At the Crossroads for Global Chemical Safety

By Baskut Tuncak

Baskut Tuncak, Staff Attorney

Next week, negotiators from over 150 countries and other stakeholders will convene in Nairobi, Kenya, to discuss the future of global chemicals management.  These critical negotiations come at decisive juncture for the Strategic Approach to Chemicals Management (SAICM), with only eight years left on its ambitious mandate to ensure sound chemicals management—eight years in which developing regions face rapidly increasing risk of exposure to dangerous chemicals.  A recent report by the UN Environment Programme (UNEP), the Global Chemicals Outlook (GCO), highlights the global nature of the chemicals industry and chemical safety.  The GCO highlights three factors responsible for increasing the vulnerability of people living in developing economies to chemical exposure.

Rio+20 Outcome: The Anthropocene Challenge

By Marcos Orellana, Rio de Janeiro (originally posted 22 June 2012)

Marcos, Alyssa and Andrea, part of CIEL’s delegation

On June 20, the United Nations Conference on Sustainable Development (Rio+20) officially started in Rio de Janeiro, Brazil.  The Conference opened with a documentary, Welcome to the Anthropocene, which was introduced by the UN’s Secretary-General.  The documentary visually portrays the alteration in Earth’s natural cycles induced by human activities.
Welcome to the Anthropocene echoes the United Nations Environment Program (UNEP) 5th edition of the Global Environmental Outlook (GEO-5), published on June 6, 2012.  The report concludes that the “scientific evidence shows that Earth systems are being pushed towards their biophysical limits.” Also it “cautions that if humanity does not urgently change its ways, several critical thresholds may be exceeded, beyond which abrupt and generally irreversible changes to the life-support functions of the planet could occur.”

Multilateralism works! An insider’s analysis of Basel COP10

By Hana Heineken, Law Fellow

My very first COP experience, the 10^th Conference of the Parties to the Basel Convention in Cartagena, Colombia, was hailed by delegates, observers, and the UNEP Executive Director Achim Steiner as the most successful Basel COP in the history of the Basel Convention.  I was fortunate to have joined CIEL’s delegation that participated in such a momentous event.

COP10 began with

Columbian IP Agreement continues to Raise Human Rights Concerns

During Columbia’s periodic review by the Office of the UN High Commissioner for Human Rights, specifically the Committee on Economic, Social and Cultural Rights, several recommendations were made relating to intellectual property (IP) rights. 

The official UN report can be found here and CIEL’s publications relating to Trade Agreements and IP can be accessed here.

With respect to Access to Medicines, examining the US-Columbia Free Trade Agreement, the Committee noted that: 

The Committee is also concerned that the Free Trade Agreement (FTA) signed between the State party and the United States contains provisions on intellectual property that may result in increase of prices of medicines and negatively impact on the enjoyment of the right to health, in particular of those with low income (arts. 1, 12).

…In this regard, the Committee recommends that the State party consider revising the intellectual property provisions of the Free Trade Agreement signed with the United States, in order to ensure protection against the increase of the price of medicines, in particular for those with low income.  (para. 10)

With respect to development projects, including those that would be under the ambit of the Clean Development Mechanism (CDM) of the Kyoto Protocol, the Committee noted:

The Committee recommends that the State party take concrete measures to review the processes concerning infrastructure, development and mining projects and fully implement decisions of the Constitutional Court in this regard. The Committee also recommends that the State party review the Presidential Directive 001 and the draft bill elaborated by the Working Party on Prior Consultation of the Ministry of the Interior. The Committee further recommends that the State party adopt legislation in consultation with and the participation of indigenous and afro-colombian people, that clearly establishes the right to free, prior and informed consent in conformity with ILO Convention 169 concerning Indigenous and Tribal Peoples in Independent Countries, as well as the relevant decisions of the Constitutional Court.  (para. 9)

On Biofuels, the committee notes that:

The Committee is concerned that the policy encouraging agro-exporting goods, such as agro-fuels, may deprive peasants from cultivating their lands. The Committee is also concerned about the unequal distribution of lands owned by a minority of the population, as well as about the absence of a genuine agrarian reform, as recommended in the previous concluding observations of the Committee (art. 11).

