General Medical Council
Regulating doctors, ensuring good medical practice
December 2004
The objective of this Memorandum is to set out the framework that the Human Fertilisation and Embryology Authority (HFEA) and the General Medical Council (GMC) have agreed for co-operation and collaboration.
Collaboration between the HFEA and the GMC will:
This Memorandum does not affect existing statutory functions or amend any other policies or agreements relating to the activities of the HFEA and the GMC.
The HFEA was established under the Human Fertilisation and Embryology Act in August 1991 to assure patients and the wider public that research and treatment undertaken in the field of assisted reproduction is conducted at the highest standards and with a robust ethical framework. The Authority's key responsibility is the licensing and monitoring of clinics and centres in the United Kingdom carrying out in vitro fertilisation, donor insemination and human embryo research. Its principal statutory functions are to:
The Authority's other tasks are to:
The GMC licenses doctors to practise medicine in the United Kingdom. The law gives the GMC four main functions:
This Memorandum relates to the areas of interface between the HFEA and the GMC. It does not place additional responsibilities on either organisation; or imply any transfer of responsibility from one to the other or sharing of statutory responsibilities.
Interfaces may arise between the GMC and the HFEA:
All arrangements for collaboration and exchange of information, set out in this Memorandum, will take account of the provisions of S.33 of the 1990 Act. This prohibits the HFEA from disclosing information received for the purposes of S.31(2) of the Act, * except where the disclosure is made so that no individual to whom the information relates can be identified. This prohibits the HFEA from disclosing information received for the purposes of Section 31 of the Act, or any other confidential information received.
Even where patients or gamete donors give consent to the Authority to the disclosure of S.31 information the HFEA cannot disclose it. It will be for the patient to provide it. The clinic may also provide the information if the criteria set out in S.33 (6) are satisfied.
Any other information obtained by the Authority on terms or in circumstances requiring it to be held in confidence cannot be disclosed by the Authority, except with the consent of the person(s) whose confidence would otherwise be protected, or which has been lawfully made available to the public before the disclosure is made.
Where issues referred by the HFEA to the GMC involve patient-related or other confidential information, the case will be referred with the data anonymised. If the GMC felt action was justified, the HFEA might then seek the necessary consent to disclosure.
It is understood by the HFEA and the GMC that statutory and other constraints on the exchange of information will be fully respected, including the requirements of the Data Protection Act and the Human Rights Act.
Subject to the statutory and other constraints, the working relationship between the HFEA and the GMC will be characterised by regular on-going contact and open exchange of information, through both formal and informal meetings and at all levels, including senior levels.
Each organisation will respect and, as appropriate, take steps to protect the confidential nature of documents and information that the other may provide.
The HFEA has legal powers to require information by Directions from any person for legitimate purposes.
The GMC has the power to demand documents from a third party. This includes documents provided to or prepared by the HFEA in confidence for purposes relating to the 1990 Act. The GMC may ask HFEA representatives to give evidence in person. Any oral evidence given by HFEA representatives would, other than in exceptional circumstances at the discretion of the relevant GMC Committee, be given in public. This does not affect the prohibition on disclosure of information in Section 33 of the 1990 Act.
Should the HFEA provide documents for use by the GMC, such documents will normally be disclosed to the doctor or doctors concerned, if any, by the GMC.
The arrangements will be kept under review by focal points at the HFEA and the GMC, whose details are at Annex A.
Examples of how the two organisations will exchange information and co-ordinate their activity include:
The HFEA and the GMC will also collaborate on external communications. This will include, for example:
An inspection or investigation conducted by the HFEA, or information received by the HFEA, may identify an issue that might raise a question about an individual doctor's fitness to practise. This could include issues which relate specifically to matters within the Authority's licensing jurisdiction, or matters not directly covered by the 1990 Act, but appropriate for referral to the GMC. The majority of such cases will originate in the work of regulation and Licence Committees. Where the Director of Regulation or a Licence Committee concludes that a referral to the GMC is appropriate, this will be undertaken by the Director of Regulation or his/her deputy.
