1. EU Council Directive on Traditional Herbal Medicinal Products Dr. Dairine Dempsey IRISH MEDICINES BOARD for IHTA AGM 23 rd April 2003

2. Overview l Herbal Medicines Project l EU Council Directive on Traditional Herbal Medicinal Products l Questions from IHTA members l Future?

3. ‘….. it does not feel it can take any action in the case of those medicines which have the sanction of traditional use, provided adequate assurance of pharmaceutical quality and safety are made available’ NDAB Annual Report 1976

4. ‘ During the last few years there has been a number of new medicinal products containing herbal ingredients marketed in Ireland. The NDAB has been increasingly concerned at the potential for adverse effects arising from such products …… which may not only exert undesirable effects per se but may interact with other medications or even foods’ NDAB Annual Report 1979

5. IMB Herbal Medicines Project l Herbal Medicines Project - June 2000 l Herbal Project Manager - September 2000 l Scientific Committee on Herbal Medicinal Products [SCHMP] - December 2000 l Draft report - November 2001 l Final Report - January 2002 l Herbal Medicines Seminar & Report – May 2002

6. Directive on Traditional Herbal Medicinal Products l Amendment to EU Council Directive 2001/83/EC l Supported by Ireland l 1 st Parliament Reading - >20 amendments l Commission position – 9 th April 2003* l Council Working Group ??? l COMMON POSITION !!! *http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2003/COMM_PDF_COM _2003_0161_F_EN.pdf

7. IMB Concerns l Scope reflects reality of market place  Non-EU traditions  Non-herbals/Combinations l ‘Recognition’ of authorisations/registrations l Committee on Herbal Medicinal Products l Lists/Monographs

8. Improvements - I Definition of Traditional Use  30 years on market in EU  15 years in EU + 15 years outside  European Parliament/European Commission Reduced to ‘at least 15 years’ Increased flexibility through CHMP

9. Improvements - II Combination Products a. Herb-Herb b. Herb-Vitamin/Mineral c. Non-herbal  European Parliament/European Commission a. and b.  included c.  ‘other non-biological substances’? Action must be ‘ancillary’ to herbal!

10. Improvements - III Authorisations/Registrations  ‘Recognise’ all authorisations and registrations  Restrictive!  European Parliament/European Commission Authorisations  MR procedure Registrations  ‘recognise’

11. Improvements - IV EMEA Committee on Herbal Medicinal Products [CHMP]  Make up  Remit  European Parliament/European Commission 5 proposals – 1 appointment Appropraite connection to the CA ‘Role & experience in evaluation of HMPs’ Extended remit – review of products that do not satisfy 30/15 years

12. Improvements - V Labels/PILs/Advertising  ‘The product is a herbal medicinal product for traditional use in a specified indication and that the efficacy of the product has not be clinically proven but relies exclusively on long-term use and experience’  European Parliament/European Commission Removed negative statement!

13. Outstanding Concerns – I CHMP & CPMP  Should not be mutually exclusive  Role of Director of the EMEA to co- ordinate  Important for appropriate implementation of both ‘well-established’ and ‘traditional’ legislation

14. Outstanding Concerns – II Lists/Monographs  Article 16f – LIST  Article 16h(3) - MONOGRAPHS  Difference?  Legal basis?

15. Industry Questions - I Should we proceed with the Irish interim national scheme? How should companies who wish to market new products proceed while awaiting legislation? What about innovation?

16. Industry Questions - II When will the CHMP publish the proposed positive list? What happens if the Directive is based on ‘products’ rather than ‘ingredients’? To what extent is the Directive restricted to minor self-limiting conditions?

17. FUTURE - I l For Industry: - recognition of role of TMPs - distinction between registered and unregistered TMPs -  consumer & healthcare professional confidence - 1 st step to harmonisation of EU market l For Consumers: - quality & choice l For Regulators: -  work!!

18. FUTURE - II IMB notes view of the UK Government: ‘An effective regulatory framework ……… This will undoubtedly entail more regulatory constraints than exist under the present inadequate and open- ended arrangements. However, subject to a successful conclusion to the negotiations, we envisage that such a legislation would permit a very wide range of traditional medicines to achieve a long secure future’

19. THANK YOU ! ?