[Ip-health] SUNS: Members discuss implementation of TRIPS "Para 6" solution

[Thiru Balasubramaniam]

SUNS #6864 Tuesday 16 February 2010

south-north development monitor SUNS [Email Edition]

thirtiethyear  6864  tuesday  16  february  2010

Trade: Members discuss implementation of TRIPS "Para 6" solution

Geneva, 15 Feb (Kanaga Raja*) -- WTO Members held an informal
consultation on 12 February on the implementation of the "Paragraph 6"
solution in respect of the TRIPS Agreement aimed at helping developing
countries with insufficient or no manufacturing capacities in the
pharmaceutical sector to import cheaper generic medicines produced
under compulsory licensing.

In Paragraph 6 of the Doha Declaration on the TRIPS Agreement and
Public Health (November 2001), Ministers recognized that WTO Members
with insufficient or no manufacturing capacities in the pharmaceutical
sector could face difficulties in making effective use of compulsory
licensing under the TRIPS Agreement.

They instructed the Council for TRIPS to find an "expeditious
solution" to this problem.

In a Decision of the General Council of 30 August 2003, WTO Members
agreed that the obligations of an exporting Member under Article 31
(f) of the TRIPS Agreement shall be waived with respect to the grant
by it of a compulsory license to the extent necessary for the purposes
of production of a pharmaceutical product and its export to an
eligible importing Member in accordance with the terms set out (in the
Decision).

Article 31(f) of the TRIPS Agreement states that production under
compulsory licensing must be predominantly for the domestic market.
This provision has hampered the ability of countries that are unable
to produce pharmaceutical products from importing cheaper generics
from countries where pharmaceuticals are patented, according to trade
officials.

In the Decision, Members agreed that the waiver will be in force until
an amendment is made to the TRIPS article.

In 2005, Members approved changes to the TRIPS Agreement making
permanent the 2003 Decision. This will be incorporated into the TRIPS
Agreement when two-thirds of the Membership has ratified the
amendments. There was a deadline of 1 December 2007 set for this, but
the General Council extended the deadline to 31 December 2009 and
subsequently to 31 December 2011. The waiver remains operative till
then, according to trade officials.

According to trade officials, Members want to improve the present
annual reviews in the TRIPS Council on how the waiver of 2003 (and the
2005 amendment to the TRIPS Agreement, when it takes effect) is working.

Paragraph 8 of the Decision on the Implementation of Paragraph 6 of
the Doha Declaration on the TRIPS Agreement and Public Health of 30
August 2003 provides that the Council for TRIPS shall review annually
the functioning of the system set out in the Decision with a view to
ensuring its effective operation and shall annually report on its
operation to the General Council.

(At a meeting of the TRIPS Council on 27-28 October 2009, several
countries including Egypt, on behalf of the African Group, Tanzania,
on behalf of the Least Developed Countries, India, Ecuador, Pakistan,
Brazil and Venezuela, called for consultations to identify any
difficulties encountered in the use of the system and suggestions to
solve these problems. See IP/C/53.)

The Chair, Ambassador Karen Tan of Singapore, held the consultation in
order to provide a platform for Members to share their experiences,
trade officials said.

Only Canada provided a description of its own experience in respect of
a compulsory license issued for a medicine to be exported to Rwanda.

So far, Canadian exports to Rwanda are the only time that the system
has been used, said trade officials. Canada said that the shipments to
Rwanda took longer than expected because the company seeking a
compulsory license needed time to find an interested importing
country, as well as on account of  Rwanda's procurement tendering
procedures.

(Canada listed several key dates in implementing the WTO system and
its Access to Medicines Regime in order to explain why it took some
time for the shipments to reach Rwanda. The Access to Medicines Regime
was designed to be demand-driven but in this case, it was driven by
the supplying company, Canada said. Any delays were not caused by the
WTO system but by the Canadian company's search for a customer and
Rwanda's procurement procedure, it added.)

[In a posting on the IP-Health list-server on 12 February, Richard
Elliot, Executive
Director of the Canadian HIV/AIDS Legal Network, noted that there is
little reason at this time to think that the Canadian Access to
Medicines Regime will be used again in the absence of some kind of
reform.  He further noted that dozens of Canadian civil society groups
have called for reforms to the Canadian regime (which they have said
is "seriously flawed"). A bill is currently before Parliament to
simplify considerably the current Canadian legislation, he added.]

According to trade officials, a number of countries including India,
China, Venezuela, Brazil, Indonesia, Ecuador, Cuba and Egypt said that
this suggested that the system is not working. The length of time that
has been taken in Canada's case also showed that the system is too
complicated, they added.

Several other countries including Argentina, Canada, Switzerland, the
US and the European Union took a different view.

According to trade officials, some of them argued that compulsory
licensing is not the objective, and that it is rather one tool among
many to ensure that the poor have access to affordable medicines. This
has been achieved by improved international procurement, increased
donations of free medicines and cut-price supplies by patent-owners,
some of them said.

