Congress Legislated Against Access to AIDS Drugs in Africa

In the past few months U.S. pharmaceutical companies had been lobbying hard to remove an amendment from the African Growth and Opportunity Act that allows the countries of Sub-Saharan Africa to pursue "compulsory licensing" of HIV/AIDS medications. Compulsory licensing involves authorizing a government or company to make and sell a product (such as a drug) without the permission of the patent holder. Licenses are generally issued on the basis of public interest, in this case, the health of an immense population. The practice is entirely legal under World Trade Organization rules.

Introduced by Sen. Dianne Feinstein (D-CA), an amendment enhanced the ability of African nations to respond to the pandemic by allowing them to license the manufacture and sale of AIDS drugs at prices that render them available to the greatest number of people. The Western pharmaceutical industry sees the practice as a threat. They are therefore seeking the removal of the Feinstein amendment.

President Clinton issues an executive order countering legislation ... see below


ACT UP Press Release
May 4, 2000, House of Representative Gallery, Washington, D.C.

ACT UP and Student Activists Disrupt House of Representatives Vote on African/Caribbean Trade Bill.
Activists Chain Themselves to House Gallery chairs & chant: "AFRICA IS NOT FOR SALE"
African/Caribbean Trade Bill: Growth and Opportunity? Or more AIDS for Africa?

WASHINGTON-- Eight activists were arrested for disrupting the vote on the African Growth and Opportunity Act/Caribbean Basin Initiative in the House of Representatives today. The activists caused the proceedings of the vote to come to standstill for ten minutes by chaining themselves to a balcony, chanting "AFRICA IS NOT FOR SALE -- AIDS DRUGS NOW," and holding a banner that read "AFRICA IS NOT FOR SALE."

The student activists from Delaware and members of Act Up Philadelphia, already critical of the African Growth and Opportunity Act (AGOA), were protesting the elimination of the provisions on access to HIV/AIDS medications and the erosion of development and child labor provisions of the bill.

"At the behest of the pharmaceutical lobby, Senator Lott and House Speaker Hastert stripped Senate language from the bill that would have increase availability of affordable generic versions of expensive patented AIDS medications for Africa," said Paul Davis from ACT UP Philadelphia. "What's worse, Congressional leadership is acting with callous indifference to hundreds of thousands of people with AIDS in the Caribbean by reversing the Clinton Administration's promise to leave internal decisions about access to HIV/AIDS pharmaceuticals up to individual countries without meddling in their domestic affairs at the WTO."

Today's action at House of Representatives Gallery follows recent reports of changes being made in the trade legislation by the House and Senate Conferees. The widely supported Senate Feinstein-Feingold HIV/AIDS amendment, which prohibited spending U.S. government money to challenge WTO-legal policies on access to HIV/AIDS pharmaceuticals, was completely eliminated by Hastert and Lott. Additionally, the converse of the Feinstein-Feingold amendment was added to the Caribbean Basin Initiative (CBI) provisions allowing the U.S. government to challenge the pharmaceutical access rules that are legal under the WTO TRIPs agreement that covers intellectual property.

"Today's action highlights not only the threats AGOA-CBI poses to millions of people across the world but the low level of discourse among our elected officials," said SharonAnn Lynch of ACT UP New York. "What public policy goal is advanced here? Should we protecting those suffering from HIV/AIDS or shielding the pharmaceutical giants from ever reducing their enormous profit margins?"

Earlier this year, ACT UP challenged the Clinton administration's attempt to gut a South African law that utilized WTO-legal policies to provide affordable, generic versions of patented HIV/AIDS medication to those that need it. In a high profile campaign, ACT UP followed Vice President Al Gore from the beginning of his campaign in Carthage, Tennessee demanding that Gore reverse his policy and encourage, rather than punish, poor countries seeking to provide life-saving medicine. Gore had been negotiating pharmaceutical company-backed erosion of South Africa policy. The ACT UP campaign ambushed Vice President Gore for the first few months of his presidential bid, including a several thousand-person demonstration at a fundraising event in Philadelphia.

After the Vice President directed the US Trade Representative to cease actions against South Africa on September 17, 1999, ACT UP campaigned to extend the trade agreement to all other poor countries. Activists took over USTR Barshefsky's office in D.C. demanding a extension of the trade agreement. At President Clinton's World AIDS Day address in Seattle on Dec. 1, it was announced that the U.S. would no longer use its economic clout to interfere with other countries' WTO compliant measures taken to increase access to medicine. This announcement was strengthened by Vice President Gore's address to the United Nations Security Council on Jan.11.

