According to EU authorities, there is no reason to worry about expanding the scope of patents, opening the door to increased litigation and damages.
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UNCLAS USEU BRUSSELS 000859
SENSITIVE
SIPDIS
White House for NSC/Price, Herrmann White House for OMB for OIRA/Dudley, Mancini USTR for USTR Schwab, EUR HHS for FAO/von Eschenbach Pass SEC for Commissioner Atkins
E.O. 12958: N/A TAGS: ECONââ¬â°[Economic Conditions], ETRDââ¬â°[Foreign Trade], EINDââ¬â°[Industry and Manufacturing], EINVââ¬â°[Foreign Investments], EFINââ¬â°[Financial and Monetary Affairs], EAGRââ¬â°[Agriculture and Forestry], ENRGââ¬â°[Energy and Power], ECINââ¬â°[Economic Integration and Cooperation], EUNââ¬â°[European Union] SUBJECT: Second Meeting of the U.S.-EU Transatlantic Economic Council, May 13, 2008, Brussels
Ref: USEU (scene-setter)
ۦ1. Summary: The May 13 U.S.-EU Transatlantic Economic Council:
-- discussed in a principals-only lunch policy issues related to Russia and protectionism (reported septel);
-- agreed that EU Commission would follow through on its November 2007 commitment to remove a major impediment to EU imports of U.S. poultry, with the EU Commission proposing legislation to allow the U.S. meat cleaning process, explicitly acknowledging the absence of a scientific basis for a continued ban and committing to work actively to get the proposal adopted;
-- acknowledged a Commission administrative fix to problems importers of U.S. cosmetics could face when implementation of the EUQs new chemicals legislation REACH begins June 1 while agreeing the Commission would take steps to provide transparency, greater legal certainty, and non-discrimination in implementation of REACH ;
-- accepted a Department of Labor offer to publish a Request for Information on the subject of suppliers declaration of conformity for low-risk electrical equipment;
-- issued a joint statement on Open Investment ;
-- welcomed steps to avoid unnecessary divergences in our approaches to regulation, improve consideration of international trade and investment impacts of our regulation, enhance import safety through better sharing of confidential information, and improve our approaches to risk assessment; and
-- discussed recent steps to further transatlantic capital markets integration, including through steps to grant equivalence to one anotherQs accounting standards, achieve mutual recognition of our comparable securities regimes, and address structural and other potential problems in our insurance markets.
End Summary
ۦ2. The U.S.-EU Transatlantic Economic Council met in Brussels on May 13, 2008. The U.S. side was co- chaired by Assistant to the President for International Economic Policy Dan Price, and included Secretary of Agriculture Ed Schafer, Secretary of Labor Elaine Chao, United States Trade Representative Susan Schwab, Treasury Deputy Secretary Robert Kimmitt, State Department Under Secretary for Economic Affairs Reuben Jeffery III, Commissioner of Food and Drugs Andrew von Eschenbach, SEC Commissioner Paul Atkins, Special Envoy to the European Union C. Boyden Gray and OMB Office of Information and Regulatory Affairs Administrator Susan Dudley. EU Commission Vice President Guenter Verheugen co-chaired on the European Union (EU) side, accompanied by Trade Commissioner Peter Mandelson, internal Market Commissioner Charlie McCreevy, Consumer Safety Commissioner Meglena Kuneva, and Taxation and Customs Commissioner Laszlo Kovacs.
ۦ3. The Council addressed a wide range of subjects, including :
-Russia and combating protectionist sentiments (in a principals-only lunch, reported separately); -steps to reduce unnecessary regulatory divergences between the U.S. and EU, improve the sharing of information relating to import safety, take better account of the trade and investment impacts of domestic regulation and improve risk analysis; -specific sectoral regulatory problems and issues such as the EU ban on the import of U.S. poultry meat processed using chlorinated pathogen reduction treatments, the U.S. requirement for independent third party certification that certain electrical equipment is safe for the workplace and the effect of the EUQs chemicals regulation on imports, especially of cosmetics; -measures being taking to integrate transatlantic capital markets, including in the areas of accounting, securities and insurance ; -the need for open investment policies; and -next steps for the Council.
ۦ4. The TEC issued a Progress Report to the Summit, including as an annex a Joint Statement on Open Investment. It also received two reports from the High-Level Regulatory Cooperation Forum: one on the analysis of trade and investment impacts of regulation, and one on our respective approaches to import safety, particularly our approaches to information sharing.
ۦ5. The co-chairs also met with a small group of EU parliamentarians. The co-chairs and the U.S. delegation then met with the TEC Advisory Group (consisting of the U.S. and European co-chairs of the Transatlantic Legislators Dialogue, the Transatlantic Business Dialogue and the Transatlantic Consumer Dialogue); these meetings, as well as the TEC co-chairs post-session debrief of the Advisory Group, are reported separately.
I. Review of TEC Achievements
ۦ6. Commissioner Verheugen opened the first plenary session commenting that the stakeholders session was a strong indicator that the TEC project would surely be successful as it already had a strong and visible impact on transatlantic economic relations. Both Price and Verheugen highlighted the significant concrete accomplishments TEC already has under its belt. Price emphasized the strategic importance of the crucial relationship, and the need to ensure sustainability of the TEC to continue to build on this relationship, identifying short, medium and long term goals. He affirmed our obligation to get it right amongst usQ so that we can get it right with others. He pointed to common commitments already made, including horizontal regulatory cooperation to bring regulatory processes in line, science-based approaches to regulation, improved transparency and more rigorous impact assessments. Price pointed to three areas where there has been concrete action beyond simply agreeing to roadmaps: 1) IPR enforcement highlighting Operation Infrastructure, the joint customs border operation in which at least 360,000 integrated circuits with 40 different faked marks were seized in the last months of 2007 2) E-Accessibility where the European Commission has invited NIST and GSA to join their experts group on developing standards while the USG has invited Commission experts to join discussion on reassessment of U.S. regulations; and 3) further enhanced cooperation on medicinal products whereby, based on the joint administrative simplification goals, there will be several specific initiatives related to inspections, including joint inspections.
ۦ7. Verheugen reminded the group of the TECQs long- term vision of removing obstacles to achieve the transatlantic economyQs full potential, ensuring our continued competitiveness. He asserted that the TECQs political guidance gets things moving even on a nasty issue like poultry. TEC accomplishments include a Federal Communications Commission commitment to begin a rulemaking on allowing use of suppliers declaration of conformity for products it regulates; a joint roadmap on patent harmonization; Food and Drug Administration/DG Enterprise cooperation on administrative simplification (including enhanced inspection cooperation), collaboration on biomarker development and validation, parallel scientific advice and other regulatory cooperation initiatives for veterinary medicines that should reduce costs of pharmaceutical R&D and get new medicines to market sooner; car safety cooperation including cooperation at the UNECE to establish new global technical regulations(GTRs), including adoption of two recent GTRs; biofuels standards cooperation; FDA/DG Enterprise agreement to facilitate and support a more routine and formal process by which the EU, US, Canadian, and Japanese alternative testing validation organizations can work more cooperatively to address validation priorities, methodologies, and processes. In addition, FDA/DG Enterprise have agreed to work together bilaterally on the regulatory acceptance with respect to cosmetics of validated animal tests. Both of these initiatives should assure public health protection and help mitigate possible interruptions to trade that may be caused by the upcoming EU ban on animal testing for cosmetics. Verheugen said this progress was going too slow to address the looming crisis, and asked why scientists cannot agree. (Comment: This reference was to the disingenuous assessment that if not for the intransigence of the U.S. scientists, the EU requirement to move to non-animal testing of cosmetics would be possible by the 11 March 2009 deadline set in EU legislation. Alternative methods to determine certain safety requirements have not yet been validated or accepted in both the EU and the U.S. as the science has not yet caught up to this EU statutorily-imposed deadline. End comment)
II. Horizontal Regulatory Cooperation and the High Level Regulatory Cooperation Forum (HLRCF):
A. Impact Assessment, Transparency and Consultation
ۦ8. EU Commission Deputy Secretary General Alexander Italianer and OMB/OIRA Administrator Susan Dudley summarized the accomplishments of the meeting of the High Level Regulatory Cooperation Forum (HLRCF) that took place on 25 April. The Secretariat General and OMB completed a joint report on including trade and investment impacts in regulatory analyses that both opened to comment. Italianer explained that although there were few comments, those who did comment (including the U.S. Chamber of Commerce and BusinessEurope) represented the major players in transatlantic trade and investment. At the HLRCF stakeholders discussion, both the USG and the European Commission broadly outlined how transparency and public participation are handled under our respective systems. Administrator Dudley added that, in the future, OMB would likely ask U.S. agencies to identify which regulations might have trade and investment impacts or might otherwise be of use to our trading partners.
