A scandal shaking the pharmaceutical market of Bosnia and Herzegovina for several years now related to the unlawful delisting of foreign medicines manufacturers has moved to a silent but almost thriller-tense phase as the country awaits the Court of Bosnia and Herzegovina’s final decision. The current countdown was preceded by a unique crisis in 2018, when two subsidiaries of foreign pharma giants that had been delisted decided to fight back, even as a number of smaller players liquidated their companies and withdrew from the market. 

Cultivation of medical cannabis has become a lucrative business in recent years. Countries around the world have started legalizing this controversial crop, approving medical cannabis in particular in some capacity. In 2018, Canada made history by passing the Cannabis Act, thus becoming the first industrialized nation in the world (and second overall, after Uruguay) to pass legislation allowing adults to purchase marijuana. In addition, over 33 states in the USA have made the use of cannabis legal for medical purposes.

Recently, the spread of COVID-19 has been classified as a “pandemic” by the World Health Organization. With the global contagion of the epidemic, rumors have appeared regarding the development of new medicines and vaccines in Turkey, as everywhere else, and this situation has caused much misleading news and information to be published by the media and on the Internet.

In 2010, France’s Agence Nationale de Sécurité du Médicament published the results of tests of breast implants produced by the French company PIP and banned their use, due to an increasing number of reports of incidents related to impaired implant integrity and subsequent health-related complications.

All European countries are now facing the SARS-CoV-2 pandemic and each state is undertaking different measures to limit the spread of the virus. Recently, the Polish government has extended the so-called “export ban list” – a list of, in particular, medicinal products and medical devices the export or sale of which abroad may be subject to the objection of the Chief Pharmaceutical Inspector. This list grew by over a thousand items in the past month and has changed from a list of products subject to parallel export due to price differences to a list of products that we want to keep in Poland. Also, the President of the Office for Registration has asked pharmaceutical companies to consider launching clinical trials in these unique circumstances.

In recent years, and for multiple reasons, cyber-attacks against healthcare providers have increased significantly on a global level. First, IT platforms and devices used by healthcare providers have a technical diversity, while sources devoted to an integrated cybersecurity system for these IT platforms are often limited, making the IT systems vulnerable and ideal targets of potential cyber-attacks. Second, health data qualifies as “highly sensitive data,” which is considered very valuable on the black market compared to other types of personal data.

Similar to other areas of human endeavour, healthcare is bound to undergo the inevitable process of digital transformation. In the last two years the Czech Republic has taken its first steps towards digitizing its healthcare system by introducing mandatory electronic prescriptions and electronic sick notes and is about to introduce an electronic medications record. Unfortunately, there has been little progress on other fronts. Moreover, the Ministry of Health has yet to complete its draft law setting common standards and rules for eHealth, and it is unlikely to meet its current goal of having the law go into effect in 2021.

A well-known chain of pharmacies launched a pilot project to run medical vending machines in Slovakia last year. Although Slovakia has not had such machines in the past, they are not uncommon abroad.

In accordance with statistical data from 2018 and 2019, Latvia’s State Agency of Medicines concluded that there is a high risk of unavailability of state-reimbursed medicines in the Latvian pharmaceutical market, mainly as a consequence of the behavior of the wholesalers. The same conclusion was reached by the Competition Council of the Republic of Latvia which, in late 2018 and 2019, published two reports on the availability of medicines. Accordingly, it was concluded that the existing regulatory framework was unable to provide an effective market protection mechanism to reduce the risk that patients in Latvia might not have access to state-reimbursed medicines, because after these medicines are made available in Latvia by producers or importers, they are exported to third countries or other EU member states by other market participants.

Advertising of medical devices is a significant market activity in the regulated pharma industry. Companies are always in search of new tactics and business strategies to remain competitive in the market and to attract new customers, in conditions of fierce market competition.

Everyone knows that law firm pitches are terrible, and nobody is happy about it – not the lawyers, not the marketing/BD teams, and definitely not the clients.

CBD products are the latest consumer fad, and demand and supply has significantly increased all over the world. The market for CBD products is projected to keep growing, and according to some estimates, the European CBD market should be worth some EUR 1.5 billion by 2023. Despite such rapid development and expansion, placing CBD products on the Slovenian market remains somewhat of a legal grey area.

The Lithuanian life sciences industry has skyrocketed over the last two decades – the average annual growth within the biotechnology and pharmaceutical research and production sector reached over 19%, with 90% of its output exported. in 2017 Lithuania reached 16th place in the Scientific American Worldview biotechnology rankings. Lithuania dominates many (much) larger Central and Eastern European countries and boasts the fastest growing life science industry in Europe.

Following its exit from the Soviet Union, the Republic of Moldova started its independent life with a poorly-regulated medical system that lacked the proper means of ensuring patient safety.

In the European Commission’s January 8 Report on the protection and enforcement of intellectual property rights in third countries, Ukraine was identified as a Priority 2 country. This category includes countries with systematic problems in the area of intellectual property protection and enforcement, causing significant harm to EU countries.

The issue of compulsory licenses for patent rights to pharmaceuticals is becoming more and more controversial in Russia, due to the growing number of important court rulings involving compulsory licenses affecting leaders of the pharma industry over the last few years.

The White Paper on Artificial Intelligence published on February 19th by the European Commission presents some important building block policy options to enable the trustworthy and secure development of artificial intelligence in the EU, fully respecting the presiding values and the fundamental rights of its citizens. The enormous volume of data which has already been generated and that yet to be generated constitutes an opportunity for Europe to position itself at the forefront of global AI policy. The use of AI brings both fears and uncertainties: on the one hand, citizens fear they will be left powerless against the information asymmetries of algorithmic decision-making, while on the other, companies are truly concerned with legal uncertainty.

CEE Legal Matters first interviewed Ingo Steinwender in 2014, near the end of his first year as Group Head of Legal at CA Immobilien Anlagen AG, one of the largest real estate companies in Austria. Six years later, we check in.