[Peace-discuss] Fwd: Africa: Contested Compromise on Generic Drugs

[Alfred Kagan]

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>Date: Wed, 3 Sep 2003 20:40:56 -0500
>Subject: Africa: Contested Compromise on Generic Drugs
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>AFRICA ACTION
>Africa Policy E-Journal
>September 3, 2003 (030903)
>                    
>Africa: Contested Compromise on Generic Drugs
>(Reposted from sources cited below)
>
>A last-minute World Trade Organization compromise in Geneva on
>intellectual property protection and access to medicines is being
>heralded by some as finally opening the doors to imports of generic
>medicines by poor countries without a manufacturing capability. In
>intense negotiations in recent months, the U.S. reached behind-the-
>scenes agreements with key countries such as Brazil, India, South
>Africa, and Kenya. The U.S. and the international pharmaceutical
>industry made some concessions after blocking an agreement for
>almost two years. However, the compromise also imposes extremely
>complicated procedures designed to protect patent rights, which
>leave enormous obstacles to overcome before affordable medicines
>are actually made available.
>
>The World Health Organization and treatment access activists stress
>that the real test will be whether affected countries and
>international agencies take full advantage of their right to put
>public health before patent rights. In a speech in Johannesburg on
>September 1, Dr. Lee Jong-wook, Director-General of the World
>Health Organization (WHO), proposed a response strategy called "3
>by 5" which aims to provide 3 million people living with AIDS with
>antiretroviral medicines by the end of 2005. For this to happen,
>rich countries would also have to provide new financial resources
>for expanded purchase of generic drugs. UNAIDS estimates that
>approximately 480,000 people could be treated immediately if
>resources were available, such as through additional funding for
>the Global Fund to Fight AIDS, TB, and Malaria.
>
>This posting contains several statements and background analyses on
>the decision, which came less than two weeks before the beginning
>of the World Trade Organization ministerial summit in Cancun, Mexico.
>
>Additional related resources:
>
>(1) New York Times, September 3, 2003
>"African HIV/AIDS Patients Show Better Adherence to Antiretroviral
>Drug Regimens Than U.S. Counterparts"
>http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=19
>651 [type URL on one line or go to http://www.nytimes.com for full
>story]
>
>(2) Doha Derailed: A Progress Report on TRIPS and Access to
>Medicines - Medecins sans Frontieres, August 2003
>http://www.accessmed-msf.org/documents/cancunbriefing.pdf
>
>+++++++++++++++++end summary/introduction+++++++++++++++++++++++
>
>(1) World Trade Organization Statements - August 30, 2003
>
>DECISION REMOVES FINAL PATENT OBSTACLE TO CHEAP DRUG IMPORTS
>
>WTO member governments broke their deadlock over intellectual
>property protection and public health today (30 August 2003).
>They agreed on legal changes that will make it easier for poorer
>countries to import cheaper generics made under compulsory
>licensing if they are unable to manufacture the medicines
>themselves.
>
>Press release:
>http://www.wto.org/english/news_e/pres03_e/pr350_e.htm
>
>Decision on implementation of paragraph 6 of the Doha Declaration
>on the TRIPS Agreement and public health:
>http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm
>[full 6-page decision with 11 points and 9 notes]
>
>**************************************************************
>
>World Health Organization http://www.who.int
>
>Statement of the World Health Organization on WTO access to
>medicines decision
>
>1 September 2003 -- The World Health Organization (WHO) is
>encouraged by the consensus reached by Members of the World Trade
>Organization (WTO) on the issue of access to medicines by
>countries with little or insufficient capacity for pharmaceutical
>production.
>
>The agreement covers all medicines. Among the diseases that could
>be more effectively tackled as a result of this decision are
>AIDS, tuberculosis and malaria.
>
>WHO will work with the countries which could make use of the new
>arrangements to assist them to achieve the full public health
>benefit from the lower prices. Given the urgency of the health
>needs in the poorest countries, the work to implement this
>agreement must proceed as quickly as possible. The full impact of
>the agreement will depend on how effectively it can be
>implemented in countries.
>
>For the agreement to have the intended impact on public health,
>countries will need to review the full range of medicines
>required from multiple suppliers, including generic producers,
>when making purchasing decisions.
>
>WHO continues to urge Member States to consider using to the full
>the TRIPS flexibilities with regard to the protection of public
>health.
