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TWN Info Service on Intellectual Property Issues (Mar07/05) 16 March 2007
Twelve
influential members of the Congress of the The letter urged for balancing the protection of innovation and the intellectual property provisions in the current FTAs which extend pharmaceutical monopolies without sufficient regard to consumer access and public health. A copy of the letter dated 12 March 2007 is reproduced below. We have also reproduced an article from SUNS #6211 Thursday, 15 March 2007 below. Best
wishes, Congress
of the Dear Ambassador Schwab: According to international health organizations, ninety percent of the 14 million people killed annually by treatable infectious disease live in the developing world. Even more die of treatable noninfectious illnesses. But despite the high disease burden in developing countries, one-third of the world's population has no access at all to essential medicines. The need for expanded access to affordable drugs is dire, and demands careful attention when international trade policies address intellectual property. Recognizing
this, the U.S. was one of 142 countries that adopted the 2001 “Doha
Declaration” on the Trade-Related Aspects of Intellectual Property Agreement
(TRIPS) and public health.1 The Doha Declaration “reaffirm[ed] the right
of WTO members to use, to the full, the provisions of the TRIPS agreement
which provide flexibility” to protect public health.2 It specifically
affirms countries' rights to interpret and implement trade obligations
in ways that protect access to essential medications.3 In the 2002 Trade
Promotion Authority Act. Congress directed the Administrative branch
to adhere to the Doha Declaration as a “principal negotiating objective”
in Regrettably,
recent We
are writing to urge the immediate reconsideration of these provisions
in recently negotiated FTAS with Our concerns are detailed below. Data Exclusivity Under WTO rules, pharmaceutical innovations receive twenty years of patent protection.5 Recent U.S. FTAs add an additional requirement: a period of “data exclusivity” that begins when a patented drug receives marketing approval.6 During this period, regulators cannot rely upon clinical test data submitted for a drug's first approval when considering marketing approval for generic versions. The effect can be to delay the availability of generics even if a patent has already expired. Current
U.S. law provides data exclusivity, but places strict caps on the periods
available.7 In contrast, the recent FTAS require data exclusivity periods
but do not require caps.8 As a result, developing countries may face
pressure to adopt longer exclusivity periods, presenting a scenario
where the wait for generics could be even longer in a developing country
than in the United States. Even if a developing country institutes limits
equal to those in the The
data exclusivity provisions ignore fundamental differences between the
development of For
any patient, five years or more without a medicine priced out of reach
can be severe. The consequences are especially serious for patients
with HIV/AIDS or other chronic diseases, where the cost of treatment
can mean the difference between life and death. Patent Extensions and “Linkage” Another
obstacle presented by the FTAS is the provision for potentially unlimited
patent extensions. U.S. law grants patent extensions when there are
delays in either the patent review or marketing approval period, but
safeguards consumer rights by limiting the total duration permitted.11
The FTAS require that countries provide patent extensions for such delays
- but do not require any lirnitations.12 Because developing countries
have scarce resources for these activities, the review and approval
processes can be lengthy. With the resulting extensions, the patent
term could be longer in a developing country than in the Further, the FTAS place an onerous “linkage” between drug approval and patent authorities.13 A typical example is the requirement that a drug regulatory authority withhold approval of a generic drug until it can certify that no patent would be violated. Such provisions put a significant burden on regulatory agencies that have neither the expertise nor the authority to enforce private patentholder rights. The problem is especially severe for developing countries where resources are already stretched thin by the primary task of monitoring the safety, efficacy, and quality of medicines on the market. The provision could compromise this fundamental mission and cause indefinite delays for the approval of generic drugs. Compulsory Licensing Compulsory
licensing is the government granting of a license to a manufacturer
other than the patentholder to produce a drug at an affordable price.