B. Risk Assessments
ۦ9. Dudley explained the conviction both sides have that we need a sound risk-based pathway to regulation. Sharing of data and analysis will help build a broader consensus on risk assessments, limiting but not excluding regulatory divergence at the risk management stage. Dudley referred to the trilateral (EU-US-Canada) government-only workshop on risk assessment, management and communication in July, whose conclusions will be reported at the fall TEC. Conclusions from this session would be folded into the broader international conference hosted by DG SANCO in November in Brussels.
ۦ10. Dan Price asked EU participants how they QsquaredQ risk assessment with their variant of the precautionary principle. SANCO Director General Robert Madelin underscored that scientists understand uncertainty and that the precautionary principle had nothing to do with risk assessment and everything to do with risk management. He stated that the objective was not zero risk, and not to default to prohibition, but he recognized the political challenge of risk managers to avoid distortion of the precautionary principle. Price felt that the risk assessment conference would help to dispel the caricature of U.S. and EU positions, allowing us to focus on our agreed goals of science- based approaches to prevent new barriers from arising.
ۦ11. SEC Commissioner Paul Atkins pointed out SECQs statutory requirement to use cost/benefit analysis when formulating new regulations. Without it, their regulations could, and likely would, be overturned in court. FDA Commissioner von Eschenbach hoped the U.S. and EU regulators would also emphasize benefits of regulated technology/activity when doing cost/benefit analysis and risk assessments. Highlighting benefits, for example for nanotechnology, is crucial when communicating risks.
ۦ12. USTR Schwab suggested that such risk discussions would go a long way towards precluding prolonged and intractable bilateral disputes by Qmanaging issues at the front end. Emphasizing the need to use sound science and objective criteria, Schwab warned that any abuse in the U.S. and the EU would be copied and worsened in third countries creating bigger non-tariff barriers.
ۦ13. Verheugen pointed out how the conversation in the room did not reflect that this is a very hot issue. He wondered how the precautionary principle impacts (EU) legislation practically, suggesting that it would be a topic for future discussion. Italianer noted that we have different priorities and societal preferences, and that the precautionary principle could lead risk managers to preclude taking any risk. Dudley commented about the risks of action and inaction, pointing out that an overly precautionary approach could create serious opportunity costs or prevent society from enjoying crucial benefits in areas such as nanotechnology and biotechnology.
ۦ14. Verheugen felt efforts to create consistent methodologies and risk assessment benchmarks would be crucial. Taking a step further, Verheugen believed that U.S. and EU policymakers looking at equivalent risk assessments should also be able to Qfind a common approach to deal with the issue at hand. Von Eschenbach added that regulatory agencies often wait for science to come to them. His hope was that aligning our regulatory processes ahead of scientific developments, for example in nanotechnology, could make sure our approaches were more integrated.
C. Import Safety
ۦ15. Dudley explained that the joint paper on strengthening transatlantic cooperation on import safety was almost complete. (Comment: the report was completed on Thursday, May 15th and released to the public on the ECQs website shortly thereafter. End comment) The report has recommendations in several product areas: motor vehicles, pharmaceuticals, cosmetics, toys, electrical equipment for consumer use, food and customs procedures. One key challenge highlighted in the report was the importance of confidentiality among regulators, especially with respect to the protection of confidential business information. The U.S. import safety working group would be providing a report on its efforts.
ۦ16. EU Consumer Safety Commissioner Meglena Kuneva stressed the importance of information sharing, stating her conviction that once U.S. legislation is adopted expanding Consumer Product Safety Commission (CPSC) authorities for external communication, information sharing would be easier. Kuneva implored the USG, specifically CPSC, to gain a more thorough understanding of their rapid alert system (RAPEX), to better understand the type of safety information that could be shared. (This was in reference to a comment made during Commissioner NordQs last Brussels visit that the RAPEX system did not contain much information useful for CPSC.) She assured all that Commission efforts to improve safety would not affect open trade policy. Kuneva reminded the group that she invited Chinese Minister Li and Commissioner Nord to Brussels in November for a trilateral meeting to Qproperly communicate priorities.
ۦ17. Price asked what precludes our regulators from sharing information, for instance on product recalls. Dudley stated that even where cooperation is already mature and deep, such as in pharmaceuticals and cosmetics, improvements can be made. She pointed out that EU and Member States need to set up mechanisms to ensure that confidentiality is adequately protected across their network. Some U.S. agencies lack statutory authority to engage in more extensive information exchange, for example CPSC. Commissioner von Eschenbach said FDA was looking beyond its borders, and that even if barriers existed to external outreach, political will could overcome those barriers and impediments.
ۦ18. Agriculture Secretary Schafer provided examples of where international cooperation in international organizations was complementary and at other times counterproductive. At the international standards setting body for food safety (aka CODEX), U.S. and the EU agreed on aflatoxin presence levels in tree nuts. However, the EU was also using CODEX to export its non-science-based, non-food-safety based policies on food labeling by recommending that CODEX focus on specific standards for biotech food labeling instead of sticking with the perfectly acceptable existing CODEX language. He asserted that TEC could help spur actions for bilateral opportunities. Here he pointed to EU legislation on equivalence of meat standards. The EUQs 17 exporting member states represent only 4% of US meat imports, but 50 percent of U.S. foreign inspection funds. Given the generally uniform EU food safety system, and more consistent EU audit results, this could allow the USDA to work on an EU-wide basis, greatly reducing resource costs.
ۦ19. Verheugen agreed on TEC prospects in this area, and suggested they consider food safety for the next meeting. Verheugen pointed to the impacts of the EUQs improved market surveillance efforts resulting in sharp increases in import bans and recalls.
ۦ20. Price asked for clarification on EUQs information sharing limitations related to reciprocity requirements. (Note: At the HLRCF, SANCO Deputy Director General Paola Testori indicated that the EU could not and would not share with the U.S. information on safety if they were not getting what they considered Qreciprocal information from the U.S. The conversation was largely related to a misunderstanding of OSHAQs responsibilities, but also related to CPSC statutory limitations.) SANCO Director General Madelin indicated that the European Commission has more discretion to share information than the U.S. He hinted that information would not be shared if not considered reciprocal. At the same time, he stated that safety information held by one side when it is known that products are also imported by the other side should be shared to avoid incident. He stated that in his experience, when agencies trust each other, issues get on the radar screen sooner. Madelin mentioned that, in other cases, they could not be confident that silence means nothing is going on. (Madelin was referring to an incident in which a U.S. technology company reported minute traces of an unapproved biotech corn event in a small amount of seed. There were no safety concerns related to the incident and no corn is shipped to the EU. Despite this, the USG shared the information with the EU shortly before the information went public, at the same time it shared the information with major corn importers such as Japan. SANCO had, however, learned of the event from the company earlier, some two months after it was reported to U.S. authorities, which is why he is concerned that it could be difficult to report to the European Parliament that silence from the U.S. side means there are no problems.)
ۦ21. Commenting on MadelinQs statement, Deputy FDA Commissioner Murray Lumpkin reminded the group that FDA (like its EU counterparts) is prohibited by statute from sharing trade secrets; however, FDA and its EU counterparts, under executed confidentiality agreements, have been sharing other non-public information (commercial confidential, investigative, pre-decisional, etc) for many years. In addition, on the matter of information that has significant public health implication, he stated that even in the case when FDA is not sure if the product is marketed in Europe, FDA notifies its European counterparts anyway just to be sure.
