The World Health Assembly is the WHO’s top decision-making body, tasked with supervising financial policies, reviewing programmatic goals, and determining organisational practices. Professor Thérèse N’Dri-Yoman, Cote d’Ivoire’s Minister of Health and the Fight Against AIDS, is presiding over this year’s WHA.

In her opening address, WHO Director-General Margaret Chan reminded member states that, “as public expectations rise, costs soar, and budgets shrink, we must look to innovation as never before. [It] does the most good when it responds to societal concerns and needs, and not just to the prospects of making a profit.”

“This is frugal, strategic innovation that sets out to develop a game-changing intervention, and makes ease of use and affordable price explicit objectives,” she added.

Call for R&D treaty draws mixed response

One of the most debated issues at the WHA so far has been a report prepared by the WHO’s Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), which calls for a binding convention on R&D to address diseases that disproportionately affect developing countries.

The working group was established by the WHA in 2010, in the context of the implementation of the Global  Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property (GSPA-PHI). The CEWG was given the mandate of examining current and proposed financing of R&D focused on diseases that disproportionately impact poor countries, along with diseases that occur in both developed and developing countries.

The call for a binding agreement has proved divisive during the early days of this year’s Assembly, with Kenya and the Union of South American Nations (UNASUR) suggesting that the WHO move forward with the negotiations towards concluding a binding convention. The US and Switzerland, however, have cautioned against prejudging the outcome of discussions on the issue.

UNASUR includes Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Guyana, Paraguay, Peru, Suriname, Uruguay, and Venezuela.

At the time Bridges went to press, results from a drafting group scheduled to meet on Wednesday evening to condense all R&D proposals into one consensus document were not yet available.

At a presentation of the report earlier this month, Nobel Laureate in Economics Joseph Stiglitz welcomed the call for a binding agreement on R&D, noting that “living in a profit-driven system means that research goes where the money is.”  (See Bridges Weekly 9 May 2012)

Yesterday, Norwegian Foreign Minister Jonas Gahr Støre voiced a similar sentiment, saying that “market forces alone will not give us equity” when it comes to public health.

Big issues lie ahead

The topic of WHO reform - which also featured prominently in last year’s World Health Assembly - is scheduled for discussion on Thursday (See Bridges Weekly 25 May 2011). According to the UN agency, this process will involve refocusing the organisation’s core business to address 21st century health challenges, reforming the financing and management of the organisation, and “transforming governance to strengthen public health.”

In her opening remarks on Monday, Chan indicated that she saw the role of the WHO “as that of a global health guardian, a protector and defender of health, including the right to health.”

On Friday, member states will discuss a framework on pandemic influenza preparedness agreed upon at the 2011 WHA that includes provisions for benefit sharing and aims to ensure greater access to vaccines for developing countries.  Members will also examine the work of the WHO’s working group on substandard/spurious/falsely-labelled/falsified/counterfeit medical products, which was a contentious issue last year.

Further analysis of this week’s WHA discussions, including topics addressed during the Thursday and Friday meetings, will be featured in next week’s Bridges.

ICTSD reporting.

The Committee on Development and Intellectual Property (CDIP) is tasked with monitoring the implementation of the 45 DA recommendations, which aim to mainstream development into the organisation’s work.

During the 7-11 May CDIP session, persistent divides over how to improve WIPO’s technical assistance activities and future work in relation to the public domain delayed agreement on a Chair’s summary until late Friday.

No decision on follow-up to TA review

At the forefront of the committee’s work was how to advance discussions on the report of an external review of WIPO’s technical co-operation, which was called for by member states as part of the WIPO Development Agenda.  The report lists a series of recommendations aimed at improving the delivery of WIPO’s technical assistance and ensuring that it is more development-oriented. The review report was briefly considered by the Committee last year but substantive discussion was postponed until last week’s session (See Bridges Weekly, 23 November 2011).

In line with a request from member states at the November 2011 Committee meeting that the WIPO Secretariat should prepare a management response, as called for in the review terms of reference, the WIPO Secretariat presented a management response to the review at last week’s meeting.

Further, in keeping with a joint US-EU request, the document includes an Annex that divides the review’s recommendations into three different clusters: recommendations that could be considered ‘redundant’ as they are “already reflected in WIPO activities or ongoing reform programs,” (cluster A); recommendations that “merit further consideration,” (cluster B); and recommendations that “raise concerns as to implementation” (cluster C).

