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healthcare & life sciences news
Take a look at the latest news of our healthcare & life sciences experts:
publication
The Legal 500 Country Comparative Guide 2024: Pharmaceutical Advertising in Bulgaria
newsletter
Regulating telemedicine and personalising healthcare: an overview of the latest revision to the Bulgarian Public Health Act
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.
press release
Austria: Schoenherr assists MedAustron with EIA permit for expansion of cancer treatment and research centre in Wiener Neustadt
Schoenherr advised EBG MedAustron GmbH on the expansion of the MedAustron cancer treatment and research centre in Wiener Neustadt. This specifically involved obtaining the EIA permit for the addition of a new irradiation room (IR5 for short), which will be operated exclusively by a new particle accelerator.
newsletter
Austria: Blood, tissue, cells and more – New EU Regulation on Substances of Human Origin
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.
newsletter
Revitalising healthcare: Austria's new healthcare reform
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.
newsletter
Hungarian government adopts new decree to tackle shrinkflation
Most of us have likely encountered a situation where we bought our favourite chocolate at the grocery store, only to be surprised upon opening it at home to find that the size and weight of the chocolate had decreased, while the packaging and price remained unchanged.
roadmap
2024
CEE
CEE team
Youth and beauty (on the edge between cosmetics and medicine)
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.
newsletter
New restrictions on the sale of energy drinks in Poland
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.
newsletter
Romania: Flavoured heated tobacco products soon to become history
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.
newsletter
Major legislative changes in Hungary's pharma and food industry
Significant legal changes occurred in the Hungarian pharmaceutical and food industry in the summer of 2023. According to Government Decree No. 333/2023. (VII. 20.), as of 1 August 2023, the National Public Health Centre (NNK) and the National Institute of Pharmacy and Nutrition (OGYÉI) merged, establishing a new authority, the National Centre for Public Health and Pharmacy (Nemzeti Népegészségügyi és Gyógyszerészeti Központ, NNGYK).
press release
05 July 2023
G.Petric G.Kulcsar N.Stepan A.Pabst N.Zafoschnig K.Pusch C.Unterdünhofen J.Frank M.Thorbauer T.Hayden
Austria: Schoenherr advises SanusX GmbH on acquisition of participation in Biome Diagnostics GmbH
Schoenherr advised SanusX GmbH, a UNIQA Group company, on the acquisition of a participation in Biome Diagnostics GmbH in a capital increase transaction.
newsletter
Regulation of nicotine pouches in the Czech Republic
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.
newsletter
Slovakia: New regulation promoting sale of healthy food in Slovak schools
As of 15 March 2023, a new regulation on the sale of certain types of foods in schools was introduced by Decree of the Ministry of Health of the Slovak Republic No. 75/2023 Coll., on details of requirements for facilities for children and adolescents (the "Decree"). The aim of the regulation is to provide a nutritionally valuable range of food in school catering establishments, mainly fresh vegetables and fruit.
roadmap
2023
E.Todorova M.Voldánová Á.Kovács V.Iurkovski A.Guzun P.Klimek-Woźniak O.Grecu P.Devínsky M.Hubman
Food Law: Using awareness to advertise with assumptions and emotions
publication
CZ: Schoenherr Journal Edition 12
The Schoenherr Journal, published by Schoenherr's Prague office, examines the latest important legal developments in the Czech Republic.
press release
Austria: Schoenherr advises MedAustron in EIA milestone of fourth treatment room at centre for ion therapy and research and receiving operating permit
Schoenherr advised the Austrian cancer treatment and research centre MedAustron in the environmental impact assessment for the commissioning of a fourth treatment room.
press release
Bulgaria: Schoenherr advises Queisser Pharma on acquisition of new office space in Sofia
Schoenherr advised Queisser Pharma Bulgaria on the asset deal acquisition of its new office space in Sofia from real estate developer Tremont. This acquisition marks one of the first office space asset deals in Bulgaria since the start of the COVID-19 pandemic.
press release
Austria: Schoenherr advises Herba Chemosan board on management buy-out
Schoenherr has advised the board of the Austrian pharmaceutical wholesaler Herba Chemosan Apotheker-AG (Herba Chemosan) on the recent management buy-out (MBO).
newsletter
Impfpflicht in Österreich – quo vadis?