Today the activists are angered by the inclusion of the CBI provision exceeding WTO trade agreements on intellectual property, coupled with the exclusion of the HIV/IDS medicine amendment and the unilateral imposition of structural adjustment conditions.

"This bill will literally result in more AIDS for Africa and the Caribbean," said ACT UP's Brian Spina. "AGOA sidesteps the middle institution of the IMF, by unilaterally forcing poor countries to adopt economic policies that have proven time after time to rapidly decrease life expectancy," he said.

Student activists from Delaware, the home state of Senator Roth the Senate sponsor and chief proponent of AGOA-CBI, joined the ACT UP demonstrators.

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House passes Africa trade bill, drops AIDS assistance
by Paul Singer, United Press International -- May 04, 2000

WASHINGTON, May 4 (UPI) -- The House Thursday passed a new trade agreement with Africa and the Caribbean over the shouts of AIDS activists furious that provisions to provide low-cost AIDS drugs to Africa were dropped in a last minute deal.

The African Growth and Opportunity Act allows the president to extend enhanced trade relations to the nations of sub-Saharan Africa and the Caribbean. The bill reduces tariffs on textiles and apparel from these countries and opens the door to talks on a broader trade agreement with sub-Saharan Africa. The bill passed on a 309-110 vote.

The bill was rushed to the House floor Thursday after an extraordinarily short conference between House and Senate members. The conferees had spent months in a "pre-conference" process trying to reconcile the different versions of the bill passed by the chambers last year, but made little progress until several late-night sessions this week. The conference report was completed Wednesday evening and rushed to the floor Thursday. The Senate is expected to take up the final measure next week.

Supporters argue that the bill had to be moved quickly because once Congress gets tied up in the appropriations process, there will be little floor time left this year for other measures. In addition, several Democrats had indicated that they would be hard pressed to vote for expanded trade relations with China - a top priority of the Republican leadership and the White House - if there was no parallel expansion of trade rights for African and Caribbean nations.

But opponents say the bill was rushed to the floor to prevent members from organizing opposition against it.

As it turned out, the loudest opposition came from AIDS activists in the House chamber, eight of whom were arrested and removed by police. The activists were protesting the conferee's decision to drop a provision to make generic AIDS drugs available in Africa, where most people cannot afford the cost of treatment at normal prices. AIDS groups estimate that in sub-Saharan Africa, 11,000 people are newly infected with AIDS each day. Standard treatment in the United States can cost as much as $15,000 per year.

Sen. Dianne Feinstein, D-Calif., had added the provision in the Senate, and said on the Senate floor April 28 that she would block the bill if the provision were removed.

Feinstein sent a letter to the White House May 3 asking President Clinton to provide the low-cost drugs to African nations through executive order, and warned that her decision the trade bill is contingent on a commitment from the White House to address the issue.


May 10, 2000

Clinton Helps Africans With AIDS
by JIM ABRAMS, Associated Press Writer

WASHINGTON (AP) - President Clinton issued an executive order Wednesday making it easier for AIDS-ravaged Africa to obtain inexpensive drugs and medical technologies.

The president took the action after nearly identical language in the order was taken out of an African trade bill that Congress is likely to pass and send to the White House this week.

The order states that the U.S. government will not seek to overturn any intellectual property law or policy imposed by a sub-Saharan African government that promotes access to HIV/AIDS pharmaceuticals and medical technologies.

``Given the devastating impact of AIDS, the United States will not require or negotiate restrictive rules in the intellectual property rights area,'' said U.S. Trade Representative Charlene Barshefsky.

Sen. Dianne Feinstein, D-Calif., who proposed the AIDS drugs amendment to the trade bill with Sen. Russell Feingold, D-Wis., praised the executive order as ``the right thing to do.''

She said it struck a balance between the need of African nations for access to AIDS drugs and the need to ensure that intellectual property is protected.

Feinstein said the order conforms to World Trade Organization rules that give countries flexibility in addressing public health concerns, in this case by assuring them access to cheap, generic AIDS drugs.

The order also states that it is U.S. policy to encourage sub-Saharan African nations to take steps to address the underlying causes of the HIV/AIDS crisis and that the United States should work with individual countries to assist them in developing effective public education campaigns.

