© Crown copyright 2005 Safeguarding public health Reform of s12(1) of the Medicines Act 1968 London...

© Crown copyright 2005

Safeguarding public health

Reform of s12(1) of the Medicines Act 1968

London 2007

Name: Richard Woodfield, MHRADate: January 2007

Date: January 2007Name: Richard Woodfield

Title: Reforms of s12(1) of the Medicine Act 1968


Crown copyright 2005

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An informal consultation….

We are here:

- to explain ideas about reform of regulation, and

- to listen




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?




What can go wrong with herbal medicines?




What can go wrong with herbal medicines - summary?

Wrong plant

Contamination

Deliberate adulteration/substitution/addition

Foreign matter

Poor information

Inaccurate diagnosis & inappropriate prescribing




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




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




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)




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




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




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




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”




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




Objective and what’s been done to meet it…




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




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




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….”




Overall UK herbal strategy: Reformed regulation of …..

OTC herbal medicines

Statutory regulation of professionS12(1) Practitioner medicines




Stool depends on strength of each leg….

OTC herbal medicines regulation

S12(1) unlicensed herbal medicines prepared by practitioner

Regulation of the profession




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




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)




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




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




What is section 12(1)

Who uses it?




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




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)




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....




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




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




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




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




Proposals for Reform of s12(1)




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




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




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)




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




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




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?




What next ….




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

© Crown copyright 2005 Safeguarding public health Reform of s12(1) of the Medicines Act 1968 London...

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