The Australian life sciences and biotech sector is likely to continue its resurgence over the next twelve months, with global trends driving strong M&A activity in life sciences and biotech M&A. We have identified 6 key themes for activity in this sector. Opportunities and Challenges – 6 Key Themes Three Key Opportunities 1 ...
The Federal Environmental Agency (“IBAMA”) published Ordinance No. 01/2017, which provides for the improvement and unification of the procedures of suspension and/or blocking of the access to the Forest Origin Document (“FOD”) module. FOD is an instrument of the National Control System of the Origin of Forest Products (“SINAFLOR”) for the control of transportation and storage of forest products. In this sense, Ordinance No ...
In recent months, the Senate passed the Act to prohibit and prevent genetic discrimination (Genetic Non-Discrimination Act). This Act also amended the Canada Labour Code and the Canadian Human Rights Act. The new Act aims to regulate the use of genetic tests, namely, tests that analyze the DNA1, RNA2 or chromosomes of a person for predictive or monitoring purposes or for establishing a diagnosis or prognosis, mainly within a contractual framework ...
On June 27, 2017, the US EPA and the Army Corps of Engineers took the first of two steps to narrow the Clean Water Act’s scope. The agencies proposed a rule rescinding the Obama Administration’s 2015 Clean Water Rule defining “waters of the United States” (“WOTUS”) and replacing it with its prior definition ...
In recent months, in a unanimous decision authored by Justice Thomas, the Supreme Court issued its much-awaited decision in Sandoz Inc. v. Amgen Inc. et al., No 15-1039, considering two critical questions in the biosimilar approval mechanisms adopted in the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...
Long-term care (LTC) facilities received a boost last week when the Centers for Medicare and Medicaid Services (CMS) reversed its position regarding the use of arbitration agreements in this setting. On June 8, 2017, CMS published a proposed rule amending LTC facilities’ conditions of participation in the Medicare and Medicaid programs to remove prohibitions on binding pre-dispute arbitration agreements ...
“It is a treasured value in humanity … that no parent would want her child to grow up thinking that she (the child was) a mistake." - Justice Choo Han Teck In 2010, a Chinese woman, trying to conceive a child with her Caucasian husband, underwent an in vitro fertilisation (“IVF”) procedure at a clinic. Like the previous time she bore a child through IVF at that clinic in 2006, no third party’s gametes were meant to be used ...
On Wednesday, April 26, 2017, the Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. et al., a landmark case that many hope will provide clarity and guidance for consumers and the pharmaceutical industry on the regulatory approval pathway for biosimilar drugs under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...
The Philippine Court of Appeals (CA) denied the petition by NGO Ang Aroroy ay Alagaan, Inc. and certain individuals, for the issuance of a writ of kalikasan against Filminera Resources Corporation, and its directors and officers. The petitioners have claimed that Filminera, which operates in the Philippine province of Masbate, had been causing environmental damage in the conduct of its mining operations in violation of local law, and that a writ of kalikasan should be issued ...
The Danish Government's Growth Team has just Presented its Recommendations for how to Strengthen Denmark's International Position within Life Science. This happened at a Press Conference with the Participation of the Chair of the Growth Team, Kåre Schultz and the Minister for Industry, Business and Financial Affairs, Brian Mikkelsen ...
Today, we are at a time where two-generation professionals are actively developing and competing with each other within their own career. The well-known "millenials" or generation "Y", born according to some analysts between the years 1981 to 1999, and where the majors of this generation are already in the 36 years of life, and those of the generation X ...
On March 23, 2017, the California Air Resources Board (CARB) approved new regulations on greenhouse gas emissions from oil and natural gas production and storage facilities. The regulations, which focus on methane emissions, represent the most aggressive effort by any U.S. jurisdiction to regulate greenhouse gas emissions from oil and natural gas production ...
A federal court in the District of Columbia has ordered the U.S. EPA to complete its review of air toxics emission standards for 13 source categories by June 30, 2020. Under the 1990 Clean Air Act Amendments, EPA must set maximum achievable control technology ("MACT") standards for stationary sources of hazardous air pollutants. The agency must review and, if necessary, revise those standards every eight years. 42 U.S.C. §§ 7412(d)(6), 7412(f)(2) ...
Upon reconsideration in Gerard v. Orange Coast Memorial Medical Center, Case No. G048039 (March 21, 2017) (Gerard II), the Fourth Appellate District decided that IWC Wage Order 5 is valid and that healthcare employees may waive one of their two required meal periods on shifts longer than 8 hours ...
The courts’ widening of liability for polluted land and groundwater continues. From two new rulings it can be understood that taking responsibility in agreements can be held against the company that has chosen to be responsible. The fact that a person who pursues an activity or takes a measure (an “operator”) which results in pollution is also liable for the pollution is made clear in chapter 10 of Sweden’s Environmental Code ...
The California State Water Resources Control Board issued a notice today that all water users diverting water in California under Water Rights Permits, Licenses, Stockpond Certificates and Registration for Livestock Stockpond, Small Domestic or Small Irrigation uses must submit their annual water use reporting for the 2016 calendar year by April 1, 2017. All such reports must be filed online via the Report Management System (RMS) located at https://rms.waterboards.ca.gov/ ...
Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices. During its last two terms, the United States Supreme Court has issued three separate opinions addressing federal preemption of state law claims under the Federal Food, Drug, and Cosmetic Act ...
The Patient Protection and Affordable Care Act ("ACA") has significantly changed the healthcare industry in the United States. Among the many changes is the new requirement that healthcare providers must provide all "Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education counseling for all women with reproductive capacity."77 Fed. Reg. 8725 (Feb. 15, 2012); see 42 U.S.C. 300gg-13(a)(4), 45 C.F.R. § 147.130(a)(1)(iv) ...
On August 1, 2016, the legislative rule promulgated to implement the Aboveground Storage Tank Act became effective. The Rule is 63 pages long and contains detailed requirements for registering, designing, installing, operating, maintaining and closing tanks subject to the AST Act. The following is a handy reference list of the more significant compliance deadlines established in the Rule ...
In the latest development relating to West Virginia’s new aboveground storage tank (“AST”) legislation, yesterday afternoon the West Virginia Department of Environmental Protection (“WVDEP”) filed with the West Virginia Secretary of State its finalized Interpretive Rule outlining mechanisms for compliance with the imminent deadlines under the Aboveground Storage Tank Act (the “AST Act”), W. Va. Code §§ 22-30-1 et seq ...
The U.S. General Services Administration recently added Green Globes as an additional third-party green building certification system for federal government construction projects. With this addition, many are now asking about the difference between Green Globes and LEED. Green Globes has emerged, in some parts of the U.S., as a rival building option to the more well-known Leadership in Energy and Environmental Design (“LEED”) system ...
The Treasury Department has announced further extensions for medium-sized and large-sized employers for compliance with the “employer mandate” of the Affordable Care Act (“ACA”). The employer mandate requires employers with a threshold level of employees to provide affordable health insurance to 95% of their full-time employees. Under the ACA, a full-time employee is defined as any employee who works on average 30 or more hours per week ...
With the spotlight recently cast upon it by the burgeoning Marcellus and other shale reserve developments, the oil and gas (“O&G”) industry has found itself increasingly the object of regulatory scrutiny. While the majority of commentary and new regulation has focused on the O&G industry’s fracking activities, the heightened regulatory attention has led to new levels of exposure in areas which the industry has traditionally not had extensive entanglement ...
