13 November 2001
Source:
http://usinfo.state.gov/cgi-bin/washfile/display.pl?p=/products/washfile/latest&f=01111202.clt&t=/products/washfile/newsitem.shtml
See related New York Times report: Suddenly, 'Idea Wars' Take On a New Global Urgency
US Department of State
International Information Programs
Washington File
_________________________________
12 November 2001
(WTO negotiators narrow differences on the issue) (2660) World Trade Organization (WTO) negotiators have made "good progress" on how to proceed with issues relating to trade-related aspects of intellectual property rights (TRIPS), says a senior U.S. trade official. In a November 12 background briefing, he said that differences between developed countries, which insist on the protection of medicinal patents, and developing countries, which want to have access to inexpensive drugs to fight AIDS and other epidemics, have been narrowed. The official said that countries participating in the WTO ministerial meeting in Doha, Qatar, are trying to draft a political declaration that would not damage or destroy the TRIPS agreement. He said that "they were starting to reach a better sense of convergence in terms of what a declaration would look like," but cautioned that a declaration is not yet complete. According to press reports, patent protection covered by the TRIPS agreement has been one of the most divisive issues between developing and developed countries during the preparations for the WTO meeting. The official also expressed cautious optimism about prospects of launching a new round of trade talks as a result of the Doha meeting. "We see pieces starting to fall into place but there is still a distance to go before we are complete," he said. Following is the transcript of the press conference: (begin transcript) November 12, 2001 Office of the U.S. Trade Representative Background Press Conference Fourth World Trade Organization Ministerial Doha, Qatar Good Morning, everyone. Thank you for coming by USTR's background press briefing I'd like to remind everyone that all the quotes today are on background and attributable to a senior U.S. trade official. Thank you. First U.S. Trade Official: Good morning to everyone. We're now kind of half way through, I guess, this process at this point, and I think for those of you who have been regularly out talking to a number of us since the sessions began on Friday night or even the pre-stages, you know this is in the more intensive portions of the meeting. Let me comment, I think, briefly, on yesterday's events and where we see today playing out. As we were with you yesterday, we talked, I think as we have the last couple of days, in terms of the role the United States is trying to play in this process of, in many cases, being the bridge on a number of issues, trying to be constructive and supportive in terms of pulling together a balanced agenda that we think brings and builds the kind of support that would be necessary to launch the negotiations, and we certainly have been working hard over the last several days to play that role. Yesterday, as you know, we finished up the topics in the morning with the Head of Delegations session, came back then in the early afternoon to hear a report on all the groups that have been working, the facilitative groups, in those intervening hours. And that work is going to continue. That was the first round of reports. It certainly wasn't meant to come back and bring the finished package on any of the particular topics. But, at least it kept people very well informed in terms of where the work was. The facilitators continued to meet during the day either in the larger sessions or in smaller groups, sometimes bilaterally, sometimes with a small group of countries, sometimes with a larger group that came and expressed their perspective on any number of issues, that then finished up later yesterday afternoon. And the Head of Delegation's meeting will take place again this morning, and we would expect there to hear a report from the facilitators, also, because there were more meetings taking place last night and, indeed, even beginning early this morning. So, I appreciate from a news perspective, this is probably the hardest time since there is so much work being done without a finished product, but I think it is safe to say where we see at this point we continue to have the same sense of cautious optimism in terms of where we are in being able to launch the negotiations. We see pieces starting to fall into place but there is still a distance to go before we're complete, so the next two days will be very intensive. With that, if I may open it up to questions. Question: Could you tell us what the status is at the moment of negotiations on TRIPS? First U.S. Trade Official: The TRIPS group met regularly through the day yesterday, and I think by last evening I believe they were starting to reach a better sense of convergence in terms of what a declaration would look like. Now, I think, as with any of the topics right now, having made that statement, it doesn't mean that a declaration is complete. But, I think the belief was by last night there was a closer agreement on a number of different issues, and the group was planning to meet and continue to work through the day. So, I think yesterday was a day of good progress on that as we move forward. Q: Jeff Armstrong, Wall Street Journal: Just to follow up on that, I understand that there was some provisional text that is now being submitted by a small working group to that general group. I wonder if you could confirm that and characterize the text? A: Yes, I think from the work that was done yesterday, that there were changes in the language that were suggested and that had been discussed within the group that has been working in terms of TRIPS. I don't think that that is, as I was commenting earlier, the stage of final text at this point. So, I think that was language to continue to explore. But there is much more convergence on the language than what we had seen