ۦ22. Kuneva asserted that, in addition, we do not sufficiently share third party information. She touted the EUQs four-year young RAPEX system as a well-built enforcement tool, complaining that US officials preferred to go to Member States. (Comment: Despite her reference to improved statistics on reporting into the RAPEX system, there is inconsistent use of this tool throughout the EU, thus requiring communication with Member States to get a fuller picture. End comment)
ۦ23. Referring to MadelinQs hints that some in the U.S. were not sufficiently sharing, Dan Price asked him to name names. During a side conversation at the end of the session, Madelin told Price about the biotech product incident.
ۦ24. Speaking more generally on the third party issue, OMBQs Dudley reported that in the April meeting between OMB and Commission, DG Enterprise Director General Zourek suggested when analyzing standards both sides should first look to see what international regulations and standards are in place. Deputy Secretary General Italianer suggested both sides needed to discuss standards. He indicated that the EU has done away with EU standards for autos and instead uses international/UN standards. FDAQs von Eschenbach stated that the US has begun to bring China and India into the international discussions on harmonization of technical requirements for registration of pharmaceuticals (ICH) and medical devices (GHTF).
D. Regulatory Burdens
ۦ25. Treasury D/S Kimmitt asked for an update on EU efforts to reduce regulations, although this was not on the formal agenda. Commissioner Verheugen described the program as part of the CommissionQs Better Regulation efforts. He indicated that fulfilling reporting requirements of various kinds cost 3.5% of EU GDP and for SMEQs the cost of complying can be as high as 10% of turnover. More than 100 reporting requirements stem from the Company Law alone. Seventeen Member States have started screening administrative procedures and the Commission is now measuring the costs of complying. The ten actions they have taken this year saved 1.9 billion Euro. Unfortunately it is not a net savings because in the meantime the EU is proposing other legislation. The Commissioner offered to share any of the details of the program with the US side.
III. Removing Barriers to Transatlantic Trade
ۦ26. The third major part of the TEC agenda was a discussion of steps either side is taking to remove barriers to transatlantic trade in key areas. In summary, on the question of suppliersQ declaration of conformity, Secretary Chao indicated the Department of Labor would publish a new Request for Information in the Federal Register. On poultry, by the end of May the Commission will table a proposal to amend two pieces of EU legislation to allow the import of poultry meat processed using pathogen reduction treatments (PRTs), as well as the use of PRTs in the EU for processing poultry meat for consumption in the EU. (Comment: EU law already allows the use of PRTs in the processing of poultry meat for export. End comment.) On REACH, the Commission asserted its pragmatic approach to the cosmetics problem would avoid immediate trade disruption. Verheugen agreed a legislative change was needed to provide legal certainty to industry, but could not commit to Commission support for such a legislative fix at this time as he cannot yet guarantee that all Commissioners would support this.
A. Suppliers Declaration of Conformity (SDOC)
ۦ27. Verheugen indicated the issue had been on the table since the first TEC meeting, and he was happy to note that OSHA is willing to review its requirement that certain electrical equipment be tested and certified under the NRTL (Nationally Recognized Testing Laboratories) system even where suppliers are willing to provide their own certifications. He hoped the request for information (RFI) would be open soon and without a pre-judged outcome.
ۦ28. Dan Price confirmed the U.S. understands this issue is a high priority for the EU; the U.S. government has given the issue a lot of attention. Secretary Chao then reviewed the many meetings Labor has had with the Commission and with other stakeholders on SDOC and confirmed the plans to release an RFI. She then outlined some of the strengths of the NRTL system including the fact that it is open to laboratories from all countries, it relies on the private sector not a government bureaucracy and it has proven effective in delivering safety in the workplace. In considering SDOC, Secretary Chao mentioned her concern about the budget impact that establishing a post market surveillance program would require and indicated several aspects could require legislative changes. She also wanted to better understand how EU Member States implemented SDOC as there appear to be different approaches in different countries. She emphasized that its process is open and that regulatory decisions are based on the best data, not the volume of submissions. Finally, she offered to talk to the Commission about other trade facilitation issues besides SDOC. Verheugen ended the discussion by expressing hope that OSHA would continue the process that has started.
B. Pathogen reduction treatments (PRT) for poultry
ۦ29. Price emphasized that (despite complaints of some about the attention paid to PRTs in the TEC), the issue had not received undue but appropriate attention. There is no substantive basis for what is an effective ban on the import of U.S. poultry meat; further, the EU had earlier agreed to lift the ban. He thanked Verheugen for his efforts to move this issue. He also distributed copies of a Financial Times article (published May 12 on page 4) on EU use of PRTs.
ۦ30. Verheugen agreed the attention to the issue was appropriate. He expressed regret that the Commissioner in charge of the issue [Comment: Probably referring to DG Environment Commissioner Dimas, but note that Commissioners Vassiliou and Fisher-Boel, who also have a role and were not present] was not at the TEC meeting and committed that the Commission would adopt a proposal to amend the two relevant pieces of legislation (Food Hygiene and Marketing Regulations) before the end of the month; these proposals will be with the Council and Parliament before the Summit. He noted that the scientific studies indicate no health concerns from the use of PRTs, and that there are no known environmental concerns related to use of PRTs in the EU. That said, he commented -- as he had done in the stakeholders meeting -- that it made no sense to him to ban imported chicken because of possible concerns about environmental impacts in Europe, especially when European producers used PRTs for exported poultry meat.
ۦ31. Verheugen expressed confidence the Council would support the changes. The European Parliament was less certain but based on the discussions earlier in the day with the European members of the Transatlantic Legislators Dialogue and a motion passed by Parliament on the transatlantic economic relationship, he believed the two largest political blocks in Parliament supported the changes. He ended his opening remarks by pointing out this issue would not have moved without the TEC.
ۦ32. Price commented that it was inconceivable that there would be an environmental risk in the EU from US use of PRTs. Ambassador Schwab thanked Verheugen but stressed that, after 12 years, real success would only result from actually selling poultry in the market, thus we look forward to the next step in the process. Ambassador Schwab asked what assurance the U.S. had that the proposal would not be blocked by the Member States, what strategy the Commission had for overcoming such obstacles, and what role the Slovenian presidency would be playing in the Council to remove this problem.
ۦ33. Price then directly asked Slovene Minister of Economy Vizjak whether the Presidency would support the proposed changes in Council and whether poultry would be flowing by the next TEC meeting. The Slovenian representative indicated Slovenia supports the changes and would try to play a major role in the discussions but since the discussions had not yet started they could not speculate where other member states were on the issue. Verheugen stressed that Member State positions would be decided at the highest levels, not by agriculture ministers. He suggested the US not put too much public pressure on the EU now as it could be counterproductive. In terms of timing Verheugen said the solution could possibly be in place by the next TEC meeting and there was a high chance it would be resolved (i.e., chicken trade would commence) by the end of the year and this administration.
ۦ34. At the end of the discussion a representative of the French Ministry of Economics stated that the Financial Times article was not accurate: France banned PRT use in 1997 and has not used them for exports since 2005.
C. REACH/Cosmetics
ۦ35. The U.S. delegation then raised concerns with the EUQs new Regulation on the Review, Evaluation and Authorization of Chemicals (REACH). Price mentioned two sets of issues: first, the June 1 deadline affecting U.S. personal care products (including cosmetics) exports; second, broader and more long-term concerns with the REACH regulation itself.
ۦ36. Price believed the cosmetics problem was unintended but that a legislative fix was necessary. Ambassador Schwab stated that REACH is an example of regulation that would have benefited from closer bilateral dialogue. She pointed to significant and growing concerns being voiced about various aspects of REACH including the list of candidate substances requiring further evaluation and authorization that could act as a Qblack listQ that creates a chilling effect and could promote substitution to untested chemicals, and the QOnly RepresentativeQ (OR) provisions that put US suppliers at a disadvantage over their EU counterparts since non-EU suppliers must use an intermediary to register and may have to divulge proprietary information to competitors. She stated that impacts from REACH implementation are broader than these few issues; implementing REACH will be a nightmare. The estimated cost for registering and testing a single substance is $100,000 and there are 400 substances in a single perfume. On cosmetics, EU ingredients for export were grandfathered from the June 1 deadline and receive a phase-in period; US ingredients were not which raises national treatment concerns. More than $2 billion in trade could be impacted by this discriminatory treatment. She predicted there will be other REACH issues in the future and said that how we resolve will be an example for the TEC.
