Tue, Jul
71 New Articles

Ukraine’s approach towards the circulation of cannabis has traditionally been strict: the cannabis market in Ukraine is not legalized, and the circulation of both cannabis itself and cannabinoids is generally prohibited. Both the Criminal Code of Ukraine and the Code of Administrative Offences of Ukraine provide for liability for illegal sowing or cultivation, manufacture, acquisition, storage, transportation, or shipment of cannabis.

In this article, we will review some long-awaited changes in Bulgarian legislation, as well as one particularly interesting precedent from the Supreme Court of Cassation case law. These were the highlights of autumn 2022 and we expect them to influence the development of national legislation in the field of healthcare/life sciences and consumer protection.

The “digitalization” buzzword can easily be found in the 21st century’s most-frequently-used vocabulary section. Something all businesses aspire to, digitalization can, depending on the specific area, represent a multitude of things, always being an inexhaustible power drive on a journey towards a modernized and efficient business playground.

The Romanian pharmaceutical sector has been constantly subject to legislative amendments and also scrutiny by numerous (tax, competition, criminal, regulatory) authorities. The base law on the healthcare system alone was modified more than 170 times in 16 years. While each authority has dealt with its own matters when regulating this sector, one of the main shortcomings is the lack of an integrated approach that, to the benefit of Romanian patients, looks holistically at aspects from clinical trials to pricing and reimbursement and claw-back tax.

A new trend is emerging in the National Institute of Pharmacy and Nutrition’s (OGYEI) recent case law on medicinal product promotion in Hungary. The OGYEI is more active, imposes higher fines, and its investigations extend to longer time periods and to a variety of promotional practices of pharma companies, instead of focusing on specific infringements as before. In numbers, the OGYEI published two to three times as many decisions annually in the past two years than before. Further, the imposed fines regularly exceed USD 75,000 and, in 2022, the OGYEI imposed its highest fine (approximately USD 100,000) in the last ten years.

Medical device manufacturers, importers, and distributors are advised to prepare for an important change in European and Polish laws on advertising for medical devices. Manufacturers do not always properly supervise their distributors in creating or revising promotional materials. This lack of oversight can lead to unexpected regulatory problems, especially under recent legal amendments. Preventive measures can help companies to avoid these problems.

The total consumption of medicines increased by 5% in 2021 compared to 2020. In financial terms, that is an increase of HRK 9.88 billion (or 17.4%) compared to 2020. Prescription-only medicines accounted for 92.9% of all consumption, while over-the-counter products accounted for 7.1%.

The electronization of healthcare (eHealth) streamlines processes in healthcare and improves the quality and availability of medical care. Some elements of eHealth already existed in Czech law, but the legislation was fragmented. To set the general framework, basic rules, and standards for the functioning of eHealth, a new Act No 325/2021 Coll., on electronization of healthcare (Act) was adopted, with effect from January 1, 2022.

An in-depth look at Aigest Milo of Kalo & Associates covering his career path, education, and top projects as a lawyer as well as a few insights about him as a manager at work and as a person outside the office.

During the past decade, the Albanian energy sector has benefited from a wave of domestic and foreign investments in hydro-power generation. Photovoltaic and wind energy generation has lagged behind for a long time. Increasing environmental concerns over the excessive use of water resources and the continuous reduction in technology costs are now shifting the government’s focus toward photovoltaic and wind energy generation.

With Albania’s construction industry accelerating, we spoke with Hoxha, Memi & Hoxha Partner Andi Memi and Tonucci & Partners Partner Enklid Milaj to find out what is being built and where.

With interesting transactions taking place recently and an overall uptick in FDI numbers, it would appear that Albania is fertile ground for high ROI. Deloitte Legal Local Partner Sabina Lalaj and Kalo & Associates Co-Managing Partner Eni Kalo zero in on the status of FDI investments in Albania, explore the most appealing sectors and investors, and make predictions for the future.

The start of the 21st century has seen the biggest changes and developments in employment law since its birth in the flames and smoke of the industrial revolution. The norm of the second half of the 20th century, comprising eight-hour shifts and nine-to-five office jobs, is now being dismantled. From remote working, flexible hours, compressed workdays and workweeks, all the way to platform work, the spectrum of employment law has never had so many colors. Even though Croatia represents a small jurisdiction, worldwide trends are certainly not bypassing it.

On June 1, 2022, Commission Regulation (EU) 2022/720 on the application of Article 101(3) of the Treaty on the Functioning of the European Union (TFEU) to categories of vertical agreements and concerted practices (EU VBER) entered into effect in all EU member states. The new EU-level rules were adopted, inter alia, to align the existing framework with the specifics of the online platform economy which plays an important role in the distribution of goods and services across the whole EU. Still, although the new VBER has significantly changed the rules on the application of Article 101(3) TFEU to vertical agreements, the existing Croatian Regulation on Block Exemption of Vertical Agreements between Undertakings (Croatian VBER) has not (yet) undergone a similar revision. 

On 1 January 2023, the Republic of Croatia will enter the eurozone and replace the Croatian kuna (HRK), the existing national currency, with the euro. Although the change has been welcomed by most stakeholders, it also leads to increased demands for regulatory compliance and additional expenses.

Nothing worse than something spoiling your party. Croatia had a perfect tourism season, with plenty of guests staying at hotels, resorts, camps, or yachts. Other industries are doing great as well. On top of everything – Croatia is admitted to the eurozone as of January 2023, and the National Bank reduced the required reserve ratio and abolished the minimum foreign currency liquidity, strongly increasing banks’ cash resources! Everything was ready for a 2023 party – plenty of funds within the banks, industry in its upward trend, the real estate sector developing, new unicorns ahead of us – it seemed like financing possibilities would be all around, with low interest rates and plenty of opportunities!

Page 1 of 2

Our Latest Issue