previously. As you know, I think we all know from having covered this issue, this is one in which, at the beginning of the discussions, all the countries were particularly focused on this topic, starting with the basic premise, as we're trying to draft the words that would set the political declaration, that they wanted to make sure we didn't do anything that would damage or destroy the TRIPS agreement. And that's continued to be the basic premise that we work on and believe that certainly we have the flexibility within the TRIPS agreement to respond to the health crises that affect so many countries today. And I think that's continued to be the guiding principal for that group as they work through those issues. So, I think they will be examining that text, exploring it. As with any of these, sometimes you're at the point now you scrutinize every word in terms of what it means and what it says, and does it express the perspective that you're trying to as clearly as possible, so I think there'll be a lot of that work done through the day. Q: Since TRIPS is a separate issue and you say you are making good progress on it, would you anticipate that you all would be able to announce that you have an agreement in that area, before maybe you have agreement on the elements you need to launch a round. If that is a correct scenario, I mean, do you think it's likely that there could be such an announcement today? A: I think we're at the point of working so hard in terms of the issue, nobody's gone beyond where we are right now in terms of the drafting process. So, we've certainly considered it to be a unique declaration to itself, as we commented, I think, earlier on, that it was something we were committed to find the right solution for, but it was separate from the rest of the declaration or the launch of the negotiations in the process. But I wouldn't anticipate at this point in terms of how it will be presented, we need to have the solution, we don't have that quite yet at this point. Second U.S. Trade Official: Just to remind you that any declaration, whether it's on that subject or another, would be a ministerial declaration and so the only way it could be announced would be if the ministers got together and agreed. You couldn't announce anything before that happened. Q: Indian Press: Two questions. One, what is happening in Singapore issues. Second, on TRIPS, one of the concerns from developing countries, based on an NGO report today, is that prices of drugs are increasing since the Uruguay Round came to be. So how do you resolve this issue? And thirdly, did Ambassador Zoellick pressure the Indian Minister in their meeting yesterday. Second U.S. Trade Official: Your first question, about the group that's meeting on Singapore issues, that continues to be a difficult issue. As you know, there are difficult issues there with respect to countries' readiness to have negotiations in some of those areas. I think it's important to make a distinction among the Singapore issues. Normally, people have in mind four issues. There are issues - government transparency, and government procurement and trade facilitation -- that appear to be significantly less controversial than investment and competition policy. So I think it's important we make those distinctions in the first instance. But, with respect to investment and competition policy, there still is the need to deal with the concerns of countries that feel that there needs to be, that they need some more preparation before they could really negotiate in those areas. So the work is to see how best to structure things so their needs are met and the needs are met of those who want to negotiate. Your second question had to do with an assertion that prices on medicine have risen. Well, I'm not aware that, I don't know what particular study you're referring to and which medicines you're referring to. So, it's not clear to me that that is the case. With all due respect to the NGOs, I certainly would like to see the underlying work that verifies that. I hope they're not just assertions, because that is not our impression. Then your third question had to do with the meeting between Amb. Zoellick and Minister Maran. I'd not like to get into details of bilateral meetings, whether it's with Minister Maran or with any other Minister. Let me say that it was a very, cordial meeting, I thought it was a constructive meeting, it went through the various issues that are under negotiation here, the six primary issues. I think that both sides had a very clear understanding of the other side's preoccupations. And neither party put down any ultimata, or threats. Thank you. Q: On the wording of the agriculture text, what is the position of the U.S. delegation, with respect to export subsidy and export credits? A: Our position is that the negotiation should cover the famous three pillars and that includes export competition, one of the pillars, and countries are free to put forward their proposals, and countries have put forward proposals on export credits in the negotiations. Q: I have sort of two related questions. First, the developing countries are asking for development consideration for them to move faster within the WTO. Have you received any concrete demands regarding what they mean by development? And, is the issue of TRIPS and the pharmaceutical products part of the development demands? I don't know if I'm being clear. The APC, the African, Pacific and Caribbean countries issued a declaration the day before yesterday saying that we need more attention to all of development in order to move faster within the WTO because we cannot cope with the previous agreement for whatever technical and development reasons. Have you received any concrete demands regarding that? And the other question has to do with the position on TRIPS, is there any coordination with the pharmaceutical industry in the U.S. regarding the position on TRIPS? A: I would like to start on the first issue, but I'd also like my colleague to comment on