E-drug: News on TRIPS Council on access to medicines
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[Warning: Long message. HH]
(Note: This is an informal report. NGOs are not allowed to sit in the
TRIPS Council meeting. This report is based on statements
countries submitted and made available on paper during and after
the meeting and informal discussions with delegations. More
countries spoke than are reported here. I apologise for the length of
this message. Ellen 't Hoen, MSF)
20 June Special TRIPs Council Session on Access to Medicines -
Global consensus at unprecedented TRIPS Council meeting on
Access to medicines.
Yesterday the TRIPS Council met to discuss access to medicines for
the first time in its history. The TRIPS council is a WTO body
comprised of all WTO members stated and meets every 3 months
to monitor the operation of the TRIPS Agreement and the
implementation of it by member states.
At the TRIPS Council meeting on access to medicines there was an
unprecedented global consensus on the need to find solutions to
access to medicines and the need to implement the TRIPS
Agreement in a manner that allows countries to adopt policies to
protect public health and to ensure that TRIPS does not stand in the
way to policies to increase access to medicines. There seemed to
be a strong global consensus on the need to take action. Only the
US was out of step. (Switzerland was also not very forthcoming but
I have not seen their intervention).
A number of developing countries stated that differential pricing and
the global fund should not divert from the need to address the
TRIPS issues. Most countries supported the proposal for a clear
statement at the Ministerial Conference in November in Qatar.
Countries also stressed that this meeting should not be a one-off
event but rather a first important step in a longer process.
Over 40 countries took the floor in yesterday's session. In
preparation of the meeting 50 countries led by Brazil had issued a
statement. This statement is available on the WTO website. Please
see the list of documents below.
The Africa Group
This session of the TRIPS Council took place following a proposal
by the Africa Group. At the meeting the AG asked for a strong
declaration at the WTO ministerial in Qatar later this year. This
statement should affirm: "nothing in the TRIPS Agreement should
prevent Members from talking measures to protect public health".
The African countries stated that IPRs are not a goal in itself but
should benefit the society as a whole. They drew attention to
article 7 and 8 and that each provision of TRIPS should be
interpreted in the light of the objectives and principles of the
agreement. Compulsory licenses are an essential tool for
governments to carry out effective health policies. The African
countries stated that they "looked towards the rich experience of
our developed country partners, which have employed compulsory
licences to great effect", which was a clear reference to the US
practices.
The group mentioned that differential pricing arrangement should
not prejudice the rights of Members under the TRIPS.
Specific demands by the Africa Group were:
- extend transition periods for TRIPS implementation
- adopt a moratorium on dispute settlement mechanisms to allow
members to take measures to protect public health
- moratorium on DSM that hinder the ability to promote access
to medicines
In addition the AG asked for improvements in the TRIPS that take
into account recent developments such as the AIDS crisis and other
infectious diseases, which were not foreseeable when the TRIPS
was drawn up. Kenya also spoke and said that article 7 and 8
clearly indicate the subordination of protection of intellectual
property rights to public policy objectives. Kenya raised questions
related to the commercial sense of 20 year patent protection. Kenya
mentioned that developing countries need time to develop and build
their own production capacity. Kenya would like to see
implementation deadlines linked to the level of industrial
development. "Developing countries need fundamentally different
IPR regimes from the ones that developed countries have." Kenya
said.
In addition to the joint submission Brazil discussed its AIDS
programme which offers universal access to ARVs and mentioned
the fact that local production capacity is at the core of its success.
Brazil also mentioned the need to be able to negotiate with the drug
companies to bring prices down and the role of the threat of
compulsory licenses in this.
Brazil favours discussions on differential prices but also stressed
that these cannot restrict the rights countries have under TRIPS.
Brazil also proposed a clear declaration on access to medicines at
the ministerial conference in Doha, Qatar to ensure a narrow
reading of the TRIPS so the TRIPS does not in any way undermine
the legitimate right of countries to formulate and implement their
own public health policies. This was supported by South Africa.
