Life Sciences 2025

Definitive global law guides offering comparative analysis from top-ranked lawyers

CHAMBERS GLOBAL PRACTICE GUIDES

Life Sciences 2025

Definitive global law guides offering comparative analysis from top-ranked lawyers

Contributing Editor Lincoln Tsang Ropes & Gray LLP

Global Practice Guides

Life Sciences

Contributing Editor Lincoln Tsang Ropes & Gray LLP

2025

Chambers Global Practice Guides For more than 20 years, Chambers Global Guides have ranked lawyers and law firms across the world. Chambers now offer clients a new series of Global Practice Guides, which contain practical guidance on doing legal business in key jurisdictions. We use our knowledge of the world’s best lawyers to select leading law firms in each jurisdiction to write the ‘Law & Practice’ sections. In addition, the ‘Trends & Developments’ sections analyse trends and developments in local legal markets. Disclaimer: The information in this guide is provided for general reference only, not as specific legal advice. Views expressed by the authors are not necessarily the views of the law firms in which they practise. For specific legal advice, a lawyer should be consulted. Content Management Director Claire Oxborrow Content Manager Jonathan Mendelowitz Senior Content Reviewers Sally McGonigal, Ethne Withers, Deborah Sinclair and Stephen Dinkeldein Content Reviewers Vivienne Button, Lawrence Garrett, Sean Marshall, Marianne Page, Heather Palomino and Adrian Ciechacki Content Coordination Manager Nancy Laidler Senior Content Coordinators Carla Cagnina and Delicia Tasinda Content Coordinator Hannah Leinmüller Head of Production Jasper John Production Coordinator Genevieve Sibayan

Published by Chambers and Partners 165 Fleet Street London EC4A 2AE Tel +44 20 7606 8844 Fax +44 20 7831 5662 Web www.chambers.com

Contents

CONTENTS INTRODUCTION Contributed by Lincoln Tsang, Ropes & Gray LLP p.5 AUSTRIA Law and Practice p.10 Contributed by Herbst Kinsky Rechtsanwälte GmbH Trends and Developments p.32 Contributed by Herbst Kinsky Rechtsanwälte GmbH BRAZIL Law and Practice p.37 Contributed by Kasznar Leonardos Intellectual Property

ISRAEL Law and Practice p.165 Contributed by Reinhold Cohn Group

JAPAN Law and Practice p.184 Contributed by Nagashima Ohno & Tsunematsu

MEXICO Law and Practice p.198

Contributed by Baker McKenzie Trends and Developments p.218 Contributed by Galicia Abogados, SC

POLAND Trends and Developments p.226 Contributed by Kieltyka Gladkowski KG Legal

Trends and Developments p.58 Contributed by Felsberg Advogados

CHINA Law and Practice p.63

PORTUGAL Law and Practice p.235 Contributed by PLMJ

Contributed by Global Law Office Trends and Developments p.83 Contributed by Han Kun Law Offices FRANCE Law and Practice p.93 Contributed by McDermott Will & Emery GERMANY Trends and Developments p.113 Contributed by D+B Lawyers GREECE Law and Practice p.118 Contributed by ALG Manousakis Law Firm Trends and Developments p.142 Contributed by ALG Manousakis Law Firm INDONESIA Law and Practice p.147 Contributed by Santoso, Martinus & Muliawan Advocates

Trends and Developments p.247 Contributed by Eversheds Sutherland SERBIA Law and Practice p.255 Contributed by BDK Advokati Trends and Developments p.273 Contributed by BDK Advokati SOUTH KOREA Law and Practice p.279 Contributed by Lee & Ko Trends and Developments p.295 Contributed by Lee & Ko SPAIN Law and Practice p.302 Contributed by Faus Moliner Trends and Developments p.323 Contributed by Faus Moliner

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Contents

SWITZERLAND Law and Practice p.329 Contributed by Bär & Karrer AG Trends and Developments p.348 Contributed by Wenger Plattner UK Law and Practice p.356 Contributed by Arnold & Porter USA Law and Practice p.374 Contributed by Arnold & Porter Trends and Developments p.389 Contributed by Ropes & Gray LLP

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INTRODUCTION Contributed by: Lincoln Tsang, Ropes & Gray LLP Ropes & Gray LLP is home to one of the world’s pre-eminent life sciences groups, with a global platform for innovators at every stage of the development life cycle. The firm’s collaborative approach – spanning more than 25 practice ar- eas and touching all offices around the world – offers one of the largest and most experienced industry-specific teams, comprising more than

300 lawyers, subject-matter experts and techni- cal advisers who deliver sophisticated transac- tional, regulatory, IP, and litigation and enforce- ment strategies to position industry innovators and investors for success. The Ropes & Gray team is sought after to lead clients in navigating the complex legal landscape in which the life sciences industry operates. advises clients on R&D strategies, product life cycle management, product acquisition, and risk and crisis management. He also regularly represents clients before various regulatory bodies in a wide range of matters concerning medicines and medical devices, including clinical trials, product approval, advertising and promotion, manufacturing, safety vigilance, and health technology appraisal related to pricing and reimbursement decision-making.

