Although
in the area of public health, TRIPs provides some safeguards (compulsory
licenses and parallel imports) for developing nations, the U.S. Government
and pharmaceutical companies strongly oppose developing countries' efforts
to make HIV/AIDS drugs more available and affordable to their people via
TRIPs safeguards, particularly with compulsory licensing (34).
The U.S. Government has put pressure to developing nations by means of
political, economic, and legal mechanisms, especially trade sanction section
301 (35). Developing countries have been threatened with
U.S. trade sanctions if they do not strengthen their patent laws, even
though such laws benefit the U.S. pharmaceutical companies and not developing
countries' own citizens. Some countries such as Thailand may be afraid
of this pressure and discontinue their projects to help their poor. On
the other hand, some countries such as India, and Brazil may be brave
enough to carry on their projects and effectively achieve. It is true
that because of compulsory licensing or parallel imports, the pharmaceutical
industry will have to accept less profit. However, the cost is small when
weighted against the interest of all patients in having increased access
to essential drugs.
In the case of parallel imports, developing countries
may possibly expect the less intimidating action under trade sanction
section 301 from the U.S. for the following reasons. First, developing
countries that are TRIPs member are free to allow parallel imports by
applying an international exhaustion doctrine. Second, compared to compulsory
licensing, there is less government involvement in parallel imports because
there is no need of government approval of the importation. Third, unlike
compulsory licensing, under parallel importation the owners of IPRs receive
a benefit from the first sale of their products at price they set. It
seems that the owners of IPRs are more voluntary in parallel imports than
compulsory licensing. Finally, the U.S. also allows parallel imports of
parallel imports of pharmaceutical products from Canada and Mexico(36) as a result of the U.S. consumer pressure and governmental health care
policy(37). Therefore, it is improper for the U.S. to
force other countries to restrict parallel imports, if the U.S. itself
allows gray market pharmaceuticals.
Therefore, the following section will explain and analyze
the controversial disagreements between the U.S. and developing countries
by selecting some actual cases taking place in Thailand, Brazil, India,
and South Africa. The situations of these developing countries will illustrate
the adverse effects of the U.S. pressure on developing countries, such
as a high price of medicines and a delay in the issuance of compulsory
licensing. Moreover, due to difficulties on compulsory licensing, parallel
imports may be considered a proper solution for increasing access to drugs
rather than compulsory licensing.
1. Thailand
Thailand has faced with the AIDS panderhic because most HIV infected patients
cannot afford the antiretroviral drug(38). In order
to reduce the price of HIV drugs, the Thai Government has attempted to
grant limited patent protection rights and support an active generic industry(39).
The Thai Government has tried to grant compulsory licensing for essential
drugs, which is consistent with the text of TRIPs Agreement.
Unfortunately, the U.S. has opposed such action, for
example, the Thai Government attempted to grant a compulsory licensing
for the drug didanosine (ddl), owned by Bristol-Myers-Squibb (U.S. multinational
pharmaceutical company). In return, the U.S. imposed a strong trade pressure
in order to, prevent the issuance of the compulsory license. Finally on
January 16, 2000, the Thai government involuntarily rejected the issuance
of the ddl compulsory license because of the U.S. trade pressures(40).
Needless to say, the threats of the U.S. Government and
pharmaceutical companies has caused hesitation and delay by the Thai Government
in issuing compulsory licenses and has impeded access to HIV/AIDS drugs
in Thailand. Nevertheless, the current Thai Patent Act, adopting an international
exhaustion doctrine, allows parallel imports that may solve the issue
of obtaining access to essential drugs and diminish the adverse effect
of U.S. pressure on Thailand.
2. Brazil
Like Thailand, Brazil also faced a HIV/AIDS crisis. However, the Government
of Brazil has successfully launched many programs to help AIDS patients
in terms of prices and access to drugs(41) Regardless
of the U.S. pressure, the Brazil Government has used both a compulsory
licensing and parallel imports strategies(42). In other
words, the Government is brave enough to step forward to protect its own
people against the U.S. Government and pharmaceutical companies by playing
an important role to support the accessibility of drugs and technology
transfer in the pharmaceutical industry.
