The McCracken review looked at how the HTA and HFEA could be more efficient. The HTA has fully incorporated its recommendations.
Justin McCracken, former Chief Executive of the Health Protection Agency, was commissioned by the Government to undertake an independent review of the HTA and Human Fertilisation and Embryology Authority (HFEA) in January last year.
The review looked at ways to further improve the efficiency, transparency and accountability of the work carried out by our organisations.
The review and the Government’s response to it was published in July 2013 and set out 18 recommendations, seven specifically for the HTA. The HTA welcomed the recommendations; progress against each of the recommendations is outlined below.
Recommendation 2 - Combined HTA/HFEA Director of Finance
"The support services of the two bodies should be combined and managed by a single Director of Finance and Resources, supporting both Chief Executives. This will facilitate further efficiency savings, estimated at £2.8M over 10 years."
- In January 2014 the HFEA and HTA appointed Sue Gallone as the new shared Director of Finance and Resources. Sue began this joint role in March 2014.
Recommendation 4 - Strengthen stakeholder engagement
"In order to improve transparency, both the HFEA and the HTA should review and strengthen their arrangements for consulting with stakeholders on their approach to regulatory activities, and should ensure that issues raised with them and their responses are publicly available and discussed regularly in open Authority meetings."
- The HTA engages with its stakeholders in a variety of ways, including through specialist groups like the Histopathology Working Group, participation in external groups and committees, e-newsletters, meetings, training, events and surveys to obtain feedback. In 2013 the HTA conducted an independent evaluation of professionals directly affected by HTA regulation and the public. This evaluation has influenced our strategic plan for 2014-2017 and communications strategy for 2014-2017. In response to this recommendation, the HTA also set up a new Stakeholder Group (see recommendation 5).
- The HTA is undertaking a fundamental review of its Codes of Practice and Standards in 2015. The aim of the review is to ensure a user-friendly experience for stakeholders – making our regulatory requirements clearer and minimising regulatory burden where possible. The HTA will undertake a public consultation exercise on the changes to the Codes in autumn 2015.
- The HTA will also conduct a public consultations in 2015 on transposing the European Coding and Import Directives into UK law.
- The HTA is developing a public engagement plan to ensure that members or the public are at the heart of our work
Recommendation 5 - Permanent fees review group
"Both the HFEA and the HTA should establish and operate a permanent fees review group to improve accountability and facilitate dialogue with licence fee payers."
- The HTA held its first Stakeholder Group meeting in November 2013. The purpose of the Group is to consider regulatory issues across all sectors to inform the continued development of HTA regulation and fee-setting. Details of the Group, including minutes and papers, can be found on the HTA’s website. The Group meets twice each year.
Recommendation 14 - Risk focused regulation
"The HTA should sharpen the risk focus of its regulatory approach, for example using progressively lighter touch inspections for high-performing licence holders as long as risk assessments indicate this is appropriate; reducing the intensity of regulatory scrutiny for lower risk activities such as public displays; and by reviewing the operation of the European Union Organ Donation Directive (EUODD) after the first round of audits."
- Compliance updates during 15/16 will refine the risk profile of each establishment we license, and inform our inspection schedule.
- We are undertaking a licensing and inspection review which will contribute to more risk focussed regulation.
- We have completed a self-assessment against the Government's Regulators' Code and have developed an action plan identifying areas of improvement.
- A new risk assessment process was introduced in August 2013. In December 2013, following a review of the audits undertaken so far, we also agreed a new audit model for the EUODD sector (with lower associated fees).
- In the post mortem sector, reports of serious incidents inform our regulatory approach
- A full review of all organ donation and transplantation (ODT) sector audits has been undertaken and we have agreed an approach for the period 2014–17. The results of the review were published as a report in March 2014 and were presented at a sector event.
- Themed inspections reduce resource and are already in place in the human application sector and we are looking at the possibility of introducing them in the research and anatomy sectors. Joint inspections with UKAS have reduced the regulatory burden on establishments in the post mortem sector (see recommendation 18).
- In the public display sector, museums holding museums accreditation were required to provide less information in the 2013/14 compliance updates.
Recommendation 16 - Increased cooperation with other regulators
"The HTA should continue to pursue closer cooperation with other regulators to eliminate any overlaps or inconsistencies in regulatory activities and to ensure that there are well understood and seamless regulatory pathways for organisations engaged in activities that are regulated by other bodies, notably the MHRA."
- The HTA has Memoranda of Understanding (MoUs) in place with the UK Accreditation Service (UKAS), HRA, HFEA and the Care Quality Commission (CQC), and is developing an MoU with the Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA).
- In late 2013, the HFEA and HTA agreed a policy whereby ovarian tissue which is intended for transplantation, can be now be stored solely under an HTA licence. An HFEA licence is no longer needed.
- The HTA has been working with other regulators to create a single source of regulatory advice for organisations developing cell therapies (see recommendation 17)
Recommendation 17 - Transfer ATMP regulation to the MHRA
"The regulation of tissue for applications aimed at developing medicinal products – ATMPs – should be transferred from the HTA to the MHRA in order to simplify the regulatory pathway for those involved in such developments."
- The HTA has worked with the MHRA to take this work forward. A co-hosted workshop took place in January 2014 to consider the options, following which a report was completed setting out a number of actions addressing the recommendations.
- The House of Lords Science and Technology Committee’s regenerative medicine report called for a single source of regulatory advice for start-up and new companies seeking to deliver cell therapies. The HTA has worked with the MHRA, the Health Research Authority (HRA) and HFEA to establish the Regulatory Advice Service for Regenerative Medicine. This advice service launched in October 2014.
Recommendation 18 - Prioritise collaboration with CPA
"The HTA should prioritise its collaborative work with Clinical Pathology Accreditation (CPA) to eliminate any duplication in the inspection activities of the two bodies by the end of the current financial year."
- After a successful pilot project, the HTA and UKAS (which took on ownership of CPA in 2009) held their first joint inspection in July 2014 and have continued to conduct joint inspections since.
- In May 2015, UKAS and HTA signed a memorandum of understanding setting out the terms under which future joint inspections and information sharing will take place.
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