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Kinstellar has successfully advised Edwards Lifesciences in the area of data protection
Kinstellar has recently provided expert legal advice to Edwards Lifesciences, a global leader in medical innovations for heart disease, as well as critical care and surgical monitoring, through a secondment arrangement, focusing on data protection. This collaboration ensured that Edwards Lifesciences navigated complex data protection regulations effectively, safeguarding their business interests and maintaining compliance with applicable laws. The expert legal advice was provided by Simona Semanová, with further support from our Kinstellar team in Prague led by Tomáš Čihula and Petr Bratský.
Amendment adopted to Czech Pharmaceuticals Act to address drug shortages
An amendment to the Pharmaceuticals Act has been adopted by the Czech parliament and officially published. As already reported in our previous newsletter, the aim of the amendment is to improve the availability of medicines on the market and to mitigate the potential negative impacts of recent and ongoing medicine supply shortages. The amendment creates new obligations for operators in the medicines market, in particular (i) additional obligations following the interruption or discontinuation of the supply of a given medicinal product; and (ii) a mandatory system of reserve stocks. Following a number of additional changes made by Czech legislators, the national pharma regulator, the State Institute for Drug Control
Amendment to Significant Market Power Act to significantly broaden law’s scope
An amendment to the Significant Market Power Act (the “Amendment”) has been passed by the Czech parliament. The Amendment, which transposes EU Directive No. 2019/633 on unfair trading practices in business-to-business relationships in the agricultural and food products supply chain, will introduce key changes to the concepts of significant market power in the Czech Republic. Specifically, the Amendment provides a new definition of significant market power by reducing the turnover threshold for the application of a statutory assumption of significant market power to EUR 2 million. In line with the related EU Directive, the amendment is designed to provide better protections for smaller businesses against unfair trading