Developed countries voiced a strong preference for basing discussions solely on cluster B, considering that “it would be unnecessary to review redundant recommendations,” such as those under cluster A.

The US, speaking on behalf of developed country bloc Group B,  added that the call for a shift in WIPO “from an IP-centric to development-oriented organisation” - as identified in some cluster C recommendations - is problematic and contradicts the organisation’s mandate “to promote the protection of IP throughout the world.”

Developing countries, for their part, stressed that the clusters represented “an opinion of the Secretariat,” with Brazil specifically saying that “there are some recommendations in cluster A that would need further consideration.”

“There is no agreement in the membership on what is relevant and what is not,” Bolivia added.

Carolyn Deere Birkbeck, who co-authored the review together with Santiago Roca, added that she “would not put as many recommendations in the ‘redundant’ category,” as several of the recommendations considered ‘redundant’ under cluster A remained pertinent in her view.

She added that, while the Secretariat has taken some ‘positive steps’ to address some of the technical assistance shortcomings highlighted in the review, there is still much to be done by the Secretariat to improve its management and coordination of assistance, which she noted ought to be of interest to all member states.

Moreover, she observed that shortcoming with regard to the ‘development orientation’ of WIPO technical assistance will require not only further actions by the Secretariat but also greater guidance from member states.

In light of these discussions, developing countries lent their support to a new joint proposal by the Development Agenda Group (DAG) and the African Group, which identifies 13 sets of concrete follow-up actions that build from the external review and management response.

These include the elaboration of ‘guidelines’ regarding future development-oriented assistance, and a request that the Secretariat prepare a ‘manual’ that details modalities and procedures for technical assistance delivery, including how, and for what activities, governments and stakeholders can acquire WIPO support.

Discussions on the follow-up to the technical assistance review will continue at the next CDIP session.

DG report receives mixed response

Also during the week-long meeting, WIPO Director General Francis Gurry presented a report on the implementation of the DA recommendations, noting that “it is time to take stock of the progress that has been made.”

“Three years and a half ago there was just a set of mere recommendations. Today, there are projects initiated, concluded, and evaluated,” he said, referring to the 23 projects carried out by the organisation that together cover 29 DA recommendations.

Several developing countries argued that, despite the progress made, the “third pillar” of the CDIP mandate - which says the Committee should serve as a forum for discussions on IP and development issues - has not been adequately implemented. One of the ways to achieve this, they said, is by inserting a standing agenda item on “IP and development,” a proposal made by Brazil in 2010 that has seen little movement to date (See Bridges Weekly 11 May 2011).

The DAG and African Groups also commented on delays in the implementation of a co-ordination mechanism aimed at ensuring that all “relevant WIPO bodies” report annually on their efforts toward integrating the DA recommendations into their work. The mechanism was adopted in 2010 by the WIPO General Assembly.

“General opposition to implementing the Development Agenda co-ordination mechanism when it comes to Programme and Budget Committee constitutes a non-comprehensive approach that undermines all those efforts,” the DAG said during the discussions.

Public domain debate heats up

Discussions on IP and the public domain proved particularly divisive, especially regarding a document prepared by the Secretariat clarifying the scope of some recommendations contained in a study on copyright and related rights and the public domain.

Recommendation 16 of the DA calls upon WIPO to consider the preservation of the public domain within the UN agency’s normative processes, along with calling for deeper analysis of “the implications and benefits of a rich and accessible public domain.”

Several developing countries urged WIPO to continue its work on public domain, yet developed countries - such as the US, the EU, Norway and Switzerland - felt it was important to “know what we want to achieve before any further work can be conducted” in this area.

Members find agreement on flexibilities, Burkina Faso project

Despite disagreements in the above-mentioned areas, the CDIP was able to find convergence on a few specific issues and projects in  the  context of DA implementation.

As in previous sessions, members highlighted the importance of addressing patent-related flexibilities at the CDIP without duplicating the work in other WIPO committees, specifically the Standing Committee on the Law of Patents.

At last week’s meeting, the Secretariat was asked to prepare a document on this subject, which will focus on four flexibilities outlined in the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS): patentability of plants, patentability of software-related inventions, criminal sanctions in patent enforcement, and security exceptions to patent rights.

The Committee also agreed to launch a project proposed by Burkina Faso to strengthen and develop the audiovisual sector in the country and in other African member states - a decision that received wide support from developed and developing countries alike.

