EU Council Directive on Traditional Herbal Medicinal Products

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EU Council Directive on Traditional Herbal
Medicinal Products
forIHTA AGM23rd April 2003

• Dr. Dairine Dempsey

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Overview

• Herbal Medicines Project
• EU Council Directive on Traditional Herbal
  Medicinal Products
• Questions from IHTA members
• Future?

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.. 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
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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
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IMB Herbal Medicines Project

• Herbal Medicines Project - June 2000
• Herbal Project Manager - September 2000
• Scientific Committee on Herbal Medicinal Products
  SCHMP - December 2000
• Draft report - November 2001
• Final Report - January 2002
• Herbal Medicines Seminar Report May 2002

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Directive on Traditional Herbal Medicinal Products

• Amendment to EU Council Directive 2001/83/EC
• Supported by Ireland
• 1st Parliament Reading - gt20 amendments
• Commission position 9th April 2003
• Council Working Group ???
• COMMON POSITION !!!
• http//pharmacos.eudra.org/F2/pharmacos/docs/Doc2
  003/COMM_PDF_COM_2003_0161_F_EN.pdf

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IMB Concerns

• Scope reflects reality of market place
• Non-EU traditions
• Non-herbals/Combinations
• Recognition of authorisations/registrations
• Committee on Herbal Medicinal Products
• Lists/Monographs

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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

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Improvements - II

• Combination Products
• Herb-Herb
• Herb-Vitamin/Mineral
• Non-herbal
• European Parliament/European Commission
• a. and b. ? included
• c. ? other non-biological substances?
• Action must be ancillary to herbal!

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Improvements - III

• Authorisations/Registrations
• Recognise all authorisations and registrations
• Restrictive!
• European Parliament/European Commission
• Authorisations ? MR procedure
• Registrations ? recognise

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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

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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!

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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

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Outstanding Concerns II

• Lists/Monographs
• Article 16f LIST
• Article 16h(3) - MONOGRAPHS
• Difference?
• Legal basis?

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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?
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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?
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FUTURE - I

• For Industry
• recognition of role of TMPs
• distinction between registered and unregistered
  TMPs
• ? consumer healthcare professional confidence
• 1st step to harmonisation of EU market
• For Consumers
• quality choice
• For Regulators
• ? work!!

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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
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THANK YOU !
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