Contributing Editor

Lincoln Tsang is a partner at Ropes & Gray LLP and heads the firm’s European life sciences practice. A former senior regulator, Lincoln concentrates his practice on UK, EU and

cross-border regulatory compliance and enforcement, including litigation, internal investigations and public policy matters affecting the life sciences industry. Lincoln

Ropes & Gray LLP 60 Ludgate Hill London EC4M 7AW UK

Tel: +44 (0) 20 3201 1500 Fax: +44 (0) 20 3201 1501 Email: lincoln.tsang@ropesgray.com Web: www.ropesgray.com

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INTRODUCTION Contributed by: Lincoln Tsang, Ropes & Gray LLP

A Brave New World of Evolving Global Life Sciences Landscapes Welcome to the 2025 edition of Chambers and Partners’ Life Sciences Global Practice Guide. As the new contributing editor for this publica- tion, I wish to express my gratitude to colleagues for their expert contributions to this Guide. They have collectively covered the latest develop- ments in a wide range of regulatory compliance, legal and policy issues in their respective juris- dictions. In addition, I wish to take the opportu- nity to make a few opening remarks. The life sciences and healthcare sector rep- resents a major knowledge-based global economy. It is anticipated to grow to approxi- mately USD4 trillion by 2033, poised for some breath-taking technological and medical trans- formations, driven by digitalisation and by the increasing convergence of biological, physical and computer sciences to expedite identification of novel therapeutic targets, novel materials, and new methodological approaches to evaluating the safety, quality, and clinical effectiveness of innovations. Post-pandemic challenges March 2025 marks nearly five years since the World Health Organization (WHO) officially declared the COVID-19 pandemic, beginning one of the most challenging periods in recent times. The pandemic also tested the resilience of the life sciences and healthcare sector at all lev- els. The sector has adapted its practices – and continues to do so – through increased agility and collaboration, spanning the full spectrum of R&D as well as healthcare delivery activities. The industry has begun to stabilise after the WHO lifted the global public health emergency status for COVID-19, given that the disease is now con- sidered to be ongoing and well established. Yet

now the world is confronted with a new wave of macroeconomic challenges such as high infla- tion and the rise in energy prices. Geopolitical friction is the new frontier that has contributed to the faltering of economic growth. Many eco- nomic commentators have remarked that high geopolitical risk has been associated with lower equity returns and higher forecast volatilities, as well as uncertainty in investment decisions. The Institute of International Finance has indicated that the global debt levels are extraordinarily high, with USD60 trillion added since 2020. The life sciences sector is not immune to these exis- tential economic vulnerabilities. Trade policy changes under new Trump administration The second term of the Trump administration in January 2025 – overseeing the world’s largest national economy and leading global trader – has started with some significant trade policy changes to achieve the USA’s economic and trade-related objectives. The Trump admin- istration has justified such trade measures as rebalancing the country’s large and persistent annual trade deficit in goods, where closed mar- kets abroad have reduced US exports and open markets in the USA have resulted in significant imports. These changes have already sent shockwaves around the world, as the new trade policy has broken with decades of free trade policy – in rec- ognition of globalisation, which involves increas- ing integration of economies around the world – by imposing tariffs on a number of key eco- nomic regions, including the USA’s traditional allies. At the time of writing (April 2025), the new US President famously considered 2 April 2025 as the “tariffs day”/“liberation day” on which the new tariffs will be enacted unless the tariff and non-tariff barriers are equalised.

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INTRODUCTION Contributed by: Lincoln Tsang, Ropes & Gray LLP

EU countermeasures The EU and the other US allies have already introduced a series of countermeasures. Trade measures and countermeasures were imposed by the EU (in 2018 and 2020 respectively) dur- ing the first Trump administration, primarily in response to the US tariffs on European steel and aluminium exports. These EU countermeasures were structured into two sets of measures, each affecting different product categories. The EU measures and countermeasures introduced in 2018 and 2020 were subsequently suspended until 31 March 2025 or otherwise will be reacti- vated on 1 April 2025 to give the USA and the EU the opportunity to work out a longer-term solu- tion. In response to the new US trade measures on European goods of 12 March 2025, on the same day the EC defended European interests in response through two sets of counter-meas- ures – namely, the reimposition of the suspend- ed 2018 and 2020 rebalancing measures, and the imposition of a new package of additional measures. The EU’s trade countermeasures were initiated by the EC according to the EU Enforcement Regulation 2014, which enables the EU to sus- pend concessions or other obligations under international trade agreements with the inten- tion of rebalancing concessions or other obliga- tions in trade relations with third countries when the treatment accorded to goods from the EU is altered to such an extent that affects the EU’s interests. This rebalancing of concessions or other obliga- tions is permissible under international trade law as now reflected in EU law. Specifically, a mem- ber of the WTO can apply a safeguard measure or seek an extension of a safeguard measure based on objective criteria (defined in EU law) in order to suspend tariff concessions and to