ۦ37. Verheugen responded that probably no one fully understood REACH, including himself. The final legislation was a complex compromise between all three bodiesQthe Commission, the Parliament and the Council. Trade offs during the legislative process led to some unintended consequences. No one wanted discrimination; no one was aware that EU ingredients had previous chemical registration (EINECs) numbers but US ingredients did not.
ۦ38. Unfortunately, according to the Commission Legal Services, this aspect of REACH cannot be changed by a simple written procedure (corrigendum) as this would be a substantive rather than technical change to the legislation. However, the Commission wanted to resolve the problem and is working out a pragmatic solution with the European Chemicals Agency (ECHA), essentially allowing suppliers of imported cosmetics and their ingredients to submit partial files on June 1 and then have a longer period of time to complete these. This should ensure there is no risk that trade would be disrupted. [ Comment: ECHA has not yet opined on whether this is feasible.]
ۦ39. On the other REACH issues, Verheugen said the candidate list and OR provisions were not discriminatory. The candidate list would be done in the most transparent way possible and the actual authorization list would not come until much later, perhaps only after 15 years. (Comment: Verheugen seems to have missed the point. The fact that the authorization list will not come until much later is precisely the problem. Inclusion of a substance on the candidate list means that it is in a sort of limbo. Consumers may well refrain from using the substance for fear that it eventually will be prohibited. They may well resort to substitutes with unproven track records. This is what is meant by a black list effect. End comment.) He suggested technical people on both sides get together to discuss the other issues.
ۦ40. Price responded that we need to finalize our understanding of the path forward. He summarized the Commission would propose an amendment to give the companies legal certainty on the cosmetics issue. Verheugen stressed he would try, but could not give that assurance because REACH is a shared responsibility and Environment Commissioner Dimas is against such a change. Price noted that it was unfortunate that two Commissioners with issues before the TEC did not attend. (Comment: Price was referring to Dimas and Fischer Boel, who also did not attend. End comment.)
IV. Capital Markets Integration
ۦ41. (SBU) Charlie McCreevy, Commissioner for Internal Market and Services, began the discussion of joint progress in capital market liberalization. McCreevy lauded the excellent cooperation between Treasury and the SEC with his Directorate General for Internal Market and Services (DGMARKT) through the five-year old Financial Markets Regulatory Dialogue (FMRD), which predates the TEC. He said the FMRD had made great strides in cooperation, which were unthinkable five years ago. McCreevy underscored how the U.S. and EU economies have become inextricably linked, accounting for 80 percent of global capital market flows.
ۦ42. He stressed how current financial turmoil has heightened the importance of transatlantic cooperation, and that increased integration enhances financial market resilience. In addition, existing priorities must continue.
A. Progress on Accounting Equivalence: ۦ43. McCreevy emphasized how the first TEC meeting in all 2007 had contributed to progress on U.S.-EU accounting convergence, based on work in the FMRD. He noted that the SECQs action in December, 2007 to abolish the reconciliation requirement for foreign companies using International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) was a Qremarkable achievementQ. McCreevey assured TEC members that the EU is making good progress toward a reciprocal declaration Q as outlined in the 2005 U.S. QEU accounting QroadmapQ Q to accept U.S. Generally Accepted Accounting Principles (GAAP) as equivalent to IFRS, allowing U.S. firms to file in the EU without reconciliation.
ۦ44. The Commission has received good technical advice on this issue from the Committee of European Securities Regulators (CESR), he noted, which issued a recommendation in January 2008 that U.S. GAAP is equivalent to IFRS. The Commission will issue a proposal to this effect within a few weeks, he continued. The Council and European Parliament will consider the proposal, said McCreevy, and he expects final approval by the end of 2008. This would meet the roadmap deadline of eliminating the reconciliation requirement by 2009.
ۦ45. McCreevy then noted the importance of also making progress on IASB governance issues. In particular, he underscored the need to improve the IASBQs transparency and public accountability. He welcomed the joint SEC, Japanese FSA, and European Commission statement at the IOSCO meeting last fall in Japan as providing a good basis for forward progress. He was encouraged that the IASB had accepted the proposal, but expressed frustration at the pace of progress. He encouraged increased monitoring and engagement by both sides on this issue to encourage changes in the IASBQs process.
ۦ46. Treasury Deputy Secretary Kimmitt complimented McCreevy in response on the good bilateral cooperation in both the FMRD and TEC. He stressed that such cooperation has been vital to addressing market confidence during the current financial crisis. Kimmitt noted that the strong consensus within the Financial Stability Forum (FSF) on how to address policy issues raised by the financial crisis closely tracked the analysis and recommendations in the PresidentQs Working Group on Financial Markets and the European CommissionQs own work in this area. Kimmitt also praised SEC work with the Commission on accounting convergence and issues around mutual recognition of securities regimes, saying this had been moving swiftly.
ۦ47. SEC Commissioner Paul Atkins likewise stressed the strength of transatlantic cooperation on security regulatory issues. He noted that open issues include the funding and governance of the IASB. In addition, he noted that more work remains to be done regarding consistency of application of IASB standards. He agreed that the SECQs decision to eliminate the reconciliation requirement between IFRS and US GAAP would have been unbelievable five years ago. He noted the March 2008 CESR recommendation that the EU make an equivalence determination. Atkins also noted that MEPS seem still confused by the U.S. process, with some seeming to think that Congressional action might be needed to make the SECs regulation on IFRS final. He clarified that no Congressional action was needed in this area and expressed an interest in helping the Commission with outreach to the European Parliament if necessary in order to facilitate approval of the CommissionQs draft regulation.
ۦ48. Atkins then asked McCreevy for a more specific timeline for EU action. McCreevy reiterated that the Commission would issue a proposed equivalence regulation within weeks, affirming that he fully expects it will be approved by the Council and European Parliament this year (despite some MEP concerns). McCreevy underscored his personal commitment to obtaining approval from Parliament and the Member States in the Council.
B. Mutual Recognition of Comparable Regimes for Brokers
ۦ49. McCreevy noted that work on mutual recognition of securities regimes is proceeding well. He recalled his joint statement with SEC Chairman Chris Cox in February 2008 defining a process to engage in discussions regarding mutual recognition of U.S. and EU Member State securities regimes in mid-2008. He stressed that the aim of such discussions should be a system based on mutual trust, greater coordination between regulators, and transparency. He welcomed the Qunilateral opennessQ associated with the SEC proposal to provide expanded exemptive relief for certain foreign brokers as an update to rule 15a-6 for large investors. However, he noted the ultimate, long-term goal of these discussions should be regulatory convergence.
ۦ50. Atkins underscored the SECs commitment to moving forward on a broad range of mutual recognition issues. He explained that the SEC is also in talks with Australia and Canada on mutual recognition, noting it might conclude an agreement first with one of these countries before the EU. He noted skepticism exists in the U.S. Senate regarding broad mutual recognition agreements in the securities area and that much work can proceed using the SECQs broad exemptive authority.
C. Insurance Issues
ۦ51. McCreevy then turned to address reinsurance collateral, which he recognized was a thorny issue in the U.S. He explained that currently EU reinsurers in the U.S. must post 100 percent collateral against their gross liabilities. In contrast, U.S. reinsurers do not face such a requirement. He estimated that the cost of the U.S. requirement to EU firms was $500 million/year. He indicated that his goal was to achieve mutual recognition for insurance supervisory systems as well, but that reform in the United States was a necessary precondition for such agreement. He expressed sympathy for the difficulty the Treasury Department faces in addressing this issue, since insurance regulation authority is reserved to U.S. states. He welcomed, therefore, the U.S. Blueprint for Financial Regulatory Reform, which proposes an optional federal charter for insurance and an interim Treasury insurance office to with authority to engage internationally. He lauded a legislative proposal in the Congress that would establish an Office of Insurance Oversight in the Treasury Department as part of the solution. He also expressed frustration with the difficulties the Commission sometimes faces in engaging the National Association of Insurance Commissioners.
ۦ52. Kimmitt noted that significant progress had been made in other areas of the Financial Markets Regulatory Dialogue because the relevant parties in the United States had authority to address the issue.
