© crown copyright 2005 safeguarding public health reform of s12(1) of the medicines act 1968 london...
TRANSCRIPT
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© Crown copyright 2005
Safeguarding public health
Reform of s12(1) of the Medicines Act 1968
London 2007
Name: Richard Woodfield, MHRADate: January 2007
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Slide 2Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Crown copyright 2005
The materials featured within these MHRA presentation notes and delegate pack are subject to Crown copyright protection for this event. Any other copy or use of Crown copyright materials featured in this presentation, in any form or medium, is subject to prior approval of the MHRA which has Delegated Authority from Her Majesty's Stationery Office (HMSO) to administer Crown copyright for MHRA originated material. Applications should be in writing, clearly stating the proposed use/reuse of the information, and should be sent to the MHRA at the following address: Conference and Education Function, 16th Floor, MHRA, 1 Nine Elms Lane, London SW8 5NQ. Fax 020 7084 3522 or e-mail [email protected]. You may not sell or resell any information reproduced to any third party without prior agreement. The permission to reproduce Crown copyright protected material does not extend to any material in this pack which is subject to a separate licence or is the copyright of a third party. Authorisation to reproduce such material must be obtained from the copyright holders concerned.
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Slide 3Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
An informal consultation….
We are here:
- to explain ideas about reform of regulation, and
- to listen
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Slide 4Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Summary
1. What can go wrong with herbal medicines?
2. Objective – and what’s been done to meet it
3. What is s12(1) and who uses it?
4. Proposals for reform of s12(1)
5. What next?
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Slide 5Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
What can go wrong with herbal medicines?
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Slide 6Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
What can go wrong with herbal medicines - summary?
Wrong plant
Contamination
Deliberate adulteration/substitution/addition
Foreign matter
Poor information
Inaccurate diagnosis & inappropriate prescribing
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Slide 7Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Wrong plant!
Digitalis (Foxglove) substituted for plantain
heart problems
Podophyllum substituted for Gentian causes cancer
Japanese Star Anise substituted for Chinese Star Anise
causes convulsions
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Slide 8Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Wrong plant!
Aristolochia species
Aristolochia fanchi root used instead of Stephania sp.
Aristolochia manschuriensis stem used instead of Clematis sp.
Aristolochic acids - nephrotoxic, genotoxic, carcinogenic
Cause kidney failure and cancer
Belgium -110 cases renal failure, 18 cancers
UK cases
Aristolochia Banning Order 2001
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Slide 9Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Deliberate addition of potentially hazardous materials
Heavy metals/ toxic elements in Ayurvedic/ TCM products
Muhayogaraj Guggulu
mercury, lead and arsenic
Fufang luhuijiaonang 11.7% mercury (over 100,000 times levels
permitted in a food)
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Slide 10Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Deliberate addition of potentially hazardous materials
Undeclared pharmaceutical substances
e.g.fenfluramine, nitrosofenfluramine,
glibenclamide, corticosteroids, sidenafil,
methyl phenidate, ephedrine
Shubao Slimming Capsules
nitrosofenfluramine associated with UK case of irreversible liver
failure > 400 cases hepatotoxicity in Japan
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Slide 11Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
What can go wrong with practitioner supply of herbal medicines (i)?
Practitioners tapping into international trade in low grade products and ingredients
Lack of awareness of issues around side effects, interactions with other medicines, use in pregnancy, babies, children, elderly
Failure to diagnose accurately; lack of awareness of limits of own competence
Delaying effective treatment for serious conditions
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Slide 12Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
What can go wrong with practitioner supply of herbal medicines (ii)?
Inadequate or cursory consultations
Communication difficulties – eg practitioner unable to ask about existing medical conditions or medication already being taken
Unhygienic premises – unsuitable for preparing medicines
What is shelf life of ingredients; how are they stored?
Failure to advise patient about safe usage
No information on contents of product. Identification of adverse drug reactions can become impossible if you don’t know what patient has taken
Lack of accountability if patient wishes to make complaint
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Slide 13Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
What is on offer at the herbal clinic?
“Our herbal remedies are 100% safe”
“Our medicines have no side
effects”
“Herbal remedies are safe because they are natural”
“Chinese medicines will not interfere with any western medicines”
“Treats heart disease”
“Safer than western medicine”
“Fights cancer”
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Slide 14Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Professional standards Dec 2006?
“What are the treatments?
