[A2k] SUNS: WHA strengthens WHO's mandate on IP and Health

[Sangeeta]

WHO: WHA strengthens WHO's mandate on IP and Health
Published in SUNS #6482 dated 27 May 2008

Geneva, 25 May (Sangeeta Shashikant) -- The highlight of the 61st World
Health Assembly was the adoption of a resolution that strengthens the
mandate of the WHO to undertake work on the inter-related issues of public
heath, intellectual property, innovation and access to medicines.

The resolution, adopted at the end of the WHA during the plenary session,
last Saturday afternoon, covers the Global Strategy (GS) and agreed parts of
the Plan of Action (POA) on Public Health, Innovation & Intellectual
Property.

The Resolution has come after two years of negotiating the GS & POA in an
Intergovernmental Working Group (IGWG) and five days of almost non-stop
negotiations in an informal open-ended drafting group throughout the period
of the WHA that began on 19 May.

The drafting group that began meeting on Tuesday and met throughout the week
often until midnight, had the task of resolving 16-bracketed paragraphs of
the GS, the POA and the Resolution that would adopt the GS & POA.

On more than one occasion, the discussions ended up taking place in
"green-room" type of meetings (i. e. meetings open to only some key
delegations e. g. India, Brazil, EU, US, Thailand, Norway, South Africa,
Chile, and Kenya) to the dissatisfaction of other delegations left out of
the negotiations.

Negotiations on the text on IP and the role of WHO were the most difficult
areas to resolve.

However, most delegates and NGOs seem pleased with the outcomes, in
particular, that the GS appears to strengthen the role of WHO in the area of
IP and Public Health.

On this, a principle in the adopted GS underscores that "the WHO shall play
a strategic and central role in the relationship between public health,
innovation and intellectual property within its mandates (including those
contained in relevant WHA resolutions), capacities and constitutional
objectives, bearing in mind those of other relevant intergovernmental
organizations. In this context, the WHO including the regional and, when
appropriate country offices, need to strengthen its institutional
competencies and relevant programs in order to play its role in implementing
this global strategy and its plan of action".

A diplomat from Brazil, which was a key player in the negotiations on the
Global Strategy, called the Resolution an "achievement" in terms of IP and
public health. He said that the GS reaffirms as well as widens the mandate
of the WHO in the area of IP and public health, and there is now no dispute
that WHO has a role to play in the area of IP.

Dr. Tido von Schoen-Angerer, Director of MSF's Access to Essential Medicines
Campaign, said "What is encouraging is that governments have clearly called
for the WHO to play a strategic and central role in intellectual property".

The atmosphere in the final plenary, which ended about three hours past the
time set for the closing of the WHA, was extremely tense and delicate as
some countries tried to exclude implementation of the most hard fought
language on IP by insisting that the WHO Director-General only implement
actions in the GS where the role of WHO as a stakeholder in the POA had been
agreed.

The Resolution urges member states to implement the specific actions
recommended in the GS and POA, to support actively the wide implementation
of the GS and POA and to consider providing adequate resources for its
implementation.

In paragraph 4, it further requests the DG, in implementing the global
strategy and agreed parts of the POA, without prejudice to the existing
mandates, to:

(1) provide support for member states upon request in implementing the GS &
POA;

(2) support effective promotion and implementation of the GS & POA;

(3) continue to implement mandates contained in existing WHA resolutions;

(4) finalise urgently the outstanding components of the POA, including
time-frames, progress indicators, estimated funding needs and to submit the
final plan of action for consideration by the 62nd WHA through the Executive
Board;

(5) coordinate with other relevant international intergovernmental
organizations including WIPO, WTO and UNCTAD, to effectively implement the
GS & POA;

(6) prepare a Quick Start programme with adequate budget provision and to
begin immediately to implement the elements of the GS & POA that fall under
the responsibility of the WHO;

(7) establish urgently a "results-oriented and time-limited" experts'
working group to examine current financing and coordination of R&D as well
as proposals for new and innovative sources of funding to stimulate R&D
needs of developing countries and open to consider proposals from Member
states;

(8) include adequate resources in the forthcoming proposed programme budgets
for effective implementation of the GS & POA; and

(9) monitor performance and progress in implementing the GS & POA.

Bolivia during the Committee meeting (before the plenary session) declared
that the Terms of Reference of the expert group (referred to in 7 above)
should be sufficiently broad to include the possible consideration of
proposals for new incentive schemes to stimulate R&D. Bolivia reserved its
right to present proposals to the expert group, adding that the resolution
should be read in the context of this understanding.

Barbados and Bolivia have submitted six proposals, some of which are on
incentive schemes, which have yet to be discussed.

Controversy over the chapeau of paragraph 4 led to a delay in adopting the
Resolution.

Switzerland, in a committee before the plenary, unexpectedly pushed for an
amendment to the Resolution wherein the WHO DG would only implement the
agreed parts of the POA where the role of WHO, as a stakeholder, had been
agreed. The matter could not be resolved during the Committee meeting and
was pushed over to the plenary.

During the official plenary, Brazil argued that the language proposed by
Switzerland would limit WHO's work in areas where it already had mandates
through existing Resolutions, adding that the main contention among Member
States was not whether WHO had a role or not. It said that there was
agreement that WHO had a role, the disagreement was whether "WHO" should be
stated in the POA for some of the specific actions as a "lead" stakeholder.

Following some suggestions by other countries including the US, the
language, which was agreed to, was "in implementing the global strategy and
agreed parts of the POA without prejudice to the existing mandates".

