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Defending GPhC Investigations and Prosecutions
The General Pharmaceutical Council (GPhC) regulate pharmacists, pharmacy technicians and pharmacies in Great Britain. Its objective is to assure and improve standards of care for people using pharmacy services. Our aim is to ensure that the GPhC comply with particular standards and procedures when investigating the kind of reports we refer to below.
The GPhC performs an important role in ensuring that the public receive safe and effective care when using pharmacy services. However, a fine balance must be struck when protecting the rights given to healthcare professionals and the corporate entities providing a valuable service to the community in increasingly difficult economic circumstances.
Most of our work concerns the operation of the three statutory committees established by the Pharmacy Order 2010. They carry out investigations, decide on registrants' fitness to practice and conduct registration appeals.
This committee considers allegations that a registrant's fitness to practice is impaired and decides whether to refer a case to the fitness to practise committee for a full inquiry. We ensure that all of the relevant matters have been properly considered so that our client’s case is fully advanced. If necessary, we challenge the ‘impairment’ issues and any decision to refer the matter to the fitness to practice committee; usually on the basis that the threshold criteria has not been met.
Fitness to Practise Committee
This committee makes decisions in cases where a registrant's fitness to practise may be impaired, for reasons concerning their conduct, professional performance or health. The potential consequences can be severe and the rules/procedures are not straightforward. The standard and burden of proof are not easily understood in the context of professional regulation. The concept of ‘impairment’ can be the subject of complex argument.
Navigating a fitness to practice tribunal without specialist representation can be very risky. The cost of an adverse decision is almost always much higher than the cost of legal representation and engaging a knowledgeable lawyer allows you to spend more time doing what you would rather do - delivering pharmacy services. We ensure that the GPhC case is fully tested and that your arguments are advanced in a manner most likely to achieve your objective.
This committee considers appeals of certain types of decision relating to applications for registration and registration status as listed in article 39 of the Pharmacy Order 2010.
Appealing the decision of a Fitness to Practice Committee needs to be done within 28 days of the decision. Interim measures may be imposed during that period and we may challenge the need for those measures.
The Pharmacy Order 2010 enables registrants to appeal certain decisions relating to fitness to practise. These may include decisions to:
- Remove the entry of a person from one or more parts of the Register
- Suspend registration or impose conditions on registration
- Vary conditions imposed on registration
- Prevent a person from making further applications for restoration to the Register
Appeals of this type are filed with the High Court and served upon the GPhC within 28 days from the date on which the written notice was sent. The time limit can be extended, but this will only happen in particular circumstances and in reality, almost all meritorious appeals can be lodged within 28 days. Having considered the appeal, the relevant court may:
- Dismiss the appeal
- Allow the appeal
- Substitute the sanction for another sanction that the Fitness to Practise Committee could have imposed
- Remit the case to the Registrar or the Fitness to Practise Committee for conclusion in accordance with the court's directions
- The court may also make any order for costs or expenses
How Does a Fitness to Practise Committee Make its Decision?
The committee should follow a three-stage process. Once the committee has heard the evidence, it must decide:
- Have the allegations been proved to the civil standard (the balance of probabilities)?
- Is the pharmacy professional’s fitness to practise impaired?
- Should any action be taken by way of a sanction against the pharmacy professional’s registration?
The burden is upon the GPhC to prove the facts alleged, although it can sometimes feel as though the burden is upon the registrant. The civil standard of proof requires the committee to find that the alleged fact is true ‘on the balance of probabilities’ or that the event is ‘more likely than not’ to have occurred. This is to be distinguished from the standard of proof in criminal cases where the prosecution must establish the case ‘beyond reasonable doubt’; a much higher standard. Many arguments arise from whether the committee has enough evidence of a certain quality before it can make a reliable determination. After all, the committee must justify its reasoning because its decisions are open to public scrutiny.