“This project is extremely interesting and it is exactly the kind of project that should inform the work of the CDIP. It promotes development through intellectual property,” the US said on behalf of Group B.

The WIPO General Assembly will discuss the work of the Committee in the fall.

ICTSD reporting.

Back in March, the Indian Patent Office announced that it had issued its first compulsory license to Indian generic drug producer Natco - a move that effectively ended Bayer’s monopoly over Nexavar, a drug that is used to treat kidney and liver cancer. (See Bridges Weekly, 14 March 2012)

Compulsory licensing is when a government authorises a party other than the patent owner to produce the patented product or process without the patent owner’s consent. The patent owner shall, nevertheless, be paid an adequate remuneration, taking into account the economic value of the authorisation.

“We will rigorously continue to defend our intellectual property rights, which are a prerequisite for bringing innovative medicines to patients,” Bayer spokesman Aloke Pradhan told AFP.

The Indian ruling “damages the international patent system and endangers pharmaceutical research,” Pradhan added.

Meanwhile, P.H. Kurian, the then-controller general of patents who issued the March ruling, told LiveMint - a business news website that partners with the Wall Street Journal - that “it’s Bayer’s prerogative to appeal against the order, and it can put its arguments before the appellate authority.”

Natco, for its part, has said that it has yet to receive a notice of an appeal. “We haven’t received any notice in this regard so far, and if the appeal comes up, we will be able to file a reply and will present our case in the hearing.”

It was not clear when the appeal would be heard as Bridges went to press on Wednesday evening.

India is the world’s third-largest pharmaceutical drug producer by volume; in 2011 the domestic pharmaceutical market reached a record US$12.2 billion in sales.

New Delhi only began issuing patents for drugs in 2005 in order to comply with the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). WTO rules explicitly allow compulsory licensing as long as procedures and conditions set out in Article 31 of TRIPS are fulfilled. The 2001 Doha Ministerial Declaration on the TRIPS Agreement and Public Health further recognised that “each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.”

Original ruling

The Indian patent authority’s March ruling found Bayer’s version of Nexavar to be “exorbitantly priced and out of reach of most of the people.” The 62-page decision also indicated that the German pharmaceutical giant had not taken “adequate or reasonable steps to start the working of the invention in the territory of India on a commercial level and to an adequate extent.”

The ruling allows Natco to sell the drug at Rs. 8,800 per patient per month, or US$175 - a 97 percent price cut compared to Nexavar. The compulsory licence was granted to Natco until 2020; the Indian company is required to pay royalties to Bayer on a quarterly basis.

Compulsory licensing decision under scrutiny by trading partners

India’s landmark decision has not escaped the notice of its trading partners, with the Office of the US Trade Representative noting in an official report last week that it would “closely monitor developments concerning compulsory licensing of patents in India following the broad interpretation of Indian law in a recent decision … while also bearing in mind the Doha Declaration on TRIPS and Public Health.”

The Special 301 report, issued annually by the Office of the USTR, also urged New Delhi “to provide an effective system for protecting against unfair commercial use, as well as unauthorised disclosure, of test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products.” (For more on the USTR report, see related article in this issue).

In the report, India was one of 13 countries placed on a “priority watch list” by Washington, a classification that indicates “significant concerns” in the area of intellectual property rights protection and enforcement.

ICTSD reporting; “Bayer challenges India cancer drug ruling,” AFP, 7 May 2012; “Bayer appeals against compulsory licence order,” LIVEMINT & THE WALL STREET JOURNAL, 5 May 2012; “UPDATE 1-India Cipla slashes generic price of Bayer’s Nexavar,” REUTERS, 3 May 2012.

The Special 301 Report - which is named after a section of the US Trade Act of 1974 - has been published every year since 1988, when amendments to the Omnibus Trade and Competitiveness Act made it mandatory. This year’s version was issued on 30 April.

“This year’s Special 301 Report is more significant than ever in light of recent US Government data showing that IP-intensive industries support as many as 40 million American jobs and up to 60 percent of US exports,” US Trade Representative (USTR) Ron Kirk said, referring to new statistics recently published  by the US Department of Commerce.

Thirteen countries were included in this year’s priority watch list, which flags the most significant concerns regarding insufficient IPR protection or enforcement. The countries named included Algeria, Argentina, Canada, Chile, China, India, Indonesia, Israel, Pakistan, Russia, Thailand, Ukraine, and Venezuela. A lower level watch list outlined 26 other US trading partners - including Mexico and some EU member states - whose IP policies, according to Washington, also merit attention.

