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.
Clinical Trials as of 31 January 2022 under New “EU” Regime
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.
What Do Amendments to the Law on Excise Bring?
The Law amending the Law on Excise (Official Gazette of RS, no. 53/2021) entered into force on 5 June 2021 and its novelties refer to the excise for alcoholic beverages.
Mandatory Mediation: An Obstacle to Access to Justice?
Mediation is essentially a dispute resolution method; and an ancient institution throughout the history of mankind that is traditionally recognized in almost all societies. Instead of bringing an action before court; by applying mediation, the disputing groups [i.e., the villagers, townsfolk or members of a profession] discuss the issue with the assistance of a third person, and that third person assists parties in reaching a settlement. In this conventional system based on the fundamental principle of freedom of will, mediation is perceived to be an “alternative” dispute resolution method free from the coercive power of state. Such situation similarly appears in the settlement of disputes between the states.
The Nature of Apartment Purchase Agreements in the Polish Private Rental Sector
The Polish private rental sector is about to enter a period of intensive development. Unlike the western EU Member States, where the share of rented apartments often significantly exceeds 50%, in Poland, only approximately 15% of apartments are rented out (about 2.3 million out of a total of 14.8 million apartments existing in Poland).
Green Light for Developers of Green Power Generation Capacities
With a view to eliminate barriers to new investments in renewable power generation capacities, the Romanian Energy Regulatory Authority (“ANRE”) has recently amended the Regulation for the connection of the users to the public interest grid (the “Connection Regulation”) for eliminating a highly debated requirement of the grid connection process. The change was made through Order no. 41/2021 for the amendment of the Connection Regulation which was published in the Official Gazette of Romania on June 23, 2021 (the “Order no. 41/2021”).
Taxpayers Holding Cross-border Financial Assets Must Be Careful: International Exchange of Information is Gaining Momentum
It is a fact that international transactions - despite global disasters such as the Covid19 pandemic - continue inevitably and without slowing down. Hence, the scope of information exchange between countries on the assets of citizens and residents is also expanding, in order to ensure that the taxes are paid in the right amount to the right jurisdiction. Information exchange between countries matter not only for dual citizens but also for people who profit or make investments overseas.
Amendments to the Execution and Bankruptcy Law: It is Now Possible to Sell Businesses as a Whole
On June 19, 2021, the Law No. 7327 Amending the Execution and Bankruptcy Law and Some Other Laws [“Amendment Law”] was published in the Official Gazette, and accordingly, significant amendments have been introduced to the Execution and Bankruptcy Law [“EBL”]. This client alert aims to outline these amendments.
Remote Work from Abroad – Do You Know What Risks the Employer May Face?
Do your employees ask for the possibility of working regularly from home? What happens if home is abroad? Remote work from abroad brings risks for any company, and each company should evaluate these risks and consider them when setting up a remote work policy for its employees.
A Growing Trend: Representations & Warranties Insurance on Cross-Border Deals
The use of representation and warranty insurance, also known as M&A insurance and warranty and indemnity insurance [“R&W Insurance”], has grown in recent years to the stage where it has now become a standard feature of the cross- border M&A landscape. Estimates suggest that in the United States, the product was used in around 50% of the private acquisitions last year. Also, statistics pertaining to the year of 2019 indicate that the R&W Insurance was purchased in 49% of large deals having a value more than 100 million Euros in the European market. As is seen, R&W Insurance is frequently being used in M&A transactions and, in many respects, is now a mainstream.
What Do Amendments to the Law On Mining and Geological Exploration Bring?
The Law amending the Law on Mining and Geological Exploration (Official Gazette of RS no. 40/2021) entered into force on 30 April 2021 and most important changes refer to specification of certain solutions and more detailed normative regulation of individual issues, harmonisation with legal regulations in the field of environmental protection, introduction of e-business etc.
Hungary Bans Single Use Plastic Products
On 1 July 2021, a new Government decree enters into force in Hungary, prohibiting the placing on the market of certain single-use plastic products and products made from oxo-degradable plastic. The decree was published in Hungary's Official Gazette on 1 June.
Stricter Liability of Statutory Body Members (and Others) in Case of Company Insolvency
The amendment to the Business Corporations Act effective from 1 January of this year (the "Amendment") brings, among other things, a significant change in the liability of members of a statutory body, which will affect the current topic of insolvency.
36 Month-Long Working Time Frame is Not Unconstitutional
The constitutional court has rejected a motion against the amendment of the Hungarian Labour Code in 2018, however, it stated the Parliament’s legislative omission. In 2018 the Hungarian Parliament adopted an amendment to the Hungarian Labour Code that resulted in the extension of the maximum duration of the working timeframe in a collective agreement up to 36 months if it is justified by objective or technical reasons, or reasons related to work organisation.
UOKiK Announces Precedential Antimonopoly Proceedings in Poland
Recently, the President of the Office of Competition and Consumer Protection (Polish name: Urząd Ochrony Konkurencji i Konsumentów “UOKiK”) announced the initiation of antimonopoly proceedings in connection with the suspected coordination of actions by the Polish Basketball League and its member clubs against their players. The aim of the collusion was, among other things, to agree the terms of termination of players' contracts and to withhold payment of their salaries.
Foreign Direct Investment in Central Europe: Latvia
The global pandemic has impacted all markets, with subsequent ramifications for M&A. Investors are now seeking greater protection against general lock-downs and supply-chain disruptions, while governments aim to protect critical supplies and services by imposing new regulations on foreign investment in crucial or strategic industries.
New Rules for Copyright and Geographical Indications
The European Commission published the Digital Single Market Strategy for Europe in 2015, the aim of which is the creation of a modern and more European copyright framework system. The Commission presented in 2016 its legislative proposals to modernise EU copyright law, which resulted in the adoption of two directives: one laying down rules on the exercise of copyright and related rights applicable to certain online transmissions of broadcasting organisations and retransmissions of television and radio programmes (“SatCab Directive”) and another on copyright and related rights in the Digital Single Market (“CDSM Directive”).
The Czech Republic’s Office for the Protection of Competition Will Intensify Its Focus on the Pharmaceutical Sector
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.