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Focus on Regulation

Dutch Child Labour Due Diligence Law

The Dutch Child Labour Due Diligence bill (the “Law“) was passed in both houses of parliament and is due to be implemented by royal ratification after 1 January 2020. The aim of the Law is to put more responsibility on companies to prevent goods and services which have come into existence through child labour to hit the Dutch market. As a result of the law entering into force, companies are advised to start establishing an action plan to mitigate risks in cases where child labour has been identified in their supply chain or activities. Continue Reading

The Court of Justice clarifies the EU customs rules applicable to customs valuation

The Court of Justice of the European Union (“Court”) just released its judgement in Case C-1/18 Oribalt Riga concerning the customs valuation methodologies applicable to generic medicines in the framework of consignment agreements (“Judgment”).

By way of background, in 2005, Oribalt Riga SIA (“Oribalt”) concluded a consignment agreement with Ranbaxy Laboratories Ltd. (“Ranbaxy”). Pursuant to this agreement, Oribalt imported generic medicines, stored and distributed them to Ranbaxy’s clients without acquiring their ownership. Oribalt determined the customs value pursuant to the “transaction value” method (i.e., the price actually paid or payable for the goods when sold for export to the EU). In 2011, Latvian authorities rejected the determination of the customs value based on that method and instead relied on the “deductive value” method (i.e., the unit price at which the imported goods or identical/similar goods are sold to unrelated buyers in the greatest aggregate quantity in the EU). Oribalt appealed Latvian Customs’ approach on the following grounds: (1) the customs value should be determined on the basis of the first applicable valuation method (i.e., the “transaction value” method); (2) if the customs value is established under the “deductive value” method, the reference values should be those of the goods imported on a date as close as possible to the date of importation of the goods considered for valuation; and (3) discounts should be taken into account for the determination of the customs value under the “deductive value” method.

On that basis, the Latvian court referred the following three questions to the Court: Continue Reading

Foreign Investment Control on the Rise – New List of EU Member States’ FDI Screening Mechanisms

Foreign direct investment (“FDI”) screenings have become a relevant factor for global transactions in recent years. More and more jurisdictions are introducing or ramping up their powers for scrutinising FDI, which parties to M&A transactions and their advisors need to consider when structuring such deals and planning for completion of the projects. In Europe, the European Commission (“Commission”) boosted this trend with its recently adopted Regulation (EU) 2019/452 of 19 March 2019 establishing a framework for the screening of FDI into the EU (“the Framework Regulation”).

In order to increase the visibility of FDI screening regimes, the Commission on 24 June 2019 published a list of FDI screening mechanisms notified by Member States [see the list here]. As part of the Framework Regulation, Member States with an FDI screening mechanism in place are obliged to notify the Commission of such mechanisms. The Commission is, in turn, responsible for maintaining an updated list of notified mechanisms. The recently published list is the first such consolidated list of FDI screening mechanisms in the EU and is likely to spur the debate about introducing such a system in those EU Member States which have not yet done so. Continue Reading

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid Inquiry Program (“TRIP”), which will assist human cell, tissue, and cellular and tissue product (HCT/P) manufacturers, as well as stakeholders that market HCT/Ps, to “obtain a rapid, preliminary, informal, non-binding assessment from the FDA regarding how specific HCT/Ps are regulated.”  Under the program, FDA will respond within three business days to each inquiry that contains sufficient detail for evaluation, “resources permitting,” informing the requestor whether an HCT/P appears to be (a) appropriately regulated under section 361 of the Public Health Service Act (PHSA), (b) appropriately regulated under section 351 of the PHS Act and/or Federal Food, Drug, and Cosmetic Act (FDCA), or (c) not an HCT/P. Continue Reading

U.S. Supreme Court Sidesteps Important TCPA Deference Issues

On June 20, 2019, the Supreme Court released its long-awaited decision in PDR v. Carlton & Harris Chiropractic.  The Court was expected to provide greater clarity about the extent to which litigants can challenge the Federal Communications Commission’s (FCC) Telephone Consumer Protection Act (TCPA) interpretations in private litigation.  Instead of deciding that issue, however, the Court vacated the Fourth Circuit’s ruling and remanded the case for further development. How the Fourth Circuit rules on remand may ultimately provide more insight on how much deference is owed to the FCC’s TCPA interpretations. Continue Reading

