responsible development of practice, innovation and a systematic approach to quality in pharmacy. I am happy to take any questions that members have on the draft order.