China's pharmaceutical industry is witnessing a notable surge in "pipeline spin-off projects", a model commonly referred to as the "Spin-off-NewCo" or "SON" model. Within the past two months, we've been advising on nearly ten SON projects. Leading pharmaceutical companies in China are more frequently adopting the SON model to separate parts of their pipelines into new, independent companies ...
August 14, 2024 By: Wendy Lee A little more than a year ago, on July 23, 2023, the Washington My Health My Data Act (WMHMDA) was passed into law. The law originally went into effect on March 31, 2024, however the compliance deadline for small businesses was June 30, 2024. This law was passed as a reaction to the Dobbs v. Jackson Supreme Court ruling and was designed to protect consumer health data ...
Simplified Stock Companies (SAS) have been implemented in El Salvador as a corporate solution aimed at micro-entrepreneurs and informal sector merchants who, due to entry barriers established in various regulatory bodies, were discouraged from forming a traditional corporate vehicle (e.g., Corporation, Limited Partnership, Limited Liability Company, among others) to conduct their business. In pursuit of the objective mentioned above, the reforms to the Commercial Code (C. Com ...
On August 1, 2024, the Department of Justice (“DOJ”) rolled out its Corporate Whistleblower Awards Pilot Program after announcing the initiative in March. Described as “[s]upercharging DOJ’s corporate investigations and prosecutions,”[1] the Pilot Program dramatically expands the pool of would-be whistleblowers and underscores the importance of robust compliance and reporting programs ...
Tax opportunities under the Indian Act Although it is not often well-understood in business and tax circles, the Indian Act (the ?Act?), coupled with federal and provincial tax laws, provides several tax planning opportunities for Indigenous taxpayers. These laws provide various tax exemptions for people who qualify as ?Indians? under the Act, as well as for ?bands? and other ?councils ...
Shipping and Bermuda’s Corporate Income Tax Act The initial taxing determination You have determined that you have a shipping entity within a “Bermuda Constituent Entity Group”, which itself is within an “In Scope MNE Group” for the purposes of the Tax Act. Furthermore, you have already made various adjustments to the taxable income in accordance with Part 6 of the Tax Act ...
Effective July 29, 2024, the Federal Trade Commission (“FTC”) has issued a final rule that expands the scope of its existing Health Breach Notification Rule (“HBNR”) to include health and wellness applications (“apps”) typically associated with wearable technologies such as smart watches ...
On July 1, 2024, the U.S. Department of Health and Human Services (HHS) released a final rule[1] outlining financial penalties, referred to as “disincentives” throughout the rule, for healthcare providers that engage in conduct that is considered “information blocking.” The 21st Century Cures Act defines information blocking as a “practice that interferes with, prevents, or materially discourages access, exchange, or use of electronic health information ...
On June 28, 2024, Exempt Resolution No. 1,160 of May 31, 2024 was published in the Official Gazette, which approved the “Technical Guideline of the Public Health Institute that establishes the requirements for the application for modifications to the sanitary registration of biological products (M-MOBI)” ...
The UAE recently amended its legal framework on abortion to expand the circumstances under which abortions are permitted and ease the rules regarding the circumstances under which abortions are permissible. Cabinet Decision No. 44/2024 (the Decision) came into effect on 21 June 2024 and progressively changed UAE’s law on abortion ...
Transfer Pricing rules are fundamentally based on the Arm’s Length Principle, articulated in art. 9 of the OECD Model Tax Convention. This principle is pivotal for bilateral and multilateral tax treaties to avoid double taxation, reiterated in point 1.6 of the OECD’s “Transfer Pricing Guidelines for Multinational Enterprises and Tax Administrations ...
The U.S. Department of Labor’s Occupational Safety and Health Administration (“OSHA”) recently cited Circles of Care, Inc., a Florida behavioral health company, for failing to provide a workplace free of recognized hazards. This citation followed an incident where a patient assaulted a mental health technician at a nurse work station ...
Recently, the Ohio General Assembly passed a bill, Substitute S.B. 40, which will enter Ohio as a party to the new Dentist and Dental Hygienist Compact, and ultimately allow dentists and hygienists practicing in other compact states to practice in Ohio. This summer, the compact will form its commission, and will continue to work on operationalizing into 2025 before officially opening privilege applications ...
The Supreme Court has overturned the Chevron Doctrine–a four decade-old ruling that enabled Federal agencies, including the Internal Revenue Service (“IRS”), to interpret ambiguous laws passed by Congress, and to have such interpretations enjoy a significant degree of deference ...
In a unanimous decision today, the Supreme Court rejected efforts to limit access to the abortion pill mifepristone, overturning an earlier decision by the 5th Circuit Court of Appeals. The Supreme Court ruled that the physicians and medical associations who brought the case did not have the right to challenge the FDA's regulation of the drug. To have standing, plaintiffs must show they have a “personal stake” in the case ...
For many years, nurses in Ohio were only required to disclose convictions to the Ohio Board of Nursing on their biennial license renewal application. However, a new regulation from the Ohio Board of Nursing now requires licensees to additionally report a guilty plea, conviction or treatment in lieu of conviction of certain crimes within 30 days of the plea or entry ...
In recent years, the regulatory framework for human genetic resources ("HGR") in China has become increasingly mature ...
Recently, modifications announced by the Department of Health and Human Services (“HHS”) to 42 C.F.R. Part 2 (“Part 2”) rules governing Confidentiality of Substance Use Disorder (“SUD”) Patient Records went into effect. This is a major rule change for Part 2 providers and the enhanced penalties and enforcement measures make compliance with the new rules essential for any Part 2 provider ...
With the first UAE corporate tax registration deadline looming (31 May 2024), companies and other businesses need to ensure that they have checked their deadline to register as a taxable person.The registration process under the Federal Law No. (47) 2022 (CT Law) is still new to the UAE and 2024 marks the first mandatory year for companies to register with the Federal Tax Authority (FTA) as a taxable person ...
The United States is on the verge of one of the biggest, if not the biggest, transformations to marijuana policy in the last 50 years. According to an Associated Press report, the Drug Enforcement Administration (DEA) is expected to reschedule marijuana from a Schedule I drug to a Schedule III drug under the Controlled Substances Act (CSA) ...
SyCipLaw's Tax Department has prepared an international edition of its Tax Issues and Practical Solutions (T.I.P.S.) for the first quarter of 2024. The SyCipLaw T.I.P.S - International Edition covers the following tax issues: 1. Are informal settlement agreements between the Commissioner of Internal Revenue and the taxpayer valid and binding? 2. While a tax case is pending in court, may the CIR and the taxpayer enter into a compromise agreement and request for judicial approval thereof? 3 ...
Between September 2021 and May 2022, the words 'stress', 'mental health' and 'depression' appeared in more than 12,000 early conciliation or employment tribunal cases , demonstrating the prevalence of this subject matter in employment-related disputes. Today, more than ever, employers are expected to afford greater consideration to workplace conditions that do or could impact upon employees’ mental health ...
China's National Medical Products Administration (NMPA) released the 2023 Drug Review Annual Report on its official website on February 4, 2024, closely followed by the 2023 Medical Device Registration Annual Report on February 5. According to the public information, more than 60 innovative drugs have been approved by NMPA from 2022 to 2023, and a total of 61 innovative medical devices have been approved in 2023 ...
On April 23, 2024, the Federal Trade Commission (“FTC”) voted to issue a final rule banning non-compete provisions in most industries in the United States (“Final Rule”). Dinsmore attorneys were quick to publish the details and impact of the Final Rule, which is available here. This supplement focuses on the impact of the Final Rule on the healthcare industry ...
