Regulation Committee

Terms of reference

1. Constitution

1.1 The Authority hereby resolves to establish a Committee to be known as the Regulation Committee ("the Committee"). The function of the Committee is to oversee the work of the Authority in relation to the licensing and inspection of treatment, storage and research facilities, and to formulate regulatory strategy on behalf of the organisation.

2. Membership

2.1  The Committee shall be appointed by the Chair from amongst the members of the Authority. The Committee shall include all Chairs of Licence Committees and shall consist of five or more members. The Committee shall comprise adequate representation by clinical and scientific members of the Authority and by members with an understanding of the patient perspective of fertility treatment. A quorum shall be not less than 50% of the total membership.

2.2 The Committee will be chaired by a lay member, and will include lay and non-lay members.

2.3 Members are appointed for a term of three years, and membership will be subject to regular review.

3. Attendance

3.1 The Director of Regulation, and such other members of the Executive staff as s/he may deem necessary, shall normally attend meetings. The HFEA Chair may attend at his/her discretion.

4. Frequency

4.1 Meetings shall be held up to 10 times a year, but will meet virtually if required for specific advice or if there.are urgent items needing consideration.

5. Delegated Decision Making Powers

5.1  The Committee will approve the annual plan of inspection of licences.

6. Duties

6.1 Licensing & Inspection

• To ensure the strategic development of HFEA regulation, in line with the wider corporate objectives.
• To ensure through review that effective procedures for the licensing and inspection of treatment, storage and research facilities are in place.
• To monitor the operation of licensing and inspection procedures, including management of risk; and to make regular reports to the Authority.
• To keep licensing and inspection policies under review, and to make recommendations to the Authority for any change.
• To ensure appropriate guidance is available to applicants and licence holders.
• To ensure appropriate recruitment, training and monitoring systems are in place for Inspectors.
• To ensure through review that effective procedures are in place to provide accurate information for  patients and to ensure that their safety, needs and views are monitored.

6.2 Code of Practice

• To keep under review the content and operation of the Code of Practice.
• To make recommendations to the Authority for any revisions or additions to the Code.

6.3 General Duties

• To conduct the business of the Committee in accordance with Standing Orders.
• To ensure members of the Committee comply with the Code of Conduct in relation to declaration of interests.
• To ensure that the work of the Committee reflects and implements the objectives of the Corporate and Business Plans agreed by the Authority.
• To submit to the Authority an annual report on the Committee's effectiveness.
• To submit to the Authority an annual report on the work of the Committee, in time to contribute to the Authority's Annual Report, and provide regular informal reports as necessary.

7.  These Terms of Reference were agreed on 9 May 2007, and will be reviewed  annually.