New procedure will speed up approval for embryo screening
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《英国医生杂志》
Clinics with experience in screening embryos will have their applications to perform pre-implantation genetic diagnosis fast tracked under new procedures, the government抯 fertility watchdog announced last week.
Applications to perform pre-implantation genetic diagnosis may be approved without first having to go through the lengthy application process of the licence committee of the Human Fertilisation and Embryology Authority (HFEA), as long as the applying clinic has proven expertise in performing embryo biopsies and wishes to screen for a condition already being successfully tested for in another clinic. Such conditions include sickle cell anaemia, cystic fibrosis, and Duchenne抯 muscular dystrophy. Clinics must have a qualified biopsy practitioner for the procedure.
Suzi Leather, the authority抯 chairwoman, said: "Our approach to regulating clinical techniques is that we should be cautious and thoroughly consider treatments on a case by case basis. 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. It should be straightforward for those clinics with a proven track record 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 patients and clinicians."
The antiabortion organisation Life has deplored the authority抯 decision. Its spokesman, Matthew O扜orman, said, "This is yet another step towards making commonplace the practice of designing children to suit parental requirements. Any legislation that seeks to relax the laws that are in place to safeguard the dignity and individuality of human beings from the moment they are conceived is morally repugnant,"
Eight clinics are currently licensed to carry out the procedure in the United Kingdom. A single cell is taken from an embryo produced by in vitro fertilisation and is tested for a disease. Only embryos free from the faulty gene are transferred into the womb. Polymerase chain reaction and fluorescent in situ hybridisation are the two established tests for disease. The tests can detect a single gene disorder, such as that which causes cystic fibrosis, or detect the sex of the embryo and the presence of a chromosomal rearrangement.
Ms Leather said: "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."
Certain applications to perform the procedure will still require approval under the old, lengthy system. These include applications to screen for conditions not already being tested for in the procedure, tissue typing, and screening for adult onset conditions.(BMJ Kunal Khanna)
Applications to perform pre-implantation genetic diagnosis may be approved without first having to go through the lengthy application process of the licence committee of the Human Fertilisation and Embryology Authority (HFEA), as long as the applying clinic has proven expertise in performing embryo biopsies and wishes to screen for a condition already being successfully tested for in another clinic. Such conditions include sickle cell anaemia, cystic fibrosis, and Duchenne抯 muscular dystrophy. Clinics must have a qualified biopsy practitioner for the procedure.
Suzi Leather, the authority抯 chairwoman, said: "Our approach to regulating clinical techniques is that we should be cautious and thoroughly consider treatments on a case by case basis. 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. It should be straightforward for those clinics with a proven track record 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 patients and clinicians."
The antiabortion organisation Life has deplored the authority抯 decision. Its spokesman, Matthew O扜orman, said, "This is yet another step towards making commonplace the practice of designing children to suit parental requirements. Any legislation that seeks to relax the laws that are in place to safeguard the dignity and individuality of human beings from the moment they are conceived is morally repugnant,"
Eight clinics are currently licensed to carry out the procedure in the United Kingdom. A single cell is taken from an embryo produced by in vitro fertilisation and is tested for a disease. Only embryos free from the faulty gene are transferred into the womb. Polymerase chain reaction and fluorescent in situ hybridisation are the two established tests for disease. The tests can detect a single gene disorder, such as that which causes cystic fibrosis, or detect the sex of the embryo and the presence of a chromosomal rearrangement.
Ms Leather said: "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."
Certain applications to perform the procedure will still require approval under the old, lengthy system. These include applications to screen for conditions not already being tested for in the procedure, tissue typing, and screening for adult onset conditions.(BMJ Kunal Khanna)