ۦ53. He appreciated the CommissionerQs understanding of the challenges created by the state-based insurance regulatory structure. Regarding reinsurance collateral, he noted that the U.S. is open to foreign insurers, which have 85 percent of the U.S. reinsurance market, so this is not a market access issue.
ۦ54. Kimmitt then noted that there are actually two different insurance issues on the TEC agenda: reinsurance collateral and the EUQs proposed treatment of the insurance companies from third countries that do not have consolidated home country supervision (the proposed Solvency 2 directive). Solvency 2 would require an equivalence determination; it seems likely that the 50 state systems in the U.S. would not receive such a determination, which could significantly affect the ability of U.S. insurance firms to operate on an equal footing in the EU.
ۦ55. Kimmitt expressed an interest in working with the Commission at the tactical level to address Solvency 2 and other insurance issues in the FMRD. He noted that one key aspect of the Treasurys proposed blueprint would be to create an optional federal charter. An intermediate step would be to create an office of federal insurance oversight inside the Treasury Department, and noted that, as Commissioner McCreevy had observed, Mr. Kanjorski and Ms. Pryce in the U.S. House of Representatives had already introduced a bill to make this a reality. He indicated that the U.S. and the EU would need to work closely together to avoid a potentially distracting and counterproductive fight over Solvency 2. He also noted that in an earlier meeting with the Commissioner that day, they had agreed to work together and that the Treasury Department would be sending specific ideas on how to address the issues raised by Solvency 2.
V. Keeping our Investment Regimes Open
ۦ56. Trade Commissioner Peter Mandelson opened this part of the meeting by underscoring the importance of working together to promote open investment regimes, calling this a Qkey economic issue for the coming decade.Q He stressed that foreign direct investment (FDI) is an important driver for the competitiveness of both the EU and U.S. economies, noting that FDI is critical to support our supply chains in foreign countries. There is nothing to gain, Mandelson continued, from tit for tat policies restricting foreign investment. He underscored that there is no international regime backstopping global openness to investment, pointing out it is subject to political pressure within countries.
ۦ57. National security reviews of investment have a legitimate place, Mandelson said, but should not be overused. In this regard, the EU and U.S. must avoid applying a double standard to Qstate backed investment. National security restrictions on investment should be Qcarefully calibrated exceptions to a strong rule,Q he explained.
ۦ58. Mandelson said the U.S.-EU Open Investment Statement adopted by the TEC was strong but should be backed up with concrete steps. He identified two specific EU concerns regarding the U.S: tax code requirements for EU firms and the negative political response to the recent Northrup-EADS military tanker contract announcement. The latter must be upheld on a technical basis, he declared, noting that we must apply our standards consistently and objectively.
ۦ59. Commissioner McCreevy underscored the EUs treaty commitments to open investment with limited exceptions. He then noted that some Member States are seeking to expand these exceptions to strategic sectors. He stressed that DG MARKT examines all EU legislation on investment to ensure compliance with EU rules, and underscored that the Barroso Commissions is more pro open-investment than prior Commissions. In his opinion, efforts to create an EU-level security
ۦ60. review process would generate a system based on the lowest common denominator, which would not be a good thing. He considered that protectionist pressure may have eased somewhat over the last year, saying it is an ongoing, fluctuating problem.
ۦ61. Dan Price responded that U.S. foreign affiliate sales overseas dwarf U.S. exports, so it is critical to get investment rules right. He encouraged the Commission to remember its roots in the pioneering bilateral investment treaties with Germany, the Netherlands, and the U.K. Those treaties created only narrow exceptions to the principle of national treatment and open investment markets to address national security issues. He encouraged the EU to lead by example globally, particularly given developments in Japan, Canada, and France.
ۦ62. Kimmitt said that a free flow of capital based on investment policies is the lubricant of the global economy. He highlighted how establishment of the U.S.-EU Investment Dialogue last fall was an early TEC success that has already borne fruit in improving legislative proposals in Germany. He noted excellent U.S.-EU cooperation in developing policy toward Sovereign Wealth Funds (SWFs) through the OECD, and he congratulated the Commission on its recent communication regarding SWFs. Even though it is important for SWFs to develop best practices in consultation with the IMF, Kimmitt noted that the U.S., EU, and other recipient countries also have responsibilities to promote basic principles of openness, transparency, nondiscrimination and predictability regarding investment policy. He underscored the importance of the first ever joint statement between the U.S and the EU on this topic as a good foundation on which to build. He suggested that in the next year the U.S. discussion will likely shift to investment by State Owned Enterprises (SOEs), which raise more complex issues than those of SWFs.
ۦ63. Much more work is needed on maintaining open investment climates, Kimmitt underscored, noting recent actions by Japan and Canada to block FDI. We need to publicize better the benefits of open investment, such as the three to four million U.S. jobs created by EU FDI. When EU business leaders are in the U.S., he said, they should visit not just FDI sites around the country and the Administration, but also Congress to highlight their role in providing jobs and other benefits associated with FDI.
VI. Sustaining the Work of the TEC
ۦ64. Verheugen then moved on to discussing next steps for the TEC. He noted that there are good reasons to hold the next meeting in Washington in October, before the U.S. elections; Price agreed. Kimmitt suggested that the TEC should discuss an agenda for the next year or two, to show continuity across administrations. Verheugen agreed, saying that stakeholders have asked for an 18 month-two year workplan. Kimmitt said that TEC members should ask stakeholders for their suggestions on such a workplan; Verheugen said this was a great idea.
VII. Finalizing the Joint Statement and Progress Report
ۦ65. Price and Verheugen then discussed finalizing the TEC joint statement and progress report. Verheugen suggested the documents needed some work, including additional language to provide greater political emphasis, before release. Price expressed serious concern about having the concluding TEC session with stakeholders and a press conference without having finalized the Joint Statement. He asked if there were any issues still open that the TEC itself should resolve. When told yes, he asked that the negotiators be brought into the room to report to the TEC plenary.
ۦ66. The first unresolved issue that was addressed concerned the language in the Progress Report on poultry. Price pushed hard for recognizing in the document that the scientific reports the Commission had received in March concluded that the use of PRTs was safe. Verheugen was clearly concerned about making such a flat statement, saying that while it applied to consumer consumption of the poultry, the environmental studies left open that some problems might arise. He also noted during the at times animated discussion that he was facing interference (presumably from the French presidency representative) and even that the staff of President Barroso was telling him not to go any farther. Price wryly commented that the Commission was unlikely to adopt a proposal that would allow for something that was unsafe, and then proposed that instead the Progress Report note that the studies showed there was no scientific basis for continuing the ban on imported poultry. A commission staffer noted the ban was on the use of PRTs, not on imports per se. After conferring with each of the Commissioners present (Mandelson for Trade, Kuneva for Consumer Safety, McCreevy for Internal Market, and Kovacs for Customs and Taxation), Verheugen agreed to this language.
ۦ67. A second issue related to poultry was related to the wording of an explicit commitment from the Commission to take active steps with the Council and the Parliament to get the proposal enacted before the next TEC meeting in the Fall. This was ultimately agreed.
ۦ68. The third issue addressed concerned REACH and cosmetics, and specifically the nature of the commitment the Commission could enter into to describe what the Commission would do, in addition to its administrative measures, to provide legal certainty for imported products. Verheugen again reiterated that he could not bind the Commission to seek an amendment to REACH, but that he would advocate this. The language ultimately agreed was softer than this, but indicates a clear commitment not to allow REACH to disrupt trade in these products.
ۦ69. Finally, Kovacs asked to make sure that the language about the EUs concerns about the U.S. legislative requirement for 100 pct scanning of containerized cargo imports was sufficiently strong. He agreed to the language after it was read to him, and seemed pleased that the TEC had agreed this issue would be addressed in more detail at the next TEC meeting.
ۦ70. The Progress Report was then closed (pending some additional political language for the opening). Price and Verheugen both agreed that the Joint Statement should be aligned with the language that had just been agreed.
ۦ71. Price and Verheugen thanked participants for an incredibly worthwhile meeting. Price said the TEC is proving its worth as a key problem-solving mechanism; Verheugen agreed.
