healthcare & life sciences news

The pharmaceutical market in Bulgaria is a dynamic and rapidly growing sector, driven by increasing healthcare demands and a robust regulatory framework. It features a competitive mix of local and international players, with a significant presence of generic and innovative medicinal products. The push for generic medicinal products has also led to a rise in previously limited patent-related cases and revocation proceedings. However, the wholesale market remains crucial for ensuring the availability and distribution of medicinal products throughout the country.

In 2011, Croatia made a significant leap in healthcare digitalisation by introducing the Central Health Information System (CEZIH), which serves as the primary platform for storing and standardising health data. The CEZIH integrates data management across various healthcare services, including general practitioners, dental care, specialist clinics, pharmacies and hospitals, while also linking these services with key stakeholders like the Croatian Health Insurance Fund (HZZO).

Laws are evolving ever more rapidly, particularly due to the fast-paced advancements in technology and digitalisation, and few as quickly as those related to consumer products across various categories. This is especially true for substances occupying a grey area, teetering on the edge of what is prohibited and what is allowed, where the market tends to be more agile and creative than the legislation attempting to keep pace. Among these "controversial" substances, hemp cannabinoids such as CBD and HHC, along with Kratom, have flooded European markets in recent years.

Welcome to the January edition of Schoenherr's to the point: technology & digitalisation newsletter!

Health technologies, such as pharmaceuticals, medical devices and in-vitro diagnostics, play a key role in the success and progress of our healthcare system. Therefore, it is important to ensure health protection when using these technologies and to promote innovation.

In light of recent events involving the discovery of human tissue and blood in waste delivered to a waste treatment plant, it is crucial to review the regulations governing the management of medical waste in Bulgaria.

The amendments to the Bulgarian Public Health Act (PHA), introduced on 8 October 2024, are aimed at modernising the healthcare system, enhancing data management and improving patient care. They prioritise the transition to electronic health records (EHR), regulate telemedicine, and introduce a digital scheduling system for medical appointments. This article provides a high-level overview of the amendments.

In Austria, almost 1,000 units of stored blood are needed every day; in Germany, it is around 15,000 units. Blood is an important emergency medication in the event of accidents, childbirth, surgeries or serious illnesses. It has a shelf life of only 42 days and cannot be produced artificially.

18 - 20 April 2024 | Belgrade

Austria's healthcare system got a long-anticipated makeover. After years of small-scale adjustments, a collective amendment – the "Vereinbarungsumsetzungsgesetz 2024" ("VUG 2024" or the "reform") – has brought a new wave of changes somewhere revolutionising healthcare in Austria. The VUG 2024 refers to a comprehensive and coordinated change made to a total of 13 legal matters, which are being modified together as a unified act for a more holistic approach. This happens to be one of the biggest reforms in the healthcare sector in recent decades.

When prompted to list the top 10 human fears, an OpenAI language model started with the fear of death and ended with the fear of rejection. The AI's advice on how to overcome these fears was clearcut: accept the impermanence of life and find meaning.

The sale of popular drinks containing taurine and caffeine, commonly referred to as "energy drinks", has been limited from 1 January 2024 in accordance with provisions introduced in the Act of 17 August 2023 amending the Public Health Act and certain other acts (Journal of Laws of 2023, item 1718). The prohibition of their sale to minors has been incorporated into Polish law and they cannot be sold in schools and other educational institutions such as kindergartens or school libraries or through vending machines.

Two months from now, the sale of flavoured heated tobacco products will be banned in Romania. Recent legislative changes aimed at aligning the country's laws with those of the European Union extend the prohibition of flavoured tobacco products from cigarettes and roll-your-own tobacco to heated tobacco products. Producers and traders will thus need to review not only their stocks, but also their labelling obligations when placing heated tobacco products on the market.

Nicotine pouches are small pouches or pads containing nicotine and no tobacco. They are placed under the lip so that the nicotine is absorbed into the body through the mucous membrane. This alternative to traditional tobacco products, especially cigarettes, has been growing in popularity in recent years.

The Schoenherr Journal, published by Schoenherr's Prague office, examines the latest important legal developments in the Czech Republic.

The new EU Clinical Trial Regulation ("Regulation No 536/2014" or "CTR") was published in May 2014 as Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use. It repeals Directive 2001/20/EC and is applicable to a certain extent as of the end of January 2022.

It's June 2019 and the key players from the digital, healthcare and pharma industry have gathered at the Health Tech Summit in Lausanne to discuss a future in which preventive medicine will be customised for each patient. The idea is based on three milestones: active life (sports), mental health (healthy lifestyle) and eating habits (food). Poor eating habits and stress especially lead to the early onset of chronic diseases, costing the healthcare system billions of euros.

On 16 December the Bulgarian Council of Ministers adopted a Decree amending the local Ordinance for exercising the right of access to medical care.