The Doha Declaration affirmed the TRIPS principle that each WTO member
country has “the freedom to determine the grounds upon which such licences
are granted.”14 However, the USTR has also refused to reference the right to compulsory licensing - or other public health exceptions - in the text of FTAs. Instead, USTR has relied upon the use of vaguely worded “side letters” that are subordinate to the agreements and non-binding on the parties. The letters also fail to provide clear and specific assurances affirming the ability of governments to take various measures to address public health needs.16 Absence of Appropriate Consumer Safeguards Certain
key elements of • The Bolar provision, a law allowing the early registration of generics so that they can enter the market promptly once a patent expires.17 •
A requirement that patent applicants describe the “best mode” to reproduce
an • Protections to address attempts to gain repeated and unjustified patents on a product.19 The absence of these safeguards further threatens access to affordable generics in poor countries. Conclusion The
world's consensus at We
call on you to pursue a trade agenda that reasserts the Sincerely, Chris
van Hollen Barbara
Lee Earl
Blumenauer John
Lewis Rahm
Emanuel l Declaration on the TRIPS Agreement and Pub!ic Health, WTO Ministerial Conference - Fourth Session, WT/MlN(O1)/DEC/2, adopted 14 November 2001 (“Doha Declaration”) (online at http://www.wto.org/english/thewto_e/minist_e/min01 _e/ mindecl_trips_e.htm); World Trade Organization, Agreement on Trade-Related Aspects of lntellectual Property Rights (1994) (“TRIPS”) (online athttp://www.wto.org/english/ tratop_e/trips_e/t_agm0_e.htm). 2
3
4 Pub. L, No. 107-210; 19 U.S.C. §3802(b)(4)(C). 5
TRIPS, Article 27.1 and Article 33. 7
21 U.S.C. §355(j). The current 8 The FTA texts use the term “at least” in regard to the 5-year period of exclusivity. (See supra note 6). 9
The FTAs with Central America and Panama let drug companies wait up
to five years 10 UNAIDS, Countries (online at http://www.unaids.org/en/Regions_Countries/ Countries/default.asp). 11
35 U.S.C. §156. In the 12 See, e.g., Peru FTA §16.9.6.; Colombia FTA §16.9.6; Panama FTA §15.9.6. 13
See, e,g.. 14
15 For example, the Singapore agreement sets three narrow conditions under which compulsory licenses will be permissible, Under this agreement, a compulsory license will only be allowed: (1) if a court determines that the patentholder engaged in “anti-competitive” behavior; (2) when a government agency or contractor needs to use the patent; or (3) in a “national emergency or other circumstances of extreme urgency,” (Singapore FTA §16.7.6). The Agreement also provides that a patent owner subject to a compulsory license under condition (2) or (3) cannot be required to transfer “technical know how” to the licensed generic manufacturer. (Singapore FTA §16.7(b)(iii)). 16 See, e,g., U.S.-Colombia FTA: “Understanding Regarding Certain Public Health Measures” and “Letter Regarding Certain Regulated Products,” signed November 22, 2006, 17 35 U.S.C. §271 (e)(1). 18 35 U.S.C. S § I12. 19
SUNS #6211 Thursday, 15 March 2007 Trade: Key Congressional Democrats against TRIPS-plus in FTAs Geneva, 14 Mar (Riaz K. Tayob) -- Twelve influential members of the United States Congress, in a letter to US Trade Representative Susan Schwab, have urged the "immediate reconsideration" of certain TRIPS plus provisions in US Free Trade Agreements so as to ensure adherence to the World Trade Organization's 2001 Doha Declaration on TRIPS and Public Health. Such
adherence, they said, should be ensured both in Free Trade Agreements
already concluded with The letter by California Democratic Congressman Henry Waxman and eleven others underscores the Congressional direction to the Administration, in the 2002 Trade Promotion Authority Act, for adherence to the Doha Declaration as a "principal negotiating objective" in US trade negotiations. Waxman is Chairman of the important Committee of the House of Representatives on Oversight and Government Reform, and is also a member of the House Committee on Energy and Commerce. With Democrats in control of the House of Representatives, Waxman and his Committee have jurisdiction over a whole range of government activities and holding the administration accountable. Seven
of the signatories are on the Under
the The
letter, dated 12 March, refers to recently negotiated Free Trade Agreements
(FTAs) with The letter points out that Congress in the 2002 TPA has directed the Administration to "adhere to the Doha Declaration as a 'principle negotiating objective' in US trade negotiations". However,
regret the members in their letter, the US FTAs undermine the commitment
to The
FTA provisions "upset an important balance between innovation and
access by elevating intellectual property at the expense of public health."
