Outlook for 2025

Trust in times of change

In a time of change and upcoming reforms, it is above all the people who make the difference. The next generation of lawyers – driven by a passion for law, exceptional talent, and immense dedication – gives us confidence. They provide the legal counsel that is currently needed and shape the future of our firm.

The generational shift at Haslinger / Nagele is not just a change in personnel – it is a commitment to both renewal and continuity. Thomas Riesz and Mario Laimgruber will join the Partnership in February, bridging the leading teams of our firm. At the same time, Cornelia Lanser and Sissy Weilharter will strengthen our ranks as newly appointed Attorneys-at-Law, further enriching our team with their expertise and commitment.

Another major milestone is the establishment of our new Life Sciences & Health Law practice team. With Alexander Hiersche, Thomas Riesz, Mathis Fister, Gisela Ernst and Dominique Korbel, this team stands for the values that characterize us: excellence, innovation and in- depth expertise.

In this section, our lawyers provide an outlook on key legal developments in their respective fields for 2025:

Digitalization – AI regulation places new responsibilities on companies

On February 2nd, 2025, the first phase of the AI regulation (“AI Act”) will take effect, marking the world’s first comprehensive regulation of artificial intelligence and ushering in a new era. Of particular practical relevance is the obligation to ensure AI literacy. This requirement mandates that companies developing, providing or using AI systems must ensure that their employees have sufficient knowledge in dealing with artificial intelligence. As a result, businesses will need to hold mandatory AI training courses or at least establish AI guidelines covering technical, legal, ethical, and application-specific AI knowledge. Additionally, from this date onward, AI systems with unacceptable risks, such as social scoring, will be prohibited.

Undoubtedly, the AI Act is a significant step forward, but it brings with it further obligations not only for developers, but also for commercial users. Non-compliance could lead to substantial fines from August 2nd, 2025. With an implementing law for the AI Act, the catalog of sanctions could even be expanded.

As the use of artificial intelligence continues to advance, the new AI literacy requirement will become relevant for a wide range of businesses. We are happy to support you in preparing for the requirements of the AI Act and implementing the necessary AI competency in your company.

Environmental procedures – EABG: Finally a Renewable Energy Expansion Acceleration Act?

Two years ago, the Renewable Energy Expansion Acceleration Act (EABG) was announced as a comprehensive measure to implement the European Renewable Energy Directive (RED III). In light of the climate and security crisis, it is encouraging that courts – most recently the Federal Administrative Court (BVwG) in connection with a project we represent – assume in direct application of RED III that renewable energy plants (including grid infrastructure) are in the overriding public interest and serve public health and safety. However, this alone is not enough. With the ideas developed in recent years – such as the first strategic environmental assessment for a power grid expansion in Austria supported by Haslinger / Nagele, successfully linking planning and project approval levels – the necessary tools are on the table to enact a comprehensive and sensible uniform framework for the expansion of renewables. The fact that this must (finally) happen in 2025 – whether in the form of the EABG, an Infrastructure Expansion Acceleration Act, an Economic Development Act, or under whatever name – is not a political question, but a matter of common sense.

Public procurement law – new requirements for sustainability and transparency

In 2025, the Net-Zero Industry Act (NZIA) will shape procurement practice in the above-threshold sector, introducing binding minimum requirements for environmental sustainability in the procurement of net-zero technologies, such as solar, wind, hydrogen, and hydropower technologies.

The new Heavy-Duty Vehicles Regulation (HDV-VO) will have a significant impact on the award of public contracts in the area of zero-emission city buses, contributing to the energy transition in transportation.

In addition, the Freedom of Information Act (IFG) will come into force on September 1st, 2025, which will present public contracting authorities with the challenge of meeting both the information and disclosure obligations under the IFG and the protection of confidential data such as business secrets of applicants and bidders when publishing information.

Public economic law – EU product law – also in full swing in 2025

The end of 2024 saw intense legislative activity in the area of EU product law: In mid-November 2024, the new Product Liability Directive (EU) 2024/2853 was published, which must be transposed into national law within two years. In December 2024, not only did amendments to the CLP Regulation (EC) 1272/2008 on the classification, labeling, and packaging of substances and mixtures come into force, but also the new General Product Safety Regulation (EU) 2023/988, which is directly applicable as a regulation.

In 2025, the legal framework for the safe circulation of products on the European market – particularly to protect human health and the environment – will continue to be expanded. This will begin with the EU Packaging Regulation, for which the necessary Council decision is imminent. Further legislative acts and amendments are already in the pipeline, making it crucial to stay up to date.

Life sciences & health law – the AI Act gains traction in practice

– and in the healthcare sector too. What does this mean for industry players?

On February 2nd, 2025, the time has come – the first provisions of the AI Act will take effect. As AI is now used in practically all areas of healthcare – from healthcare administration to the diagnosis of diseases and drug development – far-reaching impacts for the healthcare industry are to be expected:

The AI Act regulates the application of AI comprehensively, affecting not only those offering AI systems in the EU but also the users. It distinguishes between four risk categories: 1) prohibited AI systems with unacceptable risk, 2) high-risk AI systems, 3) systems with limited risk and 4) systems with minimal risk. Medical AI applications will most often fall into the category of high-risk AI systems, for which a conformity assessment is necessary and comprehensive requirements apply, such as with regard to data quality, transparent use and human supervision of the system. Violations can result in penalties of up to €35 million or 7% of annual turnover. Additionally, there is a complex interplay with other existing regulations, such as the GDPR or (if qualified as a medical device) the Medical Device Regulation (MPVO).

To be prepared for these new challenges, but also to be able to make optimum use of the innovative potential, it is essential to engage with the new regulatory framework immediately.

