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Note: This document is from the archive of the Africa Policy E-Journal, published by the Africa Policy Information Center (APIC) from 1995 to 2001 and by Africa Action from 2001 to 2003. APIC was merged into Africa Action in 2001. Please note that many outdated links in this archived document may not work.


Africa: Backsliding on Trade & Health Africa: Backsliding on Trade & Health
Date distributed (ymd): 021216
Document reposted by Africa Action

Africa Policy Electronic Distribution List: an information service provided by AFRICA ACTION (incorporating the Africa Policy Information Center, The Africa Fund, and the American Committee on Africa). Find more information for action for Africa at http://www.africaaction.org

+++++++++++++++++++++Document Profile+++++++++++++++++++++

Region: Continent-Wide
Issue Areas: +health+ +economy/development+ +security/peace+ +US policy focus+

SUMMARY CONTENTS:

Access to affordable generic medicines is essential to enable African and other developing countries to confront the HIV/AIDS pandemic, malaria, tuberculosis, and other urgent health needs. Yet in talks in Geneva rich countries, led by the USA, have blocked implentation of last year's Doha Declaration that public health needs take priority over restrictive patent legislation. In Nigeria, meanwhile, health activists succeeded in revising draft legislation to protect the right to affordable medicine. These trade issues are cloaked in complex language, but their outcome is a matter of life and death. This posting contains several of the more readable articles we have found summing up the current status, as well as links to additional resources.

+++++++++++++++++end profile++++++++++++++++++++++++++++++

Africa Action Note

Today's postings are the last for this year on the Africa Policy List. We will resume in the second week of January. Our best wishes to our readers for a safe holiday season and for strength for struggles for peace and justice in the new year.

To support our continued work with an on-line contribution, or to print out a contribution form, go to:
http://www.africaaction.org/join.htm


Last-Minute Update - Dec. 16, 2002

The letter below was received too late to include in this posting. Africa Action has signed on to the letter, and encourages other groups to do so. If you are reading this after the deadline for group sign-on has passed, please send your own communication directly to U.S. Trade Representative Robert Zoellick. Despite the end-of-year deadline, this issue will continue to be critical until promises of greater access to generic drugs become reality rather than rhetoric.

Sign-On Letter to U.S. Trade Representative on access to generic drugs for affordable treatemnt

Email your endorsements, including name, organization, and location (city, state) to: asia@critpath.org (Asia Russell) The deadline for endorsement is: 5 PM EST Thursday, December 19.

16 Dec 2002 12:45:04 -0500 (EST)

Subject: (sign on:) US org letter on WTO, para 6 negotiations

Dear Friends,

There are crucial negotiations happening at the World Trade Organization (WTO) this week regarding the TRIPS Agreement, public health, and access to medicines and your help is urgently needed.

Despite having made a promise last year at the 4th WTO Ministerial Conference in Doha, Qatar, to uphold the right of countries to protect public health and promote access to medicines for all, the United States Trade Representative (USTR)--with the support of the pharmaceutical industry--is now leading the effort to push through a disastrous "solution" to the problems developing countries face in making use of provisions in the TRIPS Agreement that allow for the production and export of affordable essential medicines. The U.S. negotiating proposals are so narrow and so restrictive as to be worse than having no solution at all.

Because the WTO is charged with solving this problem by the end of 2002, the last two weeks of the year will include intense pressure from the USTR and from the U.S. pharmaceutical industry. Your help is needed to secure a solution at the WTO that meets the needs of poor people who are suffering and dying without access to medicines.

We need your help to send a message to the USTR that organizations in the United States don't support their negotiating position.

We urge you to review the letter below and then provide your organizational endorsement.

Please give us your: Organization name, Organization, location (City, State)

email your endorsements to: asia@critpath.org (Asia Russell)

The deadline for endorsement is: 5 PM EST Thursday, December 19.

Additional information about this issue is available at:

http://www.cptech.org/ip/wto/p6
http://www.accessmed-msf.org/index.asp
http://www.healthgap.org/camp/trade.html

Sincerely,

Rachel M. Cohen, Doctors Without Borders/Medecins Sans Frontieres (MSF)
New York, NY

Asia Russell, Health GAP Philadelphia, PA

----------

The Honorable Robert B. Zoellick
United States Trade Representative
600 17th St., N.W. Washington D.C., 20508

Re: WTO negotiations on public health and TRIPS

Dear Ambassador Zoellick,

We, the undersigned, are gravely concerned by the current status of World Trade Organization (WTO) negotiations on paragraph 6 of the Ministerial Declaration on the TRIPS Agreement and Public Health (¦Doha Declaration¦), related to the production and export of essential medicines.