>
>For more information contact:
>
>Daniela Bagozzi
>Telephone: +41 22 791 4544
>Email: bagozzid at who.int <mailto:bagozzid at who.int>
>
>Iain Simpson
>Telephone: +41 22 791 3215
>Email: simpsoni at who.int <mailto:simpsoni at who.int>
>
>Melinda Henry
>Telephone: +41 (22) 791 2535
>Email: henrym at who.int <mailto:henrym at who.int>
>
>***************************************************************
>
>(3) Oxfam Statement
>
>Oxfam: WTO patent rules will still deny medicines to the poor
>
>August 30, 2003
>
>After two years of intense wrangling, the World Trade
>Organisation (WTO) appears to have reached an agreement on drug
>patents.
>
>The deal was apparently brokered tonight at an informal meeting
>and could be officially confirmed tomorrow morning. If this deal
>is confirmed, the result would be a severe disappointment, says
>international agency, Oxfam.
>
>It was hoped that the deal would secure developing countries
>greater access to low-cost copies of medicines. But thanks to the
>intransigence of the US and pharmaceutical giants, poor countries
>would still not have the same legal rights to affordable
>medicines as industrialised countries.
>
>Oxfam's Head of Advocacy in Geneva, Celine Charveriat said: "If
>agreed by the WTO, developed countries will trumpet this change
>to WTO patent rules as a big concession, but the proposed deal is
>largely cosmetic and will not make a significant difference to
>the millions of sick people who die unnecessarily in the Third
>World every year."
>
>Developing countries successfully stopped the US and the
>pharmaceutical lobby from excluding many diseases from the deal -
>an important achievement.  However, the proposed deal still
>contains serious flaws. No matter how desperate the health need,
>a developing country without the capacity to produce a needed
>drug (which is virtually all of them) will have to ask another
>government to suspend the relevant patent and license a local
>company to produce and export it.  Few countries, if any, will be
>prepared to help other countries in this way, as it would provoke
>retaliation by the US which fiercely defends the commercial
>interests of the pharmaceutical corporations.
>
>Furthermore, the agreement is wrapped in so much red tape that it
>becomes largely unworkable - it amends a clause of only 20 words,
>yet runs to more than seven whole pages. In practice, most poor
>countries will end up paying the high price for patented
>medicines or, most probably, doing without.
>
>The change in patent rules was promised by the WTO Ministerial
>Conference in Doha in 2001 in its landmark Declaration on TRIPS
>and Public Health.
>
>Charveriat added: "If confirmed, the deal would be a betrayal of
>the pledge made in the Doha Declaration to put public health
>before patent rights.  It is profoundly unfair to create fresh
>legal obstacles for developing countries trying to obtain
>affordable generic medicines, purely in the interests of an
>industry that in the US alone made US$37 billion in profit last
>year. This decision would raise questions about who really makes
>policy in the WTO, and is a bad omen for the upcoming WTO summit
>in Cancun".
>
>The international agency insisted that if the deal goes ahead it
>would not put a stop to efforts by developing countries and
>pressure groups to build on the important gains of recent years,
>such as the Doha Declaration and the reductions in the price of
>AIDS drugs.  Indeed, this outcome would strengthen the need for a
>thorough revision of the TRIPS Agreement with a view to taking
>developing countries out of the TRIPS straightjacket altogether.
>
>Ends
>
>For more information please contact Amy Barry in Oxfam's press
>office on 0044-7980664397 or abarry at oxfam.org.uk or Celine
>Charveriat in the Geneva office at 0041-79-668-6477.
>
>**************************************************************
>
>(4) Healthgap Background Analysis 
>HealthGap Listserv (sign-up at http://www.healthgap.org)
>
>The incredible shrinking Doha Declaration
>
>Brook K. Baker, Health GAP, August 26, 2003
>
>With the new Chairman's Statement on Paragraph 6, dated August
>21, 2003, it is easy to discern the U.S.'s latest plan to shrink
>the Doha Declaration to a totally ineffectual platitude with no
>real capacity to deliver cheaper, standard-quality generic
>medicines to countries that lack the same capacity to produce
>medicines efficiently as the U.S. does.  In essence, the U.S. has
>engaged in a two-part squeeze play creating "the incredible
>shrinking Doha Declaration."
>
>On one end of the vise, the U.S. has tried to limit countries
>that are permitted to import generic medicines pursuant to a
>compulsory license to address a public health need in four ways.
>First, the U.S. brokered an absolute agreement from 23 relatively
>rich countries that they would not issue compulsory licenses for
>importation under any circumstances. Obviously, many of these
>countries are large enough and have sufficiently robust generic
>industries to issue a compulsory license for domestic production.