It will be a matter for a Licence Committee, or the Director of Regulation in consultation with the Chief Executive, to determine when a referral to the GMC is made. The Licence Committee may also have to consider making a proposal to revoke a licence in view of the issue under discussion, which would involve giving the Person Responsible the opportunity to make representations before any conclusion is reached. However, this should not preclude a referral to the GMC at an earlier stage, and should not be construed as the Licence Committee prejudging the matter in advance of any representations.
If the issue raised does not relate to a licensed centre, or come within the Authority's jurisdiction, the referral to the GMC should be made by the Director of Regulation, after consultation with the Chief Executive.
In all cases, HFEA staff may, and will be encouraged to, seek informal or formal advice from the GMC focal points (listed at Annex A).
In keeping with the character of their working relations, the GMC and the HFEA will discuss matters as openly and as regularly as possible by both formal and informal contact. The GMC may raise issues with the HFEA through these meetings.
Under Section 35B(2) of the Medical Act 1983, as amended, the GMC may disclose to any person any information relating to a practitioner's conduct, professional performance or fitness to practise which the GMC consider to be in the public interest to disclose. The GMC's policy intent is to disclose such information to the HFEA when the GMC considers that to be in the public interest. The GMC may write formally to the Director of Regulation to disclose information about a fitness to practise investigation and/or to invite the HFEA to consider appropriate action. Any formal approaches to the HFEA will be taken by, or on behalf of, the Director of Fitness to Practise. The person referring the issue to the HFEA will decide, on a case by case basis, whether it is appropriate to identify to the HFEA the doctor being considered by the Fitness to Practise Directorate. The HFEA will assess any information or invitation received against the provisions of the 1990 Act and its Code of Practice.
Information passed to the HFEA may result from fitness to practise investigations. These investigations may relate to individual medical practitioners within centres licensed by the HFEA. Also, performance assessments under the GMC fitness to practise procedures may identify dysfunctional units or services.
In the event that revalidation groups, or individual members of those groups, consider that the HFEA should be informed of a concern, they will raise this issue specifically and explicitly with a focal point at the GMC. The GMC will decide whether to raise the matter either formally or informally with the HFEA. When informing the HFEA, in all cases this will be to the Director of Regulation or his or her deputy or named representative.
It is possible that an investigation by the GMC into a doctor's practice could coincide with a HFEA investigation or inspection at a licensed centre. This should emerge from the regular information-sharing detailed above. Should such a situation arise, both organisations will be guided by the following principles:
Any disagreements will normally be resolved amicably at the working level. If this is not possible senior managers at both organisations should seek to settle any issue. The Director of Regulation at the HFEA and the Director of Fitness to Practise at the GMC will jointly be responsible for ensuring a mutually satisfactory resolution.
This Memorandum will be reviewed annually in April by the focal points listed at Annex A. They will report their review to the Director of Regulation at the HFEA and the Director of Policy at the GMC, who will jointly decide whether and how to report both to members of the HFEA and to the members of the General Medical Council.
Signed:_____________________________________ Date: ________________
Angela McNab
Chief Executive
Finlay Scott
Chief Executive GMC
Caledonia House, 221 Bloomsbury Street, London WC1B 3HF
Angela McNab Chief Executive Tel. 020 7291 8214
Trish Davies Director of Regulation Tel. 020 7291 8240 Trish.Davies@HFEA.gov.uk
Regent's Place 350 Euston Road London NW1 3JN
Finlay Scott Chief Executive/Registrar 020 7189 5015 opce@gmc-uk.org
Simon Marcelli 0207 189 5027 smarcelli@gmc-uk.org Responsible for Memorandum and liaison with other organisations
Jane O'Brien Head of Standards and Ethics 0207 189 5417 jobrien@gmc-uk.org
Neil Marshall Head of Screening 020 7189 5153 nmarshall@gmc-uk.org
* This covers the treatment and keeping or use of gametes or embryos relating to identifiable individuals, or data relating to an identifiable individual who was or may have been born as a result of treatment services.