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Africa: Health, Patents Clash
AfricaFocus Bulletin
Dec 6, 2005 (051206)
(Reposted from sources cited below)
Editor's Note
In 2001, the World Trade Organization (WTO) approved the Doha
Declaration on TRIPS and Public Health which affirms the right of
countries to prioritize access to medicines and public health over
intellectual property rights. However, this statement did not
address the issue of how countries with insufficient manufacturing
capacity can make use of these rights. Now developed countries want
the WTO to extend a complex interim "solution" to the problem that
has not worked.
Although increased use of generic drugs for first-line
antiretroviral treatment has significantly lowered the cost of
treatment, and the United States has relaxed its opposition to use
of selected generic drugs in its AIDS programs, prices are still
too high for sustainable treatment of millions in need. And patent
restrictions still keep prices prohibitively high for second-line
treatments, treatments for children, and many other essential
medicines.
This AfricaFocus Bulletin contains a sign-on statement by a group
of non-governmental organizations calling on the World Trade
Organization to reject the "bad deal" of extending the unworkable
interim solution adopted two years ago. Also included are a letter
and a press release from Medecins sans Frontieres with additional
background on the problems caused by patents on essential
medicines.
For previous AfricaFocus Bulletins on health-related issues,
see http://www.africafocus.org/healthexp.php
++++++++++++++++++++++end editor's note+++++++++++++++++++++++
WTO Members should reject bad deal on medicines
3 December 2005
Joint statement by NGOS on TRIPS and Public Health
[The letter is online at
http://www.cptech.org/ip/wto/p6/ngos12032005.html To sign the
letter, interested parties should contact Thiru Balasubramaniam
(thiru@cptech.org).]
The WTO General Council is considering proposals to amend the TRIPS
Agreement in order to permit the exportation of generic medicines
produced under compulsory license to supply countries with
insufficient or no manufacturing capacity.
According to health, in particular AIDS activists, the proposals
are flawed, and poor countries should not accept a permanent
amendment that has not been shown to work in practice.
In 2001, the WTO signed the Doha Declaration on TRIPS and Public
Health (the Doha Declaration), which affirms the right of countries
to prioritize access to medicines and public health over
intellectual property rights. However, the Doha Declaration left
unfinished the issue of how countries with insufficient or no
manufacturing capacity can make use of these rights. Indeed, most
poor countries are not adequately equipped to do efficient domestic
production of medicines, while those which have capacity require
the economies of scale of a large, global market in order to reach
prices that the poor can afford. However, under the TRIPS
Agreement, there are significant limitations on exports of generic
medicines made under compulsory license.
On 30 August 2003, the Members of the WTO finally agreed on a
mechanism with many procedures for allowing trade in
compulsory-licensed medicines. The procedures have been criticized
by generic industry experts and activists alike for being too
burdensome and unworkable in practice. However, the US and the EU
are pressuring developing countries to accept that flawed August 30
agreement be locked in as a permanent amendment to the TRIPS
Agreement - despite the fact that the mechanism has not been used
since its introduction more than 2 years ago and its workability is
uncertain.
Following the August Decision, the Africa Group submitted a formal
proposal that removes many of the procedural requirements and this
proposal received wide support from civil society as well as
developing countries as a basis to rethink the mechanism that was
agreed to on 30 August 2003. This proposal is also in accordance
with the African Health Ministers' recent call in the Gaborone
Declaration on "the Ministers of Trade to seek a more appropriate
permanent solution at the WTO that revises the TRIPS agreement and
removes all constraints, including procedural requirements,
relating to the export and import of generic medicines."
Unfortunately although the Africa proposal enjoyed much support, in
the current negotiations, this proposal does not seem to be
discussed at all. Instead, developing countries are presently being
pressured to agree quickly to an amendment that includes the entire
August Decision and a re-reading of the Chairman's statement,(a
solution differing significantly from the original Africa Group
proposal) just so that WTO members have something to harvest at
Hong Kong after four years of negotiations.
In addition, while the discussion in the TRIPS Council and the
General Council have mainly been around the legal status of the
Chairman's Statement, we feel that a more in-depth focus has also
to be shown on finding a mechanism that works to facilitate access
to medicines. It must be borne in mind that the lives of millions
of people depend on finding a mechanism that works in facilitating
access to medicines.
Thus the current 30 August 2003 mechanism needs to be tested and
shown to work, before it is turned into a permanent feature of the
TRIPS agreement. If the mechanism proves ineffective in achieving
its stated goal - enhanced access to affordable medicines for
countries with insufficient or no domestic manufacturing capacity
- then WTO members should return to the drawing board and agree
to a mechanism that is more effective.
For now the 30 August 2003 mechanism is a waiver that according to
paragraph 11 only terminates "on the date on which an amendment
to the TRIPS Agreement replacing its provisions takes effect for
that Member", thus effectively it is a permanent waiver for
Members to use.