it too, because he spoke to that last night, I think, in the press briefing. I think we have seen the draft agenda, even as it came together, was a good description, I think, of both a development and growth agenda for prospective negotiations. If you go through that draft, there are a number of different, both general as well as very specific, mentions of development issues. Whether it's been in more traditional means of special and differential treatment that's proposed and a number of different sections to assist countries as they move into a broader range of development, or whether it's been in more specific areas of technical assistance and capacity building. This is an area that many of you know, particularly the Director General and the Secretariat have focused on the last couple of years, so they've been very helpful, I think, in continuing to bring that focus of attention to the issues and the membership, I think, has certainly supported it. So, it's been one that has been of concern, already, in the drafting, and I think has continued to addressing the concerns in the various working groups over the last several days, that those concerns are taken into account as the drafting is finalized. So I think those are serious and concrete issues that we need to work on, not only as countries that are coming into the WTO, but that we continue to assist them in their greater development. It's been a particular focus, I will tell you, of our discussions over the last couple months in Geneva, most especially, even, with the African countries. Because as we talked about a number of the issues they've made very clear that they wish to be participants, but that there are a number of places that they feel they need either technical assistance and /or just simply need to build the capacity within their own country. And so, we tried to be constructive not only in terms of what's done within the WTO, but working, for example, with the World Bank in terms of programs would be of benefit. We have, for example, with us as a part of our delegation, a representative from USAID who has been meeting bilaterally with countries that are so interested to find out what programs we do have that would be of assistance to them. We came with a fairly detailed brochure outlining those, so if countries were not aware, that would give them good background, but also with somebody on site they can work with. I saw, in fact, in one meeting the other day when we said we had the AID person with us who was willing to schedule appointments, people were lining up with him after the meeting to be able to do that. So I think that's been quite constructive and I've been pleased with the response to that. On TRIPS, there is with us a number of different industry groups here represented even here as we meet. So yes, they are certainly aware in terms of how those discussions are progressing, and we tried as most of the delegations do to keep our major industry groups informed, either those who are here present or with regular contact as the week has gone back. Back to the States to let them know we want them to know exactly is taking place, and hopefully be supportive in terms of what those agreements would be. First U.S. Trade Official: We have to go to the heads of delegation meeting now. We have to be there by 10:00, so, I'm sorry, we'll have to finish right now. Thank you. (end transcript) (Distributed by the Office of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)
10 November 2001
(USTR sees flexibility in existing TRIPs agreement) (2,000)
The United States is urging flexible use of the existing global accord
on trade related intellectual property rights (TRIPs) rather than
major changes that could hamper the development of new medicines.
In a background paper issued November 10 in Doha, Qatar, where
ministers from the member countries of the World Trade Organization
are meeting in hopes of launching new global trade negotiations, USTR
also outlined its proposal to extend by ten years to 2016 when the
least-developed countries have to meet their patent obligations under
TRIPs.
"This will give them the assurance that they will not be challenged in
the WTO as they take steps to address HIV/AIDS and other pandemics,"
USTR said.
The United States is further proposing a moratorium of at least five
years on WTO challenges to the actions of sub-Saharan African
developing nations as they respond to HIV/AIDS, infections related to
AIDS, and other health crises, such as malaria and tuberculosis.
On efforts by some countries to make major changes in the TRIPs accord
through sweeping exceptions to "protect public health" rather than a
more targeted approach that allows for specific exceptions, USTR
warned that such language, if adopted, would "result in commonplace
erosion of patent protections from pharmaceuticals to medical software
and thwart research into medicines to treat life-threatening diseases.
Indeed, it could subvert the entire TRIPs Agreement."
Following is the text of the background paper:
(begin text)
USTR BACKGROUND PAPER
TRIPs and Health Emergencies
The United States is committed to working with countries around the
world to end the scourge of tragic pandemics such as HIV/AIDS, malaria
and tuberculosis.
The United States understands the urgent need for affordable access to
critical medicines that will help countries deal with such health
emergencies.
The United States is pursuing a comprehensive, integrated approach to
pandemics such as HIV/AIDS, stressing education, prevention, care,
training, and treatment.
The United States supports a strong declaration in Doha affirming the
right of each WTO Member to use those provisions of the TRIPs
Agreement providing flexibility to help deal with tragic pandemics,
such as HIV/AIDS, malaria, and tuberculosis, or other circumstances of
extreme urgency. We also support affirming that TRIPs contains crucial
pharmaceutical-related patent protections providing necessary
incentives for continued research and development.
