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Annual Review of the Year 2013. Baroness Diana Warwick HTA Chair. Questions? . Annual Review of the Year 2013.

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Annual review of the year 2013

Annual Review of the Year 2013

Annual review of the year 20131

Annual Review of the Year 2013

Discussion session regulation in the public interest

Discussion session –Regulation: in the public interest?

David behan chief executive care quality commission

David BehanChief Executive, Care Quality Commission

Peter walsh chief executive action against medical accidents

Peter WalshChief Executive, Action Against Medical Accidents

Jonathan montgomery professor in health care law

Jonathan MontgomeryProfessor in Health Care Law

Regulation in the public interest mhra approach to the red tape challenge

Regulation in the public interest:MHRA approach to the Red Tape Challenge

Richard Woodfield, MHRA Policy Division

9 July 2013

Background mhra approach to better regulation
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
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

Headlines of rtc announcement
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

Links with other regulation
Links with other regulation

  • Health technology assessment

    • Cost effectiveness interface with medicines licensing

    • Budgetary pressures on health service increase sensitivity of issues

  • Human tissues

    • Joint HTA / MHRA inspections

  • 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

Sarah bedwell director of regulation hta

Sarah BedwellDirector of Regulation, HTA

Human tissue authority
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
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
How the HTA regulates

  • Advice & Guidance

  • Codes of Practice

  • Standards

  • Licenses

  • Inspection

  • Regulatory Action

Public confidence
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
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

Annual review of the year 20132

Annual Review of the Year 2013

Discussion session what you said what we ve done

Discussion session – what you said; what we’ve done!

Alan clamp chief executive hta

Alan ClampChief Executive, HTA

Post mortem sector working together to raise standards

Post mortem sector: working together to raise standards

Caroline Browne, Head of Regulation

Working together to raise standards1
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

Supporting our Anatomy and Research sectors

Dr Christopher Birkett, Head of Regulation

Supporting our anatomy sector
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
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

Influencing in Europe

Imogen Swann, Head of Regulation

Influencing in europe1
Influencing in Europe

  • EUSTITEProject

  • 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

Living organ donation assessments

Victoria Marshment, Head of Strategy and Planning

Living donation assessments
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 assessments1
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 assessments2
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
Question for you

  • What are your initial thoughts about the presentations? Any pros and cons?

  • What other suggestions do you have for our focus over the next 12 months?

  • Which parts are we not reaching and how can we reach them?

  • Do you think we are achieving the right balance between public protection and streamlining regulation?

Annual review of the year 20133

Annual Review of the Year 2013