CANADAS ACCESS TO MEDICINES REGIME CAMR

1

• CANADAS ACCESS TO MEDICINES REGIME (CAMR)

April 20, 2007

2
Canadian Patent Law

• By providing inventors with time-limited
  monopolies, patents encourage research and
  development and the diffusion of knowledge.
• In Canada, a patent gives an inventor the right
  to exclude others from making, using or selling
  an invention for a 20-year period from the date
  of its filing.
• In certain circumstances, international trade
  laws allow the government to override a patent by
  issuing a compulsory license allowing a third
  party to make, use or sell the patented invention.

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WTO Waiver on TRIPS and Public Health

• In August 2003, WTO Members agreed to waive
  certain intellectual property obligations in the
  Agreement on Trade-Related Aspects of
  Intellectual Property Rights (TRIPS) that were
  thought to be a barrier to addressing public
  health problems in the developing world.
• In particular, the obligation on a WTO Member to
  only issue a compulsory licence predominantly for
  the supply of its domestic market was waived
  because it prevented developed countries with
  pharmaceutical manufacturing capacity from
  exporting generic versions of patented drugs to
  countries with little or no such capacity.
• WTO Members wanting to use the waiver, either as
  exporters or importers, must adhere to a number
  of strict terms and conditions, and remain
  subject to all the other TRIPS obligations
  applicable to compulsory licences.

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Terms and Conditions of WTO waiver

• Only WTO Members with little or no pharmaceutical
  manufacturing capacity suffering from public
  health problems, such as HIV/AIDS, tuberculosis,
  malaria or other such epidemics, are eligible to
  import drugs.
• Importing country must notify WTO of intent prior
  to using waiver and identify name, amount of
  needed drug and its patent status in importing
  country.
• Generic company must request a voluntary licence
  from patentee(s) prior to applying for a
  compulsory licence.
• Quantity of drug produced under compulsory
  licence cannot exceed the amount notified by the
  importing country and the entirety of drug
  produced must be exported.
• Licencee must pay adequate remuneration to the
  patentee(s).
• Waiver must be used in good faith and not for
  commercial or industrial objectives.

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Canadas Access to Medicines Regime

• As a major producer of generic drugs, Canada was
  one of the first WTO Members to implement the
  waiver.
• On May 14, 2005, Canadas Access to Medicines
  Regime (CAMR), which included amendments to the
  Patent Act and the Food and Drugs Act as well as
  associated regulations, came into force.
• Given the unprecedented nature of the CAMR
  initiative, the amending legislation included a
  mandatory review provision calling upon the
  Minister of Industry to
• review the relevant patent provisions of CAMR
  within two years of the coming into force date
  and
• table a report on the review in both Houses of
  Parliament within 15 days of the reports
  completion.

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CAMR Guiding Principles

• To facilitate timely access to affordable drugs
  for importing countries, while respecting
  Canadas international trade obligations under
  TRIPS and NAFTA.
• To provide sufficient incentives for Canadian
  generic manufacturers to participate in CAMR,
  while maintaining the integrity of the domestic
  patent system.
• To ensure drugs exported under a CAMR export
  licence are as safe, efficacious and high quality
  as those sold in Canada.

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CAMR Key Features

• Eligible Importers (Schedules 2-4 of the Patent
  Act)
• Includes all least-developed countries, all WTO
  Members (except those that opted out of WTO
  waiver) and some non-WTO Member developing
  countries.
• A third party (i.e. NGO) may purchase drugs under
  CAMR with permission of an importing country.
• Eligible Drugs (Schedule 1 of the Patent Act)
• Pre-approved drug list (originally consisted of
  all drugs on WHO Essential Medicines List that
  were patented in Canada).
• Since 2005, Schedule 1 been amended twice to
  include an HIV/AIDS anti-retroviral therapy and a
  drug that could be used to treat avian influenza.
• Minister of Health must certify that generic drug
  is safe and efficacious prior to grant of export
  licence.

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Key Features

• Application Process
• Canadian generic manufacturer must seek a
  voluntary licence prior to applying for an export
  licence.
• If that process is unsuccessful, generic
  manufacturer may file a licence application with
  the Commissioner of Patents, which includes
• name, quantity of drug requested and name of
  importing country
• status of relevant Canadian patents
• various statutory and solemn declarations on
  importing country notification, outcome of
  voluntary licence application, etc.
• Royalties
• Licencee must pay royalty to patentee(s), with
  amount linked to the importing countrys level of
  development (UNHDI) and the value of the
  contract.
• Anti-diversion measures
• Drug must be distinctive from patented version
  sold in Canada and licence may be terminated by
  the Federal Court if the granting terms and
  conditions are not met, or if diversion occurs.

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International Comparison Other Implementing
Countries

• Seven other WTO Members have implemented the
  waiver, including the EU,
• Norway, Switzerland, Netherlands, India and
  China, but none have resulted in
• exports.
• Similarities with CAMR
• All require importing country to be identified
  prior to export, usually via WTO notification (or
  if non-WTO Member, to the government issuing the
  export licence).
• All require patentee(s) to be paid adequate
  remuneration.
• Most require generic manufacturer to seek
  voluntary licence from patentee(s) prior to
  applying for an export licence.
• Most require licencee to ensure that generic
  version of a patented drug meets the waivers
  anti-diversion requirements, at a minimum.
• A few provide for a pre-export drug review
  process.
• Differences with CAMR
• None rely on pre-approved lists of eligible
  importers or drugs.
• Most waive voluntary licensing requirement in
  situations of national emergency or extreme
  urgency without specifying where this must exist
  (i.e. in the importing or exporting country).
• Where drug review exists, it is optional (at
  discretion of generic manufacturer).

10
Government Review of CAMR

• To date, no eligible importing country has taken
  the WTO-mandated step of notifying an intention
  to import drugs under CAMR and no drugs have been
  exported by any of the countries that have
  implemented the waiver.
• The Minister of Health announced an early review
  of CAMR at the
• August 2006 Toronto AIDS Conference.
• On November 24, 2006, the Government released a
  consultation paper seeking public input on how
  CAMR can better deliver on Canadas commitment to
  improving access to medicines in the developing
  world, while respecting our international
  obligations and maintaining the integrity of the
  domestic patent regime.
• During the subsequent 60-day consultation period,
  Industry Canada and Health Canada received
  approximately 30 submissions from interested
  parties, primarily the pharmaceutical industry
  and NGOs.

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Stakeholder Positions on CAMR

• Positions of key stakeholders are largely
  unchanged from when CAMR was first developed
• BRANDS want little to no change to CAMR until
  regime is fully tested and want greater
  government focus on other ways of improving
  access to medicines in developing countries,
  such as funding health infrastructure and
  educational awareness.
• GENERICS minimal interest in using CAMR unless
  regime provides greater incentives for
  generic participation, including ability to
  develop greater economies of scale by
  exporting to multiple countries through same
  export licence.
• NGOs want immediate liberalization of the
  regime (eg. eliminate restrictions on
  eligible importers and drugs and eliminate
  obligation on generic company to seek
  voluntary licence prior to applying for
  export licence).

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Status of Statutory Review of CAMR

• Government will be preparing report on CAMR
  examining possible areas for improvement, taking
  into account
• Analysis of stakeholder submissions on
  consultation paper
• INDU Committee hearings and
• Input on CAMR from developing countries in
  upcoming NGO-organized workshop (April 19-20,
  2007).
• In the interim, officials will continue outreach
  activities to promote uptake of CAMR. To date,
  these activities include the creation of an
  instructional Website and significant
  bilateral/multilateral engagement with
  counterparts in developing countries.