WHA resolution on IPRs
-----------------------
[Below a final analysis and account of the debate at the WHO Assembly on the
Intellectual Property and Innovation resolution. Thanks to Third Health
Network; crossposted from IP-Health. Copied as fair use.
The link below is to the WHA's "Fourth Report of Committee A," in which they
recommend that the WHA adopt a number of resolutions. The final texts are
included. It includes the texts for
-- IPR, inovation and public health
-- Global health-sector strategy for HIB/AIDS
-- Traditional Medicine
http://www.who.int/gb/EB_WHA/PDF/WHA56/ea5666.pdf
WB]
TWN Info Service on WTO Issues (May03/5)
Third World Network
29 May 2003
Dear friends and colleagues
WHO adopts resolution on IPRs and public health after
wrangling over text
WHO Member states met at the Fifty-Sixth World Health
Assembly in Geneva on May 19-28. At the final plenary,
they adopted, among others, a resolution that provides
a mandate for the WHO to help countries develop
pharmaceutical and health policies, and regulatory
measures that can mitigate the negative impact of
trade agreements.
The text of the resolution had been subject to much
consultation and negotiation between Member states
before its eventual adoption. Developing countries and
NGOs had been pressing for a resolution that would
provide a clear mandate for the WHO to assess the
implications of TRIPS, as well as bilateral and
regional agreements, on public health and innovation.
The US had opposed this, as well as a number of other
proposals put forward, including one for the
establishment of an independent commission, similar to
the UK Commission on Intellectual Property Rights
(whose 2002 report had been critical of the TRIPS
Agreement and WIPOs efforts at harmonization of IPR
standards at higher levels).
The resolution that was finally adopted contains a
compromise text for the establishment a time-limited
body to undertake analysis of issues related to IPRs,
innovation and public health, including on appropriate
funding and incentive mechanisms for the creation of
new medicines and other products against diseases that
affect developing countries. This body is to make
concrete proposals on these issues to the WHO by
January 2005.
Please find below a report of the discussions at the
WHA. The WHA resolution on IPRs, innovation and
public health is also attached below.
We hope this is of use.
With best wishes,
Cecilia Oh
Third World Network
-------------------
WHO ASSEMBLY ADOPTS RESOLUTION ON IPRS AND PUBLIC
HEALTH
WHO Member states meeting at the World Health Assembly
(May 19-28, 2003) in Geneva adopted a resolution on
Intellectual Property Rights, Innovation and Public
Health, directing the WHO Director-General to
establish a time-limited body that would study and
make concrete proposals on the question of appropriate
funding and incentive mechanisms to promote the
creation of new medicines for diseases affecting
developing countries.
The resolution also asks the WHO to cooperate with
Member states to develop "pharmaceutical and health
policies and regulatory measures" to "mitigate the
negative impacts" of international trade agreements.
Other operative parts of the resolution include
references to the WTO TRIPS Agreement, in which Member
states were urged to use to the full the
flexibilities contained in the TRIPS Agreement in
their national laws. The resolution also called on
governments to agree on a "consensus solution" for
Paragraph 6 of the Doha Declaration on TRIPS and
Public Health before the Fifth WTO Ministerial
Conference in September this year.
(The Paragraph 6 problem refers to the inability of
many developing countries to effectively use
compulsory licences to obtain affordable medicines
from domestic generic drug producers, since the
majority of the developing countries do not have
domestic manufacturing capacity in pharmaceutical
products. WTO Members have not been able to agree on
the solution for this contentious issue, even though
the end of 2002 deadline set in the Doha Declaration
has passed.)
The compromise text of the resolution was adopted only
after prolonged consultations and negotiations,
primarily between the US, Brazil and a number of
African countries. Developed countries, in particular
the US, had not been in favour of a strong mandate for
the WHO to address IPR issues. Developing countries,
on the other hand, had been pressing for a clearer
mandate to permit the WHO to properly assess the
public health implications of tightened IPR
protection, as a result of obligations under the TRIPS
Agreement, as well as regional and bilateral trade
agreements.
