News & Analysis as of

Medical Supplies

Society of Corporate Compliance and Ethics...

Who gets treated? The ethics of a health crisis

ethikos 34, no. 5 (May 2020) - Doctors around the world are facing choices that no one wants to make. As healthcare facilities run out of beds, supplies, ventilators, and drugs, doctors must “triage”—a term coined during...more

Smart & Biggar

COVID-19 developments – federal government issues request for information for alternative suppliers for certain pharmaceuticals

Smart & Biggar on

The federal government has been proactive in seeking help from industry in tackling the pandemic. For example, Health Canada contacted Health Product Licence Holders to let them know specific areas where they may be able to...more

Proskauer Rose LLP

Price Gouging Weekly Round Up

Proskauer Rose LLP on

Price gouging enforcement and litigation is front and center for company counsel and business managers nationwide. Our weekly round-up highlights some of the most relevant news and information to our clients and friends....more

Robins Kaplan LLP

DOJ Signs Off On First COVID-Related Competitor Collaboration Not Involving Medical Supplies

Robins Kaplan LLP on

On May 15, 2020, the Antitrust Division of the Department of Justice announced its first approval of a COVID-19 competitor collaboration that does not involve equipment or medications directly related to fighting the...more

Pillsbury Winthrop Shaw Pittman LLP

The Regulation of Medical Waste During COVID-19

The rapid spread of the coronavirus has generated new interest in the regulation of medical waste. The COVID-19 crisis is generating a significant amount of regulated medical waste....more

McGuireWoods LLP

OIG Responds to Physician Group COVID-19 Personal Protective Equipment Arrangement Inquiry

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As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – May 2020 #9

Hogan Lovells on

In Washington: Speaker Nancy Pelosi (D-CA) and House Majority Leader Steny Hoyer (D-MD) released the details of their emergency remote proceedings.  The plan temporarily implements remote committee proceedings, remote...more

Hogan Lovells

Combating COVID-19: Government powers for safeguarding supply of critical products and potential conversion of production – Italy,...

Hogan Lovells on

The spread of COVID-19 is causing Europe to experience one of the greatest health crises in decades, the consequences of which are still unpredictable. Faced with this unprecedented situation, the governments of different...more

Hogan Lovells

Chinese regulators announce new requirements for exports of medical supplies and nonmedical masks

Hogan Lovells on

On 31 March 2020 the China Ministry of Commerce, the National Medical Products Administration (NMPA), and the General Administration of Customs (GAC) issued the Notice on the Orderly Exportation of Medical Supplies...more

Jones Day

How EU and UK Trademark Owners Can Prevent Unauthorised Price Gouging

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The Background: Manufacturers and brand owners of personal protective equipment ("PPE") and other "essential" items have discovered unauthorised third parties reselling their products at vastly inflated prices, including on...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Recommendations on COVID-19 Drug Development and Clinical Trials for Regulatory Approval

The U.S. Food and Drug Administration (FDA) recently issued two guidance documents outlining the agency's expectations for COVID-19 drug development. The first guidance, "COVID-19 Public Health Emergency: General...more

Faegre Drinker Biddle & Reath LLP

Do State Executive and Emergency Orders Offer Any Product Liability Protection Amidst the COVID-19 Outbreak?

As companies continue to produce, modify, and/or distribute essential medical equipment and supplies to support efforts to fight the COVID-19 outbreak, questions about whether these companies may be subject to liability...more

Society of Corporate Compliance and Ethics...

China export controls create medical supply logjam

Report on Supply Chain Compliance 3, no. 9 (April 30, 2020) - After Chinese medical supplies were criticized for low quality, including masks, tests and gloves sent to Europe, the Chinese government responded with new...more

Arent Fox

Reference Guide: Worldwide Export Controls on Face Masks and Other Medical Personal Protective Equipment (Updated May 11, 2020)

Arent Fox on

As the COVID-19 pandemic has expanded exponentially, so too has the demand by hospitals and other healthcare providers for masks and other medical personal protective equipment (PPE) to protect doctors, nurses, and other...more

Faegre Drinker Biddle & Reath LLP

FDA Releases Guidance Requiring Notification of Certain Medical Device Shortages Related to COVID-19 Testing and Treatment

Medical supply shortages have been in the limelight since COVID-19 barreled into the U.S. and many manufacturers have been doing all they can to answer the call for more supplies. In response to this issue and recently passed...more

Thompson Coburn LLP

From emergency medical products to chicken nuggets: What manufacturers and distributors need to know during COVID-19

Thompson Coburn LLP on

As the country and the world continue to adjust to the ever-changing “new normal” of COVID-19, the need for essential products, ranging from emergency medical products to critical food supplies, is at an all-time high. Over...more

Shook, Hardy & Bacon L.L.P.

COVID-19 Client Primer | UK Medical Device Product Liability

ANALYSIS - Product Liability Risks for Medical Devices in the UK - In order to fast-track the development, manufacture and supply of key medical equipment and devices vital in the fight against COVID-19, governments,...more

Health Care Compliance Association (HCCA)

DOJ cautions business community against violating antitrust laws in relation to public health products

Compliance Today (May 2020) - The U.S. Department of Justice announced in a March 9, 2020, news release, “its intention to hold accountable anyone who violates the antitrust laws of the United States in connection with the...more

Polsinelli

COVID-19 Challenges Medical Equipment Supply Chains

Polsinelli on

The COVID-19 pandemic is significantly disrupting international trade as global and domestic supply chains grapple with declining trade volumes and inadequate supplies of medical goods, including personal protective equipment...more

Seyfarth Shaw LLP

FDA Updates Emergency Use Authorization For Chinese Respirators

Seyfarth Shaw LLP on

Yesterday, the US Food and Drug Administration (FDA) revised its Emergency Use Authorization relating to disposable respirators made in China that are not approved by the US National Institute for Occupational Safety and...more

Hogan Lovells

Update on UK export licencing processes amidst the COVID-19 outbreak

Hogan Lovells on

Amidst the global COVID-19 pandemic many things are uncertain. For businesses, this is further compounded by the rapidly changing and temporary measures that governments are launching to limit the financial fallout of the...more

McNees Wallace & Nurick LLC

Price Gouging – It Could Cost You

The COVID-19 crisis has caused many state Attorney’s General, including the Pennsylvania Attorney General (“PA AG”), to encourage consumers to submit complaints and allegations of price gouging. Rest assured that all such...more

Hogan Lovells

The European Commission extends export restrictions on Personal Protective Equipment

Hogan Lovells on

The EU has extended the export restrictions on certain items of Personal Protective Equipment (PPE) for a further period of 30 days. On 24 April, the European Commission (Commission) extended the export controls on PPE...more

Pepper Hamilton LLP

Compulsory Ip Licenses For COVID-19 Relief: Beyond The Defense Protection Act

Pepper Hamilton LLP on

Stakeholders in intellectual property rights face enforcement and reputation challenges arising from the coronavirus emergency. Patents, trademarks and copyrights associated with pandemic countermeasures may be subject to...more

BakerHostetler

COVID-19 and the DPA: First Criminal Complaint Filed by the Justice Department in New York

BakerHostetler on

On Friday, April 24, 2020, the Justice Department announced the filing of a criminal complaint against a New York man, Amardeep “Bobby” Singh, for the hoarding and subsequent price gouging of personal protective equipment...more

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