“Herbal Remedies…treating a wide range of health problems, such as …. depression …. terminal illness, etc”
Clinic leaflet, Kent December 2006
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Slide 15Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Objective and what’s been done to meet it…
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Slide 16Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
MHRA objective for herbal medicines
Consumers to have
access to wide range of herbal medicines; which are
made to acceptable safety and quality standards; and which are
accompanied by appropriate information about the safe use of the product
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Slide 17Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
What’s wrong with UK regime for unlicensed herbal medicines?
Is the consumer assured of?
Systematic safety standards
Systematic quality standards
Systematic information about safe use of product
Competence and accountability of practitioner carrying out consultation and making up unlicensed medicines
Xxx
x
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Slide 18Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
The UK not alone in seeking to improve regulation….
“In line with increased international demand, the safety, efficacy and quality of the products and practices used in TM/CAM have become important concerns for both health authorities and the public”
“Therefore WHO Member States are seeking to establish policy frameworks and deciding in what ways these products and practices should be regulated….”
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Slide 19Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Overall UK herbal strategy: Reformed regulation of …..
OTC herbal medicines
Statutory regulation of professionS12(1) Practitioner medicines
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Slide 20Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Stool depends on strength of each leg….
OTC herbal medicines regulation
S12(1) unlicensed herbal medicines prepared by practitioner
Regulation of the profession
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Slide 21Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
MHRA view: routes for safe supply of herbal (or any other) medicines….
Either
The medicine should be an authorised/registered product
made to assured standards; and
with full, authorised information necessary for consumer to use product safety
Or The medicine should be supplied
by a practitioner;
required to have recognised expertise; and
subject to professional accountability
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Slide 22Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Manufactured herbal medicinesMoving to assured standards….
Until 2011 Some unlicensed herbal medicines where legally on UK market under s12(2) of the Medicines Act at April 2004
Herbal medicines with a marketing authorisation (PL)
Coming soon! Herbal medicines with a traditional herbal registration (THR)
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Slide 23Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
The first UK traditional herbal registration......
THR products made to assured standards of safety, quality and patient information
Scheme launched Oct 2005
First THR granted Oct 2006
As at Jan 2007- 17 applications received by MHRA- 1 THR granted; others will follow - more applications in the pipeline
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Slide 24Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
What about regulating herbal practitioners and their use of unlicensed herbal medicines?
Herbal Medicine Regulatory Working Group 2003- built on work of House of Lords Report on CAM (2000) and
Government’s response to it (2001)- recommended statutory regulation of herbal medicine
profession- recommended reforms of s12(1) of Medicines Act 1968
DH and MHRA held linked consultations in 2004
Work continues:
- Working group on statutory regulation of acupuncture, herbal medicine and traditional Chinese medicine practitioners
- MHRA work on s12(1) reforms
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Slide 25Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
What is section 12(1)
Who uses it?
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Slide 26Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
What is s12(1) of the Medicines Act?
Exemption from licensing provisions of Medicines Act 1968
Cannot apply to any medicines within scope of European Directive 2001/83/EC (eg industrially produced medicines)
Running a business, in which there is
- face to face consultation; request for exercise of judgement
- unlicensed herbal medicine prepared on lockable premises of occupier carrying out the business
No current requirement for the practitioner carrying out s12(1) to have any competence in diagnosis, treatment or in preparation of medicines
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Slide 27Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Some misunderstandings….
Does advising patient which herbal medicine to choose of itself bring the product within s12(1)?
No – if a herbal medicine can legally be sold without a consultation, the fact that there is a consultation doesn’t mean that s12(1) needs to exist for that activity to remain legal
Are all herbal products prepared or supplied by CAM practitioners medicines?
No - a range of herbal ingredients have non medicinal uses eg for nutritional, well being, health maintenance, cosmetic purposes, and in aromatherapy (see MHRA website “Borderline Products” for further information)
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Slide 28Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Who uses s12(1)?
Practitioners of herbal medicine within various traditions (eg western, traditional Chinese, Ayurveda)
May be some usage elsewhere, eg in some regulated healthcare professions, in acupuncture, naturopathy, aromatherapy, homoeopathy, a few shop keepers in herbal shops, some multi disciplinary CAM practitioners, weekend course “herbal practitioners”…..
Extent of usage of s12(1) outside conventional herbal practitioners very difficult to quantify....
