[Ip-health] IP Watch: WHO Draft Negotiating Text On IP Cautiously Received

[Alicia Martin-Santos]

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  WHO Draft Negotiating Text On IP Cautiously Received
    By Tove Iren S. Gerhardsen

The World Health Organization=92s (WHO) new draft negotiating document for =
the final round of what has become an intense process of analysing medicine=
s innovation and intellectual property narrows the focus to about a dozen d=
iseases but is wide-ranging on policy options, seemingly encompassing all p=
roposals. In early reactions, some criticised the draft for lacking specifi=
city, even to the point of being =93fundamentally flawed".

  The document will serve as a basis for negotiations at the second and las=
t meeting of the WHO Intergovernmental Working Group on Public Health, Inno=
vation and Intellectual Property (IGWG) on 5-10 November.

  The document (draft global strategy and plan of action, A/PH/IGWG/2/2) =
=93will be discussed at the regional consultations and should be the basis =
for negotiations at IGWG-2 in November,=94 a WHO source told Intellectual P=
roperty Watch. Meetings of WHO regional committees have been scheduled for =
August and September (IPW Monthly Reporter, Vol. 4., No. 6).

  The IGWG has been tasked with forming by May 2008 a =93global strategy an=
d plan of action=94 for boosting research and development (R&D) of medicine=
s for non-prioritised or neglected diseases, predominantly found in develop=
ing countries.

  The new document says (in a footnote) that the strategy will focus on 14 =
such diseases, including diabetes, cancer, HIV/AIDS and Chagas disease. Up =
to now, there has been some confusion about how many and which diseases mig=
ht be considered neglected.

  The document, released on 31 July, is based on a =93progress to date=94 d=
ocument prepared at the end of the first meeting of the IGWG, held on 4-8 D=
ecember 2006 (IPW, Public Health, 11 December 2006). The meeting agreed to =
focus discussion on eight areas or =93elements,=94 and these are elaborated=
 upon in the new document, both relating to the strategy and actions.

  In preparing the new text, the WHO secretariat considered additional comm=
ents and input from member states and others since the last meeting through=
 a hearing process that ended this spring. The text only lists what countri=
es want in positive terms, meaning that if some countries disagree with the=
 draft, they will have to request the deletion or amendment of existing par=
ts of the text.

  Strategy Includes Flexibilities, IP Management
  The document focuses first on the strategy and then on the actions. On th=
e draft strategy, the document lists a number of proposals, including promo=
ting legislation to apply flexibilities consistent with the World Trade Org=
anization (WTO) Agreement on Trade-Related Aspects of Intellectual Property=
 Rights (TRIPS) and other international agreements, promoting upstream R&D =
in developing countries by considering legislation compliant with TRIPS res=
earch exemptions, and =93promoting transfer of technology and the productio=
n of health products in developing countries.=94

  The draft also suggests promoting bilateral trade deals that do not conta=
in =93TRIPS-plus=94 requirements and that such bilateral deals should be =
=93regularly monitored=94 as to their impact on health, the pharmaceutical =
industry should reduce prices for developing countries, public private part=
nerships should be boosted and further discussion, a medical R&D treaty sho=
uld be supported and complementary incentive schemes separating innovation =
from prices should be explored and implemented.

  The draft strategy specifically encourages WHO to get more involved in IP=
 in collaboration with WTO and the World Intellectual Property Organization=
 to =93strengthen education and training in the management of intellectual =
property.=94
  Management of IP also is an element in the document without further speci=
fication of what this would mean. For example, it says, =93There is a cruci=
al need to strengthen capacities in developing countries to manage intellec=
tual property.=94

  The strategy should be reviewed by the World Health Assembly every two ye=
ars, starting at the end of 2009, with a comprehensive evaluation every fou=
r years, extending the process until 2015, the document says.
  The plan of action is laid out separately, still around the eight element=
s. It lists who would do what by when. For example, WHO would identify gaps=
 in R&D for neglected diseases in 2008, the pharmaceutical industry would h=
elp facilitate upstream research by 2008-2015, WHO would coordinate the pro=
cess until 2015 and governments would work on prioritising strategies and i=
ncreasing funding for R&D (especially developing country governments). The =
actions involve a wide range of stakeholders, including nongovernmental org=
anisations, UN organisations, the industry and research institutions.

