Istanbul

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VMPs - Availability - MUMS - Cascade

• Istanbul
• April 2011

Dr Joe Collins MVB PhD CBiol FSB MRCVS CertEP
CertVR
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Veterinary medicines policy within MSs

• To protect animal health and welfare
• Wide range of safe, efficacious medicinal agents
• Clinical freedom exercised in the patients
  interest
• Harmonised licensing rules
• Managed efficient route of supply
• Policing of illicit use
• To protect the food chain and user safety
• Responsible professions (vets, pharm., tox.,
  medic)
• Treat as companion animals?
• Policing of supply and use
• Residue testing

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Issues regarding Import

• From Third Countries vs. Internal Market
• Import of
• live animals
• disease
• people
• skills / techniques
• carcases
• meat products

Medicines!
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Availability Access

• Availability of effective, affordable, safe
  medicines where they are most needed
• Legacy vs. Generic
• Protection of the investment of the developer of
  a medicine and the MAH
• Promote innovation

Balance
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Medicines Directive 2001/82/EC as amended by
Directives 2004/28/EC 2009/9/EC and 2009/53/EC.

• Directives not Regulations
• Transposed
• E.g. ROI European Communities (Animal Remedies)
  (No 2) Regulations 2007
• Current review of Directive 2001/82
• No single market - harmonisation
• Heavy bureaucratic burden
• Lack of availability

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Medicines Directive 2001/82/EC as amended by
Directive 2004/28/EC.

• Article 5 (1)
• No veterinary medicinal product may be placed on
  the market of a Member State unless a marketing
  authorisation has been granted issued by the
  competent authorities of that Member State in
  accordance with this Directive .

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Marketing Authorisation

• Article 6 (1)
• A veterinary medicinal product may not be the
  subject of a marketing authorisation for the
  purpose of administering it to one or more
  food-producing species unless the
  pharmacologically active substances which it
  contains appear in Annexes I, II or III to
  Regulation (EEC) No 2377/90

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Marketing Authorisation

• Article 6 (3)
• By way of derogation, , a veterinary medicinal
  product containing pharmacologically active
  substances not included in Annexes I, II or III
  may be authorised for particular animals of the
  equidae family that have been declared, ,, as
  not being intended for slaughter for human
  consumption.
• Not Annex IV
• Not conflict with Authorised Medicinal Products

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EMA Policy no. 429080/2009

• The availability of safe and effective veterinary
  medicinal products will improve both animal
  welfare and public health Zoonoses Food.
• considerable concern , about the lack of
  veterinary medicines for minor uses, and for
  minor species MUMS and for Limited Markets.
• Article 79 of Regulation (EC)
• No 726/2004 1 requires the
• EMEA to introduce measures
• to assist applicants at the time
• of submitting applications for
• products for limited markets.

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MUMS Limited markets

• Minor use
• Low prevalence
• Limited geography
• Minor species not major (pharma)
• Cattle, sheep, pigs, poultry, salmon
• dog , cat
• Importance?
• Severity
• Licensed alternatives
• Public health/zoonosis
• Food supply issue
• Limited market (financial return)
• Volume
• Regional distribution
• Legislative (control)

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Potential MUMS Assistance - EMA

• More advice
• Free scientific advice
• Reduced data requirements
• Fee reductions
• Translation of documents

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The cascade
Linked with availability of VMPs The ability to
resort to the cascade under specified
circumstances where there is no VMP authorised
in the MS for that species and clinical
indication Directive 2001/82/EC as amended by
Directive 2004/28/EC. Article 10 cascade
for non-food animals Article 11 cascade for
food animals

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General policy objective

• to ensure animal health and welfare
• Improve availability of veterinary medicinal
  products for food producing animals
• Avoid illegal use of substances
• to continue to limit consumer exposure to
  pharmacologically active substances used in
  veterinary medicinal products for food producing
  animals ...

