Cablegate: Hhs Secretary Leavitt September Visit to France

Published: Wed 29 Oct 2008 05:55 PM
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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
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
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