1. Do you agree with the option to transfer all HFEA and HTA functions to CQC with the exception of HFEA functions relating to research that will transfer to the HRA and abolish the HFEA and HTA? Please explain why you think this.
The Association of Anatomical Pathology Technology (AAPT) does not consider the CQC best placed to deliver the effective and detailed regulation that is required in this sector, as it has no previous experience in this highly specialised area. Both HFEA and HTA are expert regulators in their field and their inception was for that specific reason – expert regulation in a highly specialised field where public confidence is paramount.
• CQC is more of a ‘broad-brush’ regulator that, although does undertake some specialist regulation (e.g. Mental Health Act Commission), we believe there is a lack of resources to undertake this specialist role safely and effectively.
• The requisite expertise already exists within HTA and a culture of regulation is already established.
• HTA is visibly committed to maintaining public confidence in an emotive and frequently high-profile subject area.
• HTA has a proven track record of understanding the work undertaken in the post mortem sector and working with professionals, such as Anatomical Pathology Technologists (APTs), to achieve clear standards for the safe, ethical and respectful examination of the deceased, and the removal of tissue and organs for scheduled purposes under the HT Act.
2. Can you quantify what impact this could have at a local level (either in relation to service providers or patients or both)?
• Loss of sector confidence in the regulatory system and resultant reluctance to engage.
• Uncertainty and increased risk of non-compliance during any transfer of functions.
• Loss of focus in larger, multi-sector regulator.
• Loss of confidence by the public. The HTA were created as a result of the Human Tissue Act 2004 and were the statutory regulator directly responsible for ensuring public confidence after the various enquiries into tissue retention.
3. Do you agree that HFEA functions relating to research should be transferred to the HRA? Please explain why you think this.
HFEA has built public confidence over a period of time and, as the incidence of IVF continues to increase, it would seem reasonable that HFEA retained all its current function.
4. Do you think that some HFEA and HTA functions might sit better with bodies other than CQC and the HRA? If so, which functions and which organisations and what do you see as the advantages of the alternative organisation?
The AAPT believes not. It would seem more appropriate that the functions of both the HFEA and the HTA should remain with their respective authorities, although some financial savings may be made by more efficient running and budgetary constraints.
5. Do you believe the HFEA and HTA should retain existing functions but deliver further efficiencies? Please explain why you think this.
Yes, provided the efficiencies proposed are realistically achievable and will not risk or dilute regulatory effectiveness.
6. Do you think that retaining functions with the HFEA and HTA could deliver savings to the public purse? If so, please explain how and quantify
Further to the answers above, it may be worth investigating whether the cost of certain practical aspects, such as physical inspection infrastructure, could be shared with another organisation already carrying out an inspecting role in the sector.
Clearly, an assessment of the suitability of the organisation and inspector, practical issues, governance, robustness of inspection, etc. would have to be carried out by HTA, but some saving in terms of rationalisation of process / staff / admin costs may be possible.
7. Within the option of retaining the HFEA and the HTA as independent regulators, are there any of their functions you think should be transferred elsewhere and, if so, which and why?
The AAPT believes that all HTA regulatory functions should remain together in a single organisation.
8. Do you have any comments on our assessment of the efficiencies associated with the different options in paragraphs 154-158 above and in the accompanying consultation Impact Assessment?
The proposed savings largely arise from rationalisation of Senior Staff, which the AAPT has no fundamental objection to, however, the statement that ‘much of the detail of how functions would be carried out by the recipient bodies would be for those organisations to decide’ concerns us. It is our belief that this specific detail is key to this consultation, and will naturally determine whether effective, safe regulation can be achieved and maintained by any successor body.
9. This consultation focuses specifically on where functions might sit and implementation will be at the discretion of the regulators. However, if you have any views as to how functions might be undertaken in future or other issues of concern that we could share with the bodies undertaking these functions as they plan for the future, please let us know.
Whatever the proposals, the AAPT is clear that the functions currently undertaken by the HTA should be kept together – to separate these functions would potentially lead to more complexity and increased risk of unlawful and/or unsuitable practices, diminishing the progress made in increasing public confidence. The HTA has improved standards in mortuaries run by the NHS, as well as Local Authorities. It is imperative that functions should continue to be undertaken by the HTA, in order that working practices continue to improve across the country as they have since 2005.
10. Do you have any other comments on the consultation proposals that you would like to share with us?
Since the HTA’s inception, it has sought to engage with APTs, through the AAPT. Therefore, a general culture of understanding and respect between the regulator and the ‘regulated’ has developed, which, along with other safeguards, such as the proposed statutory registration of APTs, is key to meaningful future development in the oversight of the post mortem sector.
Therefore, within this context, the AAPT supports option 3.
11. Can you provide examples of costs and benefits of these proposals?
Both HFEA and HTA have made considerable cuts to expenditure over the last few years. To transfer their function to regulatory bodies with little experience within these highly specialised fields can only be costly, either to the public purse, or to public confidence, especially as the reconfiguration of regulation is implemented.
12. Do you have any comments on the consultation Equality Analysis?
The Equality Analysis refers to the fact that “as the intention to continue to perform the current range of functions and maintain the level of expertise in the receiving organisations we do not envisage that this will impact the public”. As previously mentioned in section 8, the AAPT does not believe that there is sufficient detail for this part of the EA to be truly meaningful.