On 26 April, the proposal for the pharma package review was issued by the Commission. The revision is the first major review of the pharmaceutical legislation since 2004 and aims to adapt the European pharmaceutical legislation to the needs of the 21st century. The reform aims to ensure more timely and equal access, lower burdens on companies, and lower healthcare costs. The review encompasses two legislative proposals, a Directive, and a Regulation, which will serve as the EU regulatory framework...

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Welcome to “For What It’s Earth,” a bi-weekly review of the key Environmental, Social and Governance (ESG) developments from across the globe. With an increasing scrutiny of ESG factors by governmental authorities, investors, customers and stakeholders, in our newsletter we distill ESG-related policy, legal, and market developments into a streamlined note, reporting on the issues most relevant for business and industry. Recent developments to note: LitigationJewelry brand David Yurman and direct to consumer brand Mejuri Inc. settled a lawsuit brought by Yurman...

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The Minister of Labour has stated that it is necessary to “focus on attracting people to Portugal”, reiterating that the country has positioned itself as being able to have “the capacity to attract digital nomads”. Currently, there are 650,000 immigrants working in Portugal, six times more than in 2015, points out Ana Mendes Godinho. The minister defends the “contribution of foreign workers to Portuguese development”, stressing that in Social Security contributions, foreigners already represent 10% of workers who actively participate in...

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How to Maximize Efficiency and Reduce Risk in Contract Negotiations Contracts are the lifeblood of commercial relationships. Negotiating these contracts can be time-consuming, complex, and fraught with legal risks. A well-crafted “playbook” for contract negotiations can significantly streamline the process, mitigate potential risks, and ultimately save time and money for your organization and in-house counsel. In this blog post we will discuss the concept of a contract negotiation playbook, its benefits, and how companies can leverage this powerful tool. What Is...

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The EU AI Act is set to become law later this year and providers of imaging and diagnostic artificial intelligence technology (AI) need now begin to consider its potential impacts on the regulation of their technology. Many manufacturers in this space are only just getting to grips with recently updated medical/in vitro medical device law when fresh regulatory obligations appear on the horizon relating to the use of AI in those devices. Regulators and notified bodies in the same...

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The U.S. Department of Justice has conceded in Wrzesinski v US that an American citizen and a native of Poland does not owe penalties for failing to file IRS Form 3520, “Annual Return To Report Transactions With Foreign Trusts and Receipt of Certain Foreign Gifts,” after receiving $830,000 from his mother in Poland. Krzysztof Wrzesinski immigrated to America in 2005 at age 19 and for the past nine years he has been a Philadelphia police officer. In 2010, his mother, Barbara...

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The general sentiment for prospective deal making in Canada at the end of Q1 2023 might best be described as restrained optimism, especially in comparison to 2021 and early 2022. Despite continued headwinds from various macroeconomic factors, Q1 ended on an encouraging note with a modest upswing in total Canadian deal activity (by deal count) from the last quarter. This quarterly review provides a snapshot of Canada's M&A landscape for Q1 2023. In addition, we will also take a look...

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On March 15, 2023, the European Data Protection Board (EDPB) announced the launch of a coordinated enforcement action regarding the designation and position of DPO across the European Economic Area (EEA). In practice, EEA Data Protection Authorities will send questionnaires to organizations in order to assess their compliance with GDPR requirements, open formal investigations, and/or follow-up on ongoing formal investigations. As a reminder, non-compliance with GDPR requirements for the designation and position of the DPO could be subject to a...

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Two months ahead of schedule, EU lawmakers have come to an agreement on the EU Chips Act, a deal expected to double the EU’s global market share in semiconductors from 10% to at least 20% by 2030. Negotiators from the European Parliament, Council of the EU and Commission announced this week, on Tuesday, 18 April, that they had reached a provisional political agreement on the EU’s proposed regulation to strengthen Europe’s semiconductor industry. Commissioner Thierry Breton, the European Commission’s front...

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California’s Civil Rights Council has revised proposed regulations governing the use of automated-decision systems. A proposed bill, AB 331, would impose obligations on employers to evaluate the impact of an automated decision tool (ADT), prohibit use of an ADT that would contribute to algorithmic discrimination, add a new notice requirement, and create a governance program. A separate bill, SB 721, would create a temporary Working Group to deliver a report to the legislature regarding artificial intelligence. California continues to...

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