Spain and Malaysia, which had both been on last year’s second-tier list, were removed from this year’s report after adopting new regulations to better protect IPRs, Washington said. Meanwhile, Ukraine moved back to the priority list after having been on the second-tier list in last year’s report, as a result of “serious and growing concerns relating to counterfeiting and rampant piracy, including piracy over the internet,” the Office of the USTR said in a statement.

China’s IP policies - a repeated point of contention between the two trading partners - also featured heavily in the report. One of the main concerns cited by Washington was Beijing’s “indigenous innovation” policies, which it argues “effectively coerce the transfer of IPR from foreign rights holders to domestic entities.”

Trade pacts useful enforcement tools, Washington says

The report also outlines the actions taken by the Administration of President Barack Obama toward effective protection of IPRs, including the negotiation of plurilateral trade agreements. In particular, it describes the proposed Trans-Pacific Partnership (TPP) as “a key initiative to advance the multi-faceted US trade and investment interests in the Asia-Pacific.”

The TPP “will include strong standards for the protection and enforcement of IPRs,” the report noted.

The document also calls the controversial Anti-Counterfeiting Trade Agreement (ACTA) “an important new tool to fight trademark counterfeiting and copyright piracy,” underscoring that the accord “will be implemented in a way that preserves freedom of expression, fair process, and privacy.”

Report sparks mixed reactions

As in previous years, the report drew a mixed response, with supporters insisting that the report is essential for the protection of US economic interests. Critics, meanwhile, argue that the document is too heavily influenced by industry groups, and that it wrongly pushes developing countries into adopting US-style IP policies and legislation that could be detrimental to their public policy objectives, particularly in areas such as access to essential medicines.

“The Special 301 process continues to be effective in gaining high-level attention from our trading partners - attention that is needed to redress intellectual property violations and market access concerns,”  Pharmaceutical Research and Manufacturers of America (PhRMA) said in a statement, a sentiment that was echoed by other industry groups.

Washington has sought “to reduce market access barriers that US pharmaceutical and medical device companies face in many countries, and to facilitate both affordable health care today and the innovation that assures improved health care tomorrow,” PhRMA added.

Similarly, Steven J. Metalitz - counsel to the International Intellectual Property Alliance - commented that the “USTR’s report signals strongly the Administration’s commitment to protect one of our nation’s most valuable assets.”

However, Rashmi Rangnath - from advocacy group Public Knowledge - criticised the report’s vagueness and the influence of industry groups,  arguing that the process “continues to force other countries to adopt particular legislation.”

Knowledge Ecology International (KEI) also noted that, “as has become tradition, the list of grievances and the 41 countries named on the various lists are largely driven by lobbying efforts of right holders.”

“The USTR Special 301 report continues to disparage countries for taking measures to restrain drug prices or limit reimbursements on new medicines,” KEI concluded.

ICTSD reporting; “Russia, China on top copyright pirates list again,” REUTERS, 30 April 2012.

The report was prepared by the WHO’s Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG).

The working group was established by the World Health Assembly in 2010, in the context of the implementation of the global strategy and plan of action on public health, innovation, and intellectual property (GSPA-PHI). The CEWG was given the mandate of examining current and proposed financing of R&D focused on diseases that disproportionately affect poor countries, along with diseases that occur in both developed and developing countries.

“Market forces will not lead to efficient technologies and affordable medicines” against diseases that disproportionately affect developing countries, CEWG Chair John-Arne Røttingen explained at the seminar, held at the Graduate Institute of International and Development Studies.

The report suggests that all countries should aim to achieve specified levels of public funding on health R&D relevant to the needs of developing countries, and that a financing system be established under the convention based on contributions by governments.

Such a convention, the CEWG argues, should focus on the development of health technologies for diseases that occur almost exclusively in poor countries - such as HIV/AIDS, malaria, and African sleeping sickness - as well as the specific needs of developing countries regarding more globally widespread illnesses, such as cancer and diabetes.

It also advocates for the de-linking of research costs from final drug prices through upfront public financing. Pharmaceutical companies have traditionally argued that significant R&D expenditures are needed to develop new drugs. In addition, the exclusive protection afforded by patents to pharmaceutical products is an important market mechanism that allows for the channelling of resources for future R&D on innovative products.