VIII. Other TEC-Related Outcomes
ۦ72. While the TEC discussed poultry, SDOC, REACH, capital markets and investment, the process leading to the TEC, and discussions on the margins of it, brought additional accomplishments. Among other things, Verheugen agreed to chair on the EU side a Council-level video-conference of climate change and energy issues. In addition, the two sides agreed to bring experts together to get an overview of the various sanitary and phytosanitary issues each has with the other.
Comment
ۦ73. Indeed, the TEC has proved its worth if in fact the poultry issue Q a stumbling block in U.S.-EU trade relations effectively since the Chicken Wars of the early 1960s is finally resolved. The Framework and the TEC provide a vehicle for identifying priority issues to address to promote transatlantic economic integration, providing a political profile to those issues, shining a bright spotlight on the work experts are undertaking to address them, and ultimately, if necessary, actually resolving them at the political level. This can be particularly important where the issues are long- term such as ensuring greater coherence in the way the U.S. and EU approach regulation and where each side has long-cherished approaches that (intentionally or unintentionally) impede trade. Further, the opportunity to have a principals-only inter-agency/inter-services discussion of our respective approaches to such strategic economic policy issues as China, Russia, protectionism and investment provides policy makers valuable insight into how the other side perceives these issues. All these advantages should help assure the TECs continued viability through the 2008 change in Administration in the United States and change in the Commission in 2009.
Murray
VZCZCXRO0110 RR RUEHAG RUEHDF RUEHIK RUEHLZ RUEHPOD RUEHROV RUEHSR DE RUEHBS #0202/01 0431248 ZNR UUUUU ZZH R 121248Z FEB 09 FM USEU BRUSSELS TO RUEHC/SECSTATE WASHDC RUCPDOC/DEPT OF COMMERCE WASHDC INFO RHEHAAA/WHITE HOUSE WASHDC RHEHNSC/NSC WASHDC RUEATRS/DEPT OF TREASURY WASHDC RUEHRC/DEPT OF AGRICULTURE WASHDC RUEHC/DEPT OF LABOR WASHDC RUEAUSA/DEPT OF HHS WASHDC RUCNMEM/EU MEMBER STATES COLLECTIVE RUCNMEU/EU INTEREST COLLECTIVE
UNCLAS SECTION 01 OF 03 BRUSSELS 000202
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NSC FOR KRISTINA KVIEN STATE FOR E, EUR/ERA, EEB/TPP STATE PASS TO OMB/OIRA Mancini, USTR COMMERCE FOR D. DEFALCO
E.O. 12958: N/A
TAGS: ECONââ¬â°[Economic Conditions], EFINââ¬â°[Financial and Monetary Affairs], EINDââ¬â°[Industry and Manufacturing], EAGRââ¬â°[Agriculture and Forestry], ETTCââ¬â°[Trade and Technology Controls], ENRGââ¬â°[Energy and Power], KIPRââ¬â°[Intellectual Property Rights], PRELââ¬â°[External Political Relations], EUNââ¬â°[European Union] SUBJECT: CONSUMERS: TRANSATLANTIC ECONOMIC COUNCIL NEEDS STRONGER CONSUMER FOCUS, MORE TRANSPARENCY
ۦ1. (SBU) Summary: At a February 4 meeting with USEU, TransAtlantic Consumer Dialogue (TACD) representatives raised concerns over and suggested new directions for the Transatlantic Economic Council (TEC) process. TACD is concerned about the need for more transparency in the drafting of the TEC agenda, and the TEC's heavy focus on business concerns, when they believe the consumer organizations can contribute usefully to transatlantic discussions on innovation, energy technologies, IPR and other issues. USEU will continue working with TACD to help build this constructive approach. End Summary.
Background ----------
ۦ2. (SBU) At USEU's initiative, Econoffs met with representatives of the Transatlantic Consumer Dialogue (TACD) February 4 as a follow-up to the December Transatlantic Economic Council (TEC) meeting. TACD participants included Benedicte Federspiel (TACD Chair), Julian Knott, Willemien Bax and Anne-Catherine Lorrain. Bax is also Deputy Director General for the European Consumer's Organization (BEUC). (Note: TACD's U.S. and EU co-chairs, along with their Transatlantic Business and Legislators' Dialogues (TABD and TALD) counterparts, were included in the group of advisors to the TEC Co-chairs when the TEC was created in 2007. End note).
Overview --------
ۦ3. (SBU) Federspiel opened the discussion by welcoming the USG outreach to TACD and willingness to discuss a broad range of issues related to the U.S.-EU Transatlantic Economic Integration Framework (TEF), saying that "this meeting in itself sends a message." After explaining her role (current and past president, rotates among members of board, presidency alternates between US and EU consumer groups) she addressed the TEC. She said TACD members have both procedural and substantive concerns with the TEC as it has operated to date.
ۦ4. (SBU) The group's main concern, Federspiel said, is around a lack of transparency around the TEC process. This encompasses the lack of information exchanged between USG and TACD members on what has been discussed and decided, agendas and schedules for meetings, what is planned, and who has responsibility for various elements of TEC work. As a result, TACD representatives feel their suggestions have not been incorporated into the TEC agenda. She said the process of reviewing stakeholder input should be improved.
ۦ5. (SBU) In addition, Federspiel said, TEC agendas have been too heavily focused on issues of interest to business. Many issues that TEC takes up are not "consumer friendly." She suggested that moving EU TEC management away from DG Enterprise, which addresses mainly business issues, to the Council Secretariat (coordinating body for member state issues) or the Commission's interdisciplinary foreign relations directorate (DG RELEX) would help address this.
TEC Dynamics ------------
ۦ6. (SBU) USEU presented some initiatives the co-chairs have undertaken to improve the TEC, including completing and publishing a workplan and establishing parallel USG and Commission websites for TEC/TEF documents; in addition, Econoffs indicated State and Commerce will work to facilitate interagency coordination and continuity. Willemien asked whether the workplan would simply be a list of activities that occurred within the TEF framework and a list of additional planned activities, or whether we would use it as an evaluative tool, to measure the effectiveness of these activities. Econoffs explained that it is likely to be primarily a factual inventory of specific project commitments, goals, progress to date, and next steps.
BRUSSELS 00000202 002 OF 003
ۦ7. (SBU) Knott asked about the various sectoral dialogues under the TEC. Econoffs described the U.S.-EU Investment Dialogue and the High-Level Regulatory Cooperation Forum (HLRCF). The HLRCF is strong, and expected to continue with or without a TEC process. Bax said there should be greater coordination among the dialogues. She also said that BEUC had been invited to brief EU member state reps who follow transatlantic relations (COTRA working group) on their view of the TEC. Federspiel also noted that at the May 2008 TEC meeting, (she was unable to attend in December), there were definite personality problems among some participants, which led to a sometimes uncomfortable situation and less productivity for the meeting overall.
TACD Recommendations --------------------
ۦ8. (SBU) TACD shared several specific recommendations with Econoffs. TACD suggested that actual TEC meetings put a greater emphasis on discussion of broad, strategic issues (e.g. financial crisis impacts and responses). Federspiel said one challenge in balancing the dialogue would be addressing how to improve competitiveness in the transatlantic marketplace versus using the political weight of the TEC to resolve discreet, thorny, problematic issues. To this end, Federspiel suggested removing poultry from the TEC agenda, citing it as an example of an issue that had loomed too large in TEC discussions, taking up too much time to the exclusion of other issues that could have been addressed. She said the only person in the Commission who supported allowing U.S. poultry into the EU market was Verheugen, and as he was not a "dictator," he alone could not get poultry accepted, especially as 26 member states voted against allowing poultry and one, the UK, abstained.
ۦ9. (SBU) TACD interlocutors again emphasized the need to move EU management of the TEC to DG RELEX or the Council Secretariat. Federspiel pointed out that having DG Enterprise run the TEC for the Commission has led to an overemphasis on business interests on the agenda. Under this dynamic, it is difficult to get buy-in on TEC participation from Commissioners like Dimas (Environment) and Vassiliou (Health), whom she suggested would not like to put themselves in a position of going to the TEC to "be bossed around by Verheugen." She suggested DG RELEX would be a better home for the TEC due to its neutrality, but added that "TABD may not make the same recommendation."
