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.

The ascendant popularity of ESG across business sectors has also empowered the rise of its evil twin: greenwashing. To look at the interplay between the two and their implications for the pharma industry in CEE, we sat down with CMS Partners Gabriela Staber and Tomas Matejovsky. 

If you need statistical data maintained by the National Health Information System for your work or scientific research, whether demographic data on births or deaths, statistics on cancer patients, information on assisted reproduction or other information, you will be interested in a landmark decision of the Constitutional Court.