In order to improve access to drugs with affordable price
and encourage the transfer of technology, the Brazil patent law provides
patents for pharmaceuticals, but subject to a working requirement. As
a result of a "working requirement" under Article 68, it permits
the issuance of compulsory licenses in case where patent holders choose
to supply the market through imports rather than local production. The
Government put pressure on multinational pharmaceutical companies to produce
patented drugs in Brazil instead of importing the drugs into Brazil.
In response to this regulation, the U.S. requested
a WTO dispute settlement panel in February 2001. The U.S. Government claimed
that Article 68 of the Brazilian Industrial Property Law 1996 violated
the TRIPs Agreement because the 'local working' requirement discriminated
against imported products. Brazil argued that the provision allowing compulsory
licensing or parallel imports complied with the TRIPs Agreement because
it was intended to address "abuse of rights or economic power"
by the patent holder (43). During the time of dispute,
many international NGOs, and developing and least-developed countries
put intense opposition to the U.S. position. If the U.S. were to succeed
in its case, it would not only exterminate the Brazil's successful AIDS
program, but would also obstruct others from using the same approach as
Brazil to solve the issues of inaccessibility and non-affordability of
essential medicines (44).
As the result of powerful global pressures and a change
in U.S. policy under the Bush Administration, the U.S. announced on June
25, 2001 that it would withdraw the case against Brazil in a joint statement
with Brazil(45). The U.S. and Brazil have set up the
U.S.-Brazil Consultative Mechanism to find mutually agreeable "creative
solutions."(46) In return for the U.S. withdrawing
the case, Brazil agreed to consult with the U.S. prior to issuing a compulsory
license for patents held by U.S. companies, based on a case-by-case decision(47).
The U.S. action of withdrawing the case was joyfully acclaimed by developing
and least-developed countries and NGOs(48). This event
not only demonstrated a pleasant compromising solution between a developing
and developed country, but also mitigated other confrontations between
the U.S. and other developing counties who opposed the U.S. position,
particularly South Africa.
Due to a strong political commitment by Brazil to solve
the HIV/AIDS crisis without fear of U.S. pressure, Brazil is one developing
country that has successfully achieved improved accessibility to affordable
AIDS drugs. Brazil's achievement provides a good example for other developing
countries to solve AIDS issues by following Brazil's footstep. In addition,
by obtaining an adequate amount of manufacturing capacity, Brazil also
assists other developing countries to increase manufacturing capacity
through a transfer of technology(49).
3. India
Similar to other developing countries, India was threatened by U.S. trade
sanction with support of PhRMA for inadequate patent protection for pharmaceuticals(50).
The U.S. pharmaceutical companies claim that the India Patents Act of
1970 essentially provided no patent protection for pharmaceuticals. The
drug companies asserted that (1) the term of patent protection was too
short to provide protection and the examination and opposition procedure
caused too much delay and decreased the available duration of protection;
(2) the royalty for compulsory licenses was artificially low; and (3)
product patents were not available for pharmaceuticals(51).
However, India has an obligation to amend its patent law to provide the
patent product for pharmaceuticals by 2005(52). Like
Brazil, the Indian Patent Act of 1970 states that importation of a patented
product is not equivalent to a working patent in India(53).
Multinational pharmaceutical companies argue that this working requirement
is not consistent with the TRIPs Agreement.
The Patent Act of 1970 has produced considerable advantages
for the Indian pharmaceutical industry by producing inexpensive drugs
for the market, and maintaining the trade balance in the pharmaceutical
sector(54). Although India is classified as a developing
country, India has a successful pharmaceutical industry with innovative
capacities of drug development(55). Pharmaceutical prices
in India are considered among the lowest price in the world. India has
become a source of parallel imports to other developing and least-developed
countries, providing low price drugs for poor populations(56)."
However, India has enacted legislation granting patent protection, effective
2005. In other words, this favorable factor of a weak patent protection
will no longer continue to exist in the near future (2005) as a result
of the TRIPs Agreement. This change will affect the Indian pharmaceutical
by increasing drug prices, which may make India's drugs unaffordable and
inaccessible for the poor(57). Nevertheless, the strong
support by Indian Government, the innovative capacitates in pharmaceutical
industry, and the long-term benefits of a weak patent protection should
facilitate the Indian pharmaceutical industries to continually maintain
their competitive position in global market in terms of low price and
more availability. That would benefit all poor patients not only in India
but also in other developing and least-developed countries by improving
access to essential drugs, particularly HIV drugs.