Barshefsky noted that the United States had previously worked out an agreement with South Africa on the production and import of cheaper AIDS drugs. She said the executive order would make clear that the policy worked out in this agreement would be uniform throughout Africa.

Some 34 million people in sub-Saharan Africa have been infected with the disease since the onset of the AIDS epidemic, and 11.5 million have died, 83 percent of the world's total AIDS-related deaths.

Senate Majority Leader Trent Lott, R-Miss., on Tuesday criticized the intention of the president to substitute the dropped Feinstein amendment with an executive order.

``There seems to be a pattern now of him doing executive orders that exceed what he should be doing,'' Lott said at a news conference. ``That should be done legislatively ... He doesn't make the laws. And so I would hope that he would be careful about doing that.''

The trade bill, which would give African and Caribbean states significantly greater access to U.S. apparel markets, has passed the House and is expected to be approved by the Senate as early as Thursday. Clinton has strongly endorsed it.


U.S. Pledges AIDS Drug Help for Sub-Saharan Africa
by Lisa Richwine, Reuters

WASHINGTON (Reuters) - The United States said on Wednesday it was retreating from a controversial policy, pushed by U.S. drug makers, in order to help make less expensive AIDS drugs available to millions of poor patients in sub-Saharan Africa.

In an executive order, President Clinton promised U.S. officials would not stand in the way of countries that sought to obtain less costly, generic AIDS medication for their poorest citizens as long as the measures complied with international trade rules.

The announcement follows a more than year-long campaign by AIDS activists who complained that the Clinton administration, including Vice President Al Gore (news - web sites), was working on behalf of U.S. drug makers to bully developing countries from pursuing generic drugs.

Pharmaceutical companies had argued that countries' efforts to license local manufacturers to make generic AIDS drugs violated the firms' patent protections and compromised future research. U.S. officials had threatened trade sanctions against countries that pursued such licenses.

"From now on, officials will take a softer stance," U.S. Trade Representative Charlene Barshefsky said, "asking only that countries abide by the World
Trade Organization's agreement on intellectual property." That agreement gives countries more leeway to pursue less expensive medicines, she said.

Barshefsky said the administration was announcing the ``very substantial'' policy change because the spread of AIDS, which the United States recently dubbed a threat to its national security, had reached crisis levels in sub-Saharan Africa. In some areas, more than 20 percent of adults are infected with the HIV virus that causes AIDS, she said.

The order ``is intended to help stop the spread of HIV/AIDS in sub-Saharan Africa by making AIDS-related drugs and medical technologies more accessible and affordable,'' Barshefsky told reporters.

``The executive order strikes a proper balance between the needs of African countries ... and the needs to ensure that basic intellectual property rights are protected.''

Clinton's order would extend an agreement reached last September with the United States and South Africa to all sub-Saharan African countries, Barshefsky said. Measures in other countries will be considered on a case-by-case basis, she said.

 

Executive order: Access to HIV/AIDS drugs & IP/trade issues - THE WHITE HOUSE (May 10, 2000 - Press Secretary)

For Immediate Release

EXECUTIVE ORDER

ACCESS TO HIV/AIDS PHARMACEUTICALS AND MEDICAL TECHNOLOGIES

By the authority vested in me as President by the Constitution and the laws of the United States of America, including sections 141 and chapter 1 of title III of the Trade Act of 1974, as amended (19 U.S.C. 2171, 2411-2420), section 307 of the Public Health Service Act (42 U.S.C. 2421), and section 104 of the Foreign Assistance Act of 1961, as amended (22 U.S.C. 2151b), and in accordance with executive branch policy on health-related intellectual property matters to promote access to essential medicines, it is hereby ordered as follows:

Section 1. Policy. (a) In administering sections 301-310 of the Trade Act of 1974, the United States shall not seek, through negotiation or otherwise, the revocation or revision of any intellectual property law or policy of a beneficiary sub-Saharan African country, as determined by the President, that regulates HIV/AIDS pharmaceuticals or medical technologies if the law or policy of the country:

(1) promotes access to HIV/AIDS pharmaceuticals or medical technologies for affected populations in that country; and

(2) provides adequate and effective intellectual property protection consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) referred to in section 101(d)(15) of the Uruguay Round Agreements Act (19 U.S.C. 3511(d)(15)).