The United States has proposed a statement in Doha declaring that all
WTO countries, regardless of their level of development, may make full
use of the flexibilities provided for by the TRIPs Agreement *
including "compulsory licenses" and "parallel importing" to address
health crises.
-- Under "compulsory licensing," a government conditionally authorizes
third parties (or the government itself) to use a patented product
without the authorization of the patent holder.
-- Under "parallel importing," authentic patented products are
imported into a country without the authorization of the patent
holder.
We support clarifying the flexibility in the TRIPs Agreement. As Gro
Harlem Brundtland, the Director-General of the World Health
Organization, said recently, "Clarity on this flexibility would allow
[WTO] members to formulate public health policies in ways that do not
infringe on the rights of patent holders.
The United States opposes a declaration that creates a broad carve-out
to TRIPs ostensibly to "protect public health." Instead of permitting
targeted exceptions to TRIPs, this open-ended language would result in
commonplace erosion of patent protections from pharmaceuticals to
medical software * and thwart research into medicines to treat
life-threatening diseases. Indeed, it could subvert the entire TRIPs
Agreement.
The United States has proposed granting least-developed countries a
10-year extension, to 2016, to come into full compliance with all
pharmaceutical-related patent obligations under TRIPs. This will give
them the assurance that they will not be challenged in the WTO as they
take steps to address HIV/AIDS and other pandemics.
The United States has also proposed a moratorium of at least five
years on WTO challenges to the actions of sub-Saharan African
developing nations as they respond to HIV/AIDS, infections related to
AIDS, and other health crises, such as malaria and tuberculosis.
TRIPs (general)
The TRIPs Agreement strikes an appropriate balance between offering
incentives for innovation and ensuring that there is access to
medicines.
The strong patent protection embedded in TRIPs is a fundamental
element of the global health-care system. Patent systems stimulate
research, development and distribution of safe and effective drugs
that are used to prevent, treat, and cure illnesses.
As United Nations Secretary-General Kofi Annan pointed out in April,
"Intellectual property protection is key to bringing forward new
medicines, vaccines, and diagnostics urgently needed for the health of
the world*s poorest people. The United Nations fully supports the
TRIPs agreement * including the safeguards incorporated within it."
And as WHO Director-General Brundtland said recently, "Continuing
innovation is essential: This requires both incentives to invest in
research on the diseases that drive poverty and protection provided by
international agreements on intellectual property."
TRIPs is just one element of the needed global response to a pandemic
such as HIV/AIDS. The United States is pursuing a comprehensive,
integrated approach, stressing education, prevention, care, training,
and treatment.
-- The United States is the largest bilateral donor of funds for
HIV/AIDS assistance, providing over $2 billion per year on related
research, much of which helps to address developing country problems.
This represents nearly 50 percent of all international HIV/AIDS
funding. We were the first contributor, and remain the largest, at
$200 million, toward the international "Global Fund to Fight AIDS, TB
and Malaria."
A period of market exclusivity for innovated products and processes is
essential to ensure development of new health care products.
Without the economic incentives provided by patent protections, and
the expectation of market exclusivity, the private sector will be
unable to take the risks associated with research and development of
new health-care products. And the supply of new drugs, for the
treatment and cure of life-threatening diseases, would contract.
-- New drugs often cost between $250 million and $500 million to
develop, and involve more than a decade of research
-- Companies invest billions of dollars annually on thousands of
ideas, but only a small percentage ever come to market and prove
commercially successful.
-- Such invention and creation is undermined when competitors, who
bear none of the costs of unsuccessful research, are able to copy
research-based products and undercut their investment.
Strong, effective intellectual property protection is the cornerstone
on which an attractive investment climate is built, and produces
long-run economic benefits.
-- Provides incentives for innovation by helping to create an
environment in which innovation is rewarded.
-- Encourages development of lower cost methods of production and
distribution of existing products.
-- Invites introduction of new, safe and effective products,
technology and services.
-- Stimulates development of in-country markets through the adaptation
and improvement of existing products and technology.
Under the current patent system, extensive medical research is being
carried out.
-- In the United States alone, there are more than 100 new drugs for
the treatment of HIV/AIDS in development, 120 new drugs to treat heart
disease and stroke, 135 drugs to treat and prevent infectious
diseases, 400 new drugs for treating or curing various forms of
cancer, and 700 new drugs to address diseases associated with aging.
