Clause 18
Human Fertilisation and Embryology Bill [Lords]
3:00 pm
Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)
The Bill simplifies provisions in order to allow the HFEA to determine applications by a licence holder in a more flexible manner. However, this does not change the strict criteria for determining whether people are suitable to be the person responsible. That remains the same.
In 2005, the HFEA, in consultation with stakeholders, took a decision to revise its assessment process for the person responsible, and there are now formal assessments to ensure that the designated person is proficient in their role and up to date with the latest developments in their field. This process consists of various assessments that the person must satisfy. For a research licence, for example, the assessment consists of three workbooks that must be completed by the designated responsible person. One is on the regulatory framework, one is on quality management and risk, and the third covers research regulations. The workbooks also include details outlining certain person specifications, including qualifications. They state all relevant medical, biological, scientific or professional healthcare qualifications, and require the applicant to demonstrate experience, including experience and extensive knowledge of fertility-related management, clinical and scientific developments and treatments, including ethical viewpoints.
The hon. Member for Boston and Skegness went on, as he did before, to ask about the process and refusals in varying or revoking a licence. All the decisions relating to granting, revoking, suspending or varying a centre’s licence are taken by the licence committee of the authority, based on inspection. Inspections need to assess quality, effectiveness of the clinical management, and a whole list of things that I will not read into the record. I will write to him about them.
He asked specifically whether a licence could be sold, passed on or transferred to another responsible person. It could be, but the HFEA must approve any transfer of licence, and it would need to be satisfied that the transfer would go to a responsible person and under all the conditions that I have outlined, as agreed after the 2005 consultation process.
I do not know the answer to the hon. Gentleman’s last question about whether there is a difference between a responsible person and a licence holder. I have a feeling that there is not, but I do not want to commit myself unnecessarily to that and I will come back to him. I hope that he is satisfied that measures are still there to ensure that the responsible person is properly qualified and experienced in the relevant fields, and that the HFEA will scrutinise the licence and the responsible person very closely.