ۦ10. (SBU) Federspiel said that perhaps different meeting formats could be considered for the TEC, such as a shorter plenary and more time allowed for breakout sessions, where discussion could be freer. She lamented the fact that members of the TEC advisory committee were allotted five minutes to speak at the beginning of the meeting, then sat there silently for hours on end Q a wasted opportunity for the advisors to provide useful input.
ۦ11. (SBU) Knott and Federspiel emphasized above all the need to broaden the agenda to include "consumer-friendly issues." Federspiel noted that TACD had submitted recommendations for all previous meetings for the TEC, which included suggestions the agenda should not be dominated by "crises of common interest" to the consumer and business communities, but should also include positive and proactive discussions on topics such as nanotechnology, innovation, and sustainability. Knott proposed that the TEC examine the connection between innovation, access to technology and potential reexamination of IP rights, particularly for developing countries, as well as general access to knowledge. Lorrain added that patent harmonization would be interesting, along with a discussion on copyrights and other current IPR issues.
Next Steps ----------
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ۦ12. (SBU) On next steps, Knott agreed to update and send USEU four papers on TEC issues, along with other recommendations. All agreed on the usefulness of the meeting and voiced their commitment to reinforce the dialogue between the Mission and TACD, and improve communication. TACD thanked USEU again for proactively reaching out to TACD on these issues. Federspiel closed by noting that TACD would hold its annual meeting June 7-10, 2009 in Brussels, to which the Mission and senior USG TEC officials would be invited. She suggested that this provided a great opportunity to meet with Commission leaders on TEC issues. (Note: TACD formerly held meetings twice annually, one in DC and the other in Brussels, but for budgetary reasons, can now only do one per year. End note.)
Comment -------
ۦ13. (SBU) TACD clearly feels the advent of a new U.S. administration offers them the chance to correct what they see to have been an excessive focus on business issues and concerns in prior TEC meetings. TACD recommendations on TEC structural reform should be considered thoroughly as part of a larger process of USG review of the TEC's continuation, functioning and structure. USEU will work to strengthen our dialogue with the group and will work to integrate it more effectively into the network of TEC stakeholders.
MURRAY
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DE RUEHGV #0730/01 2461558 ZNR UUUUU ZZH R 031558Z SEP 09 FM USMISSION GENEVA TO RUEHC/SECSTATE WASHDC 9182 INFO RUCPDOC/USDOC WASHDC RUEHSUN/USUN ROME IT
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SECSTATE FOR IO, EEB, OES COMMERCE FOR USPTO ROME for FODAG
E.O. 12958: N/A TAGS: ECONââ¬â°[Economic Conditions], KIPRââ¬â°[Intellectual Property Rights], SENVââ¬â°[Environmental Affairs], WIPOââ¬â°[World Intellectual Property Organization] SUBJECT: WIPO Conference on Public Policy
ۦ1. SUMMARY (SBU): During the July 13-14 World Intellectual Property Organization (WIPO) Conference on Intellectual Property (IP) and Public Policy Issues in Geneva, Switzerland, participants explored and clarified the connection between IP and several major public policy issues such as climate change, public health, food security and protection of traditional knowledge. The conference was held at the behest of the WIPO Standing Committee on Patents (SCP) and provided an opportunity for WIPO not only to reinsert itself into debates on IP's role in addressing key public policy issues, but also to claim a leadership role that WIPO hopes will result in better understanding of the IP aspect of public policy issues by intergovernmental organizations, non-governmental organizations and member states. A Chair's report on the public policy conference will be submitted to the next SCP meeting in November 2009, at which time, developing countries may push to have the conference's topics become a new focal point for work under the SCP. To address concerns from some WIPO Member States that the focus of the public policy conference not be diverted from the patent system, WIPO held a separate conference on access to reading material for the visually impaired on the morning of July 13 (septel). END SUMMARY.
Climate Change --------------
ۦ2. (U) The role of IP in promoting the development and diffusion of green technologies to combat climate change was at the heart of discussions at a two-day international conference on IP and public policy issues. The overall view at the Conference was that IP is a key incentive for the creation of new green technologies to address climate change problems. To assess the extent of the climate change problem, Michel Jarraud, Secretary General the World Meteorological Organization (WMO) pointed to unequivocal scientific evidence on the tremendous impacts of climate change on health and food security. He noted that IP should be a catalyst, and not an obstacle, to solving problems associated with climate change. Jarraud emphasized the advantages of international cooperation and the need for a multi-disciplinary approach to the challenges arising from climate change, as well as the importance of facilitating technology transfer.
ۦ3. (U) Britain's Minister for Higher Education and Intellectual Property, Mr. David Lammy, and WIPO DG Gurry also provided similar messages emphasizing the importance of IP rights in facilitating the transition to clean technologies and renewable energies, and the range of options offered by the IP system in identifying, transferring, and disseminating those technologies to address climate change. Lammy specifically noted that the technology transfer issue was crucial to the success of climate change negotiations in the United Nations Framework Convention on Climate Change (UNFCCC). DG Gurry added that IP rights offered the necessary incentives to develop green technologies, noting moves by several countries to develop systems to fast track the examination of patent applications in the area of clean technologies and renewable energy. The IP system offers a proven means of encouraging investment in the clean technologies required to adapt to and mitigate climate change.
ۦ4. (U) As referenced in the speeches of UK Minister Lammy and DG Gurry, technology transfer of green technology is a key issue among NGOs, developing countries and the IP community. It is also a key feature in the UNFCCC, which is slated to have a finalized agreement by the end of the year. Wanna Tanunchaiwatana, Manager of the Technology Sub-Program of the UNFCCC, reported that draft language concerning technology transfer would commit developed countries 'to take all practicable steps to promote, facilitate and finance, as appropriate, the transfer of, or access to, environmentally sound technologies and know-how to other parties, particularly developing country parties' (Article 4.5 of the UNFCCC). Tanunchaiwatana believes that difficulty in negotiating the IP section of the UNFCC agreement does not rest with the idea of transferring IP-dependent green technologies itself, but with the broader challenge of how to implement and encourage the diffusion of all relevant technologies to reduce the impacts of climate change on a global scale. She reminded attendees of the short amount of negotiating time remaining before the December deadline, and encouraged parties to work through the current standstill on IPR in the UNFCCC talks.
ۦ5. (U) In response to the growing debate on whether the solution to climate change should mirror the compulsory license solution reached in the WTO for improving access to pharmaceuticals for poor countries, economist Daniel Johnson and Chief IP Counsel for General Electric Carl Horton noted empirical research illustrating that weakening IPR protection for climate change-related technologies is an unsound policy and will harm innovation. It was noted that there are very few patents on green technologies (fewer than in the pharmaceutical sector), making compulsory licensing unnecessary in most cases. Panelists emphasized that a lack of green technology patents in this area shows that IP is not an obstacle to development and it allows for open access and further innovation. They concluded that proposals in the UNFCCC for mandatory technology transfer and/or compulsory licensing under UNFCCC will have the unintended effect of hampering any investment and innovation in this area. It was also highlighted that technology transfer concerns must be addressed on a commercial basis and not through government enforcement.
Public Health and Traditional Knowledge ---------------------------------------
ۦ6. (U) Evident throughout the discussions related to public health was a theme calling for 'strong collaborative action' among IGOs and the private sector to address questions on IP, trade and public health. WHO Director General Dr. Margaret Chan stated that while innovation has a key role to play in new drug development, market forces alone are insufficient to ensure the delivery of affordable and universal public health solutions. She noted that both needs- and profit-driven incentives should be explored to address both access problems faced by the poor and lack of new treatments for neglected diseases.
ۦ7. (U) Dr. Chan said that international agreements can be shaped in ways favoring health needs of the poor and cited the May 2008 World Health Assembly-adopted resolution on public health, innovation and intellectual property, as a model. According to Dr. Chan, the global strategy and plan of action contained in the resolution provide agreed-upon lines of action for making health care products more accessible and affordable, especially in the developing world. Further, Chan noted that creative solutions to address the health needs of the poor that complement the IP system include UNITAID's patent pool, a voluntary system created with the intent to reduce expenses and increase access to IP essential to make medicines that are needed by poor countries facing the HIV/AIDS crisis. Chan also cited other IP-complementary solutions, such as WHO's pre-qualification program, which helps developing county producers achieve necessary quality standards to produce safe and effective medicines.