  Early Criticism over Breadth

  But the sheer breadth of the document has been criticised.
  =93The draft plan of action is fundamentally flawed because it is based o=
n the premise of trying to accommodate conflicting points of view and the r=
esult is 80 un-prioritised =91specific actions=92 which are not really spec=
ific or actionable at all,=94 said a close observer who asked to remain ano=
nymous. =93The =91specific actions=92 are simply aspirational - they embody=
 no specific commitments by governments to particular actions.=94

  =93A real plan would focus on a few key priorities - for finance, institu=
tions and new incentive mechanisms; set targets for which governments or ot=
her stakeholders could be held accountable; and identify lead institutions =
responsible for delivering and monitoring outcomes envisaged in the plan. B=
ecause of the process involved in the IGWG it will now be very difficult to=
 turn this sow=92s ear into a silk purse,=94 the source said.

  Ellen =91t Hoen of M=E9decins Sans Fronti=E8res also had mixed feelings a=
bout the document. =93It has =91everything to be done by anyone=92 in it,=
=94 she said. =93So far, the document lacks clear direction and allocation =
of responsibilities. However, it is encouraging to see that it does not shy=
 away from including new proposals such as a patent pool to deal with immed=
iate access issues and new rules to incentivise R&D.=94

  A pharmaceutical industry source told Intellectual Property Watch that it=
 was welcome that the document reflected the IGWG=92s original scope of wor=
k laid out in the 2006 report of the WHO Commission on Intellectual Propert=
y Rights, Innovation and Public Health (CIPIH) and had the ambition to cove=
r =93it all.=94 But the source was concerned that the focus appeared to be =
not only on IP but even more narrowly on flexibilities related to TRIPS and=
 compulsory licensing in particular.

  A compulsory license is issued by a government and allows the use of a pa=
tented subject und certain conditions (for example, for non-commercial use)=
 without the consent of the patent holder.

  As for suggestions to avoid TRIPS-plus in bilateral trade deals, that was=
 already a =93done deal=94 as the United States has already adopted restric=
tions in this area, the industry source said (IPW, WTO/TRIPS, 24 July 2007)=
.

  The industry source said that the risk was that if industry accepted a br=
oad and balanced approach, some of the NGOs and stakeholders would only be =
interested in two or three of the bullet points in the plan. If the only ou=
tcome of the IGWG process would be that WHO helps countries with TRIPS flex=
ibilities, =93this is a failure,=94 the industry source said.

  The document was =93cautiously welcomed=94 by international civil society=
 observers, Knowledge Ecology International (KEI) said. Spring Gombe and Th=
iru Balasubramaniam of KEI said: =93[T]he draft contains some welcome state=
ments of access to medicines, support for the use of TRIPS flexibilities an=
d new methods to create incentives for R&D for new medicines. However, the =
plan of action is vague with neither a clear sense of ownership nor any sen=
se of urgency. There is a further danger =85 that if all stakeholders are c=
onsidered equally responsible for every point of the plan of action, there =
can be no one held accountable when no action is taken. The biggest omissio=
n is the absence of any reference to money.=94

  The eight elements are: Prioritising R&D needs, promoting R&D, building a=
nd improving innovative capacity, transfer of technology, management of int=
ellectual property, improving delivery and access, ensuring sustainable fin=
ancing mechanisms and establishing monitoring and reporting systems. They =
=93provide the organising principles for the plan of action,=94 the documen=
t states.

  Tove Gerhardsen may be reached at tgerhardsen@ip-watch.ch.



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