4. South Africa
South Africa has experienced the highest increase of HIV in the world,
with 2.4 million people infected, or 6.3% of the population. Due to the
high prices of HIV drugs, the South Africa Government has attempted to
reduce the cost of medicines and increase access to HIV drug(58).
The government passed the Medicines and Related Substances Control Amendment
Act of 1997 to improve access to essential drugs. The 1997 Amendment permits
both the development of generic AIDS drugs under compulsory licensing
and the parallel importation of low-priced AIDS drugs into South Africa(59).
Allowing parallel imports has definitely given poor HIV patients increased
access to drugs in terms of low price and more availability. With inadequate
capability for pharmaceutical manufacturing(60), it
is difficult for South Africa to produce patented drugs in South Africa
under compulsory licensing. Thus, parallel imports are a more useful means
to gain access to affordable HIV drugs than compulsory licensing in South
Africa(61).
Responding to the 1997 Amendment, both the U.S. Government
and pharmaceutical companies strongly opposed South Africa's efforts to
undertake compulsory licensing or parallel imports to make HIV/ADDS drugs
or other essential medicines more available and affordable to its people(62).
The U.S. had withheld certain trade benefits from South Africa and had
threatened trade sanctions by placing South Africa on the Special 301
Watch List(63). The issue became increasingly debated
because of a South Africa court case, with the South Africa government
against the 39 largest pharmaceutical companies in the world(64).
They took South Africa to a court by claiming that South Africa's 1997
Medicines and Related Substances Control Amendment Act section 15C, allowing
a compulsory licensing and parallel imports, violated the TRIPS Agreement(65).
The three-year court case ended on April 23, 2001. The
South Africa government agreed to abide with TRIPS obligation and to set
up a joint working committee with the pharmaceutical companies to draw
up regulations governing the 1997 Medicines Act(66).
In return, the pharmaceutical companies agreed to supply drugs to South
Africa at drastically reduced prices to help poor patients(67).
The U.S. government recently acknowledged the importance of providing
affordable AIDS drugs in South Africa(68) and subsequently
lessened its pressure on South Africa, which should be a good sign for
other developing countries.
V. The Support From WTO Doha Ministerial Conference
In November 2001, the WTO Ministerial Conference met
in Doha in Qatar. Compared to the 1999 WTO Ministerial meeting in Seattle,
developing countries participated more equally in the Doha Conference(69).
The outcome of the Doha Ministerial Conference was important in terms
of public health, as presented in the Doha Ministerial Declaration and
the specific Declaration on Public Health(70). In fact,
the Doha declarations were successfully achieved because of the strong
participation of developing and least-developed countries with the support
of developed counties(71). The U.S. has changed its
domestic and foreign policy in an area of public health. The U.S. foreign
policy has become more liberal regarding the utilization of compulsory
licensing and parallel imports(72). Its domestic policy
also changed from prohibiting parallel imports to allowing parallel imports
in to the U.S. of pharmaceuticals that ,meet the U.S. standard in order
to reduce the domestic drug price(73). Moreover, the
Bush Administration has indicated concern about the HIV/AIDS crisis, and
the individuals, families and communities affected by the disease(74).
Part
3
(34)
See Weissman, Aids and Developing Countries, supra note 18, at 2; and
also see The Associated Press, Brazil is Planning to Request License for
AIDS Viracept, June 27, 2001, available at http://www.aegis.com/news/ap/2001/AP010688.html
(visited on Oct. 7, 2002). (commenting that Brazil continued to issue
compulsory licenses for an AIDS drug due to the high price of the AIDS
drug. The U.S. filed a complaint with the World Trade Organization over
Brazil law; however, this case was dropped under immense international
pressure.).
