THURSDAY, 5 AUGUST 2004
301 U.S. Regulatory Agency Approves New AIDS Treatment Drugs
(Step could significantly simplify drug treatment regimen) (620)
302 Struggle over WTO Framework Agreement Points to Challenges
Ahead
(Developing countries' willingness to open markets viewed as crucial) (1280)
*AEF301 08/04/2004
U.S. Regulatory Agency Approves New AIDS Treatment Drugs
(Step could significantly simplify drug treatment regimen) (620)
By M. Charlene Porter
Washington File Staff Writer
Washington -- The U.S. Food and Drug Administration (FDA) has approved two new fixed-dose combination drugs to combat HIV infection. The drugs should help to simplify treatment regimens for people living with the virus, according to an August 2 FDA press release.
Epzicom, manufactured by GlaxoSmithKline, and Truvada, manufactured by Gilead Sciences Inc., both work by combining drugs from different classes. Researchers have found in their 20-year study of HIV that the most effective way to attack the virus is to use drugs that disable the microbe in different ways.
This multiple-drug treatment plan creates a complicated regimen the patient must follow, involving the administration of a number of pills on a particular schedule.
"Simplifying treatment regimens by reducing the number of pills and times per day patients need to take them provides significant public health benefits," said Dr. Lester M. Crawford, acting commissioner of the FDA, in an agency press release.
Simplified treatment is of special importance in nations where there are fewer health care practitioners to monitor the patients and coax them through the difficult regimen.
Crawford said approval of these combination drugs will increase the availability of medicines to those who need them. With FDA approval, Epzicom and Truvada now become suitable products for use in treatment programs sponsored under the President's Emergency Plan for AIDS Relief (PEPFAR). The $15 billion, five-year program aims to provide anti-retroviral drug treatment for 2 million people, in addition to care and assistance for people living with or affected by HIV/AIDS, and to expand AIDS prevention programs.
Since PEPFAR received its first congressionally authorized funding early this year, an additional 50,000 people living with HIV/AIDS in the program's 15 focus countries have begun to receive drug therapy, and U.S. government officials managing the program aim to boost those numbers rapidly.
The FDA has taken another step toward speeding the delivery of AIDS drugs to the hardest hit nations of the world with the initiation of a fast-track drug approval process. The agency has invited developing world pharmaceutical companies selling generic combination drugs in their regions to submit those medicines for an expedited FDA review.
"It is our firm belief that these steps will make a huge difference in the lives of people in Africa, Asia and the Caribbean, as well as the United States," Crawford said in a Washington speech.
Confronting health crises in their countries, developing world companies received patent waivers to copy and manufacture AIDS drugs invented by Western companies. If developing world companies submit their products for FDA review and if those so-called generic drugs receive FDA approval, then the United States will purchase them for expanding treatment under the PEPFAR program, officials say.
Critics have charged in the first few months of PEPFAR that the United States is not purchasing the cheaper generic drugs -- roughly one fifth the cost of brand-name drugs -- in order to direct its dollars only to Western pharmaceutical companies. U.S. Global AIDS Ambassador Randall Tobias dismisses the criticism saying the he wants consumers in other countries to benefit from the same tough regulatory scrutiny that protects American consumers from inferior products.
"We should not have two standards ... a standard of ‘good' in the Western world and ‘good enough' elsewhere. It ought to be the same standard," Tobias said at a briefing last month held at the XV International AIDS Conference in Bangkok, Thailand.
Ranbaxy Laborators Ltd. announced in late July that it will seek FDA approval for its combination AIDS drugs. The company, based in New Delhi, India, supplies AIDS drugs to about 40 countries
(The Washington File is a product of the Bureau of International Information Programs,
U.S. Department of State. Web site: http://usinfo.state.gov)
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*AEF302 08/04/2004
Struggle over WTO Framework Agreement Points to Challenges Ahead
(Developing countries' willingness to open markets viewed as crucial) (1280)
By Bruce Odessey
Washington File Staff Writer
Washington -- By all accounts the deal reached in Geneva allowing World Trade Organization (WTO) negotiations to proceed was the easy part, an indicator of the difficulties ahead.
Launched in 2001, the negotiations, formally called the Doha Development Agenda, collapsed at the September 2003 WTO ministers' meeting in Cancún, Mexico, and stalled for nearly another year as U.S. Trade Representative Robert Zoellick and others traveled the globe trying to revive them.
Finally, after two weeks of marathon General Council negotiations, representatives of the WTO's 147 member governments on July 31 approved a framework agreement, including the long-elusive framework for agricultural trade, for their negotiators to move ahead with the really hard bargaining.
Every negotiating deadline set in 2001 had passed unmet except the original deadline for completing negotiations by the end of 2004, which was swept aside by the new framework agreement.
According to participants at the General Council meeting, a hastily crafted paragraph in the framework agreement can be read as setting no deadline for concluding the negotiations although it does schedule the next ministers' meeting for December 2005 in Hong Kong.
Although some WTO work should resume after August, participants said, serious negotiations, especially on the contentious agricultural issues, are unlikely to start up again until spring 2005, well after the U.S. general elections and a scheduled change in European Union (EU) representation.