We are concerned in particular by the position of the U.S. delegation, as we feel it is inconsistent with the commitment the U.S. made, along with all other members of the WTO, when it adopted the Doha Declaration just over one year ago. U.S. negotiators are pressuring members of the WTO to agree to a narrow and burdensome solution that in practice would be worse than no solution at all.

The WTO was charged with producing a solution to the problem expressed in paragraph 6 of the Doha Declaration, which states that:

"6. We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002."

These negotiations should be guided by the needs and interests of poor people who are suffering without access to medicines, and by the Doha Declaration itself, which states 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.¦

The following are the fundamental components of a solution that would uphold that right:

1. No restrictions on diseases A workable solution must not be restricted to medicines used in the treatment of AIDS, tuberculosis and malaria. While there is no doubt that these epidemics are ravaging developing countries, they cannot be considered the sole public health threats in poor regions--either now or in the future. Furthermore, the WTO is not the appropriate forum for determining sovereign countries' public health priorities and needs.

2. No exclusion of vaccines and other medical technologies Vaccines, diagnostics, and monitoring tests are important medical technologies for developing countries. They should not be excluded from any solution.

3. No restriction of beneficiary countries While sub-Saharan Africa is in particularly acute need of increased access to medicines, it should not be the only region to benefit from a solution. Arbitrary restrictions based on economic criteria are unnecessary and will only serve to undermine efforts to protect public health.

4. No overly burdensome "safeguards" Low-cost medicines intended for consumption in poor countries should not be diverted to wealthy country markets. However, any system of safeguarding against such diversion should not put too heavy a burden on developing countries, and should not be so burdensome as to counter to the goal of the system itself to broaden access to affordable medicines.

5. The mechanism must be workable and must not include overly burdensome procedural requirements A mechanism that will require, for example, multiple compulsory licenses, long delays, and substantial administrative burden will only perpetuate distortions in WTO intellectual property rules, rather than creating a fair system where the potential public health benefits of compulsory licensing of medicines can be enjoyed by all WTO Members.

We support the position of the World Health Organization, as stated during the WTO Council on TRIPS (September 17, 2002) that a limited exception under Article 30 is the most consistent with the public health principle stated in the Doha Declaration. An Article 30 solution will give WTO Members expeditious authorization, as requested by the Doha Declaration, to permit suppliers to export medicines for unmet public health needs to an importing country issuing a compulsory license for that product or to a country where no competing patent is on file.

We call on you to uphold the promises you made in Doha, abandon efforts to restrict the scope of the solution to the problem outlined in paragraph 6 of the Doha Declaration, and to accept the recommendations above as fundamental elements of any solution you agree to. This is a matter of life and death for millions of people in need of access to medicines throughout the world.

Sincerely,

Asia Russell
ACT UP Philadelphia Health GAP
asia@critpath.org
1 215 474 9329 office, 1 267 475 2645 mobile


Lancet http://www.thelancet.com
14 December 2002

No agreement reached in talks on access to cheap drugs

At a meeting on Nov 25-27 in Geneva, Switzerland, the Council for the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) was expected to finalise a plan that would enable generic drug manufacturers in countries such as Brazil, India, and China to export drugs still under patent, under certain circumstances, to countries with little or no manufacturing industry. Instead the TRIPs Council meeting, which followed a "mini-ministerial" meeting held earlier in November (see Lancet 2002; 360: 1670), ended without any prospect of reaching agreement.

During the meeting the USA, Japan, and Canada argued in favour of the introduction of a temporary waiver against bringing disputes to the WTO if the case concerns generics that are to be imported to the least developed countries. Other countries, particularly developing countries, supported by groups such as Oxfam and MTdecins Sans FrontiFres, preferred a permanent amendment of TRIPs. This, they suggested, would offer certainty to all parties and an encouragement to manufacturers of generics to gear up for larger-scale production.

At present, a WTO agreement interpreting TRIPs, known as the "Doha Declaration", allows countries to issue compulsory licences during national emergencies such as HIV/AIDS, malaria, tuberculosis, and other epidemics. In these circumstances, a local third-party manufacturer may produce the necessary drugs for domestic use and reasonable compensation must be paid to the patent holder.

