“Shake-Out” on the Pharmaceutical Market

by Marga Wolpert

What problems do the retroactive approval of medications cause?

Since July 1, 2003, patients in Germany have been forced to do without approximately 5200 well-tried and proven medications. This can be traced back to the tenth amendment (July 2000) related to the Medical Preparations Act, which takes a complaint of the European Commission into consideration. Now, for the first time, manufacturers of drugs that were already in circulation prior to the Medical Preparations Act, which came into force in 1978, have had to submit clinical studies or—under certain circumstances—in place of these, other scientific materials, in order to receive retroactive approval.

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Balancing the Risks in International Litigation:
Your Case May Be Better Off Right Here in Texas

by

William L. Maynard
Partner, Beirne, Maynard & Parsons, L.L.P.

Companies are often sued in the United States for product liability claims relating to accidents that occurred in other countries. In the case of large national or international corporations with operations in many jurisdictions, plaintiffs have the luxury of carefully selecting venues that are known to be plaintiff-friendly and have a history of large awards.

This “forum shopping” is especially common in cases relating to aviation accidents. Texas courts have frequently been the venue selected because of their reputation for liberal tort theories and huge damage verdicts. While U.S. defendants may be tempted to have such cases moved to the most logical foreign country for trial, doing so may, in fact, be a bad tactical and strategic decision because of the often unpredictable results and the latitude that foreign judges may have. An alternative approach is illustrated in the case of Bain v. Honeywell.

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Chinese-Foreign Cooperation in Running Schools
by
Janet Yong, Lehman, Lee & Xu (Beijing)

In an effort to facilitate the development of the education industry in China and to standardize the operation of schools by domestic entities in cooperation with foreign parties, on March 1, 2003, the Chinese Premier Zhu Rongji signed Decree No. 372 of the State Council to publish the Regulations for Chinese-Foreign Cooperation in Running Schools (the “Regulation”). This Regulation was approved by the 68th Execute Meeting of the State Council and came into effect on September 1, 2003.
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REVIEW OF AUSTRALIA'S INTERNATIONAL TAXATION ARRANGEMENTS
by
Peter Carroll (Director of Corporate & Tax Practice)

The Federal Budget delivered on 13 May 2003 announced a number of proposals to amend Australia's international tax regime. The proposals will benefit non residents investing into or through Australia as well as providing benefits for Australian companies investing offshore.

The Government has not announced a commencement date for the proposed measures and it is not clear whether the measures will be passed by the Senate in order to become law. Insofar as non residents are concerned, the measures are proposed to amend conduit rules for companies; management funds and possibly capital gains tax in respect of Australian assets.

Also, the effective date of some of these measures is yet to be announced. In the case of some of the measures, the full details of the proposals have not been announced.
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SARBANES-OXLEY - ONE YEAR LATER: WHAT EVERY EMPLOYER SHOULD KNOW ABOUT THE LAW THAT REMAINS UNCLEAR

by

E. Fredrick Preis, Jr. & Monique R. Gougisha

The Sarbanes-Oxley Act of 2002 (“the Act”) was signed into law by President Bush on July 30, 2002. This Act was the direct result of the Enron, World Com, Arthur Anderson and Adelphia scandals and its purpose is aimed specifically toward preventing accounting and corporate governance abuses and management self-dealing. Among the many complicated provisions contained in this statute is a section which creates a cause of action protecting “whistleblower” employees. These “whistleblower” provisions are extremely broad and implicate not only publicly traded companies registered with the Securities and Exchange Commission, but also their officers, employers, contractors, subcontractors and agents. Hence, businesses that are not registered with the Commission may be brought in through the “back door”. Further, the statute may provide liability for individual executives and managers. As a result, employers must work to adequately train their managers and supervisors to be mindful of the law. Moreover, because this is a new law, employers must keep abreast of the latest developments and interpretations shaping this statute.
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2004
16th Annual Meeting
hosted jointly by
Fladgate Fielder & Memery Crystal, London, England
June 2 - 6, 2004