Review of the year

1. Review of the year Adrian McNeil Chief Executive

2. Strategic aims To create a regulatory framework that: • has the confidence of professionals and the public • improves standards • costs as little as possible

3. Our remit • Human Tissue Act 2004 • Human Tissue (Quality and Safety for Human Application) Regulations 2007 • European Directives 2004/23/EC, 2006/17/EC and 2006/86/EC

4. What are we required to regulate?

5. What are we required to regulate? • All organ donations from living people • Bone marrow donation from living people

6. Our approach to regulation • risk-based • engagement • coach not cop

7. Turning the approach into reality • interpretation of legislation • guidance and standard setting • collection and analysis of data • DI training (e-learning, workshops and conferences) • Information to the regulated sectors

8. Turning the approach into reality • joint work with other regulators and agencies e.g. MHRA, NRES • answering written and phone enquiries • workshops • training seminars for stakeholders • consultations • conferences

9. Key achievements in 2008/09 • codes of practice • successful regulatory review by central government • first summary inspection reports

10. Key achievements in 2008/09 • new licensing requirements successfully implemented • new fee structure developed • moved to new accommodation

11. Key achievements in 2008/09 –organisational • organisational change • Unqualified audit • search for efficiency • low cost regulator

12. Regulatory activity – licensing

13. Regulatory activity – organ donation • approving all organ donations from living people • Independent Assessors (organ donation) and Accredited Assessors (bone marrow) trained or re-trained

14. Regulatory activity - organ donations approved in 2008/09 • 1058 donations approved (1,000 last year) • 22 paired donations (6 last year) • 15 altruistic donations (10 last year) • 51 complex panel cases (25 last year)

15. Dynamic, not static! • Increase in statutory responsibilities under the European Directives • June 2008 – first EC annual report of serious adverse events and reactions • July 2008 – licensing 40 new procurement organisations • April 2009 – EC requirement to license acellular material • April 2009 – licensing 15 new distribution organisations • April 2009 – three year report of licensing, enforcement and regulatory activities to EC • Sept 2009 – second EC report of legislative transposition • Sept 2009 – new EC inspection guidelines • Sept 2010 – implement single European coding system

16. Dynamic, not static! • 72 new licence applications in 2008/09 • increase in need for regulatory action • more whistleblowers and referrals from other agencies, e.g. police and Health and Safety Executive • more site visit inspections needed • increase in requests for advice and guidance

17. Dynamic, not static! • increase in approvals for organ donation • more Independent Assessors • increase in enquiries about body donation • new European Directive on organ donation

18. Conclusion We’ll continue to: • apply the principles of Better Regulation • work with our stakeholders to improve standards • work efficiently to deliver our remit

19. www.hta.gov.uk