◆DOCTORS WITHOUT BORDERS/MEDECINS SANS FRONTIERES (MSF)
PRESS RELEASE
Breakdown in WTO Negotiations Provides Opportunity
to Fix Flaw in Agreement on Access to Medicines
New York/Geneva, December 20, 2002 -- Delegates at the World Trade
Organization (WTO) Trade-Related Aspects of Intellectual Property Rights
(TRIPS) Council have failed to reach an agreement on the issue of the
implementation of paragraph 6 of the Doha Declaration on the TRIPS
Agreement and Public Health. Although the proposed text was detrimental to
the interests of poor countries, it was opposition from the United States,
who wanted to restrict the agreement to a limited list of diseases, that
prevented consensus. Negotiations will continue in the new year. Doctors
Without Borders/Medecins Sans Frontieres (MSF) encourages WTO members to
use this opportunity to rethink their positions and draft a fair text that
gives priority to people's health rather than the interests of wealthy
countries' pharmaceutical industries.
"Today, some people with AIDS in Malawi, Honduras or Cambodia can buy
generic triple therapies that cost US$300 per patient per year ? because
Indian and Thai producers are able to export them," explains Ellen 't Hoen
of MSF. "But unless a real solution to the paragraph 6 issue is found, the
source of affordable generics will dry up. In the future, many patients
will be excluded from access to life-saving treatment because they can't
afford brand name drugs."
In November 2001, the Doha Declaration on the TRIPS Agreement and Public
Health gave developing countries hope that the system could help them
protect access to essential medicines. The declaration stated unequivocally
that "the [TRIPS] Agreement can and should be interpreted and implemented
in a manner supportive of WTO members' right to protect public health and,
in particular, to promote access to medicines for all." This was a crucial
assertion that lives must be given priority over patents.
However, one key issue was left unresolved in Doha: how to ensure that a
country which provides pharmaceutical patents can export to a country that
has issued a compulsory license but does not have manufacturing capacity.
Paragraph 6 of the Doha Declaration acknowledged this flaw in the TRIPS
Agreement, and WTO Members instructed the TRIPS Council to "find an
expeditious solution to this problem and report to the General Council
before the end of 2002."
Given the disparity of their motives, it is not altogether surprising that
delegates failed to reach an agreement. Led by the pharmaceutical industry,
the US, Canada, Japan, the European Union, and Switzerland have directed
their efforts to distorting and undermining the spirit and intent of the
Doha Declaration. Over the weeks of negotiation, proposed texts gradually
accommodated more of their demands in a bid to assuage their extreme and
intransigent positions. The latest draft (December 16) weighed heavily in
their favor, yet was ultimately rejected by the US as too generous in the
scope of diseases.
In future discussions, it is vital that the text does not limit the
solution to certain diseases, as pushed for by the pharmaceutical industry
and the US. The Doha Declaration refers simply to the protection of "public
health." There is no public health rationale for limiting a policy that is
designed to increase medicines for all to a few diseases only.
"If the agreement is too restrictive, developing countries will
increasingly be forced to rely on supply from originator companies, who
sell at more than twice the price of generic manufacturers, even in today's
competitive market," explains Ellen 't Hoen. "There are almost thirty
million people living with HIV/AIDS in sub-Saharan Africa, and the biggest
obstacle to saving their lives is the price of treatment. Drug prices must
drop further to enable them to access these drugs. How will this happen if
the generic industry is stifled?"
The agreement must not force countries to negotiate case by case and drug
by drug, and should not require onerous conditions or unnecessary
notification procedures. If the text is to offer a real "solution" to the
production for export issue, it must be simple, workable and automatic.
Bearing in mind that if a rational and just solution is not found, poor
countries will not have the same ability to use compulsory licenses as
wealthy countries. In the end, patients in developing countries will pay
the price, in many cases with their own lives.
◆Health GAP
Press statement
For Immediate Release
December 20 2002
Thanks to U.S. bullying, no deal this year on access to medicines at the WTO
Poor countries prevent U.S. re-write of Doha agreement on public health
After marathon talks, U.S. trade negotiators have left WTO empty handed on
the issue of exported versions of affordable generic medicines, despite
stubborn efforts by Bush Administration officials to push through a deal
Health GAP called friendly to U.S. pharmaceutical companies, but worse for
poor countries than no deal at all.
"Developing countries were correct to oppose a bad deal from the U.S.," said
Sharonann Lynch of Health GAP. "While everyone would have preferred an
agreement this year, the public health stakes are too high to give in just
for the sake of a piece of paper, instead of working for a truly sustainable
solution to to problem of access to generic versions of medicines for
importing countries."
