[Ip-health] Brazil submission to WHO/IGWG

[James Packard Love]

http://www.keionline.org/misc-docs/BrazilIGWG.pdf

Rev 2 =96 26/2/07 =96 18:33

VERS=C3O PARA COMENT=C1RIOS AT=C9 27/2/07 =96 17:00

Draft Global Strategy and Plan of Action to provide a medium-term
framework based on the recommendations of the Commission on
Intellectual Property, Innovation and Public Health, to secure, inter
alia, an enhanced and sustainable basis for needs-driven, essential
health research and development relevant to diseases that
disproportionately affect developing countries, proposing clear
objectives and priorities for research and development, and
estimating funding needs in this area.
26.02.2007


I Interpretation of the mandate of Resolution WHA59.24

1)=09The Global Strategy and Plan of Action shall constitute a medium-
term framework of reference for needs-driven R&D, relevant to
diseases that disproportionately affect developing countries. The
need to redirect R&D is hereby recognized;

2)=09The Global Strategy and Plan of Action must ensure, among other
things, an enhanced and sustainable  basis for R&D. The Global
Strategy and Plan of Action must, therefore, result in the creation
of an innovative and stable financing mechanism. The UNITAID case may
serve as an example, although with different purposes. The Global
Strategy and Plan of Action must also facilitate access to research
outcomes and tools by developing countries and, in this connection,
measures should be envisaged with a view to ensure that intellectual
property regulations do not constitute a barrier thereto.

3)=09The Global Strategy and Plan of Action shall also secure
(according to the reading of the expression =93inter alia=94) that the
products needed by developing countries that will result from the R&D
medium-term framework of reference shall be (for developing
countries): a) available in sufficient quantities; b) acceptable for
users; c) effective and of good quality; d) affordable for public or
individual users;

4)=09The Global Strategy and Plan of Action shall constitute an agreed
framework of reference to ensure the complete and unobstructed
implementation of the TRIPS flexibilities (use of compulsory license;
use of the =93Bolar=94 exception and of the research exemption;  non-
linkage between regulatory approval and granting of patents; measures
to revert anti-competitive practices, such as the strict application
of patentability criteria). The promotion of the full use of the
TRIPS flexibilities should ensure the immediate entry of generic
drugs into the market upon patent expiry, for which reason measures
such as the establishment of a =93linkage=94 between the granting of
patents and the regulatory approval procedures is unwarranted. The
Global Strategy and Plan of Action should also foster the use of the
Doha Declaration in its entirety in light of the public health needs
of developing countries and also monitor the operation of the
December 6, 2005 amendment to the TRIPS Agreement with a view to
point out possible difficulties that might be present in the
production and/or export, export and/or import of products
manufactured under the mechanism established by the said amendment;
II Background for the Global Strategy and of Plan of Action

1)=094,8 billion people living in developing countries (80% of the
world population);

2)=09Of those 4,8 billion, 2,7 billion live with less than US$ 2 a day
(56,25% of the world population);

3)=09Communicable diseases account for 50% of the developing countries
burden of disease;

4)=09Non-communicable diseases have an increasing impact on the burden
of disease of developing countries;

5)=09 Poorness affects directly the acquisition of health products,
especially in developing countries.

III Principles of the Global Strategy and Plan of Action

1)=09The issues of public health rule over the issues of trade. A
paradigm shift from a trade-centered world to a health-centered world
is necessary;

2)=09=93Only through broad and sustained efforts to create a shared
future, based upon our common humanity in all its diversity, can
globalization be made fully inclusive and equitable=94 (from the
Millennium Declaration). It is only through those efforts that it
will be possible to overcome the needs o developing countries and
economies in transition;

3)=09a)  reduce by two thirds, between 1990 and 2015, the under-five
mortality rate; b) reduce by three quarters, between 1990 and 2015,
the maternal mortality ratio; c) halt by 2015 and begun to reverse
the spread of HIV/AIDS; d) halt by 2015 and begun to reverse the
incidence of malaria and other major diseases. The compromise of the
Heads of State with the Millennium Development Goals will only be
achieved, among other things, with the availability and affordability
of drugs, vaccines and diagnostic kits, in sufficient quantities, of
good and efficient quality and in acceptable forms;