The final agricultural framework followed closely a text settled July 28 by five parties -- the United States, the EU, Brazil, India and Australia -- despite complaints from food-importing countries including Japan and Switzerland and from many developing countries, participants said.
Grumbling persisted about other parts of the framework agreement as well, one participant said, yet the WTO parties "swallowed hard" to accept it, each eager to avoid taking blame for killing the negotiations outright.
Whether the negotiating round succeeds will depend to a great extent on whether developing countries except the poorest ones, which are exempted, are willing to open their markets meaningfully to imports of agricultural and industrial goods, participants said.
AGRICULTURE
The market access provisions of the agriculture framework, especially difficult for developing countries, are much less specific than provisions aimed mostly at wealthy countries for eliminating export subsidies and reducing domestic subsidies.
Vague language requires "substantial improvement in market access." Still to be negotiated are the hard numbers, including the initial tricky business of dividing tariffs into different bands for different levels of reduction and agreeing on how to give special treatment to developing countries and to politically sensitive products in all countries.
The market access language does require bigger cuts for higher agricultural tariffs but not elimination of tariffs, making possible some continued protection for politically sensitive commodities such as sugar in the United States.
At U.S. insistence, the agriculture framework requires elimination of export subsidies by a certain date still to be negotiated. It requires also elimination of export credits with repayment schedules of more than 180 days, but only negotiation of disciplines for shorter-term export credits, giving the United States scope to continue part of its program.
The framework also requires disciplines on state trading enterprises such as the government-sanctioned monopoly Canadian Wheat Board and on food aid that would displace commercial food sales.
Trade-distorting domestic support would be cut substantially under the agriculture framework, with bigger cuts required for higher levels of support, a step toward harmonization on which the United States insisted to whittle down the existing huge EU advantage.
Parties would have to reduce their trade-distorting domestic support by 20 percent from bound levels -- the top levels under existing WTO agreement -- in the first year of any eventual agriculture agreement; such first-year reduction would have little effect on U.S. spending, which already falls below bound levels.
Some language in the framework seeks to restrict what are called "blue box" subsidies, which include programs aimed at limiting agricultural production. Such support would be capped at 5 percent of a country's average total value of agricultural production during some historical period to be negotiated.
The "blue box" provisions would allow continued counter-cyclical payments to farmers (when market prices fall to a low level) under the 2002 U.S. farm bill because they would be unrelated to current production, participants said.
Under the existing WTO agreement, "de minimis" domestic subsidies -- those not counted in calculating overall trade-distorting support -- are subject to a cap. Under the framework, they would be subject also to reduction except for developing countries such as India where the spending is aimed mostly at subsistence farmers.
A deal was worked out on the controversial cotton subsidies issue between the United States and four sub-Saharan African countries: Benin, Burkina Faso, Chad and Mali. Even though the issue will remain as part of the overall agriculture negotiations -- the African countries had wanted it separated for accelerated resolution -- a special subcommittee will form to make sure it is considered "ambitiously, expeditiously and specifically."
INDUSTRIAL TARIFFS AND SERVICES
Less complete than the agriculture framework was that for industrial tariffs, what WTO calls nonagricultural market access (NAMA).
Developing countries succeeded in adding language to the start of the NAMA text offered at Cancún stating their objections. It requires that "additional negotiations are required to reach agreement on the specifics of some of these [initial] elements" including the formula for reducing tariffs, rules for participation in initiatives aimed at tariffs in single industrial sectors and additional flexibility for developing countries.
In his August 1 press conference in Geneva, U.S. Trade Representative Zoellick said the additional language does not abandon the Cancún elements but only allows some modification. He viewed the framework as preserving the U.S. interest in achieving bigger cuts for the highest tariffs, keeping the option for sectoral initiatives and placing disciplines on non-tariff barriers.
The framework sets a deadline of October 31 for submitting notices of non-tariff barriers countries want included in negotiations.
The services framework was little changed. The language was given more prominence than in earlier drafts, and a May 2005 deadline was set for revised offers.
TREATMENT OF DEVELOPING COUNTRIES
The framework makes little change from earlier language, reiterating the importance of development to the negotiations. It sets a July 2005 deadline for the Committee on Trade and Development to report back to the General Council with recommendations on special and differential treatment for developing countries and on flexibility in implementation of existing WTO obligations for those countries.
Notable during the meeting was a division between more advanced developing countries in Latin America and East Asia on one side and poorer African, Caribbean and Pacific countries on the other. They compromised and agreed to change from "shall" to "should" language stating that the concerns of small, vulnerable economies "be taken into account, without creating a sub-category of members."
Participants said the more advanced countries aimed to prevent preferential agreements for some poorer countries from becoming entrenched in the trading system. Differentiation among developing countries could emerge as another issue in negotiating a final WTO agreement.
SINGAPORE ISSUES
The four so-called Singapore issues were reduced to one issue for the remainder of the Doha round. The members agreed to launch negotiations on trade facilitation -- rules streamlining customs procedures for "expediting the movement, release and clearance of goods" at the border.
Dropped for now were the three other issues: transparency in government procurement, trade and investment, and trade and competition policy. To the dismay of some developing country opponents, however, the General Council kept them alive for future negotiations.
(The Washington File is a product of the Bureau of International Information Programs,
U.S. Department of State. Web site: http://usinfo.state.gov)
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