If a committee decides a registrant’s fitness to practise is impaired, the committee can:
- Take no action
- Agree undertakings
- Issue a warning
- Impose conditions on the registrant’s practice
- Suspend the registrant from practising
- Remove the registrant from the register in the most serious cases
The GPhC issue guidance on which sanction is appropriate in defined circumstances. We ensure that if matters are proven, the most appropriate sanction is imposed.
The GPhC usually reserve investigations for circumstances suggesting a risk to patient safety or those which could affect public confidence in pharmacy professionals.
- Examples of matters reported to the GPhC include:
- Serious unprofessional or inappropriate behaviour
- Dispensing errors
- Criminal conductDishonesty or fraud
- Working under the influence of drink or drugs
- Having a health condition that affects the ability to practise safely
- Practising while unregistered
The GPhC may also refer matters to other agencies, such as the police, HMRC or the Medicines and Healthcare Products Regulatory Agency (MHRA), which is of particular relevance to pharmacists.
The MHRA is an executive agency of the Department of Health and Social Care in the United Kingdom and is responsible for ensuring that medicines and medical devices work and are acceptably safe. However, they will also investigate the misuse of drugs and in particular, the unlawful diversion of prescription drugs to unregulated markets.
We have particular experience in MHRA investigations and prosecutions of this type. Our team can represent you during an interview under caution at the police station (where the MHRA officers are often accompanied by police officers) and throughout any resulting criminal prosecution, including appeal and confiscation proceedings where relevant.
Standards for Pharmacy Professionals
Offering specialist representation for pharmacy professionals involves acknowledging the standards to which the industry must work. Pharmacy professionals must:
- Provide person-centred care
- Work in partnership with others
- Communicate effectively
- Maintain, develop and use their professional knowledge and skillsUse professional judgement
- Behave in a professional manner
- Respect and maintain the person’s confidentiality and privacy
- Speak up when they have concerns or when things go wrong
- Demonstrate leadership
A large part of defending our clients involves demonstrating how these standards have been met or if they have not been met, what action can be taken to meet them in the shortest possible time.
Standards for Registered Pharmacies
Parallel standards for the corporate entities are expressed as five principles and are all equally important.
- The governance arrangements safeguard the health, safety and wellbeing of patients and the public.
- Staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public.
- The environment and condition of the premises from which pharmacy services are provided, and any associated premises, safeguard the health, safety and wellbeing of patients and the public.
- The way in which pharmacy services, including the management of medicines and medical devices, are delivered safeguard the health, safety and wellbeing of patients and the public.
- The equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public.
We work with consultants who offer external audits (mock inspections), advice on Care Quality Commission (CQC) issues and a full range of services to ensure compliance with the requirements of the following measures:
- Wholesale Distribution Authorisation (WDA)
- Good Distribution Practice (GDP)
- Responsible Person Guidance (RP)Quality systems (QS)
Ancillary services include:
- Licence acquisition
- GPhC compliance advice and training
- Pharmacy automation
- Setting up a pharmacy business
- Pharmacy business development
In this way, we offer a holistic approach to avoiding problems in the first place and dealing with problems effectively if they arise, either in the course of dealing with an inspection or defending a prosecution. Other departments at JMW are experienced in working in this sector to ensure that clients have a ‘one-stop shop’ for all of their regulatory and commercial requirements.
Why Choose JMW?
If you are facing an investigation or prosecution by the GPhC and/or any of the agencies they refer matters to, feel free to call for a no obligation discussion. We can usually provide initial advice free of charge and our fees are often met by the pharmacy’s professional indemnity insurance policy. If not, we can often offer fixed fees for stages within a case and if fees are charged on an hourly rate, our rates are very competitive.
We will happily discuss how we can help. Some typical questions are below:
- The GPhC want to inspect the pharmacy. What can I expect?
- The GPhC want to interview me about fitness to practise.
- I have been referred to the Fitness to Practise Committee. What are my options?
- I want to appeal a decision made by the Fitness to Practise Committee?