[Federal Register Volume 69, Number 105 (Tuesday, June 1, 2004)]
[Notices]
[Pages 30882-30883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12205]


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DEPARTMENT OF COMMERCE

International Trade Administration


Drug Pricing Study

AGENCY: International Trade Administration, Commerce.

ACTION: Notice on inquiry.

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SUMMARY: Information is sought pursuant to a study of international 
drug pricing as required by section 1123 of the Medicare Prescription 
Drug, Improvement and Modernization Act of 2003.
    This information will result in a report on trade in 
pharmaceuticals, focusing on the drug pricing practices of countries 
that are members of the Organization for Economic Cooperation and 
Development (OECD) and the effects of those practices on drug pricing 
in the United States, R&D, and innovation.

DATES: Submit comments, preferably via e-mail, on or before July 1, 
2004.

FOR FURTHER INFORMATION CONTACT: Submit comments to: Kristie Mikus at: 
[email protected].

ADDRESSES: Department of Commerce, 14th and Constitution Avenue, Room 
4039, Washington, DC 20230.

SUPPLEMENTARY INFORMATION: The International Trade Administration (ITA) 
publishes this notice to solicit information, per the requirements of 
the Medicare Prescription Drug, Improvement and Modernization Act of 
2003. The Act directs the Secretary of Commerce, in consultation with 
the International Trade Commission, the Secretary of Health and Human 
Services and the U.S. Trade Representative, to conduct a study and 
produce a report on trade in pharmaceuticals, focusing on the drug 
pricing practices of countries that are members of the Organization for 
Economic Cooperation and Development (OECD).
    Specifically, the Conference Report to the act states:

    Report on Trade in Pharmaceuticals. The Conference agreement 
directs the Secretary of Commerce, in consultation with the 
International Trade Commission, the Secretary of Health and Human 
Services and the United States Trade Representative, to conduct a 
study and report on drug pricing practices of countries that are 
members of the Organization for Economic Cooperation and Development 
and whether those practices utilize non-tariff barriers with respect 
to trade in pharmaceuticals. The study shall include an analysis of 
the use of price controls, reference pricing, and other actions that 
affect the market access of United States pharmaceutical products.
    The study shall include the following:
    Identification of the countries that use price controls or other 
such practices with respect to pharmaceutical trade.
    Assessment of the price controls and other such practices used 
by the countries identified.
    Estimate of additional costs to U.S. consumers due to price 
controls and other such practices, and the extent to which 
additional costs would be reduced for U.S. consumers if price 
controls and other such practices were reduced or eliminated.
    Estimate of the impact such price controls, intellectual 
property laws, and other such measures have on fair pricing, 
innovation, generic competition, and research and development in the 
United States and each country identified.

    Consequently, the Department is seeking input to the following
    Consequently, the Department is seeking input to the following 
questions. However, in responding to these questions, please feel free 
to also include any additional information or input relevant to the 
study's mandate.
     How do OECD countries set pharmaceutical prices? Within 
OECD countries, what mechanisms do governments use to control 
pharmaceutical expenditures?
     If price controls and other government cost control 
mechanisms were eliminated in OECD countries, how and to what degree 
would pharmaceutical prices and expenditures change in those countries 
and in the United States? What effects would these changes have on the 
sales and profits of pharmaceutical manufacturers?
     How do patent laws and their application affect the levels 
of and differences in prices of patented drugs in OECD countries?
     How would U.S. consumers be affected if price controls and 
other government cost control mechanisms were eliminated in OECD 
countries?
     What factors influence, and how do companies determine 
research and development (R&D) expenditures? How would higher prices 
and revenues from sales in OECD countries affect R&D?
     What is the relationship between increased R&D by 
pharmaceutical manufacturers and the introduction of new drugs?
     Could OECD countries reduce costs by increasing the use of 
generic drugs? What steps would the governments need

[[Page 30883]]

to take to facilitate the use of generic drugs?
     Are there means by which OECD countries could improve 
incentives for developing innovative medicines without significantly 
increasing spending on drugs?
     List any additional drug pricing practices by OECD 
countries that utilize non-tariff barriers.

    Dated: May 25, 2004.
Jonathan Menes,
Executive Director, Trade Development.
[FR Doc. 04-12205 Filed 5-28-04; 8:45 am]
BILLING CODE 3510-DR-M