(35) See Myles Getlan, Comment, TRIPS and the
Future of Section 301: A Comparative Study in Trade Dispute Resolution,
34 COLUM. J. TRANSNAT’L L. 173, 173 (1995). (pointing out that that
improving IPRs protection in other countries by the section 301 approach
has failed and suggest that the most effective way to strengthen intellectual
property protection abroad should be to improve the GATT dispute resolution
process.); and also see Adam Smith, A High Price to Pay: The Costs of
the U.S. Economic Sanctions and the Need for Process Oriented Reform,
4 UCLA J. Int'l L. & Foreign Aff. 325, 325-46 (1999). (suggesting
that the U.S. should limit its use of trade sanction as an instrument
of foreign policy because the trade sanctions can harm the U.S.'s short-term
and long-term economic interest.).
(36) See The Medicine Equity and Drug
Safety Act of 2000 (MEDSA) H.R. Rep. No. 106-948, at 38 (2000). MEDSA
was passed as section 745 of Public Law 106-387.; see William Davis, Comment,
The Medicine Equity and Drug Safety Act of 2000: Releasing Gray Market
Pharmaceuticals, 9 TUL. J. INT'L & COMP. L. 483 (2001) (pointing out
that the MEDSA was a piecemeal compromise aimed at lowering pharmaceutical
prices by allowing wholesalers and pharmacists to buy U.S. approved drugs
abroad and resell them in the United States. Before issuing the MEDSA,
the United States expressly banned the resale or parallel imports of foreign-purchased
pharmaceuticals under the Prescription Drug Marketing Act of 1987.); see
Prescription Drug Marketing Act of 1987, Pub. L. No. 100-293, 21 U.S.C.
381(d) (2000); see JOHN F. CALFEE, PRICE. MARKETS AND THE PHARMACEUTICAL
REVOLUTION 1-3 (2000); and also see infra note 777.
(37)
See Melody Petersen, Drug-Cost Bill May Not Dent Industry Profit, N.Y.
TIMES. Sept. 28, 2000. at Cl.; and also see Robert Pear, FOr Price Break
on Drugs. Congress Looks to Canada. , N.Y. TIMES, Sept. 9, 2001, at 22.
(38) See Judy Rein, Article, International Governance
through Trade Agreements: Patent Protection for Essential Medicines, 21
NW. J. INT'L L. & BUS. 379, 402 (2001), cited in Global Trade and
Access to Medicine: AIDS Treatments in Thailand, 354 Lancet 1893, 1984
Nov. 27, 1999. (the cost of triple therapy is USD 675 per month, while
the average monthly salary of an office worker is only USD 120. The high
price certainly reduces access to HIV drugs because HIV infected patients
cannot afford to the price of therapy.)
(39) For example, Thailand Government Pharmaceutical
Organization (GPO) has been producing generic AZT for a quarter of the
price of the brand name version for several years. See Sutin Wannabovom,
Thais Protest U.S. Firm's AIDS Drug Monopoly, available at http://biz.yahoo.com/rf/991222/bg/html
(visited Oct. 28, 2002)
(40) See Thailand: Government Rejects Compulsory
Licensing for ddl, Kaiser Daily HIV/AIDS Report, Thursday, Jan. 20, 2000,
available at http.//report.kff.org/achive/aids/2000/01/kh00120.3,htm (visited
Oct. 28, 2002).; Thailand : U.S. and 'Gig Pharma' Orchestrate Pressure,
Access to Essential Medicines Report, Jan. 11, 2001, available at http://www.msf.org/countries/page.cfm?
articleid-CACADFAI-C511-43ED-ADE7... (visited Oct. 28. 2002); and also
see The Letter from James Love, Consumer Project on Technology, available
at http://www.cptech.org/ip/health/Thailand/tmr-jan22-2000.html. (visited
Oct. 28, 2002).; To increase access to drugs besides a compulsory license,
Thailand allows parallel imports of drugs from other countries in Asia.
The U.S. pharmaceutical companies have argued strongly against Thailand
allowing parallel imports. The information is available at www.phrma.org/issues/int/thailand.html
(visited Oct. 28, 2002)
(41) See Rosenberg, supra note 22, at
1.; and also see Brazil Fights for Affordable Drugs Against HIV/AIDS,
Rev Panam Salud Publica/Pan Am J Public Health 9(5), 2001, at 332-33,
available at http://www.paho.org/English/DBI/ES/v9n5-TEMA-Brazil.pdf.
(visited Oct. 16. 2002). [hereinafter Brazil Fights for Affordable Drugs]
(explaining that Brazil's policy of providing patient with free antiretroviral
(ARV) drugs has played a significant role in the country's achievements.