South Africa illustrated the need for clarification and support for the
use of the safeguards by recounting the 3 year court battle with the
drug companies over the medicines law which the drug companies
claimed was not TRIPS compliant. SA also referred to a "major
trading partner" making the same allegations at the time. Both the
companies and the "major trading partner" had to back down from
these positions.
India raised questions around the wording of article 8 which gives
countries the right to adopt measures needed to protect public
health but also mentions that "these measures would have to be
consistent with the provisions of the TRIPS agreement". India said
that this is a curious formulation: there is no need to state that you
are o.k. and advocates for a clear right to make an exception as is
possible under other agreements for example to protect the
environment. India mentioned that it seems strange to protect
human life, options for health exceptions seem weaker than in other
areas such as the environment. GATT (a WTO General Agreement
on Tariffs and Trade) article XX protection of human health is
considered an exception. India stated, "It would appear that in the
very same organisation that is the WTO, the way in which
protection of human health is dealt with in the two agreement
namely GATT and TRIPS, are different".
India in particular drew attention to the future scenarios of drug
access when TRIPS is fully implemented without maximum
flexibility to take measures for protection of public health. India
discussed compulsory licensing in detail and added its voice to
those who asked to resolve the production for export issue. India
also asked for this issue to be discussed in Doha. "Our ministers at
the Doha Ministerial Conference can send a powerful message to
the world that WTO cares for the people and it is not an
organisation, as generally perceived, designed just to serve the
business interests of big companies" India concluded. Developing
countries particularly felt supported by the European Union
statement that acknowledged the problems patent protection
can create for access to medicines and offered to willingness
to resolves issues related to compulsory licensing in particular
production for export. The EC also referred to articles 7 (social
and economic welfare) and 8 (protection of public health) as
the framework for designing legislation that meets health policy
needs and for interpreting the TRIPS Agreement.
The EC also drew attention to the waiver of certain procedural
requirements for issuing a compulsory license in cases of public
non- commercial use and other circumstances of extreme urgency.
Hereby referring specifically to the HIV/AIDs crisis. The EC
recognised that article 6 allows for parallel import but drew
attention to the fact that a tiered pricing system of pharmaceuticals
requires measures to prevent tiered priced drugs from popping up in
rich country markets. In their conclusion the European Communities
and its member states acknowledged that IPRs play a role with
regard to access to medicines but also said that TRIPS cannot be
held responsible for the health crisis in the developing world, TRIPS
should also not stand in the way for action to combat the crisis.
The EC also called for closer collaboration between WTO, WIPO
and WHO.
The USA was scheduled to speak before lunch but asked for a
postponement of their intervention. Because the US had not
submitted a contribution prior to the meeting participants were keen
to find out what the US had to say, particularly because by lunch
time it a clear consensus for action had began to emerge.
The US statement was disappointing. The US did not acknowledge
that TRIPS can create problems for assuring access to medicines.
The US stressed the importance of TRIPS in stimulating innovation
ignoring the fact that millions do not have access to these
innovations. The US claimed in its statement that patents do not
create monopolies and that because of the disclosure requirement
patent systems encourage R&D and competition, and transfer and
dissemination of technology.
The US also urged countries to only refer to WTO documents on
TRIPS and patents and "avoid documents circulated by other
individuals and organisations that lack the WTO's expertise". (I
presume this is a reference to NGOs materials, WHO documents
and academic legal publications on these issues???)
The US noted with interest the "permissive" readings of article 31
(compulsory licensing) in the EC document.
The US confirmed the "Clinton executive order" and said would not
raise objections if WTO member states availed themselves of the
flexibility afforded by the TRIPS to address major health crisis. The
US reminded member states that the most significant flexibility of
the TRIPS is the transition period developing countries have to
implement the TRIPS Agreement. They mentioned Bolar as an other
important flexibility.