At the meeting, the USA attempted to limit the diseases that might be covered by the new agreement to HIV/AIDS, tuberculosis, and malaria, and "other infectious epidemics of comparable gravity and scale that may arise in the future". This restrictive language was not acceptable to other members, however. Disagreement also arose at the meeting as to what might constitute reasonable compensation and who might be liable to pay it.

The USA further endeavoured to limit the number of countries that might benefit from the importation of cheaper generic versions of patented drugs. The Council agreed that the 49 least developed countries should be automatically entitled to benefit, but no agreement was reached on the extension of this to other developing countries. Developing countries rejected this division.

The US position is undoubtedly in line with the desires of industry. A letter dated 25 Nov, 2002, from 20 pharmaceutical companies to the US Trade Representative, Robert Zoellick, states: "An open-ended or unclear exception to the standards for patent protection would seriously undermine our interest and set back the long-term public health objectives Doha was designed to achieve. We urge you to negotiate a solution that is specifically limited to the diseases that were the focus of the Doha Declaration, namely HIV/AIDS, TB and malaria and other epidemics of similar scale. In addition, it should be clear that only truly disadvantaged countries in sub-Saharan Africa, be the recipient of the changed rules." - Bebe Loff


http://www.twnside.org.sg/title/5246a.htm

TRIPS consultations on implementing Doha recessed

[brief excerpts only; for full text see link]

Geneva, 29 Nov (Chakravarthi Raghavan) -

... The African position was set out in a statement at the TRIPS Council by Kenya on behalf of the group, and received the support of other developing countries from Asia and Latin America. "If discussions continue on the same lines as has been conducted to date, then it is unlikely that a desired solution will be forthcoming, particularly one meant to address the public health problems afflicting Africa," said the Kenyan Ambassador Ms Amina Chawahir Mohammad at the meeting of the TRIPS Council Friday afternoon in a statement for the African Group.

The decision of the African group was reached after an assessment by them in the light of the US moves to restrict the scope of any decision to implement para 6 of the Doha declaration to epidemics as a result of three specific diseases (HIV/AIDS, TB and Malaria), Japan's call to exclude 'vaccines', and the EC's to place severe restrictions on suppliers and exporters of generic pharmaceuticals in developing countries.

Though the positions of these three, and of Canada and Switzerland, seemed different, trade diplomats of developing countries said that in effect, they were each defending and promoting one or the other particular interests of the big pharmaceutical TNCs, and together making sure that the Doha declaration about available flexibilities cannot be implemented.

...

With the US trying to limit the recourse to the three specific diseases, Japan trying to exclude 'vaccines', and the EC placing such restrictions that no developing country generic producers would supply or export to other countries, the African group decided to call a halt. ...

The Kenyan ambassador said: "... some of the proposals (in the Motta text of 24 November) appear to be replacing the Declaration and adding extra obligations on members instead of addressing the difficulties identified in paragraph 6. For instance we have spent a lot of our time in defining the scope and coverage of diseases and products while the Declaration is very clear on this. Similarly we have laboured on defining which member qualifies to benefit from the solution, yet paragraph 6 of the Declaration is definite enough. And frankly, we appear to be getting nowhere on the issue of technology transfer and domestic markets, as well as the main approach to adopting the solution."

...

"Due to the foregoing," the Kenyan envoy said, "the African Group is disappointed and frustrated by the progress made so far. The Group feels that if discussions continue on the same line as they have been conducted to date, then it is unlikely that the desired solution will be forthcoming, particularly one meant to address the public health problems afflicting Africa.

"Members may wish to seriously reflect on the reasons why the African Group raised this issue in the TRIPS Council prior to Doha and their subsequent expectations after Doha as stated in various communications to the TRIPS Council. This will probably give them a better understanding of the nature of the solution Africa expects." ...

Trade diplomats and observers said that they expect the US and the EC to try and apply more pressures in the African capitals to get their way.

After attempting to divide the developing countries as between Africans and the Asians and Latin Americans, the majors in recent days also sought to divide the Africans themselves, and all this has now become counter-productive. ...