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Agency seeks input on “comparative advantage” requirement for new opioids

Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework,” outlining the benefit-risk framework the Agency intends to use in assessing whether a new opioid drug application meets the statutory standard for approval.  FDA also announced it will hold a public meeting on September 17 to discuss this benefit-risk assessment framework as well as potential new preapproval incentives to foster the development of new treatments for pain and opioid addiction.  This public meeting will fulfill the SUPPORT Act requirement that FDA hold at least one public meeting annually to “address the challenges and barriers of developing non-addictive medical products intended to treat acute or chronic pain or addiction.”

The draft guidance explains how FDA intends to apply its existing benefit-risk assessment framework to evaluate the benefits of a candidate opioid analgesic drug as well as any risks, including abuse, overdose, addiction, or opioid use disorder.  FDA also indicated it will consider the benefits and risks of the opioid analgesic at issue with those of other approved therapies, including opioid and non-opioid alternatives, in addition to the broader public health risks posed by the candidate drug to both patients and non-patients.

Importantly, while FDA will consider how the new opioid analgesic compares to existing therapies, a sponsor will not be required to show that its drug is superior to the other treatments for approval.  Nonetheless, at the public meeting in September, FDA seeks stakeholders’ input regarding the addition of a comparative advantage requirement for approval of potential opioid analgesic drugs as well as: Continue Reading

The European Commission releases an updated Borderline Manual for medical devices

Introduction

The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is intended to assist manufacturers in determining whether their product falls within the definition of a medical device laid down in the Council Directive 93/42/EEC concerning medical devices (MDD).

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What comes out, must go back in: Court sides with FDA on “same surgical procedure” and “homologous use” definitions governing human cell and tissue products

FDA authority to crack down on illegally marketed stem cell treatments confirmed

On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug Administration’s (FDA) motion for summary judgment, and stopping the clinic from offering its stem cell therapy to patients. The court found that the population of stromal and vascular cells in the clinic’s therapy, known as Stromal Vascular Fraction (SVF), constitutes a biological drug product that FDA must review and license before it can be commercially marketed. The court also found that the clinic’s manufacturing procedures and its promotion violated statutory requirements, causing the clinic’s cellular product to be adulterated and misbranded.

Critically, the court rejected the clinic’s argument that because its SVF procedure merely extracts and reinserts cells during the “same surgical procedure,” it is exempt from FDA regulation. Instead, the court adopted FDA’s view that the clinic’s separation of stromal and vascular cells from surgically-removed adipose (fat) tissue disqualified the procedure from this exception. The court held that the exception only applies to a procedure where the human cell, tissue, or cellular or tissue-based product (HCT/P) that is implanted into a patient includes “all” of “the antecedent HCT/P removed from the patient in its original form.” The case is a critical ruling supporting FDA’s increasing enforcement against stem cell clinics. It also clarifies FDA’s authority to regulate SVF therapies in particular, and bolsters FDA’s effort to gain more control over the HCT/P field more broadly.
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The French “PACTE” Law: Growing Space for Social and Environmental Topics in Corporate Management of French Companies

Under the new law on Business Growth and Transformation (the so-called “PACTE Law”), the management of French companies must take into consideration social and environmental issues. Companies are also encouraged to incorporate social objectives into their corporate purpose. This blog looks at the new law and what it means for businesses.

On 11 April 2019, the members of the National Assembly of the French Parliament adopted the PACTE Law. After a decision from the French Constitutional Council on 16 April 2019, the PACTE Law was eventually enacted and then published on 23 May 2019. Continue Reading

OFAC Issues Press Release for a Finding of Violation Against State Street Bank and Trust Co. Where No Penalty was Assessed

OFAC has announced a Finding of Violation –and not a penalty–against State Street Bank and Trust Co. (SSBT) for processing 45 pension payments totaling under $12,000 on behalf of a pension plan participant who was a US citizen with a US bank account but was living in Iran.

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