Regulation of Dietary Supplements and Homeopathic Products in the European Union

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Regulation of Dietary Supplements and
Homeopathic Products in the European Union

• Jill B. Deal, Principal
• deal_at_fr.com
• Fish Richardson P.C., Washington, DC office
• http//www.fr.com/reg
• Regulatory Affairs Professional Society
• London, England
• April 28, 1998

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Summary

• Dietary supplements
• Homeopathic products
• Practical tips for selling products in
  partially/unharmonized markets
• Borderline product issues

3
Regulation of Dietary Supplements (Dietary
Integrators) in the EU is not harmonized
?

• What does this mean

4
Understanding the current EU market for dietary
supplements

• Consumer demand increasing
• Trade complaints increasing due to conflicting
  member state regulations
• EU Commission Green Paper
• EU Commission Discussion Paper
• Introduction of harmonizing legislation in 1998
  or 1999?

MAYBE!
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Open issues

• 1. Definition?
• 2. Guiding principles on availability?
• 3. Restrictions or preferences?
• 4. Maximum limits? For some? For all?
• 5. How will maximum limits be determined?
• 6. Labeling? Warnings? Prohibition of claims?
• 7. Special procedures for placement on market?
• 8. Special packaging rules?

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• Understanding why U.S. manufacturers should watch
  progress of legislation on dietary integrators
  carefully
• How a Positive or Negative List Directive Works

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Influencing Legislation in the EU Understanding
the Role of Trade Associations

• Commission (DG III)
• Pan European trade associations
• national trade associations
• member companies

8
Pressure points for influencing EU legislation

• Office of the United States Trade Representative
  (USTR), Department of Commerce Office of European
  Affairs, State Department, U.S. Embassy to EU in
  Brussels
• EU trade associations
• EU Commission contacts

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Regulation of Homeopathic Products in the EU
Directive 92/73
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Definition of homeopathic product

• any medicinal product prepared from products,
  substances, or compositions called homeopathic
  stocks in accordance with a homeopathic
  manufacturing procedure described by the European
  Pharmacopeia or, in the absence thereof, by the
  pharmacopeia currently used officially in the
  Member States

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92/73 creates a simplified registration procedure
for homeopathic products meeting the requirements
of the directive

• 1. Oral or external administration only
• 2. No therapeutic indication may appear
• 3. Sufficient degree of dilution to ensure safety
  (either 1 part/10,000 of the mother tincture AND
  where the active principle is a prescription only
  medicine, 1/100 of smallest dose used in
  allopathic medicine
• 4. Must bear the scientific name of the
  stock/stocks and not a proprietary/trade name
• 5. Member state where registered will determine
  the classification
• 6. Homeopathic medicinal products must appear
  on the label

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Labeling information limited to the following

• 1. Scientific name
• 2. Name and address of person responsible for
  placement on market
• 3. Method of administration
• 4. Expiry date
• 5. Contents of sales presentation
• 6. Any special storage precautions
• 7. Manufacturer batch number
• 8. Registration Number
• 9. Homeopathic medicinal product without
  approved therapeutic indications
• 10. Warning to consult a doctor if symptoms
  persist
• 11. Any required reimbursement information

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Application for registration must include

• 1. Scientific name
• 2. Dossier explaining source of supply and
  controls plus bibliography
• 3. Manufacturing and control file
• 4. Manufacturing authorization
• 5. Marketing authorizations
• 6. Specimen of sales presentation
• 7. Stability Data
• 8. Proof of efficacy not required

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Member State Implementation of 92/73
Commission Report to the European Parliament and
Council on Application of Directives 92/73 and
92/74
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Member State Implementation of 92/73
Commission Report to the European Parliament and
Council on Application of Directives 92/73 and
92/74 (cont.)
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Implications of Commission Report on Homeopathics

• Possible legislation addressing the following
  subjects
• 1. Improve mutual recognition provisions to
  ensure a greater degree of harmonization
• 2. Increase the scope of products which can be
  registered, e.g., explicit inclusion of other
  routes of administration
• 3. Amend to allow for fantasy names for
  combination products
• 4. Amend the labeling legend to read homeopathic
  medicinal product without medical claim
• 5. Require member states to have clinical trial
  procedures

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Practical tips for marketing in partially
harmonized or unharmonized markets in the EU
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Focus on UK implementation

• Guidance Documents issued by the UK Medicines
  Control Agency
• The Homeopathic Registration Scheme Guidance for
  Manufacturers and Suppliers (March 1994)
• UK Homeopathic Registration Scheme Guidance
  Notes The Control and Quality of Homeopathic
  Stocks (June 1994)
• UK Homeopathic Registration Scheme Guidance
  Notes The Manufacture and Control of Dosage
  Forms for Homeopathic Products (June 1994)

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Borderline products

• Definition of Medicinal Product under Directive
  65/65
• Any substance or combination of substances
  presented for preventing disease in human beings
  or animals
• Any substance or combination of substances which
  may be administered to human beings or animals
  with a view towards making a medical diagnosis in
  human beings or in animals is likewise considered
  to be a medicinal product

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Interpretations of the term Medicinal Product
by the European Court of Justice (ECJ)

• Case C-369/88 DeLattre (1991) Directive 65/65
  provides two definitions of medicinal product,
  one relating to presentation, the other to
  function
• Presentation
• Case C-227/82 Van Bennekom (1983) presented for
  preventing disease means not only when a product
  is expressly indicated or recommended but also
  whenever any averagely well-informed consumer
  gains the impression that the product is a
  medicinal product.

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Function

• Case No. 112/89 Upjohn v. Farzoo
• It is for national courts to determine on a
  case-by-case basis the classification of each
  product having regard to its pharmacological
  properties as they may be ascertained in the
  current state of scientific knowledge, to the way
  in which it is used, to the extent to which it is
  sold and to consumer familiarity with it.

Extremely broad discretion granted to member
states by ECJ !!