Articles

As with many healthcare systems worldwide, the Czech Republic faces challenges regarding sustainable funding and escalating healthcare costs, particularly concerning chronic and rare diseases.

Aiming to address emerging needs in public healthcare, on 12 April 2024, the Ministry of Health of the Czech Republic introduced a draft amendment to the Act on Public Health Insurance and other related laws, which is proposed to take effect on 1 January 2026. In this article, we provide an overview of the key areas affected by the legislative proposal, namely (i) price and reimbursement regulation of medicinal products and medical devices, (ii) preventive care support, (iii) reimbursement of cross-border healthcare services, and (iv) dental care reimbursement.

At the heart of the global economy and public health, the life sciences industry is a driving force for progress in an ever-evolving web of laws and regulations.

Recent legislative initiatives in the EU illustrate some of the regulatory challenges – and opportunities – for the life sciences industry on a pan-European level.

Dive into our article below where we highlight some of the legal topics that we consider key for the life sciences industry in 2024 and how they might impact the industry.

Read further, download the article: Key EU Legislative Initiatives Shaping the Life Sciences Landscape in 2024

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.

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.

The Turkish Medicines and Medical Devices Agency published Guidelines on 29 December 2023 to regulate pharmaceutical exports by entities other than pharmaceutical warehouses, aiming to ensure compliance with national and international standards and safeguard public health. These Guidelines require that only authorized companies can export pharmaceutical products and dietary foods for special medical purposes, necessitating a valid export permit. They outline the process for obtaining export permits, the responsibilities of exporting companies, including their obligation to report any issues with exported products, and the joint liability of the license holder and exporter for the export operations.