Bangkok

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Bangkok

• A Strong Generic Competition
• for a Sustainable Agriculture and 
• an Innovative Dominant Industry

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I Changing context

• World population
• Strain on natural resources
• Globalisation
• More science

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I Forces at work

• Public opinion
• Food safety public health
• Environmental concern
• Surge for intellectual property rigths

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I From TRIPS to national legislations

• Bilateral agreements
• Multilateral approach

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II The European experience

• Legislation with influence on the ability to
• manufacture, market and use PPP
• REACH
• Classification and labeling legislation
• Major accident prevention directive (Seveso)
• Transport regulation
• Legislation resulting from Envir. health
  strategy (SCALE) ?
• Worker protection legislation
• Water Framework Directive and daughter
  legislation
• EU marine strategy
• Regulation on persistent organic pollutants (POP)
• Environmental liability directive
• Prior Informed Consent regulation (PIC)
• Waste legislation
• Etc.

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II The European experience

• Directive 91/414/EEC
• Thematic strategy for the sustainable use of
  plant protection products
• aiming at
• single market, harmonized rules
• high standards for the protection of public
  health and the environment

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II The European experience

• two major points of contention
• Data protection
• A fully harmonised and centralised process for
  the registration of PPP

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II The European experience

• take a step back, and consider
• with objectivity proportionality
• What are the aims and objectives of the
  regulation ?

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II The European experience

• a directive rightly criticised
• Achievements 400 actives substances removed
• REACH an unbearable threat

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II The European experience

• the facts
• The ghost of an INDEPENDANT generic industry
• A thriving dominant industry
• Consumers anxiety
• Farmersdistrust of the regulation

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II The European experience

• Ensuring return on investment
• RD IP
• Data function justification

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II The European experience

• Justification for an exclusive use of data
• Reviewing existing substances
• Ever-greening
• Provisional autorisation
• When it extends beyond patent
• Does not promote innovation

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II The European experience

• So that the innovative industry innovates in the
  interest of health and the environment
• By hindering the preservation or the arrival of
  generics, the protection of data hinders
  innovation and comes to oppose the essential
  objectives aimed by the EU directive.

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II The European experience

• For an EU review that does not preclude plant
  diversity
• Minor crops
• Minor uses
• Resistance phenomena

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II The European experience

• For an objective re-evaluation exempt from
  conflicts of interests.
• Public authority

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II The European experience

• For a PPP regulation consistent with those of
  other regulated products.
• C-114/04 point 24 pharma plant protection
• Centralised MA
• Free movement of agricultural produce
• Thus, and indeed beyond differences of opinion
  and corporatist interests, the revision of
  directive 91/414/EEC has to exclude the
  protection of data and include the notion of
  centralised MA if only not to be inconsistent
  with the objectives it sets and with the
  community provisions of which it is an integral
  part.

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II The European experience
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III PROPOSED AMENDMENTSas from Commisssion
communication 17th July 2006

• National provisional authorisation of PPP
  containing a new active substance
• Mutual recognition of PPP
• substance already approved
• Comparative assessment of PPP
• Data sharing for the renewal of approval of an
  active substance
• Informing neighbours on PPP use

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III PROPOSED AMENDMENTSas from Commisssion
communication 17th July 2006

• National provisional authorisation
• It is proposed to remove the national provisional
  authorisation

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III PROPOSED AMENDMENTSas from Commisssion
communication 17th July 2006

• Mutual recognition of PPP
• substance already approved
•  It is proposed that mutual recognition becomes
  the norm and that Member States within a zone
  could only amend the authorisations in accordance
  with already existing legislation on the
  protection of the health of distributors, users
  or workers.

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III PROPOSED AMENDMENTSas from Commisssion
communication 17th July 2006

• Comparative assessment of PPP
•  Identification at EU level of substances
  candidates for substitution and comparative
  assessment of plant protection products at
  national level. Clear criteria are also foreseen
  for identification of substances candidates for
  substitution. 

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III PROPOSED AMENDMENTSas from Commisssion
communication 17th July 2006

• Data sharing for the renewal of approval of an
  active substance
•  It is proposed to simplify the system. Data
  protection for 10 years after the first
  authorisation is maintained. This will mean 10
  years exclusivity for new substances (as is the
  case today) and 10 years exclusivity for new
  authorizations (new formulation or new use, as is
  already the case now). All provisions on data
  protection at renewal of approval are removed.
• Also, studies on vertebrates may not be repeated.
  
• Companies can agree between themselves on the
  sharing of vertebrate data and the cost thereof.
  If they do not agree, Member States use the data
  anyhow for a second applicant and companies have
  to go to national courts if they want to be
  compensated. 

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III PROPOSED AMENDMENTSas from Commisssion
communication 17th July 2006

• Informing neighbours on PPP use
•  It is proposed that the authorisation may
  provide for an obligation to inform neighbours
  who notified their interest to be informed.
  Moreover records have to be kept by farmers on
  all plant protection products used and to be made
  available on request to neighbours and the
  drinking water industry.  

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IV CONCLUSION

• C-112/02 Judgment of 01/04/2004, Kohlpharma
  (Rec.2004,p.I-3369)
• Canada Brazil India

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Thank you

• www.audace.org

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Bangkok

• A Strong Generic Competition
• for a Sustainable Agriculture and 
• an Innovative Dominant Industry
• 27th 28th July 2006