WHO report on IPRs, innovation and public health
The resolution was in response to the WHO report on
intellectual property rights, innovation and public
health. The WHO report had highlighted concerns about
the impact of intellectual property rights on prices
of medicines. The report noted that when intellectual
property rights were used beyond the original intent
of stimulating innovation, as a commercial tool that
overly restricts competition, the cost to society,
particularly in developing countries, would be high.
According to the report, whilst a range of mechanisms
(e.g., relaxed patent requirements, tiered pricing,
voluntary licensing, compulsory licensing, bulk
purchasing and corporate donations) may be employed to
achieve the most favourable pricing for patented
medicines in developing countries, analysis suggest
that those approaches which facilitate competition
have the greatest impact on reducing price. This
would imply that measures like relaxing patent
requirements, compulsory licensing would be more
effective in lowering cost than tiered pricing or
corporate donations.
The WHO report also raised concerns over the extending
scope of patents and the adverse effects on future
innovation, noting that "(I)n some circumstances,
intellectual property rights might have a perverse
effect on innovation. Much would depend on the stage
of product development at which protection is applied,
and what is admissible as an invention. The report
said it was unclear whether extending scope of patents
to include mechanisms of action, uses, and other
features of a pharmaceutical product would promote or
hinder innovation in the long run. In addition, the
report pointed out that protection of research data
from use by potential generic competitors might have
competition-limiting effects.
Although cautiously worded, the WHO report sounded a
warning on the implications of high standards of
intellectual property rights on access to medicines,
citing studies predicting price increases of two-fold
or more as a result of the full implementation of the
TRIPS Agreement. It also raised the question of how
poor countries could best manage intellectual property
systems, given that the resource implications for a
developing country of putting in place the structure
needed to implement TRIPS are likely to be
significant. The report further noted that bilateral
and regional trade agreements that extract TRIPS-plus
obligations from developing countries may fail to
reflect the need for special treatment for
health-related products.
Doing away with Doha US proposal
The US had been first in putting forward its proposal
for the resolution. Asserting that strengthened IP
protection was the best way to stimulate investments
in research and development, the US proposal requested
the WHO to refer Member states to the WTO and WIPO for
assistance on development of national technology and
innovation strategies, which would include effective
systems for intellectual property rights that respond
to public policy objectives, inter alia compliance
with TRIPS requirements and the flexibilities
therein. It further requested the D-G to promote
innovation in the field of public health by
encouraging respect for strong intellectual property
rights.
The proposal was criticized by NGOs for its
non-reference to the Doha Declaration on TRIPS and
Public Health. A joint statement issued by public
health, development and humanitarian groups including
MSF, Oxfam, Health Gap, the Peoples Health Movement
and Health Action International, urged WHO Member
states to reject the proposal.
The proposals contained in this draft are based on an
almost blind belief in the IP system, without regard
for the reality for patients in desperate need for
newer, more effective health technologies and access
to existing essential medicines, said the NGO
statement. In addition, the NGOs were critical of the
fact that the US proposal had made no mention of the
Doha Declaration on the TRIPS Agreement and Public
Health, which had re-affirmed developing countries
right, among others, to interpret the TRIPS Agreement
in a manner supportive of public health and promotion
of access to medicines for all. The Doha Declaration
had also confirmed that developing countries were able
to use, to their full, safeguards against exclusive
patent rights, such as compulsory licences and
parallel imports.
It is incomprehensible that the proposal makes no
reference to the WTO Ministerial Declaration on the
TRIPS Agreement and Public Health (the Doha
Declaration), no reference to the need to find an
economically viable, workable solution to the
Paragraph 6 (production for export) problem that will,
consistent with the Doha Declaration, ensure access to
medicines for all, the NGOs said.
The US proposal did not find much favour with the
developing countries, either. (Indeed, it was a cause
for some snickering in the WHA when the joke went
around that the US had finally managed to find a
co-sponsor for its proposal the new government of
Iraq.)
Counter proposal from developing countries
A counter to the US proposal was initiated by Brazil,
which was later co-sponsored by Bolivia, Ecuador,
Indonesia, Peru, Venezuela and South Africa, on behalf
of the Members of the WHO African Region.