This issue is too important for countries to quickly agree to an
amendment just to be able to claim that the WTO system still works
and can deliver for development. The developed countries, in
particular the US and EU are desperate to deflect attention from
their lack of movement in agriculture and their anti-development
proposals in NAMA and Services. If the price of making that claim
is the lives of people living with treatable but deadly diseases,
then developing countries should not pay it.
*Initial Signatories*
Oxfam International
Christian Aid
Consumer Project of Technology (CPTech)
Ecumenical Advocacy Alliance (EAA)
Health Action International-Asia Pacific
Health-GAP
Act Up Paris
Essential Action
Reseau pour l'Acces aux Medicaments Essentiels (RAME)
Institute for Agricultural Trade Policy (IATP)
Essential Inventions
Third World Network
Médecins sans Frontières
Letter on TRIPS and Access to Medicines
http://www.accessmed-msf.org
Mr Pascal Lamy
Director General
World Trade Organization
Rue de Lausanne 154
CH-1211 Geneva 21
Switzerland
20th September 2005
Dear Mr Lamy,
We are writing to you to congratulate you on your appointment as
director general of the World Trade Organization and to raise
concerns about access to medicines, an issue we know you are very
familiar with.
The HIV/AIDS crisis has shown the urgent need to ensure that
essential medicines are available at affordable prices. Today
approximately half of the one million people in the developing
world who receive antiretroviral drugs rely on generic production.
The fixed-dose combinations, produced in India, greatly simplify
the administration of antiretroviral therapy and have been critical
to scaling up treatment in resource-poor settings.
The 2001 WTO Doha Declaration on TRIPS and Public Health was a
vital step in increasing access to medicines. It provides
unambiguous support to any government that need to protect the
health of their people to use the TRIPS flexibilities to overcome
the barriers posed by patents, and helps the least developed
countries by extending the transition period for enforcing and
granting pharmaceutical product patents until at least 2016.
Since then, however, there has been a systematic dismantling of the
Doha Declaration through bilateral trade agreements in which much
higher levels of intellectual property protection are demanded than
required by the WTO.
The impact of patent protection on HIV programmes will become very
apparent in the coming years when large numbers of patients
currently on treatment will need to switch to newer, second line
medicines. These drugs are at least 4-10 times as expensive as
first-line treatments, and almost all are patented or are likely to
be patented in those countries that have capacity to produce them
generically such as India, Brazil and Thailand.
Today MSF is treating 45000 people living with AIDS. Already, this
represents a major part of our overall spending. At current
projections, we estimate that overall programme costs could at
least double in the next few years as significant numbers of
patients will require secondline medicines. Obvious, MSF's needs
are just a small indication of the problems governments throughout
the developing world will face. In addition, the impact of patents
is not limited to antiretroviral drugs, but will increasingly be
felt across all diseases with all medicines brought to market from
now on.
A second critical question for the WTO is how to ensure that
innovation meets the health needs of neglected patients in the
developing world. The WTO TRIPS agreement came with promises of
increased innovation and investment in research and development. As
far as the needs of people in developing countries are concerned
these promises have not been fulfilled. So far, increased patent
protection in developing countries has not contributed to increased
innovation.
An R&D system that is driven by patent and profit motives neglects
the health needs of the poor. The patent system is intended as a
stimulus for innovation, but there is no mechanism for directing
that innovation, and as a result many diseases are completely
ignored. We face the consequences on a daily basis in our projects,
for example to diagnose TB in HIV patients and in children; to
treat tropical diseases like leishmaniasis, which affects 12
million people; to monitor HIV patient progress, and to treat HIV
in children.
Recently established product development partnerships provide some
cause for hope, but all are heavily dependent on philanthropic
donations, with negligible contributions by governments. For
example, through its funding of the Drugs For Neglected Diseases
Initiative MSF is contributing more finances to tackling the
problem than the European Union and all European governments
combined. The few promising drug development projects that exist
lack secure funding to move them into clinical trials.
In view of the above, the WTO should increase its work to support
access to medicines. We ask you to take action to stop the erosion
of the Doha Declaration on TRIPS and Public Health through
bilateral and regional FTAs.
We specifically ask you to hold a meeting to examine whether the
current WTO rules on patents and their flexibilities are sufficient
to address the needs in developing countries with regard to access
to existing products and ensuring the development of new therapies.
In particular, the 2003 August 30 decision to allow production of
generic medicines for exports needs to be reviewed. This meeting
should also address the question how bilateral and regional trade
agreements affect access to medicines and how the WTO plans to
provide effective technical assistance on the implementation of the
Doha declaration in an increasingly TRIPS-plus environment.
It is crucial that the WTO addresses the question how it can
contribute to a better mechanism for essential health Research and
Development to ensure that health needs of people in developing
countries are met. We ask you to initiate a discussion at the WTO
about how the failure of the TRIPS Agreement to address essential
health needs can best be addressed.
