Pan American Health Organization April 24, 2002 III Pan American Conference on Drug Regulatory Harmo

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Pan American Health OrganizationApril 24,
2002III Pan American Conference on Drug
Regulatory Harmonization

• Linda R. Horton
• Law Offices of Hogan Hartson, LLP
• Washington D.C.
• lrhorton_at_hhlaw.com

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Effects of Regional Integration on Pharmaceutical
Regulation

• THE FREE TRADE AREA OF THE AMERICAS
• AREA LIBRE DE LAS AMERICAS

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The FTAA and Regulations

• What are issues in the Technical Barriers to
  Trade negotiation that affect regulations.
• The provisions are general, covering many
  products, and not only pharmaceuticals.
• What the FTAA is.and is not!

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What trade agreements require of regulators.

• World Trade Organization (WTO) Technical Barriers
  to Trade (TBT) Agreement

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Core discipline of TBT

• The Parties shall ensure that their technical
  regulations are not prepared, adopted or applied
  with a view to or with the effect of creating
  unnecessary barriers to international trade. For
  this purpose, technical regulations shall not be
  more trade- restrictive than necessary to fulfil
  a legitimate objective, taking account of the
  risks non-fulfilment would create.
• TBT Article 2.2

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Parties have a right to Regulate...

• Parties have a right to establish standards and
  technical regulations to achieve legitimate
  objectives, such as the protection of human,
  animal or plant life or health protection of the
  environment or prevention of practices that may
  mislead or deceive the consumer.

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• But Not to Have Unnecessary Technical Barriers to
  Trade
• But what is unnecessary?
• And who decides?

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What should be included in FTAA?

• FREE TRADE AREA OF THE AMERICAS
• DRAFT of July 3, 2001
• downloaded from
• http//www.ftaa-alca.org

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CHAPTER ON STANDARDS AND TECHNICAL BARRIERS TO
TRADE

• Area of Application
• 1.1 The provisions of this Chapter apply to
  standards -related measures activities,
  of the Parties, in other words standards,
  technical regulations, conformity assessment
  authorization procedures and metrology
  ,accreditation technical regulations,
  conformity assessment procedures, metrology
  measures activities (scientific, industrial
  and legal) of the Parties, as well as to
  measures related to these that could directly or
  indirectly affect trade in goods or services
  between the Parties.

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The FTAA is still being negotiated!

• The draft is full of square brackets, indicating
  that many similar ideas are in play but there is
  little agreement yet.
• The final text could be very simple.or it could
  be very complicated.
• Here is what a simple FTAA TBT could be

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Simple TBT Agreement

• 1. Each Party shall make every effort to fully
  implement and abide by the WTO TBT Agreement
• 2. In order to assist the less developed Parties,
  the more developed Parties will make all
  reasonable efforts to provide technical
  assistance
• 3. The Parties hereby establish a Committee on
  Technical Barriers to Trade.

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The agreement could repeat theTBT...

• The Parties could recognize the rights and
  obligations in the WTO TBT Agreement, and agree
  to abide by its principles of
• transparency,
• most-favored-nation treatment,
• non-discriminationNondiscrimination treating
  other Parties goods no less favorably than like
  goods of domestic origin or of any other
  country.

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Or the Agreement could add more details or
obligations...

• What should the language be on
• Harmonization?
• Equivalence?
• Mutual recognition?

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International Standards and Participation in
International Fora

• Common themes Parties shall
• strive to use international standards.
• encourage their adoption.
• urge their standardizing bodies to participate
  fully in international standardizing bodies.
• seek to coordinate positions.

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Definitions

• International Standard a standard, or other
  guide or recommendation, adopted by an
  international standardizing body and made
  available to the public.
• International Standardization Body would
  include WHO/PAHO.

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Examples of language on harmonization

• the Parties shall make efforts to harmonize,
  whenever possible, the standards-related
  activities referred to in 1.1, as well as the
  guidelines and practices established by related
  international technical fora.

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Example on equivalence

• 4.6 The Parties shall give favorable
  consideration to the possibility of accepting
  equivalent technical regulations of other
  Parties, even if these regulations differ from
  their own, provided they are satisfied that these
  regulations appropriately fulfil the objectives
  of their own regulations.
• Issues Who has burden of proof?
• If a request is denied, should there be a written
  explanation?
• Should the Parties adopt common criteria on on
  equivalence determinations?

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On mutual recognition

• Examples of language being discussed
• 5.11 The Parties are encouraged, at the request
  of other Parties, to be willing to enter into
  negotiations for the mutual recognition of the
  results of each others conformity assessment
  procedures.
• 5.13 Parties shall support cooperation among
  testing laboratoriesand inspection bodies to
  promote mutual acceptance of conformity
  assessments and ensuing results.

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Other Issues

• Risk Assessment Include provisions similar to
  those for in the Sanitary and Phytosanitary
  Measures Agreement?
• Transparency Include notification of new
  requirements? Inquiry points?
• Technical Cooperation and Assistance bilateral
  international organizations
• Special and Differential Treatment? For example
  more developed parties shall make all reasonable
  efforts to provide technical assistanceto...less
  developed parties

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Consultations and Dispute Settlement

• 11.1 In the event of a dispute between parties
  regarding the TBT provisions, the Party affected
  may have recourse to
• the Committee on Technical Barriers to Trade, or
• the dispute settlement mechanism under this
  agreement.
• Parties may not seek remedies
• through both avenues
• simultaneously.

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What the FTAA is...

• A trade negotiation
• in which countries agree to reduce or eliminate
• tariffs and
• other barriers to trade
• And we do not yet
• know what it will say.

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What the FTAA is not...

• The FTAA is not FORCING regulators of the
  Americas to harmonize their requirements for
  pharmaceuticals or other products, but
• But it is STRONGLY ENCOURAGING harmonization.

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What the FTAA is for participants in this PAHO
conference...

• The FTAA is an inspiration
• The FTAA is motivation
• The FTAA is an opportunity
• The FTAA is an incentive

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FTAA as an inspiration

• Trade officials in our governments are
  negotiating the FTAA.
• The pharmaceutical regulators, convened by PAHO,
  can harmonize requirements and cooperate with
  each other to eliminate duplication.
• Harmonization is good for public health as well
  as trade.

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Harmonization saves money and improves compliance

• When requirements are similar, compliance is
  easier. Example ICH adverse events reporting
• Upward harmonization possible
• Reduced industry costs mean...
• Reduced consumer costs (consumers pay for drugs
  from their pockets or through taxes or insurance)
• Products reach patients sooner

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Harmonizationa win-win-winfor industry, users,
governments!

• So regulatory cooperation is not part of trade
  negotiation, but is a desirable parallel
  activity, that also reduces expenditures on
  unproductive costs.
• Armonizacion es un ganar-ganar-ganar!

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Thank you! Muchas gracias! Obrigado! Et Merci!
Linda Horton, Hogan Hartson, LLP 202-637-5795
lrhorton_at_hhlaw.com