[Federal Register Volume 69, Number 136 (Friday, July 16, 2004)]
[Notices]
[Pages 42688-42689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16219]


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DEPARTMENT OF COMMERCE

International Trade Administration

[Docket 040621190-4190-01]


Drug Pricing Study

AGENCY: International Trade Administration, Commerce.

ACTION: Notice of hearing.

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SUMMARY: Information is sought related to a study of international drug 
pricing, mandated by Section 1123 of the Medicare Prescription Drug, 
Improvement and Modernization Act of 2003 (the Act). This information 
will contribute to 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 Canada, Poland, France, Germany, United Kingdom, Japan, 
Switzerland, Greece, Australia, Korea, and Mexico) and the effects of 
those practices on drug pricing in the United States, research and 
development, and innovation. The Department is therefore holding a 
public hearing on August 3, 2004, and requesting written testimony in 
advance of the hearing.

DATES: Notification of intent to testify and written testimony should 
be submitted no later than 5 p.m. August 2, 2004. The hearing will be 
conducted on: August 3, 2004. For members of the public who are unable 
to attend the public hearing or who wish to submit rebuttal comments, 
ITA will accept comments from August 3 until August 13, 2004.

ADDRESSES: Schedule time for testimony and submit written testimony 
through Kristie Mikus: Department of Commerce, 14th and Constitution 
Avenue, Room 4053, Washington, DC 20230, e-mail 
[email protected]; telephone (202) 482-0131; fax (202) 482-2565. 
The hearing will be conducted at: Department of Commerce, 14th and 
Constitution Avenue, Room 3407, Washington, DC 20230, on August 3, 
2004.

FOR FURTHER INFORMATION CONTACT: For further information, please 
contact Kristie Mikus at (202) 482-0131 or at [email protected].

SUPPLEMENTARY INFORMATION: The International Trade Administration (ITA) 
publishes this notice of a public hearing to solicit information, as 
mandated by the Act. The hearing will take place on August 3, 2004 at 9 
a.m. at the Department of Commerce, 14th and Constitution Avenue, Room 
3407, Washington, DC, and will conclude at 5 p.m. or the close of 
business.
    The Act directs the President's designees to conduct a study and 
report on issues related to trade and pharmaceuticals. Public Law 108-
173, 117 Stat. 2066, 2469. Legislative history provides additional 
information concerning Congress' intent on the matter. Specifically, 
Conference Report 108-391 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 OECD. 
Specifically, the Conference Report to the Act states:

[[Page 42689]]

    ``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 because of such 
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 are 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.''

    ITA previously published a Request for Comments on June 1, 2004, 
Federal Register, Volume 69, Number 105, Page 30882-30883. The comment 
period for this request for comments closed on July 1, 2004. However, 
additional information is needed to complete the report for Congress. 
Consequently, the Department is seeking input to the following 
questions. However, in responding to these questions, please feel free 
to also include any relevant additional information or input. 
Individual testimony will be limited to 15 minutes. Because of the 
finite amount of time available during the public hearing, ITA may not 
be able to accommodate everyone who expresses an interest in testifying 
at the hearing. Therefore, ITA will provide an additional comment 
period between August 3 and August 13 to allow the public to submit 
comments on the questions below or in response to testimonies.
     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? What effects would 
these changes have on the sales and profits of pharmaceutical 
manufacturers?
     How do patent laws and their application affect prices of 
patented drugs in OECD countries?
     If price controls and other government cost control 
mechanisms were eliminated in OECD countries, what effect would there 
be on U.S. consumers?
     What factors influence, and how do companies determine 
research and development (R&D) expenditures? How would R&D be affected 
by higher prices and revenues from sales in OECD countries?
     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 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?
    Once completed, the report produced by ITA will be submitted to 
Congress and made available to the public.

    Dated: July 13, 2004.
Douglas B. Baker,
Deputy Assistant Secretary for Service Industries, Tourism and Finance 
for the Office of the Assistant Secretary for Trade Development.
[FR Doc. 04-16219 Filed 7-15-04; 8:45 am]
BILLING CODE 3510-25-P