Human Tissue Authority

The regulator for human tissue and organs

Development

To make the right investment to continuously improve delivery

To ensure that the HTA’s regulatory approach remains relevant, we actively prepare for the future. We do this through our development activities, which seek to ensure public confidence will be maintained as new and innovative uses of human tissue emerge.

We see innovation across all the sectors we regulate and keep abreast of developments to inform our policy work, which often involves working with other organisations. Our Human Application sector is rapidly developing and the pace of change requires us to be agile in our response to policy and regulatory questions. We work closely with the Medicines and Healthcare products Regulatory Agency and other regulators on the Regulatory Advice Service on Regenerative Medicine (RASRM). We expect enquiries to the RASRM from those developing Advance Therapy Medicinal Products (ATMPs), as well as other novel therapies using human tissues and cells, to increase over coming years.

Where an innovative tissue use or new business model is unregulated and where there is the need for an authoritative voice on the issues, we will provide advice and guidance to both the public and professionals when we believe we are best placed to do so. In the coming year we expect to issue such guidance on cryopreservation and taphonomy.

Over the next two years, we will continue to improve our systems and processes to allow us to do more with the resources we have.

Our overarching aim is to maintain public confidence, and we recognise there is more we can do directly in this area. This includes both work we can undertake alone – such as a greater ongoing dialogue with the public – and work in partnership, with other regulators and public-facing bodies.

We will continue to work to produce better public-focussed information that reaches a wider audience, and responds to what the public have told us is important to them – involving people where we can.

Over the next two years, the HTA will take a positive role in discussions and debates on the future of regulation in the health sector, most notably in the post-Brexit environment. We will ensure we reflect our experience of regulating our diverse sectors in submissions and dialogue that will inform negotiating positions. We will be available to offer advice and guidance to colleagues across government and beyond as and when it is needed.

 

Objectives for 2017/18

Our Development objectives remain, to:

  • Reduce regulatory burdens where risks to public confidence are lowest.
  • Make it clearer how to achieve compliance with new and existing regulatory requirements.
  • Make continuous improvements to our systems and processes to minimise wasted or duplicated effort.
  • Take opportunities to better inform and involve the public.

In the remaining period covered by the Strategy, we will:

  • Continue to develop our approach to engaging with licensed establishments to increase compliance (previously referred to as Designated Individual engagement).
  • Undertake a comprehensive assessment of risk across the human application sector and amend our processes as necessary (in addition to our standard risk assessment across all sectors).
  • Based on the outcome of our independent enquiries audit, and the work undertaken by the enquiries improvement project, refine our processes to improve further the timeliness and quality of enquiry responses.
  • Implement the EU Directives on Coding and Import / Export, working with establishments to ensure as smooth a transition as possible.
  • Carry out a content review of the public information on our website, and continue to develop new material – with input from the public – which is widely shared; this is to improve public understanding of what we do, and what we expect from those we regulate.
  • Continue to upgrade and develop our Customer Relationship Management (CRM) system, website, and online portal to better meet our business needs.

Last updated on: 6 Apr 2017