Annual review of the year 2013
Sponsored Links
This presentation is the property of its rightful owner.
1 / 37

Annual Review of the Year 2013 PowerPoint PPT Presentation


  • 47 Views
  • Uploaded on
  • Presentation posted in: General

Annual Review of the Year 2013. www.hta.gov.uk. http://twitter.com/HTA_UK. http://www.Facebook.com/HumanTissueAuthority. Baroness Diana Warwick HTA Chair. Questions? . Annual Review of the Year 2013. www.hta.gov.uk. http://twitter.com/HTA_UK. http://www.Facebook.com/HumanTissueAuthority.

Download Presentation

Annual Review of the Year 2013

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Annual Review of the Year 2013

www.hta.gov.uk

http://twitter.com/HTA_UK

http://www.Facebook.com/HumanTissueAuthority


Baroness Diana WarwickHTA Chair


Questions?


Annual Review of the Year 2013

www.hta.gov.uk

http://twitter.com/HTA_UK

http://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


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


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

  • 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 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_UK

http://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 standards


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

  • 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

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

  • 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 2013

www.hta.gov.uk

http://twitter.com/HTA_UK

http://www.Facebook.com/HumanTissueAuthority


  • Login