Human Tissue Authority

The regulator for human tissue and organs

Our priorities

This business plan sets out our ambitions for 2018/19. The HTA operates a continuous business planning process - we maintain a pipeline of proposed business activities over a three-year period, which allows us to adapt and plan in response to changes in our operating environment.

Our overarching aim remains to protect public and professional confidence in the safe and proper use of human tissue – we do this by utilising a combination of regulatory tools, which we deploy according to risk across each of the sectors we regulate. Our core delivery activities are centred around licensing, inspection, incident reporting, assessment of living organ donation, providing advice and guidance, and communicating and engaging with stakeholders.

We have a long established culture of working with establishments to ensure that they meet our standards, targeting our resources at the areas of greatest risk to patient safety and public confidence. We encourage improvement through provision of high quality advice and guidance and sharing best practice, publishing our inspection reports so we are transparent about our findings, and so that others can learn. When things go wrong we ensure that establishments take appropriate action, including measures to prevent future incidents from happening.

Whilst we have an influential role in supporting establishments to improve, we recognise that public confidence cannot be safeguarded by the HTA alone. It is also dependent on the individuals and organisations working with human tissue to act in accordance with the law and the wider regulatory framework.

We therefore continue to engage and work in partnership with the sectors we regulate.

Implementation of our new standards

We will continue to work with establishments to fully embed our new Codes of Practice and Standards. In 2018/19 we will feedback to establishments to share the learning we have gained from regulating to the new standards, and the outcomes of the 2017/18 compliance updates.

Joint working

We understand that we do not regulate in a vacuum, and that it is important that we work jointly with other regulators and bodies to provide clarity on regulatory requirements, reduce burden where appropriate and share information to inform our regulatory approach. Over this business year we will continue to review existing relationships to ensure they deliver operationally, identify where our expert knowledge could add value in new partnerships and seek to reduce burden where we can achieve assurance from other sources.

Human Application

We continue to see the development of new products, preparation methodologies and therapeutic applications of human tissue, which increasingly require us to take an agile approach to our regulation. We work closely with other health regulators, both bilaterally and through the Regulatory Advice Service for Regenerative Medicine (RASRM), to provide clarity on the regulation of borderline products and those that span multiple regulatory remits and respond to emerging issues.

With the Regulations to transpose the EU Directives on Import and Coding coming into force on 1 April 2018, we will continue to work closely with establishments to fully implement and embed the requirements as we begin to inspect against them.

Last year we undertook an evaluation of risk in the human application sector; this year we will look to strengthen our arrangements for oversight of licensable activities carried out by third parties and improve our risk-based approach to inspection.

Organ Donation and Transplantation

In October 2017, the Prime Minister announced her intention to introduce a system of ‘opt-out’ for organ donation. We look forward to the Government’s response to the recent public consultation, and will continue to work closely with colleagues at DHSC to ensure that public and professional confidence remain paramount considerations as any new system develops.

In 2018/19 we will also look at ways we can develop and further support our network of Independent and Accredited Assessors, as we seek to build sustainability across our systems.

Our Transplantation Advisory Group will continue to play a key role in shaping our regulatory approach, as will our relationships with stakeholders such as NHSBT and the British Transplantation Society.

Research

Our collaborative work with the Health Research Authority (HRA) continues, with HTA input into training events and the HRA’s e-learning module on ‘research using human tissue’. In 2018/19 we will also build on the outcomes of the joint HRA/Human Tissue Authority (HTA) public dialogue project on sharing patient data with tissue for research, to inform our regulatory approach in the sector. Both organisations continue to benefit from a secondment arrangement, which allows direct input into a number of HRA strands of work.

Post Mortem

We have strong and constructive links with a range of professional stakeholder groups, including the Royal College of Pathologists, the Association of Anatomical Pathology Technicians, the Coroner’s Society of England and Wales and the Home Office Forensic Science Regulation Unit. We engage with these bodies formally through our Histopathology Working Group, and through other joint working initiatives including HTA input into training and events.

We will also continue to explore opportunities for collaboration with the United Kingdom Accreditation Service (UKAS), where there is potential to reduce burden for our licensed establishments.

Anatomy

We continue to have a good working relationship with establishments and representative bodies, including the Anatomy Associations Advisory Committee (AAAC), who are proactive in highlighting emerging issues in the sector. The HTA also frequently attend and present at sector related meetings.

We have recently seen an increase in public interest in issues relating to body donation. We receive a large number of calls on this topic and continue to provide advice and guidance to members of the public, including directing them to their nearest medical school.

Public Display

This is our smallest sector, and considered to be one of the lowest risk, particularly for static collections. This makes it important that we work with our stakeholders to ensure that our regulation remains proportionate. We have increased our engagement with establishments in this sector through our licensed establishment engagement programme and Stakeholder and Fees Group, and will continue to look for ways that we can develop our regulatory approach to ensure that burden is minimised.

Professional and public engagement

We recognise the importance of engaging with both professionals and the public on our work. We will continue with our programme aimed at improving our engagement with Designated Individuals and licensed establishments, including regular meetings with a panel of representatives to receive feedback, share learning from our work, develop our digital engagement channels and scope training opportunities.

Our website remains the primary channel through which we provide access to HTA related guidance and information. We will use the results of our recent website and digital communications surveys to inform a review of the content we publish and ensure it continues to meet users’ needs.

Following the public evaluation in 2017/18, and the development of the HTA’s Public Panel, the focus for the next business year will build on the insight we have gained from this work. We will continue to work closely with members of the public who are interested in our work, and seek to further develop and strengthen our relationships with other public facing and representative bodies. This will include consideration of how we can use digital channels for engagement, as well as ensuring that our key information for the public - such as our Public Guides to the Codes and our Code A: Guiding principles and the fundamental principle of consent – are accessible both on and offline, when and where they need it.

Exit from the European Union

Many of the sectors we regulate have the potential to be affected by the UK’s withdrawal from the European Union. In particular, as Competent Authority for two sets of EU Directives, we recognise the importance of our role in advising Government and contributing to plans for a range of outcomes as the negotiations proceed.

Along with colleagues at the Department of Health and Social Care, we are fully committed to continuing the close working relationship with our European partners, in the interests of public health and safety.
 

Last updated on: 22 May 2018