CBC (Canadian Broadcasting Corporation) Radio One 3 December 2002

http://cbc.ca/insite/COMMENTARY/2002/12/3.html

Transcript: Commentary on Patents / Generic Drugs

Introduction:

The latest round of talks on drug patents is deadlocked at the World Trade Organization. At issue: what access should poor nations have to cheaper generic drugs. Richard Elliott is a lawyer for Canada's HIV/AIDs Legal Network. On Commentary he says Canada should change its position.

Richard Elliott:

The World Health Organization estimates one-third of the world's people lack access to essential medicines. Last week, the U reported that 42 million people around the world have HIV. Most live in developing countries, with no access to affordable medicines.

One factor is the high cost of drugs protected by patents, which give the patent-holder a monopoly on making or selling the drug. Access to cheaper, generic drugs would make the limited health care budgets of developing countries go further.

One way to achieve this is compulsory licensing - breaking patent monopolies by authorizing another company to make a generic version, with payment of a royalty to the patent-holder. Industrialized countries have used this approach. Last year, during the anthrax scare, the US and Canada threatened to break the patent on the drug ciprofloxacin. In response, the company holding the patent agreed to reduce its price.

Brazil, a developing country, can provide free treatment to over 100 thousand people with HIV because government labs currently manufacture several drugs not under patent in Brazil. In the case of patented drugs, Brazil can credibly threaten to issue compulsory licenses, leading drug companies to lower their prices.

But most developing countries cannot use compulsory licensing, because they lack this capacity to make their own drugs. So, they must import them from a country that can manufacture. And where the drug is under patent in that country, a compulsory license will likely be needed in order to produce generic drugs for export.

Enter the World Trade Organization and the hypocrisy of some industrialized countries.

The WTO's patent treaty says compulsory licenses may only be used "predominantly" for supplying the domestic market of the country issuing the license. This severely restricts the production of generic drugs for export to developing countries. A year ago, trade ministers at the WTO agreed to solve this problem by the end of this year.

But negotiations stalled last week because wealthy countries such as the US, the European Union, Switzerland, Japan - and Canada - insisted on unacceptable limits. They want to restrict any solution to a handful of diseases such as HIV/AIDS or other "pandemics". But what about cancer or dengue fever or river blindness or a host of other illnesses? Why should wealthy countries, who are ready to circumvent patents for a few anthrax cases, dictate to poor countries the diseases for which they can get generics? This is hypocrisy of the highest order and with deadly consequences.

The government's recent Speech from the Throne declared that Canada "will contribute to reducing the global divide between rich and poor." The Prime Minister should instruct his trade officials to stop imposing double standards at the WTO. Canada's current stance belies its professed concern for the welfare of the developing world.

For Commentary, I'm Richard Elliott in Toronto.

Richard Elliott
Director, Policy & Research / Directeur, politiques et recherche Canadian HIV/AIDS Legal Network /
Reseau juridique canadien VIH/SIDA
890 Yonge Street, Suite 700, Toronto, Canada M4W 3P4
Tel : +1 (416) 595-1666 Fax +1 (416) 595-0094
E-mail: relliott@aidslaw.ca
Web: http://www.aidslaw.ca

The Canadian HIV/AIDS Legal Network is a partner organisation of the AIDS Law Project of South Africa. -- Le Reseau juridique canadien VIH/SIDA est un organisme partenaire du AIDS Law Project de l''Afrique du Sud.


IP bill:Advocates win provisions for public health

November 26, 2002

By Olayide Akanni
Email: larayide@yahoo.co.uk
Nigeria-AIDS eForum

[To subscribe, send a blank email to:
subscribe-eForum@nigeria-aids.org
View message archives at http://www.nigeria-aids.org/eforum.cfm

The Nigeria-AIDS eForum is a project of Journalists Against AIDS (JAAIDS) Nigeria. http://www.nigeria-aids.org]

A meeting to revise final drafts of an Intellectual Property (IP) bill for Nigeria ended in Abuja last Friday, with health advocates winning vital clauses that would protect right of Nigerians to access to cheap and affordable treatment.

The new bill is being drafted in compliance with the Agreements on Trade-Related Aspects of Intellectual Property Rights (TRIPS), to which Nigeria is a signatory. The Abuja meeting was particularly important as it made final decisions on the draft bill, which will, among other things, regulate mechanisms for access to affordable medicines by the Nigerian government in public health emergencies, such as HIV/AIDS.