4)=09To develop a global partnership for development; to develop
further an open, rule-based, predictable, non-discriminatory trading
and financial system; in cooperation with pharmaceutical companies,
provide access to affordable, essential drugs (vaccines and
diagnostic kits) in developing countries in sufficient quantities, of
good and efficient quality and in acceptable forms;

5)=09In order to achieve the above mentioned millennium development
goals with expected efficiency and efficacy it is imperative that: a)
developed countries increase their official development aid (ODA); b)
a coordinating mechanism among donors =96 countries, UN and its
specialized agencies, partnerships, alliances, foundations, NGOs =96 be
set up to increase the efficiency and efficacy of actions of aid and
development, avoid duplications; c) an international effort is put in
motion to help developing countries increase their capacities;

6)=09The intellectual property system has proved not to live up to the
alleged positive effects over the increment of innovation for the
development of health products necessary for diseases that
disproportionately affect developing countries, a perception that
pervades the IP Commission Report. Increased attention should be
drawn to negative effects that intellectual-property regulations
might produce over the access to medicines as well as to research in
the medical area, with a view to recommend measures aimed at curbing
possible distortions that might be identified in this domain.

7)=09Until the time the medium-term framework is adopted, the
international debate on the full use of the flexibilities provided
for in the TRIPS Agreement shall be updated with the support of the
WHO and all the UN system, with a view to incorporate them into the
national legislations of developing countries. The above mentioned
flexibilities refer, inter alia, to the use of: a) compulsory
licensing in accordance with Article 31 of the TRIPS; b) research
exemption; c) early working, also known as the Bolar exception; d)
measures to revert anti-competitive practices, such as the strict
application of patentability criteria. The promotion of the full use
of the TRIPS flexibilities should ensure the immediate entry of
generic drugs into the market upon patent expiry, for which reason
measures such as the establishment of a =93linkage=94 between the
granting of patents and the regulatory approval procedures is
unwarranted. Also with the purpose of prompting the immediate entry
of generics into the market upon patent expiry, concrete measures
should be examined to protect undisclosed information in a manner
that is compliant with Article 39.3 of the TRIPS Agreement
(=93protection against unfair commercial use=94) but that does not
require the granting of exclusive rights or compensation;

8)=09The health products, necessary for developing countries, that will
result from the medium-term framework =96 drugs, vaccines and
diagnostic kits =96 shall be affordable for public health or individual
users; shall be available in sufficient quantities to satisfy demand;
shall be acceptable to users; shall be efficient and of good quality;
shall be acceptable (based on General Comment n=BA 14 of ECOSOC on
Article 12 of the International Convention on Economic, Social and
Cultural Rights relative to the meaning of the right to health). It
must be pointed out that target 13 of goal 8 of the Millennium
Development Goals is the same in principle;

9)=09Until the time the medium-term framework is adopted, the immediate
entry into the market of generic producers shall be stimulated and
supported by the WHO and the UN system.

IV Basis for the Global Strategy

1)=09Left to itself, the market and some of its incentives and
mechanism, such as patent protection, are not by themselves capable
of establishing enduring and stable conditions for research,
development and production of health products relevant for developing
countries. In that context, an innovative financial mechanism must be
created to ensure that financial resources are invested in the
research, development and production of health products relevant for
developing countries. Besides needed structural measures in terms of
intellectual property, the establishment of such an innovative
financial mechanism, with financial resources coming from a specific
taxing would ensure continuity and stability, both lacking in almost
all the funds created in support of the Millennium Development Goals.
Such a financial mechanism would have the advantage of being of a
structural nature rather than wholly dependent on unknown variables.
A good example might be UNITAID, although with very different purposes;

2)=09One of the fundamental problems in dealing with health questions
in developing countries is the urgent necessity to revert the brain
drainage of health professionals. It is therefore necessary in that
context to support the alliance for health work with a view to
strengthen the position of developing countries and promote
partnerships to create an effective health working force;

3)=09Some developing countries have fragile health systems, making it
harder for the health systems to deliver health. A strong mechanism
to support the development of capacities for the optimal use of
external resources must be put in place to correct that. One of the
prerequisites of such a mechanism is the correct formulation of
priorities that will in turn enable the coming up of effective and
consistent solutions. For that purpose it is necessary to support the
creation or the strengthening of schools of public health, of
national institutes of public health, through which evidence based
decisions will be available in those countries. The work being done
by the International Alliance of National Public Health Institutes is
clearly a good reference in this matter;

