1. The Herbal Medicines Advisory Committee (HMAC) Alison Denham FNIMH EHTPA Regulation Conference 12 May 2007

2. The Herbal Medicines Advisory Committee What is it? What are its duties? Who is on it? What is discussed? Changes to 12(1) Opportunities?

3. What is it? Medicines and Healthcare products Regulatory Agency (MHRA), changes in the structure led to four main committees set up in December 2005: Commission on Human Medicines Herbal Medicines Advisory Committee Advisory board on the Registration of Homeopathic Products British Pharmacopoeia Commission.

4. What is it? These committees advise the Minister directly; in a legal sense, the decision or advice of the MHRA is taken to be the view of the Minister, and are supported by Expert Advisory Groups eg pharmacovigilance Meetings every 2 months from May 2006 Meetings bring together committee members and MHRA staff

5. What are its duties? to advise on: Products for purchase by customers for own use: products with a traditional herbal registration (Directive on Traditional Herbal Medicinal Products), or where the MHRA may to refuse registration and appeals from manufacturers unlicensed herbal medicines (up to 2011)

6. to advise on: unlicensed herbal medicines made up to meet the needs of individual patients (Section 12(1) of the Medicines Act 1968) and associated regulatory reforms, review of herbs restricted or prohibited in medicines (SI2130/1977) and, extensions to the scope of Section 12(1).

7. Who is on it? 17 members, appointed for 4 years cannot have any relevant financial interests appointed using NHS Appointments Commission procedures give own opinion in discussion role of professional members is not to represent

8. Members: Wide variety of opinions and expertise: Chair, Professor Philip Routledge 2 lay people 5 herbal practitioners 1 aromatherapist 4 doctors (1 GP, 2 hospital, 1 anthroposophical) 5 pharmacists/scientists

9. Lay Members: 2 lay members to broaden discussion eg wording on product information leaflets reviewed sources of information available and expressed concerns about lack of access to good quality consumer information which promote the aims of the Committee: to improve public health protection and promote informed consumer choice

10. What is discussed? Lively debate on: applications for registration under the THMPD safety concerns on Cimicifuga racemosa and Polygonum multiflorum pharmacovigilance statistics on reports to the MHRA of adverse drug reactions possibly associated with herbal products review of changes required to Section 12(1) of the Medicines Act 1968. Minutes available at http://www.mhra.gov.uk/home by using the tab “Committees” at the top of website.http://www.mhra.gov.uk/home

11. Changes to 12(1): proposes that 12(1) exemption is restricted to registered herbalists setting criteria for a thorough face to face consultation leading to exercise of professional judgement quality (including making herbal preparations), safe practice and dispensary management would be covered by the code of conduct of the statutory register more flexible than legislation, under greater professional control, able to respond more quickly when safety concerns arise

12. Opportunities? The work of the Committee is about opening our profession up to public debate Committee Members will want to be reassured that the code of conduct protects public safety But, this also allows a wider debate on risk management …

13. Opportunities? increased public profile of the herbal profession wider debate on safety and effectiveness Green Medicine, sustainable sourcing of medicinal plants

14. Questions?