>But still the U.S. has succeeded in shrinking the richest part of
>the international market, essentially engaging in protectionism
>at a historic level.  Second, the U.S. convinced some other,
>generally smaller or poorer countries (12 in all [note:  China was
>listed twice!]) to agree to issue compulsory licenses for import
>only in order to address national emergencies or other
>circumstances of extreme urgency.  Another piece of the potential
>market for generic medicines was thereby lopped off, certainly
>including some countries that don't need to import (China) but also
>including countries that have no domestic capacity whatsoever
>(Qatar).Third, the U.S., and presumably the E.U., forced the E.U.
>accession countries, 10 in all, to import only on an emergency or
>urgency basis and to relinquish even this right upon accession into
>the E.U.  This will certainly have a devastating impact on the
>costs of medicines in some very poor Eastern European countries,
>including some that are facing an escalating HIV/AIDS crisis.
>
>To this total of 45 countries that have expressly relinquished
>their sovereign right to import generic medicines for public
>health purposes pursuant to a compulsory license, the U.S. has
>imposed a fourth condition that threatens importation for many
>other middle-income developing countries.  Basically, the U.S. has
>set up a notification-and-review process whereby countries that say
>that they need to import generics because of incapacity in their
>pharmaceutical sector will be forced to prove and then defend
>such determinations.  The standard for proving "insufficient
>capacity" is already terribly uncertain.  Accordingly, the
>reporting-and-review process will, as a practical matter, deter
>countries from risking involvement in a damaging and costly WTO
>dispute resolution process simply because they could import
>generic medicines much more cheaply than they could produce them at
>home. This prove-and-review standard doesn't name countries, but it
>will certainly have a deterrent effect on countries which might try
>to import cheaper generics.
>
>Accordingly, this demand-end of the vise is designed to
>dramatically shrink the potential market for generic drugs and to
>exclude virtually all markets with meaningful and stable
>purchasing power.
>
>At the other end of the vise, the supply end, the U.S. is trying
>to dramatically increase the risks and costs of producing generic
>medicines for export.  In part, the risk factors for generic
>producers include the shrinking markets mentioned above.  In
>particular, generic producers will be uncertain whether a
>particular country has properly determined that it lacks
>sufficient pharmaceutical capacity or that there is a public health
>emergency - a decision that can not only be reviewed in the WTO,
>but a decision that might prompt a lawsuit by a patent-holder.
>
>Moreover, the U.S. is also adding to the direct costs of
>manufacturing generic medicines by its overly stringent
>anti-diversion standards, which should more accurately be called
>bloated-pricing standards.  As amply described by DG Shah's
>Comments on the draft Chairman Statement, varying pill size,
>shape, and color is not cost-free, particularly when moving from
>round, white tablets or capsules.  Although there may well be some
>sense in not using a proprietary name (a trade mark infringement)
>or the  same packaging, there is virtually no sense in adding
>dramatically to costs (and potential bio-availablity) by changing
>size and shape.  This added and unnecessary cost burden is
>especially eggregious, as DG Shah points out, when you might have
>to change trade dress, size and shape for multiple small markets.
>
>Shrink the market, increase costs, and add burdensome procedural
>requirements - is that the simple and efficient solution promised
>at Doha? The answer is obviously no.  And the answer is no
>because the U.S. remains more committed to maximizing profits for
>the most profitable industry in the world, Big Pharma, than it is
>to the million of lives at stake.
>
>Activists are accused of rhetorical excess when we talk about
>trade barriers, intellectual property barriers, and lives hanging
>in the balance. To bureaucrats in the USTR these lives are
>literally and casually traded for profit - profit for the
>pharmaceutical puppet masters who hide behind the scene and pull
>the strings. Unfortunately, for reasons that cannot be fathomed,
>certain developing countries, including some in leadership
>positions and that face escalting public health dilemmas, are
>content to trade their citizens' health for minor reductions in
>farm export subsidizies or for temporary access to textile markets
>(before an even cheaper producer arrives on the scene).  In other
>words, the responsibility for the incredible shrinking Doha
>Declaration certainly rests primarily with the U.S. (and
>secondarily with the E.U. and Japan), but developing countries are
>becoming complicit in their own destruction.
>
>When unified in the aftermath of the Anthrax scare, developing
>countries succeeded in overpowering the U.S. bully-boys and
>producing the Doha Declaration.  Now, they are letting the
>world's biggest bully talk them and conditionalize them to death.
