The Human Fertilisation and Embryology Act 2008 (the 2008 Act) brings the regulation of:
- Preimplantation Genetic Diagnosis PGD
- HLA tissue typing and
- Preimplantation Genetic Screening for Aneuploidy PGS
known collectively as ‘embryo testing’ onto a statutory footing for the first time.
This change in the law has required us to review the HFEA’s approach to licensing embryo testing.
What are the changes – PGD?
The new system for licensing PGD will involve the following stages, from 1st October 2009:
- If you wish to set up a PGD service then you will need to apply to the HFEA to have this activity added to your licence. The criteria for assessing the application will continue to be whether your centre has competent embryo biopsy practitioners and has the necessary procedures and facilities in place, as laid out in licence conditions and the Code of Practice.
- If you are already licensed to carry out PGD and wish to offer PGD for a new genetic condition (i.e. a condition that has not previously been licensed by the Authority) then you must apply to the Authority to do so, setting out how you consider the genetic condition in question meets both the significant risk and seriousness requirements in the amended Act. You will not need to have an applicant couple or family in mind upon whom to base the application.
Upon receipt of any application:
- A lay summary of the condition will be published on the HFEA website to allow any interested parties to comment on the application. These comments will also be reviewed by the Licence Committee assessing the application.
- Advice from peer reviewers and, where necessary, other organisations or groups will be sought to help the Authority determine the significant risk and seriousness of the disease/condition.
- The decision on whether embryo testing should be allowed for the particular disease/condition will be determined by the Authority’s Licence Committee using the criteria in its decision-making tool.
- If the genetic condition in question is approved, the condition will be published on the HFEA website and all PGD centres will be notified, via email, of its approval. All PGD licensed centres will then be able to offer PGD for the newly approved condition.
- Each Centre will have to notify the HFEA when they first carry out PGD for any newly approved disorder. This notification must be sent within 5 working days of you carrying out thes embryo testing (see General Direction 0008). The notification should be sent to firstname.lastname@example.org.
- The HFEA will publish a central list of the conditions / diseases for which PGD licensed centres are permitted to carry out PGD. An updated list will be available from early October. This list will serve as an informative reference point for clinics and patients.
- The Choose a fertility clinic on the HFEA website will indicate which centres are licensed for PGD and which conditions each of those centres have tested for.
- From 1st October 2009, all PGD licensed centres will be able to carry out PGD for any of the conditions on the central list without having to seek permission from the HFEA to do so. Centres will however have to notify the HFEA, when they first carry out PGD for any condition / disease that they have not previously used PGD for, in accordance with Directions 0008. Notification should be sent to email@example.com
- The HFEA will review all conditions / diseases on the central list every five years for their suitability for PGD under the legislation current at the time of review. The first review will take place in Spring 2010.
- Conditions currently licensed on a case by case basis are exceptional to these changes. These include late on-set, lower penetrance disorders and cases involving preimplantation tissue typing. These conditions will continue to be licensed on a case-by-case basis after the Authority’s Licence Committee has assessed their suitability for PGD using the criteria in its decision-making tool.
There are two new applications forms relating to embryo screening. One to be used when applying for authorisation to carry out embryo testing for a condition that has not previously been authorised by the Authority. One to be used when applying for authorisation to carry out embryo testing for case-by-case conditions / disorders or for tissue typing.
Publication of PGD conditions
In September 2009, the Authority agreed to publish a complete list of all licensed PGD conditions, along with the OMIM number of each licensed condition.
Certain conditions were withheld from publication previously due to concerns about the risk of patient identification. The Authority has recently reconsidered this position and found this risk to be negligible. This decision was made on the basis of a range of considerations, including the distance people travel for treatment (including from overseas), the use by patients of donor gametes or prenatal genetic screening, and the possibility of conceiving an unaffected child without PGD and IVF. Such conditions will therefore be added to the central list of conditions / diseases for which PGD licensed centres are permitted to carry out PGD
Publication of a complete central list will be important for clinics under the revised PGD licensing system. From the 1st of October all PGD licensed clinics will be able to test for any condition / disease on the central list. Clinics wishing to test for a condition they have not previously tested for will need to be able to refer to the list to see whether they will require the approval of a Licence Committee, or whether they will simply need to notify us. A complete list will also assist patients looking for information about the availability of PGD.
When making an application for a new condition / disease, you may feel, that there are particular 'exceptional circumstances' where there is a heightened risk of patient identification for a particular reason. If this is the case, you should provide evidence supporting this assertion along with your application. The Chair and Chief Executive of the Authority will then decide on the basis of this evidence and evidence from peer reviewers whether or not to withhold publication of the condition / disease from the central list.
If you’d like further information on this decision, see the Committee decision
What are the changes – PGS?
If your centre is licensed to carry PGS then, from the 1 October 2009, you will no longer need to seek permission from the HFEA in order to screen for additional chromosomes or if you wish to use new methods for screening embryos.
However, you will be expected to follow the requirements set out in Licence conditions and the guidance set out in the 8th edition of the Code of Practice. For examples you must have validated any new process used for screening embryos and these genetic tests must be carried out in a suitably accredited laboratory.
Accreditation of Genetic laboratories
When the European directive on Tissues and cells (2004/23/EC) was transferred into UK law in July 2007 the HFEA made it a requirement of licensed centres that diagnostic laboratory tests, including genetic tests, must be carried out by a laboratory which has suitable accreditation (for example from CPA (UK) Ltd or another body accrediting to an equivalent standard).
Since 2007 the HFEA has been satisfied if licensed centres provided evidence that they are working towards this requirement. Over time the HFEA has expected an increasing number of centres to achieve accreditation and progress will be followed up by your centre's inspector.
When will the embryo testing licensing system change?
The new system will come into effect from 1st October 2009.
- A list of all existing licensed PGD conditions will be published
- All PGD centres are able to offer PGD for all licensed conditions (but a centre must notify the HFEA the first time it tests for each condition)
- New conditions will have to be approved by a Licence Committee
- All PGD conditions will be reviewed after five years
- Centres offering PGS will not need permission from the HFEA to screen for additional chromosomes or if new methods are being used
Page last updated: 21 August 2009