Annual Review of the Year

Baroness Diana Warwick HTA Chair

Questions?

Annual Review of the Year

Discussion session – Regulation: in the public interest?

David Behan Chief Executive, Care Quality Commission

Peter Walsh Chief Executive, Action Against Medical Accidents

Jonathan Montgomery Professor in Health Care Law

Regulation in the public interest: MHRA approach to the Red Tape Challenge Richard Woodfield, MHRA Policy Division 9 July 2013

10 Background: MHRA approach to better regulation In 2012 MHRA consolidated and simplified over 200 statutory instruments: 1000 pages down to 300 Better regulation of medicines initiative (BROMI) pioneered "do and tell" for changes to some licences since 2005 Regulatory Excellence programme launched April 2013 to coordinate changes to regulatory requirements for industry, (European, domestic and burden reduction) Operational Excellence programme launched in parallel to manage changes to business processes and organisational structure

Red Tape Challenge timetable Live phase –5 weeks from March 2012 –253 regulations offered for comment –Received 600 online comments and 60 written submissions Period of consideration and business engagement Ministerial star chamber October 2012 Outcome announced 26 March 2013

12 Headlines of RTC announcement RTC process validated EU-derived legal statue book for medicines and associated MHRA policy areas Exercise was about business efficiency not removing public health protections Implementing various projects to remove unnecessary burdens on industry and improve processing of applications - implemented during this Parliament New streamlined procedure for reclassifying medicines from prescription to over-the-counter launched December 2012

13 Links with other regulation Pharmacy regulation –Greater reliance on professional regulation and standards rather than detailed medicines legislation –Dispensing errors Prescribers guidance –GMC Guidance to prescribers on off label and unlicensed medicines Health technology assessment –Cost effectiveness interface with medicines licensing –Budgetary pressures on health service increase sensitivity of issues Human tissues –Joint HTA / MHRA inspections

Sarah Bedwell Director of Regulation, HTA

Human Tissue Authority Created in 2005 Human Tissue Act came into force in 2006 EU Tissue and Cells Directives 2007 EU Organ Donation Directive 2012

Strategic goal With the interests of both the public and those we regulate at the centre of our work, our overall strategic goal is to maintain and build confidence in the removal, storage and use of human tissue by ensuring that these activities are undertaken safely and ethically, and with proper consent.

How the HTA regulates Advice & Guidance Codes of Practice Standards Licenses Inspection Regulatory Action

Public confidence Increasing public understanding Access to information Open about risks Clear about the reasons for regulatory action Rise to the challenges set by the Francis Inquiry

The future High quality assessment of risk Act on that risk – reduce burden of regulation Work closely with others Clear about regulatory pathways Continuous review of inspection cycles Maintain our quality

Questions?

Annual Review of the Year

Discussion session – what you said; what weve done!

Alan Clamp Chief Executive, HTA

Post mortem sector: working together to raise standards Caroline Browne, Head of Regulation

Working together to raise standards MethodOutcomes Consultation Histopathology Working Group New policy on microscope slides Changes to incident reporting Common response to consultation on Coroners Law reform Process for review of RCPath guidance Collaboration SANDSNew consent form, guidance documents and learning descriptors MRC Brain Bank Steering Committee FAQs on brain donation, supported by Chief Coroner Advice & guidance HO/ACPO/HMICImproved procedures for the management of tissue retained by the police COASA/AAPTTraining for coroners officers and APTs

Working together to raise standards The HTA has improved standards in mortuaries run by the NHS, as well as Local Authorities. It is imperative that functions should continue to be undertaken by the HTA, in order that working practices continue to improve across the country as they have since The Association of Anatomical Pathology Technology (AAPT)

Supporting our Anatomy and Research sectors Dr Christopher Birkett, Head of Regulation

Supporting our anatomy sector Providing advice, clarity and on going support Engagement Professional bodies Speaking at meetings Enquiries E-newsletter New FAQs

Supporting our research sector One part of a bigger regulated field Working together is vital HRA/NRES Transplant research Working with others e.g. MRC

Influencing in Europe Imogen Swann, Head of Regulation

Influencing in Europe EUSTITE Project SoHo vigilance and surveillance project Expert working group on import and export of tissue and cells Coding Proposing changes to Directives to reflect scientific development

Living organ donation assessments Victoria Marshment, Head of Strategy and Planning

Living donation assessments New framework introduced in September 2012 Input and review from Independent Assessors and Living Donor Coordinators throughout Frequent interaction – both formal and informal Feedback on the systems and processes Small, but important changes

Living donation assessments Introduction of portal Guidance on referral of and submission dates for altruistic donor chains Removal of mandatory renewal at six months Donor declarations Donor information leaflets Flowcharts

Living donation assessments Looking forward: Remote interviews – video conferencing? Living lung programme Republic of Ireland and the national sharing systems Possible delegation of adult-to-adult living liver cases Assessing paired and pooled cases as they are submitted

Question for you 1. What are your initial thoughts about the presentations? Any pros and cons? 2. What other suggestions do you have for our focus over the next 12 months? 3. Which parts are we not reaching and how can we reach them? 4. Do you think we are achieving the right balance between public protection and streamlining regulation?

Annual Review of the Year