Pakistan and Nigeria (on behalf of the African Group) called for what
Pakistan called a "performance evaluation" - to learn the lessons of
how the WTO system is being implemented without changing the system
itself, said trade officials.

India proposed the holding of a workshop open to non-governmental
organizations and other practitioners as well as delegates.

In its intervention at the informal meeting, India said that it has
always been of the view that the Doha Declaration on TRIPS and Public
Health constituted a major landmark in the short history of TRIPS
because it recognized the primacy of public health needs and the
sensitivity of this Agreement to the problems faced by the poor in the
less developed countries.

Along with several other Members, India worked relentlessly on the
Doha Ministerial Declaration on Public Health (2001) and the Decision
of 30 August 2003 on implementation of Para 6 of the Doha Ministerial
Declaration. The hope was that the August 30 Decision would genuinely
and completely address the problems faced by WTO Members with
insufficient or no manufacturing capacities in the pharmaceutical
sector to address their public health problems.

"Today, obviously, we are disappointed since the Para 6 provision has
been used only once in over 6 years."

Complimenting Canada on its efforts to supply AIDS drugs to Rwanda
through operationalisation of the Para 6 system, India however noted
that it took about three years to supply the medicine.

"God forbid, if Rwanda were to order additional medicines, they would
need to go through the same process again."

India recalled that it had mentioned during the last TRIPS Council
meeting in October 2009 that while Members take stock of the
acceptances of the Protocol, it is also time for reflection on the
obstacles to use of the system.

"The Para 6 system, it may be recalled, was supposed to be an
'expeditious solution' to the crisis in access to medicines by
countries with insufficient or no manufacturing capacity. Experience
shows that it has neither been 'expeditious' nor a 'solution' to
public health needs."

Access to medicines is a crucial issue particularly to the poorest
populations of the world, said India, further noting that the issue
has rightly attracted considerable interest in the UN Human Rights
Council and has been highlighted in the report of the Special
Rapporteur on the right of everyone to the enjoyment of the highest
attainable standard of physical and mental health.

India stressed that it is time to move beyond the ritualistic
consideration of the item in the year-end TRIPS Council meeting of
October.

Numerous studies have been done on this issue by experts, including
some studies commissioned by the European Parliament and Civil Society
Organizations (CSOs) engaged in public health. Empirical evidence of
the actual functioning of the Para 6 system is also available in the
Canada-Rwanda case.

"It is therefore time for an in-depth study on the subject to be done
through the establishment of a Dedicated Workshop to discuss
'Implementation of the Para 6 system and the Canada-Rwanda experience'."

As for participation, India suggested that the Workshop be open to all
WTO Members and CSOs in the public health sector who could share their
practical experiences. Experts in the field of public health should
also be invited. Apotex, the Canadian pharmaceutical manufacturer,
should be invited to share their first-hand experience.

India called for the workshop to be established as soon as possible so
that it could report to the TRIPS Council meeting in October this year
where a review as mandated in Para 8 of the Decision on the
Implementation of Paragraph 6 of the Doha Declaration on the TRIPS
Agreement and Public Health of 30 August 2003 could take place (WT/L/
540).

The recommendations emerging from the Workshop could then be
considered in the TRIPS Council for further necessary action, said
India.

In its intervention at the informal consultations, Brazil welcomed the
opportunity to discuss and identify the obstacles that have prevented
developing countries from making full use of the Paragraph 6 system of
the Doha Declaration.

Designed to provide affordable medicines to countries with limited or
no manufacturing capacity, the Paragraph 6 system is a milestone in
the history of the implementation of the TRIPS Agreement, said Brazil,
adding that nevertheless, normative advancements always face the
challenge of implementation - and this system is no exception. "Years
after its adoption, it has yet to fulfill this objective."

Pointing out that it had accepted the Protocol amending the TRIPS
Agreement on 13 November 2008, Brazil said that to this moment,
however, it has not yet had the opportunity to use the system, either
as a supplier or a beneficiary. "Only once has the system been used,
and we know the difficulties faced by the supplier and the
beneficiary. This solitary example indicates that we are probably not
in the right path," said Brazil.

In order to improve the Paragraph 6 system, it is crucial to
understand the difficulties countries and international organizations
have had in implementing it. For this reason, Brazil said that it
strongly supports the proposal for a workshop under the auspices of
the TRIPS Council, which could bring together all relevant stakeholders.

According to trade officials, India's call for a workshop was
supported by Brazil, China, Venezuela, Pakistan, Indonesia, Ecuador,
Nigeria (on behalf of the African Group), and Cuba.

Several others including the US were unsure about opening the
discussion to participants other than delegates (such as NGOs). They
were willing to participate in consultations on future steps, which
would include the proposal by India for a workshop, said trade
officials.

The US pointed out that the WTO already provides opportunities for
dialogue with others in the annual WTO Public Forums.

The Chair said that she will report to the TRIPS Council meeting of
2-3 March.

After that, the Council will have a new Chair and Ambassador Tan said
that she would recommend that her successor undertake consultations on
future steps, including the possibility of a workshop, in order to
make the annual review more useful.

(* With inputs from Riaz K Tayob.)



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


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