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Recently published case law from Hungary’s National Institute of Pharmacy and Nutrition – the Hungarian acronym is OGYEI – deals with various aspects of pharmaceutical promotional activities and interactions with health care providers. The OGYEI investigated the commercial practices of Aramis Pharma Kft., Lilly Hungaria Kft., and Sager Pharma Kft., and imposed fines following the discovery of infringements.

The significance of medical devices is most certainly on the rise, considering not only its importance to patients, for whom medical devices represent life enhancing products, but also developments in innovation, economics, and in the regulatory and legal sphere. Issues such as data privacy in the field of medical devices were not noticeable until connectivity became a trend in medical devices and the GDPR was adopted. Similarly, the possibility of a cyber-attack on a medical device connected to the Internet became a possibility. Even though the question of product liability has always been present, recent decisions by the European Court of Justice provided new interpretations of existing legal terms and, importantly, introduced product batch liability. 

The enforcement of pharmaceutical patent rights in Russia is a multi-aspect issue. One such aspect, well known to the industry and patent owners, is the attempt to prevent pharmaceuticals that may infringe on prior patent rights from being registered by the Russian healthcare authorities.

In late 2018, the Competition Council of the Republic of Latvia published the final report on its most recent in-depth sector inquiry on the distribution practices of reimbursed medicines on the wholesale market and potential competition restrictions therein. The sector inquiry had lasted for almost two years, during which the Competition Council gathered information from both the public and the private sectors, approaching seven producers, twelve wholesalers, and several public institutions, such as the State Agency of Medicines and the Health Inspectorate, among others. Although the Competition Council proclaimed that the main goal of the sector inquiry was to analyze potential competition restrictions on the wholesale market, which could be apparent because of the vertical integration of wholesalers and leading pharmacy chains and the exclusivity status of the wholesalers, no infringements proceedings were initiated as a result. Notwithstanding the lack of subsequent infringement proceedings, however, some crucial conclusions were drawn.

At the end of April, 2019, Sopharma Trading announced the creation of “SOinventure” – a corporate acceleration program in the field of health-tech, organized in partnership with Bulgarian investment fund Eleven Ventures. We decided to ask Mr. Ivaylo Simov, Partner at Eleven Ventures, and Mr. Dimitar Dimitrov, CEO of Sopharma Trading, three questions about the development of the alliance between healthcare and new technology, and we added our experience-based opinion to their answers.

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