CEE Legal Matters
In-depth coverage of the news and newsmakers that shape Europe's emerging markets
The Health Ministry and the Ministry of Internal Affairs have issued Order no. 1204/99/09.07.2021 to supplement Order no. 874/81/2020, which established an obligation to wear a protective mask, epidemiological triage and mandatory hand disinfection to prevent contamination with the SARS-CoV-2 virus during the state of alert (the “Order”) and have published it in the Official Gazette no. 683 dated 9 July 2021.
The global crisis, which arose as a consequence of the COVID-19 pandemic, brought light, among other things, to the weaknesses of the Serbian public health care system. The daily mass collection of a person’s data on health – which, according to the Serbian Data Protection Act, is considered particularly sensitive data – became a regular occurrence during the pandemic.
On 31 January 2022, the “new” Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC (the “Regulation“) will enter into force. After several delays (the launch was originally planned for 2015), the European Medicines Agency (the “EMA”) has confirmed to the Commission that the EU portal and the EU database, which were a prerequisite for the launch, are now fully functioning. At the same time, the EMA confirmed that the EU portal and database will be put into operation on 31 January 2022. As of this date, the Regulation will become fully applicable in all EU Member States.
According to its recently published annual report, the Office for the Protection of Competition of the Czech Republic (the "Office") plans a thorough investigation of the pharmaceutical sector, in terms of compliance with both competition and public procurement rules.
On January 18, 2021, CEE Legal Matters reported that Cobalt had advised Practica Capital on its investment in Lithuanian start-up Biomatter Designs – part of the latter's EUR 500,000 investment round. CEEIHM spoke with Donatas Keras, Co-Founding Partner at Practica Capital to learn more about the matter.
Access, equity, quality, and cost-effectiveness are key issues facing healthcare in both developed and less developed countries. Modern information and communication technologies (ICTs), such as computers, the Internet, and cell phones, are revolutionizing how individuals communicate with each other, seek, and exchange information, and enrich their lives. These technologies have great potential to help address contemporary global health problems.
According to the Life Science Report Austria, Austrian biotech companies recorded a turnover of USD 379.3 million in 2017, with USD 206.3 million – or 54.6% – flowing into research and development.