Intellectual property protection – 2025 brings new changes, not just good intentions

The EU has adopted a comprehensive reform of design law, which includes both the Design Directive 2024/2823 (to be transposed into national law) and the directly applicable Design Regulation 2024/2822. This reform aims to modernize and simplify design protection in the EU.

The outdated term “Community Design” has been replaced with “Union Design;” however, the term “design” is now predominantly used both nationally and in practical use by the European Union Intellectual Property Office. The registered design has also been redefined and now also includes digital and virtual manifestations, including dynamic, flowing or animated representations. This allows for the protection of designs that involve movement or changes of state and thus takes into account technological innovations, such as digital designs and virtual products.

A significant innovation is the introduction of a repair clause that harmonizes design protection for visible spare parts. This clause allows third parties to use design rights to restore the original appearance of a complex product by repairing it without having to obtain the consent of the design owner. This is intended to promote competition in the spare parts market and make cost-effective repairs more accessible to consumers.

The regulation will come into force on May 1st, 2025, and will be directly applicable in all EU member states. The Design Directive must be transposed into national law by December 9th, 2027.

Commercial law – sustainability reporting

To implement Directive (EU) 2022/2464 regarding sustainability reporting by companies, a ministerial draft of the Sustainability Reporting Act (NaBeG) is currently available. Members of civil society and other interested parties will be able to better understand the impact of the company’s activities on sustainability aspects and the impact of sustainability aspects on the company’s business performance, financial results and position by having access to relevant information. The ministerial draft stipulates that in the future, “large companies” and “companies of public interest” include information on reporting on sustainability aspects in the management report in a clearly recognizable section provided for this purpose. This aims to give sustainability reporting the same importance as financial reporting.

Environmental law – everything new in contaminated site remediation

Contaminated site remediation has been revamped with the ALSAG Amendment 2024.

While measures for the securing and remediation of contaminated sites were previously approved under the WRG 1959, AWG 2002, and GewO 1994, as of January 1st, 2025, independent substantive and procedural law requirements of the ALSAG apply to contaminated site measures.

The new regulations, in line with the principle of remediation, require that both risk assessment and the setting of remediation goals for contaminated site measures consider site- and usage-specific factors. In addition, the revitalization of former industrial and commercial sites will now be more strongly promoted to counteract land consumption in Austria.

Life Sciences & Gesundheitsrecht – Änderungen im Pharmarecht

2025 will also be an exciting year in the pharmaceutical industry. Significant changes to pharmaceutical legislation (EU pharma legislation) are set to be negotiated. This involves nothing less than improving access to innovations, reducing bureaucratic hurdles, accelerating approval processes, and combating antimicrobial resistance, to name just a few key points of the envisaged reform. Further details of the comprehensive drafts are expected to be clarified in 2025 under the Polish presidency of the Council of the European Union. This EU pharma package represents the largest regulatory reform in two decades.

Gisela Ernst discusses some of the planned changes in a recent blog post.

State aid law – COVID-19 subsidies – let’s do it again!

In the summer, the Republic of Austria took over the tasks of the COVID-19 Federal Financing Agency (COFAG) – regulated by the COFAG Reorganization and Liquidation Act. This has various implications for subsidy applicants and recipients.

Claims for performance due to unpaid COVID grants must now be made against the Republic of Austria. Where payments were refused based on unlawful funding guidelines (the Constitutional Court annulled certain provisions), the question of public authority liability also arises.

COFAG’s claims for repayment are now to be enforced by the tax authorities. Formerly civil law repayment claims have suddenly become public law reimbursement claims, with long limitation periods and high interest charges. Does this also apply to claims for repayment under civil law that are already time-barred? Constitutional concerns are warranted.

And speaking of constitutional law: Many provisions in funding guidelines are still being examined by the Constitutional Court – decisions in this area will provide further clarity for current funding instruments and for the constitutional and state aid law-compliant design of future funding instruments.

ESG & compliance – 2025: a year of challenges and opportunities

2025 will bring significant developments in the area of ESG and compliance. New requirements, such as the Corporate Sustainability Due Diligence Directive (CSDDD), the expanded sustainability reporting obligations (CSRD) and the EU Deforestation Regulation (EUDR), will significantly increase the obligations for companies. At the same time, personal liability for management and board members is increasing.

Companies must systematically integrate sustainability and due diligence obligations in order to minimize legal risks and secure competitive advantages. Adapting to rising standards in a timely manner not only offers compliance security, but also strategic opportunities in a sustainable business world.

Take action now to future-proof your ESG strategy! We will be happy to support you. Stay updated on the latest developments here:

Update on EU-Russia sanctions

Shell exempt from CO2 reduction – a setback for climate protection?

White-collar crime law – cellphone seizure and other changes in criminal proceedings

On December 27th, 2024, a long-awaited and far-reaching reform of the Code of Criminal Procedure was passed. Cellphone seizure, which had been discussed extensively in the media for over a year, was finally passed into law. The aim was to establish a constitutionally compliant framework for how law enforcement authorities can access electronic storage devices and utilize the information they contain.

Beyond this, the reform also introduces far-reaching improvements for victims of property crimes. A previous legal loophole has been closed, now allowing public prosecutors and courts to distribute funds from bank accounts directly to victims.

Finally, the legislature has also sought to address media criticism regarding excessively long proceedings, particularly in white-collar crime cases. As a general rule, the maximum duration of the preliminary proceedings has been reduced to two years. Additionally, previous minimum waiting periods for filing a request to terminate an investigation have been removed. However, whether these changes will actually lead to faster proceedings remains controversial and will become apparent in the years to come.

Disclaimer

This article is for general information only and does not replace legal advice. Haslinger / Nagele Rechtsanwälte GmbH assumes no liability for the content and correctness of this article.

 

27. January 2025

 

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