impose new or increased customs duties. These objective criteria set out in EU law are: • effectiveness in inducing compliance of third countries with international trade rules; • potential to provide relief to economic opera- tors within the EU affected by third-country measures; • availability of alternative sources of supply for the goods concerned in order to avoid or minimise any negative impact on downstream industries, contracting authorities, entities, or final consumers within the EU; • avoidance of disproportionate administrative complexity and costs in the application of the measures; and • any specific criteria that may be established in international trade agreements. Impact on life sciences and healthcare sector The uncertainty surrounding the trade tariffs will likely increase the costs on goods and hence increase price spikes, disrupt the supply chains, and bring about serious supply shortages. This is particularly impactful for the life sciences and healthcare sector, which has relied upon on international trade and an interconnected global economy in order to research, develop and manufacture healthcare products – particu- larly essential and critical medicines, as well as healthcare products that global citizens have taken for granted. Supply shortages will have seriously momentous consequences on public health and patient care. The COVID-19 pandem- ic also emphasised the increasing interdepend- ency and interconnectivity of various geograph- ical regions in providing raw materials for the manufacture and distribution of critical public health countermeasures for hospitals, including prophylactic vaccines and personal protective clothing.

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INTRODUCTION Contributed by: Lincoln Tsang, Ropes & Gray LLP

Moreover, the trade wars will hurt the ongoing global development of AI and digital health. Tariff and export control policies will have much larger effects on AI hardware supply chains. Industry has already responded by urging the Trump administration and the EU to exclude medical products from expanding tariff wars, in the hope of avoiding price increases and supply shortages. On 2 April 2025, President Trump issued an executive order (the Reciprocal Tariffs Execu- tive Order) imposing a reciprocal tariff of 10% at baseline on all US trading partners, effective 5 April 2025. An additional reciprocal tariff will be imposed on 57 countries, effective 9 April 2025. Annex II to the Reciprocal Tariffs Executive Order excludes certain named medicines or categories of medicines – as well as key ingredients used in drug formulation – from the reciprocal tariffs. However, it is not apparent that the exclusion applies to medical devices and medical tech- nologies – although semiconductor devices and semiconductor-based transducers are excluded. Tariff relief for pharmaceuticals could be short-lived, as the Reciprocal Tariffs Execu- tive Order contemplates applying the so-called Section 232 investigation to pharmaceuticals alongside lumber, semiconductors, and other sectors. Sector-specific import duties could be on the horizon following such an investigation, given the declared Trump policy to strengthen the USA’s pharmaceutical manufacturing capac- ity so as to avoid relying on imported medicines. Following the President’s decision to pause many of the tariffs worldwide for 90 days, the EU suspended retaliatory counter-tariffs on 10 April 2025; however the interim measures do not remove the trade uncertainties.

The impact of commercial trade policies has not attracted a great deal of attention in the life sci- ences sector until very recently. This is largely because, since the late 1980s, key geographical regions – through the processes of the Interna- tional Council for Harmonisation (in the case of pharmaceuticals) and the Global Harmonisation Task Force (now rebranded as the International Medical Devices Regulatory Forum) – have striv- en to promote harmonisation efforts to standard- ise regulatory requirements in order to minimise friction in the transboundary movement of medi- cines and healthcare products. Changing role of USA in global public health The WHO also has a pivotal role in promoting global public health and global harmonization. The USA has been by far the biggest financial contributor to the WHO’s global health initia- tives, contributing circa USD960 million. On 20 January 2025, the executive order by the Presi- dent famously entitled “Withdrawing the United States from the World” gave official notice of the USA’s intention to withdraw from the WHO, citing grounds arising from the WHO’s mis- handling of the COVID-19 pandemic and other global health crises, its failure to adopt urgently needed reforms, and its inability to demonstrate independence from the inappropriate political influence of WHO member states. The significant leadership change in US health- care regulation will also likely result in potentially seismic legislative and policy regulatory policy changes, as well as challenge operational resil- ience in a number of key federal public health agencies. These can be globally impactful, given that the USA has significant influence on the global regulatory compliance landscape and has been instrumental in leading many interna- tional co-operative initiatives. Moreover, the new Trump administration has already declared its

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INTRODUCTION Contributed by: Lincoln Tsang, Ropes & Gray LLP

desire to trim down the government and reduce federal spending under the directions of the Department of Government Efficiency (DOGE). The new policy has already caused substantial rippling effects. The question will remain as to whether the USA will continue to play a global leadership role and maintain the treasured internal scientific exper- tise to usher the global public health and patient safety agenda. Only time will tell.

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AUSTRIA

Czech Republic

Germany

Slovak

Vienna

Austria

Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl Herbst Kinsky Rechtsanwälte GmbH

Hungary

Italy

Slovenia

Croatia

Contents 1. Life Sciences Regulatory Framework p.13 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices p.13 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation p.14 1.3 Different Categories of Pharmaceuticals and Medical Devices p.14 2. Clinical Trials p.15 2.1 Regulation of Clinical Trials p.15 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial p.15 2.3 Public Availability of the Conduct of a Clinical Trial p.17 2.4 Restriction on Using Online Tools to Support Clinical Trials p.17 2.5 Use of Data Resulting From Clinical Trials p.17 2.6 Databases Containing Personal or Sensitive Data p.18 3. Marketing Authorisations for Pharmaceuticals or Medical Devices p.18 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices p.19 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices p.20 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations p.21 3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations p.22 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices p.23 4. Regulatory Reliance and Fast Track Registration Routes p.24 4.1 Fast Track Registration Routes p.24 4.2 Regulatory Reliance p.24 5. Manufacturing of Pharmaceuticals and Medical Devices p.24 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices p.24 6. Distribution of Pharmaceuticals and Medical Devices p.25 3.1 Product Classification: Pharmaceuticals or Medical Devices p.18 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products p.19