4)=09Professor Hiroko Yamane, one of the authors of the Commission
Report stated that =93Nowhere (in the Report) is there a clear picture
of what types of medicines (old or novel) are actually needed, and
which policy tools and incentives are specifically required=94. It is
therefore necessary =96 in case this hasn=92t already been done =96 to
establish on a consensual manner among specialists what types of
drugs, vaccines and diagnostic kits are needed by developing countries;

5)=09Other than R&D there are many issues that must be considered to
support projects geared to the development of health products.
Strengthening of health systems, for example, is a prerequisite. The
WHO could convene in that context an ad hoc committee of specialists,
with the participation of national authorities, to draw up a needs-
driven agenda  and the solutions that can be put in place in short,
middle and long time frames. The =93needs-driven agenda=94 would normally
include the necessities of human resources in all relevant areas,
making possible the build=97up of a network of interrelated competences
that must be put in place in a can-do public health system.
Inspiration could be thought after the model of the UNAIDS =93Three
Ones=94 principle: 1) one national institution to coordinate the
efforts to put in place the =93needs-driven agenda=94; 2) one common
strategy to build the =93needs-driven agenda=94; 3) one authority to
evaluate and monitor the work done. Nothing of this presently exists,
but it must be put in place in order to achieve the possibility of
governing interdependence;

6)=09Until the medium-term framework is adopted there will be need to
establish a governance for the international health initiatives. The
=93Three Ones=94 principle could be put to work here for the purpose of
having an ordered structure that will help focus and converge the
different initiatives, resources flows and interests. Such a
structure could be: 1) an institution to coordinate the workings of
the =93needs-driven agenda=94 that in essence would consist in bringing
in focus the different initiatives, resources flows and interests.
This institution could be WHO; 2) a global strategy to do 1). This
would probably need the drafting of an agreed set of principles and
action plan. Again it would be WHO the natural forum for this to be
carried on; 3) an independent agency to evaluate and monitor the work
done by WHO. In any case it is essential that the principles of the
Rome Declaration act as a reference for any work on cooperation with
potential donors.

7)=09Structural measures on intellectual property play a critical role
in the development and access to drugs, vaccines and diagnostic kits.
In this connection, the following aspects, inter alia, should be
discussed and recommendations made: a) measures that ensure special
conditions of access by research institutions in developing countries
to research results or research tools regarding diseases that might
affect those countries; b) measures to ensure full implementation of
the flexibilities that facilitate the immediate entry of generic
medicines  into the market (e.g., the broadening of cases of research
exemption); c) measures that ensure that generic drugs are available
on patent expiry; d) measures that announce world-widely information
on patents that are expiring and also guarantee access to the
necessary information, by disclosing the patent in a manner
sufficiently clear and complete for the invention to be carried out
by a person skilled in the art, as well as the best mode for carrying
out the invention; e) measures to improve the quality of patent
examination, with a view to prevent the granting of =93broad patents=94;
f) monitoring the implementation of the amendment of the TRIPS
Agreement, adopted on December 6, 2005, in order to identify possible
difficulties that might arise in its operation, and suggest possible
measures to solve such difficulties.


V The Global Strategy

1)=09Operative paragraph 3 of Resolution WHA59.24 establishes an
Intergovernmental Working Group open to all interested Member States
to draw up a global strategy and plan of action in order to provide a
medium-term framework based on the recommendations of the Commission
with the aim of securing an enhanced and sustainable basis for needs-
driven, essential health research and development relevant to
diseases that disproportionately affect developing countries. In that
context the global strategy shall:

i)=09Establish a R&D agenda that covers the health needs of developing
countries, in accordance with the purpose of Resolution WHA 59.24;

ii)=09Propose partnerships to carry on the above R&D agenda;

iii)=09Propose innovative financial with a view to finance the
activities that result from the R&D agenda;

iv)=09Propose a governance system for the innovative financial mechanism;

v)=09Ensure that the health products that result from the medium-term
framework, necessary for developing countries =96 drugs, vaccines and
diagnostic kits =96 shall be affordable for public health or individual
users; shall be available in sufficient quantities to satisfy demand;
shall be acceptable to users; shall be efficient and of good quality;
shall be acceptable;

