Publications

Introduction The question if a self-employed person should qualify as an employee remains a hot topic. Qualification as an employee can have far-reaching consequences, such as the obligation to pay premiums and payroll taxes retroactively, as well as dismissal protection, continued salary payment during illness, vacation days and vacation allowance. Should pension premiums also be paid retroactively? Pension as a condition of employment The principle of the Pension Act is that an employer is not obligated to offer a pension to his employees. Nevertheless, an employer may involuntarily be bound to a pension plan, for example because a collective bargaining agreement requires it or because an industry pension fund is compulsory. Retrospective premium obligation? Employers operating in sectors in which employees are entitled to pensions under a collective bargaining agreement or a compulsory industry pension fund might face retrospective liability for past pension contributions if a self-employed person is deemed to be an employee. After all, for pension funds, the premium is due even if an employee was not yet registered. The North Holland District Court recently ruled on a case in which an employee was employed as an employee from 1 January 2022, having first worked as a self-employed person for the company from 1 January 2016. He had always done the same work as other employees, who had always accrued pension benefits. The employee in question had also accrued a pension since 1 January 2022. The employer had offered the pension scheme to its employees without obligation. Was the self-employed worker now entitled to pension accrual retroactively from 1 January 2016? The court ruled that there was no legal basis for the retroactive payment of pension benefits in this particular case.  Practical tips Although the consequence of a self-employed person being classified as an employee does not always result in pension premiums being due retroactively, employers would do well to take into account the risk of pension premiums being due when assessing the risks of hiring self-employed persons, and to make organisational, financial and/or contractual provisions for this if necessary. Contact Do you have questions about pension in case of self-employment or would you like to exchange views? Please feel free to contact Jaap Harrijvan or one of our other employment law specialists.

On 14 May 2025, the Administrative Division of the District Court of The Hague (‘the Court’) rendered its decision in  proceedings between Boehringer Ingelheim Vetmedica GmbH (‘Boehringer’) and the Dutch Patent Office (Octrooicentrum Nederland, ‘OCNL’). The Court upheld OCNL’s refusal to grant an SPC for a veterinary medicinal product containing the active ingredient ciclesonide. This case is of particular interest as it clarifies that, for the purpose of determining the ‘’first’’ marketing authorisation (‘’MA’’) within the meaning of Article 3(d) of Regulation 469/2009 (‘’SPC Regulation’’) ,  no distinction is to be made between MAs granted for human or veterinary use. The Court considered it an acte éclairé based on the CJEU’s decisions in Santen (C-673/18) and Pharmacia (C-31/03).   What preceded Boehringer holds EP 2 934 479 (‘’EP 479), which claims the use of ciclesonide for the treatment of airway disease in horses. Boehringer markets its product under the brand name ‘Aservo’. EP 479 was granted on 19 September 2018 on the basis of an application filed in 2013. On 28 January 2020 Boehringer received the MA for its product Aservo (EU/2/I9/249). On 30 March 2005, an unrelated company to these proceedings, Covis Pharma Europe B.V., received a MA (RVG 31633) for the medicinal product containing the active ingredient ciclesonide used to control persistent asthma in adults and adolescents (aged 12 years and older). It was marketed under the brand ‘Alvesco’. On 22 June 2020, Boehringer filed an SPC application with OCNL based on EP 479 and its MA for Aservo. OCNL rejected Boehringer’s application, arguing that the veterinary MA could not be considered the “first MA” under Article 3(d) of the SPC Regulation in light of the earlier MA for Alvesco. Boehringer objected against that rejection. In April 2024 OCNL, declared Boehringer’s objection unfounded. Therefore, Boehringer appealed to the Administrative Division of the Court. Assessment of the Court – First MA The Court analyses the caselaw of the CJEU in order to answer the question how to interpret ‘’first MA’’ within the meaning of Article 3(d) of the SPC Regulation. First, the Court considers the interpretation given by the CJEU in Santen of the term ‘’product’’ under Articles 1(b) and 4 of the SPC Regulation, as exclusively referring to the active substance or combination of active substances, irrespectively of the therapeutic use or target species. The term “product” needs to be interpreted strictly. The first MA relates to the authorisation of a product containing the active substance or combination of active substances in question, regardless of the therapeutic application of the active substance(s) for which that MA was granted (see also CJEU decision Abraxis Bioscience (C-443/17)). The Court further refers to Pharmacia, in which