The Migration Advisory Committee (MAC) has today published its report1 on immigration reform. As the MAC itself acknowledges, there will be “winners” and “losers” in any policy for immigration reform.On an initial reading of the report, it would appear the reforms proposed, while impacting all sectors, would be most challenging for those sectors employing a low-skilled workforce ...
After almost 13 months of negotiations, on August 27, 2018 the United States and Mexico reached a preliminary commercial understanding, which they have termed an “agreement in principle,” to modernize the North American Free Trade Agreement (“NAFTA”). Canada has not yet joined in the agreement, and the question of Canada’s ultimate participation will affect the substance of the deal, its posture under the U.S ...
The Occupational Safety and Health Administration (“OSHA”) issued a final rule to “Improve Tracking of Workplace Injuries and Illnesses, “ which requires employers to electronically submit their injury and illness records to OSHA. Specifically, establishments with 250 or more employees must annually submit their Forms 300, 300A, and 301. And, establishments with 20 to 249 employees must annually submit their Form 300A ...
With the ever-changing developments regarding trade policy, we wanted to take this opportunity to provide some clarity regarding the Administration's actions under Section 301 of the Trade Act of 1974, regarding products imported from China. Tariffs on Chinese Imports Section 301 of the Trade Act allows the President to take action against a foreign government that violates an international trade agreement or restricts U.S. commerce - in this case, China ...
The Israeli Securities Law was amended (Amendment No. 63) with a goal of turning the Tel-Aviv Stock Exchange (TASE) into a more competitive, efficient and profitable stock exchange, by outlining an ownership structure change of the TASE. The ownership structure change allows private investors, in addition to institutional investors, to acquire means of control over the TASE ...
DJIBOUTI: International Free Trade Zone launchedThe first phase of the Djibouti International Free Trade Zone (“DIFTZ”), expected to be the largest free trade zone in Africa, was launched on 5 July 2018. The DIFTZ will house a variety of manufacturing plants and offer investors various incentives, including tax exemptions ...
Earlier this year, the Ministry of Energy and Mineral resources ("MEMR") issued Press Release No. 00022/04/SJI/2018 to continue arranging dozens of overlapping regulations and permits ("Simplification"). So far, 90 regulations and 96 certifications/recommendation/permits ("Regulations") have started since 22 January 2018 ...
"The global healthcare deal frenzy is set to continue for at least another 18 months as technology giants including Amazon, strategic players and private equity firms step up their fight for limited assets ...
In order to implement Government Regulation No. 24 of 2018 which introduced an online system for processing and issuing certain business licenses (known as the Online Single Submission “OSS” system), earlier this year, the Investment Coordinating Board (“BKPM”) issued 2 new regulations on investment, ie BKPM Regulation No. 6 of 2018 on the Guidelines and Procedure for Capital Investment Licensing and Facilities (“Regulation 6/2018”) and Regulation No ...
The skilled nursing sector has seen a significant number of facility divestitures and closures in the last few years. Quite frankly, this negative trend is due in part to a reluctance by some operators to implement clinical-based care standards and a lack of honest self-evaluation to improve the clinical care provided at skilled nursing facilities. Outdated operating models – solely meeting the basic needs of patients – does not bode well for SNF operators to survive ...
The Israeli Parliament (the Knesset) recently approved (on July 18, 2018), an amendment to the Israeli Restrictive Trade Practices Law, 5748-1988 (the “Law“) regarding parallel importing (the Restrictive Trade Practices Law (Amendment 20 – Temporary Order), 5778-2018) (the “Amendment“) ...
The Danish government has now published its life science growth plan, which aims at making Denmark a leading life science nation in Europe. The growth plan is based on the recommendations submitted by the Growth Team for Life Science. Plesner has previously reported on the topic.1 The growth plan contains 36 initiatives in 6 key areas. One of the many initiatives is a pilot scheme for risk sharing in the drug reimbursement system ...
Resolution number 217/2018 was published in the Brazilian PTO’s Official Bulletin number 2470, and amends Resolution number 80/2013, which refers to the fast-track examination for patent applications related to products, pharmaceutical processes, equipment and materials related to public health, aiming to accelerate patent applications considered strategic to the Brazilian Public Healthcare System ...
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. Three Key Opportunities Demographic Trend According to the Australian Institute of Health and Welfare, healthcare expenditure in Australia is growing faster than population growth and GDP growth ...
The fast-changing landscape of competition law in AfricaAt the turn of the century, only a handful of Africa’s 54 nation states had operational competition legislation and enforcement. However, in line with developments in the rest of the world, many African countries have since enacted competition legislation and established working competition authorities ...
On July 11, 2018, then-U.S. Food and Drug Administration Commissioner Scott Gottlieb made a public statement about the agency’s efforts to advance the development of gene therapies.[1] Gottlieb pointed out that the FDA has approved three separate gene therapy products and the agency has issued six scientific guidance documents intended to serve as building blocks of a modern, comprehensive framework for how the FDA can advance the field of gene therapy ...
The Affordable Care Act ("ACA") is alive and well, despite renewed legal challenges and the elimination of the “individual mandate” beginning next year. While the Tax Cuts and Jobs Act reduced the tax penalty for individuals who don’t have health coverage to $0, effective for 2019, employers continue to be subject to penalties for failing to comply with certain ACA rules ...
In recent months a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1that do not have a sanitary registration to be imported into Chile. The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164” ...
On June 28, 2018, Attorney General Jeff Sessions and Department of Health and Human Services (HHS) Secretary Alex M. Azar III announced the ninth year of the national health care fraud takedown. The takedown resulted in the largest government action against health care fraud, which involved more than 600 defendants from over 50 federal districts. The targeted fraud schemes accounted for more than $2 billion in false billings ...
Artificial intelligence technologies are extremely promising in healthcare.1 By examining, cross-referencing and comparing a phenomenal amount of data.2 AI lets researchers work more quickly at a lower cost3 and facilitates doctors’ decision-making with regard to diagnosis, treatment and choice of prescription. The integration of AI into the healthcare field can take various forms:4 Management of electronic medical records (e.g ...
This week, the U.S. Department of Labor (DOL) issued final rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer group or association to provide health coverage for their employees ...
On June 5, I wrote about the suspension of the California End of Life Option Act (“EOLOA”) in the wake of Ahn v. Hestrin and several related court proceedings in May. On Friday, June 15, the Fourth District Court of Appeal determined that the EOLOA will in fact remain enforceable pending further proceedings. Thus, eligible Californians who have requested end-of-life drugs in accordance with the EOLOA may continue with the process described in that law ...
The hits keep coming to plaintiffs’ attorneys seeking to invalidate nursing home arbitration agreements. Last year, the plaintiffs’ bar could smell victory when the Centers for Medicare & Medicaid Services (CMS) announced its new rule banning arbitration clauses in nursing home admission contracts ...
The business world continues to be a multinational place, with marketplaces and supply chains that cut across national borders. Global expansion efforts have also spawned a growing desire for cross-border deal making. These mergers and acquisitions, however, are easily complicated by language and cultural differences, in addition to local politics and regulatory regimes ...