>Not only should they reject the Chairman's draft statement, they
>should reject the Motta text of December 2002.  It too contained
>too many compromises of vital interests.  Developing countries
>would do better to rely on the text of the Doha Declaration and the
>flexibilities of the TRIPS Agreement.  Then willing generic
>producers could export under Article 30 (permitting limited
>exceptions to patent rights) to willing importers that have
>issued compulsory licenses.  People living with diseases need a
>full-size, fully operational Doha Declaration, not a shrunken pale
>imitation ghost-written by the U.S. pharmaceutical industry.
>
>************************************************************
>
>(5) Statement from Consumer Project on Technology
>
>CPTech Statement on WTO deal on exports of medicines
>
>August 30, 2003
>
>James Love (home +1.703.522.4380, cell +1.202.361.3040, work
>+1.202.387.8030, james.love at cptech.org). 
>Consumer Project on Technology
>http://www.cptech.org/ip/health
>
>"Today's decision on the implementation of paragraph 6 of the
>Doha Declaration on TRIPS and Public Health puts the WTO into
>unchartered  waters.  The WTO secretariat, the TRIPS Council and
>the Chair of the  TRIPS council will now begin to routinely
>review the issuance of  individual licenses, and the WTO will now
>as a matter of expected  practice, oversee the use of compulsory
>licensing in the most intimate  terms, looking at the terms of
>individual licenses, evaluating the basis  for deciding
>manufacturing capacity is insufficient, or reviewing or  second
>guessing any of the new terms and obligations that the new
>implementation language introduces into the regulation of
>compulsory  licensing of patents on medicines. 
>
>The persons who have negotiated this agreement have given the
>world a new model for explicitly endorsing  protectionism.  The
>United States, Europe, Canada, Australia, Japan and  other
>developed economies will be allowed to bar imports from developing
>country generic suppliers -- under completely irrational
>protectionist measures that are defended by the WTO Secretariat and
>its most powerful  members as a humanitarian gesture.
>
>"The European Commission's DG-Trade has engineered this agreement
>as an  attack on a position endorsed by its own parliament that
>was a far more  elegant and rational solution to the export issue.
>
>The EU Parliament  Amendment 196 was 52 words.  The new WTO deal
>is more than 3,200 words.  The extra 3,150 words were not needed
>and will create a morass of  uncertainty and gamesmanship.  The new
>deal will predictably be used to  prejudice other more useful
>export strategies under Articles 30 or 31.k  of the TRIPS
>agreement.
>
>"The new agreement has very modest benefits, and it has very
>substantial costs, risks and uncertainties.
>
>"On the positive side, the new agreement completely rejects the
>efforts  of the US, Japan, the European Union and the WTO
>Secretariat to limit  the scope of diseases for compulsory
>licensing, and it also does not  require high standards such as
>epidemics or emergencies.  Routine public health problems can be
>addressed in the new agreement.   The developing  countries did
>hold the line on this, under enormous pressure from major
>pharmaceutical companies and the trade delegates who lobby on
>behalf of  the biggest pharmaceutical companies.
>
>"The next step for public health activists will be to be more
>pro-active  on trade and public health, both locally and
>globally Locally it is  now time for countries to give effect to
>paragraph 4 of the Doha  Declaration, and actually issue compulsory
>licenses to promote access to  medicine for all.  If it can be said
>at the WTO, it can be done back home. 
>
>Globally, it is now time for NGOs to take greater control of the
>global debate over how best to fund R&D.  On the hand, we have
>scenarios  of ever increasing shares of GDP being spent to
>support a largely  non-innovative big pharma system of extremely
>costly marketing efforts,  and a growing police state designed to
>stop the trade in expensive  medicines.  On the other hand, there
>are new ideas on how trade  agreements should more efficiently
>address global support for R&D, and  new ideas on how to best fund
>innovation for new medicinal products.  We think the latter
>agenda is better for everyone."
>
>+++++++++++++++++++++Document Profile+++++++++++++++++++++
>
>Date distributed (ymd): 030903
>Region: Continent-Wide
>Issue Areas: +health+ +economy/development+ 
>
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-- 


Al Kagan
African Studies Bibliographer and Professor of Library Administration
Africana Unit, Room 328
University of Illinois Library
1408 W. Gregory Drive
Urbana, IL 61801, USA

tel. 217-333-6519
fax. 217-333-2214
e-mail. akagan at uiuc.edu