Background
It is good practice for all regulators to have a policy setting out their regulatory aims and their approach to regulation. Our Compliance and Enforcement Policy is a public statement of the circumstances in which licensed fertility clinics can expect us to take regulatory action against them, the range of regulatory action we might take, and the statutory enforcement clinics may face.
The aim of this revised policy is to provide a clear framework in which individual regulatory decisions can be made when necessary, using a step by step procedure, whilst recognising the differing circumstances of each clinic. This is not a ‘tick box’ exercise. The policy sets out a risk-based approach and enables HFEA inspectors to make a consistent appraisal of non-compliances whilst taking account of wider factors including the clinic’s attitude to regulation and its history of compliance.
This consultation is an opportunity for stakeholders to provide feedback on the draft new policy and we are keen that as many as possible take part. We encourage you to share the survey link below with fellow professionals in the sector and your legal teams.
The consultation will run until 31 January 2021. Once the consultation closes, your responses will be collated and considered, and a final draft of the policy will be presented to the Authority in March 2021 for approval before going live in April 2021.
There are 12 questions and the survey should take about 15 to 20 minutes to complete. The consultation can be found here.
Thank you in advance for your input.
How the new policy will be applied
The policy sets out the Authority’s regulatory aims (see paragraph 5) and differs from previous policies in that it includes a clear step by step procedure to be followed when the policy is engaged. Inspectors will use a standard template alongside the policy to document their decisions and the conclusion(s) reached.
Whilst this policy will ensure that every clinic is treated the same in procedural terms, it is important to understand that regulatory action (see paragraphs 27 and 28) or statutory enforcement action (see paragraph 29), may vary from clinic to clinic. This is because the sector is not homogenous; different facts and circumstances may be relevant in one case which are not relevant in another. We call these aggravating and mitigating factors (see paragraphs 23 and 24). The list of factors set out in the policy is not an exhaustive one and there may be others that are relevant and taken into consideration.
In addition to any aggravating and mitigating factors, the Person Responsible (‘PR’) may be another differentiating factor. Whilst every PR has the same statutory duties, whether or how each PR chooses to fulfil their duties varies considerably. The range of factors that may be considered when assessing the PR’s actions in any circumstances are set out at paragraph 25.
An initial risk score will be determined by reference to the highest risk factor(s) or the worst-case scenario(s). Any relevant aggravating and mitigating factors and the PR’s role will be considered; these factors may have a bearing on both impact and likelihood and potentially drive the risk score up or down. A final risk score will be determined after all relevant factors have been considered.
The final risk score will then be referenced against the Regulatory Action Table (‘RAT’) which will indicate whether standard action, formal action or statutory enforcement action should be recommended and in the case of licence applications, will indicate what length of licence should be recommended.
View the new draft Compliance and Enforcement policy
Publication date: 9 April 2026