The Committee recommends that the State party develop agricultural policies which prioritize the production of food; implement programs that protect national food production with incentives for small producers; and ensure the restitution of lands taken from indigenous and afro-colombian peoples, as well as peasant communities.   (para. 22)

Regarding Access to Knowledge and Education:

The Committee recommends that the State party take immediate measures to ensure access of all children without discrimination, to free and compulsory primary education.  (para. 29)

In addition to these recommendations by the Committee, on GMOs the Seeds Group presented its report on Genetically Modified Organisms and the Human Rights of Indigenous Peoples in Columbia.  The report states: 

The policies and practices of the Colombian State concerning genetically modified organisms (GMOs) have violated, and threaten to continue violating, the rights of indigenous peoples in Colombia, including their rights to self-determination, prior consultation, participation, property, culture, food, heath, and a healthy environment.

In 2005, the Colombian State issued a decree that regulates the approval of GMOs. Though indigenous peoples will be affected by the release of genetically modified (GM) seeds, they were not consulted before the approval of this decree; nor does the decree provide for any consultation during the approval process for each seed. Under this decree, the processes by which certain GM seeds have been approved have violated the Colombian State’s obligation to apply the precautionary principle, and have not taken into account scientific studies that have demonstrated the threat that GM seeds pose to native seeds, human health, and the environment.

The next periodic report of Columbia is due to be submitted by July 2015.

Human Rights, Technology Transfer & Climate Change

On the margins of the WIPO Committee on Development and IP (CDIP), CIEL organized a series of presentations and commentary on the topic of Human Rights and Technology Transfer, in the context of climate change.  Information on what agreements were reached in the CDIP can be found on the CIEL IP Quarterly Update, Second Quarter of 2010.

The speakers included:

• Mr. Robert Archer, Executive Director of the International Council on Human Rights Policy (ICHRP)
• Mr. Michael Waibel, Post-doctoral researcher at Cambridge University
• Mr. Baskut Tuncak, Law Fellow, Center for International Environmental Law (CIEL)
• Ms. Caroline Dommen, Quaker United Nations Office (QUNO)
• Mr. Subhas Gujadhur, First Secretary of the Permanent Mission of Mauritius to Geneva

Mr. Archer began the event with a summary of the Human Rights dimension of climate change, based in part on their earlier publication “Climate Change and Human Rights: A Rough Guide.”

Mr. Waibel followed with an overview of Technology Transfer in the International Agreements on intellectual property and environmental protection.  His presentation can be viewed here.

Mr. Tuncak then spoke of how and to what benefit human rights obligations can inform discussions on technology transfer.

Finally. Ms. Dommen and Mr. Gujadhur provided their perspective on the preceding presentations.

For further information, please see IP Watch’s coverage here and/or contact Baskut Tuncak at btuncak [at] ciel [dot] org

Balancing or Swinging? Genes, ACTA and other Recent Developments in IP

The past thirty days have given those who follow developments in innovation policy quite a bit of material.  First, on March 29th, a US district court (SDNY) held that neither isolated genes nor methods of analyzing or comparing genes were patentable subject matter in Association for Molecular Pathology v. US Patent and Trademark Office (USPTO).   Then, recently, the very controversial and secret Anti-Counterfeiting Trade Agreement (ACTA) was officially released in draft form (available here).

First, in the case of genes, the ACLU is calling the court’s decision “a huge victory for womens' health and scientific freedom.”  

The case centered around Myriad Genetics’ patents over BRCA1 and BRCA2, genes which are associated with breast and ovarian cancer.  The plaintiffs challenged these patents as invalid, arguing that genes are not patentable under the “product of nature” exemption from patentable subject matter (35 USC s. 101).

Seemingly an obvious argument by the plaintiffs, the defendant bio-tech industry has argued (successfully) that genes – in their “isolated” or “purified” form – were not a product of nature and hence, a patentable invention.  The defendants’ lawyers repeated this argument before the court in this case, arguing for the patentability of Myriad’s claims over BRCA1 and BRCA2. 

