Abortion (Scotland) Amendment Regulations 2021 – proposed changes: business and regulatory impact assessment

2. Purpose and intended effect

The Abortion (Scotland) Amendment Regulations 2021 (the 2021 Regulations) amend the Abortion (Scotland) Regulations 1991 ("the 1991 Regulations") to change the arrangements by which notifications of a termination of a pregnancy must be given to the Chief Medical Officer (CMO) by a registered medical practitioner (RMP – in other words a doctor) who has carried out the termination of pregnancy.

The changes aim to modernise the process for providing notifications to the CMO and also streamline the process by which data about abortions is submitted by providers, which is currently via the CMO as part of the notification. The 2021 Regulations will make the following changes to the 1991 Regulations:

• increase the deadline for giving notice of a termination from "within 7 days" of the termination to "before the fifteenth day of the calendar month immediately following the calendar month in which the practitioner terminated the pregnancy";
• remove the restriction that notifications must be sent by post or delivered in a sealed envelope, so allowing notice to be given using electronic communication as an alternative;
• remove the form currently prescribed in the 1991 Regulations (which is commonly known as the 'yellow form') which requires information to be provided including about the woman who has had a termination, the termination itself and the doctor who terminated the pregnancy;
• require a simpler notification to be sent to the CMO containing only the name of the doctor who terminated the pregnancy and the name of the doctor's employer (Health Board or private abortion provider).

Currently, patient data provided as part of a notification is used by Public Health Scotland (PHS) to create abortion statistics. As a consequence of the fact that detailed patient data will no longer be part of the notification to the CMO, arrangements will be put in place by PHS to receive this data directly from providers electronically, for the purpose of producing abortion statistics.

To provide assurance that patient data will continue to be collected by PHS for the creation of statistics, the intention is that Scottish Ministers will issue a Direction to Health Boards requiring that they provide such data to PHS. The one approved private provider has given an undertaking to provide data directly to PHS.

2.1 Background

There are over 13,000 terminations carried out every year in Scotland. The Abortion Act 1967 sets out legal requirements which must be met before an abortion can be carried out lawfully in Scotland. The Act requires the Scottish Ministers to make regulations to require the RMP who terminates a pregnancy to give notice of the termination, and such other information as the Ministers wish to provide for in those regulations, to the CMO.

The 1991 Regulations set out requirements which must be met in relation to the notifications made to the CMO. They require that notifications are made within seven days of the abortion taking place; that notifications must be sent by post or delivered in a sealed envelope, and that they must include certain information, as currently prescribed by the yellow form included in Schedule 2 of the 1991 Regulations.

The Regulations permit the information provided in the notification forms to be shared by the CMO with PHS, which uses the information contained in the forms to produce abortion statistics.

Current practice

Currently, the 'yellow form' is filled in by hand, usually by NHS Board admin staff, and signed by the relevant doctor. Patient data, including that provided as part of the consultation with the patient, is usually retrieved from NHS IT systems in order to complete the form.

The forms are placed in sealed envelopes and are sent by courier or recorded delivery, or hand delivered, to the CMO within seven days of the abortion taking place. The CMO's office then transports the envelopes to PHS. Staff in PHS then enter the data they require from the forms onto its Abortion Act Scotland electronic database in order to allow them to compile abortion statistics. The hard copies of the forms are kept securely locked away for six years before being securely destroyed.

2.2 Rationale for Government intervention

The 2021 Regulations are necessary to enable notifications to the CMO to be sent electronically (for example by email) and to update the requirements around notifications to ensure that special category (formerly known as 'sensitive') personal data is no longer sent to the CMO in order reduce data security risks. The extended time limit for notifications also takes account of the fact that some doctors find it difficult to meet the seven day timescales due to work pressures.

These changes are needed to improve the security of personal data provided for the abortion statistics and reduce any risks of a data breach by asking providers to submit this directly to PHS in future via secure electronic means, rather than submitting the data to CMO on paper forms and CMO's office then transferring the forms on to PHS to enter the relevant information in their database. While steps are already made to mitigate risks of data security breaches, minimising the numbers of individuals needing to handle and having access to the data, as well as using electronic transfer, is expected to reduce risks further. Given that most other health data is already provided directly to PHS electronically, this will ensure data is provided in a more efficient and secure way.