[Ip-health] The IGWG bracketed text for the WHA

[James Love]

Spring Gombe put this together.  These are the paragraphs that are still
unresolved, and will be negotiated at the WHA in a couple of weeks.
Jamie

---------
Elements still in brackets:

The focus

3. [Governments (2), the pharmaceutical industry, charitable foundations
and nongovernmental organizations have taken initiatives in recent years
to develop new products against diseases affecting developing countries
and to increase access to existing health products and medical devices.
However, these initiatives are not sufficient to surmount the challenges
of meeting the goal of ensuring access and innovation for needed health
products and medical devices. More efforts should be made to avoid
suffering and reduce preventable mortality and to meet the
health-related Millennium Development Goals and to implement States=E2=80=
=99
obligations arising under applicable human rights treaties with
provisions relevant to health.[and to implement obligations arising
under human rights treaties with provisions relevant to health.]/[and to
implement health-related provisions contained in the international human
rights instruments.]]

footnote 2 2
 [Where appropriate, refers equally to regional economic integration
organizations in their areas of competence and in accordance with WHA
Resolution 59.24 , para 3(2).]

4.  [Proposals should be developed for health-needs driven research and
development that include a range of incentive mechanisms, including also
addressing the linkage between the cost of research and development and
the price of medicines, vaccines, diagnostic kits and other health-care
products and a method for tailoring the optimal mix of incentives to a
particular condition or product with the objective of addressing
diseases that disproportionately affect developing countries.]
(consensus pending USA)


The aim

14(b)=09Promote R&D focusing on Type II and Type III diseases and the
specific R&D needs of developing countries in relation to Type I
diseases1; (consensus except for footnote)

*footnote:
 [The Commission on Macroeconomics and Health as referred to in the
CIPIH report, specifies the definitions of Type I, II and III diseases,
and the specific diseases on which this draft strategy focuses, are as
followed: Type I diseases are incident in both rich and poor countries,
with large numbers of vulnerable populations in each. The strategy will
focus on the Type I diseases which are increasingly prevalence in
developing countries, for example, diabetes, cardiovascular diseases and
cancer.  Type II diseases are incident in both rich and poor countries,
but with a substantial proportion of the cases in poor countries.  For
the purposes of the Strategy, the focus is on HIV/AIDS and TB.  Type III
diseases are those that are overwhelmingly or exclusively incident in
developing countries.  For the purpose of the strategy, the focus is on
the nine neglected infectious diseases that disproportionately affect
poor and marginalized population, prioritized by the UNICEF/ UNDP/ World
Bank/ WHO Special Programme for Research and training in Tropical
Diseases: Chagas disease, dengue and dengue haemorrhagic fever,
leishmaniasis, leprosy, lymphatic filariasis, malaria, onchocerciasis,
schistosomiasis and human African trypanosomiasis. Nevertheless, Member
States can either expand or narrow the list of diseases as appropriate.]
(will be revisited)

The Principles
17. [The right of everyone to the enjoyment of the highest attainable
standard of physical and mental health is recognized [as a fundamental
human right] in the international Human Rights
[commitments]/[instruments],[and as a fundamental human right as
recognized]/ [in particular,] in the International Covenant on Economic,
Social and Cultural Rights ][Article 12.1.] (consensus to delete pending
Ecuador)

18. [The objectives of public health and the interests of trade should
be appropriately [coordinated and  mutually supportive]/[balanced and
coordinated.]]

or

[The right to health takes precedence over commercial interests.]

The elements

Element 4: Transfer of technology

4.1(b)=09 promote transfer of technology and production of health products
in developing countries through investment and capacity building,
including by providing guidance on appropriate technologies. (consensus
pending USA)

Element 5: Application and management of intellectual property to
contribute to innovation and promote public health

5.1(a)=09encourage and support the application and management of
intellectual property in a manner that maximises health related
innovation and that is consistent with the provisions of the TRIPS
Agreement and instruments related to that agreement and meets the
specific R&D =EF=81=9Band access) needs of developing countries. (consensus
pending consideration by Suriname)


5.(b) [avoid the incorporation of TRIPS-plus measures in any trade
agreements and in national legislation that may have negative impact on
access to health products or treatments in developing countries]

6.

or

[delete subparagraph (b)]

or

[encourage those Member States, which so desire, when incorporating
measures beyond  TRIPS to take into account the impact on access to
health products in light of public health priorities without prejudice
to the sovereign rights of Member States]


5.3 (b) [assess the impact of data-exclusivity on access to medicines]

or

[delete subparagraph (b)] (move to Element 5.2)

5.3 (c) [consider adopting and/or effectively implementing competition
policies in order  to prevent or correct anti-competitive practices
related to health products; and the use of pro-competitive measures
under [the intellectual property law and national legislation]]

5.3 (d) [Consider developing guidelines for patent examiners on how
properly to apply  patentability criteria in a way that promotes high
quality patents and while taking into  account a public health
perspective.]

or

[delete (d)]

5.3(e) [avoid restrictions for the use of or reliance on undisclosed
test data in ways that would exclude fair competition or impede the use
of flexibilities built into TRIPS]

or

[delete (e)]

Element 6: Improving delivery and access

6.2 (e) [To consider developing and strengthening, where appropriate,
legislative,  regulatory oversight mechanisms and other measures to
minimize the risks to public health resulting from the [production,
trafficking and] use of drugs which have been counterfeited2,
adulterated,[have expired or are substandard, including by prohibiting
the production and trafficking of counterfeit and substandard
products]/[ have expired,  through health promotion, surveillance and
health regulation.]]

footnote* 2
 [Definition of counterfeit medicines: WHO defines counterfeit medicines
as medicines which are deliberately and fraudulently mislabeled with
respect to identity or source. Counterfeiting occurs both with branded
and generic products and counterfeit medicines may include products with
the correct ingredients but fake packaging, with wrong ingredients,
without active ingredients or with insufficient active ingredients.]

OR

[A medical product is counterfeit when there is a false representation
in relation to its identity, history, or source. This applies to the
product, its container, packaging or other labelling information.
Counterfeiting can apply to both branded and generic products.
Counterfeits may include products with correct ingredients/components,
with wrong  ingredients/components, without active ingredients, with
incorrect amounts of active ingredients, or with fake packaging.]


6.3(d) [encourage pharmaceutical companies to continue or to adopt
pricing policies, including differential pricing policies, that are
conducive to promoting access to quality, safe, efficacious and
affordable health products in developing countries, consistent with
national law] (consensus pending USA)

6.3 (e) [stimulate the development of policies to monitor pricing to
improve affordability of health products and strengthen WHO=E2=80=99s ongoi=
ng
work on pharmaceutical pricing]
(consensus pending USA)

6.3 [(f) adopt or effectively implement competition policies in order to
prevent or remedy anti-competitive practices related to the use of
medicinal patents, including the use of measures that favour competition
available under intellectual property law] (cross ref to potential
duplication with para 5.3(c))


--
_____________________________
James Love, Knowledge Ecology International (KEI)
http://www.keionline.org, mailto:james.love@keionline.org
voice +1.202.332.2670, fax +1.202.332.2673, US mobile +1.202.361.3040, Gene=
va mobile +41.76.413.6584

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