Tag Archives: Regulations

New California ballot initiative would expand protections over health data

Californians may have a new privacy initiative on their November 2020 ballot after the California Privacy Rights and Enforcement Act of 2020 (CPREA) was proposed last week. If enacted, this new law would revise and expand upon the California Consumer Privacy Act (CCPA) – which goes into effect in January – by, among other features, creating heightened standards around the use … Continue Reading

Planes, Trains and Over-the-Counter Pills

This post was written by John Wilkinson, Nicola Maguire and Adam Lewington. In November 2013, the Human Medicines (Amendment) (No.2) Regulations 2013 (the “Amendment”) came into effect, amending the Human Medicines Regulations 2012, which set out a “comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and … Continue Reading

Lessons for Life Sciences Companies With Global Operations that include Countries Sanctioned by the U.S.

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
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