Inzidenzen, (Intensiv-)Bettenbelegungen, COVID-19-Virus(varianten), eine Durchimpfungsrate von 90 %, nicht zuletzt die Omikron-Variante sind seit Monaten aus dem Wortschatz der medialen Berichterstattung über die omnipräsente und themenbestimmende COVID-19-Pandemie kaum wegzudenken.
roadmap
The EU Clinical Trial Regulation: big data and … human rights
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.
press release
02 December 2021
R.Perner M.Marschall M.Woller S.Aichhorn-Wöss C.Haid A.Pabst T.Waidmann D.Komarek M.Thorbauer
Austria: Schoenherr advises Sanofi on acquisition of Origimm Biotechnology GmbH
Schoenherr advised Sanofi, a global leader in healthcare, on the acquisition of 100 % of the shares in Origimm Biotechnology GmbH, a private Austrian biotechnology company.
press release
Austria: Schoenherr advises Nice & Green S.A. on innovative convertible notes funding programme with Marinomed Biotech AG
Schoenherr advised Swiss investment firm Nice & Green S.A. on an innovative convertible notes funding programme (CNFP) with Vienna Stock Exchange listed Marinomed Biotech AG.
press release
Bulgaria: Schoenherr advises on top Bulgarian dental distributor transaction involving Abris Capital Partners
press release
30 July 2021
C.Herbst M.Lang V.Weiss A.Natterer T.Waidmann J.Stalzer A.Amann E.Hlina N.Zafoschnig D.Komarek
Austria: Schoenherr advises Cerba HealthCare on acquisition of Lifebrain from Investindustrial
Schoenherr advised French diagnostic centre group Cerba HealthCare on the acquisition of the Lifebrain Group from Investindustrial. Lifebrain owns and operates diagnostic laboratory centres throughout Italy and in Austria. The signing of the transaction took place on 18 July 2021 and closing is subject to regulatory clearances expected in Q4 2021.
press release
Austria: Schoenherr advises BASF on transaction with Novartis/Sandoz at major industrial site in Kundl, Tyrol
Schoenherr advised BASF SE (BASF) on a major investment project at the Kundl/Schaftenau Campus in Tyrol, Austria. On 26 April 2021, BASF entered into an agreement with Sandoz GmbH, a subsidiary of the Novartis Group, which is already operating various biotech production facilities in Kundl and Schaftenau.
newsletter
The newly amended Notice on Handling of Duplicate Marketing Authorisation Applications – during a pandemic, availability is all that matters
roadmap
Ready for the cladogenesis of traditional healthcare?
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.
newsletter
Bulgaria: First legislative amendments introducing telemedicine/telehealth
On 16 December the Bulgarian Council of Ministers adopted a Decree amending the local Ordinance for exercising the right of access to medical care.
publication
Grundlagen im Lebensmittelrecht
Ernährung als essentieller Bestandteil der Medizin ist aufgrund von rasant wachsenden wissenschaftlichen Erkenntnissen immer deutlicher ins Zentrum gerückt.
media coverage
Pharmaforschung: ICC-Schiedsgericht spricht Schönherr-Mandantin Millionenbetrag zu
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.
press release
Austria: Schoenherr advises Austrian start-up Carbomed on multi-million euro financing round
After Schoenherr recently advised the Austrian fintech company Bitpanda on the largest European Series A financing round in 2020, the firm successfully advised on another start-up financing: Under the leadership of partner Thomas Kulnigg, the Schoenherr team advised Carbomed Medical Solutions, an Austrian FemTech start-up, on a EUR 3m financing. The financing round was led by aws Gründerfonds.
press release
Austria: Schoenherr advises listed AddLife on its acquisition of DACH Medical Group
Schoenherr, together with Advokatfirman Delphi, advised AddLife, a Swedish Medtech company listed on the Nasdaq Nordic Exchange, Stockholm, on the acquisition of all shares in the DACH Medical Group Holding AG. The transaction agreement was signed on 1 October 2020.
newsletter
New Foodstuff Act in Bulgaria
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.
newsletter
Bulgaria: healthcare & life sciences in a global pandemic
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.
newsletter
Exportverbote für Arzneispezialitäten
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.
newsletter
Export bans for medicinal products
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.
press release
Austria: Schoenherr advises Neuraxpharm on the acquisition of Easypharm
Schoenherr advised Neuraxpharm, a portfolio company of Apax partners, on the acquisition of Austrian consumer healthcare company Easypharm OTC GmbH. The deal was closed on 20 January 2020
newsletter
Hungarian government settles pharma debts: An opportunity for factoring companies? | Hungary
Hungarian hospitals are facing problems paying for drugs and medical devices. Many suppliers have claims worth millions of euros and are having difficulty enforcing them against either the hospitals or the Hungarian government.
newsletter
Bulgaria: New Legislation in the Rose Cultivation Sector
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".
blog
Telemedicine on the rise in Austria?