Consequently, "they threaten to restrict access to life-saving
medicines and create conditions where poor countries could wait even
longer than the Specifically, the letter raises concerns about data exclusivity (exclusive rights over use of clinical test data submitted for a drug's first approval), patent extensions (when there are delays in a patent review or marketing approval), patent "linkage" (between drug approval and patent authorities), compulsory licensing (government grant of a license, to make use of the patented invention without the consent of the patent holder to a manufacturer other than the patent holder) and the absence of appropriate consumer safeguards. Clinical
test data refers to information submitted to regulatory authorities
for approval and marketing of a drug. Recent US FTAs add the requirement
for a period of data exclusivity on clinical test data from the date
when the patented drug is approved by the regulator. This means that
during the data exclusivity period, regulators cannot rely on the clinical
test data submitted for a drug's first approval when considering subsequent
applications for approval for generic versions of the drug, as a result
delaying the availability of generics even if a patent has already expired.
The FTAs with [The TRIPS agreement has no provisions for disciplines on data exclusivity - SUNS.] The
letter states that "even if a developing country institutes limits
equal to those in the It
gives the example of FTAs with Central America and The
letter clarifies that when periods of marketing exclusivity were introduced
in the However, says the letter, today there exists a "competitive generic market" and data or marketing exclusivity "does not improve generic access in these countries and creates potential for serious harm." The
FTAs require that the patent term, normally twenty years under TRIPS,
be extended when there are delays in either the review of the patent
or marketing approval period. The FTA provisions allow "for potentially
unlimited patent extensions." The FTA provisions are different
from The letter also regards as "onerous" the linkage between drug approval and patent authorities, where for example, a drug regulatory authority is required to withhold approval of a generic drug until it can certify that no patent would be violated. This provision is "especially severe" for under-resourced drug regulatory authorities and could "cause indefinite delays" for the approval of generic drugs and compromise their fundamental mission of monitoring the safety, efficacy and quality of medicines on the market. Such provisions, the letter adds, put a significant burden on regulatory agencies that have neither the expertise nor the authority to enforce private patent holder rights. The letter regards compulsory licensing as the government granting a licence to a manufacturer other than the patent holder to produce a drug at an affordable price. It recalls the Doha Declaration which reaffirms the TRIPS principle that each WTO member country has "the freedom to determine the ground upon which such licenses are granted." The
[The Doha Declaration on TRIPS and Public Health states that "the TRIPS Agreement does not and should not prevent members from taking measures to protect public health." - SUNS.] Key
elements of For example, states the letter, the US law provides mechanisms to counter abusive "evergreening" of patents (minor modifications to an invention and attempts to gain another 20 year patent protection for the allegedly new invention). In
conclusion, the letter states that the "world's consensus at All the signatories are Democrats. Besides Waxman, the other signatories are: Jim McDermott, Tom Allen, Lloyd Doggett, Jance D. Schakowsky, Pete Stark, Diana DeGette, Chris Van Hollen, Barbara Lee, Earl Blumenauer, John Lewis and Rahm Emanuel. Of the members, Pete Stark, Chris Van Hollen, Jim McDermott, Lloyd Doggett, Earn Blumenauer, John Lewis and Rahm Emmanuel are on the Ways and Means Committee of the House. Tom Allen is a member of the House Budget Committee and of Energy and Commerce. Janice D. Schakowsky is a member of the House Energy and Commerce Committee and the sub-committee on Oversight and Investigations. Diana DeGette is a member of the House Energy and Commerce Committee. Barbara Lee is a member of the House Black Caucus and of the Progressive Caucus.
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