In Brief

BIOTECH LIABILITY TALKS PROGRESS ON SCOPE, DAMAGE, CAUSATION

The Open-ended Ad Hoc Working Group on Liability and Redress of the Cartagena Protocol on Biosafety, meeting on 20-24 February in Montreal, Canada, for their second meeting, were able to make some progress to bridge the broad chasms that separate positions on how the Protocol should treat the contentious issue. The talks were mandated by the Protocol itself in Article 27, which urges Parties to adopt before 2009 a "process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms" (see Bridges Trade BioRes, 28 October 2005). Discussions in Montreal focused on the scope of damage resulting from transboundary movements of living modified organisms (LMOs), the definition of "damage" and how to establish a causal link to the damage, and the actor to be held liable for the damage. On all three issues, delegates put together compilations of operational legal-type texts from a number of Parties. The operational texts mark a step closer among the positions on the three issues, building on narrative analysis submitted by some Parties and civil society before the meeting, and although divergences remain represented in the text and some criticised the tedious issue-by-issue, position-by-position process that led to their formation, the next meeting of the Working Group will likely seek to create similar papers for the eight outstanding issues. Parties have yet to address channelling of liability, role of parties of import and export, standard of liability; limitation of liability; mechanisms of financial security; settlement of claims; standing/right to bring claims; non- parties; complementary capacity building measures; and choice of instrument.

The question of the type of instrument that should embody the new regime on liability and redress for biotechnology was touched on, as was the standard of liability (e.g. a strict or fault-based standard) and how to finance the final instrument. Industry representatives as well as exporting countries expressed concern that financial security mechanisms, such as compulsory insurance, might operate as an economic trade barrier. However, sources suggested that detailed debates on these elements are being held until a more advanced phase of negotiations.

ICTSD Reporting; ENB Reporting, Vol. 9 No. 345, 27 February 2006.

US-COLOMBIA FTA SIGNED, SAYS ENVIRONMENTAL LAWS TO BE UPHELD

A trade promotion agreement signed by the US and Colombia on 27 February incorporates environmental provisions in a dedicated chapter of the text as well, in a side Environmental Cooperation Agreement and in a side understanding on the importance of traditional knowledge (TK) and biodiversity. The environmental chapter of the bilateral free trade agreement says that domestic environmental laws must be upheld and not diminished for the sake of attracting trade or investment, and makes that obligation subject to the dispute settlement procedures of the accord. In addition, it says that proceedings for the administration and enforcement of environmental laws should remain fair and transparent and that innovative market-based mechanisms to protect the environment should be encouraged. It also establishes an Environmental Affairs Council of high-level officials to ensure that these provisions are enforced. Furthermore, the side Environmental Cooperation Agreement, which creates a framework for undertaking environmental capacity building in Colombia, mandates the formation of an Environmental Cooperation Commission. The understanding on TK and biodiversity recognises their potential contribution to cultural, economic and social development, and notes that the two countries will "endeavour to seek ways to share information that will provide quality patent examination". It also recognises the importance of using contracts to achieve prior informed consent and equitable benefit sharing on the use of genetic resources and TK, similarly to a Peru deal signed in December 2005 (see Bridges Trade BioRes, 3 February 2006).

This is the second bilateral FTA to emerge from the Andean FTA negotiations that the US launched with Colombia, Ecuador and Peru in May 2004 (with Bolivia as an observer). After the joint talks faltered over disagreements on a number of different issues -- in particular, Ecuador's opposition to some of the US' demands on intellectual property rights -- the US and Peru signed a bilateral deal in December 2005 (see BRIDGES Weekly, 25 January 2006, http://www.ictsd.org/weekly/06-01-25/story3.htm).

ICTSD Reporting; "Free Trade with Colombia: Summary of the Agreement," US TRADE REPRESENTATIVE, 27 February 2006; "Colombia Trade News," COLOMBIAN GOVERNMENT TRADE BUREAU, 1 March 2006; "Colombian Students Oppose FTA," PRENSA LATINA, 28 February 2006.

NORWAY TO TAKE EU TO WTO OVER SALMON ANTIDUMPING MEASURES

The Norwegian foreign ministry on 21 February said it would on 22 March formally challenge the antidumping measures imposed by the EU on its farmed salmon through the WTO Dispute Settlement Mechanism (DSM). This move comes after the Council of the European Union on 21 January decided to continue to impose a minimum import price of EUR 2.80 per kg of whole fish equivalent for farmed salmon originating from Norway for five years in response to what they allege is dumping of Norwegian salmon on EU markets. While according to the EU their measures are in accordance with the WTO Anti-Dumping Agreement WTO rules, Norway claims they violate them and hopes for their repeal through the WTO DSM.