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Cascade for food-producing animals article 11

• the veterinarian responsible may, under his
  direct personal responsibility and in particular
  to avoid causing unacceptable suffering, treat
  the animals with
• (a) a VMP authorised in the Member State
  concerned for use with another animal species,
  or for another condition in the same species or
• (b) if there is no product as referred to in
  point (a), either
• (i) a medicinal product for human use
  authorised in the Member State concerned in
  accordance with Directive 2001/83/EC .or
• (ii) a veterinary medicinal product authorised
  in another Member State in accordance with this
  Directive for use in the same species or in
  another food-producing species or
• (c) if there is no product as referred to in
  subparagraph (b), and within the limits of the
  law of the Member State concerned, a veterinary
  medicinal product prepared extemporaneously by a
  person authorised to do so

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• provided that pharmacologically active
  substances included in the medicinal product are
  listed in Annex I, II or III to Regulation (EEC)
  No 2377/90, and that the veterinarian responsible
  specifies an appropriate withdrawal period.

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Cascade for Non-Food Producing Animals

• by way of exception, the veterinarian
  responsible may, under
• his/her direct personal responsibility and in
  particular to
• avoid causing unacceptable suffering treat the
  animals concerned with
  (a) a veterinary medicinal product
  authorisedfor use in another animal species, or
  for another condition in the same species or
• (b) if there is no product as referred to in
  point (a), either
• (i) a medicinal product authorised for human use
  in the Member State concerned ..or
• (ii) in accordance with specific national
  measures, a veterinary medicinal product
  authorised in another Member State .or
• (c) if there is no product as referred to in
  subparagraph (b) and within the limits of the law
  of the Member State concerned, of a veterinary
  medicinal product prepared extemporaneously by a
  person authorised to do so .
• Identified as not being intended for slaughter
  for human consumption

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Cascade

• no authorised veterinary medicinal product
• another animal species, another disease
  condition
• human use
• another MS
• prepared extemporaneously
• In addition
• Specify an appropriate withdrawal period
• Or ensure exclusion from the food chain

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Essential Substances

• Article 10 (3)
• ...the Commission shall establish a list of
  substances essential for the treatment of equidae
  and for which the withdrawal period shall be not
  less than six months.
• Essential substances may be used only in
  accordance with Article 10(1) of Directive
  2001/82/EC
• The details must be recorded
• in Section IX of the
• identification document for
• equidae

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Essential Substances

• Commission Regulation 1950/2006 established a
  list of substances essential for the treatment of
  equidae
• Positives list not a negatives list
• The cascade applies, i.e. exceptional use,
  protect the welfare of the animal, under the
  direct responsibility of the veterinarian.
• Non-annex medicines (EC 2377/90)
• Essential to protect health / welfare
• Subject to change MSs /- professions

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Essential Medicines

• Sedatives 9
• Cardio-respiratory medicines 12
• Analgesics and anaesthetics 8
• Muscular function 4
• GI Tract 4
• Antimicrobial agents 10
• Anticonvulsants 2
• Ophthalmic 13
• Misc. 9

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Medicines Directive 2001/82/EC as amended by
Regulation EC 470/2009

• The Commission shall establish a list of
  substances
• which are essential for the treatment of equidae,
  or
• which bring added clinical benefit compared to
  other treatment options available for equidae
• and for which the withdrawal period shall be not
  less than six months according to the control
  mechanisms laid down in Commission Decisions
  93/623/EEC and 2000/68/EC.

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New Terms of Reference

• Cascade provisions apply YES
• Annex IV medicines - NO
• Purely economic considerations NO
• Multiples in same class YES
• Different modes of action YES
• Chronic therapies - NO
• Different routes of action YES
• Different pharmacokinetic profile YES

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CVMP proposal 2009

• 21 additions 1 replacement 3 removals
• One extra antimicrobial Polymyxin B
• Chronic therapies Cyproheptadine
• Radiopharmaceutical Tc99
• Not halothane existing user-safety concerns
• Not phenylbutazone outstanding information on
  the teratogenic and carcinogenic potential

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Balance

• Availability (theoretical)
• MUMS
• Cascade
• Essential Substances
• Added Clinical Benefit
• Access (practical)
• Innovation protection
• Routes of sale supply
• Labelling problems
• Recording problems
• Safety
• Animals
• Users
• Consumers

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