RTPR’s Costin Taracila Talks About The Deal of the Year in Romania.
Deal Expanded: Interview with DLA Piper on 2020 DOTY for Hungary
DLA Piper’s Andras Nemescsoi and Gabor Molnar Talk About The Deal of the Year in Hungary.
Deal Expanded: Interview with CMS on 2020 DOTY for the Czech Republic
CMS’s Lukas Janicek and Robert Gray Talk About The Deal of the Year in The Czech Republic.
Deal Expanded: Interview with Savoric & Partners on 2020 DOTY for Croatia
Savoric & Partners’ Boris Savoric and Lovro Gasparac Talk About The Deal of the Year in Croatia.
Deal Expanded: Interview with CMS on 2020 DOTY for Bulgaria
CMS’s Kostadin Sirleshtov and Atanas Bangachev Talk About The Deal of the Year in Bulgaria.
Deal Expanded: Interview with Schoenherr on 2020 DOTY for Bulgaria
Schoenherr’s Alexandra Doytchinova and Stefana Tsekova Talk About The Deal of the Year in Bulgaria.
Kosovo: Transformation and Reform of the Pharmaceutical Industry in Kosovo
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.
Pharmaceutical Advertising Guide in Bosnia and Herzegovina
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.
Enacting Telemedicine in Romania
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.
Healthcare/Pharma/Life Sciences in Hungary
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.
Ad-Hoc Reparations in Croatia’s Healthcare System: What is Pacta Sunt Servanda?
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.
Turkey: Life Sciences and Waste Management in Turkey in the Pandemic Era
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.
Ukraine: Lawful Options for Promoting Rx Pharmaceuticals in the Ukrainian Market
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.
Czech Republic: Data Privacy in Clinical Trials
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.
Stricter Rules for the Promotion of Medical Devices in Romania
[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.
Greece: Legal and Regulatory Aspects of Greek Pharmaceutical Co-Promotion and Co-Marketing Agreements
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.
Slovenia: The Implications of the MDR to Slovenia’s MedTech Community
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.
Polish Healthcare Landscape Dominated by Pandemic
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.