Recently, the National Medical Products Administration (the "NMPA") issued the "Pilot Work Plan for the Segmented Production of Biological Products" (the "Pilot Plan"), introducing a pilot initiative for the segmented production of biological products. This represents a breakthrough in the regulation of segmented production, a long-awaited achievement in the biopharmaceutical industry ...
PROOF OF INCAPACITY: ANALYSIS OF CIUSSS DE L?OUEST-DE-L?LE-DE-MONTREAL (ST. MARY?S HOSPITAL CENTER) v. RC 1 Summary The authors comment on this decision rendered on September 20, 2024, in which the Court of Appeal ruled on the capacity to consent to care in the presence of a psychiatric disorder ...
In a long-awaited decision, the Pennsylvania Supreme Court has held that “direct physical loss” language in commercial property policies is not ambiguous and that COVID-related business-interruption claims do not trigger the insuring clause of these policies. Based on this ruling, business interruption claims filed for losses caused by pandemic-related closures are not covered under standard commercial property policies ...
On September 8, 2024, the Ministry of Commerce, together with the National Health Commission and the National Medical Products Administration (hereinafter referred to as the "Three Departments"), publicly issued theNotice on Carrying Out Pilot Programs to Expand Opening-Up in the Healthcare Sector(hereinafter referred to as the "Notice"), announcing that,effective immediately, foreign-invested enterprises are permitted to engage in the development and application of human stem cells, gene diagno
On August 28, 2024, the National Medical Products Administration (NMPA) released the Medical Device Administration Law (Draft for Comment) (hereinafter referred to as the "Draft") for public comments ...
A podcast series that explores privacy themes within some of the most well-known movies. In this season finale, William Moore and Nikita Kanda look at the 1990’s cult movie, ‘The Truman Show’. Whether you are a film buff, a privacy advocate, or simply curious about the intersection of storytelling and privacy, take a journey with us as we explore how the big screen tackles privacy ...
China's pharmaceutical industry is witnessing a notable surge in "pipeline spin-off projects", a model commonly referred to as the "Spin-off-NewCo" or "SON" model. Within the past two months, we've been advising on nearly ten SON projects. Leading pharmaceutical companies in China are more frequently adopting the SON model to separate parts of their pipelines into new, independent companies ...
On July 5, 2024, the Financial Market Commission (“CMF”) updated its "Frequently Asked Questions" document related to General Rule No. 502 (“NCG 502”). The NCG 502 regulates the registration, authorization, and obligations of financial service providers under Law No. 21.521, known as the "Fintech Law ...
A podcast series that explores privacy themes within some of the most well-known movies. In this episode, William Moore and Paula Kelly return to the Wizarding World to once again discuss the Harry Potter films. Whether you are a film buff, a privacy advocate, or simply curious about the intersection of storytelling and privacy, take a journey with us as we explore how the big screen tackles privacy ...
Ban on foreign information security services from “unfriendly” jurisdictions Decree No. 250 of the Russian President dated 1 May 2022 “On Additional Measures to Ensure the Information Security of the Russian Federation” previously imposed restrictions on the ****use of foreign information security means**** ...
Introduction The EU Deforestation Regulation (‘EUDR’) waspublishedin the Official Journal on 9 June 2023 and entered into force on 29 June 2023,marking the start of its implementation phase. As the EU legislator has adopted a decentralized enforcement approach, Member States need to set up the necessary legal frameworks to fulfil their enforcement duties under the EUDR ...
The State Duma will consider a draft law on the possibility for the plaintiff to receive personal data (“PD”) of the defendant Amendments are planned to be made to the ****Civil Procedure Code**** of the Russian Federation. It is proposed to grant the plaintiff the right to file a ****motion**** to the court for assistance in ****establishing information about the defendant****, which is necessary to file a claim in court, but the plaintiff does not have ...
What’s worse than wanting to go to a concert for your favorite music artist and spending one-third of the ticket price in “convenience fees”? Apparently, getting hacked and losing roughly 560 million individual’s personal data—which is exactly what happened to Ticketmaster on May 20, 2024 ...
The Federation Council clarified how the Russian Digital Code will look like Work on the ****Digital Code****, which will become the basis for legal regulation of relations in the field of ****information**** and ****digital technologies****, will take at least another ****year****, and a significant part of the future document is planned to be devoted to the protection of ****personal**** and ****biometric data**** ...
In recent years, the regulatory framework for human genetic resources ("HGR") in China has become increasingly mature ...
The Russian government has approved draft amendments to the Russian Criminal Code that increase the severity of punishment for leaks of personal data (“PD”) The amendments have changed slightly compared with the version adopted in the first reading ...
Can social media platforms be considered products for the purpose of a product liability action in New York? At least one court seems to think so — but as we explain below, its opinion appears to be the first of its kind, although there is limited precedent in New York either way. On March 18, Justice Paula Feroleto of the New York Supreme Court, Erie County, denied a motion to dismiss in Patterson v. Meta Platforms Inc ...
China's National Medical Products Administration (NMPA) released the 2023 Drug Review Annual Report on its official website on February 4, 2024, closely followed by the 2023 Medical Device Registration Annual Report on February 5. According to the public information, more than 60 innovative drugs have been approved by NMPA from 2022 to 2023, and a total of 61 innovative medical devices have been approved in 2023 ...
On 21 September 2023,the EU Court of Justice (‘CJEU’) handed down its ruling in the Apotheke B. case (C-47/22), and it is a good example of the high threshold set by the EU Court of Justice to uphold the Community Code’s main aim of protecting public health ...
The Presidential Administration has not approved amendments to the second reading of the draft law on turnover fines for personal data (“PD”) leaks Despite the positive review of the draft law from the Government Commission, the State Legal Department of the President has prepared a ****negative review**** of the draft law on ****turnover fines**** for businesses for ****PD leaks**** ...
Two Montréal landmarks have proudly hosted some of the city?s most memorable sporting events. The Olympic Stadium and the IGA Stadium (Figures 1 and 2), which have been and remain quintessential in our sporting history, are in need of renovations so that sports fans can continue to ?raise the roof? for years to come. Figure 1: The Olympic Stadium: A prominent feature of the Montréal skyline. Figure 2: The National Bank Open at the IGA stadium ...
On April 17, 2024 the Securities and Exchange Commission (“SEC”) Division of Examinations (the “Division”) issued a Risk Alert regarding investment advisers’ compliance with amended Investment Advisers Act Rule 206(4)-1 (the “Marketing Rule”) ...
Do social media users have a fair choice between giving up their privacy and paying a subscription fee? The European Data Protection Board has given its opinion on what’s fair for large platforms in the latest shake up of personalised online advertising. When it comes to justifying processing personal data for targeted advertising under EU data protection laws, Meta (along with other online platforms) has been feeling the squeeze ...
A podcast series that explores privacy themes within some of the most well-known movies. In this episode, William Moore and Max Schrems discuss “The Social Network”. Whether you are a film buff, a privacy advocate, or simply curious about the intersection of storytelling and privacy, take a journey with us as we explore how the big screen tackles privacy ...