Seven out of the 328 pages of the new green/conservative government's programme are dedicated to the health sector. One bullet point on this programme for the next five years is to implement telemedicine treatment in the best possible way. The government further explains that it aims to promote digitalisation in diagnosis, treatment and medical research and thus strengthen Austria as a health hub.
roadmap
2020
bulgaria croatia czech republic hungary moldova poland romania slovakia slovenia türkiye ukraine austria
P.Devínsky L.Çelepçi A.Mihaljević* D.Vlahov Buhin* E.Todorova L.Dočekalová M.Voldánová D.Gera V.Iurkovski A.Guzun P.Klimek-Woźniak A.Natterer P.Halwa
cee overview - healthcare & life sciences
press release
Schoenherr wins two awards from leading financial journal Ziarul Financiar
Schoenherr Romania won two awards at the Business Lawyers' Gala held by the leading local financial journal Ziarul Financiar on 24 September in Bucharest.
press release
Schoenherr advises Apax Partners on the acquisition of a majority stake in ADCO Group
Schoenherr Czech Republic and Poland acted as a collateral advisor to Apax Partners, the global private equity advisory firm managing Apax Funds ("Apax") on the acquisition of a majority stake in the ADCO Group, the global market leader in the mobile sanitary unit sector.
newsletter
Growing cannabis in Bulgaria: Legal but still stigmatised
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.
newsletter
Bulgarian Courts and the Deepest Recesses of Marketing
Some local interpretations of the concepts of clean labelling and claims related to children's development and health
newsletter
Czech Republic: Health products distributor fined for resale price maintenance
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)
publication
Cannabidiols in Austria
Hypes come and go.What Bitcoin was for the financial sector in 2017 is currently cannabidiol, or "CBD" short, for the food industry. But how is the substance to be legally classified?
publication
Kautabak in Portionsbeuteln - Anmerkung zu EuGH, Urteil vom 17.10.2018, C-425/17
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?
media coverage
CBD: Ein Rechtsbruch, der keiner ist
Der Versuch des Sozialministeriums, Cannabidiol-haltige Lebensmittel im Erlassweg zu verbieten, ist untauglich. Sich dagegen zu wehren, ist dennoch schwierig.
newsletter
Austria: Decree forbids sale of CBD products
Exactly four months ago, we reported that the Austrian pastry shop Aida was starting to sell cakes containing CBD and explained the legal situation. In the meantime, everything has changed. Or has it?
newsletter
Healthcare Update - Mastering New Trends: Teleradiology* - Austria
Technology and innovation are key drivers of advancement in a variety of industries, and certainly in healthcare. The level of patient care can be improved considerably with the right mix of traditional and innovative treatments and solutions. Nevertheless, there are regulatory challenges to overcome.
press release
Austria/CEE: Schoenherr establishes sector group for Healthcare & Life Sciences
Schoenherr has established a new Healthcare & Life Sciences group to provide more comprehensive advice to clients active in the healthcare sector.
newsletter
Non-compliance in the Healthcare Sector - Iceberg ahead! - Austria
If anyone needed a wakeup call as to how critical a functioning compliance system and culture is, look no further than the recent reports in the Austrian media about allegations of fraud launched against a surgeon working at one of Vienna's most renowned public-sector hospitals.
newsletter
Austria: Let them eat space cake
As of tomorrow, the traditional Austrian bakery Aida, which is known for its staff dressed in baby pink, will sell brownies containing CBD. The price will be EUR 4.20 – an inside joke, since "four-twenty" is code for the consumption of cannabis.
newsletter
European Union: Your Web Doctor will see you now - software as a medical device
Patients nowadays have access to an enormous range of medical knowledge through social media, websites and health apps (in combination with wearables). The latter have become increasingly popular in recent years because of their ability to monitor in real time pulse, blood pressure, blood glucose levels and other parameters.
publication
Austria: Two Years Of Online Sales Of Medicinal Products In Austria
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.
newsletter
Bulgaria has liberalised the legal requirements on mixtures containing 1,4-Butanediol and y-Butyrolactone
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.
publication
EuGH zu Dextro Energy GmbH & CO KG gegen Kommission: Health Claims für Glucose trotz wissenschaftlichem Nachweis zurückgewiesen
Dextro Energy beantragte die Zulassung gesundheitsbezogener Angaben für die gleichnamigen Zuckertäfelchen. Trotz positiver Bewertung durch die EFSA hat die Kommission den Antrag abgewiesen.
newsletter
New Rules for Issuing Pharmacy Permits in Poland
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.
newsletter
Legislative vacuum filled: Czech Republic introduces comprehensive new national legislation on e-cigarettes
New legislation regulating e-cigarettes in the Czech Republic entered into force on 1 March 2017, introducing specific safety and quality requirements on e-cigarettes in the country for the first time.
newsletter
Bulgaria: Amendment to the pricing and reimbursements process for pharmaceuticals
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).
roadmap
Bulgaria: The Yoghurt War – A Bulgarian Food Law Case
For five years, a dispute about the differences between Bulgarian sour milk (the traditional yoghurt) and regular yoghurt led to dozens of court proceedings.
roadmap
Bulgaria: Junk Food - To Tax or not to Tax?
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.
roadmap
Bulgaria: Is This Chicken That I Have, Or Is This Fish?*
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"?
roadmap
Slovakia: Beware of Non-Compliance with Food Law
Food law in Slovakia is generally harmonised with the European legislation. But there are still local specifics worthy of attention due to more frequent inspection activities of regulators.