HFEA announce new process to speed up applications for embryo screening
19 January 2005
The Human Fertilisation and Embryology Authority (HFEA) has announced a new policy to streamline the approval of applications for preimplantation genetic diagnosis (PGD) embryo screening.
Under the new guidelines, if a clinic, with proven expertise in performing embryo biopsies, applies for a licence to carry out screening for a particular condition, which is already being carried out successfully in another clinic - such as screening for sickle cell anaemia, cystic fibrosis and Duchenne's muscular dystrophy - the HFEA will approve the application without having to go through the full HFEA licence committee process, providing the same technique and methods are used.
Suzi Leather, Chair of the HFEA said:
"Our approach to regulating clinical techniques is that we should be cautious and thoroughly consider treatments on a case-by-case basis while techniques are still relatively new and unproven. Once a technique is established with a proven track record of effectiveness and safety then we will adopt a much more proportionate ‘lighter touch' approach.
"PGD is now an established technique for screening embryos which has been carried out under HFEA scrutiny for several years and we have assessed all the relevant evidence gathered over this time.
"We have decided that whilst PGD is a specialised procedure, which can only be carried out by a qualified embryo biopsy practitioner, it should be straightforward for those clinics with a proven track record in the appropriate techniques to be able to carry out screening for any of the conditions currently approved.
"This will streamline the system, cutting down on bureaucracy and speeding up the approval process which will benefit both the patients who benefit from this treatment and the clinicians treating them".
However, a number of less common specialised applications of PGD will still require thorough consideration by an HFEA licence committee on a case by case basis. These include:
- Licensing for new conditions,
- PGD/HLA (Human Leukocyte Antigen) tissue typing,
- HLA on its own,
- Late onset conditions or susceptibility genes
Ends
Notes to editors
8 UK clinics are currently licensed to carry out PGD.
In the 12 month period between March 2002 and 2003, there were 155 PGD cycles.
Clinics must have a qualified biopsy practitioner for PGD. These are embryologists who have done a number of biopsies under supervision and completed an exam by the HFEA scientific inspector.
The two techniques in PGD embryo screening currently licensed in the UK are PCR and FISH. PCR (polymerase chain reaction) is used to detect a single gene disorder e.g. cystic fibrosis in an embryo. FISH (Fluorescent in situ hybridisation) is used to detect the sex of an embryo for the presence of a chromosomal rearrangement in an embryo.
The HFEA was set up in August 1991 as part of the Human Fertilisation and Embryology Act 1990. The HFEA's principal tasks are to license and monitor clinics that carry out in vitro fertilisation (IVF), donor insemination (DI) and human embryo research. The HFEA also regulates the storage of gametes (eggs and sperm) and embryos.
Page last updated: 11 March 2009
