Articles for the ‘Life Sciences’ Category

Overview Of Changes in Information Security and Personal Data Protection Affecting Wholesale and Retail Trade of Medicinal Products in Russia

Published 21 July 2025 by Overview Of Changes in Information Security and Personal Data Protection Affecting Wholesale and Retail Trade of Medicinal Products in Russia Lidings, Russia

Key updates in Russian data security & healthcare CII: New rules for personal data consent (effective Sept 2025), healthcare CII categorization, and penalties for non-compliance. Essential for pharma & medical retailers

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Significant Turnaround in Russian Antitrust Practice of Protecting the Exclusivity of Drugs

Published 01 November 2024 by Boris Malakhov Lidings, Russia

Despite the fact that the issue of intellectual property rights turnover is included in the perimeter of antimonopoly regulation, until recently the Russian Antitrust Agency took rather an observant position.

The regulator’s position was that the issue of patent infringement is a private legal dispute between original and generic manufacturers, which should not affect the turnover of drugs, particularly the execution of contracts based on the results of public procurement. Only in isolated cases the Russian Antitrust Agency has established the fact of patent infringement and issued a corresponding order on the inadmissibility of anti-competitive practices.

Now the reverse trend has clearly emerged.

More in our update.

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Guideline on Medicine Priority Assessment Has Been Updated

Published 24 June 2024 by Dicle Doğan Gün + Partners, Turkey

The Turkish Medicines and Medical Devices Agency updated its Guidelines on Scientific Meetings and Educational Events for medical devices on 4 January 2024, introducing a notable change of imposing a fee for event applications, set at TRY 1,114.02, effective immediately. This update eliminates the need to upload a commitment letter for event notifications and aims to streamline processes and enhance transparency in industry activities. However, the decision to charge fees has sparked criticism for potentially reducing the number of notifications by imposing additional financial burdens on companies. Further, similar fees will apply to pharmaceutical companies, although guidelines for pharmaceutical products have not been updated yet.

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Guideline on Co-Marketing of Medicines has been Updated

Published 24 June 2024 by Dicle Doğan Gün + Partners, Turkey

The Turkish Medicines and Medical Devices Agency updated its Guidelines on Scientific Meetings and Educational Events for medical devices on 4 January 2024, introducing a notable change of imposing a fee for event applications, set at TRY 1,114.02, effective immediately. This update eliminates the need to upload a commitment letter for event notifications and aims to streamline processes and enhance transparency in industry activities. However, the decision to charge fees has sparked criticism for potentially reducing the number of notifications by imposing additional financial burdens on companies. Further, similar fees will apply to pharmaceutical companies, although guidelines for pharmaceutical products have not been updated yet.

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AI in Health Care

Published 04 June 2024 by Maarten SchutMaarten Schut Kennedy van der Laan Kennedy Van der Laan, The Netherlands

We cannot imagine life without AI anymore. The health care world too makes increasing use of AI. In this fact sheet we will describe in broad outline what care providers should pay attention to when purchasing and using AI from a health care law perspective. We will also give tips and recommendations for good use.

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