6.1 Wholesale of Pharmaceuticals and Medical Devices p.25 6.2 Different Classifications Applicable to Pharmaceuticals p.26

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AUSTRIA CONTENTS

7. Import and Export of Pharmaceuticals and Medical Devices p.26 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies p.26 7.2 Importer of Record of Pharmaceuticals and Medical Devices p.26 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices p.27 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports p.27 7.5 Trade Blocs and Free Trade Agreements p.28 8. Pharmaceutical and Medical Device Pricing and Reimbursement p.28 8.1 Price Control for Pharmaceuticals and Medical Devices p.28 8.2 Price Levels of Pharmaceuticals or Medical Devices p.29 8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds p.29

8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices p.30 8.5 Regulation of Prescriptions and Dispensing by Pharmacies p.30

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AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH

Herbst Kinsky Rechtsanwälte GmbH has be - come one of Austria’s leading commercial law firms since its establishment in 2005. Its spe- cialised and highly committed lawyers combine many years of experience gained abroad and in reputable Austrian law firms. The firm’s prac- tice covers a full range of services in all areas of commercial, corporate, civil and public law, including banking, insurance and capital mar-

kets, corporate and M&A, IP, IT and life scienc- es, antitrust and competition, data protection, real estate, dispute resolution and arbitration. Herbst Kinsky Rechtsanwälte has established a particularly strong presence in the field of life sciences and healthcare. The firm’s clients range from large international privately held and publicly listed companies to SMEs, as well as start-ups. Michael Cepic joined Herbst Kinsky Rechtsanwälte GmbH as an associate in November 2023 and specialises in the areas of life sciences, IP, data protection law and litigation. Before joining Herbst Kinsky, Michael worked as a research associate at the University of Vienna contributing to biomedical and law enforcement research projects. In addition to his law degree, he holds a BSc in biology.

Authors

Sonja Hebenstreit is a partner at Herbst Kinsky Rechtsanwälte GmbH, which she joined in 2005. She specialises in the fields of intellectual and industrial property law, unfair

competition, life sciences and data protection. Sonja represents Austrian and international clients – including (biotech) start-ups and numerous pharmaceutical and medical devices companies – in a variety of regulatory, licensing and contractual issues, as well as in data protection, unfair competition and reimbursement matters.

Maximilian Kröpfl is an attorney at law and joined Herbst Kinsky Rechtsanwälte GmbH in October 2023. He specialises and advises clients in the areas of data protection law, IT and

technology, intellectual property and unfair competition. Before joining Herbst Kinsky, he worked for an Austrian telecommunications company, served as an accredited parliamentary assistant to a member of the European Parliament, and practised as an associate in two renowned Vienna law firms.

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AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH

Herbst Kinsky Rechtsanwälte GmbH Dr Karl Lueger Platz 5

Vienna A-1010 Austria Tel: +43 1 904 21 80 Fax: +43 1 904 21 80 210 Email: office@herbstkinsky.at Web: www.herbstkinsky.at

1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices Austrian law regarding medicinal products is heavily influenced by European Union legisla- tion. The primary national legal framework for pharmaceuticals (referred to as “medicinal prod- ucts”) intended for human use is the Austrian Medicinal Products Act ( Arzneimittelgesetz , or AMG). This act incorporates the key provisions of EU legislation, particularly Directive 2001/83/ EC. As of 28 January 2022, medicinal products intended for veterinary use are regulated by the Regulation on Veterinary Medicinal Products (Regulation (EU) 2019/6). Starting in January 2024, the new Austrian Veterinary Medicinal Products Act ( Tierarzneimittelgesetz ) has sup- plementd this regulation in Austria. Specific provisions in relation to medicinal prod- ucts can also be found in other Austrian laws, such as the Austrian Pharmaceutical Products Import Act ( Arzneiwareneinfuhrgesetz , or AWEG)

or the Austrian Prescription Act ( Rezeptpfli - chtgesetz ). Furthermore, the manufacture and distribution of medicinal products is governed by several national ordinances ( Durchführungs- verordnungen ), which are based on the AMG, including the Medicinal Products Operations Ordinance ( Arzneimittelbetriebsordnung , or AMBO). Medicinal products law is also increasingly regu- lated by directly applicable EU regulations – for example, Regulation (EC) 726/2004 (see 3.4 Procedure for Obtaining a Marketing Authorisa- tion for Pharmaceutical and Medical Devices), Regulation (EU) 536/2014 (“Clinical Trials Regu- lation”, or CTR), and Regulation (EC) 1394/2007 (“Advanced Therapy Medicinal Products Regu- lation”, or ATMPR). As of 26 May 2021, medical devices have mainly been governed by the Regulation (EU) 2017/745 (“Medical Devices Regulation”, or MDR), which is complemented by the Austrian Medical Devic- es Act 2021 ( Medizinproduktegesetz , or MPG) providing for rules regarding the safety, function- ality and quality of medical devices with regard to their construction, operation, use and main-