ۦ8. (U) World Trade Organization (WTO) Director General Pascal Lamy also underlined a need for effective international partnerships. With interdependent issues of public health, climate change, biodiversity and food security, "no single international agency has a monopoly on these diverse areas of policy," said Lamy. Noting that climate change will likely have a severe impact on disease patterns and on agriculture, Lamy stressed that the effective use of the IP system and of TRIPS flexibilities are important, but do not stand alone: IP law and policy must be harnessed with drug procurement policies, pro-competition safeguards, and regulation of drugs for safety and quality.
ۦ9. (U) Tony Wood, Vice President of Medicinal Chemistry at Pfizer Global Research and Development, noted that IP is absolutely essential from the researchers' point of view. He added that 10 to 12 years elapse between inventing the right molecule and undertaking all the necessary testing and trials to bring it to market. Without patents, the research would be held as a trade secret during testing, holding back medical research that is aided by disclosure in patent applications.
ۦ10. (U) Joseph Straus of the Max Planck Institute for Intellectual Property agreed, saying a precondition of access to medications is their existence, which means research and development must be incentivized. Robert Sebbag, Vice President of Access to Medicines at Sanofi-Aventis, added that important progress is being made to effectively address access to medicine concerns for the poor through public and private partnerships. Moreover, he noted that the industry is utilizing alternative models to deliver lower profit medicines at higher volumes to treat neglected diseases without dismantling the patent system. He reminded the audience that access to affordable medicines is just one piece of the puzzle, and that education and communication are key in fighting diseases.
TRADITIONAL KNOWLEDGE ---------------------
ۦ11. (U) Discussions also centered on the role of traditional knowledge in addressing IP and public health concerns. Claudia Ines Chamas, senior advisor in the Secretariat of Sciences and Technology and Strategic Inputs at Brazil's Ministry of Health noted that for many neglected diseases, the medicines are old, toxic, expensive, or in short supply. She stated that access to medicine is not possible without reasonable efforts towards increasing local capacity and building a local basis of knowledge. Yonah Seleti, Director General of South Africa's Department of Science and Technology stated that the "African renaissance can only be borne on the role of indigenous knowledge systems". According to Seleti, indigenous people have enormous economic and social potential in their knowledge, but the current IP system sometimes fails to protect that knowledge. It was also noted that misappropriation of traditional knowledge must be stopped.
ۦ12. (U) Vinod Kumar Gupta, head of the Information Technology Division at the Traditional Knowledge Digital Library (TKDL), a project of the Council of Scientific and Industrial Research in India, reported on his efforts to use the TKDL to catalogue traditional knowledge in a patent-like format so that it is easier to identify as prior art. He mentioned that a recent agreement with the European Patent Office has made the database available for patent examiners to use in grant procedures, and a similar agreement is expected soon with the U.S. Patent and Trademark Office. He concluded by noting that collaborative research between traditional knowledge and modern medicine can yield great public health benefits, but IP agreements must find ways to protect traditional knowledge.
ۦ13. (SBU) COMMENT: It should be noted that, though not specifically raised at the Conference, the issue of providing IP protection for traditional knowledge/access to genetic resources/traditional cultural expressions (TKGRTCE) has been examined by Member States for several years at WIPO's Intergovernmental Committee (IGC) on TKGRTCEs. WIPO technical assistance units also continue to provide essential advice to developing and least developed countries on the effective use of existing IP principles and systems for these IP-related interests. All Member States support the need for protecting traditional knowledge and are committed to making progress on the protection, preservation and promotion of TKGRTCEs. However, the Africa Group, along with Brazil, India, Indonesia, Iran, Pakistan, and many Caribbean nations are currently demanding that an internationally-binding treaty be negotiated at the IGC and concluded and signed by Member States in 2012. Developed countries, as well as two developing countries (South Korea and Singapore), believe that it would be premature to agree upon the nature of the text to be negotiated (i.e. that it would be a binding treaty) without a pre-agreement on the content of that text. The U.S. and others also maintain that no outcome of the IGC should be precluded, including the adoption of a legally binding international instrument, but that, at this point, no outcome should be prejudged either. END COMMENT
Food Security -------------
ۦ14. (U) In opening remarks under the topic of IP and Sustainable Agriculture, Algerian Ambassador Idriss Jazaory stated that the number of malnourished people in the world has topped one billion. WIPO's role here is to ensure that the system for IP protection contributes to the creation of new food and agricultural resources, but at the same time does not become an obstacle to the most vulnerable people in the most vulnerable places having access to them, said Jazaory. He noted that IPR could be used to justify food cartels or to alleviate hunger; how this plays out depends on the international community.
ۦ15. (U) Shakeel Bhatti, Secretary of the International Treaty on Plant Genetic Resources for Food and Agriculture at the Food and Agriculture Organization (FAO) of the United Nations added that access to seeds has impacted food security. The treaty has, he said, made significant breakthroughs in funding its access and benefit sharing system, while waiting for the built-in time lag of 5 to 7 years before commercial products start growing out of it.
ۦ16. (U) Kanayo Nwanze, President of the International Fund for Agricultural Development (IFAD) noted that it is not tenable to separate IP from sustainable development. Intellectual property rights can serve as catalysts for sustainable agricultural growth, but there needs to be a shift in thinking on technology development from the public/private divide to partnerships and equitable benefits for both stakeholders.
ۦ17. (U) Richard Jefferson, Chief Executive of non-profit Cambia, proposed one way in which the IP system might be set up for improved collaboration. He reported on the Initiative for Open Innovation, a new project in collaboration with WIPO and the Gates Foundation launched in July 2009, which aims to create a "free, open, global web-based facility" that will map in all languages not only patents, but also regulatory data and science and technology literature, cross-referencing them with key genes and compounds, creating 'patent landscapes' that will allow for a clear picture of what is patented, where it is patented, and who controls it.
ۦ18. (U) As a part of the Initiative for Open Innovation, Cambia has proposed the creation of a new legal tool they call a 'concord;' a mutual agreement not to assert IP rights in a particular field of use. For example, Jefferson said companies might agree not to assert any IP rights related to research, development, manufacture, delivery or support of malaria interventions. The patents might be enforced for other purposes, but this allows for collaborative innovation to solve specific problems, and will reduce costs for small players who want to work on such problems.
ۦ19. (U) Michael Kock, the Global Head of IP at agriculture technology firm Syngenta International, compared the seed industry to the entertainment industry, as copying and counterfeits continue to be major problems for the seed industry. He clarified that Syngenta does not seek patents for plants/seeds in least developed countries or enforce rights used in subsistence farming. He noted that the enforcement issues arise in the context of use by large farmers in developed countries. He continued in emphasizing that the disclosure of origin of genetic resources, which has been proposed as a way to protect small growers, is problematic because it increases uncertainty for innovators and will discourage the use of genetic diversity. A key area that would further innovation in the seed industry would be patent harmonization of plant protection, as the existing rules under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) allow for protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. As a result, there are varying degrees of patent protection for plants from one territory to another.
Closing remarks --------------- ۦ20. (SBU) In summarizing the two-day Conference, the Chair of the Standing Committee of Patents (SCP), Maximiliano Santa Cruz (Chile), noted that IP is not an end in itself, but an instrument to promote innovation, creativity and the dissemination of knowledge. He added that while the IP system may present some challenges, it can also be part of the solution to development questions. The SCP Chair noted that a common theme during the Conference was that innovation and technology coupled with technology transfer is no doubt an important contribution to solving problems that may arise in other areas of development. The Chair is charged with reporting back to Member States on the outcome of the Conference. Though proposals have yet to be made, certain developing countries are likely to push for further discussion of the topics raised at the Conference, particularly those concerning technology transfer at future SCP meetings, as well as follow up conferences.
ۦ21. (U) All PowerPoint Presentations and audio speeches can be found at: http://www.wipo.int/meetings/en/2009/ip_gc_ge / program.html
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