Although all WTO members, including the U.S., signed a WTO declaration at
Doha last year permitting countries to prioritize public health and access
to medicines for all over the intellectual property rights of pharmaceutical
companies, the U.S. has worked to reverse this agreement and undermine its
implementation, say the activists.
A year of negotiations revolved around one aspect of the Doha Declaration:
how to revise restrictions in WTO rules to permit countries without the
ability to make generic drugs to obtain needed medicines from exporting
countries.
The U.S.--along with the EU, Japan and the pharmaceutical industry--lobbied
stubbornly for strict limitations, conditions, and new burdensome
procedures in its draft texts. Activists say the U.S. proposals would have
meant a solution leaving poor countries worse off than before.
A restriction in eligibility to a handful of diseases is one aspect
of the U.S. proposal that stalled negotiations for weeks, and predicted
tonight's impasse.
"U.S. intransigence shut down these talks, and will continue to shut down
debate about this issue. What business do U.S. trade negotiators have
playing doctor?" asked Brook Baker of Health GAP. "Millions are suffering
and dying without medicines, but the U.S. wanted to limit this deal as much
as possible. Developing countries were right to hold their ground--a
deadlock in the short term is preferable to a deal that traps poor countries
in the long term."
Because WTO rules on patents do not come into full affect for relevant
countries until 2005, there is no immediate damage caused by a slower
timeline. However, activists point out, a bad deal signed this year would
likely result in lasting damage to efforts to increase sustainable medicines
access.
"Instead of supporting access to medicines for all, as it promised at Doha,
the U.S. pursued a unilateral strategy driven by profit maximization
for the most profitable industry in the world," continued Asia Russell of
Health GAP. "And this time, it backfired."
Advocacy organizations and developing countries have lobbied for various
solutions that would correct WTO export restrictions on important medicines
without increasing burdens to poorer countries and without narrowing the
scope of the Doha Declaration, which authorizes countries to uphold public
health and promote access to medicines for all.
◆2002/12/20 U.S. STICKS TO HARD LINE ON TRIPS, AS SUPACHAI TRIES TO BROKER DEAL
Inside US Trade Date: December 20, 2002
山田さんより
日本のとった行動などについても、詳しく載っています。
このInside US Tradeというのは、雑誌でしょうか、新聞でしょうか?
U.S. STICKS TO HARD LINE ON TRIPS, AS SUPACHAI TRIES TO BROKER DEAL
_______________________________________________
Date: December 20, 2002
The top official of the World Trade Organization, Supachai Panitchpakdi,
yesterday (Dec. 19) launched a last-ditch effort to break a week-long
deadlock in the negotiations over new rules that would allow countries to
source the manufacture of generic copies of patented drugs abroad. With the
U.S. insisting on strict limits for the disease coverage of a potential
deal, Supachai kicked off a series of informal meetings that are expected to
continue until a General Council session on Dec. 20.
Supachai got involved in the process after the U.S. resisted repeated
efforts over the past two weeks to strike a compromise. Trade officials in
Geneva, including the official in charge of the negotiations, warned that
the U.S. position would prevent a deal. Under last year's Doha declaration,
the new rules are to be negotiated by Dec. 31.
Supachai convened an initial meeting starting at 4 p.m. Dec. 19 Geneva time,
but that meeting was suspended after countries failed to bridge their
differences. A second meeting was set for later in the evening and a Dec. 20
morning meeting will precede the 10 a.m. session of the Council on Trade
Related Aspects of Intellectual Property Rights, which is responsible for
negotiating the issue
If there is no agreement on Dec. 20, the General Council will likely discuss
how or whether negotiations will continue, trade officials said. The U.S.
last week floated the idea of revisiting the issue at a mid-February
mini-ministerial in Japan, trade officials said. In addition, some countries
have discussed resuming talks in January after the Christmas break.
But one developing country official said developing countries did not want
to continue negotiations for fear this would only lead to more pressure from
the U.S. to limit the scope of disease coverage and result in a worse deal.
The Chairman of the TRIPS Council Eduardo Perez Motta, earlier this week
called on the U.S. to be more flexible in a Dec. 17 interview with Inside
U.S. Trade. He cautioned that missing the end-of-year deadline set by
ministers in Doha creates a "very bad precedent for the future of the
round," and noted that there was no mandate for continuing talks beyond Dec.
31.
He said even if a country has no stake in a particular deadline, there are
others coming in a few months that do affect its interests, a reference to
spring deadlines for making critical decisions affecting the agriculture,
services and industrial market access negotiations. "There are systemic
costs of not complying with the dates set by ministers," Motta said. At the
same time, he said, failing to meet the deadline would not be "the end of
the world."
Motta cautioned against putting off decisions until the September 2003
ministerial in Cancun. "If we overcrowd that ministerial we are just
creating a monster we are not going to be able to live with," he said.
