FAQs about the licensing process and regulation

What is the regulatory process?

The HFEA regulatory priorities are ensuring patient safety and promoting the highest standards of clinical care and effectiveness by making sure clinics comply with the HFE 1990 Act.

Regulation starts with an HFEA Licence Committee looking at a licence application from a clinic. Licence Committee decisions are based on inspections. Inspections assess the quality and effectiveness of the clinics management of:

  • Clinic organisation
  • Services to patients and donors
  • Premises and equipment
  • Information provided to patients and to the HFEA
  • Clinical and laboratory processes and competence of staff

The Licence Committee will consider the application in relation to the requirements of the HFE Act, and the HFEA Code of Practice.

Once a Licence Committee has come to a decision regarding an application, it will either:

  • Grant a licence 
  • Grant a licence subject to specific conditions 
  • Refuse a licence (with reasons why set out in writing)

Licences are only issued after the clinic has accepted licence conditions in writing.

Clinics have the right to appeal (see "What is the appeal process?")

Return to top

What is the Licence Committee, what power do they have, what do they do?

The Licence Committees of the HFEA are the gatekeepers for all licensed activities in assisted reproduction technology (ART) and embryo research.

The Committees' decisions about licensing specific treatments or research projects follow the legal framework set out by Parliament (the Human Fertilisation & Embryology Act 1990). Licence Committee meetings take place about 30 times each year.

  • Only Authority Members sit on Licence Committees. HFEA Authority Members are appointed by the NHS Appointments Commission. The Members decide HFEA policies and review treatment and research licence applications.
  • Licence committee members reflect a wide range of interests and expertise, from medicine to law and religion to philosophy, to ensure that the HFEA has an objective, independent and appropriately informed view. The HFE Act requires that the Chair, Deputy Chair and at least half of the HFEA Members are neither doctors providing infertility treatment nor scientists involved in human embryo research.

Return to top

What are the legal requirements on clinics?

Clinics must maintain appropriate standards of quality and safety, appoint a "Person Responsible" for compliance matters, record, submit and verify information, provide information and the opportunity of counselling to patients and take account of the welfare of the children born as a result of certain fertility treatments.

These obligations flow from with the Human Fertilisation and Embryology Act 1990 (HFE Act) (as amended by the Human Fertilisation and Embryology Act (Quality and Safety) Regulations 2007)

  • This covers all uses of sperm, eggs and embryos for human application and all research involving the use of live human embryos. 
  • These terms and conditions are set out in licences, which are legal documents that every clinic must have before it can offer and carry out a licensable fertility treatment at specified premises

Return to top

What is the process if a clinic exercises its right of appeal against the Licence Committee decision?

The HFE Act provides a right of appeal if a Licence Committee refuses to grant or proposes to vary or revoke a licence.  Clinics have 28 days in which to appeal against any Licence Committee decision.

  • The first stage is a clinic appealing against a Licence Committee intention to revoke or vary a clinic's licence. This involves a clinic making representations to the Licence Committee addressing the reasons why the Licence Committee came to its original determination.
  • If the clinic's appeal is not upheld it can appeal to a committee of different Authority Members. An appeal at this stage will involve no member of the Authority who took any part in the proceedings that resulted in the original determination.
  • The final stage allows an appeal to the High Court or, in Scotland, the Court of Session on a point of law.

Full details are set out in sections 19, 20 and 21 of the HFE Act.

Return to top

 

What is the timeline for an appeal against an Licence Committee decision?

At all stages of the appeal process (except for appeal to the High Court or Court of Session), a clinic has 28 days from when a Licence Committee or Authority decision is served, to give notice that it intends to appeal.

- The time needed to hear each stage of the appeal will naturally reflect the unique circumstances of each individual case as well as the need to gather evidence and confirm the availability of relevant HFEA and clinic staff and legal representatives.

Return to top
 

What would be the impact of a court case on the appeal process?

It is not possible to predict precisely how this will impact on the appeal process or advise timescales in advance as these will be shaped by the unique characteristics of each individual case.

- This is because there are no timescales stipulated by the HFE 1990 (Act) regarding the final stage of appeal to the High Court or the Court in Session.
- However, there is a 3 month time limit from the date of the decision complained of to lodge judicial review proceedings at the High Court under the Civil Procedure Rules.

Return to top

 

What is a short term licence?

Every time a Licence Committee grants a licence, they will decide the appropriate length of the licence according to the circumstances of each clinic.

For example, a short term licence might be granted if a clinic's licence is about to expire and the question of whether or not it should be renewed was still being considered by the Licence Committee.

