CEE Legal Matters
In-depth coverage of the news and newsmakers that shape Europe's emerging markets
Managed Entry Agreements consist of various forms of confidential arrangements between pharmaceutical companies and paying healthcare systems that aim to facilitate access to new technologies in public healthcare systems. MEAs make innovative and costly medicines or medical technologies affordable to patients by providing conditional access to a reimbursement system for a limited period and on balanced terms.
The mechanism of patent protection is most in demand in the Pharmaceuticals industry, and a review of judicial practice in Russia demonstrates how zealously pharmaceutical companies protect their exclusive rights to gain a market advantage.
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.