The developing country proposal sought to highlight
the developing country concerns, urging Member states
to adapt national laws to accommodate the provisions
considered in TRIPS Agreement. It also urged
countries to adapt their laws to accommodate those
provisions related to Paragraph 6 of the Doha
Declaration, whilst maintaining efforts to reach a
consensus solution for Paragraph 6 at the WTO. It was
understood that this referred to the call for
developing countries to adopt national legal measures
that would permit the production and export generic
versions of patented medicines, including the use of
the Article 30 exception under the TRIPS Agreement.
The proposal also asked the WHO to establish an
independent commission to collect data and proposals,
and to provide analysis and diagnosis of the
relationship between intellectual property rights,
public goods, innovation and public health. The
proposal would have the commission provide, on the
basis of its analysis and diagnosis, concrete
proposals for action to the WHOs Executive Board by
January 2005.
It is understood that the developing countries had
wanted an international commission, along similar
lines as that of the UK Commission on Intellectual
Property Rights (CIPR). The CIPR report had warned
against the adverse effects on innovation and access
to medicines as a result of TRIPS implementation and
had also been critical of efforts at the WIPO to
harmonize IPR standards at higher levels.
In addition, the developing country proposal requests
the D-G to collaborate with Member states in
monitoring and analyzing the pharmaceutical and public
health implications of bilateral and regional trade
agreements (both existing and future ones) so as to
be able to evaluate whether the implications differ
from those of existing multilateral agreements.
Compromise
The Brazilian proposal eventually became the basis on
which a compromise text was drawn up, when it became
clear that the US proposal would not get much support.
An informal drafting group, comprising the Brazilian,
US and a number of African delegations, could be seen
at the coffee lounge, intensely negotiating over the
controversial aspects. After last-minute negotiations
in a working group, the draft resolution was adopted
by the delegates in the Committee to be submitted for
final adoption at the plenary.
NGOs and health activists expressed some
disappointment with the final text of the resolution.
They felt that the earlier proposals put forward by
developing countries had been weakened or deleted
altogether due to the hard-line stance adopted by the
US delegation during the negotiations, which prevented
stronger language on a number of key concerns for the
developing countries.
These included the compromise struck on the
establishment of the independent commission, which had
now became an appropriate time-limited body for
which terms of reference had still be established.
There were concerns that there would be further
attempts to limit the mandate of the body through the
process of establishing its terms of reference.
In light of the concerns and questions raised in the
WHO report, NGOs and health activists at the WHA said
that there was a need for an independent body that
could examine the issues and provide clear proposals
for action.
Another issue had been the call for WHO to assess the
implications of bilateral and regional trade
agreements, in which developing countries are often
required to adopt TRIPS-plus obligations. Observers
pointed out that the WHO report had also identified
the need for assessment of such agreements. The
paragraph had now been changed to one that asked the
WHO to cooperate with Member states, at their request,
to develop "pharmaceutical and health policies and
regulatory measures" to "mitigate the negative
impacts" of international trade agreements.
NGOs said they were also disappointed that a text
proposal from the Chinese, which would have the WHO
Member states re-affirm the primacy of health
interests over trade ones, as well as include
references to the difficulties of developing countries
making effective use of compulsory licensing in
accordance with the Doha Declaration, had not been
included. China had also proposed that Member states
should be able to relax, when necessary, patent
requirements in order to meet the needs of developing
countries for basic drugs.
A number of the developing country delegates said it
had been a difficult negotiation, but thought the
resolution should be seen as a first step to pave the
way for more coherent work by the WHO on the IPRs and
public health issue.