You have announced that the weeks to come will be devoted to
internal and external consultations. We would be more than happy to
meet with you to discuss our concerns in more detail. Sincerely
yours,
Dr Karim Laouabdia
Campaign for Access to Essential Medicines
Medecins Sans Frontieres
Prices of AIDS Medicines in Developing Countries continue to be a
concern
28 June, 2005
For more information, please contact
V‚ronique Terrasse, MSF, tel ++41-(0)22-8498 900 or
veronique.terrasse@geneva.msf.org
Geneva Tuesday June 28th 2005 - - In a new edition of a pricing
guide published today , Medecins Sans Frontieres shows that while
generic production has brought down the prices of most first-line
antiretrovirals (ARVs) from over $10,000 in 2000 to as little as
$150 per patient in June 2005, prices of newer ARVs and
formulations for children are up to 12 times higher. Yet access to
newer drugs is increasingly critical as the growing number of
people with HIV/AIDS currently on treatment will inevitably develop
resistance to first-line treatments.
MSF currently provides ARV treatment for approximately 35,000
people in about 30 countries. Approximately 70% of the patients in
MSF's projects are on World Health Organization (WHO)-recommended
three-in-one combination pills as first-line therapy.
"But we are already beginning to confront the 'second-line crisis'
that newer treatment programmes may not feel for several years,"
said Dr Felipe Garcia de la Vega, AIDS specialist with MSF's
Campaign for Access to Essential Medicines. "Although our clinical
outcomes are good so far the average survival rate in our
projects is 80% after 12 months on treatment some of our
programmes have been operating for more than five years now and we
are have naturally started having to switch some of our patients to
second-line treatments as they have developed resistance to
first-line drugs."
"Today, MSF pays less than $250 per person per year for
WHO-prequalified first-line treatments sourced from Indian generic
manufacturers. This has only been possible because there have not
been patents on pharmaceuticals in key manufacturing countries like
Brazil and India, and because there has been robust generic
competition," said Fernando Pascual, pharmacist and one of the
authors of the MSF report. "But when we switch to second-line
treatments, the price increases six- to 12-fold. Treating a child
can be four times more expensive than treating an adult," Pascual
said.
January 1st 2005 saw the implementation of the World Trade
Organization's Agreement on Trade-related Aspects of Intellectual
Property Rights (TRIPS) in India, one of the main sources of
generic ARVs today. India must now recognise product patents on
medicines. This may lead to there only being one producer the
patent holder for newer drugs. In the absence of competition,
this sole supplier can set a monopoly price.
In MSF's AIDS projects, for instance, the number of patients taking
lopinavir/ritonavir and other second-line ARVs is small, but the
organisation pays exorbitant prices for the drug. "In Guatemala,
where MSF provides ARV treatment for 1,700 people with HIV/AIDS,
Abbott charges $2.66 per capsule," said Fernando Pascual. "Although
MSF is treating just 11 patients with lopinavir/ritonavir, we pay
more than $5,800 per person per year for the one drug alone."
According to the MSF report, the current pricing system based on
companies giving voluntary discounts to developing countries is not
sufficient to guarantee affordability of medicines, now or in the
future. The problems with this mechanism, known as differential
pricing, fall into three broad categories. First, some
single-source drugs are simply very expensive. For instance, the
differential price for abacavir announced by GlaxoSmithKline is
over $800 per patient per year in developing countries. Second,
prices announced by pharmaceutical companies are not available in
reality because manufacturers have not registered or are not
marketing their drugs in countries. This is the case not only for
certain originator products in Mozambique and Cambodia but also
some generics in Latin America. Third, some companies do not offer
discounts to middle-income countries.
WHO estimates that out of the 6.5 million people needing ARVs in
developing countries today, approximately one million are receiving
them. Most of them are currently taking first-line treatments. But
many of them will need access to second-line drugs within the next
few years. The consequences are already felt in countries like
Brazil, which has been running a nationwide AIDS treatment
programme since 1996: the country today spends 63% of its total
AIDS drug budget on three products (Abbott's lopinavir/ritonavir,
Gilead's tenofovir and Merck's efavirenz).
"It is urgent to address how high the final drug bill is in a few
years' time, and who will foot it to meet patients' needs," said Dr
Garcia de la Vega. "G8 countries and other donors are discussing
universal access to ARVs, but this will remain an impossible goal
if prices continue to soar. It is vital that governments and
international organisations such as WHO take and encourage
immediate steps - such as compulsory licensing - that allow
countries to make or import more affordable generic medicines."
AfricaFocus Bulletin is an independent electronic publication
providing reposted commentary and analysis on African issues, with
a particular focus on U.S. and international policies. AfricaFocus
Bulletin is edited by William Minter.
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