1. © Crown copyright 2005 Safeguarding public health Reform of s12(1) of the Medicines Act 1968 London 2007 Name: Richard Woodfield, MHRA Date: January 2007

2. Slide 2 Date: January 2007 Name: 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, 16 th Floor, MHRA, 1 Nine Elms Lane, London SW8 5NQ. Fax 020 7084 3522 or e-mail speakers@mhra.gsi.gov.uk. 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.

3. Slide 3 Date: January 2007 Name: 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

4. Slide 4 Date: January 2007 Name: 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 whats been done to meet it 3. What is s12(1) and who uses it? 4. Proposals for reform of s12(1) 5. What next?

5. Slide 5 Date: January 2007 Name: Richard Woodfield Title: Reforms of s12(1) of the Medicine Act 1968 © Crown copyright 2005 What can go wrong with herbal medicines?

6. Slide 6 Date: January 2007 Name: 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

7. Slide 7 Date: January 2007 Name: 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

8. Slide 8 Date: January 2007 Name: 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

9. Slide 9 Date: January 2007 Name: 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)

10. Slide 10 Date: January 2007 Name: 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

11. Slide 11 Date: January 2007 Name: 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

12. Slide 12 Date: January 2007 Name: 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 dont know what patient has taken Lack of accountability if patient wishes to make complaint

13. Slide 13 Date: January 2007 Name: 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

14. Slide 14 Date: January 2007 Name: 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

15. Slide 15 Date: January 2007 Name: Richard Woodfield Title: Reforms of s12(1) of the Medicine Act 1968 © Crown copyright 2005 Objective and whats been done to meet it…

16. Slide 16 Date: January 2007 Name: 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

17. Slide 17 Date: January 2007 Name: Richard Woodfield Title: Reforms of s12(1) of the Medicine Act 1968 © Crown copyright 2005 Whats 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 XxxxXxxx

18. Slide 18 Date: January 2007 Name: 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….

19. Slide 19 Date: January 2007 Name: 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 profession S12(1) Practitioner medicines

20. Slide 20 Date: January 2007 Name: 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

21. Slide 21 Date: January 2007 Name: 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

22. Slide 22 Date: January 2007 Name: Richard Woodfield Title: Reforms of s12(1) of the Medicine Act 1968 © Crown copyright 2005 Manufactured herbal medicines Moving 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)

23. Slide 23 Date: January 2007 Name: 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

24. Slide 24 Date: January 2007 Name: 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 Governments 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

25. Slide 25 Date: January 2007 Name: Richard Woodfield Title: Reforms of s12(1) of the Medicine Act 1968 © Crown copyright 2005 What is section 12(1) Who uses it?

26. Slide 26 Date: January 2007 Name: 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

27. Slide 27 Date: January 2007 Name: 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 doesnt 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)

28. Slide 28 Date: January 2007 Name: 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....

29. Slide 29 Date: January 2007 Name: 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

30. Slide 30 Date: January 2007 Name: 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

31. Slide 31 Date: January 2007 Name: 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 MHRAs 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

32. Slide 32 Date: January 2007 Name: 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

33. Slide 33 Date: January 2007 Name: Richard Woodfield Title: Reforms of s12(1) of the Medicine Act 1968 © Crown copyright 2005 Proposals for Reform of s12(1)

34. Slide 34 Date: January 2007 Name: 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 patients needs) should be: -identifiable in law -recognised as competent/expert in the practice of herbal medicine -professionally accountable

35. Slide 35 Date: January 2007 Name: 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

36. Slide 36 Date: January 2007 Name: 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)

37. Slide 37 Date: January 2007 Name: 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 3 rd 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

38. Slide 38 Date: January 2007 Name: 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

39. Slide 39 Date: January 2007 Name: 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?

40. Slide 40 Date: January 2007 Name: Richard Woodfield Title: Reforms of s12(1) of the Medicine Act 1968 © Crown copyright 2005 What next ….

41. Slide 41 Date: January 2007 Name: 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: caroline.brennan@mhra.gsi.gov.uk 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