The fundamental goal of each company is to increase sales. For this purpose, players that operate in the Ukrainian pharma market utilize a wide range of promotional activities. However, Ukrainian laws on health protection allow very few of them when it comes to prescription (or “Rx”) pharmaceuticals.

The COVID-19 pandemic has accelerated the digital evolution of clinical trials. Introducing new technologies and ways of working with clinical data, improving clinical data access, review, and monitoring processes, and making better use of the data for further scientific research are trends that are here to stay. Side by side with these developments come legal questions about personal data protection. The aim of this article is to shed light on the core legal issue in data processing within clinical trials: its legal basis.

[Updated on 8 July 2021] Further to the entry into force of EU Medical Devices Regulation 2017/745 on May 26 2021, the Romanian Government issued an Emergency Ordinance setting forth the institutional framework for ensuring the MDR’s direct application (“GEO no. 46/2021”) and announced that the Ministry of Health will issue the secondary legislation in the following months.

For at least the last 15 years, co-promotion and co-marketing agreements between pharmaceutical companies have been valuable instruments for cost-effective marketing of pharmaceutical products. Both types of agreement are used both locally and globally to effectively allocate the skills and expertise of marketing teams based on product type, therapeutic category, and product maturity.

On May 26, 2021, the EU’s new Medical Device Regulation came into force, significantly changing the applicable regime, including – of particular interest to the dynamic Slovenian MedTech start-up community – by providing a new definition of software applications that need to be certified as medical devices.

The COVID-19 pandemic has taken its toll on Poland, as it has on other European countries. In April, Poland recorded by far the biggest number of COVID-19 fatalities since the onset of the pandemic in March of last year. Consequently, most of the government’s plans to reform healthcare/pharmaceutical legislation have been either frozen or postponed. Most recent legislation has been aimed at legalizing the lockdown or enacting other pandemic measures, such as social distancing and mask-wearing in public spaces, as well as speeding up the vaccination rollout across the country. However, these new laws were essentially technical adjustments to the current framework, rather than revolutionary changes.