However, as acknowledged by the 2001 Doha Declaration on TRIPS and Public Health, while intellectual property protection is important for the development of new medicines, its effects on prices is also an important consideration as it can make products less affordable for poor countries.

According to the CEWG report, an R&D convention should not serve as “a replacement for the existing intellectual property rights system,” but should instead act as a supplementary instrument in areas “where the current system does not function.”

“Living in a profit-driven system means that research goes where the money is,” Stiglitz - who previously held the role of World Bank Chief Economist - said.

He also stressed the need for shaping a well-designed IP regime, given that “intellectual property does not lead to efficient allocation of resources” when it comes to R&D and “patents can be an impediment to innovation.”

Suerie Moon - Research Director and Co-Chair of the Forum on Global Governance for Health at the Harvard Global Health Institute, and a commentator at the event - argued that the implementation of the right to health is primarily a responsibility of governments and invited them to support a binding approach for an R&D treaty at the WHO. “Soft norms have not been enough,” Moon said.

Concluding such a convention could be a valuable opportunity for the WHO to reaffirm the organisation’s role in global norm-setting, she added, given that recent discussions on WHO reform have identified this area as one where the organisation has a unique role to play.

Kenyan Ambassador to the United Nations Tom Mboya Okeyo echoed this sentiment, noting that “what is needed is not the setting up of more Working Groups but to develop further the negotiated global strategy on Public Health Innovation and Intellectual Property into a Research and Development Convention within the context of WHO reform.”

James Love, director of Knowledge Ecology International, said that the WHO should consider broadening the scope of the proposed R&D treaty in order to address global health needs involving high-income countries.

For instance, he suggested, such a treaty could include funding more R&D for new antibiotic drugs or products for influenza pandemics, or to fund independent clinical trials to test products.

The CEWG report will be discussed at the upcoming World Health Assembly on 21-26 May. The organisation’s Executive Board will follow on 28-29 May.

ICTSD reporting.

“The European Parliament cannot guarantee adequate protection for citizens’ rights in the future under ACTA,” Martin warned in his recommendation.

ACTA is a plurilateral trade pact seeking to strengthen global standards for the enforcement of intellectual property rights in order to combat counterfeiting and piracy.

For the EU, the pact will become legally binding when signed and ratified both by the EU as a bloc and by its 27 member states individually. The EU Parliament’s express consent is needed before the agreement is adopted.

Growing concerns about ACTA - including protests throughout the continent - led the European Commission to refer the pact to the European Court of Justice earlier this year, whose legal opinion on the accord’s compatibility with EU law is still pending (See Bridges Weekly, 22 February 2012).

Martin: ACTA may cause more harm than good

Earlier last month, Martin released a draft recommendation to the EU Parliament expressing the same concerns that he officially presented to the EU International Trade Committee (INTA) last week. The document cautioned against ACTA’s ambiguities with regard to individual criminalisation, the definition of “commercial-scale” counterfeiting and online piracy, the role of internet service providers, and the possible seizures of in-transit generic medicines.

“The intended benefits of this international agreement are far outweighed by the potential threats to civil liberties,” Martin stated in the recommendation.

However, Martin acknowledged that intellectual property is “the raw material of the Union” and recognised that “the problems which ACTA seeks to address are real and growing,” inviting the European Commission to come up with new proposals to protect European intellectual property.

Martin also mentioned the possibility of renegotiating the agreement and suggested that the Commission might be able to “go back to other contracting parties” to modify the present text of the treaty after a rejection from the Parliament.

Continued apprehension about agreement’s impact on internet freedoms

Martin’s recommendation followed an opinion by the European Data Protection Supervisor (EDPS) - an independent authority appointed by the EU Parliament and the European Council devoted to protecting personal data and privacy - which highlights various concerns about the implementation of some provisions of the treaty in the digital environment.

The EDPS underscored that the ACTA provisions regarding intellectual property rights (IPRs) enforcement on the internet “raise concerns from a data protection perspective [and] are highly intrusive to the private sphere of individuals.”

“The indiscriminate or widespread monitoring of internet users’ behaviour … in relation to trivial, small-scale not for profit infringement would be disproportionate,” notes the document, adding that such measures would also be in violation of EU law.

Meanwhile, Marielle Gallo, the ACTA rapporteur for the EU Committee on Legal Affairs (JURI), expressed her support for the pact and proposed that the EP give its consent. JURI is one of the four committees that is expected to submit an opinion to the INTA prior to the trade committee issuing its recommendation to Parliament.

