This post was written by Daniel Kadar. As a champion for the protection of personally identifiable information and with broad definitions for the concepts of personal and medical data, France has established a very specific set of policies requiring that all bodies hosting medical data must apply for official accreditation or work with an accredited … Continue Reading
Reed Smith’s Global Regulatory Enforcement Law blog features a post on the recent publication of the application decree to the “French Sunshine Act” by the French Ministry of Health. “A Brave New World? The ‘French Sunshine Act’ imposes online disclosure of contracts with HCPs, as well as of payments of ‘advantages’ to HCPs, dating back … Continue Reading
This post was written by Katherine Yang, Amy Yin, Vicki Lung, Gordon B. Schatz, Jay J. Yan, John J. Tan, Mao Rong and May Wong. Reed Smith’s China Life Sciences and Health Industry Client Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health … Continue Reading
This post was written by Katherine Yang, Amy Yin, Vicki Lung, Gordon B. Schatz, Jay J. Yan, John J. Tan, Mao Rong and May Wong. Reed Smith’s China Life Sciences and Health Industry Client Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health … Continue Reading
Reed Smith's Global Regulatory Enforcement blog features a post on a December 2012 French Supreme Court ruling in a case involving a French Director in a health care company who had been dismissed on the grounds of a clear breach of health care compliance obligations as set forth in the French Public Health Code. The outcome: even though a company is acting in a highly regulated environment such as health care, compliance breaches must be integrated in the employer-employee relationship if they are to justify termination in France. As Reed Smith Partner Daniel Kadar notes, this case serves as a reminder to any international health care organization that the worldwide adoption of compliance guidelines and of a Code of Conduct is not in itself a sufficient protection against compliance breaches - everything depends on how these tools are implemented locally.… Continue Reading
This post was written by Jay J. Yan, John J. Tan, Mao Rong, Katherine Yang, Amy Yin, Vicki Lung, May Wong and Gordon B. Schatz. Reed Smith’s China Life Sciences and Health Industry Client Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health … Continue Reading
On December 17, 2012, Trial Regulations on Centralized Procurement of High-Value Consumable Medical Supplies were issued by China's Ministry of Health (MOH) and five other government agencies. Immediately taking effect upon issuance, these regulations implemented procedures for the centralized purchasing of medical devices ranging from cardiac catheters to dental fillings to intracranial implants. These regulations represent the latest step in China's continuing efforts to improve the process of how medical products are bid for and purchased.… Continue Reading
This post was written by Jay J. Yan, John J. Tan, Mao Rong, Katherine Yang, May Wong, Amy Yin, Vicki Lung and Gordon B. Schatz. Reed Smith’s China Life Sciences and Health Industry Client Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health … Continue Reading
This post was written by Jay J. Yan, John J. Tan, Mao Rong, Katherine Yang, May Wong, Vicki Lung and Gordon B. Schatz. Reed Smith’s China Life Sciences and Health Industry Client Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries. … Continue Reading
This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Mao Rong, Katherine Yang, May Wong, Amy Yin and Gordon B. Schatz. Reed Smith’s China Life Sciences and Health Industry Client Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life … Continue Reading
This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Mao Rong, Katherine Yang, May Wong, Amy Yin and Gordon B. Schatz. Reed Smith’s China Life Sciences and Health Industry Client Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ … Continue Reading
This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Mao Rong, Katherine Yang, May Wong, Amy Yin and Gordon B. Schatz. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health … Continue Reading
This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Katherine Yang, May Wong and Gordon B. Schatz. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries Some important … Continue Reading
InsideCounsel recently published, "E-discovery: The need for a transnational approach to cross-border discovery disputes," an article on international discovery issues and the benefit of a respectful approach to document productions outside of the U.S. Written by Reed Smith Records & E-Discovery Group members David R. Cohen, Regis W. Stafford, Jr. and Caitlin R. Gifford, the piece notes that proposed EU Data Protection Directive regulations have the potential to subject multinational companies to sanctions of up to two percent of annual worldwide revenue for serious breaches, including unlawful data transfers to the U.S. In addition, although not binding on U.S. courts, the ABA recently issued a resolution and recommendation that states in part that U.S. courts should "consider and respect the data protection and privacy laws of any foreign sovereign..." This article underscores the importance of a comprehensive global approach to document production in cross-border litigation.… Continue Reading
Recent posts on www.lifescienceslegalupdate.com include:
"Supreme Court Rules That Juries - Not Judges - Must Determine Facts Supporting Large Criminal Fines"
The Reed Smith Global Regulatory Enforcement Law blog has an interesting post about a recent U.S. Supreme Court ruling that protects the Sixth Amendment rights of defendants in high-stakes criminal cases. In Southern Union Co. v. United States, the Court ruled that any fact supporting a "substantial" criminal fine must be found by a jury applying the "beyond a reasonable doubt" standard. In this post, Efrem M. Grail and Kyle R. Bahr explain the opinion and discuss the wide impact it will have on criminal actions, from investigation to sentencing.
View the entire entry:
https://www.lifescienceslegalupdate.com/2012/07/articles/health-care/supreme-court-rules-that-juries-not-judges-must-determine-facts-supporting-large-criminal-fines/
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"Life Sciences Health Industry China Briefing - June 2012 (July 20, 2012)"
Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.… Continue Reading
On July 10, 2012, OFAC announced that Great Western Malting Co. ("Great Western"), a U.S. company, agreed to pay $1.35 million to settle apparent violations of the Cuban Assets Control Regulations. Great Western produces malt for the brewing, distilling and food markets. OFAC's settlement announcement indicates that Great Western's U.S.-based personnel provided back-office support for a foreign affiliate's sales of foreign-origin barley malt to Cuba. This case is noteworthy because the liability appears to be based solely on Great Western's facilitation of its foreign affiliates' sales of foreign products.
This enforcement action is a warning to companies operating globally with business in the United States and in U.S.-sanctioned countries -- particularly U.S.-based companies whose foreign affiliates and subsidiaries conduct business in Cuba, Iran, Sudan, or Syria. Companies should consider whether they have sufficient internal controls in place to prevent inadvertent back-office support or other forms of facilitation of their related companies' sales in sanctioned countries.… Continue Reading
This post was written by John Tan, Jay J. Yan, Mao Rong, Katherine Yang, and Gordon B. Schatz. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries. Some important developments during May include: Introduction … Continue Reading
Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.… Continue Reading
Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries. Some developments during March include: American Medical Device Maker Accused of Bribery to Doctors in China and other Countries Qiagen Inks HPV Screening Deal with … Continue Reading
This post was written by Jay J. Yan, Mao Rong, Zack Dong, Katherine Yang, Joyce Sun, Sara Lai and Gordon B. Schatz. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries. Some important developments … Continue Reading
Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.
Some important developments during January include:
- Outline of China's Nursing Development Plan from 2011 to 2015
- Promulgation of Eight Recommended Medical Product Industry Standards
- Strengthening Implementation of 2010 GMP Amendment
- Circulation of the 12th Five-Year Plan for Medical Device Technology Industry… Continue Reading
Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.… Continue Reading
Health care and cosmetic companies operating in France are subject to new transparency requirements, comparable to the U.S. "Sunshine Act," that were adopted in December 2011.… Continue Reading
This post was written by Jay Yan, Mao Rong, Zack Dong, Zhao Hong, Gordon Schatz, Dr. David Kan and Katherine Yang. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries. Some important developments during … Continue Reading
