Following
the seven-and-a-half-hour session, member governments will now
consider how to proceed, including whether to draft a statement for
ministers to issue at the November Ministerial Conference in Doha.
Most speakers described the discussion as a first step, and not a
one-off event.
The
special discussion on Intellectual Property and Access to Medicines
was one item on the agenda of this week’s regular meeting of the WTO
Council on Trade-related Aspects of Intellectual Property Rights
(TRIPS). It was held at the request of the African Group, i.e. all
African members of the WTO.
Two
papers were circulated for the meeting: one from the European Union
and another from a group of around 50 developing countries.
(These
papers
can be found here,
along with a statement from WTO Director-General Mike Moore. For a
background explanation of some of the issues, including the provisions
cited here, see the WTO
fact sheet on TRIPS and pharmaceuticals.)
Over
40 delegations spoke. A wide range of issues were discussed, some for
the first time ever in the TRIPS Council. Among the main items were:
1.
Overall principles back to top
Virtually
all speakers said patent protection is needed as an incentive for new
pharmaceuticals to be invented. All agreed that the TRIPS agreement
contains flexibilities allowing governments to deal with public
health.
TRIPS
should not be part of the problem but part of the solution, many
delegations said.
So
the discussion focused on the overall objectives and principles of the
TRIPS Agreement (Articles 7 and 8) and the flexibilities
included in the agreement to deal with specific circumstances.
Several
delegations said that patent protection is only one issue among many
that relate to the health problems of poor countries. Among the other
issues are public health infrastructure and pricing policies. But
several delegations also said these should be discussed in
organizations that are more directly responsible for these issues, and
not in the TRIPS Council.
Many
developing countries argued that Articles 7 and 8 mean that
the TRIPS Agreement should be understood to allow governments the
freedom to meet public health objectives. Some called for this
interpretation to be underscored by a political declaration at the
forthcoming Ministerial Conference in Doha, which would allow
governments to pursue health policies in the secure knowledge that
they would not be violating TRIPS. No one objected to a declaration in
Doha. Some said they are willing to discuss the contents.
Several
delegations said governments should not be put under pressure
bilaterally or in the WTO to limit their use of the flexibilities
built into the TRIPS Agreement. Some
countries (African Group, Norway) urged WTO members, particularly
developed countries, not to take legal action under the WTO dispute
settlement procedure on TRIPS and public health issues.
Some
developing countries also called for deadlines for implementing the
TRIPS Agreement, particularly provisions related to public health, to
be postponed — the transition period for developing countries in
general ended on 1 January 2000, and for least-developed
countries it ends on 1 January 2006.
The
US argued that patent protection for pharmaceuticals serves public
health policies because it creates new medicines. Switzerland said
that if there were no patents, there would be no new medicines, and
there would therefore be no discussion on affordable medicines.
Speakers
broadly took the view that the TRIPS Agreement contains enough flexibility to allow governments to
pursue public health objectives. Some developing countries echoed the
view of the developing countries’ group’s paper, that this should
be clarified, and if that proves insufficient, members should consider
amending the agreement.
2. Flexibility — compulsory licensing back to top
Several
delegations said that governments are free to set their own
justifications for compulsory licensing because the TRIPS Agreement
does not spell out all the possible reasons.
On
one criterion mentioned in the TRIPS Agreement (national emergency),
most delegations, including developed countries such as the US, EU,
Japan, said the current HIV/AIDS epidemic is clearly an emergency in
sub-Saharan Africa and other countries in similar circumstances.
A
particular subject raised for the first time in the TRIPS Council, and
one that was discussed a lot, was the scope to produce for export
under compulsory licensing, in order to supply a poor-country market.
This
was considered important because many smaller developing countries may
want to use compulsory licensing for import rather than local
production. The TRIPS Agreement says products made under compulsory
licences should be “predominantly for the domestic market”. Many
participants indicated their desire to ensure that the agreement does
not stand in the way of countries using compulsory licenses for
import.
There
was some discussion of the details of when this might or might not be
possible. Most developing countries called for the provisions to be
interpreted leniently.
Some
developing countries argued that compulsory licensing could be used to
develop local production — which they said is necessary for public
health and technology transfer — if a patent-holder does not produce
the medicine in the country. The US and Switzerland said this would be
an industrial development policy (strengthening local industry) and
not a health policy.
3. Flexibility — parallel imports back to top
Developing
countries said parallel imports are clearly allowed under Article 6
and that it is essential to ensure prices are as low as possible. The
EU, US and Switzerland warned that this could undermine “differential
pricing” (companies selling at lower prices in poorer markets) if
cheaper products flow into developed countries’ markets.
4. Other issues back to top
Test
data: Article 39.3 of the TRIPS Agreement says governments have
to protect confidential test data — used to decide whether “new
chemical entities” are safe for public consumption — against “unfair
commercial use”.
In the meeting, the
EU, Switzerland, US and Japan said the most effective way of implementing this provision is to provide a period of exclusive use of the data for the company that developed it. Some developing countries contested this interpretation. The EU, Switzerland and Japan said that their interpretation should not impede compulsory licensing of patented pharmaceuticals, notably under the fast-track procedures where a national emergency is involved.
Differential
pricing: Many developed and developing countries said differential
pricing is also a suitable method for access to medicines although
some developing countries said this should be discussed elsewhere
because it is not part of the WTO’s mandate.
5. What next? back to top
The
chairperson will consult with members. Then, on Friday morning the
TRIPS Council will meet informally to discuss whatever is proposed. A
decision on next steps could be reached on Friday. |