“ACTA does not create new intellectual property rights for the Contracting Parties. In other words, that which is currently protected by European legislation remains protected; that which was not protected is still not protected,” Gallo stated.

The INTA has postponed its vote on a final recommendation to the EU Parliament until June to allow more time for discussions and let other committees draft their opinions. The final Parliamentary vote is expected to take place in July.

ICTSD reporting; “ACTA: reject and maybe renegotiate, says European Parliament rapporteur,” INTA, 25 April 2012; “Euro MP David Martin dismisses anti-counterfeiting treaty,” BBC NEWS, 16 April 2012; “EU privacy chief warns of internet spying threat,” REUTERS, 24 April 2012.

The 21st session of the WIPO Intergovernmental Committee on Genetic Resources, Traditional Knowledge, and Folklore (IGC) met from 16-20 April in Geneva, Switzerland.

The Committee was created in 2000 amid concerns by biodiversity-rich countries and indigenous peoples regarding the misappropriation of their genetic resources and associated traditional knowledge.

The IGC’s mandate was renewed last year at the WIPO General Assembly, with countries setting the goal of engaging in text-based negotiations to reach agreement on an international legal instrument(s) for the effective protection of genetic resources, traditional knowledge, and traditional cultural expressions. With this goal in mind, the first IGC of this year - held in February - saw members focus solely on genetic resources (See Bridges Weekly, 22 February 2012).

The IGC was also asked to submit texts to this year’s WIPO General Assembly, where members will consider progress made and decide on whether to convene a diplomatic conference (See Bridges Weekly, 28 July 2011).

“We probably won’t have a nice, clean text necessary to convene a diplomatic conference tomorrow,” Chair Wayne McCook of Jamaica conceded on Friday, urging delegates to think of innovative ways to advance the committee’s work in the future.

No agreement over definition of TK, beneficiaries of protection

Last year’s renewed mandate urged the Committee to advance negotiations at last week’s session on four key issues: subject matter of protection, beneficiaries, scope of protection, and limitations and exceptions.

To this end, discussions at last week’s meeting were based on the draft articles text prepared in two revisions by three facilitators from Canada, Colombia, and Egypt, respectively.

Member states were unable to find common ground on whether a definition of traditional knowledge should be broad in scope or more detailed and descriptive.

South Africa underlined the need to define TK as ‘dynamic and evolving’, given that “traditional knowledge changes in the passage from generation to generation.”

“If we remove the terms ‘dynamic and evolving’ it becomes a static, frozen concept,” added the South African delegate.

Bolivia, for its part, asked that TK be defined as ‘inalienable, indivisible and imprescriptible’, as TK “cannot be given away by indigenous people, it cannot be fragmented, it is a unit.”

Some developed countries, however, urged members to instead adopt a broader definition without descriptive terms.

“Increasing elements decreases the value of the definition,” Australia argued.

Differences also persisted over who should be the potential beneficiaries of protection under a potential TK instrument, with several members arguing against a proposal that would include individuals, families, nations, and other national entities as beneficiaries of protection.

The EU, for instance, highlighted that “references to families and individuals are ambiguous” and “nations should not be considered as beneficiaries.”

Other proposals spark disagreements

Developed countries asked for the insertion of extensive exceptions and limitations in the draft articles. In particular, the US presented a proposal by which national authorities may exclude from protection “diagnostic, therapeutic and surgical methods for the treatment of humans or animals” and “traditional knowledge that is already available without restriction to the general public.”

In addition, Norway presented a proposal for a disclosure requirement regarding any process or product related to TK in patent and plant variety applications. India welcomed the proposal, but considered it should go beyond patents and plant varieties to encompass all intellectual property rights.

WHO: link between TK and public health
During the session, a representative from the World Health Organization (WHO) highlighted the growing importance of traditional medicines, as well as their widespread use in Africa, Asia, and South America.

Noting the overlap in the work of the IGC and the WHO, the representative stated that an IP system for the protection of TK should not  “restrict access to traditional medicine to the detriment of efforts to further develop existing treatments, to develop new products or to provide access to such treatments.”

Indigenous participation

The IGC also discussed proposals to reform the rules of participation for observers and indigenous people groups in the committee.

