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18 November 1991

To All Directors of Centres

Dear Director

CONFIDENTIALITY OF PATIENT AND DONOR INFORMATION

Many of you have expressed concern about the effect of the confidentiality provisions in the Human Fertilisation and Embryology Act 1990 (HF&E Act). The Authority has sought advice on this matter and is now able to issue further guidance.

The Legal Position

Parliament decided that because of the sensitive nature of infertility treatment, especially that using donor gametes, patients should have control of information about their treatment which could identify them. The Act therefore, prohibits licensed infertility treatment and embryo research centres from disclosing identifying information about patients and donors to anyone except to the patients or donors themselves, to members and staff of the HFEA, to other people who are covered by a licence for the purpose of licensed activities and to the courts in rare circumstances specified in the Act*. Only the patient or donor may pass on identifying information to someone else. Breach of these confidentiality provisions in the Act is a criminal offence punishable by up to two years1 imprisonment or a fine or both.

Guidance given

The Authority has sought to give guidance to centres on the basis of the following tenets:

a. that the law is complied with;

b. that it is generally in the patients'  interest that treatment information relevant to her medical care is passed on to those involved in her care;

c. that the patient must be in control of the decisions about who receives what information about her treatment.

* Court cases under the Congenital Disabilities (Civil Liability) Act 1976 or to establish parentage.

Further Guidance

There has been some uncertainty about two particular aspects of confidentiality: the definition of treatment services and the people who may be covered by a licence. We have now received further legal advice about these two aspects of the confidentiality provisions which centres should find helpful:

i. the definition of treatment services

In the context of section 33(5) of the Act, the restriction on disclosure of information about treatment services relates only to information held by a person as a licence holder. It therefore covers any information about patients undergoing licensed treatment. This means that the HF&E Act imposes no restrictions on disclosure of information about procedures and treatments given by a licensed clinician to patients who are not undergoing licensed treatment services.

ii. persons to whom a licence applies

Under the provisions of 17(2) a licence can apply to:

a. the person responsible,

b. any person designated in the licence, or in a notice given to the Authority by the person responsible, as a person to whom a licence applies, and

c. any person acting under the direction of the person responsible or of any person so designated.

Where they have not already done so, centres should, therefore, inform the Authority about all those groups or individuals involved in providing treatment services who are acting under the responsibility of the person responsible so that they may be considered by a licence committee. To ensure that centres are complying, the licence committee will take account of section 17(1) of the Act and will wish to be assured that the person responsible is sure that

"the other persons to whom the licence applies are of such character, and are so qualified by training or experience, as to be suitable persons to participate in the activities authorised by the licence".

This may include, for example, theatre staff and laboratory staff. Inspectors will ask to see a list of all staff involved during the course of inspections. The person responsible should ensure that all such persons are aware of the implications of being covered by a licence. Under section 33(6) people covered by a licence may disclose identifying information about patients and their licensed infertility treatment to other people covered by a licence for the purpose of licensed activities. This does not affect the provisions in paragraphs 3.4 to 3.9 of the Code of Practice about passing information on to the GP.

Examples of other problems to which solutions have been found are attached at Annex A. The Authority is, however, aware that to comply properly with confidentiality provisions of the Act will mean a heavy and increasing burden for centres. The Authority has reached the conclusion that the confidentiality provisions of the Act are too restrictive. I have therefore written to the Minister for Health seeking her help in finding a solution.

I hope this is helpful. Please contact Jo Taylor on 071 600 3272 if you have any enquiries about this letter.

Yours faithfully

 

COLIN CAMPBELL
 
ANNEX A

Q1 How can a person covered by a licence arrange for information about a named patient's treatment to be passed on to an unlicensed practitioner who is also involved in the management of that patient?

A. A letter addressed to the patient may be passed through the patient to her GP and a centre may inform the GP that the patient has a letter to pass on if she wishes to do so. Alternatively a patient may request that the centre sends a copy of the letter to the GP on her behalf. In this case, centres should use the request form at Annex A to the Code of Practice and give the patient full details of the contents of the letter. The letter must still be addressed to the patient and the original sent to her at the same time as the copy is sent to the GP.

Q2 How can a GP being asked to prescribe drugs for a patient be informed about her treatment?

A. A letter addressed to the patient may be passed through the patient to her GP requesting that the drugs are supplied. A centre may inform the GP that the patient has the letter to pass on if she wishes to do so. As in the answer to Q1 above, the patient may request that the centre sends a copy of the letter to the GP on her behalf. In this case the centre should use the request form at Annex A to the Code of Practice and give the patient full details of the contents of the letter. The letter must still be addressed to the patient and the original sent to her at the same time as the copy is sent to the GP.

Q3 Can a licensed centre storing sperm for a cancer patient check with a GP that the patient is still alive?

A. When the patient is referred to a storage centre he should be asked to give his GP a copy of a letter from his specialist or from the centre stating that he is having sperm stored because of treatment for cancer which may affect his fertility. Once the GP has this information, the clinic may write to him asking if the patient is still alive without breach of the confidentiality provisions. For those patients with sperm already in store on 1 August, where a GP has already been informed of this fact, an approach can be made to the GP without breach of the Act.

Q4 Can a centre communicate with a patient's GP before the decision whether or not to provide the licensed treatment has been taken?

A. At this stage a centre is not giving information about the provision of treatment services to an identifiable person as it has not decided whether to treat the patient. A centre can therefore contact a GP about tests or a patient's suitability for treatment, with the patient's consent.

Q5 Can hospital staff outside the licensed infertility unit itself (eg theatre, general ward and laboratory staff) have access to information about a named patient where this is necessary for the provision of health care?

A. Staff who are involved with the provision of the treatment will be covered by the licence under section 17(2) of the Act if they are acting under the direction of the person responsible. All those covered by a licence may have access to information about a named patient for the purpose of providing licensed infertility treatment.

Q6 How can a licensed centre deal with district health authorities as is required under the new NHS management system?

A. This may be done by using a coding system so that the health authority is not given the name of the patient but a code number. Alternatively, the health authority is given only the number of treatment cycles provided for all patients within their health district. (Some health authorities have accepted this solution but we are aware that others are unhappy about paying for treatment without first checking that the patient is covered by their authority.)

Q7 Do the confidentiality provisions apply to other treatment not requiring a licence which may be given to enable women undergoing licensed treatment to carry children?

A. The definition of treatment services, for the purposes of the confidentiality provisions, only relates to information about patients undergoing licensed treatment.

Page last updated: 15 August 2012

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