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Slide 29Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Examples of problems with quantifying s12(1) activity (i)
Aromatherapy – MHRA would not generally regard typical essential oils for external use as medicinal – but
- medicinal claims for an aromatherapy product would make product medicinal
- supplying essential oil products for internal use would normally be regarded as medicinal
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Slide 30Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Examples of problems with quantifying s12(1) activity (ii)
MHRA field work suggests indeterminate practice has grown up in unregulated sector, eg:
- clinic having a shop front where assistant dispenses remedies made up by a practitioner – is there a consultation carried out to professional standards?
- outlets where herbal remedy made up at request of customer with the possibility of some form of consultation/advice on request
Some activity seems to blur retail/practitioner activity
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Slide 31Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Examples of problems with quantifying s12(1) activity (iii)
Many herbal ingredients have more than one use
Advice is in MHRA’s guidance Note 8 “ A guide to what is a medicinal product”
- Guidance sheet on herbal ingredients; includes
- List of herbal ingredients and their reported uses
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Slide 32Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Which products are medicines?
Any substance or combination of substances presented for treating or preventing disease in human beings
Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis”
Definition in 2001/83/EC (as amended by 2004/27/EC)
Guidance about borderline products (including herbal products) on MHRA website: www.mhra.gov.uk
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Slide 33Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Proposals for Reform of s12(1)
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Slide 34Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
MHRA proposed foundations for reform of s12(1)
MHRA suggests that single most effective safeguard for public is that practitioners who use s12(1) (ie to run a business to identify individual needs through consultation and then make up unlicensed herbal medicine suitable to meet patient’s needs) should be:
- identifiable in law
- recognised as competent/expert in the practice of herbal medicine
- professionally accountable
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Slide 35Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Summary of MHRA proposals for s12(1) reforms (i)
Use of s12(1) restricted to statutorily regulated healthcare professionals who are held professionally accountable
Significant elements of regulation achieved via professional code(s); some elements in medicines legislation
Transitional period giving s12(1) users opportunity to join register
Face to face consultation requirement in legislation to remain; other aspects of consultation to be covered in codes of practice
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Slide 36Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Summary of MHRA proposals for s12(1) reforms (ii)
Efficacy – professional responsibility
Quality of s12(1) products – safeguards mainly via code agreed with the profession
Safety of s12(1) products – restriction on named potent ingredients via legislation and/or agreement with the profession – (review when DH proposals on statutory regulation further advanced)
Herbal formulary of acceptable herbs to be developed by profession; to be reviewed by Herbal Medicines Advisory Committee (HMAC)
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Slide 37Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Summary of MHRA proposals for s12(1) reforms (iii)
Statutorily regulated healthcare professionals to be able to commission manufacture from a 3rd party of an unlicensed herbal medicine to meet special needs:
- registered herbal practitioners could be regarded as authorised health care professionals under Art 5.1 of Directive 2001/83/EC
- implement via revised version of existing “specials” scheme
Possibility of limited extension of s12(1) to certain non herbal ingredients used in traditional medicines
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Slide 38Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Regulatory impact – the dilemma
If anyone can use s12(1)
Disincentive – why register if you can carry on practising anyway?
Message to public is “buyer beware”?
Jeopardise efforts to improve standards eg in TCM sector?
Undermine programme to improve standards in OTC sector?
If s12(1) limited to statutorily regulated, accountable professionals
CAM practitioners would need to join statutory register if they wished to operate a business preparing herbal medicines to meet individual needs identified in consultation
Impact on practitioners who make limited use of s12(1) provision?
Unregistered practitioners restricted to supplying herbals that are not medicines, and to regulated herbal medicines
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Slide 39Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Questions……
If you support s12(1) remaining open to all, how should the public be protected from unprofessional practitioners operating to low standards?
If you believe that in future some but not all unregistered practitioners should be able to use s12(1) how would you distinguish in law which practitioners are competent?
If s12(1) is restricted to statutorily regulated practitioners how much notice would be needed before change is introduced?
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Slide 40Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
What next ….
![Page 41: © Crown copyright 2005 Safeguarding public health Reform of s12(1) of the Medicines Act 1968 London 2007 Name: Richard Woodfield, MHRA Date: January 2007](https://reader037.vdocuments.us/reader037/viewer/2022110116/551a0bf8550346ad578b4714/html5/thumbnails/41.jpg)
Slide 41Date: January 2007Name: Richard Woodfield
Title: Reforms of s12(1) of the Medicine Act 1968
© Crown copyright 2005
Next Steps ….
Initially informal consultation until end March
Views welcome! To: [email protected]
Take stock in light of:- comments raised- progress of work on statutory regulation
of profession
Updated proposals for formal consultation alongside DH consultation on the regulation of the profession