As discussed in our previous Alert, the French government has imposed Sunshine-like obligations on the pharmaceutical industry. Article 2 of Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products ("loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé" or "Loi Bertrand") inserted Articles L. 1453-1 in the French Code of Public Health ("Code de la santé publique" or "CSP"). Article L ...
In Louisiana Generating LLC v. Illinois Union Ins. Co., No. 12-30651 (5th Cir. May 15, 2013), the United States Court of Appeals for the Fifth Circuit held that a lawsuit brought by the Environmental Protection Agency ("EPA") alleging violations of the Clean Air Act ("CAA") obligated an insurer to defend its insured ...
On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that are subject to current good manufacturing practice (cGMP) requirements ...
Another natural disaster has devastated a community. By now, all are aware of the tragedy the tornado inflicted on residents of Moore, Oklahoma, destroying lives and property. We join in offering our condolences to those affected by the storm. Although there is no way to replace lost lives, as with other catastrophes, there are likely to be a myriad of financial issues that will need to be addressed to rebuild and replace property. Maximizing insurance recoveries is one component ...
Every year, tornadoes in the United States cause dozens of fatalities and inflict billions of dollars in property damage. The EF5 tornado that struck Moore, Oklahoma on May 20 was the most powerful and destructive storm yet of the 2013 season. Although the Moore tornado is only one of 343 tornadoes already reported nationwide through May 23, more than 1300 occur annually in the United States, based on a three-year average ...
After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
Last week, a federal jury in South Carolina found that Tuomey Healthcare System, Inc. violated the Stark Law and the False Claims Act by submitting false claims for reimbursement to the United States, resulting in $39 million in damages to the government. United States ex rel. Drakeford v. Tuomey Healthcare Sys., Inc., No. 3:05-2858-MBS (D.S.C. May 8, 2013) ...
In a recent decision by the Court of Appeal of Québec, the Honourable Jacques Chamberland, J.C.A. reviewed the application of exclusion clauses contained in a home insurance policy in the context of criminal activities1. THE FACTSThe Appellant, Union canadienne compagnie d’assurance insured the building of respondent, Mrs. Lise Houle and her spouse, Christian Alexandre. The latter was growing cannabis in the insured building ...
Battered women who fear for their safety, mothers unable to support their children, dysfunctional families in need. A reality for many women is the presence of domestic violence in their lives. This situation, although occurring in all social and economic levels, is much more obvious and has more serious consequences in low-income communities ...
In recent months, high profile M&A warranty claims1 and falling premiums have dramatically increased the utilization of "representations and warranty insurance" (RWI), also known as "warranty and indemnity insurance," in mergers, acquisitions and related transactions. By one account, demand for transactional risk insurance policy limits in North America grew by eighty-six percent (86%) in 2012 ...
The Office of the Civil Registrar General of the National Statistics Office promulgated Administrative Order No. 1 series of 2012 (AO 1) on October 24, 2012. The AO implements the provisions of Republic Act 10172, the amendatory law to Republic Act 9048, and supplements Administrative Order 1 series of 2001, which, in turn, implements RA 9048. Both statutes provide a means of correcting erroneous entries in the civil registry without need of judicial action ...
1 The regulator The Insurance Commission is the insurance regulator. It is a government agency under the Department of Finance. The Commission supervises and regulates the operations of insurance and reinsurance corporations, which need to be authorised ...
On April 17, 2013, the Health and Human Services Office of Inspector General (OIG) released an Updated Provider Self-Disclosure Protocol (SDP), which replaces the original SDP published in 1998. The SDP is used by providers and suppliers to voluntarily disclose violations of the fraud and abuse laws. According to the OIG, it has received more than 800 disclosures since the SDP’s inception, resulting in more than $280 million in recoveries ...
The decision of the Indian Supreme Court to deny Novartis’s application for patent protection for an improved version of its patented Glivec drug – the culmination of a seven-year battle - has certainly made the headlines. There are a number of reasons for this. First, Glivec is a well-known drug – described by some as a ‘wonder drug’ – that’s used to combat cancer, including leukaemia and gastro-intestinal cancer ...
Traditional knowledge (TK), for example folklore, is a controversial issue and we’ve written about it before. The government feels that TK should be legally protected, and that this should be achieved through amendments to the intellectual property (IP) statutes. The IP community has no issue with TK being protected, but it’s not very comfortable with this being done through IP legislation ...
The New Amparo Law-On April 2, 2013, the Amparo Law, Regulatory of Articles 103 and 107 of the Constitution of the United Mexican Estates, was published in the Official Gazette of the Federation. This new law broadens the constitutional defense of rights, since more individuals can have access to the amparo actions ...
The decision of the Court of Appeal in the La Capitale Case has been expected since February 2012 when the Superior Court dismissed the Class Action taken against an insurer who, with the consent of the policyholder, had unilaterally modified the waiver of premiums clause in a group insurance contract2. To better understand the context, please refer to our NEWSLETTER IN JUNE 2012 following the Superior Court judgment ...
On March 22, 2013, the Department of Homeland Security ("DHS") announced that it will submit to the Office of Management and Budget ("OMB") a new Information Collection Request ("ICR") related to the implementation of the Chemical Facility Anti-Terrorism Standards ("CFATS") Personnel Surety Program ("PSP"). DHS is soliciting comments during a 60-day public comment period (which ends May 21, 2013) prior to the submission of the ICR to OMB ...
In 2008 the government introduced important intellectual property (IP) legislation. The Intellectual Property Rights from Publicly Financed Research and Development Act 51 of 2008 - which only came into force on 2 August 2010 – governs the ownership and exploitation of IP which flows from publicly financed research and development (R&D) ...
On March 1, 2013, the Court of Appeal rendered a judgment on the insurer's duty to defend and indemnify the insured in the area of commercial general liability insurance.1 It confirmed the decision of the trial judge which had held that the insurer has the duty to defend and indemnify,2 and ordered it to reimburse its insured for the amounts paid to settle the claim of a third party and the amounts incurred by the insured in defending itself against the action ...
In 2008 the government introduced important intellectual property (IP) legislation. The Intellectual Property Rights from Publicly Financed Research and DevelopmentAct 51 of 2008 - which only came into force on 2 August 2010– governs the ownership and exploitation of IP which flows from publicly financed research and development (R&D) ...