2)=09Until the medium-term framework is adopted, immediate entry of
generic producers shall be stimulated and supported by the WHO and
the UN system;

3)=09Until the medium-term framework is adopted the international
debate on the full use of the flexibilities provided for in the TRIPS
Agreement shall be updated with the support of the WHO and all the UN
system, with a view to incorporate them into the national
legislations of developing countries. The above mentioned
flexibilities refer, inter alia, to the use of: a) compulsory
licensing in accordance with Article 31 of the TRIPS; b) research
exemption; c) early working, also known as the Bolar exception; d)
measures to revert anti-competitive practices, such as the strict
application of patentability criteria. The promotion of the full use
of the TRIPS flexibilities should  ensure the immediate entry of
generic drugs into the market upon patent expiry, for which reason
measures such as the establishment of a =93linkage=94 between the
granting of patents and the regulatory approval procedures is
unwarranted. Also with the purpose of prompting the immediate entry
of generics into the market upon patent expiry, concrete measures
should be examined to protect undisclosed information in a manner
that is compliant with Article 39.3 of the TRIPS Agreement
(=93protection against unfair commercial use=94) but that does not
require the granting of exclusive rights or compensation;

VI The Plan of Action

1)=09Strengthen public health schools and the national institutes of
health , with a view to generate scientific evidence and create a
critical mass of specialists in health to ensure the establishment
and support of all public health programs;

2)=09Promote the necessary training to absorb transference of technology;

3)=09Training of personnel and strengthening of the warehouse and
distribution systems for drugs, vaccines and diagnostic kits;

4)=09Training of personnel and strengthening of clinical and
epidemiological laboratories;

5)=09Propose measures to improve governance of the whole set of
donnors, with a view to optimize humanitarian actions in the area of
health;

6)=09Ensure facilitated access to research outputs or research tools
that may be of relevance to meet public health needs of developing
countries. Research institutions in developing countries should be
afforded the possibility of taking part in research activities that
might have a bearing on diseases affecting them. Therefore, measures
should be devised to permit the availability of research outputs and
tools for developing countries;

7)=09Ensure research exemption. In order to guarantee that research
activity in developing countries is carried out without the risk of
colliding against =93patent thickets=94, the issue of research exemption
should be examined with a view to recommend the widening of cases
where this exemption applies;

8)=09Ensure early working exception: Examine the impact of provisions
seeking to establish a =93linkage=94 between market approval procedures
and the patent system over the full implementation of early working
exceptions and recommend ways to ensure that the exception can be
applied to its full extent;

9)=09Discuss concrete measures to ensure that countries are able to put
in place measures that allow for the immediate introduction of
generic medicines as the patent term expires;

10)=09Assess the impact produced by data exclusivity regulations and
provisions that establish linkage between the patent system and
market approval procedures over the immediate entry of generic
medicines in the market after the expiration of the patent term;

11)=09Examine concrete measures that can be implemented to comply with
the requirement for the protection of undisclosed test data against
unfair commercial use, as set out by the TRIPS Agreement, that do not
involve the granting of property rights neither the need to
remunerate the party concerned;

12)=09Identify ways and means to fully implement the flexibilities
provided for in the TRIPS Agreement with a view to ensure access to
medicines;

13)=09Consider measures to ensure the strict application of the
patentability criteria in order to obtain the best interpretation for
public health in line with the stated in paragraph 4 of Doha
Declaration on TRIPS and Public Health;

14)=09Asses the impact of lax application of the patentability criteria
over possible research that could be developed by competitors and
recommend measures to be taken in order to prevent such anti-
competitive practices;

15)=09Point out possible difficulties that might be present in the
export of products manufactured under compulsory licensing, pursuant
to the amendment of the TRIPS Agreement and propose possible ways to
solve these difficulties;

16)=09Recommend an effective participation of health representatives on
IP negotiations in order to ensure that the results of the
regulations take into consideration public health flexibilities and
safeguards.




----------------------------------------------
James Packard Love
Knowledge Ecology International
http://www.keionline.org
james.love@keionline.org
Washington, DC +1.202.332.2670

"If everyone thinks the same: No one thinks." Bill Walton"