However, the US attempted in the last minutes prior to the adoption of the
Resolution to propose changes to paragraph 4 as follows "in implementing
provisions of the GS and in a manner consistent with the POA", which
threatened to derail the entire process.

However, after a plea by Brazil and by the WHO Director-General, Dr.
Margaret Chan, the US dropped its request.

In her appeal to the US, Dr Chan said that "I am well aware of your
thinking", adding that she had sat through the informal deliberations. She
further said that she will deliver nothing more or less than what is
required.

According to an expert within the WHO, the language that has been agreed
upon gives WHO all the mandate it needs to implement the GS since in the
agreed parts of the POA, the disagreement is simply over whether WHO should
be the "lead" stakeholder. However, there is agreement that WHO should play
some role.

The GS adopted by the Resolution contains consensus text on "The context",
"The aim", "The principles", and specific actions on eight Elements, i. e.
on Prioritising research and development needs (Element 1); Promoting
research and development (Element 2); Building and improving innovative
capacity (Element 3); Transfer of technology (Element 4); Application and
management of intellectual property to contribute to innovation and to
promote public health (Element 5); Improving delivery and access (Element 6)
; Promoting sustainable financing mechanisms (Element 7); Establishing
monitoring and reporting systems (Element 8).

The POA contains four columns. Two columns contain the Elements and specific
actions found in the GS, while two other columns list the stakeholders and
the time frame. Lead stakeholders are highlighted in bold.

Some parts of the "stakeholders" especially in the area of IP are still in
brackets (i. e not agreed) and the main contention is whether WHO should be
the "lead" stakeholder.

According to sources, during the week, there were strong attempts by several
developed countries to remove WHO as a "stakeholder" especially where it
concerned IP. However, this attempt was not successful. Sources say that
there is agreement that WHO should play some role, but contention remains as
to whether WHO should be stated as a "lead" stakeholder.

Despite week-long informal negotiations on the 16 bracketed paragraphs of
the GS, consensus on the full text of the GS was only achieved on Saturday
morning in the Committee, wherein two remaining bracketed paragraphs were
cleared.

Bolivia, Cuba, Nicaragua, Dominican Republic, Argentina, Honduras, Ecuador,
and Venezuela were keen to reflect in the GS that the right to health takes
precedence over commercial interests.

However, due to significant opposition to its inclusion particularly from
the developed countries, this addition was dropped. However, Venezuela
insisted that it be recorded that the issue of the right to health over
commercial interests is a topic that continues to be relevant, further
adding that the WHO is the natural forum.

Ecuador also dropped its proposal to include reference to the WIPO
Development Agenda under a specific action in Element 5 (on application and
management of IP).

Of the entire GS, Elements 5 and 6 were among the most controversial. Some
specific actions under these elements (such as on anti-competitive measures,
TRIPS-plus) took hours of negotiations before agreement was achieved.

Areas where no agreement could be reached and thus have been deleted from
the GS include data exclusivity, developing guidelines for patent examiners
on applying patentability criteria and counterfeiting of medical products.

According to sources, another major achievement is the removal of specific
listing of diseases. Previously under the part on "Aims", what remained in
brackets was a footnote which referred to Type I, II and III diseases, and
which mentioned the "specific diseases" on which the draft strategy will
focus.

The final version of the GS removed the list of diseases and states as
follows under Aims: "For the purposes of this strategy, the definitions of
Type I, II and III diseases are as referred to by the Commission on
Macroeconomics and Health and further elaborated in the CIPIH report: Type I
diseases are incident in both rich and poor countries, with large numbers of
vulnerable populations in each. Type II diseases are incident in rich and
poor countries, but with a substantial proportion of the cases in poor
countries. Type III diseases are those that are overwhelmingly or
exclusively incident in developing countries. The prevalence of diseases and
thereby their categorization in the typology can evolve over time."

Overall, some key parts in Element 5 that have been agreed to in the GS are:

(1) development of user-friendly global databases which contain information
on the administrative status of health related patents;

(2) promote active and effective participation of health representatives in
IP related negotiations;

(3) providing as appropriate upon request in collaboration with other
competent international organizations technical support to countries that
intend to make use of TRIPS flexibilities;

(4) take into account where appropriate the impact on public health when
considering adopting or implementing more extensive intellectual property
protection than is required by TRIPS (TRIPS plus);

(5) encourage finding ways in ongoing discussions, to prevent
misappropriation of health related traditional knowledge and consider where
appropriate legislative and other measures to prevent misappropriation;

(6) explore and promote a range of incentives for R&D including addressing
where appropriate the de-linkage between the costs of R&D and the price of
health products.

Under Element 6 (on improving delivery and access), some key areas reflected
in the GS are:

(1) invest in developing health delivery infrastructure and encourage
financing of health products;

(2) encourage pool procurement mechanisms;

(3) promote ethical principles for clinical trials involving human beings as
a requirement of registration of medicines and health related technologies;

(4) support the production and introduction of generic version in developing
countries, through the development of national legislation and/or policies
that encourage generic production and entry including a regulatory exception
or Bolar type provision;

(5) frame and implement policies to improve access to safe and effective
health products;

(6) consider where appropriate the development of policies to monitor
pricing and to improve affordability of health products;

(7) consider where necessary taking appropriate measures to prevent the
abuse of IP by right holders or the resort to practices which unreasonably
restrain trade or adversely affect the international transfer of
technology.+