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AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH

1.3 Different Categories of Pharmaceuticals and Medical Devices In Austrian medicinal products law, various cri- teria exist based on which medicinal products are categorised and regulated differently. By way of an example, the AMG distinguishes between medicinal products available for the patient only upon prescription and over-the-counter (OTC) medicinal products available without prescrip- tion. Medicinal products requiring prescription may not be advertised to the general public (“laymen”) but, rather, only to healthcare pro- fessionals under the preconditions laid down in the AMG. The AMG makes another relevant distinction between medicinal products that are, in princi- ple, subject to marketing authorisation – known as “medicinal specialities” ( Arzneispezialitäten ) – and medicinal products not subject to such authorisation. Furthermore, the AMG differenti- ates on the basis of the material composition of a medicinal product (eg, biological medicinal products, herbal medicinal products, radioactive medicinal products, or homoeopathic medicinal products). Likewise, the Ministry of Health may qualify medical devices as requiring a prescription or as only available through certain specialised dealers. Prescription-only medical devices may not be advertised to the general public, either. However, in practice, the vast majority of medi- cal devices are freely available and not qualified as prescription-only or are exclusively available in specialist stores. There is an important distinction between in-vit- ro diagnostic (IVD) devices, which are governed by the In Vitro Diagnostic Regulation (IVDR), and other medical devices, which fall under the Medical Device Regulation (MDR). Additionally,

tenance. Since 26 May 2022, in vitro diagnostic (IVD) devices have been governed by Regulation (EU) 2017/746 (“In Vitro Diagnostics Regulation”, or IVDR), which is likewise complemented by the MPG. The MPG came into force on 1 July 2021 for medical devices and on 26 May 2022 for IVD devices. The competent national authority for medicinal products, medical devices and IVD devices is the Austrian Federal Office for Safety in Healthcare ( Bundesamt für Sicherheit im Gesundheitswes- en , or BASG). The BASG is responsible for the approval and control of medicinal products in Austria and the control and approval of clinical trials (see 2.2 Procedure for Securing Authori- sation to Undertake a Clinical Trial ). Together with the competent European agencies, the BASG further monitors at the national level the medicinal products, medical devices, and IVD devices already on the market in terms of their efficacy, safety, production, transport, and stor- age. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation Decisions by regulatory bodies qualify as spe- cific administrative acts ( Bescheide ), which can be challenged by the addressee – or by a (third) party having a legal interest, if applicable – by lodging an appeal with the regulatory body that issued the administrative act. The decision on the appeal is made by the competent adminis- trative court. Appeals against administrative acts must be made in writing and – unless the respective regulation provides otherwise – filed within four weeks of the date of the decision to be chal- lenged. The appellant is not legally obligated to be represented by an attorney.

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AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH

the MDR and IVDR categorise devices based on their purpose or use, such as active devices, implantable devices, invasive devices, or single- use devices. They also classify devices accord- ing to their inherent risks: • medical devices are classified into Classes I, IIa, IIb, and III; while • IVD devices are categorised into Classes A, B, C, and D. As of 1 February 2022, the regulatory system for clinical trials of medicinal products underwent a comprehensive restructuring aimed at further harmonising the rules on the conduct of clini- cal trials within the EU member states. The legal framework of clinical trials on medicinal products is now essentially defined by the CTR, thereby replacing the former system for clinical trials based on Directive 2001/20/EC. Supplemen- tary provisions for national implementation and within the scope of so-called opening clauses of the CTR have been introduced into the Austrian legal system through the AMG. 2. Clinical Trials 2.1 Regulation of Clinical Trials If genetically modified organisms (GMOs) are used for therapeutic purposes – as defined in Section 4(24) of the Austrian Gene Technology Act ( Gentechnikgesetz , or GTG) – in the course of a clinical trial, a prior permit according to Sec- tion 74 of the GTG must also be obtained. Clinical trials of medical devices (known as “clin- ical investigations”) are mainly regulated by the MDR and clinical trials of IVD devices (known as “performance studies”) are regulated by the IVDR. Supplementary provisions have been included in the MPG.