the CJEU held that no fundamental distinction is to be made between human and veterinary medicinal products in applying the SPC Regulation. The difference in intended use (human or animal) is not a decisive criterion for the grant of an SPC. The Court observes that Boehringer’s reading of Neurim could not be reconciled with the CJEU’s subsequent judgments, particularly Santen, in which the Court expressly distanced itself from its decision in Neurim. According to the Court the text of Article 3(d) of the SPC Regulation is clear: the MA on which the SPC is based must be the first MA for marketing of the product. Both MAs relate to the same product, i.e. ciclesonide. For the interpretation of first MA it is irrelevant whether the MA has been granted for human or veterinary use. The SPC application for Aservo was correctly rejected. The Court concludes that the legal framework, as clarified by the CJEU, leaves no room for a broader interpretation and considers the matter an acte éclairé. There is no need refer the case to the CJEU for preliminary questions. Conclusion When assessing the meaning of first MA, as mentioned in Article 3(d) of the SPC Regulation, it is irrelevant to make a distinction between an MA granted for human or for veterinary use. If the active ingredient is the same, they both relate to the same product. The NL decision does not stand alone. Some of the courts in other EU states have followed the same line of reasoning when dealing with Boehringer’s SPC applications for Aservo. In France, the French Patent Office refused to grant the SPC, which decision was upheld by the Paris Court of Appeal on 17 January 2025. The court explicitly referred to Abraxis and Santen, confirming that a prior MA for human use precludes the grant of a subsequent SPC for veterinary use of the same active substance. In Germany, the application was likewise rejected by the German Patent and Trade Mark Office. An appeal is currently pending before the Federal Patent Court (Bundespatentgericht). Although SPCs have reportedly been granted in some other Member States, the NL Dutch Court observes that these decisions often lack explicit reasoning, may reflect different national administrative practices, and do not alter the uniform interpretation required under EU law.

The transition to a sustainable economy requires not only innovation and decisiveness, but also smart financing solutions. Two instruments that are playing an increasingly important role in this regard are green bonds and sustainability-linked loans (SLLs). In this blog, we explain what these forms of financing entail, what the legal considerations are and how we support our clients in this regard. What are green bonds? Green bonds are bonds whose proceeds are used exclusively for sustainable projects. Examples include the construction of a wind farm, making real estate more sustainable or investing in clean public transport. The issuer – often a company, bank or government – contractually commits to spending the money raised only on these green projects. A practical example: A Dutch developer issues a green bond to finance the construction of a new solar park. Investors, including local entrepreneurs and even private individuals, can thus be sure that their money is contributing to the (local) energy transition. Each year, the developer reports on progress and environmental gains, such as the amount of green electricity generated. What are sustainability-linked loans (SLLs)? SLLs are loans in which the interest rate or other conditions are linked to the borrower’s achievement of sustainability targets. What makes them special is that the borrowed money can be spent freely, but the borrower commits to achieving specific ESG targets, such as reducing CO2 emissions or increasing the proportion of women in management. Real-life example: An international manufacturing company takes out an SLL with a bank. The loan agreement stipulates that the interest rate will fall by 0.2% if the company manages to reduce its CO2 emissions by 15% within three years. If the target is not achieved, the interest rate will increase. This creates a financial incentive to do business sustainably. Legal considerations With both forms of financing, it is essential to set out the agreements clearly and in a verifiable manner. This includes: Clear definitions of ‘green’ projects or KPIs; Independent assessment and reporting; Consequences of not achieving the targets; Transparency towards investors and regulators. Our ESG team The lawyers in our ESG team are happy to advise on drafting and assessing these contracts, structuring the financing and complying with the increasingly stringent regulations in the field of sustainability. Our ESG project team combines in-depth knowledge of financing law with up-to-date insights into sustainability legislation. We advise on setting up green bonds and SLLs, from the initial exploration to closing and post-closing reporting. Want to know more? Would you like to know what green bonds or SLLs can do for your organisation, or do you have questions about the legal aspects? Feel free to contact our ESG project team. We are happy to work with you to find sustainable financing solutions that work in practice.

