On July 1, 2009, pharmaceutical and medical device manufacturers of FDA-approved drugs or medical devices doing business in Massachusetts or doing business with health care practitioners (“HCPs”) licensed in Massachusetts (regardless of where benefits are provided or expenditures are made) (“Companies”) must be in compliance with the Massachusetts Code of Conduct Law. This requirement is contained in regulations issued by the Massachusetts Department of Public Health (the “DPH”) on March 11, 2009 (the “Regulations”).
Read More Deadline Approaches for Compliance with Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulations
UK: Interpreting the Drop Down Clause in a Master Policy
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The Florida Office of Insurance Regulation Enters Cooperation Agreement with Germany’s Financial Regulator
The Follow-on Biologics Debate and the June 2009 FTC Report on Follow-on Biologic Drug Competition
On June 10, 2009, the Federal Trade Commission released a detailed report entitled: “Emerging Health Care Issues: Follow-on Biologic Drug Competition.” The FTC Report is important because it provides the most current government-sector analysis of the U.S. biologics market and the FTC’s recommendations for legislation designed to allow for “follow-on” versions of such drug products. …
Read More The Follow-on Biologics Debate and the June 2009 FTC Report on Follow-on Biologic Drug Competition
The Potential Impact of the Proposed Financial Regulatory Overhaul on the Insurance and Reinsurance Industry
As we previously reported here, President Obama has proposed a broad overhaul of the federal financial regulatory system. Click here to see the Treasury Department’s report on the proposal. The proposed reforms if adopted by Congress would have far-reaching impacts upon the U.S. financial system, including new regulation of hedge funds, over-the-counter derivatives, rating agencies and securitizations and enhanced regulation of banks, investment banks and bank holding companies. …
Read More The Potential Impact of the Proposed Financial Regulatory Overhaul on the Insurance and Reinsurance Industry
EU: European Commission Considers Reform to EC Regulation No 44/2001
The European Commission has published a report and a green paper on the application of EC Regulation No 44/2001 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (the Regulation). Copies of the report and the green paper can be found here and here. …
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Chile: A Mature Latin American Insurance Market Seeking to Modernize
By most measures, Chile is considered the third largest insurance market in Latin America. It is widely considered to have the most stable market and political environment in the region. These advantages, however, are significantly counterbalanced by the relatively high costs of doing business in the nation and the advanced development of the country’s insurance market, as reflected by the region’s highest insurance penetration rate (6%). …
Read More Chile: A Mature Latin American Insurance Market Seeking to Modernize
NY Federal Court: Availability of Consequential Damages Not Limited to Commercial Property Insurance
In Woodworth v. Erie Insurance Company, No. 05-CV-6344CJS (Jun. 12, 2009), the federal district court for the Western District of New York held that recovery of consequential damages under Bi-Economy Mkt., Inc. v. Harleysville Ins. Co. of NY, 10 N.Y. 3d 187 (2008), is not limited to commercial property insurance claims. …
Read More NY Federal Court: Availability of Consequential Damages Not Limited to Commercial Property Insurance
UK: Compensation for Pleural Plaques Restored in Scotland
As previously reported, the Scottish Parliament has acted to restore compensation for pleural plaques in Scotland. …
Read More UK: Compensation for Pleural Plaques Restored in Scotland