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Q&A Regarding Procedures before the Chilean Public Health Institute and the Power to Set Prices for Certain Pharmaceutical Products, Medical Devices, Etc. is Established
Carey, March 2020

Q&A procedures before the Public Health Institute (ISP)   May I file for sanitary registrations? Requests for sanitary registrations for pharmaceutical products, cosmetics and others regulated, as well as for their modifications, may be filed for through the GICONA portal, and official tariffs shall be paid only through electronic transfer of funds...

Bills of Law on Sanitary Matters, filed in the context of the current situation
Carey, March 2020

In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13...

Drug Exports in a Time of Pandemic
Wardynski & Partners, March 2020

The Minister of Health is issuing successive anti-export lists covering an increasingly wide catalogue of products at risk of shortages. This is to ensure access to drugs and medical devices for patients in Poland, especially during the difficult time of the COVID-19 pandemic...

Consumer Law and SERNACs Supervisory Role Facing Covid-19 Pandemic
Carey, March 2020

  Covid-19 has had an impact on ongoing consumer contracts and their relations with suppliers. The rapid spread of the virus led the authorities to declare State of Disaster in the country, raising concern about the (i) fulfillment of consumer contracts of goods and services and (ii) an eventual price manipulation...

FDA Increase Supplies in Response to COVID-19
Haynes and Boone, LLP, March 2020

FDA Takes Action to Increase U.S. Supplies in Response to COVID-19. The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices. The FDA is engaging the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S...

FDA Warns Consumers About Unauthorized Fraudulent COVID19 Products
Haynes and Boone, LLP, March 2020

FDA Warns Consumers About Unauthorized Fraudulent COVID-19 Products.The FDA issued a Consumer Update advising consumers to be beware of fraudulent coronavirus tests, vaccines and treatments. The FDA has seen unauthorized fraudulent test kits for COVID-19 being sold online. Currently, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19...

FDA Revised Guidance on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
Haynes and Boone, LLP, March 2020

The FDA revised its guidance on postmarket adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing COVID-19 pandemic. The FDA acknowledges that companies, and the agency, itself, may be hit with workforce shortages during a pandemic at the same time that adverse event reporting for products deployed for the pandemic may increase...

HHS Extends PREP Act Immunity to COVID-19 Countermeasures
Haynes and Boone, LLP, March 2020

The U.S...

FDA Issues "Immediately in Effect" Guidance to Accelerate Availability of COVID-19 Diagnostic Tests
Haynes and Boone, LLP, March 2020

The FDA issued immediately-in-effectguidanceto accelerate the development of certain laboratory tests for the urgent need caused by SARS-CoV-2. The FDA provides recommendations, among others, for serological tests, puts forth a policy for states to take responsibility for tests, and announces enforcement discretion for commercial manufacturers using new commercially developed tests prior to the FDA granting an emergency use authorization, under certain circumstances...

FDA Issues Temporary Guidance on Food Supplier Verification Audit Requirement
Haynes and Boone, LLP, March 2020

To help prevent disruptions in the food supply-chain during the COVID-19 pandemic, the FDA issued a temporary policy for Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements. The policy states that the FDA will temporarily not enforce FSMA supplier verification onsite audit requirements if other appropriate supplier verification methods are used instead...

Health Law Vitals - COVID-19 Edition - March 2020
Haynes and Boone, LLP, March 2020

Regulators Expand Opportunities for Telehealth Services Under COVID-19 Shadow By: Phil Kim, Kayla Cristales, and Jennifer Kreick As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services...

Regulators Expand Opportunities for Telehealth Services Under COVID-19 Shadow
Haynes and Boone, LLP, March 2020

As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services.Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient’s health...

CMS Issues Guidance for Healthcare Providers Grappling with COVID-19
Haynes and Boone, LLP, March 2020

As COVID-19 continues to spread, CMS has issued guidance to various healthcare providers, including, among others, home health agencies, nursing homes, and hospitals that are caring for the nation’s most at-risk patient populations.The guidance is intended to curb transmission and ensure healthcare providers have the information and resources necessary to respond to patient needs...

COVID-19: FDA Clinical Trial Guidance
Verrill, March 2020

On March 18, 2020, the U.S. Food & Drug Administration (“FDA”) published guidance for clinical trial sponsors, investigators, and institutional review boards (“IRBs”) on conducting clinical trials in the midst of the COVID-19 pandemic. In the guidance, FDA outlines important considerations for assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity...

