Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative)

I beg to move amendment No. 143, in clause 18, page 13, line 29, after ‘person’, insert

‘and is so qualified by training and experience’.

The amendment relates to the variation of a licence. Under section 16 of the 1990 Act, the initial applicant had to satisfy the licensing committee that the character, qualifications and experience of the applicant were suitable. My understanding is that, under this Bill, the person to whom the licence is transferred will not need to satisfy the authority that they are anything more than suitable. There is a difference between those two definitions. One could have a suitable character without the required qualifications and necessary experience. Is the Minister happy with that difference? Would she not prefer a more robust system, with a new inspection under the person responsible or the licence holder?

Will the Minister also clarify whether there is a prohibition on the sale of a licence? Can a licence effectively be bought and sold within the context of the criteria I have just mentioned?

I have one further issue with regard to this amendment. In proposed new section 18A(3), a very clear distinction is made between

“the person responsible”

and

“the holder of the licence (if different).”

Will the Minister say how many licences have been granted where the person responsible and the licence holder are not the same person? In the revocation categories, again, it refers only to “the person responsible”, not the licence holder, which implies that one, “the holder of the licence”, is a subset of the other, “the person responsible”. If they are different, why are they not different in the revocation categories, and if they are the same, why is there a distinction in the first part of clause 18?

Roger Gale (North Thanet, Conservative)

The hon. Gentleman has indicated a rather broad range of questions, which effectively constitute a stand part debate. I am perfectly content with that.

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.

Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative)

I am grateful to the Minister for that reply. The only outstanding issue is the one to which she referred at the end. It would be helpful if after the Committee I could explain to her in more detail what I feel is not consistent. Perhaps I was not clear enough in my explanation—I will not go through it again now, but it is something that should be looked at. I am happy to receive a response from the Minister after she has had a chance to discuss it with her officials and I beg to ask leave to withdraw the amendment.