Blockchain: more than just hype Blockchain is often associated with cryptocurrencies such as Bitcoin, and that is only partly justified. Blockchain technology has a much broader scope. In the world of M&A, blockchain offers a disruptive force that can transform traditional processes. From streamlining due diligence to tokenising ownership certificates, blockchain offers concrete benefits that not only save time and money, but also increase security and transparency. For M&A professionals, investors and entrepreneurs, blockchain is no longer a futuristic concept, but a strategic tool that can fundamentally change the way transactions are carried out. Because of the potential of blockchain, we also use this innovative application within La Gro. In 2019, La Gro (Benjamin Niemeijer) was nominated for the Gouden Zandloper (Golden Hourglass) award for the issuance of share certificates via blockchain technology. What is blockchain and how does it work? Blockchain is a digital and decentralised ledger, similar to a digital database. Transactions can be recorded on the blockchain in a secure and transparent manner. Each transaction forms a ‘block’ of code. Once a block is full, it is added to a chain of previous blocks. Hence the term ‘blockchain’. This chain of data blocks is shared and validated by a network of users. This ensures that data cannot be manipulated. This makes blockchain reliable and transparent and offers enormous certainty about the accuracy of the data. Application of blockchain in M&A Blockchain has the potential to play an important role in the M&A process, where a lot of time is traditionally spent analysing and verifying data and where certainty about the accuracy of that data is crucial. Tokenisation: the new era of property transfer One of the most disruptive applications of blockchain in M&A is tokenisation. Tokenisation is the digitisation of ownership (proofs) (such as shares, real estate or other assets) in the form of tokens on a blockchain. This process offers a level of security and efficiency that traditional methods (such as notarial deeds and shareholder registers) cannot match. Smart contracts: automation of critical processes Smart contracts are digital agreements that are automatically executed once predefined conditions are met. In the M&A process, smart contracts can be used for escrow arrangements (the automatic release of funds once certain conditions are met) and earn-out agreements (relevant information for calculating earn-outs can be recorded on the blockchain). Suppose an earn-out depends on the turnover of an acquired company. By recording turnover data on the blockchain, all parties involved have access to the same, immutable data, making manipulation impossible. This provides certainty for all parties, largely prevents discussions about the accuracy of the figures and speeds up the settlement of the earn-out. Faster and more reliable due diligence The due diligence process is often one of the most time-consuming parts of an M&A transaction. Blockchain can significantly speed up this process through, among other things, transparency (data is shared via a blockchain-based data room, where all parties have access to the same, immutable information) and reliability (because data on the blockchain cannot be manipulated, buyers and sellers can rely on the accuracy of the information). This means that due diligence is not only faster, but also less prone to errors. For M&A professionals, this means significant savings in time and costs, while improving the quality of the process. Disruptive value of blockchain for M&A The application of blockchain in M&A is also relevant and valuable for the following aspects: Efficiency and cost savings: the old-fashioned process of maintaining shareholder registers and drawing up deeds of transfer is time-consuming, expensive and prone to human error. A shareholder register can get lost, be incomplete or contain incorrect numbers. Blockchain can eliminate the need for intermediaries such as notaries, drastically reducing transaction costs. Reliability, transparency and security: a blockchain-based register is up to date, immutable and, with a good system, always accessible and consultable. This prevents situations in which (shareholder) registers are incomplete or out of date. Flexibility: for companies that regularly want to transfer small amounts of (certified) shares (e.g. in the case of employee participation or interests in a fund), blockchain offers a fast and secure solution. Decentralisation: no more dependence on central parties such as notaries or banks. Immutability: data on the blockchain is permanent and cannot be manipulated. Accessibility: blockchain makes it possible to trade ownership and assets worldwide, without the limitations of traditional systems. A concrete example: using blockchain technology, share certificates can be transferred within seconds at minimal cost. This makes it easier for start-ups and other companies to attract investors, even for small amounts, because transaction costs are negligible and ownership rights are immediately established. Conclusion: blockchain as a strategic tool Blockchain is no longer a hype, but a technology that is ready to transform the world of mergers and acquisitions. From tokenising ownership to automating contracts and accelerating due diligence, the benefits are clear and concrete. For M&A professionals, this means not only a more efficient process, but also a competitive advantage in an increasingly fast-changing market. Studio M&A La Gro Do you have questions about the applications of blockchain in M&A? Or would you like to learn more about how this technology can improve your transactions? Then come to our event Studio M&A La Gro on 19 June 2025 and discover how blockchain can transform your M&A processes. Keep an eye on our website and further posts.