However, the judge did not agree in the least bit with the defendants.  Judge Sweet held that a purified form of a natural product (e.g. a gene) must have "markedly different characteristics" than the unpurified form of that product to be patent eligible subject matter.  Then, citing in re Bilski (US Court of Appeals for the Federal Circuit), a decision which could invalidate thousands of business method patents if upheld by the US Supreme Court, the judge held that the method for analyzing the genes for cancer were not patentable either. 

If upheld on appeal, the BRCA case will have broadly sweeping implications.  The implication for health are clear – when available, doctors will be able to provide gene based tests, results and treatments at a lower cost, thereby increasing access and potentially lowering national health-care costs.

However, the case could also have implications for the food, biofuel, and other bio-based industries.  For example, patents over isolated genes and methods for their analysis are also found in many commercially viable transgenic plants (a.k.a GM crops/foods, GMOs, etc), owned by Monsanto, Syngenta and others in the very concentrated agriculture biotech industry.  For example, see Monsanto’s patent over “DNA constructs and Methods to Enhance the Production of Commercially Viable Transgenic Plants” (US pat. no 7,575,917).

Regarding genes and biofuels, see DuPont’s patent over genes for polyunsaturated fatty acid production using transgenic algae, bacteria, yeast and/or fungi (US pat. no. 7,695,950).  Algae is a second-generation (non-food crop) biofuel, which can be used to produce biodiesel and other biofuels.  Biodiesels are long chain esters, such as the polyunsaturated fatty acids produced by the transgenic algae claimed in DuPont's patent.  The US Dept of Energy claims that algae-based biodiesels are the only viable alternative energy source for automobiles, and thus it is no surprise that Exxon Mobil is investing heavily in algae biofuels.

Turning to ACTA, negotiating parties to the Agreement (US, EU, Japan, New Zealand, and others) – which is basically a new IP treaty in a thinly-veiled disguise – appear to have bowed to pressure from civil society, officially releasing the ACTA Draft.  Knowledge Ecology International (KEI), a leading NGO in advocating for transparency in ACTA negotiations, has stated that the disclosure comes far to late and is incomplete, lacking information on the negotiating parties‘ positions.  

ACTA negotiators are fudging the meaning of counterfeit, confusing copied products, where the consumer is aware of the authenticity of products such as generic medicine and audio/video reproductions, with actually counterfeit products – those which are intended deceive consumers.  Counterfeit medicines are very dangerous and a serious problem.  Awareness should be raised on this issue, but not by equating low-cost generic medicines to deadly counterfeit medicines.  This is the issue that has been at the heart of the ongoing dispute over the EU’s seizure of generic medicines that were in transit from India to Africa through EU ports. 

Medecins Sans Frontieres (aka, Doctors Without Borders) is concerned that the key elements of the ACTA – injunctions, border measures, criminal penalties and enforcement practices – may obstruct and deter legitimate generic competition.  MSF is also concerned about another anti-counterfeiting measure – the 2008 Kenyan Anti-Counterfeiting Legislation, which could not only impact the supply of anti-retroviral medications in Kenya, but throughout the African continent, given the influence of Kenya's laws on the legislative activities of other African countries.  Of particular concern are provisions in the Kenyan legislation on enforcement, and the vague definition of "counterfeit."  For more opinion and information, also see Michael Geist's blog and website on the ACTA (thanks Philip). 

Under current international IP and Trade agreements, TRIPS and the GATT, goods in transit – such as the generic medicines that were seized by the EU- are exempt from IP laws, which are territorial, while the goods are in transit.  In other words, under current international law, a Dutch patent on XYZ drug compound is inapplicable to a generic copy of that drug whose final destination is not in the Netherlands.  The enforceable patents in importing territory are what is applicable.  However, as suspected for some time, the draft ACTA agreement has the potential to go beyond current international IP norms and limiting access to medicines, depending on how the final negotiations shape up (see Dr. Henning Grosse Ruse-Kahn’s analysis of the ACTA text here)

So, are IP norms and laws moving towards a more balanced, a less “one-size-fits-all” approach?   In the case of gene patents, it depends what happens with the BRCA case on appeal, which might in turn depend on what the US Supreme Court has to say about the Federal Circuit Court of Appeals opinion in Bilski.  In the case of ACTA, in the end it will depend on what negotiators agree upon as the final text, which could depend on how much transparency is provided in the negotiations.  We'll see if US Trade Representative Ambassador Ron Kirk is correct when he said "people will walk away from the table" if the ACTA negotiation is made public.

