HHS SECRETARY LEAVITT SEPTEMBER VISIT TO FRANCE

UNCLAS PARIS 001982 SENSITIVE SIPDIS E.O. 12958: N/A TAGS: TBIO KFLU ECON SENV AMED KSCA SUBJECT: HHS SECRETARY LEAVITT SEPTEMBER VISIT TO FRANCE ¶1. (SBU) Summary: U.S. Secretary of Health and Human Services (HHS) Michael O. Leavitt traveled to France from September 8, 2008 to September 10, 2008 to promote U.S. interests in the areas of food and drug safety, pandemic influenza preparedness, and the development of medical countermeasures. In bilateral meetings, between European Union (EU) Health Ministers, and with representatives of the private sector, the Secretary emphasized the importance of the U.S./European partnership, and pressed for closer cooperation on key public-health challenges of global scope. End summary. ¶2. (SBU) On 8 September, Leavitt met with the American Chamber of Commerce (AMCHAM) in Paris to discuss product safety and pharmaceutical pricing, specifically research and development costs for new drugs which have been primarily borne by the American market. He challenged the group, composed mostly of food and drug representatives, to discuss international pharmaceutical pricing, and encouraged them to establish common, international industry-driven standards for product safety. ¶3. (SBU) The Secretary met a small group composed of industry leaders, including Bristol Meyers Squibb, Dechert, Pfizer, and Kraft Foods, to discuss President Bush's Action Plan on Import Safety, the World Health Organization bio-similars debate, EU pharmaceutical pricing contributions, genetic modification and cloning, and electronic medical records. Leavitt delivered a strong message that the U.S. consumer alone should not fund pharmaceutical innovation, and he stressed the need for EU countries to contribute, not in direct payments to the companies, but by allowing their citizens to purchase these drugs. ¶4. (SBU) Similarly, Leavitt affirmed that science has found animal cloning and genetically modified foods safe, and that the market should be the place for consumers to express their preferences. He criticized European Government regulations to ban sales of bioengineered products. Regarding medical product safety, Leavitt mentioned the HHS/FDA-European Medicines Agency (EMEA)-Australian pilot project for joint inspections of drug-manufacturing facilities, and emphasized this common approach should be the beginning of a process in which Government regulatory authorities should accredit industry standardization certifications, ideally with common acceptance of such certifications. ¶5. (SBU) Following this meeting, Secretary Leavitt met with a separate group of AMCHAM member companies, and re-iterated his messages on product safety and pharmaceutical pricing. He focused on the "globalization" of the HHS Food and Drug Administration, and outlined the international staffing strategy for HHS/FDA, which includes presence in the European Union. Leavitt closed by emphasizing that product safety was closely tied to trade; and that all countries would benefit from an open and transparent system that includes certification of products before export. ¶6. (SBU) On September 8, 2008, Secretary Leavitt met with senior leadership from the Institute Pasteur (IP) to discuss pandemic-influenza preparedness, the HHS-IP cooperative agreement on influenza and the international negotiations over the sharing of influenza samples. Professor Dautry, President of the IP updated Secretary Leavitt on the progress at the eight international IP sites funded under the HHS-IP cooperative agreement. Both sides expressed frustration at the current state of negotiations over sample-sharing, and agreed Indonesia was in violation of the International Health Regulations (2005). (Comment: IP and HHS agreed in 2006 to put in abeyance aspects of their cooperative agreement and MOU that have to do with exchanging samples pending the resolution of the global negotiations on sample-sharing. This has prevented the two sides from fully taking advantage of their collaboration. End comment.) ¶7. (SBU) IP Staff provided updates on the HHS-IP countries in Asia (Cambodia, Laos, and Viet Nam) which have made some progress. The five U.S.-supported sites in Africa have not reported significant progress programmatically; however, they have established communication channels for information-exchange. Both sides mentioned the need for better coordination between IP and the HHS/Center for Disease Control and Prevention (CDC) field staff with similar pandemic-influenza missions. Echoing the Secretary's frustration with Indonesia Prof. Dautry agreed the conversation with the Indonesian Minister of Health is now "political and not technical". IP leaders also affirmed Secretary Leavitt's belief that sanctions should be under consideration for those who do not share virus samples, as sharing samples is a "basic tenet of the International Health Regulations." ¶8. (SBU) On September 8-9, 2008, Secretary Leavitt traveled to Angers, France where he met with colleagues from Italy, France, Germany, and the European Commission on the margins of the EU informal Health Ministers' conference. He also