In light of the extension of the emergency period until 31 January 2021, and in order to ensure – where possible – the continuity of trials while reducing contacts between clinical staff and patients, on September 17 the AIFA published an updated version of its Guidelines for the management of clinical trials during the COVID-19 emergency
The NSW Fair Trading enforcement grace period for new disclosure obligations added to the Fair Trading Act 1987 (NSW) expires on 31 December 2020. The changes commenced on 1 July 2020 and imposed new disclosure obligations on affected businesses. The new disclosure obligations require:
suppliers to disclose terms or conditions of contracts that substantially prejudice consumers. The disclosures must be made before the business supplies the goods or services;1Â and
intermediaries to disclose the financial incentives arrangements they have with suppliers. The disclosures must be made before the business acts under an arrangement where it may receive a commission or referral fee.2
The National Institute of Pharmacy and Nutrition (“OGYÉI”) published new decisions on its webpage concerning pharmaceutical promotional activities and interactions with HCPs. The OGYÉI investigated the commercial practices of Aramis Pharma Kft., Lilly Hungária Kft. and Sager Pharma Kft. and imposed fines due to alleged infringements.
Our market-leading UK trade and competition team will share their insights from 26 January – 3 February 2021 as we discuss the impact of the new UK-EU arrangements and adapting your business to the global realities post-Brexit. Full information about these sessions can be found here. Customs and Product Regulation…
From 1 January 2021, businesses must navigate a divergent UK-EU trade and competition regime for the first time…
The long awaited Federal Law No. 15 of 2020 on Consumer Protection (“Consumer Protection Law”) has been issued on 10 November 2020 and is a major update which aims to revamp and repeal the old UAE consumer protection laws, being Federal Law No. 24 of 2006 (“Old Law”). Due to the rapid rise of e-commerce globally, including in the UAE, the Consumer Protection Law now acknowledges and captures e-commerce service providers. The Consumer Protection Law has also now imposed a restriction on using personal data of customers for marketing and promotion purposes.
The SEC recently adopted amendments that dramatically reshape the rules governing investment adviser marketing by creating a single rule (“Marketing Rule”) for investment adviser advertising and referral arrangements. The new approach is an elegant solution designed to fulfill the SEC staff’s objective of retaining a principles-based framework while modernizing the rule to remain flexible to accommodate evolving technologies such as social media. The Marketing Rule is effective within 60 days after publication in the Federal Register, but advisers have 18 months to transition to the new requirements.Â
On 22 October 2020, the Minister of Health (MOH) issued MOH Regulation No. 28 of 2020 on the Procurement of Vaccines for Corona Virus Disease 2019 (“COVID-19”) (“MOH Regulation 28”). MOH Regulation 28 is an implementing regulation of the Presidential Regulation No. 99 on the Procurement of COVID-19 Vaccine and Vaccination of COVID-19 (“PR 99”). We have addressed some of the key takeaways under PR 99 in our previous client alert. You can find the link to the client alert here.
MOH Regulation 28 regulates on four main themes of COVID-19 vaccine procurement: Â (i) types and amount of vaccine for procurement, (ii) procedure for procurement of vaccines, (iii) procedure for payment for vaccines and (iv) guidance and supervision on the procurement of vaccines.
As stipulated under PR 99, MOH has appointed PT Bio Farma (Persero) (“Bio Farma”) as the state-owned enterprise that will lead the procurement and distribution of COVID-19 vaccine in Indonesia. MOH Regulation 28 applies for all COVID-19 vaccines yet to come, not limited to the one that is being developed under the partnership between Government of Indonesia (GOI) (i.e., through Bio Farma) and Sinovac.
The EU has urged member countries to grant more legal powers to the EU in pursuit of a ‘Health Union’, which would enable the EU to better manage future crises. This announcement comes in the wake of the COVID-19 pandemic, which exposed areas of weakness and gaps in the EU’s health powers. Critics argue that the pandemic has seen a lack of effective measures to monitor medicines shortages, that the EU Infectious Diseases Agency’s advice lacked effectiveness, and that there was a disjointed approach to the virus across EU member states. In response, the Commission expressed desire to make the following changes:
create an EU-wide pandemic preparedness plan
align testing methods with EU labs
give the European Medicines Agency (EMA) more power to mitigate drug shortages
Following the growing viability of meat substitutes such as plant-based meats and cultured meats, the Singapore Food Agency (SFA) has released an updated document detailing its requirements regarding the safety assessment of novel foods (“Safety Assessment Requirements”). This document is expected to be revised periodically as the novel food space evolves to facilitate industry safety assessments and maintain food safety standards.