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Practice Industry: Crossborder Trade & Investment, Healthcare & Pharmaceuticals, Life Sciences
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Arendt & Medernach | December 2018

In December of 2018, EU Court of Justice Advocate General Campos Sánchez-Bordona concluded that the United Kingdom may unilaterally withdraw its intention to leave the European Union before 29 March 2019 and therefore remain in the EU. This is so long as the revocation notice is made before the formal conclusion of a withdrawal agreement and it respects the UK’s constitutional requirements ...

Deacons | March 2020

The State Taxation Administration (STA) released several announcements in the beginning of February which established preferential tax policies for facilitating the prevention and control of the outbreak of the novel coronavirus (COVID-19) and supporting enterprises to resume their business operations. Certain preferential tax treatments are specifically offered to enterprises and individuals that are directly involved in the prevention and control of the outbreak of COVID-19 ...

ALTIUS/Tiberghien | November 2020

The legal status of CBD, a naturally occurring compound found in the cannabis plant, is murky. Certain Member States are more restrictive about it than others. The Court of Justice of the EU has very recently provided clarification in the context of a preliminary ruling (case C-663/18 of 19 November 2020). This case revolves around CBD’s ban in France, after it had been imported from the Czech Republic where it was lawfully produced ...

Han Kun Law Offices | June 2021

On June 10, 2021, the Standing Committee of the National People’s Congress adopted the Anti-Foreign Sanctions Law (the “Anti-Sanctions Law”) ...

Buchalter | December 2023

By: Daniel Silva, Sanjay Bhandari, and Manisha Malhotra The Paycheck Protection Program (“PPP”) emerged as a lifeline for small businesses grappling with the unprecedented challenges of the COVID-19 pandemic. Lenders navigated a landscape of regulations that Congress quickly drafted in response to the pandemic. These regulations and obligations evolved, subtly yet materially, from the first and second rounds of PPP “draws ...

Lavery Lawyers | October 2023

A patent landscape provides a bird?s-eye view of the patenting activity related to a specific technology. It can be an invaluable tool for your organization as the analysis of patent data reveals business, scientific and technological trends. Indeed, many industries increasingly rely on patent landscapes to provides a basis for understanding innovation activity in their field ...

Waller | October 2017

President Donald Trump announced that the federal government will halt payments known as cost share reduction (CSR) payments. The CSR payments amounted to approximately $7 billion this year, and served as a subsidy to enable lower-income Americans to afford health insurance coverage ...

Dinsmore & Shohl LLP | October 2021

Companies that have imports from China subject to List 3 and List 4a Section 301 tariffs may still have an opportunity to protect their right to seek a refund from the U.S. Government. To do so, a company would need to file a lawsuit in the Court of International Trade (CIT) challenging the List 3 and/or List 4a tariffs as unauthorized under the Trade Act of 1974 and implemented in violation of the Administrative Procedure Act ...

Dinsmore & Shohl LLP | July 2022

Within hours of the U.S. Supreme Court’s decision overturning Roe v. Wade, Ohio’s Heartbeat Bill, originally passed in 2019, became effective when the U.S. District Court, Southern District of Ohio, lifted its long pending injunction against the Ohio law ...

The last two years have seen an expansion of regulations related to Foreign Direct Investment (FDI), both in the United States and abroad. COVID-19 is driving further expansion of FDI in the U.S. and elsewhere. Owners and investors need to know — expansion of regulations gaps closed in national security reviews new inclusion of medical supplies and food non-controlling investments also scrutinized Whether by intent or coincidence, the U.S ...

Haynes and Boone, LLP | June 2003

On October 16, 2003, the Health Insurance Portability and Accountability Act (“HIPAA”) requires employer-sponsored group health plans and others to be in compliance with the Transaction and Code Sets (“TCS”) standards for electronic transactions adopted by the Department of Health and Human Services (“HHS”). The federal government has been warned of potential disruption in the claim submission and payment cycles because the health care industry remains substantially non-compliant ...