Jointly organized by the Commercial Law Development Programme of the United States Department of Commerce, the federal ministry of commerce, the Nigerian Copyright Commission, National Office of Technology Acquisition and Promotion (NOTAP) and the Nigerian Intellectual Property Bar, the meeting was funded by the US Agency for International Development.

Extensive deliberations over the three-day meeting, which held at the Nicon Hilton Hotel, resulted in the inclusion and simplification of important language in the bill, relating to safeguards for the protection of public health.

The bill now includes stronger provisions authorizing the implementation of health safe guards such as compulsory licensing, parallel importation and Bolar exceptions, recommended under TRIPS.

The provisions were not won easily however. Critical civil society groups in Nigeria had been excluded from preparations for the meeting and only became aware of its importance barely a week to the event. Health advocates, under the platform of the Treatment Action Campaign (TAM) - a coalition of civil society groups working in the area of HIV/AIDS treatment and care - had immediately protested to organizers about their non-inclusion and demanded for an invitation to participate at the Abuja meeting. TAM members also circulated press statements and called a press conference in Abuja on the eve of the meeting to register their displeasure over noninvolvement of treatment groups in such and important policy-making process.

The activists argued that the absence of input especially of people living with HIV/AIDS (PLWHA) in the drafting process could likely jeopardize the on-going national antiretroviral (ARV) treatment programme, particularly if important health safeguards such as Bolar exceptions, compulsory licensing and parallel importation are not explicitly included in the bill.

Following the protests, seven representatives of TAM were able to fully participate in the meeting. The representatives were Mohammed Farouk, Rolake Nwagwu and Mary Ashie (AIDS Alliance in Nigeria), Obatunde Oladapo (Positive Life Association of Nigeria), Ebenezer Durojaye and Ifeanyi Okekearu (Centre for the Right to Health) and Olayide Akanni (Journalists Against AIDS Nigeria). Dr. Nasir Sani-Gwarzo of the federal ministry of health and Dr. Jerome Mafeni of Policy Project/Nigeria also attended the three-day meeting.

Delegates attending the workshop were drafted into three working groups and were expected to review and make final recommendations on corrections made in an earlier draft of the bill developed at a meeting last April. The working group on Patents and Designs dealt with the sections containing the health safeguards and many of the health advocates attending the meeting naturally gravitated towards that group.

Reviewing the draft bill, the advocates found out that many of its provisions concerning the health safeguards were confusing and not expressed in clear language. After extensive deliberations, participants were able to come up with clearer working language for the draft sections of the proposed Patent and Industrial Designs Act.

Some of the mechanisms now included in the draft bill were: the setting-up of an administrative procedure which will govern the issuance of compulsory licensing, extension of authority to issue a compulsory license to health commissioners, and the deletion of confusing clauses in the provisions under parallel importation.

The reviewed draft IP bill is to be presented to the Ministries of Commerce and Justice before its passage to the National Assembly and eventual enactment into law.

Members of TAM have pledged to follow the progress of the draft bill through these various stages in order to ensure that the IP Act that would be passed into law by the national assembly truly reflects the full interests of public health.


Additional Current Documents

Patents, Pills and Public Health - Can TRIPS Deliver? Panos Institute, December 2002
http://www.panos.org.uk
Includes section on "Access to unpatented medicines in Nigeria"

Commission on Intellectual Property Rights
(Independent commission set up by British government) Final Report, September 2002
http://www.iprcommission.org
Report finds intellectual property rights impose costs on most developing countries and do not help to reduce poverty.

Consumer Project on Technology
Page on Patent Exception for Exports to Address Health Needs http://www.cptech.org/ip/wto/p6/
Comprehensive documentation on negotiations. Includes details on U.S. unsuccesfull attempts to bully African countries into agreeing to U.S. position, and statements by CPTech, Oxfam, Third World Network, Medecins sans Frontieres

Pharma's Relentless Drive for Profits Explains U.S. Trade Negotiations
Professor Brook K. Baker, Health GAP, December 10, 2002 http://lists.essential.org/pipermail/ip-health/2002-December/003831.html


This material is being reposted for wider distribution by Africa Action (incorporating the Africa Policy Information Center, The Africa Fund, and the American Committee on Africa). Africa Action's information services provide accessible information and analysis in order to promote U.S. and international policies toward Africa that advance economic, political and social justice and the full spectrum of human rights.

URL for this file: http://www.africafocus.org/docs02/acc0212.php