[Ip-health] WTO media release on June TRIPS Council: Council debates anti-counterfeiting talks, patents on life

Thiru Balasubramaniam thiru at keionline.org
Fri Aug 6 01:00:53 PDT 2010



TRIPS and public health

The Par.6 system and the annual review. The 2003 “waiver” (and the  
2005 pending TRIPS amendment) removes a requirement that generics  
produced under compulsory licence should be mainly for the domestic  
market, which would hinder 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. See explanation.

The TRIPS Council reviews how well the system is working every year,  
usually in October, but more recently with little depth or detail.

Agreed and not agreed: Following a number of consultations earlier  
this year, members have now agreed that at this October meeting, the  
TRIPS Council will set aside a whole day to discuss the issue. They  
also agree that they would like some kind of additional meeting or  
workshop before that to discuss experiences in using or trying to use  
the system in practice.

They disagree on whether the earlier meeting should include  
representatives of non-governmental organizations, pharmaceutical  
companies and other experts (proposed by India, China and some other  
developing countries), or whether it should only be for members’  
delegates (the view of mainly developed countries). Some others are  

Two proposed compromises were suggested in this meeting, neither  
receiving consensus approval.

Chairperson Martin Glass suggested two events in September, one for  
delegates under the auspices of the TRIPS Council and another for  
broader participation as part of the WTO’s Public Forum. However,  
India, China and others said they wanted the broader event also to be  
a TRIPS Council activity.

India’s proposed compromise was for a two-part TRIPS Council event  
with one session for delegates only and the other for broader  

Countries favouring an event with broader participation said similar  
workshops have been organized in other subjects in the WTO. Those  
opposing it said the first step should be for members to exchange  
information on their experiences, which would then help delegates set  
the agenda for a broader event, if one is needed. These countries said  
members have not yet described any problems they have faced in trying  
to use the system, even though there have been numerous opportunities  
to do so.

Amb.Glass will continue his consultations on the event or events to be  
held before the October annual review. (Some countries also said they  
would like the additional event to be held close to the October review  
so that delegates from capitals could attend.)

Underlying the difference is the view from some developing countries  
that the “Par.6” system may not be working since it has only been used  
once, and that one occasion (exports from Canada to Rwanda) took a  
long time, a view repeated in this meeting.

Canada, the only country to have described its experience in the TRIPS  
Council, repeated that the time spent on implementing the actual Par.6  
requirements was short, and that additional time needed overall was  
because of other factors.

Some other developed countries argued that the Par.6 system itself  
might not be the reason for the system being rarely used: patented  
medicines might be available at lower prices that are influenced by  
the threat of a compulsory licence; or generics could be made in  
countries that are able to manufacture them and where the medicines  
are not under patent protection, for example.

These countries also said that before the discussion is broadened to  
include outsiders, members should describe what exactly the problems  
are. Are they, for example, the notification requirement of the Par.6  
system? Or the packaging and other methods needed to prevent the drugs  
being diverted to the wrong markets? Or difficulties in finding  
generic producers? Or issues to do with ensuring that the generics are  
effective and safe (a topic that the African Group  wants to discuss)?

When one country mentioned that it was aware of other attempts to use  
the system, which had not borne fruit, another delegation said that  
members should provide details.


  Enforcement trends

Concern: China and India, supported by a number of other developing  
countries, called for this topic to be discussed because they are  
concerned about provisions that go beyond the standards of the TRIPS  
Agreement in bilateral, regional and plurilateral agreements, in this  
case on enforcement.

Causing particular concern to them is the draft Anti-Counterfeiting  
Trade Agreement (ACTA) being negotiated by Australia, Canada, the EU  
and its 27 member states, Japan, Rep.Korea, Mexico, Morocco, New  
Zealand, Singapore, Switzerland and the US.

Briefly, China’s and India’s lengthy statements argued that ACTA and  
other agreements could:

Conflict with TRIPS Agreement (a reference to TRIPS Art.1.1) and other  
WTO agreements, and cause legal uncertainty

Undermine the balance of rights, obligations and flexibilities that  
were carefully negotiated in the various WTO agreements

Distort trade or create trade barriers, and disrupt goods in transit  
or transhipment

Undermine flexibilities built into TRIPS (such as for public health,  
and trade in generic medicines)

Undermine governments’ freedom to allocate resources on intellectual  
property by forcing them to focus on enforcement

Set a precedent that would require regional and other agreements to  
follow suit. (One example cited was negotiations involving CARIFORUM,  
the group of Caribbean states. However, a delegation representing  
CARIFORUM said it understood the concerns but denied that CARIFORUM  
would have to apply ACTA’s provisions.)

They also argued that the focus on enforcement did not take into  
account a country’s level of development.

A number of developing countries broadly supported the concern.

Reaction: ACTA participants voiced their concerns about what they saw  
as a steadily increasing level of counterfeiting and piracy. They  
countered that the draft ACTA agreement will not conflict with TRIPS  
and other WTO provisions. They denied it would upset the negotiated  
balance, distort legitimate trade or undermine TRIPS flexibilities.  
One said generic medicines would not be affected since ACTA does not  
deal with patents.

They said that ACTA was necessary because counterfeiting is no longer  
a question of products such as fake luxury watches, but involves  
commercial scale production of fake medicines, car and aircraft parts  
and other products, which are dangerous to health and safety, and that  
developing countries are particularly vulnerable.

Some of them also said they had to get together outside the WTO  
because countries had opposed discussing enforcement substantively in  
the TRIPS Council.

Conclusion: The TRIPS Council took note of the comments. (This is not  
a permanent agenda item and whether or not it is discussed in future  
meetings depends on what members propose.)


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

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

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