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.

A review of the Romanian pharma market reveals the real challenges faced by pharmaceutical companies and the impact of those challenges on patients.

At the beginning of April 2019, the Serbian Parliament adopted the new Law on Healthcare Protection (the “Law”), with the aim of improving the legal framework and facilitate better functioning of the healthcare system in Serbia, aligning it more closely to EU standards in this field.

The worldwide legal marijuana trade has grown significantly in recent years. According to some sources, the United States accounts for a global market share of 90 percent of all legal marijuana traded.

It is no secret that North Macedonia is facing the issue of usage of products for plant protection which often fail to meet legal standards. Namely, Macedonian manufacturers producing agricultural products for human and animal nutrition often use unauthorized products which fail to meet safety criteria and may have suspicious origins. Although this issue is not as widely-discussed as air pollution in North Macedonia, it contributes significantly to the existing environmental pollution problem and has a huge impact on the health of plants, people, and the environment.

With the June 7, 2019 initiation of the draft Patient Insurance Act, the Estonian Ministry of Social Affairs has achieved an important milestone in the development of the Estonian health care system. This draft act marks a principal change towards the creation of a patient-centric health care system, which will have a major effect on patients, health care service providers, health care professionals, insurance companies, and society at large.

Use of Artificial intelligence is growing rapidly. Some of the world’s largest industries are using AI as frequently as any other business tool. Still, there are industries which seem to be more risk averse. Pharma integrates AI at the rate of 31% in the service operations sector, 31% in the product/service development sector, and 27% in the marketing sector. Does that mean that pharma is lagging in implementing AI?

Medical professionals in Slovakia must adhere to current professional standards. Failure to do so may result in administrative, civil, or criminal liability. Patients have several options how to proceed in the event of alleged medical malpractice.

Pharmaceutical products have been in the spotlight of the Council of the European Union’s Product Liability Directive since its adoption in 1985. Despite the amount of time that has passed, some legal uncertainties remain that strike directly at the notion of defectiveness, as well as the causal link between the defect and the damage (which proved to be even more important in the case of pharmaceutical products). Establishing such causal link in cases involving vaccines is notoriously difficult, especially from the perspective of a lay consumer. This has led some EU member states, such as France, to introduce case law aimed at facilitating the burden of proof in specific sectors.

It is a good time for the CEE region, and for Poland. In September 2018 Poland became the first country in CEE to be ranked as a “developed market” in the FTSE Russell index. And the Polish Life Sciences market, which had previously been driven by a transition economy dogma, has made a leap from a purely generic market to a more innovative one. A few recent developments may allow Poland to become a leader in the CEE Life Sciences industry.

The Czech Republic was one of the first countries in Europe to allow the use of cannabis for medical purposes. This was achieved in 2013 by means of an amendment to the Act on Pharmaceuticals, which was subsequently implemented by the “Cannabis Regulation.” Despite this, access to medical cannabis still remains difficult for many patients.

The Supreme Court of Cassation in Italy has recently rendered a decision that products containing Cannabidiol (CBD) shall be prohibited from being marketed on the Italian market, even if they contain less than 0.2% of the psychoactive substance Tetrahydrocannabinol (THC). The sale of such products had previously been permitted based on an amendment to the law regulating hemp production that removed the requirement to obtain a permit for “cannabis light.” This led to a “cannabis light boom.” The change was triggered based on the opinion of the Highest Italian Sanitary Council that even such “cannabis light” products could conceivably endanger human health. Following the Supreme Court of Cassation’s ruling, only products specified as medicinal products or certain agricultural varieties may be sold.