For non-interventional studies, the CTR and the MDR/IVDR provisions do not apply. Instead, there are specific national provisions in the AMG and the MPG for these studies, including provi- sions concerning data protection and inspec- tions by the BASG. The following may also apply: • general provisions of civil, criminal and data protection law; or • specific rules for clinical research under, for example, the Austrian Hospital and Sanatoria Act ( Krankenanstalten- und Kuranstaltenge- setz , or KAKuG) or the Austrian University Act 2002 ( Universitätsgesetz , or UG). 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial Since 31 January 2023, all new applications for clinical trials of medicinal products must be submitted in accordance with the CTR. The authorisation procedure is initiated by the spon- sor sending the application dossier to the EU member states concerned via the EU portal, known as the Clinical Trials Information System (CTIS). The reporting member state must then carry out a validation within ten days and notify the sponsor via the portal of the results. In Aus- tria, the BASG is responsible for the validation procedure, whereby the ethics committee can issue an opinion on certain parts of the applica- tion (Section 31, paragraph 4 of the AMG). The validation procedure is followed by the evalua- tion procedure, which is divided into two parts. • Part I is a co-ordinated assessment of the application between the reporting and con- cerned member states takes place, in which aspects of the clinical trial – such as whether it is minimally interventional, the expected therapeutic and public health benefits, and the risk of harm posed to the trial subjects – are evaluated. The assessment report must

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AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH

be prepared and submitted within 45 days of validation; however, this term may be extend- ed under certain conditions. The responsi- bilities regarding Part I of the assessment procedure are divided nationally between the BASG and an assessing ethics committee (Section 35 of the AMG). • Part II of the evaluation procedure includes the aspects to be assessed nationally by each member state – for example, require- ments for informed consent, patient recruit- ment, and subject insurance. The evaluation report must also be submitted within 45 days of validation. In Austria, the responsibility for preparing the assessment report in Part II is assigned to the evaluating ethics committee. The decision to authorise the clinical trial must then be taken by each member state within five days of the conclusion of the evaluation proce- dure. If a timely notification is not made, the con- clusion regarding Part I of the assessment report is automatically deemed to be the decision of the respective member state. The approval of a clinical investigation into a medical device for the purposes of the conform- ity assessment referred to in Article 62, para- graph 1 of the MDR essentially follows the MDR. Depending on the type of investigation, different procedures are provided for (eg, authorisation procedure/notification procedure/instruction procedure). An application for authorisation must be submit- ted electronically to the BASG. Upon receipt of the application, the BASG must carry out the validation within ten days. With regard to Class I investigational devices or Class IIa/IIb non-invasive devices, the clinical investigation may be commenced immediately

after validation – provided that the BASG has confirmed proper notification and the ethics committee has given a favourable opinion (ie, notification procedure). In the case of other investigational devices (Class III investigational devices or Class IIa/IIb invasive devices), the clinical investigation may only commence after notification of the authori- sation by the BASG – again with the prerequisite that a favourable opinion by the competent eth- ics committee must be provided. The decision about the authorisation must usually be commu- nicated to the sponsor within 45 days of valida- tion (ie, authorisation procedure). For clinical investigations of medical devices that already bear a CE marking, thereby confirming conformité européenne (“European conformity”), a different procedure applies under certain con- ditions (Article 74 MDR). The sponsor must notify the BASG of the conduct of such investigation at least 30 days before it begins. In this case, the BASG will confirm the notification without further subsequent assessment (ie, information procedure). Clinical investigations of medical devices for other purposes than the demonstration of con- formity are also subject to prior approval by the BASG if they have an impact on the diagnostics and/or therapy of a trial subject (Article 82 of the MDR, in conjunction with Section 13, paragraph 3 of the MPG); otherwise, it is only necessary to conduct an information procedure. For performance studies on IVD devices, the provisions of the MPG are largely applicable mutatis mutandis – although there are certain exceptions (see Article 66 et seq of the IVDR and Section 36 of the MPG for comparison).

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AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH

2.3 Public Availability of the Conduct of a Clinical Trial For medicinal products, information on clinical trials initiated under the CTR as of 31 January 2022 (including the start and end dates of the tri- al, details of the sponsor, and trial results) is pub- licly available on the EU Clinical Trials website. Information on clinical trials initiated under the former system of Directive 2001/20/EC (before 31 January 2022) may still be accessed via the EU Clinical Trials Register. No publicly accessible register is currently provided at the EU or national level for clinical investigations and performance studies under the MDR and the IVDR. However, information on such trials will be accessible via the EUDAMED database as soon as the entire EUDAMED sys- tem has been declared fully functional. At the national level, the legislator did not exer- cise the option to provide for the maintenance of a (publicly accessible) register for non-interven- tional studies of medical devices via ordinance. 2.4 Restriction on Using Online Tools to Support Clinical Trials In Austria, it is not generally prohibited to con- duct the consent procedure remotely or to remotely supervise certain tasks/procedures carried out at home by a physician. Remote access to source data for the purpose of moni- toring is also permissible; however, this only applies to original electronic medical records and where a correspondingly validated record system is being used. In December 2022, the EU Decentralised Clinical Trial (DCT) project team published a recommen- dation paper on decentralised (remote) elements in clinical trials. The team comprises experts from the Clinical Trial Coordination Group, the

Clinical Trial Expert Group, European Medicines Agency (EMA) scientific committees, EMA work- ing parties, and EMA staff. This document also includes guidance concerning national provi- sions on the use of online tools in clinical stud- ies within the EU. As regards special measures due to COVID-19, see 11.2 Special Measures Relating to Clinical Trials . 2.5 Use of Data Resulting From Clinical Trials Clinical studies involve the processing of patients’ contact and health information, which qualify as personal data as defined by Article 4(1) of the General Data Protection Regulation (EU) 2016/679 (GDPR). To the extent that patients are identified or at least identifiable in data resulting from the clinical trial, these data sets must also be qualified as special categories of personal data (sensitive data). The processing of personal data in the context of a clinical trial is generally based on the patient’s consent pursuant to Article 6, paragraph 1(a) – in the case of sensitive data in conjunction with Article 9, paragraph 2(a) – of the GDPR. Accord- ingly, any disclosure of personal data to third parties must be covered by this consent. Furthermore, personal data can also be pro- cessed in the course of scientific research on the basis of the Austrian Research Organization Act ( Forschungsorganisationsgesetz , or FOG), pro- vided that the processing methods mentioned there, such as anonymisation or pseudonymisa- tion, are concerned (Article 2(2)(1) FOG).

