VZCZCXYZ0005
PP RUEHWEB

DE RUEHFR #1982/01 3031755
ZNR UUUUU ZZH
P 291755Z OCT 08
FM AMEMBASSY PARIS
TO RUEHC/SECSTATE WASHDC PRIORITY 4673
INFO RUEAUSA/DEPT OF HHS WASHDC PRIORITY

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