Human Tissue Authority

The regulator for human tissue and organs

Our priorities

This business plan sets out our ambitions for 2019/20. 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 ethical use of human tissue, as set out in our governing legislation. 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 on 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 the 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 the HTA has a statutory duty to superintend compliance and an influential role in promoting good practice, public confidence in the use of human tissue cannot be safeguarded by the HTA alone. Public confidence is also dependent on the individuals and organisations that undertake activities within the HTA’s remit acting within the standards and requirements of the legislation. Our network of Designated Individuals and Persons Designate are vital partners in our regulatory framework, and we continue to engage and work with those in key roles across the sectors we regulate.

Organisational change and smarter working

In order to achieve our vision the HTA is embarking upon a Development Programme, which aims to see the organisation working in smarter ways to make most effective use of our people, business technology and information and data. Preparations for a move to a new office location in 2021 provide additional opportunity to improve how we operate.

The benefits to the HTA, and therefore its stakeholders, of this Programme are based around improvements to systems and processes that facilitate a more targeted, risk-based, approach to regulation. This will also lead to a streamlining of our interactions with the public and professionals ensuring the information needs of each audience is met in the timeliest and most appropriate manner and that the regulatory burden can reduce where possible. The benefits include improved horizon scanning, better targeting of regulatory effort to risk and more innovative use of data and technology to improve regulatory outcomes.

EU exit

As the Competent Authority for two sets of EU Directives covering the human application and organ donation and transplantation sectors, the HTA has worked closely with DHSC and its arm’s length bodies to prepare for the UK’s exit from the European Union. We will continue to do so, implementing any legislative changes into operational practice and providing advice and guidance for our licensed establishments to enable them to comply with amendments to the applicable Regulations.

We have the appropriate governance and accountability structures in place to monitor and assess the impact of EU Exit on the HTA, and resource has been allocated which can be redirected as required. 

Introduction of Deemed Consent in England

The Organ Donation (Deemed Consent) Act 2019 received Royal Assent on 15 March 2019; when the new law comes into force it will change the legal basis for consent for deceased organ donation in England. Close engagement with public and professional stakeholders will remain an important priority as we make amendments to our Codes of Practice to support the introduction of the new system form April 2020.

Communications and Engagement

We continue to engage with and involve both professionals and the public on our work, and provide timely advice and guidance on areas that affect them.

For professionals, our focus over the next year and beyond will be on developing and improving our digital engagement channels, as well as continuing to work with our existing advisory groups. Over the last year we have been reviewing the content across our website, and the next phase in this programme of work will be to redevelop the site to improve the structure and design, whilst meeting new accessibility requirements.

For members of the public, we will focus on how we can best make information about the HTA and the areas we regulate accessible when they need them – this will include working with other organisations such as patient facing groups and professional bodies. We will continue to work with our public panel, a virtual group of the public who have volunteered to input into our work on an as needed basis, to ensure that the best quality and most accessible content is available online for the public.

Last updated on: 2 Jul 2019