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In brief
TRIPS and biodiversity
New in this meeting was a Bolivian paper
IP/C/W/545 describing approach the country’s constitution takes and
calling for a total ban on patenting all life forms, protecting the rights of
indigenous communities, their traditional knowledge and “food sovereignty”
against monopoly power of major corporations.
Most statements reflected members’
unchanged
positions in this issue.
Technical cooperation
Among the issues discussed were least-developed countries’ priority needs
(explained in a new web page:
http://www.wto.org/english/tratop_e/trips_e/ldc_e.htm).
Bangladesh has joined Uganda and Sierra Leone in submitting its priorities.
The information provided to members included the EU’s latest paper on its
technical cooperation activities. The EU highlighted a €16m project with China
(€5m coming from China itself), and €1.2m project in Bangladesh with a
contribution from the World Intellectual Property Organization.
Information and transparency
The Secretariat reported on progress in improving the information available
online. This is partly in response to a letter from the General Council
chairperson to all councils and committees on ways to make notifications and
other information flows more up-to-date and more complete in the areas they
handle.
In October 2009, the Secretariat presented a background note
IP/C/W/543
summarizing the relevant procedures and their use, with suggestions on how to
make the notification system more transparent and easier to use.
In this meeting the Secretariat reported that a new set of pages serving as a
toolkit for notifying countries’ intellectual property laws, regulations and
other information will soon be published on the WTO website. The Secretariat is
also working with the
World Intellectual Property Organization (WIPO)
on accessing WIPO’s improved electronic database of laws.
‘Non-violation’ disputes
“Non-violation”
is shorthand for the arcane question of whether there can be legal grounds for
complaint under TRIPS even when the TRIPS Agreement has not been violated.
Members disagree on whether these complaints have a place in TRIPS but have
agreed to refrain from launching disputes on them, the restraint officially
known as a “moratorium”. More recently the moratoriums have been extended from
one Ministerial Conference to the next.
In December 2009, the
Geneva Ministerial Conference agreed
to extend the moratorium further until the next meeting, which they decided to
hold in 2011.
In depth: TRIPS and health
1. ‘Paragraph 6’
The debate is about a
2003 “waiver” (a
waiver allows countries to bypass a WTO rule under certain circumstances), and
an almost identical amendment to WTO
intellectual property rules, agreed in 2005 and now waiting for the required
number of
WTO members to accept it.
(More here)
Since the last TRIPS Council meeting in October, Nicaragua and Pakistan have
accepted the permanent amendment of the TRIPS Agreement.
The deadline for governments to accept the amendment was extended for two more
years until 31 December 2011 by the WTO General Council on 17 December 2009. In
practice, how members use the system would be the same, since the waiver and
amendment are almost identical. The waiver will remain in force until the
amendment takes effect. But a full amendment would make the legal situation more
permanent.
The rule change removes a requirement that generics
produced under compulsory licence should be mainly for the domestic market,
which would limit their export to countries that cannot make the medicines. It
is sometimes called the “Paragraph 6” system after the provision in the
2001 Doha Declaration on TRIPS
and Public Health
that led to its creation.
The system allows generic medicines made under
“compulsory licences”
to be exported to countries that cannot produce the medicines themselves.
So
far, it has only been used once
for exports from Canada to Rwanda, and this has led to questions about whether
the system is working effectively.
Delegations generally agree that it would be useful to look at real experiences,
and the new chairperson, Martin Glass of Hong Kong, China, who took over at the
end of the meeting, will contact members on how to proceed, including the
proposal to hold a workshop on the issue before the TRIPS Council’s formal
annual review of the system in October.
So is it working? A number of developing countries repeated their belief that
the system might not be an effective solution because of its limited use so far.
They repeated their call for a workshop to look at real-life experiences in
using the system or in trying to use the system.
A number of developed countries continued to counter that the single case does
not prove anything because the system is only one of a range of options for
allowing the sick in poorer countries access to more affordable medicines.
These include foundation funds and other means of buying medicines more cheaply,
and patent holders lowering prices in some markets because of the threat of
compulsory licensing (whether for export or to supply domestic markets).
Several pointed out that the only factual evidence brought to the TRIPS Council
so far — by Canada — suggests the length of time needed for Canada to export to
Rwanda was not caused by the system but by other factors.