The U.S. is alone among WTO members in rejecting a Dec. 16 compromise
agreement which defines the scope of the agreement by referring to the
"public health problems as recognized in paragraph one of the" ministerial
declaration on TRIPS and public health. This formulation is too open ended
and ambiguous for the U.S. and the pharmaceutical industry represented by
PhRMA but developing countries have said this paragraph one formulation is
their bottom line on the scope of diseases.
"I don't find any spaces or proposals that could work" to bridge the
differences on scope, Motta said. He pointed out that the ambiguities that
are inherent in the wording of paragraph one "are the result of the
negotiations in Doha" by trade ministers.
Instead, U.S. negotiators are demanding a limit to the disease coverage to
"HIV/AIDS, malaria, tuberculosis or other infectious epidemics of comparable
gravity and scale, including those that may arise in the future." This
slightly deviates from language proposed by the U.S. pharmaceutical industry
in that it implicitly acknowledges the possibility that there may already be
comparably serious infectious epidemics.
The Dec. 16 draft does exclude vaccines from the proposed solution, which
Japan had pushed to omit.
At informal TRIPS Council meetings on Dec. 16-17, all the major players in
the negotiations, with the exception of the U.S., signaled they could accept
the Dec. 16 draft. Japan offered a degree of support to the U.S. by saying
it shared U.S. concerns on the scope of the agreement. But Japan also told
the TRIPS meeting that it was ready to join the consensus on a deal,
signaling it would not stand in the way of a deal if the U.S. backed down.
At the Dec.16 meeting, 17 countries, including Central European countries,
Korea, Chile, Botswana, Taiwan, Lesotho and Pakistan said they could accept
Motta's Dec. 16 draft. At the next day's meeting, there was near unanimous
approval of the draft, trade officials said.
In presenting his draft, Motta said this was his final attempt to reach a
compromise and that he would not revise it or offer a new one before WTO
members are due to leave Geneva at the end of the week.
Developing country leaders India and Brazil and Kenya, speaking for the
Africa Group, said they could accept the chairman's draft as long as there
was no move to further limit the scope of diseases, although these countries
took issue with other specific elements of the draft deal.
"[I]n a spirit of compromise the Africa Group is prepared to go along with
the consensus on the document, if there is consensus; on condition that the
current text is not re-opened, particularly with relation to the scope of
disease coverage. We believe that the Declaration is absolutely clear on
this matter and any proposals that would reduce the rights and flexibility
in that context would be unacceptable," Kenya's WTO Ambassador told the Dec.
16 TRIPS council.
The U.S. had mounted a concerted effort over the last two weeks to sway
African countries toward its position on scope, trade officials said. But
that effort failed, despite U.S. offers of flexibility to African countries
on their drive to have compulsory licenses apply region-wide to African
countries that are linked in trade pacts.
In the Dec. 16 meeting, Japan said it hoped that the scope of diseases
covered by an agreement could be clarified as much as possible but it was
not holding out to any specific language for the clarification. It shared
the U.S. view that ailments like asthma and obesity should not be covered.
Japan has also sought to float compromise language alternatives to the U.S.
One idea would waive current restrictions on export of generic copies only
to address grave public health crises. A second proposal would explicitly
exclude health problems which are not infectious and do not constitute
humanitarian emergencies at the level of AIDS/HIV, TB and malaria. At press
time, the U.S. had not moved off its previous position on scope, but had not
given a direct response to Japan's proposal, a trade official said.
Switzerland also said it would not block consensus because of the scope of
diseases, since it had already said it would support limits based on the
formulation in paragraph one of the TRIPS and Public Health declaration.
That paragraph "recognizes the gravity of the public health problems
afflicting many developing and least-developed countries, especially those
resulting from HIV/AIDS, tuberculosis, malaria and other epidemics."
In an effort to address the U.S. position, Switzerland last week proposed
that the deal define scope by referring to "grave public health problems
especially those resulting from HIV/AIDS, tuberculosis, malaria and other
epidemics of comparable gravity." But the U.S. rejected this formulation,
saying the scope should be limited to infectious diseases and should not
cover other epidemics such as ailments resulting from tobacco use.
