annual review of the year 2013
TRANSCRIPT
Annual Review of the Year 2013
www.hta.gov.uk
http://twitter.com/HTA_UKhttp://www.Facebook.com/HumanTissueAuthority
Baroness Diana WarwickHTA Chair
Questions?
Annual Review of the Year 2013
www.hta.gov.uk
http://twitter.com/HTA_UKhttp://www.Facebook.com/HumanTissueAuthority
Discussion session –Regulation: in the public interest?
David BehanChief Executive, Care Quality Commission
Peter WalshChief Executive, Action Against Medical Accidents
Jonathan MontgomeryProfessor in Health Care Law
Regulation in the public interest:
MHRA approach to the Red Tape Challenge
Richard Woodfield, MHRA Policy Division 9 July 2013
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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
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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
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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 BedwellDirector 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 2013
www.hta.gov.uk
http://twitter.com/HTA_UKhttp://www.Facebook.com/HumanTissueAuthority
Discussion session – what you said; what we’ve done!
Alan ClampChief Executive, HTA
Post mortem sector: working together to raise standards
Caroline Browne, Head of Regulation
Working together to raise standardsMethod Outcomes
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
SANDS • New consent form, guidance documents and learning descriptors
MRC Brain Bank Steering Committee
• FAQs on brain donation, supported by Chief Coroner
Advice & guidance
HO/ACPO/HMIC • Improved procedures for the management of tissue retained by the police
COASA/AAPT • Training 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 2005.”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 2013
www.hta.gov.uk
http://twitter.com/HTA_UKhttp://www.Facebook.com/HumanTissueAuthority