Submenue Archives

In Canada

Canada: Exploring a unique response to business and human rights (Webinar)

October 9, 2021 by Kevin Coon 1 Min Read

To address international human rights and responsible business conduct, in 2019 Canada established the Office of the Canadian Ombudsperson for Responsible Enterprise.The CORE represents the Government of Canada’s commitment to provide a mechanism to respond to concerns raised about the protection and respect for human rights by Canadian-based companies doing business around the globe in the garment, mining, and oil and gas sectors. On 28 October, Baker McKenzie will explore the mandate of the CORE as well as the mechanisms it has put in place to address human rights complaints.

In Asia-Pacific

Indonesia: Corporate PPAs

October 9, 2021 by Nadia Soraya, Norman S. Bissett, Anita Sungkono and Meyliana Santy 6 Mins Read

Unlike in other jurisdictions, straightforward corporate power purchase agreements are not possible in Indonesia, as only the Indonesian state-owned power utility PT PLN (Persero) (PLN) and private power developers that have the relevant business area approval can sell electricity to end customers. As a result, there is a general perception among developers and corporates alike that it is not possible to implement corporate PPA structures in Indonesia. In fact, this is not the case, and as the Government of Indonesia makes a big push for rooftop solar schemes, we expect to see an uptick in structures that enable private developers to arrange for electricity generation to customers.

In Europe

Italy: New guidance on translation of labels and repackaging of medical devices

October 8, 2021 by Roberto Cursano and Riccardo Ovidi 2 Mins Read

On 18 August 2021, the Medical Device Coordination Group, composed of representatives of all Member States and chaired by a representative of the European Commission, published the guidance on procedures for the translation of labels and instructions for use, as well as the repackaging of medical devices. The guidance is intended to provide assistance to distributors and importers carrying out the above activities by clarifying the relevant requirements, pursuant to Article 16 of the Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices, respectively.

In Cybersecurity, Data and Tech

Italy: Clinical trials – the new EU information system will start on 31 January 2022

October 8, 2021 by Roberto Cursano and Riccardo Ovidi 1 Min Read

With a decision published in the EU Official Journal on 31 July 2021, the European Commission confirmed that the EU Portal and Database have achieved full functionality. This implies that Regulation (EU) No. 536/2014 on clinical trials will be applicable as of 31 January 2022, in accordance with the provisions of Article 99 of the same Regulation.

In Europe

Italy: Council of State – Evidences of efficacy and safety of medicines must be based on rigorous clinical studies

October 8, 2021 by Roberto Cursano and Riccardo Ovidi 2 Mins Read

With judgment No. 5212 of 9 July 2021, the Council of State confirmed the decision of the Italian Medicine Agency whereby the latter requested a pharmaceutical company to remove from the package leaflet of an over-the-counter medicine all references to the indication concerning spastic-painful symptoms of the genitourinary tract, considering the relevant data inadequate to support such an indication.

In Covid-19

US 50 State Shelter-in-Place / Reopening Tracker

October 8, 2021 by Michael Brewer, Susan Eandi, Teresa H. Michaud, Lewis Popoff and Robin Samuel 2 Mins Read

Shelter-in-place or stay-at-home orders have been prevalent throughout the United States since March 2020 as state and local governments have sought to protect their citizens from the spread of the COVID-19 virus while at the same time reopen their economies in accordance with phased reopening plans. Illinois, Iowa and New Mexico extended their state-wide orders and/or the duration of the current phase of their reopening plans. Washington amended its state-wide mask mandate to require facial coverings for large outdoor events with 500 or more individual, regardless of vaccination status.

In Africa

Africa: Increasing Competition Policy Enforcement Across the Continent

October 7, 2021 by Angelo Tzarevski 6 Mins Read

Regulators view competition policy as a key driver of economic growth. Although over the past two years African competition regulators have actively engaged in efforts to address pandemic-related challenges, there has also been a general upward trend in competition policy enforcement across the continent.

Cross-border lending in Asia Pacific continues to grow steadily despite external factors such as COVID-19. While the region is not immune to external factors, borrowing volumes for financial institutions, credit funds and other market participants remain high in Asia Pacific. Considering the demographics of many of the nations, the various financial centers and many market participants investing more substantially in some of those financial centers, we remain optimistic that lending activity across Asia Pacific will continue to grow.

In Europe

United Kingdom: TLRC Report – The tax tribunals – The next 10 years

October 7, 2021 by Jessica Susannah Eden and Naoko Uehara 2 Mins Read

Taxpayers have the right to appeal HMRC’s decisions to the Tax Tribunal in most circumstances. In reality, many find the appeal process too arduous, time consuming and risky; resulting in taxpayers conceding or settling matters with otherwise good prospects of success. We expect that the recommendations of the Tax Law Review Committee, if implemented, will improve taxpayers’ access to justice and level the playing field between taxpayers and HMRC.

In Brazil

Brazil: Labor courts recognizing contractual changes and terminations made through text messaging apps as lawful

October 6, 2021 by Priscila Kirchhoff, Clarissa Lehmen, Tricia Maria Sa Pacheco de Oliveira and Leticia Ribeiro C Figueiredo 2 Mins Read

Due to the pandemic and social distancing measures, employers and employees are making use of communication apps to convey changes in the work routine and even termination of the employment agreement. As a result, many lawsuits have been filed before labor courts challenging the use of communication apps for these purposes.