CRIMINAL Counterfeit VaccinesBy Andre Augusto Mendes Machado and Mariana Murad Leiva Counterfeiting vaccines may lead to criminal liability, usually for the crime foreseen in article 273 of the Brazilian Penal Code, that punishes with imprisonment from 10 to 15 years in addition to the payment of a fine the acts of "falsifying, corrupting, adulterating or modifying products intended for therapeutic or medicinal purposes" ...
Although the U.S. Department of Justice (DOJ) reported a slight decrease in settlements with life sciences companies in FY2019 (the most recent year for which data is available),[1] this likely will be a temporary trend. Several significant settlements and investigations in 2020 provide key insights into government enforcement priorities as we look toward 2021 ...
Denmark has a large life science sector, including a number of biotech and pharmaceutical companies and research activities. The sector is highly regulated and covered by extensive and complicated statutory requirements, executive orders and ethical standards. Denmark has incorporated most of the EU regulation and Danish law is thus to a large extent in conformity with the general EU regulation and practice of, for example, the European Medicines Agency (‘EMA’) ...
On September 8, 2021, Mr. Éric Girard, Minister of Finance, presented his Draft Regulation specifying the classes of liability insurance contracts that may derogate from public policy rules previously applicable to liability insurance (the? Draft Regulation ?), Namely those set out in articles 2500 and 2503 of the Civil Code of Quebec (? CCQ? ) concerning the insurer? s duty to defend and the exclusive application of insurance coverage to injured third parties ...
A recently unsealed decision from the United States District Court for the District of Maryland demonstrates that insurers cannot hide behind the attorney-client privilege and work-product doctrine to shield claim files from discovery. The court made clear that involving counsel in claim handling does not operate to make either doctrine automatically apply. Charter Oak Fire Ins. Co. v. Am. Capital Ltd., No. 8:09-cv-100 (D. Md. Nov. 6, 2013) ...
The U.S. District Court for the Middle District of Louisiana held that "actions of civil authority" that do not prohibit access to an insured’s premises do not trigger civil authority coverage under a first-party policy. Kean, Miller, Hawthorne, D’Armond, McCowan & Jarman, LLP v. National Fire Ins. Co. of Hartford, No. 06-770-C, 2007 U.S. Dist. LEXIS 64208 (M.D.La. Aug ...
One of the objectives of Product Oversight and Governance requirements is for manufacturers and distributors of an insurance or investment product to take into consideration the interests of customers when designing and /or distributing the relevant product ...
MamoTCV has contributed to the 10th Edition of The Insurance and Reinsurance Law Review. This edition was edited by Simon Cooper (Ince Gordon Dadds LLP) and provides an overview of the legal and regulatory regime for (re)insurance undertakings and intermediaries in 30 jurisdictions. The publication provides guidance on legal and market developments in each jurisdiction aiding comparative analysis ...
Maximising benefits: The importance of efficiently leveraging W&I Insurance to structure M&A deals Warranty and Indemnity (“W&I”) insurance is a risk management tool that transfers the liability of the seller to the insurer. W&I insurance typically covers the breach of warranties and indemnities provided by a seller/warrantor and the occurrence of events that were unknown or undisclosed to a buyer ...
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 ...
Fast-growing e-commerce has changed lifestyles and invented new ways of consumption, amid which demand has rapidly increased for Internet-based medical services such as online drug sales and online medical diagnosis. Since the regulation and promotion of "Internet-based healthcare services" was included as part of the Outline of the "Healthy China 2030" Plan, China's Internet healthcare industry has been flourishing, channeled by a series of favorable policy decisions ...
On March 17, 2020, the Trump administration announced an expansion of Medicare coverage for virtual health services. The Medicare expansion is intended to make medical offices more available to people who need to be seen in-person and to mitigate the spread of the novel Coronavirus. Medicare can now pay for office, hospital, and other visits furnished via virtual services across the country, including a patient’s place of residence, starting March 6, 2020 ...
Acquisition of intended exclusively for the production of parenteral bags INFARMED - the Portuguese National Authority for Medicines and Healthcare Products (“Infarmed”) has recently adopted Decision 089/CD/2022, concerning the regulatory framework for the acquisition of medicines without a national Marketing Authorisation (“AIM”), intended exclusively for the production of parenteral bags ...
On the 5th August 2022, the Malta Financial Services Authority (hereinafter referred to as “the MFSA”) issued a Circular on the amendments to: the Glossary of Terms, Chapter 5 of the Insurance Rules and the Insurance Business (Exemptions) Regulations ...
The MFSA issued a Circular on the 22nd of December 2022 in which it proposed amendments to the Companies Act (Cell Companies carrying on business of Insurance) Regulations, Subsidiary Legislation 386.10 (“the PCC Regulations”). The PCC Regulations provide for the creation and regulation of cell companies ...
On February 25, 2021, the Ministry of Health and Social Protection issued Resolution 223 of 2021 (the “Resolution”) to update the general biosecurity measures set for the management of Covid-19 in Colombia. The main novelties included in this regulation are mentioned below: 1. Scope The Resolution extended the scope of the general biosecurity measures to all "social and economic activities carried out by individuals" ...
Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017 ...
On May 7, 2020, the amendment to Decree No. 466 was published in the Official Gazette, which approves the Regulation of Pharmacies, Drugstores and other pharmaceutical establishments, regarding the sale of medicines through electronic means. Particularly, article 8 of said Decree is modified, in order to allow the electronic sale of medicines in pharmacies, incorporating the following sentence: "Pharmacies may dispense medicines through electronic means ...
On 13 June 2013, the Supreme Court of the United States handed down its unanimous decision in the ongoing case of Association for Molecular Pathology et al v Myriad Genetics, Inc. et al 12-398, 569 US __ (2013). This case is the first brought in the US directly challenging the patentability of human genes and for that reason is extremely important to any entity involved in the biotechnology industry which relies on human genetics research as part of innovation strategy ...
It seems every week, there is a new story about a company being impacted by a major data breach and the consequences that follow from such breach, including the inevitable lawsuits, public relations nightmare, and governmental investigations. These breach stories are then followed by articles about the high costs to deal with these breach events, including costs to notify consumers, to identify the source of the breach, to pay for credit monitoring, among many other costs ...
New technology is most often associated with telecommunications, IT or robotics. Food is seen as a group of products in which innovation is little important, because it is believed that consumers are mostly concerned with prices and quality, but not innovations. However, the dynamic growth in market share of functional foods calls for a critical review of myths that have arisen around R&D projects in the food sector ...
Natural products play an important role in pharmaceutical innovation. They are active components in many medicines. For example, nearly half of the small molecules used to treat cancer are natural products or directly derived from natural products.1 They are also components of vaccines. The pharmaceutical industry is constantly seeking access to natural products and the traditional knowledge associated with them ...
