Pharmacy regulatory and GDPR

Our expert team understands the political landscape within which you work and can help you meet your professional, legal and regulatory obligations.

Regulatory

The pharmacy profession is different to other regulated health professions (eg GPs) in that the individual pharmacist is subject to regulation by the regulator (the GPhC) but so is the pharmacy itself. The GMC has no powers to investigate a GP practice as an entity, whereas in contrast the GPhC can take steps to remove a pharmacy from its register if it does not meet the required standards.

At DR Solicitors we appreciate this unique position and we can assist with investigations into an individual pharmacist, or dealing with the outcomes of a pharmacy inspection.

We have acted for pharmacists in relation to conduct, health and performance matters. For example we have assisted pharmacists accused of stealing stock, pharmacists with addiction issues and pharmacists accused of supplying medicines inappropriately or without clinical justification – sometimes with fatal consequences.

We can assist you from the first contact with the GPhC to the conclusion of the case at a final hearing, if matters proceed that far. We can also appeal GPhC decisions as appropriate and represent you at Interim Orders Hearings (see the FAQ below for more on Interim Orders Hearings).

We have particular experience in assisting pharmacists with distance selling matters, an area that the GPhC are currently much focused on and tend to prosecute robustly.

If you or your pharmacy is investigated by the GPhC we appreciate that this will likely be one of the most stressful periods of your life and we recognise that supporting you through the process can be just as important as providing expert legal advice.

We also have experience of representing pharmacists at Coroners Inquests and DR Solicitors can be with you at every step of that process, from drafting a formal statement for the Coroner to appearing for you at the Inquest itself, if required.

If you do find yourself being investigated by the police, CQC or ICO in relation to data and regulatory breaches, we can represent you.

GDPR and data protection

GDPR, data protection, freedom of information, cyber-security – these buzz words aren’t going away. In fact, there is an ever increasing risk to a practice for failure to comply with the associated regulations and legislation, which in themselves are something of a moving target. We have a specialist team of solicitors who can help you navigate GDPR, advise on best practice and prevention, and for when things don’t go according to plan, on how to put things right and damage limitation.

Here are some of the ways we have helped pharmacists:

CQC registration & regulatory issues
challenging CQC decisions
representing pharmacists and pharmacies during GPhC investigations
representing pharmacists at Interim Order and Fitness to Practice hearings
respresnting pharmacists at Coroners Inquests
appealing against Fitness to Practice decisions and GPhC investigations
assisting with NHS Pharmacy Contract applications
responding to data subject access requests
advising on GDPR and data protection

FAQs

Do I have to attend an Interim Orders Hearing?
I have been suspended - what next?
I am under investigation - should I respond?
Will I have to give evidence at a Coroner's Inquest?

Do I have to attend an Interim Orders Hearing?
The GPhC can fix an interim Orders Hearing if they consider that there is a current risk to patients or serious public interest concerns. At an Interim Orders hearing the GPhC makes representations before the Panel and you have the right to do the same. Interim Orders hearings are typically fixed at very short notice and the Panel that hears the case have the power to suspend a pharmacist if they consider that necessary and proportional. An Interim Order Hearing can be fixed in relation to any matter that gives the GPhC sufficient concern. If you receive notice of an Interim Orders hearing you should immediately seek legal advice as the common position of the GPhC at such hearings is to seek suspension of the pharmacist.
I have been suspended - what next?
A suspension must be reviewed every 6 months by a Review Panel, but one can request an earlier review if there has been a material change in circumstances or new information has come to light. It can however be difficult to shift an Interim Order when one has been made.
I am under investigation - should I respond?
The GPhC will frequently ask for a registrants comments without providing full details of the allegations, or any records or papers. Most pharmacists will want to assist the regulator and not be seen as uncooperative so there is a temptation to respond in detail at the earliest opportunity. However, one should be very careful in responding to allegations without having full notice of the detailed allegations and also the records. In some cases it may be appropriate to respond in detail at an early stage but we strongly advise any pharmacist to take expert advice before doing so, or indeed responding in any way.
Will I have to give evidence at a Coroner's Inquest?
You may not have to give evidence at an Inquest if the Coroner does not think that is required and there are no objections from other participants. This is why drafting a concise statement is very important, as a good and full statement may satisfy the Coroner that you do not need to give evidence in person. The Coroner has no power to issues fines or criminal sanctions, their purpose is to investigate the circumstances of the death. However, criticisms made at an Inquest can have serious repercussions professionally (eg GPhC referral, civil court action) and if one is designated an Interested Person then legal representation should always be sought to protect your interests.