アメリカ合州国副大統領のディック・チェイニーは昨晩、貧困国への廉価な治療薬への供給のための国際的な制度作りをストップさせた。これは、アメリカ合州国の巨大製薬企業のホワイトハウスへの強力な働きかけを受けてのものである。
アメリカ合州国は、多くの途上国において治療薬を高嶺の花にしている地球規模の特許法制を緩和することを拒否した。そのことで、アメリカ合州国は140にものぼる世界貿易機関の他の加盟国全ての、怒りを含んだ反発に直面した。
WTOのジュネーブ本部において行われていた、アフリカ・アジア・ラテンアメリカに対して、人々の命を救うために広範囲の治療薬を輸入することを認める制度作りのための協議は、昨夜、ホワイトハウスの反対に直面して瓦解した。
ブラジルの交渉担当者であるアントーニオ・デ・アギアール・パトリオータ Antonio de Aguiar Patriota は、「アメリカ合州国は、この合意に乗ることは出来ない、と発表した」と述べた。ジュネーブの情報筋は、アメリカ合州国の交渉における方針は、直接ホワイトハウスから来たものであり、チェイニー副大統領がアメリカ合州国の交渉担当者ロバート・ゼーリック Robert Zoellick から交渉の手綱を奪って行われたものであると述べた。
ゼーリックは、昨年ドーハで行われたWTO閣僚会議において定められた、入手可能な医薬品に関する取り決め(訳注:ドーハ宣言のこと)をまとめる手助けを行った人物である。この取り決めは、途上国が公衆衛生上の利益のために特許権を乗り越えることを可能とするものであった。
しかし、アメリカ合州国の製薬企業は、このドーハ宣言について、出来るだけせまい解釈を押しつけ、さらに、対象となる医薬品について、HIV/AIDS、マラリア、結核および、アフリカに特有のその他のわずかな疾病に対する治療薬に制限するために必死の努力を続けたのである。
会議に出席した交渉団は、この交渉自体は来月再開される予定だが、昨夜の失敗は、農業補助金の削減から、サービスにより徹底した競争原理を導入することまでを含む、昨年の「ドーハ合意」全体を破産のがけっぷちに追い込みかねないものだ、と述べた。
この日のより早い時間、アメリカの製薬業界は、ブッシュ政権に対する働きかけの活動が実を結ぶであろうことに自信を示していた。
アメリカ合州国の主導的な製薬企業を代表する組織である米国製薬研究・製造業者連合(PhRMA: Phermaceutical Research and Manufacturers in America)のシャノン・ハーツフェルド Shannon herzfeld は、貿易に関する専門誌である「インサイド・US・トレード」誌 Inside US Trade に対して次のように述べている。「私は、アメリカ合州国が自らの立場を変更するという兆候を、いささかも見いだしていない」。
製薬業界は、新薬開発の研究に年間数十億ドルを費やしており、もしコピー薬製造業者がこれらの企業のもつ特許を無視して安い値段で医薬品を製造すれば、新薬研究は不可能になってしまうと主張している。
しかし、貧困国を代弁して働きかけを行っている援助団体などは、廉価な治療薬は先進国において販売されている値段で治療薬を買うことができない国々においてのみ販売されるはずであると指摘する。彼らは、ホワイトハウスが米国の巨大製薬企業の道具となっていると批判する。
アメリカ合州国のロビー団体である「技術に関する消費者プロジェクト」Consumer Project on Technology のジェイミー・ラブ Jamie Love は、「今朝、ジュネーブでこんなジョークが飛ばされていたよ。『メルク Merck とファイザー Pfizer (いずれも多国籍製薬企業)の最高経営責任者たちがまだ寝ているから、米国はまだ意志決定が出来ないんだよ』」と述べた。「ジョージ・ブッシュは、自分の子どもたちが治療を受けることができる病気について、貧しい国の貧しい子どもたちについては立入禁止とする、と主張しているんだ」
製薬企業は、HIV/AIDSを除いては、アメリカ合州国が示している短いリストに掲載された病気についてほとんど研究を行っていない。アメリカ合州国は、先進国に劣らず途上国でも人々の命を奪っている癌、喘息、肺炎などの疾病を、対象疾患からはずしている。
「製薬企業は、自分たちの利益になる病気に関しては対象に含めない、という論議をしている」とジェイミー・ラブは述べた。
廉価な治療薬に関する協議は、途上国が、アメリカ合州国およびヨーロッパ連合の要請によって一年前に開始されたWTO新ラウンド交渉に参加し続ける上で不可欠な課題であるとみなされている。(了)
◆米国、貧困国から薬を取り上げようとして一歩後退
Wall Street Journal 23 December 2002
Health; U.S. Retreats From Earlier Move To Keep Drugs From Poor Nations
By MICHAEL M. PHILLIPS, Staff Reporter of THE WALL STREET JOURNAL
UNAIDS配信の Today's Top News (24.12.02)から標記のウォール・ストリート・ジャーナルの記事を訳して紹介します。
米国の新聞記事ですから、米政府が失った道義的な威信を問題にしています。最後は米国が全面に立ったおかげで米国に追従した日本の問題が目立ちませんが、昨年のドーハでは炭疽菌治療薬のコンパルソリー・ライセンス問題で米国が先に一歩引いた後、最強硬派として振る舞ったのがスイスと日本だったことを忘れるわけにはいきません。
(斉藤 龍一郎)