(b) The United States shall encourage all beneficiary sub-Saharan African countries to implement policies designed to address the underlying causes of the HIV/AIDS crisis by, among other things, making efforts to encourage practices that will prevent further transmission and infection and to stimulate development of the infrastructure necessary to deliver adequate health services, and by encouraging policies that provide an incentive for public and private research on, and development of, vaccines and other medical innovations that will combat the HIV/AIDS epidemic in Africa.

Sec. 2. Rationale: (a) This order finds that:

(1) since the onset of the worldwide HIV/AIDS epidemic, approximately 34 million people living in sub-Saharan Africa have been infected with the disease;

(2) of those infected, approximately 11.5 million have died;

(3) the deaths represent 83 percent of the total HIV/AIDS-related deaths worldwide; and

(4) access to effective therapeutics for HIV/AIDS is determined by issues of price, health system infrastructure for delivery, and sustainable financing.

(b) In light of these findings, this order recognizes that:

(1) it is in the interest of the United States to take all reasonable steps to prevent further spread of infectious disease, particularly HIV/AIDS;

(2) there is critical need for effective incentives to develop new pharmaceuticals, vaccines, and therapies to combat the HIV/AIDS crisis, including effective global intellectual property standards designed to foster pharmaceutical and medical innovation;

(3) the overriding priority for responding to the crisis of HIV/AIDS in sub-Saharan Africa should be to improve public education and to encourage practices that will prevent further transmission and infection, and to stimulate development of the infrastructure necessary to deliver adequate health care services;

(4) the United States should work with individual countries in sub-Saharan Africa to assist them in development of effective public education campaigns aimed at the prevention of HIV/AIDS transmission and infection, and to improve their health care infrastructure to promote improved access to quality health care for their citizens in general, and particularly with respect to the HIV/AIDS epidemic;

(5) an effective United States response to the crisis in sub-Saharan Africa must focus in the short term on preventive programs designed to reduce the frequency of new infections and remove the stigma of the disease, and should place a priority on basic health services that can be used to treat opportunistic infections, sexually transmitted infections, and complications associated with HIV/AIDS so as to prolong the duration and improve the quality of life of those with the disease;

(6) an effective United States response to the crisis must also focus on the development of HIV/AIDS vaccines to prevent the spread of the disease;

(7) the innovative capacity of the United States in the commercial and public pharmaceutical research sectors is unmatched in the world, and the participation of both these sectors will be a critical element in any successful program to respond to the HIV/AIDS crisis in sub-Saharan Africa;

(8) the TRIPS Agreement recognizes the importance of promoting effective and adequate protection of intellectual property rights and the right of countries to adopt measures necessary to protect public health;

(9) individual countries should have the ability to take measures to address the HIV/AIDS epidemic, provided that such measures are consistent with their international obligations; and

(10) successful initiatives will require effective partnerships and cooperation among governments, inter-national organizations, nongovernmental organizations, and the private sector, and greater consideration should be given to financial, legal, and other incentives that will promote improved prevention and treatment actions.

Sec. 3. Scope. (a) This order prohibits the United States Government from taking action pursuant to section 301(b) of the Trade Act of 1974 with respect to any law or policy in beneficiary sub-Saharan African countries that promotes access to HIV/AIDS pharmaceuticals or medical technologies and that provides adequate and effective intellectual property protection consistent with the TRIPS Agreement. However, this order does not prohibit United States Government officials from evaluating, determining, or expressing concern about whether such a law or policy promotes access to HIV/AIDS pharmaceuticals or medical technologies or provides adequate and effective intellectual property protection consistent with the TRIPS Agreement. In addition, this order does not prohibit United States Government officials from consulting with or otherwise discussing with sub-Saharan African governments whether such law or policy meets the conditions set forth in section 1(a) of this order. Moreover, this order does not prohibit the United States Government from invoking the dispute settlement procedures of the World Trade Organization to examine whether any such law or policy is consistent with the Uruguay Round Agreements, referred to in section 101(d) of the Uruguay Round Agreements Act.

(b) This order is intended only to improve the internal management of the executive branch and is not intended to, and does not create, any right or benefit, substantive or procedural, enforceable at law or equity by a party against the United States, its agencies or instrumentalities, its officers or employees, or any other person.

WILLIAM J. CLINTON
THE WHITE HOUSE, May 10, 2000


see also:

Life is Our Life's Work , they say . _we say it should read. . .
Your Life's Savings (or Your Life) is our Company's Work.

South African and ACT UP Activism _Actions and Updates



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