Impact of The Coronavirus (COVID-19) Pandemic on Proceedings Before the Trade Mark And Design Offices
Heuking Khn Ler Wojtek, March 2020

The currently unstoppable strong spread of COVID-19 and the resulting restrictions on public life, such as quarantine measures and curfews, which are imposed in EU Member States and worldwide and which are sometimes very drastic, are also increasingly impairing the ability to work and communicate. In the meantime, various IP Offices have also reacted to this. 1...

COVID-19 Expanded Access Template
Verrill, March 2020

We are aware that many companies and health care providers are working to expedite the transfer of investigational drugs that may be helpful in treating patients suffering from COVID-19. Although these expanded access arrangements are not required to be and are not always documented in written agreements, there can be benefits to both parties (company and treatment provider) to memorializing the circumstances of the provision of an investigational drug...

Can a Member State in Times of Corona Crisis Prohibit a Pharmaceutical Company to Deliver Certain Products (Such as Testing Kits Or Protective Medical Gear) to other EU Countries?
ALTIUS/Tiberghien, March 2020

  With the Corona crisis, countries such as Germany, France and the Czech Republic have already announced bans on exports of protective gear to avoid shortages at their countries. But is this in conformity with the principle of free movement of goods as provided for in articles 34-36 TFEU? This principle is one of the cornerstones of the European Union's internal market which implies that national barriers to the free movement of goods within the EU need to be removed...

Responsible Research During the COVID-19 Pandemic
Verrill, March 2020

The world has been thrown off its stride by the 2019 novel coronavirus SARS-CoV-2 and the resulting disease, “COVID-19.” At the time of this Alert, the full impact of SARS-CoV-2 and COVID-19 is still unknown...

Two Proposed Rules Aim to Increase Organ Donation in the U.S.
Verrill, February 2020

On December 17, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule to revise the Conditions for Coverage that Organ Procurement Organizations (“OPOs”) must satisfy in order for organ procurement costs to be paid by Medicare and Medicaid (the “OPO Proposed Rule”)...

More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries
Verrill, January 2020

The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to establish new exemptions particularly relevant to the health care and life sciences industries...

The Danish Regions Propose to Establish a Treatment Council
Plesner, December 2019

The Danish Regions have proposed a new model for establishing a so-called Treatment Council which is to assess whether the price of treatments and health technology measure up to the effect for the patients. The model will now go out for consultation.   The purpose and scope  In their proposal, the Danish Regions want to establish a Treatment Council which is to make recommendations regarding the use of medical devices and health technology...

Federal Circuit Clarifies Limits of Safe Harbor Defense in Amgen v. Hospira
Patterson Belknap Webb & Tyler LLP, December 2019

Recently, in Amgen Inc. v. Hospira, Inc.,[1] the Federal Circuit clarified the limits of the Safe Harbor defense in cases involving patented manufacturing methods. In a case brought in the District of Delaware, Amgen alleged that Hospira infringed several patent claims over methods of manufacturing erythropoietin (EPO), a biologic drug used to treat anemia...

New Kickback Law Targeting Opioid Treatment Facilities Could Affect Traditional Lab Arrangements
Dinsmore & Shohl LLP, January 2019

Eliminating Kickbacks in Recovery Act Overview On October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) as part of the SUPPORT Act, which is a comprehensive attempt to combat the opioid epidemic.  EKRA established an all-payer anti-kickback prohibition that extends to arrangements with recovery homes, clinical treatment facilities, and laboratories. Unlike the Anti-Kickback Statute (AKS) under 42 U.S...

Health Law Vitals - A Healthcare Newsletter from Haynes and Boone, December 2018
Haynes and Boone, LLP, December 2018

Should States Embrace Telehealth Parity? Parity in telehealth is the notion that health services provided via telehealth technology should be treated equally as health services provided face-to-face. This is consistent with coverage parity, which requires payors to provide the same level of insurance coverage for patient encounters and services, while payment parity (a.k.a...

Federal Circuit Clarifies Law of Obviousness-Type Double Patenting: Patent Term Extension and Patent Term Due to URAA Are Safe from Gilead v. Natco
Patterson Belknap Webb & Tyler LLP, December 2018

In two decisions on Friday, the Federal Circuit clarified the law of obviousness-type double patenting (ODP) and provided certainty to biopharma patent owners.  In Novartis AG v. Ezra Ventures LLC, the court held that ODP does not invalidate an otherwise valid patent term extension (PTE) granted under 35 U.S.C. § 156 (extending the term of a pharmaceutical patent to compensate for regulatory delays).  And in Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc...

 

 

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