The Canadian account was first outlined in an informal consultation on 12
February. Canada asked for it to be put on the record of this formal TRIPS
Council meeting. (Chairperson Karen Tan’s oral report on the consultation is
below)
Canada says that after the company, Apotex, received fast-track approval for its
generic (TriAvir, a fixed dose combination tablet of lamivudine, 150mg +
nevirapine, 200mg + zidovudine, 300mg) in June 2006, Apotex took over a year to
find an interested importing country. In July 2007 Apotex had found a customer
and contacted the patent holders to negotiate a voluntary licence (this step is
normally required for any compulsory licence, not only those under the Paragraph
6 system). In September 2007, Apotex asked for a compulsory licence; approval
took two weeks, Canada says. Rwanda’s public tender then took until May 2008,
when Apotex started production, making the first delivery in September 2008,
Canada says. (Details below)
Although the new chairperson will consult members on how to proceed, some
developed countries pointed out that the informal consultation on 12 February
was already held in response to a call from developing country critics who
wanted an opportunity for members to share their experience in using or trying
to use the system. Only Canada actually did so, they said.
2. Generics detained in transit in the EU
This issue involves generics in transit through the EU
and alleged violations of either trademarks or patents in the transit country.
See fact sheet
here and
here.
India and Brazil continued to complain about EU members’ customs authorities
detaining genuine (ie, not counterfeit) generic medicines in transit through EU
ports and destined for developing countries.
India accused the EU of paying lip service to reforming the Customs Regulation
1383/2003, which governs the detentions, and failing to provide information.
India and Brazil did not cite new cases in this meeting but complained that the
threat of detentions remains. As in previous meetings, they raised the issue
under “other business”.
The EU said that it had provided information in lengthy bilateral meetings, and
that its customs officers have to be able to check shipments because of the
large amount of counterfeit drugs.
Background: the original complaint. This was first raised by India and Brazil in
meetings of the General Council in February 2009 (see
minutes)and
the TRIPS Council in March 2009 and then again in the July and October meetings
in the same year (see
minutes).
Cases cited previously include at Rotterdam (Losartan, an anti-hypertension
medicine), Frankfurt in May 2009 (Amoxicillin, a antibiotic) and in Paris in
October 2009 (Clopidogrel, a blood thinner).
India and Brazil, supported by a number of developing countries said that they
were dissatisfied with assurances given by the EU originally, after the numerous
seizures by Dutch authorities during 2008. Later seizures had occurred after the
end of the EU’s MEDIFAKE campaign based on its Customs Regulation 1383/2003,
they said. The two said that by permitting the seizures, the regulation violated
GATT (on goods in transit), TRIPS, and the Doha Declaration on TRIPS and Public
Health as it created barriers to the legitimate trade in generic medicines. They
said the regulation also contravened international humanitarian law which
recognized the right to health.
They accused developed countries of deliberately confusing medicine quality with
intellectual property protection as part of an orchestrated campaign to impose
“TRIPS plus” enforcement norms on other members. They said the actions rendered
hollow the EU’s proclaimed commitment to better access to medicines for
developing countries.
They described the EU’s response to efforts to resolve the issue bilaterally as
insufficient, and called on the EU to urgently review the regulation and bring
it into conformity with its WTO obligations under GATT and TRIPS.
Background: the reply. The EU said its commitment to access to medicines was
well illustrated and that this policy had not changed. While not hindering trade
in generic medicines, it was important to stop dangerous fake medicines and for
that purpose detention by customs to allow verification of the product by the
right holder was legitimate and necessary, the EU said.
The discussion concerned a few cases of temporary detention of medicines (not
seizure), and all the consignments had ultimately been returned to their
importers, the EU stressed. It said it had reacted effectively to India's and
Brazil's concerns, as patent right holders had publicly committed themselves not
to seize generic medicines for patent infringements, and no new cases had
occurred.
The medicines detained in Frankfurt were going to Denmark and were therefore not
a case of transit, the EU said. It added that the regular review of Regulation
1383/2003 was open and could address any concerns that India and Brazil might
have.
Observers
Members continued to disagree on whether the
Secretariat of the Convention on Biological Diversity should be an observer in
the council, even if invited ad hoc meeting by meeting. A suggestion was also
made for the African Regional
Industrial Property Organization (ARIPO) and Organisation Africaine de la
Propriété Intellectuelle (OAPI)
to be accepted as ad hoc observers on the basis of their earlier requests. The
chairperson agreed to hold consultations. But without consensus, the situation
is unchanged. For the new suggestion some members said they need time to
consider it.
Chairperson:
Ambassador Karen Tan of Singapore, temporarily, handing over at the end of the
meeting to Mr Martin Glass of Hong Kong, China.
Next meetings
These dates could still be changed:
- Tuesday-Wednesday 8—9 June 2010
- Tuesday-Wednesday 26—27 October 2010
The 12 February consultation on TRIPS and public health
What the chairperson reported
Ambassador Tan reminded delegations that paragraph 8 of the Decision on
the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS
Agreement and Public Health 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. The TRIPS Council held
its sixth review of the Paragraph 6 System at its meeting in October.
The seventh review is scheduled to take place in October this year.
