Thailand, TRIPS, and Compulsory Licensing

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Thailand, TRIPS, and Compulsory Licensing

• Tanyaporn Wansom
• 2007-2008 Global Health Chair,
• American Medical Student Association
• 2006 WHO Duke University Global Health Fellow
• 2006-2007 Fogarty-Ellison Fellow, RIHES, Chiang
  Mai, Thailand

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Outline of presentation

• Important definitions to understand
• TRIPS
• Doha Declaration
• Generic Product
• Patent
• Compulsory Licensing
• Current events surrounding Thailands compulsory
  license for Kaletra and the Abbott response

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What is TRIPS, anyway?

• What is TRIPS?
• Who needs to follow TRIPS?
• What are the consequences for those who do not
  follow TRIPS?

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TRIPS Flexibilities

• Parallel Importation
• Compulsory licensing
• Allows a government to produce or import a
  generic medicine without consent of the patent
  holder for a limited period of time
• The patent holder still receives compensation in
  the form of a royalty (usually a percentage of
  drug price)
• Doha Declaration
• Each Member has the right to grant compulsory
  licenses and the freedom to determine the grounds
  upon which such licenses are granted... .
• Each Member has the right to determine what
  constitutes a national emergency or other
  circumstances of extreme urgency, it being
  understood that public health crises, including
  those relation to HIV/AIDS, tuberculosis, malaria
  and other epidemics, can represent a national
  emergency or other circumstance of extreme
  urgency.

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Thailand and Compulsory Licensing

• Even though compulsory licensing is legal, under
  international trade law, few countries have been
  able to use it.
• Why?
• US/Europe/Big Pharma pressure
• Threat of sanctions
• Threat of investors/business
• The threat of compulsory licensing has also been
  used as leverage in negotiations with drug
  companies to reduce prices
• Brazil and Kaletra

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The MOPH and Compulsory Licensing

• Since last year, the MOPH has issued compulsory
  licenses for three drugs
• Efavirenz (Merck)
• Kaletra (Abbott)
• Plavix (Sanofi-Aventix)
• This talk will focus on two CLs
• Efavirenz CL, issued in November 2006
• Kaletra CL, issued in Jan 2007

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Efavirenz Background

• EFV often used in first line regimens in Thailand
  (d4T/3TC/EFV, AZT/3TC/EFV)
• Previously, EFV was being sold by Merck at a
  no-profit price of 1400 baht/pt/month
• Thailand placed an order with an Indian generic
  company that would reduce prices to 800 baht/
  pt/mo GPO said it could produce for 600-700
  baht/pt/mo

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Conditions of Efavirenz CL

• (1) CL issued until 31st December 2011.
• (2) CL limited to the provision of Efavirenz to
  not more than 200,000 patients per year, for
  those covered under the National Health Security
  System Act B.E.2545, Social Security Act B.E.
  2533, and the Civil Servants and government
  employees medical benefits scheme.
• (3) A royalty fee of 0.5 percent of the GPO
  total sale value of the imported or locally
  produced Efavirenz will be paid to the patent
  holder (Merck)

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Feb 2007

• Merck announces worldwide reduction in EFV prices
• Thailands new price is now 700 baht/pt/month

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Kaletra Background

• Protease inhibitor combination (lopinavir/ritonavi
  r)
• Covered for patients under NAPHA program
• One of the most expensive AIDS drugs currently
  registered in Thailand at 2200 (72,000 baht)
  per patient per year

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Kaletra CL

• Minister of Public Health Dr. Mongkol Na
  Songkhla
• Public health interest and the interests of the
  people must come before commercial interest.
• Issuing a Kaletra CL would allow either
  importation or in-country generic production,
  reducing prices by 50 or more from current
  prices

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Kaletra CL conditions

• Under the following conditions for Kaletra
• (1) Effective until 31st January 2012.
• (2) The use of the above patent rights will be
  limited to the provision of Efavirenz to not more
  than 50,000 patients per year, for those covered
  under the National Health Security System Act
  B.E. 2545, Social Security Act B.E. 2533, and the
  Civil Servants and government employees medical
  benefits scheme.
• (3) A royalty fee of 0.5 percent of the GPO
  total sale value of the imported or locally
  produced LopinavirRitonavir will be paid to the
  patent holder.

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Abbotts response

• After Thailand issued the Kaletra CL, Abbott
• Withdrew all Abbott products currently undergoing
  registration in Thailand, including the
  heat-stable form of Kaletra
• Announced that it would refuse to release any
  future (new) Abbott products on the Thai market
• Abbott states that it will stick to its decision
  until Thailand reverses its decision on the
  Kaletra CL
• This kind of action is unprecedented and has
  never been attempted by any other pharmaceutical
  company

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April 2007

• Abbott announced price cut from 2200 to 1000
  for a one-year course of Kaletra in Thailand
• Clinton Foundation is offering a generic version
  for 695/year from Matrix Labs in India
• Thai MOPH states that he will not enforce CLs if
  Pharma can match generic prices (May 2007)

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Abbott Support

• US Trade Representative Susan Schwab Thailand
  is now on the Priority Watch List
• Some US (pro-PhRMA) senators, such as Sen. Joe
  Lieberman
• PhRMA (Pharmaceutical Research and Manufacturers
  of America)
• Bayer official support
• USA for Innovation new nonprofit funded by
  Abbott as a PR firm to speak out against Thailand

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Thai support

• Many groups have come out in support of
  Thailands CL, including
• Thai NGOs Thai Network of People Living with
  HIV/AIDS (TNP), AIDS Access Foundation, TTAG,
  and more
• Global NGOs MSF, Oxfam, KEI, Third World
  Network, CP-Tech, Health GAP, etc.
• UNAIDS, Clinton Foundation
• Rep. Henry Waxman 30 other Reps sent a letter
  to the USTR asking for Thailand to be taken off
  the Priority Watch List (6/20/2007)
• France has issued a statement of support for
  Thailand

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Action on the Ground

• ACT-UP Paris and Abbott website
• Abbott protests/birddogging
• Chicago
• Boycott of Abbott products
• Speaking out against pro-PhARMA letters, ads,
  etc. in national and local newspapers (May media
  war)
• Standing up and continuing to pressure Abbott!

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More information

• Thai White Paper (www.moph.go.th)
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• Thai Network of People Living with HIV/AIDS
  (TNP)
• www.thaiplus.net
• Abbott worldwide boycott
• Sign-on letter (petition) to Abbott
• www.abbottsgreed.com
• www.essentialaction.org
• www.keionline.org