# \[e-drug\] CPT on Africa Trade bill negotiations **URL:** \ **Category:** e-drug\ **Created:** [April 12, 2000, 7:40pm UTC](https://talk.edrugplus.org/t/e-drug-cpt-on-africa-trade-bill-negotiations/7944 "2000-04-12T19:40:43Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![love](https://avatars.discourse-cdn.com/v4/letter/l/dec6dc/32.png) [@love](https://talk.edrugplus.org/u/love)\ **Post date:** [April 12, 2000, 7:40pm UTC](https://talk.edrugplus.org/t/e-drug-cpt-on-africa-trade-bill-negotiations/7944/1 "2000-04-12T19:40:43Z")
E-drug: CPT on Africa Trade bill negotiations -------------------------------------------------------------------------                          James Love                          Consumer Project on Technology                          P.O. Box 19367, Washington, DC 20036                          [http://www.cptech.org](http://www.cptech.org)                          202.387.8030; fax 202.234.5176 April 11, 2000 Senator William Roth Senator Diane Feinstein Senator Russell Feingold Representative Dennis Hastert Representative Charles Rangel Dear Members of Congress: I am writing to express our opposition to the current proposals for a compromise on the Feinstein/Feingold amendment to the Africa trade bill, concerning access to medicines for the treatment of HIV/AIDS. It is our opinion that the proposed language should be rejected, on the grounds that it fails to achieve the objective of the original amendment -- namely to restrain US government bullying of African countries over the pricing of pharmaceutical drugs. In its original form, the amendment would cut off funds to federal agencies that sought      "through negotiation or otherwise, the revocation or      revision of any intellectual property or competition      law or policy that regulates HIV/AIDS pharmaceuticals      or medical technologies of a beneficiary sub-Saharan      African country" if the policy promoted access to medicines for HIV/AIDS, and was consistent with the World Trade Organization (WTO) TRIPS agreement on the protection of intellectual property. The amendment sought to eliminate so called "TRIPS Plus" pressures from the US government -- that is, the current US policy of pressuring countries to adopt stronger forms of intellectual property protection than are required by the WTO. This amendment is needed to address an appalling aspect of US foreign policy. In the face of a horrific public health crisis, US trade officials are forcing African and other developing countries to enact pharmaceutical policies that raise the price of medicines, far beyond what is required by even the World Trade Organization in its TRIPS accord on intellectual property rights. Under the proposed "compromise" legislation, the "no TRIPS plus" provision has been replaced with a complex presidential review of African country policies. This review seeks to determine if the US government should pressure countries to adopt intellectual property protections that exceed the WTO requirements. The April 6 compromise proposal sets standards for a country to obtain relief from bullying. African countries are unlikely to meet those standards. Indeed, the April 6 compromise proposal uses precisely the language that has been used against poor countries for many years, as a public relations cover story for a decidedly commercial agenda on behalf of US firms. Rather than change US policy, the April 6 language would embrace and codify the very justification for trade pressures that have been used in dozens of country disputes. The April 6 language would evaluate African policies to broaden access to medicines and determine if the practices would be tolerated, or become the basis for a variety of trade pressures, including linkage to benefits of the Africa trade legislation. The six part review is as follows: (1) the measure is not inconsistent with the Agreement on      Trade-Related Aspects of Intellectual Property Rights      referred to in section 101(d)(15) of the Uruguay Round      Agreements Act; Discussion: In the original provision, this would be the only                test. Is the policy permitted under the WTO rules                for intellectual property? Now this is just the                beginning. (2) the country is making significant progress toward developing      the infrastructure necessary to ensure that the      pharmaceuticals or medical technologies are properly      distributed to the affected population in the country; Discussion: Virtually all African countries have woefully                inadequate medical infrastructures. It is trivial                to flunk a country on this item. (Indeed, US                government could flunk on this item, given the                widespread misuse of prescription drugs in this                country.) Right now, the US government is using                the infrastructure issue to justify its trade                pressures against African countries that want to                grant compulsory licensing of pharmaceutical                patents to make drugs available at lower prices.                Indeed, the high price of drugs is said by some US                government officials to be a good thing for                Africa, because "they" cannot use the drugs                properly. Of course, there will surely be misuse                of drugs in Africa (as there is now in many US                households). No one wants the misuse of drugs in                Africa, and the issue of drug resistant strains of                HIV/AIDS is not a trivial public health concern.                However, the solution is to encourage investments                in the medical infrastructure, not to raise the                prices of medicines. Indeed, the high cost of                medicine is a huge problem for African public                health workers. Pharmaceutical drugs already                represent 40 to 60 percent of the cost of public                health services in some African countries. (3) the country has engaged in meaningful efforts to improve      public understanding of HIV/AIDS and to encourage practices      that will prevent further transmission and infection; Discussion: Many African countries have HIV/AIDS infection                rates as high as 10 to 25 percent of persons 15 to                40 years old, and it will not be difficult to                flunk countries for not having meaningful                prevention efforts. Indeed, some US communities                would fail this test too. For example, what about                US schools that do not provide real sex education,                or communities that will not distribute condoms or                clean needles to target populations, in the USA? (4) the country has taken all reasonable steps to ensure the      safety and efficacy of the pharmaceuticals or medical      technologies; Discussion: "All reasonable steps" is a very high standard.                