Return to top

How long does it take for the Authority sitting as an Appeal meeting to make a decision on an appeal?

This depends on the unique circumstances of each case, the Appeal meeting must review all the evidence received. For this reason it is not possible to give a definitive timeframe for a decision.

When the Appeal meeting is considering it's decision on the appeal, it will take into account how the outcome of the appeal will impact on treatment at that clinic and the needs of patients currently undergoing treatment, or who have sperm, eggs or embryos stored there.

Return to top

What are the mechanics of closing a centre

Moves to close any centre would follow a decision by a Licence Committee which would look into the circumstances at a clinic

  • It is not possible to say whether a clinic will be closed until the Licence Committee makes a decision, and a clinic could - if it decided - also invoke the appeals process.
  • Even if a clinic's licence is revoked then the Licence Committee responsible would consider the needs of patients currently having treatment at that clinic, or who had sperm, eggs or embryos stored there.
  • Options would include allowing patients to conclude specific phases of their treatment prior to alternative arrangements being made. The Committee would determine the best and most suitable options to safeguard patients' interests, while protecting them from any risk of harm.

    - If the Licence Committee revokes a treatment licence at a particular clinic, this does not mean the clinic itself closes down completely and has no further contact with patients. Clinics still have a duty of care to patients.

Although a clinic without an HFEA licence would not be able to provide certain services (such as egg collection, donor insemination, fertilisation or embryo transfer), the medical staff should still be there and would continue to have a duty of care towards patients. This would include giving advice on options for continuing treatment at another clinic.

Return to top

 

How do I make a complaint about a licensed clinic?

The HFEA has a procedure for complaints about HFEA licensed clinics. This covers complaints which may suggest that a licensed clinic has failed to comply with the terms or conditions of its licence or a failure by a clinic to follow its own complaints procedure. The purpose of this complaints policy is to ensure clinics meet the standards required by the HFE Act and Code of Practice and that these standards are maintained.  

More information about making a complaint about a licensed clinic.

Return to top

 

How do I make a complaint about the HFEA?

Complaints against the HFEA should be made in writing to the Complaints Officer at the HFEA. This procedure covers complaints about all aspects of the work of the HFEA in carrying out its regulatory, communication and information roles and responsibilities, including its policies and procedures. 
This process does not include complaints which concern a decision by a Licence Committee - this can only be done by the licence applicant.

Full details about making a complaint about the HFEA

Return to top
 

Would conditions on a clinic's licence affect my treatment?

If a condition is placed on a clinic's licence, it may or may not affect someone's treatment. If your clinic has a new condition placed on its licence and you are concerned then you should discuss this with your clinic and they should be able to advise you.

Return to top

 

What happens to my stored sperm, eggs or embryos if a clinic closes down?

  • Although a clinic without an HFEA Licence would not be able to provide certain services, such as donor insemination, fertilisation or embryo transfer, the medical staff should still be there and continue to have a duty of care towards you.
  • All clinics should have a contingency plan in place where arrangements are made for your stored sperm, eggs or embryos to be transferred to another clinic.
    In the first instance, the process is for you to contact the clinic directly to find out what contingency plan they have in place, and to discuss the ongoing care of your samples.

 

Return to top

What is the process for transferring sperm, eggs or embryos to another clinic?

  • All clinics should have arrangements with other clinics where they can transfer your sperm, eggs or embryos to.
  • All the supporting information, such as patient records and consent forms should be sent along with your sperm, eggs or embryos to the other clinic. We suggest that you contact your clinic for further information on the process.

Return to top

Are my samples safe in storage?

  • Yes, if a clinic were to close, there are processes in place and the medical staff should still be there and continue to have a duty of care towards you.
  • All clinics should have a contingency plan in place where arrangements are made for your stored sperm, eggs or embryos to be transferred to another clinic.

Return to top

 

I am in the middle of treatment, how will this affect me?

If a clinic were to close in the first instance, if you have any concerns you should discuss these concerns with the clinic's staff. Ask a lot of questions and if necessary ask another clinic for a second opinion before making any decisions about your treatment.

If the licence is revoked?

  • If the HFEA revokes a licence, then the licence committee responsible would consider the needs of patients currently having treatment at the clinic.
  • The Committee would advise on the best and most suitable options to safeguard patients' interests.
  • They might for example decide, if there is no immediate risk to patients, that some treatment could continue for a limited time.

If conditions are placed on the clinic (such as to limit the number of embryos that can be transferred or to prohibit carrying out certain treatments, like IVF)?