---------------
Agenda Item 14.9
Intellectual property rights, innovation and public
health
The Fifty-sixth World Health Assembly,
Having considered the report on intellectual property
rights, innovation and public health;[1]
Considering that available data indicates that of some
1400 new products developed by the pharmaceutical
industry between 1975 and 1999, only 13 were for
tropical diseases and three were for tuberculosis;
Aware that the developed countries represent nearly
90% of global pharmaceutical sales, whereas of the 14
million global deaths due to infectious diseases, 90%
occur in the developing countries;
Concerned about the insufficient research and
development in so-called neglected diseases and
poverty-related diseases, and noting that research
and development in the pharmaceutical sector must
address public health needs and not only potential
market gains;
Mindful of concerns about the current patent
protection system, especially as regards access to
medicines in developing countries;
Recalling that, in accordance with the Declaration on
the TRIPS Agreement and Public Health (Doha
Declaration), the Agreement on Trade-Related Aspects
of Intellectual Property Rights (TRIPS) does not and
should not prevent Members from taking measures to
protect public health and, in particular, to promote
access to medicines for all;
Noting that the TRIPS Agreement contains flexibilities
and that in order to use them adequately, Member
States need to adapt national patent legislation;
Reaffirming resolution WHA52.19 on the revised drug
strategy, resolution WHA54.11 on WHO medicines
strategy and resolution WHA55.14 on ensuring
accessibility of essential medicines;
Considering that Member States should urge the
pharmaceutical industry to reinvigorate its efforts to
develop innovations that add real therapeutic
advantage in treating the worlds major killer
diseases, especially in developing countries;
Recognizing the importance of intellectual property
rights in fostering research and development in
innovative medicines and the important role played by
intellectual property with regard to the development
of essential medicines;
Taking into account that in order to tackle new public
health problems with international impact, such as the
emergence of severe acute respiratory syndrome (SARS),
access to new medicines with potential therapeutic
effect, and health innovations and discoveries should
be
universally available without discrimination;
Further considering the continuing efforts of WTO
Members to reach a solution for paragraph 6 of the
Doha Declaration which recognizes 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;
Reasserting the need to accomplish target 7 of
Millennium Development Goal 6 and target 17 of
Millennium Development Goal 8;
Noting resolutions 2001/33 and 2003/29 of the
Commission on Human Rights on access to medicines in
the context of pandemics such as HIV/AIDS,
1. URGES Member States:
(1) to reaffirm that public health interests are
paramount in both pharmaceutical and health policies;
(2) to consider, whenever necessary, adapting national
legislation in order to use to the full the
flexibilities contained in the Agreement on
Trade-Related Aspects of Intellectual Property Rights
(TRIPS);
(3) to maintain efforts aimed at reaching, within WTO
and before the Fifth WTO Ministerial Conference, a
consensus solution for paragraph 6 of the Doha
Declaration, with a view to meeting the needs of the
developing countries;
(4) to seek to establish conditions conducive to
research and development that spur the development of
new medicines for diseases that affect developing
countries;
2. REQUESTS the Director-General:
(1) to continue to support Member States in the
exchange and transfer of technology and research
findings, according high priority to access to
antiretroviral drugs to combat HIV/AIDS and medicines
to control tuberculosis, malaria and other major
health problems, in the context of paragraph 7 of the
Doha Declaration which promotes and encourages
technology transfer;
(2) by the time of the 113th session of the Executive
Board (January 2004), to establish the terms of
reference for an appropriate time-limited body to
collect data and proposals from the different actors
involved and produce an analysis of intellectual
property rights, innovation, and public health,
including the question of appropriate funding and
incentive mechanisms for the creation of new medicines
and other products against diseases that
disproportionately affect developing countries, and to
submit a progress report to the Fifty-seventh World
Health Assembly and a final report with concrete
proposals to the Executive Board at its 115th session
(January 2005);
(3) to cooperate with Member States, at their request,
and with international organizations in monitoring and
analysing the pharmaceutical and public health
implications of relevant international agreements,
including trade agreements, so that Member States can
effectively assess and subsequently develop
pharmaceutical and health policies and regulatory
measures that address their concerns and priorities,
and are able to maximize the positive and mitigate the
negative impact of those agreements;
(4) to encourage developed countries to make renewed
commitments to investing in biomedical and behavioural
research, including, where possible, appropriate
research with developing country partners.
---------------
[1] Document 56/17
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