USTR Seeks Comments on Expansion of WTO List of Duty-Free Pharmaceutical Products
The Office of the U.S. Trade Representative (USTR) has issued a notice stating that the Trade Policy Staff Committee (TPSC) is seeking comments in connection with negotiations on the expansion of the list of pharmaceuticals subject to reciprocal duty elimination (Pharmaceutical List) by certain members of the World Trade Organization (WTO).
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The TPSC explains that the Pharmaceutical List is the result of an agreement between the U.S. and 16 trading partners during the Uruguay Round of multilateral trade negotiations. Under the Pharmaceutical List, participants provide reciprocal elimination of duties on certain pharmaceutical products and chemical intermediates.
The Pharmaceutical List initially eliminated duties on approximately 7,000 pharmaceutical products and chemical intermediates in January 1995, and subsequent additions have been made in April 1997 and July 1999. (See ITT's Online Archives or 07/08/99 news, 99070745, for BP summary of the 1999 additions.)
(The products and chemical intermediates eligible to enter the U.S. duty-free as a result of the Pharmaceutical List agreement and additions are enumerated in the Pharmaceutical Appendix to the HTS.)
TPSC, USTR Preparing for Negotiations on Additions to Pharmaceutical List
The USTR notice states that negotiations will begin in 2004 in the WTO with a view to adding new pharmaceuticals to the Pharmaceutical List. According to the notice, negotiators will be reviewing the international nonproprietary names (INNs) on the most recent World Health Organization (WHO) lists (i.e. lists 79-90) in this latest review cycle.
In preparation for these negotiations, the TPSC, led by the USTR and with input from appropriate industry association and private sector advisory groups, is in the process of preparing negotiating positions.
The TPSC states that it is inviting comments on expansion of the Pharmaceutical List, specifically with respect to: the addition of pharmaceutical active ingredients; prefixes and suffixes that could be associated with an active ingredient in order to designate its salt, ester, or hydrate form; or chemical intermediaries intended for the manufacture of pharmaceutical active ingredients.
TPSC is also requesting comments on, among other things, pharmaceutical items that would be in the U.S.' interest to add to the existing Pharmaceutical List.
(The TSPC notes that any amendments to the Pharmaceutical List will be subject to approval by all negotiation participants.)
-written comments are due by noon, September 17, 2004
USTR Contacts - Gloria Blue (procedural questions) (202) 395-3475
Sarah Bovim (questions on expansion of List) (202) 395-4994
Pharmaceutical Appendix to HTS available at http://hotdocs.usitc.gov/tariff_chapters_current/0410pharmappx.pdf
Initial list of proposed negotiation items available at www.ustr.gov
USTR Notice (FR Pub 08/12/04) available at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-18424.pdf