Articles

Forthcoming changes to the public health insurance system in the Czech Republic: what you need to know

Published 03 May 2024 by Kateřina Slavíková. HAVEL & PARTNERS | Czech Republic, Czech Republic

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.

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Key EU Legislative Initiatives Shaping the Life Sciences Landscape in 2024

Published 26 March 2024 by Jacob Gunst. Gorrissen Federspiel, Denmark

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

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Webinar: The interplay of the Medical Device Regulation, AI and data protection in medical technology

Published 28 May 2024 by Dr. Oliver Stöckel. SKW Schwarz, Germany

In the dynamic world of medical technology, it is essential to always be aware of the latest regulatory requirements. The introduction of the AI Act poses new legal challenges for medtech companies when using AI.

In addition, the requirements of the MDR and data protection must still be complied with, particularly with regard to the handling of sensitive health data. But how exactly does the “magic triangle” of MDR, AI Act and data protection work in medical technology?

Using practical examples we will answer this question and would like to invite you to our free webinar (in German language):

“The interplay of the Medical Device Regulation, AI and data protection in medical technology”
on Thursday, June 13, 2024
from 12:30 – 13:30
via MS Teams

Register for free today and benefit from our in-depth knowledge and expertise in the field of digital health: to the registration

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Türkiye’s Update: Key Changes in Named Patient Program

Published 23 May 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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Named Patient Program in Turkey

Published 18 March 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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