Ernährung als essentieller Bestandteil der Medizin ist aufgrund von rasant wachsenden wissenschaftlichen Erkenntnissen immer deutlicher ins Zentrum gerückt.

Erfolg für AOP Orphan Pharmaceuticals vor einem Frankfurter ICC-Schiedsgericht: Das Wiener Pharmaunternehmen setzte sich mit der Ansicht durch, dass ein Vertrag mit dem taiwanesischen Arzneimittelhersteller Pharmaessentia weiter Bestand hat und bekam in dem Verfahren 143 Millionen Euro zugesprochen, unter anderem für Schadenersatz und Kosten.

To a large extent, the draft of the new Foodstuff Act1 (New Law or the Law) was developed in 2015. However, its adoption was long discussed with the European Commission and postponed several times.

Healthcare and life sciences have a special status as a type of legal practice. The debate about what this specialisation entails, and to what extent it even qualifies as legal work, is endless. However, as a crisis is also an opportunity, the coronavirus pandemic has defined the areas where law, healthcare and the life sciences overlap.

Am 01.04.2020 tritt die Verordnung über die Sicherstellung der Arzneimittelversorgung ("AMVS-VO") in Kraft. COVID-19 war zwar nicht der Grund für die Erlassung der Verordnung, die Auswirkungen der Corona-Pandemie könnten jedoch schnell zum ersten größeren Anwendungsfall der AMVS-VO werden.

On 1 April 2020, the Ordinance on Ensuring the Supply of Medicinal Products (Verordnung über die Sicherstellung der Arzneimittelversorgung, "AMVS-VO" or the "Ordinance") will enter into force.

Worried about COVID-19? During the outbreak, it is challenging for patients to seek in-person medical care.

Bulgaria is well-known for its roses, more precisely its oilseed roses (маслодайни рози). Oilseed roses are famously used to produce rose oil, which is one of the most expensive oils, commonly referred to as "liquid gold".

Bulgarian legislation on the legal cultivation of cannabis makes for interesting reading. Some readers might feel that the regulations and definitions are the most hilarious things ever, and this article aims to shed light on why this may be, while running you through some legalities.

Die Aufmachung eines zum Verzehr bestimmten Produkts kann irreführend sein, auch wenn die Angaben im Zutatenverzeichnis zutreffen.

Der vollständige Artikel ist hier zu finden.

Some local interpretations of the concepts of clean labelling and claims related to children's development and health

The Office for the Protection of Economic Competition recently fined Czech health products supplier TCM Herbs Kc853,000 (approximately €33,500) for resale price maintenance (RPM).(1)

Muss auf den Verpackungen von Kautabak fortan der Hinweis “Bitte nicht Lutschen. Nur zum Kauen geeignet und bestimmt” ausgewiesen sein, damit das Produkt zulässigerweise vertrieben wird?

Austrian legislators have been reluctant – if not outright hostile – to permit any kind of online sale of medicinal products within the country. It has been just over two years since Austrian pharmacies were finally granted the right to sell medicinal products to consumers.

On 20 December 2017, the Bulgarian parliament voted on a legislative amendment that will allow the marketing of risky substances containing mixtures intended for industry use.

A new law meant to fight food waste in Romania came into force in late May but is now inapplicable, as its provisions are unclear and application norms have yet to be published.

On 15 May 2017 the President of Poland executed the Act of 7 April 2017 amending the Pharmaceutical Law (the "Amending Act"), which changes the current regulations of the Act of 6 September 2001 Pharmaceutical Law (Journal of Laws of 2016, items 2142 and 2003) regarding the issuance of permits to operate public pharmacies.

The amendment aims at alleviating the existing regime for pricing of pharmaceuticals for home treatment of chronic, genetic and/or rare diseases and paid by the National Health Insurance Fund (NHIF). 

For five years, a dispute about the differences between Bulgarian sour milk (the traditional yoghurt) and regular yoghurt led to dozens of court proceedings.

The adoption of two Romanian laws that envisage the promotion of national products sparked intense debates over their practical consequences.

In early 2015 the Bulgarian Ministry of Health (“Ministry”) announced its intention to follow the example of Denmark and to propose a tax on “unhealthy foods”. The aim is to limit the consumption of foods which increase the risk of chronic diseases such as obesity, heart disease, diabetes type two etc. The opinion of the National Centre for Public Health (“Opinion”) justified the Ministry’s idea that the high costs associated with widespread chronic diseases legitimise the imposition of fiscal measures. The intended taxes will affect four groups of foods which contribute to the increased risk of chronic diseases.

In 2003 Ms. Simpson, confused by a food label, dropped this line in a TV-show and immediately landed in the "dumb blonde" stereotype. Ten years later, Bulgarian consumers face the same confusion, wondering, "Is this chicken, or is this … water"?