A key to the broad public access to ARVs has been the local manufacturing
of cheaper generic equivalents of the medicines developed and patented
in wealthier countries. By 1999 this approach had cut treatment costs
in Brazil by 70%.)
(42)
See Article 68 and 71 of Brazil patent law (compulsory licenses), translated
into English by the World Intellectual Property Organization, available
at http://www.cotech.org/ip/health/cl/brazil1.html. (visited Oct 18. 2002)
(43) See Brazil Fights for Affordable Drugs,
supra note 41, at 334-36.; and also see Paul Champ & Amir Attaran,
Patent Rights and Local Working Under the WTO-TRIPS Agreement: An Analysis
of the US.-Brazil Patent Dispute, 27 YALE J. INT'L L.365, 367 (2002).
(pointing out that local working requirement is generally permissible
based on the broad reading of a whole context of TRIPs)
(44) See Ellen 't Hoen, Article, Public
Health and International Law : TRIPS, Pharmaceutical Patents, and Access
to Essential Medicines: A Long Way From Seattle to Doha, 3 CHI. J. INT'L
L. 27, 33 (2002).; and also see Brazil Fights for Affordable Drugs, supra
note 41, at 336.
(45) See Helen Cooper, U.S. Drops WTO Complaint
Against Brazilian Patent Law, Wall St J. Eur A2 (June 26, 2001).; and
also see USTR Press Release, United States and Brazil Agree to Use Newly
Created Consultative Mechanism to Promote Cooperation on HIV/AIDS and
Address WTO Patent Dispute, June 25, 2001, available at http://www.ustr.gov/release/2001/06/01-46.htm
(visited Oct. 18, 2002).
(46) Id.
(47) See Chakravarthi Raghavan, US. Beats a (Tactical)
Retreat over Brazil's Patent Iaw, available at http://www.twnside.org.sg/title/tactical.htm.
(visited on Oct. 16, 2002).
(48) See Id. The NGOs welcomed the US action
such as Elen 't Hoen of Medicins sans Fortier (MSF), Oxfam, and Jame Love
of the US Consumer Project on Technology.
(49) See Hoen, supra note 44, at 33.
(50) See Pharmaceutical Research and Manufactures
of America, PhRMA Special 301 Submission Priority Foreign Countries, 8
(2001), available at http://www.phrma.org/intnat/all.phtml?prefix=reg.
(visited on Dec. 2. 2001)
(51) See Shodeep Baneriji, The Indian Intellectual
Property Rights Regime and the TRIPS Agreement, in INTELLECTUAL PROPERTY
RIGHTS IN EMERGING MARKETS (Clarisa Long, ed.) at 58-59.; and see ASEAN
Workshop on TRIPs and Pharmaceuticals, supra note 10, at 7.
(52) See Suresh Koshy, The Effect of TRIPS on
Indian Patent Law: A Pharmaceutical Industry Perspective, 1 B.U. J. SCI.
& TECH. L. 4, 9-10 (1995); and also see Carsten Fink, How Strong Patent
Protection in India Might Affect the Behavior or Mansnational Pharmaceutical
Industries, Development Research Group, The World Bank, at 3.
(53) See Baneriji, supra note 51, at 67-68, and
80. (explaining that section 83(a) states "patents are granted to
encourage inventions and to secure that the inventions are worked in India
on a commercial scale" and section 33(b) provides "they are
not granted merely to enable patentees to enjoy a monopoly for the importation
of the patented article.")
(54)
See Koshy, supra note 52, at para.23.
(55) See Carlos M. Correa, Implications of the
Doha Declaration on the TRIPS Agreement and Public Health, June 2002,
WHO/EDM/PAR/2002.3, (Health Economics and Drugs EDM Series No.12, WHO)
at Annex 2 Table of Levels of Development of Pharmaceutical Industry,
by Country (Source : Balance R, Pogany J, Forstner H. The World's Pharmaceutical
Industry. An International Perspective on Innovation, Competition and
Policy. Vienna, United Nations Industrial Development Organization, 1992)
[hereinafter Correa, Implications of Doha Declaration on TRIPS and Public
Health]
(56) See Shubha Ghosh, Pills. Patents, and Power.
