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Vol. I: Issue 17 - December 15, 2006

TRIPS
Canada Changes Drug Data Exclusivity Rules to Address U.S. Industry Concerns.

In response to long-standing criticism and concerns raised by the U.S. Government and U.S. innovative pharmaceutical industry, including an alleged violation of its WTO TRIPS obligations, Canada has amended its drug approval regulations.

Prior to the amendments, Canada had a five year period of data exclusivity like the United States which prevents generic companies from relying on the clinical data generated by brand name companies to demonstrate safety and efficacy for marketing approval for a period of five years after the market approval of the brand name drug. During that five year period a generic drug cannot obtain marketing approval based on the brand name drug's clinical test data even though the generic drug is bioequivalent to the brand name drug. More…


After Doha: Practical Approaches for Cutting the Costs of Trade - Making the Most of FTAs. In our discussion of special duty programs in the last issue, we noted that the U.S. has negotiated a number of “FTAs” with key allies and trading partners, and more are in the works all of the time. At a detailed level, the agreements differ from one to the next, but the over-arching purpose remains the same: to facilitate trade between the signatory countries. As a result, companies that are invested in trade with an FTA partner — or a would-be FTA partner — can realize enormous savings by getting involved in the FTA negotiation process and then reap the rewards when the agreement takes effect. More…



Commerce Initiates First Countervailing Duty Investigation Involving Chinese Subsidies in 15 Years. The decision by the Commerce Department on November 21, 2006 to investigate subsidies given by the People's Republic of China to the paper industry marks the first CVD petition against China since 1991. More…

 


Change expected soon in scope of US sanctions on North Korea.
Since the United Nations Security Council issued Resolution 1718 on October 14, 2006, imposing sanctions on North Korea for nuclear testing, U.S. sanctions and export laws have not changed. This may soon change. More…

Recent Changes in U.S. Policy Expand Business Opportunities in Sudan.
Characterized by ongoing civil war and gross human rights violations, Sudan has been the object of U.S. arms and economic embargoes for years. The concurrent passage of the Darfur Peace and Accountability Act (“DPAA”) and issuance of Executive Order 13412, however, have marked a significant change in the almost total U.S. ban on business in the country. More…



Hours before the close of the 109th Session of Congress, the House and Senate approved a package of trade legislation with wide-ranging implications for the international business community.  More…



U.S. DOT Decision to Scuttle Foreign Control Rule Leaves U.S.-EU Open Skies Accord in Doubt. Bowing to widespread opposition from Congress and U.S. labor, the U.S. Department of Transportation (“DOT”) last week terminated its controversial proposal to redefine “actual control” of U.S. airlines and permit further control by foreign entities, vowing to find “other ways to rationalize and simplify our domestic investment regime.” More…



REACH Regulation on track for adoption by EU Council. On December 13, 2006, the European Parliament irrevocably voted in favor of the intensely debated and highly controversial REACH Regulation. More…



Did you knowThe Sanctions Practice at C&M includes seven lawyers with experience in OFAC sanctions programs and other international economic and trade sanctions regimes.  More…


MARKET ACCESS
New EU Market Strategy Enters Final Phase With Consultations to Identify Priority Barriers and Key Markets.
Citing the recent Report on Market Access prepared by Crowell & Moring, DG-Trade of the European Commission has now opened up a public consultation on the EU's new market access policy, in part, due to the Report's findings that EU industries and enterprises strongly believe that significant changes are required to improve its effectiveness. The shape of the renewed EU's Market Access Strategy is now becoming relatively well-defined, although the policy itself has not been finalised. The main thrust will be to focus more closely on the key barriers to trade today, particularly non-tariff barriers, among the EU's major trading partners with a special focus on the so-called emerging economies. Input from EU business is now being sought to identify precise high-priority barriers for the Commission's attention. More…

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