14 June 1999
The HFEA explained in its 1997 Annual Report that it was modifying its licensing system to make it more efficient and cost effective. This resulted in the introduction of the three year licensing cycle with one full and two interim focused inspections and the greater use of the shortened application. That Annual Report also indicated that the HFEA would be considering how to refine its inspection and licensing system even further during 1998/99. This letter updates you on that work.
The HFEA recognises that a high percentage of existing centres understand the regulatory requirements. Conversely it often takes time for a new centre to adjust to the unique demands of the HFE Act. Taking these facts into account, the HFEA has sought to utilise those sections of the 1990 Act that accommodate flexibility within the licensing process. The resulting refinements that the HFEA will be introducing are summarised below.
- Centres that have been licensed for three consecutive years will now normally be granted three-year licences, but, if an inspection or event produces grounds for concern, it will be within a Licence Committee's powers to vary, suspend or even revoke a centre's licence;
- Centres that have not yet been licensed for three years would need to be the subject of two licence renewals before being offered a three year licence;
- The three year licensing cycle composed of one full and two interim (focused) inspections will remain. Full inspection teams will be used for all inspections associated with a licence's renewal. In deciding the composition of an interim inspection's team Licence Committees will be influenced by a number of factors including the size of the centre, its activities, the centre's recent history of compliance with regulatory requirements and any immediate Licence Committee actions taken to enforce compliance. Interim inspection teams will range from the equivalent of a foil inspection team through to an Inspector Co-ordinator acting alone;
- Inspection teams will continue to examine compliance with additional licence conditions, the adoption of recommendations and the suitability of premises. In order to achieve greater consistency between inspection teams regarding specialist areas, a series of checklists are being prepared regarding the clinical, embryological/andrological and social and ethical/counselling areas. A licence renewal inspection will cover all areas. Additionally patient treatment records will be examined at every inspection using a set procedure. This subject may be designated as a particular focus, if appropriate;
- Centres will continue to submit full licence applications prior to an licence renewal inspection, but interim inspections will be preceded by the submission of an information pack containing only material that had been changed since the previous inspection (changes will need to be clearly indicated), unless a Licence Committee specifies otherwise;
- Three standard licence conditions will be introduced requiring:
- the permanent display of the top sheet of a centre's licence (listing the procedures for which the centre is licensed and, where appropriate, the number of additional licence conditions specific to the centre) with the full licence being obtainable from the Person Responsible on request;
- the phased collection of licence fee income during the three year licence period; and
- the submission of information in support of an interim inspection.
It should be noted that:
- The changes outlined above apply only to the renewal of treatment and storage licences;
- Since the HFEA already operates a three year licensing cycle, Licence Committee decisions regarding inspections will remain in force for the duration of current licences. The revised system will be systematically phased in with centres issued with one, two and three year licences according to their existing position in the current cycle until all centres have three year licences. This will not result in any centre being placed at a financial disadvantage; and
- The issuing of three year licences and the systematic identification of inspection teams will commence in June 1999.
The HFEA believes that these changes represent an evolutionary step and that they should reduce the stresses and strains associated with licence renewal.
Should you have any queries or anxieties regarding the revised system, please take them up initially with your Inspector Co-ordinator, She will also inform the Licensing Manager and the Chief Executive of these so that common queries and concerns can be addressed on a collective basis. Queries regarding the revised system may also be raised at inspections, regional meetings or whenever you happen to be at Paxton House. If you are still troubled by the changes, we can arrange to visit you at your centre to discuss them. The HFEA intends to monitor these changes and would welcome your feedback.
I trust that together we can ensure that the introduction of these refinements is a success.
Mrs Ruth Deech
Page last updated: 03 April 2009