[Ip-health] IP-Watch: Lamy Challenges Discontented WTO Members To Use TRIPS Public Health Review

[Thiru Balasubramaniam]

http://ip-watch.org/weblog/wp-trackback.php?p=3D1357

Intellectual Property Watch

9 December 2008
Lamy Challenges Discontented WTO Members To Use TRIPS Public Health
Review

By William New
Confronted with longstanding assertions that World Trade Organization
rules intended to bring greater access to medicines to poor countries
are not working, WTO Director General Pascal Lamy said Tuesday
discontented members should use the annual review of those rules if
they have a complaint.

=93It is precisely to address these kinds of situations that WTO members
agreed to subject this system to periodic review,=94 Lamy told a
generics industry gathering. =93I would note that WTO members did not
raise concerns during the last annual review of the operation of the
system and instead, led by the African Group, reaffirmed the system
two years after its adoption.=94

Lamy spoke to the 11th annual conference of the International Generic
Pharmaceutical Alliance being held in Geneva from 8-10 December.
Lamy=92s four-year term as director general ends late next year, but he
will run again and so far appears to be unopposed.

At WTO, the 1994 Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS) sets the rules on access to medicines. In
August 2003, the WTO General Council adopted a Decision on the
Implementation of Paragraph 6 of the 2001 Doha Declaration on the
TRIPS Agreement and Public Health. Paragraph 6 called for a resolution
to the problem of countries lacking pharmaceutical manufacturing
capabilities but who see a need to obtain cheaper medicines through a
compulsory licence. The 2003 Decision created a waiver to the WTO rule
that products manufactured under compulsory licence must be
substantially all for the domestic market.

Paragraph 8 of the 2003 Decision required the TRIPS Council to review
annually the functioning of the system set out in the Decision with a
view to ensuring its effective operation, and annually report on its
operation to the General Council.

So far, Lamy said, no country has raised significant concern in this
review.

But a developing country official attending the speech afterward
questioned the validity of the review process. =93What review?=94 he said.
=93There isn=92t really a review.=94

Only one developing country has used the paragraph 6 process so far in
five years =96 Rwanda, in September, with Canada. Health activists have
repeatedly said the waiver is too cumbersome to be useful and effective.

Asked afterward whether intimidation by developed nations might be
hindering smaller economies from using flexibilities, Lamy told
Intellectual Property Watch that Rwanda offers evidence to the contrary.

But in his speech, he left open the possibility that the WTO processes
of continuous improvement might ultimately lead to further changes.
=93Just like any WTO agreement, the paragraph 6 system should be
periodically reviewed and lessons drawn from these evaluations so that
the WTO can continue its effort to make it work as a contribution
among others to enhancing access to medicines,=94 he said.

Generics producers tend to be sceptical of rules protecting patent
rights holders, most of whom are in developed nations. In recent
years, critics have increasing pointed to patents as a deterrent to
the effective flow of critical medicines to the poor worldwide.

But Lamy gave a view frequently repeated by the brand-name industry:
that intellectual property rights =93constitute only one piece of a much
bigger puzzle that determines the level of access to medicines in a
given country.=94 The other factors include infrastructure and the
national health system, or the procurement regime. And he highlighted
the industry argument that tariffs on imports of healthcare products
are problematic, plus cited the need for stronger protection against
counterfeit products as well.

Other Views

Other participants highlighted shortcomings in the current IP system
and TRIPS in relation to access to medicines. Michelle Childs of
M=E9dicins Sans Fronti=E8res (MSF) pointed to a problem of patent linkage,
in which she said US and European originator industries are pressuring
drug authorities to link the market approval process of generic
medicines to the patent status of the reference product. This has the
effect of bolstering patents without proper consideration, interferes
with the ability to use TRIPS flexibilities and is TRIPS-plus, she said.

Childs discussed a proposed patent pool approach for medicines,
proposed by UNITAID and recognised by key World Health Organization
bodies. She said it offers potential benefits to generics producers.

Christoph Spennemann of the UN Conference on Trade and Development and
others described the impact of data exclusivity on generics
production, as originator companies in the past have managed to get
5-10 years of exclusive rights over their test data, which can delay
the introduction of generics after the patent expires.

Julia Pike, IP director and counsel at generics distributor Hospira,
described the legal battles happening around the world between
generics and brand-name companies. She and Yehuda Livneh, general
patent counsel at generics producer Teva Pharmaceutical, said patent
holders must see a bigger financial impact to losing cases in order to
deter them from abusing their patent rights. Involving third parties
and measuring damages can increase this impact, Pike said. Teva won a
big case against Abbott in the Netherlands but the cost was not very
high to Abbott when it lost, one said.

Roger Kampf of the WTO, speaking on his own behalf, raised doubt that
industries would be very interested in patent pooling, and said that a
proposal by Pike for a common Europe-wide litigation framework with
common procedures would be a TRIPS-plus measure. =93That shows that
TRIPS-plus does not always come from the R&D industry, but can also
come from your side from time to time,=94 Kampf said.

Separately, a presenter from China at the event showed statistics that
said China will be number two in the generics industry after the
United States by 2012.

Lamy: =91Guardian of TRIPS Flexibilities=92

Lamy highlighted the rights of WTO members to use flexibilities in
TRIPS for public health reasons. An even organiser referred to Lamy as
the =93guardian of the TRIPS flexibilities,=94 which are important to the
generics industry.

Lamy acknowledged that so-called TRIPS-plus provisions =96 those that
reach beyond what was agreed in TRIPS =96 may have a negative impact in
bilateral trade agreements with small countries. =93Certain of the
provisions may potentially have a bearing on access to medicines, as
well as on the generic industry,=94 he said. But he noted that developed
countries negotiating such terms have more recently insisted such
provisions are =93not meant to affect the ability of the parties to take
measures to protect public health.=94

In the end, Lamy called on the generics industry, with its ample
global market share, to participate more fully as a stakeholder on
issues of access to medicines. The problems have ameliorated, but
further improvements can follow.

=93We are open to review, to draw lessons on what works and does not
work,=94 Lamy said. =93I accept this notion that I should be guardian of
the TRIPS flexibilities.=94

WTO Negotiations: TRIPS on Sideline

Meanwhile, in ongoing negotiations at the WTO, TRIPS issues appear to
be on hold while agriculture and industrial goods talks are addressed
and a decision is made on whether to hold a ministerial next week.
Norwegian Foreign Minister Jonas Store is being tapped again by Lamy
to lead discussions on TRIPS issues but the minister is waiting to
come in a ministerial context, not now, an official from a TRIPS
amendment proponent nation said.

William New may be reached at wnew@ip-watch.ch.


------------------------------------------------------------


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997