E-DRUG: WHO Assembly analysis
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[another good review of the WHO Assembly; crossposted with thanks from
IP-Health. WB]
Now that the dust has settled at the 56th World Health Assembly, it might
be useful to analyze what if any progress is likely at the WHO in the
battle against HIV/AIDS. Others may certainly have things to add (or to
disagree with), but here's my take on the Assembly.
A full commitment 3 Million by 2005.
The most promising outcome of the Assembly was the statement by the newly
elected Director-General, J. W. Lee, that he "committed" the WHO to
achieving the Barcelona goal of 3 million people living with HIV/AIDS in
developing countries in antiretroviral treatment by the end of 2005.
Although the written version of his prepared remarks were less direct ("I
will ensure that WHO provides leadership toward the bold "three-by-five"
target), his speech, by my memory anyway, was more concrete. This goal, of
course, cannot be reached without adequate financing, a matter of some
desperation at this point given the near bankruptcy of the Global Fund.
However, it also can not be reached unless there is a sea change in the
planning process whereby developing countries get "technical assistance" on
utilizing all existing programmatic capacity on HIV/AIDS treatment, care,
and prevention and further TA on capacity building within the health care
sector. (It is interesting to note that in the passed resolution, the
World Health Assembly backed away from "endorsing" the three-by-five goal
and instead is "bearing it in mind" per the weak will and skepticism of
some European countries.)
In its report on "WHO's contribution to the follow-up of the United Nations
General Assembly special session on HIV/AIDS," the Secretariat stated that:
"WHO is working with an international coalition of partners to draft and
implement a plan of action for extending access to ARV treatments to three
million people by 2005. The plan will include technical assistance and
information sharing to guide countries in implementing national treatment
programmes." (Paragraph 16.)
Health GAP and other activists at the WHA urged the Director General to
issue this plan as soon as possible, hopefully by the Sept. U.N. review of
the UNGASS Declaration of Commitment. Despite the value of a global plan,
however, the real test of the WHO's newfound commitment to three-by-five
will be the technical assistance it provides on the ground, in country, to
national health ministries and other stakeholders. As many know, Health
GAP considers the lack of technical assistance concerning scale-up and
capacity building to be a key obstacle to the realization of universal
access to treatment by 2010 (50% coverage by 2005 and an additional 10%
each year thereafter). Fortunately, the Director General is committed to
bringing in new staff that will collaborate with health ministries and
others to customize scale-up and capacity building plans to local
circumstances. This will be challenging work, but the Secretariat actually
envisions much less work in Geneva and much more work in country, calling
this initiative a "commitment to results at the country level." In support
of this approach, the Assembly, in its Resolution on a Global Health Sector
Strategy for HIV/AIDS, passed a provision which requests that the
Director-General "support, mobilize, and facilitate efforts of Members
States and other concerned parties" to achieve the three-by-five goal.
Fund and the Global Fund and TA to CCMs - mixed success.
Health GAP, Act Up Paris, and other Fund-The-Fund allies had a goal of
getting the Assembly to endorse a dues-based commitment to full funding of
the Global Fund to Fight AIDS, TB and Malaria, but activists were not
successful in getting explicit language to that effect. Instead, there is
a veiled reference in the final HIV/AIDS resolution that Member States are
exhorted, as a matter of urgency, "to take all necessary steps, including
the mobilization of resources, to fulfil their obligation under the [UNGASS
Declaration of Commitment]." Since the UNGASS Declaration had acknowledged
the need for funding levels of $7-10 billion for HIV/AIDS alone by 2005 and
since those numbers have been expanding based on more precise calculations
and on the inclusion of capacity building goals and coverage of TB and
malaria (e.g., WHO Commission on Macroeconomics and Health), the context of
this statement is clear - the global fight against HIV/AIDS is still
grossly underfunded, particularly at the Global Fund which has virtually no
resources to commit to an estimated $1.6 billion of new, high quality
proposals expected in Round Three (due date May 31).
Another way to energize the Global Fund and to demonstrate the extent of
unmet need and capacity is for developing countries to become bolder in
submitting robust treatment proposals to the Global Fund whereby they
request scale-up and capacity building in a much more dynamic way.
Countries have been discouraged from doing so so far because of persistent
underfunding of the Global Fund, first by the U.S. and then by other rich
donors. When subtle messages weren't enough, donor representatives forced
countries like Malawi to reduce the scale of their treatment proposals.
And, of course, developing countries face their own crises of political
commitment to AIDS treatment, especially given the uncertain sustainability
of treatment programs initiated with Global Fund dollars.
To try to counteract this downward cycle of reduced expectations and
suppressed demand, Health GAP and others have been trying to force the
Global Fund to clarify that well-rounded proposals should ordinarily
include robust treatment plans. Health GAP has also urged that developing
countries' Country Coordinating Mechanisms received technical assistance on
crafting high quality treatment-focused proposals. Thus, in addition to
providing technical assistance on capacity utilization and expansion, the
WHO's AIDS Strategy Resolution also addresses helping CCMs file robust
proposals to the Global Fund. Health GAP had urged the Secretariat to be
proactive in providing technical assistance to CCMs, but the conservative
politics at the Assembly resulted in a resolution that conditions technical
assistance on countries asking for it. Hopefully the message will get out
to countries that they can't not ask.