During the last session of the IGC, indigenous groups staged a walk-out from the committee and avowed to withdraw their participation until member states “change the rules of procedure to permit our full and equitable participation at all levels of the IGC.” (See Bridges Weekly, 22 February 2012)

At last week’s meeting, member states agreed to a proposal by the Indigenous Caucus - a group of indigenous peoples’ organisations at the IGC - requesting that the Secretariat prepare an information document on the practical, procedural, and financial implications of greater involvement of indigenous peoples’ representatives in the work of the Committee. The information document is expected to be circulated for members’ consideration at the next IGC session in July, which will focus solely on traditional cultural expressions.

The WIPO General Assembly will review the IGC’s work in September.

ICTSD reporting.

The 2008 Anti-Counterfeit Act was approved by the Kenyan Parliament with the intent of prohibiting trade in counterfeit goods and establishing an Anti-Counterfeiting Agency. (See Bridges Review, June 2009) The legal challenge to the act began in 2009 with a lawsuit filed by three petitioners with HIV/AIDS.

High Court Judge Mumbi Ngugi found that the act fails to clearly distinguish between counterfeited drugs and generic medicines. The ruling affirms that this legislative misstep may lead to confusion, which in turn could hinder access to life-saving medicines, particularly for people living with HIV.

“The right to life, dignity, and health of people like the petitioners who are infected with the HIV virus cannot be secured by a vague provison in a situation where those charged with the responsibility of enforcement of the law may not have a clear understanding of the difference between generic and counterfeit medicine,” Judge Mumbi Ngugi stated in the ruling.

“The Anti-Counterfeit Act has, in my view, prioritised enforcement of intellectual property rights in dealing with the problem of counterfeit medicine. It has not taken an approach focused on quality and standards which would achieve … the protection of the petitioners in particular and the general public from substandard medicine,” Ngugi added.

Following doubts in July 2010 over the act’s consistency with the Kenyan Constitution on the right to life and the right to the highest standard of health, the High Court suspended implementation of the act’s provisions on counterfeited drugs until a decision on the case could be taken.

Last Friday’s ruling reaffirmed the suspension, underscoring that “there can be no room for ambiguity where the right to health and life of the petitioners and the many other Kenyans who are affected by HIV/AIDS are at stake.”

Health activists welcome decision

After the ruling, UNAIDS Executive Director Michel Sidibé declared that “the High Court of Kenya has upheld a fundamental element of the right to health.”

According to UNAIDS, 1.6 million people in Kenya live with HIV/AIDS; an estimated 743,000 Kenyans are eligible for antiretroviral treatment, of whom 539,000 are currently receiving it. Generic drugs are the most widely used medicines in Kenya.

“We must have both generic drugs and strong anti-counterfeit laws. Generic drugs give more people access to life-saving treatment - while anti-counterfeit laws keep people safe,” Sidibé added.

Several health advocacy groups similarly applauded the decision.  AIDS Law Project Executive Director Jacinta Nyachae - in a joint statement issued by Médecins Sans Frontières, Health Action International Africa, and the Kenya Ethical and Legal Issues Network on HIV and AIDS - welcomed the High Court ruling and underlined the possible ripple effect the decision could have on Kenya’s neighbours.

“Kenya is leading the way in protecting access to medicines and public health and we are watching the actions of the East African Community member states to see if they follow suit,” Nyachae concluded.

ICTSD reporting; “Kenyan court ruling upholds access to generic drugs,” REUTERS AFRICA, 20 April 2012.

Espinel was nominated in 2009 by US President Barack Obama to better coordinate the work of US federal agencies in this area. The report is the second since her appointment to the post.

“Fighting intellectual property rights infringement in other countries is a critical component of enforcing intellectual property rights,” Espinel said in the report, encouraging the use of plurilateral treaties and free trade agreements (FTAs) for this purpose.

According to Espinel, the signing of the controversial Anti-Counterfeiting Trade Agreement (ACTA) by the US and seven other negotiating parties in October “represents a considerable improvement in international trade norms for effectively combating the global proliferation of commercial-scale counterfeiting and piracy.” (See Bridges Weekly, 5 October 2011).

Notably, the IPEC report also stressed the importance of ensuring transparency in IP policy making - a subject which has been a major point of contention regarding the ACTA negotiations (see Bridges Weekly, 17 March 2010).

The report also highlighted progress in the fight against counterfeit products, particularly pharmaceuticals, while recognising that “new legislative and non-legislative tools are needed to address offshore infringement and counterfeiting.”

