What type of licence will you need to apply for?
Licensed activities
The HFEA has the power to issue a number of different types of licences, depending upon which activities a clinic or laboratory wishes to carry out. For example, a clinic wishing to carry out IVF or associated treatments will need to obtain a ‘Treatment and storage’ licence. The main types of licences are:
- Treatment – for clinics offering IUI and other basic fertility treatments which do not involve the creation of embryos
- Treatment and storage – for clinics offering IVF, ICSI and gamete and embryo storage
- Treatment (including embryo testing) and storage – for clinics offering IVF, ICSI, gamete and embryo storage and embryo testing
- Research – for laboratories carrying out research on human embryos
Each type of licence allows the clinic or laboratory to carry out certain licensed activities. So, a clinic with a ‘Treatment’ licence may process and use gametes, but it may not create or store embryos, whilst a clinic with a ‘Treatment (including embryo testing) and storage’ licence may carry out any of the activities permitted by the Human Fertilisation and Embryology Act.
Authorised processes
Licensed clinics are also authorised to use certain laboratory processes in order to carry out each licensed activity. For example, clinics carrying out the licensed activity ‘Creation of embryos’ can use IVF or ICSI to do so.
The table below shows which processes are authorised for use in clinical practice.
|
Licensed activity |
Authorised processes |
| Procuring gametes | Egg collection Surgical sperm collection Ovarian tissue collection |
| Keeping gametes | Culture of eggs |
| Processing gametes |
Semen preparation (including the use of reagents to increase sperm motility) |
| Distribution of gametes | Transfer of sperm between centres Transfer of eggs between centres |
| Use of gametes | IUI GIFT IVF ICSI |
| Storage of gametes | Freezing of eggs Freezing of sperm Vitrification of eggs Freezing of testicular tissue (not for transplantation purposes unless a HTA licence is in place) Freezing of ovarian tissue (not for transplantation purposes unless a HTA licence is in place) |
| Storage of embryos | Freezing of pronucleate embryos Freezing of early cleavage embryos Freezing of blastocysts Vitrification of embryos Vitrification of blastocysts |
| Creation of embryos | IVF ICSI |
| Procuring embryos | Lavage |
| Keeping embryos | Culture system |
| Testing embryos |
PGD |
| Processing embryos | Culture Assisted hatching (mechanical, chemical, laser) Morphological grading Manipulation Thawing/re-warming of blastocysts and embryos Non-invasive assessments |
| Distribution of embryos | Transfer of embryos between centres |
| Placing permitted embryo in a woman | Embryo transfer |
| Using embryos in training | Embryo biopsy Blastocyst biopsy Cryopreservation and thawing techniques Vitrification Assisted hatching (mechanical, chemical, laser) Embryo handling and manipulation Assessment of embryos |
The table below shows which processes are prohibited for use in clinical practice.
Licensed activity
Prohibited process
Use of gametes
Use of immature sperm (e.g. spermatids)
Novel processes
If you wish to use a novel process, which does not appear either on the authorised or the prohibited processes lists, you may need to apply to the HFEA to seek permission to use it in clinical practice. *The HFEA’s Scientific and Clinical Advances Advisory Committee considered the use of Calcium Ionophore as an egg activation technique and highlighted the theoretical risks relating to embryo viability (eg, premature activation and triploid embryos).
The application will be discussed by our Scientific and Clinical Advances Advisory Committee (SCAAC), which will give advice on the safety and efficacy of the process to our Statutory Approvals Committee (see Standing Orders). The Statutory Approvals Committee will then decide whether or not to add the process to the authorised processes list. If it decides that it should, any clinic or laboratory may use the process, provided they are licensed to carry out of the associated licensed activity.
Apply to have a novel process considered
Given the theoretical risks of using Calcium Ionophore, centres using it are expected to do so only in selected patients, such as those with PLCz deficiency. Centres are expected to document their rationale for using Calcium Ionophore for individual cases. As with all treatments and processes, centres should ensure that patients are fully informed about the efficacy and potential risks and that validation is carried out.
Prohibited processes
If a process does not appear on the list above, it may have been considered by the HFEA’s Compliance Committee but determined to be inappropriate for use in clinical practice. This may have been because the Scientific and Clinical Advances Advisory Committee, on reviewing the evidence, has advised that there is not enough evidence of safety or efficacy about a particular process for it to be authorised for use in a clinical laboratory.
Page last updated: 28 August 2009