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A report and new draft bill on the regulation of healthcare professionals was published by the Law Commission of England and Wales, the Scottish Law Commission and the Northern Ireland Law Commission (the ‘law commissions’) on April 2, 2014. In light of the Francis Report, which investigated the failings in patient treatment at Mid-Staffordshire NHS Foundation Trust, the law commissions’ remit was to review existing UK law relating to the regulation of healthcare professionals.

Nine healthcare regulatory bodies, including the General Pharmaceutical Council (GPhC) and Pharmaceutical Society of Northern Ireland, were within the remit of the review. The law commissions’ recommendations aim to create “a clear, modern and effective” legal framework for the regulation of health and social care professionals.

While the GPhC, which is strongly supportive of these aims, is a recently established healthcare regulator and therefore may argue that it already operates within a clear, modern and effective legal framework, there will still be some significant changes to how pharmacists are regulated if the draft bill is adopted.

The draft bill creates a single legal framework for all healthcare regulators, whose existing governing legislation (such as the Pharmacy Order 2010) will be repealed and replaced with a single Act of Parliament, which will provide the legal framework for all regulated healthcare professionals.

Improved consistency

The law commissions have attempted the difficult task of striving for greater consistency between the actions of healthcare regulators while allowing them greater autonomy. Greater consistency has been sought in certain areas where this is necessary in the public interest (such as the conduct of fitness to practise, or FTP, hearings). Otherwise, regulators will be given greater autonomy to deliver their functions in a way that is suited to their particular profession.

Primarily, regulators will be given powers to make or amend rules concerning issues such as registration, renewals, education, standards and continuing professional development, without the requirement for governmental approval, which currently leads to significant delays in delivering regulatory change. As the GPhC’s recent request to obtain powers of covert surveillance against its members amply demonstrates, this is not always a bad thing. However, this does not mean that the GPhC will be allowed to operate unchecked by government. There will be a requirement for consultation (as there currently is under regulation 5(1) of the Pharmacy Order) if the GPhC considers changing its rules. Any changes will be subject to oversight by the Professional Standards Authority.

The draft bill establishes a single set of overarching objectives for all the regulators when exercising their functions. Each regulator’s main objective will be to “protect, promote and maintain the health, safety and well-being of the public”, which reflects regulation 6(1) of the Pharmacy Order.

As is already the case for pharmacy, each regulator must keep a register for its profession. However, the government would also have the ability to introduce barring schemes, which would list those who are prohibited from practising a profession. All regulators must establish a formal appeals process for decisions on registration matters, which must be supplemented by a further right of appeal to the higher courts. Regulations 40 and 41 of the Pharmacy Order currently provide these rights for pharmacists.

Setting professional standards

Regulators will be required to set professional standards for their registrants. The GPhC is ahead of the game in this regard, having first published in 2010 its ‘Standards for conduct, ethics and performance’, with which most pharmacists will be familiar. A failure to comply with the standards may be taken into account in FTP proceedings.

The regulators will be required to determine standards of continuing professional development and will be able to remove registrants from the register if they fail to comply. The government will be given regulation-making powers to introduce systems of revalidation. The GPhC has already begun work on revalidation for pharmacists, with an estimated introduction date of 2018.

A registrant’s FTP will be regarded as impaired by reason only on one or more of the following statutory grounds:

• Deficient professional performance
• Disgraceful misconduct
• Inclusion of the person on a barred list
• A determination by another regulator to the effect that FTP is impaired
• Adverse physical or mental health
• Insufficient proficiency in the knowledge and use of the English language
• Convictions or cautions
• Certain other court disposals.

This largely reflects the current position under regulation 51 of the Pharmacy Order, except with the addition of the word “disgraceful” in relation to misconduct, and the new grounds of inclusion on a barred list and impairment based on a registrant’s insufficient proficiency in English.

FTP decisions

The draft bill requires that all FTP cases must be referred if there is a realistic prospect of a finding of impairment, except where it is not in the public interest to make a referral. The draft bill expands the range of disposals available at the investigation stage. Regulators will be able to issue advice and warnings and agree undertakings or voluntary removal following an investigation. Each regulator will also be able to initiate a review of certain investigation decisions where the case has not been referred to an FTP panel.

The civil rules of evidence and the civil standard of proof will continue to be applied to FTP hearings. Most hearings will continue to be in public, except for interim order and health cases. All FTP panels will be able to impose the following sanctions: advice, warnings, conditions, suspension and removal from the register, and be able to agree undertakings and voluntary removal. The statutory right of appeal against the decision of an FTP panel to the higher courts would be maintained.

Finally, the government, which is looking to implement the draft bill before the end of the year, will be given regulation-making powers to introduce a new adjudication system, which would allow a regulator to appeal panel decisions that do not, in its view, achieve sufficient protection of the public. So don’t breathe out too deeply with a sigh of relief if you walk away from an FTP determination with just a slap on the wrists. The GPhC may well have the final word.

_{Richard Hough is an associate solicitor and pharmacist at Brabners LLP. Contact him on 0151 600 3302 or at richard.hough@brabners.com}