On the “Paragraph 6 system”, which helps countries import cheaper generic medicines, they also agreed that the deadline should be extended for another two years for countries to accept an amendment to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, as the number of countries doing so gradually rises. The WTO General Council is expected to approve the decision when it meets in December.
But they delayed a decision on a long-standing, controversial and legally complex question, which could be taken up at the 15–17 December 2011 Ministerial Conference in Geneva. This about the possibility of countries challenging each other in the WTO dispute settlement procedure on intellectual property issues even if the TRIPS agreement has not been violated, and only an expected right has been thwarted: “non-violation” cases in TRIPS.
The possibility of filing non-violation cases in intellectual property was ruled out temporarily in the TRIPS Agreement. This “moratorium” on cases of this kind has so far been extended from one ministerial conference to the next. Switzerland and the US continue to oppose extending the moratorium but they are willing to continue consulting. Most members oppose non-violation cases and want the moratorium extended or the possibility scrapped completely.
The council reviewed China’s implementation of its intellectual property obligations for the last time under Beijing’s 2001 membership agreement, with some praise for the efforts the country has made in protecting intellectual property but also concerns about the amount of counterfeiting and piracy.
The two-day meeting also spent some time on a trio of issues related to biodiversity, biopiracy and patenting life forms (see www.wto.org/tripsbio), with the discussion largely following that of previous meetings.
And it examined various aspects of technical assistance, and developed countries’ incentives for their companies and institutions to transfer technology to least developed countries.
First, a decision:
TRIPS and public health: the Par.6 system and the annual review
Full explanations: www.wto.org/tripshealth
See also: the 2010 review, and follow-up
Background. This was the annual review of how the “Par.6 system” is working. The system removes an intellectual property obstacle that would have prevented countries from using compulsory licences to manufacture generic medicines exclusively for export to countries unable to make them themselves. It refers to paragraph 6 of the 2001 Doha Declaration on TRIPS and Public Health.
The General Council first agreed to remove the obstacle through a 2003 “waiver”, a legal means allowing WTO members not to comply with an obligation or provision in a WTO agreement. Two years later it agreed to an almost identical amendment to the TRIPS Agreement, which is still pending.
Accepting the amendment
More information here
The TRIPS Council agreed to extend the deadline for accepting the 2005 amendment for another two years until 31 December 2013, the third extension. This is needed in order to allow the number of accepting members to reach the two-thirds required for the amendment to take effect.
The extension will be put to the General Council’s December meeting, which is expected to approve it — both the General Council and the TRIPS Council consist of all 153 WTO members.
The number of countries accepting the amendment is rising steadily. Argentina, Indonesia and New Zealand accepted it just before this meeting, and Turkey, Costa Rica and Rwanda said they will do so soon. Rwanda has already benefited from imports under the system.
Ecuador and Cuba said they are not ready to accept the amendment — Ecuador, because it considers the system not to be working; Cuba because it thinks the TRIPS Council still needs to study the situation more. The EU said this position is unfair to potential importing countries.
The WTO Secretariat repeated the clarification that accepting the amendment is completely independent from revising a country’s own laws and regulations to implement the Par.6 system. When enough countries have accepted the amendment, they will be allowing their fellow-members to use it; when they revise their own laws and regulations, they allow themselves to use it.
This clarification has encouraged at least one country — New Zealand — to accept the amendment before its law is modified. A number of others had already made that choice.
The review lasted just over two hours, considerably shorter than the previous year’s review. This was partly because chairperson González urged members not to repeat what they had said in the October 2010 review and March 2011 follow-up. He had supplied them with detailed references to paragraphs in the minutes of these meetings (documents IP/C/M/64 and IP/C/M/65).
It was organized under six headings:
- members’ experience in using or considering using the system (only used once for Canadian exports to Rwanda)
- implementing the system in domestic law and regulations
- accepting the amendment
- capacity building on the Par.6 system and related flexibilities
- alternatives to the system for access to medicines, including procurement and other means
- next steps and recommendations
The comments were broadly on these themes:
Update on Canada’s revised law. Canada said the Private Member’s Bill C-393 for amending Canada’s Access to Medicines Regime (CAMR), which is the law for Canada to export under compulsory licensing (ie, the Par.6 system), died before it could be passed because Parliament was dissolved for the May general election. The government opposed the bill and therefore has no plans to revive it, Canada said. It could not say whether any member of Parliament will propose a new bill.
Is the Par.6 system working? Should there be a workshop? Some developing countries continued to argue that since the system has only been used once, it is too complicated to be effective. Some others questioned whether it is working and said they need more information. They repeated the call for a workshop open to all members with other participants also invited such as non-governmental organizations, and research-based and generic pharmaceutical companies.
Some asked the EU and US about their practices related to a provision of the TRIPS Agreement — Art.31(k) — on actions for dealing with anti-competitive practices, They referred to court cases which they said waived the restrictions on compulsory licences for export, allowing the entire production to be exported and therefore serving as an alternative to the Par.6 system.
Some developed countries continued to argue that the number of times the system has been used is not a good measure of its effectiveness because it is only one among a wide range of policies for making medicines more available and affordable.
Compulsory licensing under the Par.6 system can also be used as a bargaining chip to lower prices. When it is used it is working and when it is not used it could still be working, one delegation said.
These developed countries also remarked that potential importers under the Par.6 system have not described their experience in using or considering using the system. This was among their reasons for arguing that work should continue among members within the TRIPS Council, some adding that delegations could seek information from outside organizations and introduce that into the council’s discussions.