On compulsory licensing the US made a peculiar comment, stating
the obvious that granting of a compulsory license is not necessary
when a product is not patent protected. (The purpose of this
comment is beyond me, but then I do not avoid documents on
TRIPS and medicines by others than the WTO ;-)).
The US stressed that article 31 must be read in the light of article
27.1 referring to the case against Brazil. The US mentioned article
8.1, which allows countries to take measures to protect public
health, but stressed the requirement "consistent with the
agreement". Most other comments on art 31 were confined to
paraphrasing the provisions of the TRIPS.
On the issue of production for export under a compulsory license,
the US offered no suggestions and said that the EC proposal "raises
questions that should be addressed if there is further discussion of
this concept". The US stressed that through trade and abolition of
trade distorting requirements such as local working requirements
drugs will be efficiently produced and transported to markets
needing the products. They mentioned that "recent studies have
shown that local production does not necessarily result in lower
prices". (I assume they do not refer to Brazil where AIDS drug
prices dropped by 78% as a result of local production of generic
versions.)
The US recognised that they employ compulsory licenses, but they
are "used to remedy an abuse, and not in the normal course of
doing business". Therefore one cannot draw the conclusion
according to them that there would be no negative effects where
member states to permit widespread use of compulsory licensing.
On Parallel imports the US stated that article 6 of TRIPS does not
authorize parallel imports, and that PI stands in the way of
differential pricing and increases the risk to import counterfeits and
unapproved drugs. It is not clear whether the US meant to say that
it is the recognition of international exhaustion by countries
authorizes parallel imports rather than the TRIPS or that they meant
to say that PI is not authorised at all.
The US mentioned their recent announcement of the proposal for
a Global Fund to fight HIV/AIDS, malaria and tuberculosis and the
fact that they contributed 200 million$ to it. The Japan statement
was not available yet at the end of the meeting but it seems that
the Japan position was close to the EU's.
Activities of NGOs
MSF, OXFAM and Third World Network were briefing delegations
and monitor what was happening at the meeting. On 19 June we
held a joint press briefing, which was attended by over 30
journalists. The WTO does not recognise NGOs as observers and
we were not allowed to sit in the meetings. Luckily many of the
delegations were prepared to regularly come out and provide us
with updates and documents that were circulating. Several
countries referred in their statements to the work of NGOs and
mentioned MSF and OXFAM specifically. The Third World Network
was also present at the WTO.
Activities of WHO
WHO has observer status at the TRIPS Council and was
represented by four persons from the Health and Technology
cluster. Unfortunately WHO did not make a statement at the
TRIPS Council. (perhaps someone from WHO reading this
can comment on why this was the case).
What is next?
The TRIPS Council will continue to meet this week to discuss other
issues. The Chair will consult with Member states on the follow up
of this meeting. This will be clearer on Friday. From discussions in
the corridors it seemed that most countries wanted to keep the
issue on the agenda of the TRIPS Council and start work on a
Ministerial declaration on access to medicines in Doha, Qatar.efore
the meeting the following official submissions were made available
(the numbers will allow you to find them on the WTO website along
with a statement from Mike Moore.
http://www.wto.org/english/tratop_e/trips_e/counciljun01_e.htm
- IP/C/W/296 "TRIPS an public health� submission by the Africa
Group, Barbados, Bolivia, Brazil, Dominican republic, Ecuador,
Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay,
Philippines, Peru, Sri Lanka, Thailand and Venezuela. A total of 50
countries
- IP/C/W/280 "Communication from the European Communities
and their Member States�
Ellen 't Hoen, LL.M.
MSF- Access to Essential Medicines Campaign
8, rue Saint-Sabin, 75544 Paris Cedex 11
tel: + 33 (0) 1 40212836
fax: + 33 (0) 1 48066868
e-mail: ellen.t.hoen@paris.msf.org
Web-site: www.accessmed-msf.org
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