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The HFEA Code of Practice is being updated – here's how to get involved

30 April 2018
By Laura Riley
Head of Regulatory Policy, Human Fertilisation and Embryology Authority
Appeared in BioNews 947

An updated edition of the Human Fertilisation and Embryology Authority (HFEA) Code of Practice is currently open for consultation, until Friday 1 June. The HFEA produces the Code of Practice to help licensed clinics to comply with the legal requirements set out in the Human Fertilisation and Embryology Act. The new edition aims to provide all staff at licensed clinics with a clear and up-to-date reference point about the HFEA's expectations in relation to interpreting the law that governs all our work. 

This edition of the code has some new inclusions and other wide-ranging revisions, particularly relating to:

  • emotional support – requiring clinics to have a policy setting out how all staff will provide emotional support before, during and after treatment
  • information for patients – requiring clinics to provide information about the effectiveness of treatments and treatment add-ons, strengthened guidance relating to Ovarian Hyperstimulation Syndrome (OHSS) and other treatment risks, encouragement for centres to display their success rates 'per embryo transferred'
  • leadership in relation to patient care and clinic activities – making explicit reference to supporting leadership capability and training, the Person Responsible's authority and autonomy to carry out the role to the best of his or her abilities (including where the Person Responsible is not the sole owner of the clinic), expectations towards evidence that Persons Responsible have systems in place to ensure that staff understand their legal obligations, are competent, have access to appropriate training and development, and can contribute to discussions and decisions about patient care

Other areas of guidance where we propose amendments include around extension of storage, consent, screening, egg sharing, OHSS and surrogacy.

We note an increasing appetite at clinic level for more guidance around surrogacy arrangements. Furthermore, the Department of Health and Social Care recently issued new guidance around surrogacy arrangements in England and Wales, and plans to seek an update in the law in relation to surrogacy. If passed, for the first time this would permit intended parents who are single people, to apply for parental orders to transfer legal parenthood to themselves.

The HFEA's new draft code therefore seeks to clarify what clinics should consider when treating people entering into a surrogacy arrangement, including around considering candidates' suitability to enter into a surrogacy arrangement, and the need for appropriate emotional support to be provided throughout the process. We have proposed that implications counselling be provided to the parties in advance of surrogacy arrangements, to help both the surrogate and intended parents to understand the arrangement and its implications for them.

To help inform the development of this new draft edition, the HFEA convened a Code of Practice Review working group in December 2017, made up of clinicians, embryologists, counsellors, nurses and other key stakeholders delivering licensed fertility services to patients – the core professional audience for the code. We also engaged directly with relevant professional and regulatory bodies, patient groups and licensed clinic representatives on relevant areas of the draft code.

One of the most valuable approaches to us in the development of the draft Code of Practice was holding open workshops about our Code of Practice review in early 2018. These were an opportunity to talk through the proposed changes with over 100 attendees, gathered from all disciplines and working at all levels of clinical care and research practice. 

These workshops – held in London, Edinburgh, Manchester and Bristol – were incredibly valuable to us in developing a shared understanding of what these proposed changes will mean to clinical and research practice. 

Staff from licensed centres across the UK shared examples of their good practice in raising the overall standards of care and support that all patients can expect, for which we thank them. They have directly informed both the revised code drafting and changes to the relevant directions and our policy thinking at the HFEA. Thank you to all who attended those workshops.

One of the striking outcomes of the workshops was the commonality of themes and often quite strong consensus on the proposed direction of travel that arose. We will take account of all views, and this public consultation forms an important part of doing that. However, we also hope that the support for principles within the new Code – particularly around patient emotional support, information provision and leadership – that we heard at the workshops, is reflective of our ongoing efforts to build a two-way, listening regulatory relationship where we engage the sector well in advance of, and outside of, the set points for formal public consultation. 

After this consultation closes and the HFEA has taken account of the responses, then with the approval of the Secretary of State for Health, the new edition of the Code of Practice will come into force in October 2018. 

How to give us your comments

  • The consultation is available online as a web-based survey. This includes excerpts from the new draft code text for comment.
  • The same consultation survey questions and new draft code excerpts are also available in PDF format. These can be emailed back to the HFEA at enquiriesteam@hfea.gov.uk.
  • The updated draft new edition of the Code is available to view in full (with the proposed revisions highlighted). 

If you have any questions about the consultation process or the new edition of the code, please contact Erin Barton at the HFEA on erin.barton@hfea.gov.uk.

SOURCES & REFERENCES
HFEA Code of Practice
HFEA |  1 October 2017
RELATED ARTICLES FROM THE BIONEWS ARCHIVE
8 May 2018 - by Anthony Ryb 
Should everyone stepping through their doctor's door enquiring about fertility treatment receive a counselling session? Probably not, although in most situations it would certainly be useful for them. Should everyone who has decided to go ahead with fertility treatment receive a counselling session prior to starting treatment? In my opinion, that is a definite yes...
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