2023 is gearing up to be an interesting year for those in the life sciences sector, with upcoming reforms to the established regulatory and IP landscapes that will impact innovator strategies in R&D, commercialization, and patent enforcement. While reforms are currently under draft by the European Commission, the key areas of anticipated change are highlighted in a newly published article in The Life Sciences Lawyer.
Pharma companies often employ Medical Science Liaisons (MSLs) in order to provide healthcare professionals (HCPs) with high-quality professional and scientific information that lacks promotional content thereby distinguishing it from the information provided by medical sales representatives.
In a recently published decision, the National Institute of Pharmacy and Nutrition (NIPN) stated that it does not support distinction between professional and promotional communication. This position leaves pharma companies with two options: either to register MSLs with the NIPN as a medical sales representative, or to try to severely restrict the information an MSL may share with HCPs.
The US Food and Drug Administration ensures the quality of drug products by carefully monitoring both domestic and foreign drug manufacturers’ compliance with its Current Good Manufacturing Practice regulations. With over 350 manufacturing establishments supplying the US drug market, China represents one of the two countries with the most foreign drug establishments subject to FDA inspection.
Starting from 31 January 2023, the Clinical Trial Information System (CTIS), provided for in Art. 80 of Regulation EU 536/2014, will become the single point of access for the submission, authorization and supervision of clinical trial applications in the EU and the European Economic Area (EEA) countries.
On 19 December 2022, the Recommendation Paper on Decentralized Elements in Clinical Trials was published on the website of the European Medicines Agency (EMA), with the aim to facilitate the conduct of decentralized clinical trials in the EU, while safeguarding the rights and well-being of participants and the robustness and reliability of the data collected.
The amendments to the Law on the Regulation of Electronic Commerce that was adopted on 1 July 2022 will enter into force on 1 January 2023. As part of these amendments, the Regulation on Electronic Commerce Intermediary Service Providers and Electronic Commerce Service Providers was published on the Official Gazette no. 32058 dated 29 December 2022.
The Regulation aims to detail and clarify the requirements under the Law.
In the last month, the Hungarian National Institute of Pharmacy and Nutrition (NIPN) published five new decisions on its website relative to the promotional practices of companies under investigation. The NIPN imposed fines for infringements within the range of HUF 3 million (approx. EUR 7,700) to HUF 31 million (approx. EUR 79,500).
This is the fourth in a series of client alerts in relation to Law No. 4 of 2023 on the Development and Strengthening of the Financial Sector (“P2SK Law”), dated 12 January 2023. Aside from asserting the provisions that have been stipulated by the Financial Service Authority, the P2SK Law sets out several new provisions that open a new chapter in the financial conglomeration and consolidation. The P2SK Law now requires financial conglomerates to establish or appoint a financial holding company, a legal entity that is expected to control, consolidate and be responsible for all of the financial conglomerate’s activities. The P2SK Law also affirms OJK’s authority to give written orders to financial services companies to push for financial consolidation.
Crypto asset advertisers should be aware that they must now comply with new regulatory requirements around the publishing of crypt asset advertisements in South Africa. The South African Advertising Regulatory Board’s Code of Advertising Practice was broadened to include new requirements for crypto assets in January 2023. Crypto asset advertisers should prioritize compliance with new requirements under the ARB Code because, although the ARB’s rulings are not binding, an adverse decision is usually accepted by the advertising and publishing community and can result in reputational consequences for advertisers.
The New Criminal Code became the first piece of legislation passed into Law in 2023 and was promulgated on 2 January as Law No. 1 of 2023. This alert takes a look at how the New Criminal Code reintroduces crimes related to fraudulent acts against creditors. In the absence of any criminal provisions under Law No. 37 of 2004 on Bankruptcy and Debt Suspension of Payment, any criminal sanctions for fraudulent-related acts against creditors are those originally set out in the old criminal code. The New Criminal Code reinvents the provisions in the old criminal code and reintroduces them as a new section in the fraudulent-related acts against creditors.