The pharmaceutical sector in Kosovo is undergoing three major policy and legal reforms to increase its competitiveness and transparency. These reforms are part of a national project to improve the underdeveloped and under-regulated pharmaceutical market which would, in turn, encourage increased spending in the healthcare and pharmaceutical sector.

The Law on Medication and Medical Devices (Official Gazette no. 58/08) and the Rulebook on Manner of Marketing of Medicines and Medical Devices (Official Gazette no. 40/10) regulate the advertising of medicines and medical devices in Bosnia & Herzegovina.

Not all the impacts of the COVID-19 crisis on Romanian society are negative. The crisis also led to the much-overdue regulation of telemedicine in Romania.

During the COVID-19 pandemic, the Healthcare/Pharma/Life Sciences sector has, not surprisingly, come into focus, with the production licencing and supply of vaccines and the ability of hospitals and healthcare facilities to operate and the production of healthcare products all attracting attention.

A freely-accessible public healthcare system has always been considered one of the pillars of the modern welfare state. However, the dearth of adequate managerial skills and advance planning within the healthcare framework has often led to systemic problems, like issues with financing for a system that is regarded as a public service by users and a private business by service suppliers. This problem has once again resurfaced in the Croatian health sector, with debts accumulated by public hospitals and pharmacies standing in the way of a regular supply of medicinal products and medical devices by manufacturers, wholesalers, and pharmacies.

As a large country with a population of over 82 million and a comprehensive public and private healthcare system designed to provide an accessible and equitable medical service to each and every person living in Turkey, the potential for every life science-related sector in the country could easily be deemed as advanced.

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.

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.

On March 5, 2020, CEE Legal Matters reported that Schoenherr had advised Fintur Holdings B.V. on its USD 31.5 million sale of its 100% holding of Moldcell S.A., to CG Cell Technologies DAC. Gladei & Partners advised CG Cell Technologies. We spoke to Vladimir Iurkovski at Schoenherr and Roger Gladei at Gladei & Partners for more information about the deal.

BizLaw.md, a Romanian-language portal dedicated to business law in the Republic of Moldova, is celebrating its fifth anniversary. We spoke with its founder, Efrim Rosca & Asociatii Managing Partner Oleg Efrim, to learn more about the project and his plans going forward.

My Indian guru, a sine-qua-non vegetarian, adores the Moldovan pies (placinte poale-n brau) made by my mom. When back home in India he will definitely once again become a chapati devotee, but for now he is in Chisinau, enjoying the taste and flavor of my mom’s baking.

An interview with Gianluca Carlesso of The Carlesso Law Firm, about his path from Italy to Romania.