Pre-qualification
Health GAP, HAI, and others at the Assembly argued that the WHO's drug
pre-qualification system should be strengthened and extended.
Unfortunately, there was no formal resolution on the Medicines Policy and
activists were unsuccessful in getting a statement on pre-qualification
squeezed into the AIDS Strategy Resolution. Nonetheless, the importance of
enhancing the pre-qualification process, of adding resources, and of
providing more pro-active assistance re registration of generics, included
those with fixed dose combination, was discussed informally with the
Secretariat and was raised from the floor during the medicines policy
debate. However, this program, critical to the fast-track registration of
generic ARVs in developing countries is crucial and its progress should be
carefully monitored.
Access to Medicines - Prioritizing Health over Intellectual Property.
The last major issue at the WHA, from a treatment access perspective, was
the "Report by the Secretariat on intellectual property rights, innovation,
and public health." As Jamie Love as already reported, this was a pretty
disappointing document both with respect to product innovation and with
respect to access to medicines. Fortunately, Brazil and other developing
countries became active at the Assembly, with constructive interventions
from NGOs, in developing a resolution for submission to the General
Assembly. The U.S. badly miscalculated its hand and submitted a truly
brutal proposal that championed the expansion of intellectual property
rights as the only mechanism for spurring innovation. The U.S. went so far
as to ignore the adoption of the Doha Declaration on the TRIPS Agreement
and Public Health, and thus was condemned publically and privately for its
IPR hubris.
In the end, the resolution that passed: (1) reaffirmed "that public health
interests are paramount in both pharmaceutical and health policies," (2)
urged Members states "to consider, whenever necessary, adapting national
legislation in order to use to the full the flexibilities contained in
[TRIPS]," (3) urged Member states to "maintain efforts aimed at reaching,
within the 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) requesting the Director-General
to support Member States in the exchange and transfer of technology,
especially with respect to ARVs and other medicines to control
tuberculosis, malaria, and other major health problems, and (5) to
cooperate with Member States, at their request, in monitoring and analyzing
the pharmaceutical and public health implication of relevant international
agreement, including trade agreements.
In this regard, it is also useful to note that China succeeded in inserting
two access to medicines provisions in the AIDS Strategy Resolution: (1)
reaffirming that public health is paramount in both pharmaceutical and
health policies and recognizing difficulties developing countries have
utilizing compulsory licenses and, when necessary, using flexibilities in
TRIPS to access medicines against HIV/AIDS and (2) urging the
Director-General to mobilize support of actions taken by countries with an
AIDS epidemic to obtain affordable and accessible drugs to combat HIV/AIDS.
With respect to IP issues, the IP and AIDS Strategy Resolutions as passed
contained three major deficits. First, the Resolutions did not directly
encourage the Director-General to continue to intervene in WTO negotiations
from a pro-public health perspective, especially concerning the
desirability of utilizing an Article 30 solution for the
production-for-export problem. Given the rambling attack by the U.S. from
the floor about the WHO's intervention to the TRIPS Council on Sept. 17,
2002, it is obvious how important such interventions might be in
crystalizing the best response to paragraph 6 problem. Second, the
Resolutions did not directly address the obligation of the WHO to monitor
bilateral and regional trade agreements and to provide technical assistance
to developing Member States about avoiding TRIPS- and Doha-plus
intellectual property protections. This issue is referenced in paragraph
19 of the Secretariat's IP Report where it acknowledges that bilateral and
regional trade agreements frequently fail to reflect the need for special
treatment for health-related products. Finally, Health GAP and other
activists had requested that the WHO provide technical assistance to
developing countries concerning revision of their intellectual property
laws to make maximum use of the flexibility in the TRIPS Agreement and in
the Doha Declaration. At present, WIPO and USAID provide "Trojan-horse"
technical assistance which is strongly biased towards enhanced, TRIPS-plus
IP protection. To counteract this disabling assistance, the WHO should
beef-up its capacity to provide concrete technical assistance on national
IP reform (including roll-back of premature TRIPS compliance or of
TRIPS-plus legislation) and on strategies for issuing compulsory licenses
on essential AIDS medicines.
Obviously, the intellectual property debate is the most highly political
and contentious area of policy for the WHO in its battle against the AIDS
pandemic. No one would gladly get in a fight with the U.S. and with Big
Pharma on these issues because they fight long and dirty to maximize
pharmaceutical hegemony for patent holders. However, activists will need
to continue to place pressure on the WHO to assist people living with
HIV/AIDS in their long struggle to access affordable medicines, which
increasingly means accessing low cost, quality generics, whether produced
locally or imported. Intellectual property is at the center of this
conundrum, the it must continue to be addressed by the WHO and others.
Brook K. Baker
Health GAP
B.Baker@neu.edu
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