A strong IPR regime has additional benefits.
-- It helps attract foreign direct investment; companies will be more
willing to invest in countries secure in the knowledge that there is a
legal structure to protect their innovations from unauthorized
copying.
-- It discourages brain drain, encouraging the best and the brightest
in developing
nations to carry out their research at home, knowing the fruits of
their labors will enjoy patent protections.
Cipro
Health and Human Services Secretary Tommy Thompson negotiated with
Bayer the per-tablet price at which the federal government would
purchase Cipro. His actions were fully consistent with the
international agreements to which the United States is a party.
-- Contrary to media reports, Secretary Thompson never threatened to
break Bayer's patent.
-- He stated, publicly, that if he or the Congress had contemplated
breaking the
patent, compensation would have to be paid to the patent owner
(Bayer), as required by TRIPS.
The TRIPs Agreement contains flexibilities that can be utilized in
times of crisis or emergency. Given the discovery of anthrax in New
York, Florida, and the Washington, DC metropolitan area, and the risk
of individuals being infected with a potentially deadly virus, the
United States would be permitted under TRIPs to exercise its rights to
go outside the patent process. Moreover, U.S. law entitles patent
holders to seek "reasonable and entire compensation" in the event of
non-commercial use of their patents by the U.S. Government.
These flexibilities are not limited to the United States. They are
available to every other member of the WTO.
Canada
-- The compromise agreement on the purchase of Cipro involving the
Canadian government, Bayer, and a generic drug producer does not
appear to violate the TRIPs Agreement.
-- The Canadian health authorities are acquiring Cipro exclusively
from Bayer during the period of patent protection.
-- The compromise is an improvement over the Canadian government*s
original action, which would have involved the purchase of Cipro with
no involvement from Bayer.
-- The Canadian experience illustrates how easily public pressure can
build for prompt governmental responses to health issues. Fortunately,
the Canadian government recognized that acting within TRIPs rules was
the most sensible and effective response.
Evolution of USG Policy
-- 9/17/99: Clinton administration drops its demands that South Africa
ease parts of a pharmaceutical-import law, dealing with compulsory
licensing and parallel importing. This law had earlier prompted a
legal challenge by American and international pharmaceutical
companies.
-- 12/1/99: The Clinton administration announces its intention to
develop a "cooperative approach" on IPR health issues to ensure that
U.S. trade laws remain sufficiently flexible to respond to "legitimate
public health crises" throughout the world. South Africa removed from
the special 301 "watch list." South Africa had been placed on the list
because of its policies on compulsory licensing and parallel imports
were seen as conflicting with TRIPs.
-- 5/10/00: President Clinton issues an executive order pledging that
the United States "shall not seek, through negotiation or otherwise,
the revocation or revision of any intellectual property law or policy"
of sub-Saharan Africa countries, as long as these laws or policies
promote access to drugs to treat HIV/AIDS and are consistent with the
TRIPs Agreement. Effect is to hold these countries to only a TRIPs
standard, not a TRIPs-plus standard.
-- 2/22/01: USTR issues the following statement: "The HIV/AIDS crisis
is a terrible tragedy for countries, families and individuals. USTR is
not considering a change in the present flexible policy: Consistent
with our overall effort to protect America's investment in
intellectual property, USTR will seek to contribute to Administration
efforts to work with countries that develop serious programs to
prevent and treat this horrible disease."
-- 6/25/01: USTR announces that the United States and Brazil have
agreed to transfer their disagreement over a provision of Brazil's
patent law from formal WTO litigation to a newly created bilateral
consultative mechanism (the provision is designed to pressure patent
owners to manufacture their invention in Brazil). The consultative
mechanism permits more effective, and less confrontational,
consideration of intellectual property issues and ensures that such
discussions do not divert attention away from the shared goal of
combating the spread of HIV/AIDS.
-- 10/13/01: USTR proposes at Singapore Ministerial that at Doha
Ministers agree to extend the TRIPs transition period regarding
pharmaceuticals for all least-developed countries and commit to a
dispute settlement moratorium for sub-Saharan African developing
countries on measures to address pandemics such as HIV/AIDS.
Note: Since December 1999, U.S. policy has been to apply no higher
standard than the TRIPs Agreement in situations where foreign
governments are trying to address health crises. The policy has not
been limited to any region.
(end text)
(Distributed by the Office of International Information Programs, U.S.
Department of State. Web site: http://usinfo.state.gov)