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AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH

2.6 Databases Containing Personal or Sensitive Data The processing of personal data (including sen- sitive data) within databases is subject to com- pliance with the GDPR, (potentially) the FOG and the Austrian Data Protection Act ( Datens- chutzgesetz , or DSG). 3. Marketing Authorisations for Pharmaceuticals or Medical Devices 3.1 Product Classification: Pharmaceuticals or Medical Devices The distinction between medicinal products and medical devices is made in accordance with the product definitions as outlined in the AMG (Sec- tion 1, paragraph 1) and the MDR (Article 2(1)). “Medicinal products”, within the meaning of the AMG, are substances or preparations of sub- stances that either: • are intended for use in or on the body and as agents with properties to cure or alleviate or prevent diseases or pathological complaints (so-called presentation medicinal products); or • may be applied in or on the body or adminis- tered to a human (so-called functional medici- nal products) with a view to either: (a) restoring, correcting or modifying physi- ological functions by a pharmacological, immunological or metabolic action; or (b) making a medical diagnosis. According to the MDR, the term “medical device” means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human

beings for one or more of the following specific medical purposes, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means: • the diagnosis, prevention, monitoring, predic- tion, prognosis, treatment or alleviation of disease; • the diagnosis, monitoring, treatment, alle- viation of, or compensation for, an injury or disability; • the investigation, replacement or modifica- tion of the anatomy or of a physiological or pathological process or state; and • for providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tis- sue donations. Furthermore, devices for the control or support of conception and certain products specifi- cally intended for the cleaning, disinfection or sterilisation of devices will be deemed medical devices. The distinction between medicinal products and medical devices can be made, in most cases, on the basis of the principal mode of action of the product (see Article 1, paragraph 6(b) of the MDR). A product with an essentially pharma- cological, immunological or metabolic action should not be classified as a medical device. The principal mode of action of medical devices is mostly of a physical or mechanical kind. In the case of diagnostic devices, distinction must be made on the basis of the nature of the product (substance/instrument, apparatus, etc) and the place of application (in vivo or in vitro).

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AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH

In Austria, manufacturers of products (or their representatives) may initiate a procedure with the BASG, whereby questions concerning the product classification – including the demar- cation between the medicinal product and the medical device status of the product – will be clarified (Section 10 of the MPG and Section 49a of the AMG). 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products Within the meaning of the AMG, the term “bio- logical medicinal products” comprises: • certain immunological medicinal products; • certain medicinal products manufactured by using human blood or blood plasma as a starting material; and • medicinal products listed in Annex I (1) and (1a) Regulation (EC) 726/2004, such as: (a) medicinal products developed by means of recombinant DNA technology, con- trolled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes (including transformed mammalian cells), or hybridoma and monoclonal antibody methods; and (b) ATMP. Austrian law does not provide for a marketing authorisation procedure specific to biological medicinal products. However, for medicinal products listed in Annex 1(1) and (1a) Regulation (EC) 726/2004, a central marketing authorisation according to said regulation is mandatory. In addition, differences with regard to the required application documents may arise for different types of biological medicinal products. Furthermore, the AMG contains specific pro- visions for certain immunological medicinal products, as well as medicinal products manu-

factured by the use of human blood or blood plasma. According to Section 7, paragraph 8 of the AMG, for example, blood and blood compo- nents intended for direct transfusion are exempt from the obligation to obtain a marketing author- isation. Also, a batch release may be required as a prerequisite for supplying certain biological medicinal products in national Austrian law (see Section 26 of the AMG). Lastly, specific provi- sions for so-called biosimilars can be found in Section 10, paragraph 6 of the AMG. 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices The BASG generally grants a national market- ing authorisation of a medicinal product for a period of five years (Section 20, paragraph 1 of the AMG). An extension of the marketing authori- sation (at the request of the marketing authori- sation holder) is valid without a time limit unless the BASG again sets a time limit of five years for reasons of pharmacovigilance. If an authorised medicinal product has not actu- ally been placed on the domestic market within three years of the marketing authorisation being granted or has not been on the market for three consecutive years, the marketing authorisation may expire in accordance with Section 22 of the AMG (the so-called sunset clause). In cer- tain cases, the marketing authorisation must also be revoked. Similar rules apply according to Regulation (EC) 726/2004 with regard to the period of validity of marketing authorisations for medicinal products authorised under the cen- tralised procedure. The placing on the market of medical devices is not subject to a marketing authorisation; however, the manufacturer must perform a con- formity assessment procedure (see 3.4 Proce-