It is used in the United States to prevent imports                of Claritin or Tamoxifen from Canada at a fraction                of the US price, a policy now challenged in a half                dozen bills before the US Congress. This is                precisely the argument used by the                USTR/State/DOC/White House, etc. to oppose                Parallel Imports in South Africa, as outlined in                some detail in the highly relevant February 5,                1999 US Department of State Report, "U. S.                Government Efforts to Negotiate the Repeal,                Termination or Withdrawal of Article 15(c) of the                South African Medicines and Related Substances Act                of 1965."                [http://www.cptech.org/ip/health/sa/stdept-feb51999](http://www.cptech.org/ip/health/sa/stdept-feb51999)                .html                No African country is now taking "all reasonable                steps" to ensure "safety and efficacy" of                pharmaceuticals. The US fast track approval                procedures for new drug approvals don't either.                Does any country meet this standard? Also, in                Thailand, the US requires the government to                engaged in years of unnecessary efficacy and                safety testing for (off patent) drugs, to keep                cheaper generic drugs off the market.                [http://www.cptech.org/ip/health/c/thailand/](http://www.cptech.org/ip/health/c/thailand/) (5) the country has otherwise made reasonable efforts to work      with the patent holder to address the problems of supply of      the product; Discussion: This is one of the main attacks by US trade                officials regarding both compulsory licensing and                parallel importing. See the                [http://www.cptech.org/ip/health](http://www.cptech.org/ip/health) web page, and                specifically the pages on South Africa and                Thailand for current examples. In South Africa,                the US wanted to create a complex system whereby                South Africa had to prove that it would negotiate                with patent owners and prove the country benefited                from buying drugs outside its national borders                (parallel imports), before shopping outside South                Africa for cheaper drugs (how would they even know                what the best price was?). In Thailand, the US                put pressure on the government for years to delay                the issuance of a compulsory license for a                formulation patent for ddI, a US government                invention for HIV/AIDS. In the Dominican                Republic, the US claims that a 180 day period of                negotiation for a voluntary license isn't long                enough. The US government uses arguments like                this to undermine needed "fast track" compulsory                licensing efforts in poor countries (many poor                countries do not have the capacity to undertake                extensive litigation, or even evaluate patent                claims, and issue in South Africa and Thai cases).                It is also relevant to point out that the US                government itself does not even negotiate with                patent owners for public use. It just takes                patents under 28 USC section 1498, and pays                compensation for a taking, a practice not even                emulated by countries that are subject to US trade                pressures. See also the December 28, 1993 US                Presidential Executive Order 12889 that relates to                NAFTA, where President Clinton said:                     "Sec. 6. Government Use of                     Patented Technology. (a) Each                     agency shall, within 30 days                     from the date this order is                     issued, modify or adopt                     procedures to ensure                     compliance with Article                     1709(10) of the NAFTA                     regarding notice when patented                     technology is used by or for                     the Federal Government without                     a license from the owner,                     except that the requirement of                     Article 1709(10)(b) regarding                     reasonable efforts to obtain                     advance authorization from the                     patent owner:                     "(1) is hereby waived for an                     invention used or manufactured                     by or for the Federal                     Government, except that the                     patent owner must be notified                     whenever the agency or its                     contractor, without making a                     patent search, knows or has                     demonstrable reasonable                     grounds to know that an                     invention described in and                     covered by a valid United                     States patent is or will be                     used or manufactured without a                     license; and                     "(2) is waived whenever a                     national emergency or other                     circumstances of extreme                     urgency exists, except that                     the patent owner must be                     notified as soon as it is                     reasonably practicable to do                     so." (6) the country is not otherwise engaged in a persistent pattern      of conduct that denies adequate and effective protection of      intellectual property rights. Discussion: This is the standard open ended "TRIPS Plus"                language from US trade law, and it completes the                process of turning a "no TRIPS plus" provision                into a "TRIPS plus" provision for the Africa Trade                bill. An example of how this worked is the 1999                301 citation for South Africa for permitting its                public health doctors from addressing the World                Health Organization on the need for access to                medicine -- an act deemed hostile to intellectual                property rights and a barrier to US trade. Also,                the 1998 and 1999 complaints by the US that South                Africa permitted generic registration of                Paclitaxel (generic Taxol), because some countries                (in the EU) still provided exclusive rights to                data from the NIH sponsored clinical trials on                Taxol (even though those rights expired in the US                in 1997). Here is the 1999 USTR 301 Report on                South Africa:                "South Africa: South Africa's                Medicines Act appears to grant the                Health Minister ill defined                authority to issue compulsory                licenses, authorize parallel                imports, and potentially otherwise                abrogate patent rights.                