State Creation of Gray Markets as a Limit on Patent Rights, 53 FLA. L.
REV. 789, 814 (2001). (pointing out that the main source of the parallel
imports in South Africa is from India, which until recently did not recognize
patents on medicine.)
(57) Id. 82-86.; see Jayashree Watal, Introducing
Product Patents in the Indian Pharmaceutical Sector: Implications for
Prices and Welfare, 20 World Competition: Review of Law and Economic,l,
5-21(1996).; and also see Watal, supra note 5, at 733-52. (pointing out
that if the patent protection raised the drug price in India, India might
take advantage of cheaper drugs from Bangladesh.)
(58) See David Benjamin Snyder, Comment, South
Africa's Medicines and Related Substances Control Amendment Act A Spoonful
of Sugar or a Bitter Pill to Swallow?, 18 DICK. J. INT'L L. 175 (1999).
(59) Id. at 180-4. (pointing out that
allowing parallel imports under the exhaustion doctrine have obvious potential
benefits for consumers because of the increase in competition created.
Section 15(C) (b) clearly permits parallel imports by allowing" people
to import a manufacturer's patented pharmaceuticals sold in other countries
into South Africa.)
(60)
See Correa, Implications of Doha Declaration on TRIPS and Public Health,
supra note 55, at Annex 2. (stating that South Africa only has the capacities
to produce finished products from imported ingredients.)
(61) The main source of the parallel imports
is from India, which until recently did not recognize patents on medicine
(but has enacted legislation granting patent protection that will be effective
in 2005). See Ghosh, supra note 760, at 814.
(62) See Weissman, Aids and Developing Countries,
supra note 18, at 2.; and also see The Associated Press. Brazil is Planning
to Request License for AIDS V racept, June 27, 2001, available at http://www.aegis.com/news/ap/2001/AP010688.htm1.
(visited Oct. 7, 2002). (explaining that Brazil continued to consider
issuing a compulsory licenses for an AIDS drug. The U.S. had filed a complaint
with the World Trade Organization over Brazil law; however, this case
was dropped under immense international pressure.)
(63) Press Release, Office of the U.S. Made Representative,
U.S.T.R. Announces Results of Special 301 Annual Review (Apr. 30, 1999),
available at http://www.ustr.gov/release/1999/04/99-41.html. (visited
May 14, 2002).
(64) See Pharmaceutical Manufacturers Association
of South Africa and 41 others v. President of the Republic of South Africa
and 9 Others, The High Court of South Africa (Transvaal Provincial Division)
Case No. 4183/98. (field Feb 18, 1998)
(65) Id.; and see South Africa Medicines and
Related Substances Control Act No. 101 of 1965, Amendment No. 70, Section
15 (C) (1997), available at http://lists.essential.org/pipermail/pharm-plicy/2001-January/000607.html.;
see Duane Nash, Berkeley Technology Law Journal Annual Review of Law and
Technology: VI Foreign & International Law South Africa's Medicines
and Related Substances Control Amendment Act of 1997, 15 BERKELEY TECH.
L.J. 485 (2000).; see Winston P. Nagan, International Intellectual Property,
Access to Health Care, and Human Rights: South Africa v. United States,
14 FLA. J. INT'L L. 155 (2002) (pointing out that both compulsory licensing
and parallel import schemes are permissible under the TRIPs Agreement.);
and also see Frederick M. Abbott, II Discontinuities in the Intellectual
Property Regime : The TRIPS-Legality of Measures liken to Address Public
Health Crisis : A Synopsis, 7 WID. L. SYMP. J. 71, 82-84 (2001). [hereinafter,
Abbott, TRIPS and Public Health Crisis] (noting that section 15 (C) is
not overbroad or ambiguous and entirely consistent with the acceptance
for authorizing international exhaustion and parallel imports.)
(66) See Steven Lee Myers, South Africa and U.S.
End Dispute Over Drugs, N.Y. TIMES, Sept. 18, 1999, at A8.
(67) See HIV and AIDS Drugs in Africa, available at http://www.avert.org/aidsdrugsafrica.htm
(visited on Oct. 16, 2002).