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AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH

dure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices ). According to Article 56 of the MDR, certificates of conformity issued by the notified bodies will be valid for the period they indicate, which must not exceed five years. Upon application by the manufacturer, the validity may be extended for further periods (of no more than five years), based on a re-assessment. The CE marking will be suspended, restricted or withdrawn if a noti- fied body finds that the manufacturer no longer meets the requirements of the MDR. 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices Marketing Authorisation for Medicinal Products There are, in practice, four different procedures for obtaining a marketing authorisation for medicinal products. • Marketing authorisation must be obtained via the centralised procedure for medicinal prod- ucts according to Annex I Regulation (EC) 726/2004 (eg, ATMP). Under certain condi- tions (see Article 3, paragraph 2), the cen- tralised procedure is also available for other medicinal products. A marketing authorisation obtained under the centralised procedure is issued by the European Commission and is valid in all EU member states. Applications must be submitted to the EMA. • For other medicinal products, marketing authorisation may be obtained under the national procedure according to Sections 7 et seq of the AMG via application to the BASG. The BASG is also the competent authority for issuing the national marketing authorisation, which is only valid on Austrian territory. • Where a national authorisation already exists in a member state, it may be extended to the

territory of other member states through a mutual recognition procedure (Section 18a of the AMG). • For medicinal products that cannot be authorised under the centralised proce- dure, marketing authorisation in different EU member states may be applied for through a decentralised procedure (Section 18a of the AMG). Variations to marketing authorisations Variations to marketing authorisations are gov- erned by Regulation (EC) 1234/2008 for all types of authorisations. Depending on the degree of health risk and the impact on quality, safety and efficacy, either a simple notification procedure, a notification obligation with a prohibition reserva- tion or a prior authorisation procedure is required. In contrast, applications for authorisation exten- sions (eg, in the case of relevant changes to the active substance) must be evaluated according to the same procedure as the application for the original authorisation. Transfers of marketing authorisations Transfers of marketing authorisations obtained through the centralised procedure must be requested from the EMA in accordance with the guidelines established in Regulation (EC) 2141/96. If this process is not followed, then Section 25 of the AMG applies. According to this section, a waiver declaration of the authorisa- tion from the previous marketing authorisation holder and an acceptance declaration from the new holder (transferee) must be submitted to the BASG. Medical Device and IVD Device Compliance Placing medical devices and IVD devices on the market is not subject to obtaining a marketing authorisation; however, medical devices or IVD devices may only be placed on the market or

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AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH

put into service if they comply with the MDR/ IVDR. Specifically, they must meet the general safety and performance requirements, taking into account their intended purpose. Also, an assessment of the conformity of the device must be conducted, and a corresponding declaration of conformity must be issued. Depending on the risk classification of a medical device, a notified body must be involved in the process. The CE marking of the product indicates conformity with the applicable requirements. Transfers of CE markings are not provided for in the MDR/IVDR. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations Medicinal Products As far as medicinal products are subject to a marketing authorisation, such marketing authori- sation is a prerequisite for lawful placing on the market in Austria. For this reason, opportunities to supply such medicinal products to patients without marketing authorisation are limited. Nevertheless, there are a number of exceptions to this principle. The following are among the exceptions to the authorisation requirement. • Named Patient Use (Section 8, paragraph 1(2) of the AMG) – no marketing authorisation is needed if a physician or dentist authorised to practise independently in Austria certifies that: (a) a medicinal product is urgently needed to prevent a threat to life or serious damage to the health of a specific patient; and (b) this threat or damage cannot be pre- vented with an authorised and available medicinal product according to the state of the art. • Compassionate Use Programmes (Section 8a of the AMG and Article 83 of Regulation (EC) 726/2004) – marketing authorisation is

not needed within Compassionate Use Pro- grammes, which may be established (subject to prior approval by the BASG) for a defined group of patients suffering from a debilitating chronic or severe disease or whose disease is life-threatening and cannot be satisfacto- rily treated with an authorised and available medicinal product. • Clinical trials (Section 8, paragraph 1(1) of the AMG) – medicinal products intended for the use in non-clinical or clinical studies or clini- cal trials do not need a marketing authorisa- tion. • Hospital exemption (Section 7, paragraph 4 of the AMG and Article 28 of Regulation (EC) 1394/2007) – ATMP that are manufactured on a non-routine basis in Austria on the basis of an individual medical prescription specifi- cally for a particular patient, in order to be used on that patient in an Austrian hospital under the exclusive professional responsibility of a physician, are not subject to marketing authorisation. • Officinal and magisterial medicinal prepara- tions (Section 7, paragraphs 2 and 3 of the AMG) – certain medicinal products manufac- tured in pharmacies are not subject to mar- keting authorisation. Further exemptions are listed in Sections 7 et seq of the AMG. It should be noted that a marketing authorisa- tion is a prerequisite for placing medicinal prod- ucts on the market but not for their use. For this reason, medicinal products can, in principle, be used on patients beyond the scope of their marketing authorisation (off-label use). In this context, however, the physician has increased obligations to provide information to the patient.

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