In the context of its review last October, the Council asked her to hold
a round of informal consultations on the operation of the System before
today’s formal meeting. The purpose, she said, was to provide a platform
to share experiences and to look at concerns in an informal setting,
without prejudging the outcome. In response to this request, she held an
informal meeting on 12 February.
Overall, the chairperson said she found the informal meeting to be very
constructive. She felt that members were interested in sharing
experiences on the use of the System and ready to engage in practical
and fact-based discussions in order to have a full understanding of the
operation of the system.
As regards the specific points made by delegations, some of them were
concerned that the system had been used only once by Rwanda and Canada,
which raised the question of whether the system had met its objective of
providing an expeditious solution to problems faced by countries with
insufficient or no manufacturing capacities in the pharmaceutical
sector, she said. The meeting also heard that the fact that the system
had only been used once did not imply that it was inadequate, since
there were also other ways to get medicines to patients, she said. Some
delegations argued that the number of licences issued under the system
was not the proper measure of its success, and that the use of the
system by Rwanda and Canada had demonstrated that the system could work
effectively; the system could only play a supportive role in the wider
effort to improve access to essential medicines, and its mere existence
might have had a positive impact on drug prices, Ambassador Tan said.
The chairperson reported that concerns were also expressed about a
period of some three years that it had taken to deliver the medicines to
Rwanda in this particular case. She said Canada shared experience on its
use of the system, giving a detailed account of the timeline of the
shipments under the system, attributing the bulk of the time consumed
not to the specific requirements of the Paragraph 6 system, but to
factors such as identifying a recipient country for the available
medicine, and the government procurement process in the recipient
country which required a competitive tendering process.
As regards the topics that might warrant more discussion, she said some
delegations suggested that the focus could be on the experience from the
use of the system by Rwanda and Canada to consider whether the system is
working effectively. Some delegations said that the performance of the
system could be appraised more generally to assess whether there were
any procedural problems regarding its operation, she recalled.
Some members said that, bearing in mind that the system was
demand-driven, it would be helpful to know whether there were some
concrete obstacles why potential importers did not procure under it.
Among other issues mentioned that might merit further discussion were
safety and efficacy of medicines procured under the system, government
procurement, and the dissemination of information with a view to
building capacity in developing countries to use the system, she said.
Members also discussed the appropriate ways to address these issues,
agreeing that annual reviews were a good platform for sharing
experiences and evaluating the operation of the system, she reported.
However, she went on, some delegations wished to complement this work by
organizing a dedicated workshop open to all stakeholders. Some other
delegations said that the review process was a member-driven exercise,
but believed that its usefulness could be enhanced, for example by more
factual input, she said
Finally, she reported that there were calls for the Chair to consult
with interested delegations on how to best address the issues raised in
the discussion. A number of delegations expressed their willingness to
participate in any consultations that the chair might decide to hold on
the matter, she concluded.
Experience: Canada
Canada listed key dates in implementing the WTO system and Canada’s
Access to Medicines Regime in order to explain why it took some time for
the shipments of Apotex’s TriAvir (a fixed dose combination tablet of
lamivudine, 150mg + nevirapine, 200mg + zidovudine, 300mg) 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, nor was much time taken up
by Canada’s Access to Medicines Regime, it said. The total time needed
to supply the medicines included a period when the Canadian company
first had to search for a customer, and later Rwanda’s procurement
procedure, which had to be respected, Canada added.
These are the dates that Canada gave:
AUGUST 2003 — The WTO waiver (“Paragraph 6 solution”) is agreed
SEPTEMBER 2003 — Canada announces its intention to implement the system
MAY 2004 — Canadian Parliament amends the law, setting up the legal
framework to allow compulsory licensing for export
MAY 2005 — Canada’s new law and implementing regulations take effect
DECEMBER 2005 — Canadian health authorities government are asked by
Apotex Inc to approve a generic medicine. The product then undergoes a
fast-track approval procedure to ensure quality and efficacy
JUNE 2006 — The review is completed (it normally takes about 12 months,
Canada said). Apotex starts a year-long search for a customer
JULY 2007 — Apotex identifies Rwanda as its customer, and writes to
three patent holders to seek a voluntary licence (required under the
TRIPS Agreement before a compulsory licence can be issued). (Rwanda
notifies the WTO that it intends to import)
SEPTEMBER 2007 — Apotex applies for a compulsory licence to export to
Rwanda. The Canadian government approves this in two weeks.
OCTOBER 2007 —
Canada notifies the WTO that it has issued a compulsory licence.
Rwanda opens a public tender to supply the medicines.
MAY 2008 — Apotex announces it has won the public tender under Rwanda’s
rules, starts production.
SEPTEMBER 2008 — The first half is delivered
SEPTEMBER 2009 — The second half is delivered
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