In 2017 the HTA undertook a fundamental evaluation of the extent to which our strategic approach protects public and professional confidence in the proper use, and quality and safety of, human tissues, cells and organs. We based this evaluation on evidence and analysis from a variety of sources, including the views of those working in establishments we regulate, a new evaluation of public opinion, analysis of the data we hold, and the views and opinions of HTA staff and Authority Members.
As a statutory body, our aim remains unchanged. As such, our review focused on evaluating our future operating environment and whether our resources are optimally aligned to where the risks are greatest.
An assessment of the evidence provided us with great reassurance that both the public and professionals think we are on the right track with our regulatory approach. However, the review identified a number of opportunities and challenges relating to our operating environment that will require us to adapt as an organisation.
The pace of innovation in cell, tissue and organ based therapies, in life sciences research, and the use of imaging and artificial intelligence in pathology, all have the potential to impact hugely on the way the sectors we regulate work. Many of these developments were unforeseen when the legislation was framed, and we need to be realistic about the limited opportunity for legislative change.
As one of the regulators operating in the field of life sciences, we are clear that effective, right-touch regulation can make a positive contribution to patient outcomes and economic growth. We are determined to play our role in the ambitious plans set out by the Government through the Industrial Strategy. In this last year we have also contributed to the development of the proposed legislative changes to consent provisions for organ donation in England, and have been fully engaged in preparations for the UK’s exit from the European Union.
We recognise that our staff are our key asset – their skill and dedication lie at the heart of our organisation - and therefore staff recruitment and retention contribute significantly to our strategic risk. As the regulator of six increasingly complex and diverse sectors, and with continued pressure to control our resources, we are acutely aware of the demands this can place on our staff.
Our strategy therefore continues to focus on the steps we need to take over the next three years in order to operate in a more sustainable way by 2021, building in greater resilience and agility in the face of increasing complexity and uncertainty in our external environment. To achieve this we have further refined and shaped our plans for how we need to adapt as an organisation:
By sustainable, we mean taking a new approach to recruiting, developing and retaining high quality staff and working in new ways to reduce the growing pressures on the staff we have.
By resilience, we mean adapting our operating model to retain staff for longer and developing strategic alliances with other organisations to put us in a better position to manage unexpected demands.
By agility, we mean providing a highly responsive regulatory framework that supports innovative uses of organs, tissues and cells, burnishes our reputation as an expert regulator and actively supports the Industrial Strategy for Life Sciences.
Success will mean retaining alignment with core principles and values, whilst developing our staff in a flexible manner to lead and adapt to innovations in our area of regulation.
When we launched our new strategy last year we acknowledged that 2018/19 was a transition between the previous 3 year strategy and the new priorities. During the last year we have laid the foundations for changing the way we work. In 2019/20 our business plan will focus on the initial phase of our organisational change programme, and delivering this alongside our core regulatory activity.
In order to meet the challenges ahead we require continued focus on our:
- People - recognising our staff as our key asset, widening the pool of candidates for recruitment beyond the South East and investing in training and development
- Business Technology - ensuring our systems are not reliant on location and making strategic choices about key business systems
- Information and data - meeting our obligations relating to data security and using information and data as a key strategic resource
- Finance - being clear about managing our fee levels based on work load and regulatory effort, including longer term planning to ensure continued financial viability