TRIPS plus FTAs

1
TRIPS plus FTAs

• Rohit Malpani
• Oxfam America

2
Public health consequences of TRIPS plus FTAs

• Prospective studies on FTAs with TRIPS plus
  provisions
• US Colombia FTA By 2020, the Colombian health
  system would pay an additional 940 million per
  year to cover the cost of medicines.
• US-Peru FTA Prices for medicines would rise 9.6
  in the first year, 100 percent in 10 years, and
  162 in 18 years.
• US-Thailand FTA Restricted use of compulsory
  licensing would mean an additional 3.2 billion
  spent on HIV and AIDS treatment program over 20
  years.

3
Measuring consequences of FTAs that have already
been enacted

• US-Jordan FTA
• USTR says
• Since 2000, there have been 32 innovative product
  launches in Jordan, a substantial increase in the
  rate of approval of innovative drugs, helping
  facilitate Jordanian consumers access to
  medicines.
• The Jordanian drug industry has begun to develop
  its own innovative medicines. This is an example
  of how strong IP protection can bring substantial
  benefits to developing countries.

4
Oxfam study in Jordan (still incomplete)

• Basic findings
• Jordanian law now includes linkage, data
  exclusivity, broad subject matter patentability,
  restricted use of compulsory licensing, DE for
  new uses (3 years)
• FDI Only 3 manufacturers have licensing
  agreements with foreign firms and most were
  signed long before the US-Jordan FTA in 2001.
  (More lawsuits than new licensing agreements)

5
Oxfam Jordan study

• 95 of drugs produced by Jordanian manufacturers
  are generic, 5 are under-patent drugs produced
  via licensing agmts.
• Other FDI only consists of scientific offices
  engaged in marketing activities no FDI for
  manufacturing.
• By comparison Egypt has received 223 million
  USD (40 by foreign-based research companies)

6
Oxfam Jordan study

• Local production as total consumption 40.75
  (1999) to 26 (2003)
• Imports 102.9 JDM (1999) to 202.4 (2005)
• 18 medicines received addition DE for new uses
  (up to June 2006)
• In 2002, new products with no generic equivalents
  captured 3 of market. By 2006, new products
  captured 9.25.
• 2002 (local sales of patented medicines) 2.9
  million USD first 2 quarters 2006 14.4 million
  dollars

7
Oxfam Jordan study

• Top 26 drugs in U.S. (blockbusters) only 9
  available in Jordan.
• Of 5 largest U.S. companies of 82 products,
  only 33 registered in Jordan.
• No innovative medicines developed in Jordan
  only exporting off-patent medicines.
• Researcher needs to identify medicines for which
  generic launch delayed due to TRIPS plus rules
  and compare with prices in Egypt (if generic
  version available).

8
Other consequences of FTAs

• Chile out-of-cycle review and injunctions sought
  by U.S. and Swiss companies
• Implementation of TRIPS plus rules in CAFTA
  countries.
• Side letters support or deride? Some Dems seem
  to think side letters are sufficient to address
  public health concerns.

9
Side letters

• Legal basis of side letters not an integral
  part of the agreement only an understanding
  and only for limited public health concerns
  anyways.
• shall constitute an agreement only in Morocco
  FTA others do not contain this language

10
Ideas

• Prescription drug prices in the U.S. and linking
  to prices of medicines in other countries.
• Leahy Bill Life Saving Medicines Export Act
• GAO report (Kennedy-Waxman) and TPA