The one country that has imported under the Par.6 system, Rwanda, did speak. It said it fully supports the system and is about to accept the TRIPS amendment.
Australia’s plain packaging bill for tobacco products
The bill, first discussed in the last meeting, has passed the lower house and is now in the Senate, Australia reported. It is part Australia’s anti-smoking campaign. (See also this Australian government web page, which includes images of samples of the proposed packaging.)
Ukraine (represented by Economy Vice Minister Valery Pjatnitsky), and a number of developing countries (Dominican Rep, Mexico, Nigeria, Cuba, Nicaragua, Honduras, El Salvador, Zimbabwe) repeated their concern that the law will violate Australia’s obligations under the TRIPS Agreement by preventing cigarette and cigar companies from using their trademarks, ultimately hurting their poor farmers. Some argued that the plain packaging will make counterfeiting easier, and some said it will cut costs and lower prices, stimulating demand rather than inhibiting it.
Chile, China, Switzerland, India and the EU asserted countries’ right to use flexibilities in the TRIPS Agreement for public health purposes, including tobacco control, sought more information and some of them urged Australia to ensure that its measures do not conflict with the agreement. Brazil stressed all countries’ right to adopt measures to protect public health, which it consider an important general principle for the relationship between intellectual property protection and health.
Uruguay, New Zealand and Norway supported Australia, which described how serious a problem smoking is and assured members that the policy has been studied carefully to ensure it does not violate TRIPS provisions and that it will be effective in reducing smoking. The World Health Organization described the serious global picture and said plain packaging is part of its Framework Convention on Tobacco Control.
The issue has also been raised in the Technical Barriers to Trade (TBT) Committee.
Anti-Counterfeiting Trade Agreement (ACTA)
The ACTA text is in document IP/C/W/563.
Many participants in the ACTA negotiations (Australia, Canada, the EU, Rep. Korea, Japan, New Zealand, Singapore, Switzerland and the US) informed the membership about the agreement, which eight of them signed on 1 October 2011 and the EU, Mexico and Switzerland are expected to sign soon.
They described ACTA as a means of strengthening the enforcement of intellectual property rights without altering the obligations of the TRIPS Agreement. The Doha Declaration on TRIPS and Public Health, which makes health a priority, is upheld (in the preamble), they said, and generic medicines in transit or traded across borders will not be affected because the agreement excludes patents from actions at the border (footnote 6 of Article 13).
India, Angola, Ecuador, Brazil, China, Chile, Venezuela and Zimbabwe repeated a number of concerns raised in previous meetings (June and October 2010, including whether access to medicines would be impeded, or pressure would increase on countries to protect intellectual property to a higher standard than required in the WTO (the ACTA countries said they would not), and the implications for the WTO system of discussing an agreement negotiated outside the WTO.
The question of discussing intellectual property enforcement routinely in the TRIPS Council has been controversial from time to time. Some developed countries wanted to discuss it because they considered counterfeiting and piracy to be a serious problem; developing countries resisted, fearing that this would target them and be used to argue for new standards more stringent than those in TRIPS. The ACTA countries said this background of opposition to work on enforcement in the WTO was one reason why they negotiated the agreement outside the WTO. Then some developing countries raised the ACTA negotiations in some meetings, one of the complaints being a lack of information.
In this meeting India said it appreciated the information and the briefings that had been given by the ACTA countries, although it still has concerns.
China’s final transitional review
See also: www.wto.org/china and all documents on China’s TRIPS transitional review.
This was the TRIPS Council’s final transitional review of how China is implementing its intellectual property rights obligations under the TRIPS Agreement and its 2001 membership deal. The reviews are a unique requirement in China’s the membership agreement for a range of WTO subjects including intellectual property, annually for the first eight years and once more after 10 years.
Japan (document IP/C/W/556), the US, EU, Rep. Korea and Canada praised China for the efforts it has put into protecting intellectual property rights, the information it has supplied to the committee, in some cases the bilateral cooperation that has taken place and the campaigns on protection.
But they and their companies remain seriously concerned about counterfeiting and piracy, particularly digital, hi-tech and brandname products. They commented on a range of issues, such as the threshold set to determine whether a case is serious enough to justify prosecution and other aspects of the enforcement process. Some were also concerned about legislation involving compulsory technology transfer.
Mexico’s particular concern was about the protection of tequila and mescal as geographical indications, partly linked to a sanitary and phytosanitary regulation setting a maximum alcohol content which Mexico said is too low for some types of the spirits. It also complained about a Chinese beer (“Cerono”) mimicking Mexico’s Corona brand.
India wanted China to explain a law prevent patenting on “scientific discoveries”. Nigeria said it is concerned about exports of substandard and counterfeit products.
China circulated a document (IP/C/W/564) before the meeting, outlining latest developments in revising its copyright, trademark and patent laws, enforcement, and other intellectual property issues. In the meeting it explained these at length in reply to members’ questions.
It concluded by thanking members for cooperation over the 10 years of the review and pledged to continue to work with them bilaterally and in the WTO. China said its government had shown the political will to implement and enforce intellectual property protection and highlighted the Chinese population’s increasing awareness about the issue.
Chairperson: Ambassador Federico A González (Paraguay)
TRIPS Council (regular) meetings (could change):
Tuesday-Wednesday 28–29 February
Tuesday-Wednesday 5–6 June
Tuesday-Wednesday 6–7 November