Farmed salmon imports to the EU have been the subject of disputes for a number of years because of losses suffered by the UK and Ireland salmon industries that have been attributed to import competition. In mid-2004, the Commission adopted quotas to safeguard EU producers from Norway, Chile and Faroe Islands imports. Those safeguard measures, however, were revoked in April 2005 and replaced with provisional anti-dumping duties only targeted at Norway ranging between 6.8 percent and 24.5 percent added to the value of Norwegian salmon imports (see Bridges Trade BioRes, 29 April 2005). The change followed complaints by EU salmon producers that Norwegian exporters were engaging in unfair pricing -- in particular selling under cost of production -- and a confirmation of these complaints by a EU investigation. These 'ad valorem' duties, which were collected by the EU at ports, were changed in June 2005 to a provisional minimum import price that requires Norwegian exporters to ship their products above that price, which the EU claims reflects production costs in Norway. Norway has challenged the allegation that export prices are below production costs, saying that the minimum price will make them lose market share in the EU.

"European Commission regrets Norwegian decision to take EU to WTO over anti-dumping measures on Salmon," EU PRESS RELEASE, 21 February 2006; "Anti-dumping. Norwegian Salmon. Memo," EUROPEAN COMMISSION, 16 February 2006; "Norway takes salmon row to WTO in surprise move," EU OBSERVER, 22 February 2006.

LEGAL STATUS OF MARINE GENETIC RESOURCES IN QUESTION

A 13-17 February informal meeting of a UN General Assembly Working Group on marine biological diversity struggled with the legal status of and access and benefit sharing arrangements for marine genetic resources on the high seas. Delegates, meeting in New York with a mandate to study issues relating to the conservation and sustainable use of marine biological diversity beyond areas of national jurisdiction, clashed in particular over the legal status of marine genetic resources and whether they fall under the 'common heritage of mankind' principle or the 'freedom of the high seas' principle. While the G77/China adhere to the regime of the common heritage of mankind, namely that no state can claim or exercise sovereignty or sovereign rights over any part of the marine genetic resources, some countries within the group stressed that the benefits arising from marine genetic resources should be shared with developing countries by expanding the jurisdiction of the International Seabed Authority (ISA) or through new international regulations. While they pointed to article 136 of the UN Convention on the Law of the Sea as justification for the relevance of the common heritage principle to marine genetic resources, the US and Japan argued that this regime applies only to mineral resources whereas marine genetic resources should be subject to the freedom of the high seas principle, namely that the high seas are open to all States, and pointed to article 87 of UNCLOS to justify their position.

Countries also discussed how destructive fishing practices on marine ecosystems and genetic resources. The EU proposed a new UNCLOS implementation agreement and the creation of marine protected areas, invoking the precautionary principle in the face of overwhelming evidence of disastrous impacts of practices such as bottom trawling on ecosystems. However, the idea of such an agreement met with opposition from the US, Japan, Korea, Norway and Iceland and was not embraced by developing countries, either, as it said little on the issue of marine genetic resources. In the absence of a new agreement, these groups as well as Mexico, New Zealand and the EU urged delegates to adopt short-term measures to address the most critical threats to marine biodiversity.

ICTSD reporting; Earth Negotiations Bulletin; "Protection for High Seas Biodiversity - Time to Get Serious," DSCC, 13 January 2006; "EU Position Change Signals Real Hope for Deep Oceans," DSCC Press Release, 17 January 2006.

EU: NO LICENCE FOR MEDICINE IN GM GOAT MILK

An application to licence the world's first medicine to be produced from a genetically modified (GM) animal was turned down by the European Medicines Agency (EMEA) on 24 February. GTC Biotherapeutics, a company based in the US, engineered goats to contain a human gene that codes for anti-thrombin, an anticoagulant. The result was goats that produce in their milk a substance that inhibits blood clots from forming. The medicine, called Atryn, would have been used by people with an inherited disease leaving them prone to developing blood clots. However, the EMEA decided that the company applying for the licence had failed to demonstrate the benefits of the drug outweighed its risks. EMEA said the testing process on patients giving birth or undergoing surgery was insufficient and not supportive. On the other side of the Atlantic, the US Food and Drug Administration (FDA) is continuing to consider a preliminary report that showed that meat and milk products from cloned farm animals and their offspring were as safe for human consumption as conventional animals, though a regulatory decision on food from cloned animals has been postponed for several months and is expected soon (see Bridges Trade BioRes, 24 June 2005). The World Organization for Animal Health (OIE) at its last General Session decided to undertake further investigations on the need for international standards on the use of animals that have been genetically engineered to produce medicines or chemicals (see Bridges TradeBioRes, 10 June 2005).

ICTSD Reporting; "'Pharmed' goat drug not approved," BBC NEWS, 24 February 2006; "'Pharmed" goats seek drug licence", BBC NEWS, 22 February 2006.