addressed the Ministers over dinner on September 8. Principal topics of the discussions included product safety, pandemic-influenza preparedness (including sample-sharing),and the establishment of a global marketplace for medical countermeasures. ¶9. (SBU) Italian Under Secretary for Health Ferruccio Fazio agreed that sharing of influenza samples should be required for more than risk-assessment purposes, and needs to include basic research to learn more about how the virus mutates and binds to receptors in the human body. The two sides discussed the renewal of the HHS-Italy Memorandum of Understanding (MOU) on Health Cooperation as a vehicle to express the two nations shared commitment to influenza research and sample-sharing. Other items discussed for inclusion in the MOU would be the development of medical countermeasure, general preparedness planning, and product safety. ¶10. (SBU) European Commissioner for Health Androulla Vassilou, host of the 2008 Global Health Security Initiative (GHSI) Ministerial in Brussels, Belgium discussed the agenda for the GHSI Ministerial including coordination of preparedness plans, sample-sharing, and risk communication. The Secretary briefed the Commissioner on the plans to establish HHS/FDA liaisons in Europe, and Commissioner Vassilou expressed interest in having a senior HHS official at the U.S. Mission in EU in Brussels; Secretary Leavitt committed to placing an HHS/FDA liaison officer in Brussels in calendar year 2008, pending approval from USEU Ambassador Silverberg. ¶11. (SBU) On September 9, at a breakfast for French Minister of Health, Roselyne Bachelot said that Leavitt's remarks on health security were helpful in advancing the agenda of the informal meeting of EU Health Ministers and discussed plans for cooperation in developing medical countermeasures, bilaterally and within the Global Health Security Initiative. They discussed the November 2008 deadline for completing the sample-sharing negotiations, and expressed their shared displeasure with the Indonesian position adopted to-date. Both countries identified points of contact (Bill Steiger, U.S and Didier Houssin, France) with the responsibility of updating each other regularly in advance of the negotiations. Professor Houssin is drafting a paper to define access to vaccines would be acceptable for sharing with the countries who are currently involved in the sample-sharing debate. (Comment: Common in the French and U.S. positions is the idea that access to vaccines should not be linked to the specific sharing of samples but that countries that do not share viral samples should face sanctions for their bad behavior. End comment.) ¶8. (SBU) Finally, Secretary Leavitt met with German Parliamentary Secretary Marion Caspers-Merks, who asked how to communicate quickly between the two Governments on security and safety matters; she cited the recent cases of Chinese heparin contamination as an example. Secretary The Secretary indicated the joint HHS/FDA-EMEA-Australia pilot project on inspecting pharmaceutical plants is a way to start identifying the right communications channels. Casper-Merks indicated that, while she liked the joint inspection pilot, she would also like to better understand how large the problem of risk is; Germany funds the WHO's report on drug safety, but progress is very slow. HHS is focused on collaboration with countries of known risk, like China, as a way to help learn more about drugs and food before they enter the U.S. border. Casper-Merks then agreed the U.S. approach to independent, third-party certification would be a possible solution, and suggested adding product safety to the GHSI Ministerial agenda in December 2008. French Minister of Health Bachelot's suggestion to discuss medical counter-measures, would also be a good GHSI agenda item. Casper-Marks indicated that internal EU consensus is very difficult to achieve, and might only be possible in a crisis. The first step will be country-level work on medical countermeasures. A second step would be identifying who would be doing what in the EU towards these efforts. Secretary Leavitt focusing on a defined area of common interest, like the next-generation anthrax vaccine, might be the best path forward. Merks added that her Government's bottom line was, "what does it cost and what do I get," and that, even though Germany has limited funds, it would be willing to contribute to joint efforts. Secretary Leavitt agreed to select one medical countermeasure and then expand collaboration. On the last topic raised, pandemic-influenza preparedness, Casper-Merks agreed on the need to preserve the WHO Global Influenza Surveillance Network, and that the functions of this Network should continue with or without Indonesia if it is unwilling to share samples. Merks indicated State Secretary of Health Theo Schroeder is the German point of contact for these negotiations. The meeting closed with Secretary Leavitt's comment that sample-sharing had become a political issue, and if it is not resolved by November 2008, Indonesia should suffer some penalty for not cooperating; Casper-Merks agreed with this approach. STAPLETON