29 October 2015
Dear Colleague
Introduction of new licensing and regulatory system for mitochondrial donation
Today regulations come into force which permit the use of mitochondrial donation for the avoidance of serious mitochondrial disease – a treatment has not yet been offered at any clinic in the world. The statutory provisions governing this new treatment are set out in the Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 and prescribe the steps UK clinics must take before they can offer this new treatment.
I am writing to tell you about how mitochondrial donation will be regulated and the broad steps you must take if you wish to perform this new treatment. We have introduced a new licensing and regulatory system, including Code of Practice guidance, consent forms, licence conditions and general directions.
If you are interested in offering mitochondrial donation at your clinic, your first step is to contact your HFEA Inspector who can talk to you about the process.
Before you can submit an application
As with any new treatment it is important that mitochondrial donation is judged to be safe and effective before it is made available. An expert panel convened by the HFEA has considered the safety and efficacy of maternal spindle transfer (MST) and pronuclear transfer (PNT) in three reports and it has recommended a number of tests which it believes should be completed before the treatment is offered. Once these tests have been carried out we will convene an expert panel to consider the results, and their report will be presented to the HFEA. If the panel is satisfied and we accept their recommendations, you will be able to apply to be licensed to offer the treatment. We will notify you once this has taken place and the application process can begin.
Applying to perform mitochondrial donation at your clinic
To apply to perform mitochondrial donation for treatment purposes at your clinic you must follow a two-stage process:
- Stage one: You will need to apply to vary your licence to include specific permission to carry out MST and/or PNT. This will follow the same process as a clinic applying to vary its licence for other purposes (such as the addition of embryo testing) ie, by way of an application to our Licence Committee. The Inspectorate will assess the suitability of your premises and processes. You will also need to evidence the competency of your proposed embryologist in carrying out these techniques in line with key performance indicators (to be determined by the HFEA, with advice from an expert panel). Only those embryologists assessed as competent by the Authority to undertake MST, PNT, or both, will be permitted to undertake mitochondrial donation. Along with your application you must submit to us your patient information and mechanisms for following up children born from mitochondrial donation.
If the application is approved, you will be licensed and will not need to repeat this stage unless you wish to seek approval to change your approved embryologist(s). A link to the ‘Variation of HFEA treatment and storage licence to allow mitochondrial donation’ form is below. The information you must submit is set out in General Directions 0008. - Stage two: If your application is successful, you will then need to apply for approval to treat a specific patient. There must be a ‘particular risk’ of the patient’s egg or embryo having a mitochondrial abnormality caused by mitochondrial DNA, and a ‘significant risk’ that a child with those abnormalities will have, or develop, a ‘serious’ mitochondrial disease. Such applications will be considered by our Statutory Approvals Committee (SAC).
You must complete this step for each individual patient by submitting the ‘Mitochondrial donation: new case application’ form.
Registering and submitting information to the HFEA
Once you have completed the above steps, you must submit information to us about your patients, donors and treatments that we will hold on the Register. In addition to the patient and partner (or sperm donor) registration information submitted for standard IVF cycles, you will also need to register the mitochondrial donors and PNT only sperm donors (where applicable). The registration requirements are set out in amended General Directions 0005. A link to the new forms and a guide to help you submit this information to us can be found below.
Taking consent
We have developed specific consent forms so that the questions are tailored to these particular treatments, recognising the different information needs of the patients and donors, and reflecting the consent provisions in the Regulations.
You must not use donors or provide treatment to patients who have not given specific consent to the use of their eggs, sperm and embryos in mitochondrial donation. Only clinics licensed to perform mitochondrial donation can recruit mitochondrial donors (and store and use eggs/embryos which have undergone MST or PNT) and obtain consent from patients and donors. It is however possible for clinics who are not licensed to carry out mitochondrial donation to obtain consent from sperm donors for the use of their sperm in the treatment of others, including in the process as PNT as well as IVF/ICSI, using the ‘Consent to donating your sperm (including for use in pronuclear transfer)’ form.
We have also published a guide to help you to use them with your patients.
New Code of Practice guidance, directions and licence conditions
We have published a standalone guidance note on mitochondrial donation and have made a number of minor consequential changes to our existing guidance and requirements to cover the use of mitochondrial donation in clinical treatment. A link to the new Code of Practice guidance note (including licence conditions), consequential changes to our existing guidance and revised directions is at the bottom of this letter.
Guidance is provided on the following areas:
- Which staff should be involved in mitochondrial donation.
- Patients who would be eligible for mitochondrial donation.
- Genetic consultation and counselling.
- Information for those seeking mitochondrial donation and prospective mitochondrial donors.
- The importance of informing children of their origins
- Eligibility requirements for mitochondrial donors
- Consent
- Import of eggs or embryos which have undergone mitochondrial donation
- Follow-up arrangements.
Follow-up reporting
You must have a documented process for monitoring children born following mitochondrial donation, including long-term medical follow-up, where patients have consented.
Following treatment, you must submit to us an annual report on patient uptake of follow-up and (non-patient specific) information on the outcomes. These requirements are outlined in General Directions 0005. A link to the ‘Mitochondrial donation follow-up information sheet’ that must be submitted is below.
New forms, guidance and requirements
To view the new forms and guidance please follow these links:
- Variation of HFEA treatment and storage licence to allow mitochondrial donation form
- Mitochondrial donation: new case application form
- Register information forms and guidance
- Consent forms and clinic guide
- Mitochondrial donation Code of Practice guidance note
- Consequential amendments to Code of Practice guidance:
- PDF version (changes are in red for illustrative purposes)
- Full updated code of practice - Revised Directions (PDF versions below have changes in red for illustrative purposes):
- 0001 - Gamete and Embryo donation
- 0005 - Collecting and recording information for the HFEA
- 0006 - Imports and exports
- 0007 - Consent
- 0008 - Information to be submitted to the HFEA as part of the licensing process
- 0012 - Retention of records - Mitochondrial donation follow-up information sheet
Please review the new forms, guidance, General Directions and licence conditions and ensure your staff are aware of the changes. If you have any questions about them, please contact your Inspector in the first instance.
Page last updated: 29 October 2015