However, Espinel clarified that the Obama Administration “will not support legislation that reduces freedom of expression, increases cybersecurity risk (including authority to tamper with the DNS system), or undermines the dynamic, innovative global Internet,” in line with earlier statements made by the White House in response to the protests against the controversial PROTECT IP Act (PIPA) and the Stop Online Piracy Act (SOPA) (see Bridges Weekly, 18 January 2012).

China at the forefront

US enforcement efforts in 2011 focused heavily on Beijing, the report noted, with China being the number one source of infringing products seized at the US border.

Trade tensions have been running high between Washington and Beijing during recent months as both sides prepare for potential leadership transitions, with China’s protection of IPRs being one of several topics where the two trading partners have found themselves repeatedly at odds.

Espinel’s report expressed particular concern over evidence suggesting that economic espionage and trade secret theft is being conducted on behalf of Chinese companies, calling it “an emerging trend.” The US Department of Justice and the Federal Bureau of Investigation reported an increase of 29 percent in investigations into these alleged practices in 2011 compared to 2010.

However, the report also welcomed some recent changes in Chinese policy, particularly Beijing’s decision to make permanent an existing leadership structure that had led and coordinated IP enforcement across China since 2010.

“With regard to the US concerns concerning trade imbalance, IPR protection, indigenous innovation and investment environment, the Chinese side has taken steps to address them and will continue to do so,” Chinese Vice-President Xi Jinping told a Washington audience earlier this year.

ICTSD reporting; “Second Annual US IP Enforcement Report Shows Extensive Efforts at Home and Abroad,” IP WATCH, 2 April 2012.

At yesterday’s meeting of the European Parliament’s International Trade Committee (INTA), 21 members voted against ACTA Rapporteur David Martin’s proposal, five voted in favour, and two abstained.

ACTA is a plurilateral trade pact seeking to strengthen global standards for the enforcement of intellectual property rights in order to combat counterfeiting and piracy. Many developing countries and consumer organisations have criticised it for its possible effects on internet freedoms and access to medicines (see Bridges Weekly, 7 March 2012).

Last February growing protests across the European continent prompted the European Commission - the EU’s executive branch - to decide to refer the treaty to the European Court of Justice (ECJ) in order to assess the pact’s compatibility with EU’s individual fundamental rights and freedoms (see Bridges, 22 February 2012).

A coalition of NGO groups, such as Oxfam and Médecins Sans Frontières, have argued that the Commission’s referral was “an attempt to deflect growing protests and avoid ACTA being definitely rejected by national governments and the European Parliament.”

Soon after the Commission’s referral, ACTA Rapporteur to the European Parliament David Martin asked INTA to support his plan to submit a referral to the ECJ on the basis of the Parliament’s set of questions, rather than having Parliament limiting itself to the European Commission’s referral of ACTA.

The EU signed the agreement last January, following Australia, Canada, Japan, South Korea, Morocco, New Zealand, Singapore, and the United States (see Bridges Weekly, 1 February 2012). It will enter into force only after six of its eleven negotiating parties have ratified the treaty.

In the EU, the pact will become legally binding when signed and ratified both by the EU as a bloc and by its 27 member states. At the EU level, the Parliament’s express consent is needed before the agreement is adopted.

INTA decision sets the stage for June vote

Citizen advocacy group La Quadrature du Net welcomed the move by INTA, noting that the Parliament can now proceed with its work on ACTA, but that “MEPs will have to shed the light on the democratic and political issues raised by ACTA, such as the extra-judicial measures aimed at stepping up the repression of online sharing.”

“If Parliament refers ACTA to the court, then it can no longer vote on it,” German Member of the European Parliament (MEP) Daniel Caspary said in explaining the rejection.

For his part, Martin defended his proposal, stating that it was not “a political trick” intended to delay the process but was intended rather “to shed some light that would help members of Parliament make their decision.”

Despite the rejection of his proposal, Martin indicated he would adhere to the previously agreed timetable for Parliament’s decision on ACTA and present his report on the pact in April. On the basis of Martin’s report, the Committee should vote on its recommendation to the EU Parliament over the treaty’s adoption in May. The Parliament’s ultimate decision on ACTA should be taken at its June plenary session.

“I am glad that the calendar is clear now and things will move faster. We need to stop discussing the procedure and start the political debate on the content”" Martin added.

ICTSD reporting; “ACTA: reasons for committee vote against referral to Court of Justice”, INTA, 28 March 2012.