Dinsmore & Shohl LLP | April 2019

The U.S. Food and Drug Administration (FDA) recently announced new steps it is taking to determine a framework for lawful marketing of appropriate cannabis and cannabis-derived products.[i] As expressed in the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), the FDA has the authority to regulate products containing cannabis or cannabis-derived compounds ...

PLMJ | February 2021

Some facts and figures that set out the landscape of merger control, antitrust enforcement and competition litigation in Portugal in 2020. Interim Measures The PCA ordered the Portuguese Professional Football League to suspend its decision preventing teams in the First and Second Football Leagues from signing players that have unilaterally terminated their contracts due to the COVID-19 pandemic ...

Waller | April 2020

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) includes $100 billion for Medicare and Medicaid-enrolled suppliers/providers that provide diagnosis, testing or care for individuals with possible/actual cases of COVID-19 ...

Simonsen Vogt Wiig AS | December 2023

There was considerable anticipation regarding whether the negotiations would be successfully concluded during this meeting. Without an agreement, there was a risk of significant delays in the adoption of the framework. This was undesirable for EU institutions that have invested considerable prestige in leading the regulation of AI globally. Read more about the most contentious issues leading up to the last negotiation meeting in this article ...

Wardynski & Partners | October 2013

In the innovativeness of its economy, Poland ranks 4th from last in the European Union, but greater support is planned for highly innovative projects that show promise for implementation and commercialisation in Poland. At a session of the Polish Parliament’s Innovation and New Technology Committee on 19 June 2013, the Ministry of Regional Development presented the guidelines for operational programmes Smart Growth 2014–2020 and IT & Telecommunications 2014–2020 ...

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 ...

MinterEllison | October 2018

Information is critical to the conduct of health and medical research. Much of the time the information relates to individuals. Higher education institutions regularly collect, use, disclose and hold information, including health information, for research purposes ...

Waller | March 2020

As the COVID-19 outbreak spreads and officials recommend or impose increasingly restrictive steps to mitigate the impact to public health, more companies are assessing what impact the outbreak is likely to have on their business and are considering whether that impact may necessitate furloughing workers. Following is a summary of some of the core compliance issues employers should consider as they develop contingency plans that may include furloughs ...

Deacons | January 2007

In M&A transactions, the principal terms negotiated by the parties are usually the structure, price, representations, warranties and undertakings and indemnities. Whereas in most jurisdictions parties are at liberty to agree on these terms, in China the outcome of the negotiations between Chinese and foreign parties may not be as final as hoped for ...

Plesner | July 2018

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 ...

Dinsmore & Shohl LLP | April 2020

Physicians and medical professionals throughout the world are facing and attempting to treat one of the most serious and deadly viruses that has affected the world in our lifetime. Medical professionals are on the front lines and in a position, despite their best efforts to protect themselves, to contract the disease. Medical professionals do not only fear for their own lives but also for the lives of their family members if they unintentionally bring this disease home ...

Haynes and Boone, LLP | December 2013

Physician-owned distributorships (PODs) and other physician-owned entities (POEs) have emerged as a favored vehicle to reduce costs, but the popularity of PODs and POEs has led to increased scrutiny by federal regulators. In June 2011, the United States Senate called on the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) and Centers for Medicare & Medicaid Services to investigate the proliferation of PODs and corresponding utilization practices ...

Dykema | February 2008

CMS recently released new regulations intended to curb the ability of a physician to earn a profit on either the technical component (TC) or professional component (PC) of tests ordered by the physician, but performed by another party. The regulation is effective January 1, 2008 and applies to all Medicare-covered diagnostic tests including imaging and anatomic pathology, but excluding clinical laboratory tests ...

Waller | August 2020

As healthcare providers pursue transactions during and in the wake of COVID-19, both buyers and targets should prepare for heightened scrutiny during the due diligence process. Getting organized ahead of a sale can dramatically expedite timelines and reduce deal fatigue for all parties, particularly in light of the heavier-than-normal due diligence process as a result of the pandemic. Click here for a full PDF of this report ...

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