Search for:
Category

Regulatory

Category

In Commonwealth Director of Public Prosecutions v Citigroup Global Markets Australia Pty Ltd [2021] FCA 511, the Federal Court has handed down an important decision which highlights the dilemma that may be faced by an immunity applicant in complying with its duty to provide full, frank and truthful disclosure and to co-operate under the ACCC’s Immunity and Cooperation Policy for Cartel Conduct (ACCC Policy) and maintaining legal professional privilege over witness accounts provided to solicitors at an early stage in an investigation.

On 6 April 2021, the Italian Medicines Agency (Agenzia Italiana del Farmarco or AIFA) published a document updating the requirements to be reported in the outer labelling of centralized medicinal products placed on the Italian market (so-called “Blue Box”). In this respect, it should be noted that the Blue Box is that area, marked by a blue border, included in the label of a medicinal product intended to contain specific information relevant for each Member State in whose territory the product is marketed.

In its press release No. 642 of 12 April 2021, the Italian Medicines Agency (AIFA) indicated a substantial increase of reports concerning medicinal products purchased online from unauthorized channels that were found to be falsified or illegal. The most recent cases include purchases of products with anti-cellulite activities and medicines used in the treatment of erectile dysfunctions.

On 5 May 2021, the European Commission (“Commission”) published a proposed Regulation, along with an impact assessment report, aiming to address potential distortions caused by foreign subsidies in the Single Market (“Proposed Regulation”). This Proposed Regulation will create substantial new obligations for companies if adopted in its current form.

On 10 May, the Council of the European Union adopted a revised version of the EU’s Dual-Use Regulation. Key changes include two new general export authorisations, stricter controls on cyber-surveillance and technical assistance, changes to the licensing framework, and provisions allowing for increased co-ordination between Member States.

The City of Chicago recently issued nexus guidance and a limited safe harbor for City tax purposes in light of the US Supreme Court’s pivotal South Dakota v. Wayfair ruling and the State of Illinois’ statutory economic nexus standards. True to form, the City implemented its new nexus standards by executive action via publication of a “nexus and safe harbor” “information bulletin” on its website, as opposed to the Chicago City Council more formally adopting a new ordinance.

With judgment No. 4816 of 26 April 2021, the Administrative Court ruled on an appeal for the annulment of the final award of a Framework Agreement for the supply to public hospitals of digital mammography devices, related services, equipment and optional services. The appellant claimed that the successful bidder should have been excluded for the tender procedure for having unlawfully used a continuous cooperation agreement, pursuant to art. 105, paragraph 3, letter c-bis), of the Code of public contracts.

Over a year into the global pandemic, businesses have had to pivot to survive and adjust to new ways of conducting business. Now, more than ever, Asia Pacific business leaders are making the necessary strategic changes to meet the needs of a vastly changed business landscape — and deciding where legal expertise may be needed most to limit and manage disruption and soften risks. This report will delve into how businesses view rising protectionism, regulatory scrutiny and foreign investment restrictions, and how these views are directly impacting their supply chain strategies.