(68) See Vice President Gore's June 25, 1999 Letter to
James E. Clybum, Endorsing the Use of Compulsory Licensing and Parallel
Imports of Pharmaceutical Drugs in South Africa, available at http://www.cptech.org/ip/health/sa/vp-feb-25-99.htm1.
(visited Sept. 27, 2002).; On July 26, 1999, the Treatment Action Campaign
(TAC) met with the U.S. representatives to discuss the use of compulsory
licensing and parallel imports to make HIV/AIDS drugs available at affordable
prices in South Africa. This information is available at http://www.hri.ca/partners/alp/press/gore-press.shtml.
(visited Sept. 27, 2002).
(69) See Peter Lichtenbaum, Article, Reflections on The
WTO Doha Ministerial: "Special Teatment" vs. "Equal Participation:"
Striking A Balance in The Doha Negotiations, 17 AM. U. INT’L L.REV.
1003, 1021 (2002).; and also see Peter M. Gerhart, Article, Reflections
on The WTO Doha Ministerial : Slow Transformations : The WTO As A Distributive
Organization, 17 AM. U. INT'L L.REV. 1045, 1090-92 and 1094 (2002).
(70) See Doha Ministerial Declaration (Nov. 14, 2001),
WT/MIN(01)/DEC/W/1, available at http://www.wto.org/english/ thewto_e/minist_e/min01_e.htm.
[hereinafter Doha Ministerial Declaration]; and also see Declaration on
The TRIPS Agreement and Public Health (Nov. 14, 2001), available at http://www.wto.org/english/thewto_e/minist_e/min01_e/mindeci_tripe_e.htm.
[hereinafter Doha TRIPs and Public Health Declaration]
(71) During the draft of Ministerial Declaration on TRIPS
and Public Health, there are three proposals from (1) a group of developed
countries (the United States, Australia, Canada, Japan, and Switzerland);
(2) a group of developing countries (the Africa Group and 19 countries);
and (3) the EU. Those text drafts are respectively available at http://www.wto.org/
english/tratop_e/trips_e/mindecdraft_w313_e.htm; http://www.wto.org/english/tratop_e/trips_e/paper_develop_w296_e.htm;
and http://www.wto.org/english/tratop_e/trips_e/paper_eu_w280_e.htm. (visited
Oct. 8, 2002); see TRIPs and Public Health vs TRIPs and Pandemics?, BRIDGES
Monthly Vol. 5, No. 7 Sept. 2001, available at http://www ictsd.org/ministerial/doha/bridgesmonthly5-7.htm
(visited Oct. 18, 2002).
(72) See Exec. Order No 13, 155, 65 Fed Reg 30, 521 (2000);
and also see Hoen, supra note 748, at 34-35.; see A Press Release from
the Office of the USTR, dated Sept. 17, 1999, available at http://www.ustr.gov/release/1999/09/00-76.html
(reporting that the U.S. promised to drop threats of trade sanction against
South Africa); and also see John A. Harrelson, IV Note : TRIPS, Pharmaceutical
Patents, and The HIV/AIDS Crisis: Finding the Proper Balance Between Intellectual
Property Rights and Compassion, 7 WID. L. SYMP. J. 175 (2001).
(73) Before issuing the Medicine Equity and Drug Safety
Act of 2000(MEDSA), the United States expressly banned the resale or parallel
imports of foreign-purchased pharmaceuticals under the Prescription Drug
Marketing Act of 1987. The MEDSA was a piecemeal compromise aimed at lowering
pharmaceutical prices by allowing wholesalers and pharmacists to buy U.S.
approved drugs abroad and resell them in the United States, passing the
discounted foreign prices along to the consumer. See Prescription Drug
Marketing Act of 1987, Pub. L. No. 100-293. See 21 U.S.C. 381(d) (2000)
[hereinafter called PDMA]; see Davis, supra note 739, at 483. (pointing
out that there is an opportunity for arbitrage in the pharmaceutical industry
among the U.S. foreign neighbors.); and also see H.R. Conf. Rep. No. 106-948m
at 39 (2001)
(74) See USTR Press Release, United States and Brazil
Agree to Use Newly Created Consultative Mechanism to Promote Cooperation
on HIV/AIDS and Address wTO Patent Dispute, June 25, 2001, available at
http://www.ustr.gov/release/2001/06/01-46.htm (visited Oct. 18, 2002). |