The HFEA improvement programme

At the Human Fertilisation and Embryology Authority (HFEA) we are making changes and improving the way we regulate and provide information. The Human Fertilisation & Embryology Bill and other regulatory changes have given us the opportunity to review the way we work and embark on an improvement programme that will encompass all aspects of our work.

This improvement programme will be carried out with consultation of our stakeholders, centres, patients, donors and the public to ensure that all changes are properly reviewed before implementation. The two main areas of change will be in how we regulate centres and how we provide information for all audiences.

Regulation

Overview

Our objective is to improve the effectiveness and usability of the Code of Practice as we revise it to comply with the new requirements of Human Fertilisation and Embryology legislation. Also, we will ensure we pay a proper regard to the "better regulation" requirements in the recent Regulators´ Compliance Code.

The main focus of our regulatory improvements will be the new 8th Code of Practice and related improvements to our inspection licensing and processes including better linkage between our inspection process and the revised code.

Our Approach

The key aspects of our approach to the new Code of Practice are:

• To help and encourage licensed centres to understand and meet regulatory requirements more easily
• To better differentiate between requirements and guidance
• To remove unnecessary guidance and reduce complexity
• Greater consistency and alignment to the Inspection Process.

Developing the Revised Code of Practice

The principles and guidance that will form the 8th Code are currently being drafted. A consultation workshop of 16 representatives from a broad range of centres was held on 25 June 2008 as a first step in an informal consultation process to help ensure the draft code meets requirements.

A second workshop with centres will be held on 22nd October.This will be followed by a formal consultation exercise starting this November and finishing in February 2009.

Implementation of the new Code is expected to take place in October 2009 and we aim to ensure centres have ample time to implement the changes.

Information

Overview

Legislative changes will require us to open up our Register to researchers and donors, and to broaden the rights of access for donor-conceived people. Also, centres will have new requirements for collecting and distributing information.

Ensuring Best Practice in Collecting and Providing Information

At the HFEA we have put the following programme in place:

• Instigating a root and branch review of internal and external information requirements
• Developing disclosure of information policies covering Opening of the Register and Information for Researchers
• Implementation of the Cabinet Office´s Information Governance and Assurance Programme
• Upgrading IT systems to deliver additional information requirements
• Undertaking a thorough review of the presentation of clinical data and the measurement of performance by licensed centres with consultation with clinicians and other stakeholders.

We are involving centres and stakeholders in the improvement of collection and provision of Information.

We are involving stakeholders throughout this process of developing our information provision. Three user forums have been organized with clinicians to discuss the new version of EDI and the future modification of Register Forms.

Meanwhile, we have been visiting centres up and down the country to directly seek your views.

From November, information presentation and the performance measurement of licensed centres will form an important part of the public consultation programme alongside the revised Code of Practice.

In addition, we will be organising events with researchers and patients, donors and members of the public to discuss their information requirements.

For further information contact Rachel Hopkins at rachel.hopkins@hfea.gov.uk

Also see, FAQs - HFEA Improvement Programme