  • All clinics should have an ongoing duty of care towards patients and should make arrangements for you to be able to continue your treatment.

If the PR is replaced?

  • This should have no effect on your treatment, as Persons Responsible change quite regularly subject to the approval of a Licence Committee and assume immediate responsibility at the clinic.
  • Persons Responsible are the individuals that ensure the clinic complies with the requirements of the HFE Act 1990 and are responsible for both for the quality of service provided and the ethical issues involved in providing that service.
  • The replacement Person Responsible is approved on the basis of relevant qualifications and experience to ensure they are suitable for the role. Your treatment should not be affected by this changeover of staff.
  • If you are feeling concerned about this, please contact your clinic directly.

If my clinic is issued with a short term licence or Directions?

  • All clinics should have a contingency plan in place, where your treatment and supporting documents can be transferred to another clinic. 
  • The clinic will be advised to finish off treatments and ensure that arrangements have been made for patients to be transferred to another clinic.

Return to top

 

What should I do if I'm just about to start treatment at my clinic and....

The licence is revoked?

  • All clinics should have arrangements with other clinics where they can transfer your sperm, eggs or embryos to. 
  • All the supporting information, such as patient records and consent forms should be sent to the other clinic. 
  • You may also wish to choose another clinic. You can find a list of HFEA-licensed clinics on our website by using the 'Find a clinic' search
  • We also have a list of things to consider when choosing a clinic.

The PR is replaced?

  • This should have no effect on your treatment, as Persons Responsible change quite regularly and assume responsibility at the clinic. 
  • Persons Responsible are the individuals that ensure the clinic complies with the requirements of the HFE Act 1990 and are responsible for both for the quality of service provided and the ethical issues faced in providing that service. 
  • The replacement Person Responsible is chosen based on a series of relevant qualifications and experience to ensure they are suitable for the role. Your treatment should not be affected by this changeover of staff. 
  • If you are feeling concerned about this, please contact your clinic directly.

It is issued with a short term licence?

  • All clinics should have a contingency plan in place, where your treatment and supporting documents can be transferred to another clinic.
  • The clinic will be advised to finish off treatments and ensure that arrangements have been made for patients to be transferred to another clinic.

If conditions are placed on the licence? (such as not being able to carry out other treatments)

  • If the conditions mean that you cannot have your treatment at the clinic anymore, then your treatment details and patient records should be transferred to another clinic.
  • All clinics should have arrangements with other clinics in this situation.

 

Return to top
 

Will a new PR have an impact on my treatment?

  • Any changes to the Person Responsible at a centre need not affect which doctor or other clinical staff are providing treatment to an individual.
  • Regardless of who the Person Responsible is, they are the individual that ensures the clinic complies with the requirements of the HFE Act 1990 and are responsible for both for the quality of service provided and the ethical issues faced in providing that service.
  • The replacement Person Responsible is chosen based on a series of relevant qualifications and experience to ensure they are suitable for the role. Your treatment should not be affected by this changeover of staff.
  • If you are feeling concerned about this, please contact your clinic directly. 
  • It is not uncommon for Persons Responsible to change quite regularly and assume responsibility at the clinic.

Return to top

 

Can I transfer my treatment to another clinic? What is the process?

  • Yes. Every clinic should have arrangements in place for transferring treatment details to another clinic.
  • Depending on the stage of your treatment, your sperm, eggs or embryos should be transferred to the other clinic, alongside all the necessary supporting documents.
  • If you have a specific clinic in mind, you should inform your clinic and they should be able to advise you on what to do next. 
  • You can find a list of HFEA-licensed clinics on our website by using the 'Find a clinic' search

Return to top

 

My treatment ends after the expiry of the short term licence, what should I do?

  • If the terms of the licence mean that you cannot continue treatment at a clinic, then they should have a contingency plan for this in place to ensure that your sperm, eggs or embryos along with supporting documents are transferred to another clinic.
  • A special direction will be issued to the clinic to enable them to finish current treatments.

Return to top

 

How should I choose a clinic using the success rate statistics?

  • When looking at the success rates for a clinic, it's very important that you look at the figures that are most relevant for your circumstances.
  • Looking at the 'average' success rate for a clinic is not helpful, as it will not tell you how likely you are to have successful treatment there.
  • We have an advanced search on our website where you can select your location, age group, type of treatment and service to find a clinic that is best for your circumstances.
  • The success rates we publish should only be used as a guide to a clinic's performance, rather than a guarantee of success for an individual.

 

Return to top
Last updated: 14 September 2007