World Bank discusses Trade and Climate Change

The World Bank, along with two other NGOs, held a panel discussion today on the trade implications of the ongoing climate negotiations.  The final presentation, on Technology Transfer and Climate Change was the most substantive, as detailed below.  The presentations did not address either labeling schemes, standards, border carbon adjustments, or subsidies.  For an in depth discussion of these topics, please see the 2009 CIEL publication, Is World Trade Law a Barrier to Saving our Climate?, available at: http://www.ciel.org/Publications/ClimateTradeReport_foee-ciel_sep09.pdf

Richard
Baldwin
began by discussing possible implications
of Copenhagen outcomes for the world trading system, and coping policies
to
minimize conflicts in the trading system.  In order to prevent what he
called a "train wreck" in the making, he encouraged Industrialized
Countries and Emerging Economies like Brazil, India, China and Russia,
to agree upon climate change rules for trade outside of the WTO
system.  He especially emphasized not letting the WTO's Dispute
Settlement Body take up the issue of climate related trade measures.

Dominique
van
der Mensbrugghe, Lead Economist at the World Bank, followed with an
outline of some of the probable changes in patterns of international
trade that rising global temperatures might precipitate.  His primary
emphasis was on the implications of climate change on agriculture.  A
representative of the World Health Organization (WHO) questioned why the health
related aspects, i.e. the human rights implications of climate change,
were not being addressed by the presentation, which was not answered by
Mr. van der Mensbrugghe.

Aaron Cosbey of the
International Institute for Sustainable Development discussed technology transfer and development assistance.  In using the IPCC 4 definition of Technology Transfer, he argued that weakening IPRs to stimulate the transfer of climate technologies is insufficient for the dissemination of these technologies to developing countries.   Rather, Mr. Cosbey emphasized the need for developing countries to have  enabling environments in place for investment.  He suggested learning from the experience of the trade regime, vis-a-vis Aid for Trade, to improve the investment climate in these countries, rather than looking at the experience of the WTO in handling another global challenge – access to medicines – with the Doha Declaration on Public Health.  He cited three reasons for the relative insignificance of IPRs in the dissemination of climate technologies: (1) the requirement for trade-secret protected know-how to implement patented technologies; (2) the significant barrier of a poor investment climate in many developing countries; and (3) the inapplicability of public health and IP lessons to energy-related technologies. 

However, in response to a question posed by CIEL, Mr. Cosbey did acknowledge that his analysis did not account for either patents on the most cutting edge of alternative energy technologies (i.e. cleanest), or the expected emergence of Carbon Capture and Sequestration (CCS) for "Clean[er] Coal."  These advancements will be covered by patents for several years to come, and likely will not have the same level competition enjoyed by current climate technologies.  The World Bank, in its 2010 Development Report, projects that about 25% of the necessary reduction of greenhouse gasses (GHGs) by 2050 will come from CCS technology, which is expected to be an exceptionally concentrated industry. 

Indeed, his hypothesis on the impact of IPRs assumes a sufficiently competitive environment, where alternative suppliers of solar panels, wind turbines, etc, are readily available.  This is the case with older technologies that are in the public domain.  However, in order to reduce greenhouse emissions to 350 PPM, the World Bank, IPCC, and other researchers are united in stating the necessity that more efficient technologies be developed, deployed and disseminated to developing countries.  Thus, it is entirely possible that as advancements in energy generation/GHG reduction are developed (in large part with public funding) the importance of patents held by the private sector will increase tremendously.