Implementation of the law has been                suspended pending the resolution of                a constitutional challenge in the                South African courts. Undisclosed                test data is also not adequately                protected under South African law.                During the past year, South African                representatives have led a faction                of nations in the World Health                Organization (WHO) in calling for a                reduction in the level of                protection provided for                pharmaceuticals in TRIPS.                Copyright piracy and trademark                counterfeiting is widespread and                the U.S. copyright industry                estimates that trade losses due to                piracy of copyrighted works                increased more than 35 percent                between 1997 and 1998. However, the                South African Government recently                took the welcome step of adopting a                implementing strategy to its 1997                Counterfeit Goods Act which could                strengthen enforcement. We call on                the Government of South Africa to                bring its IPR regime into full                compliance with TRIPS before the                January 1, 2000 deadline, ensure                that all Government offices use                only legitimate software, and                clarify that the powers granted in                the Medicines Act are consistent                with its international obligations                and will not be used to weaken or                abrogate pharmaceutical patent                protection."           Note that the language in 6 above permits the           government to tie copyright violations to the issue of           access to medicines for AIDS. Note also that the USTR           report repeatedly mischaracterised South Africa law.           For example, while the USTR referred to the fact that           South Africa's decision to permit parallel imports           would violate patent rights, it did not report that US           patent law already permits parallel imports. (US           barriers to parallel imports are based upon health and           safety grounds, not intellectual property grounds). As           noted above, USTR even considered South Africa Ministry           of Health participation in WHO meetings on access to           drugs as a barrier to US trade, and demanded an           effective end to public criticisms of US policy           positions on patent rights -- an appalling foreign           policy decision even without considering the truly           terrible public health tragedy in Africa. For these reasons, we urge you to reject the proposed compromise language on the Africa trade bill. It will give the misleading impression that Congress has fixed a problem while conferring all of the substance and power to the current morally flawed policy.                Sincerely,                James Love \<------Feinstein/Feingold amendment as passed the Senate----\>      (c) LIMITATION ON USE OF FUNDS- Funds appropriated or otherwise made available to any department or agency of the United States may not be obligated or expended to seek, through negotiation or otherwise, the revocation or revision of any intellectual property or competition law or policy that regulates HIV/AIDS pharmaceuticals or medical technologies of a beneficiary sub-Saharan African country if the law or policy promotes access to HIV/AIDS pharmaceuticals or medical technologies and the law or policy of the country provides adequate and effective intellectual property protection consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights referred to in section 101(d)(15) of the Uruguay Round Agreements Act. \<----(as of April 6) Proposed compromise language---------\>      (C) POLICY OF UNITED STATES GOVERNMENT TOWARDS BENEFICIARY COUNTRIES - The President shall encourage all beneficiary sub-Saharan African countries to implement policies designed to address the underlying causes of the HIV/AIDS crisis, including through efforts to encourage practices that will prevent further transmission and infections and to stimulate development of the infrastructure necessary to deliver adequate health care services. In addition, the President shall encourage policies that provide an incentive for public and private research on and development of vaccines and other medical innovations that would contribute to combating the HIV/AIDS crisis facing Africa. Where a measure relating to the distribution of HIV/AIDS pharmaceuticals or medical technologies in a beneficiary country has been identified under section 182 of the Trade Act of 1974, the President shall determine whether -            (1) the measure is not inconsistent with the Agreement on      Trade-Related Aspects of Intellectual Property Rights referred to in section 101(d)(15) of the Uruguay Round Agreements Act;      (2) the country is making significant progress toward developing the infrastructure necessary to ensure that the pharmaceuticals or medical technologies are properly distributed to the affected population in the country;      (3) the country has engaged in meaningful efforts to improve public understanding of HIV/AIDS and to encourage practices that will prevent further transmission and infection;      (4) the country has taken all reasonable steps to ensure the safety and efficacy of the pharmaceuticals or medical technologies;      (5) the country has otherwise made reasonable efforts to work with the patent holder to address the problems of supply of the product;      (6) the country is not otherwise engaged in a persistent pattern of conduct that denies adequate and effective protection of intellectual property rights.            Where the President determines that the beneficiary country and the measure it intends to adopt satisfies the requirements set out in this subsection, he shall instruct the United States Trade Representative not to seek, through negotiation or otherwise, the revocation or revision of such measure within the beneficiary country.