The Netherlands Authority for Consumers and Markets (ACM) has recently issued a clear call to companies in the food sector: review and improve your sustainability claims. This call is not optional. The ACM emphasizes that it will actively monitor compliance with the rules and, if necessary, take enforcement action. What does this mean for companies in the food sector? Why this call? Sustainability claims are playing an increasingly significant role in the marketing of food products. Consumers want to make informed choices and consider sustainability in their purchasing decisions. However, the ACM has observed that many claims in the food sector are unclear. This not only undermines consumer trust but can also lead to unfair competition among companies. For example, the ACM notes that it is often unclear what labels, logos, and certifications represent or what a sustainability claim specifically entails. The ACM has previously scrutinized sustainability claims in other sectors, such as clothing, energy, and transportation. Now, it is the food sector’s turn. The Sustainability Claims Guidelines: the basis for compliance The ACM directs companies to its updated Sustainability Claims Guidelines (2023). These guidelines outline five key rules that sustainability claims must adhere to: Use clear, specific, and complete sustainability claims; Substantiate sustainability claims with facts and keep them up to date; Make fair comparisons with other products or competitors; Describe future sustainability ambitions in concrete and measurable terms; Ensure that visual claims and certifications are helpful and not misleading. What’s at stake? The ACM has announced that it will actively check whether companies have adjusted their sustainability claims following this call. If claims do not comply, the ACM has stated that it may take enforcement action. Companies using sustainability claims that do not meet the Sustainability Claims Guidelines may face fines or orders subject to penalty payments. What can your company do? To avoid risks and ensure compliance with the law, it is essential for companies to take action now. A few practical tips: Inventory Your Sustainability Claims. Map out all the claims you use on products, in advertisements, and in stores; Assess Your Claims Against the Sustainability Claims Guidelines. Verify whether your claims comply with the ACM’s five key rules as outlined in the Sustainability Claims Guidelines; Collaborate with Experts. Have your claims reviewed both legally and substantively by specialists. This can help identify and mitigate risks; Communicate Transparently. Ensure that your claims are understandable to consumers and supported by clear information; Stay Up-to-Date. Closely monitor developments in laws and regulations regarding sustainability claims. Conclusion The ACM’s call is a clear warning to the food sector: ensure that your sustainability claims are honest, clear, and substantiated. If not, the ACM may proceed with enforcement. Do you need assistance in reviewing or adjusting your sustainability claims? We are happy to help you mitigate risks and bring your claims into compliance with the law. Feel free to contact Arnout Koeman or one of our other specialists.

On February 19, 2025, a bill was proposed that limits the compensation scheme for the transition payment in case of dismissal due to long-term disability to small employers. This proposal has significant implications for employers. The compensation scheme, originally intended to relieve employers, will now only be available to small employers. This article discusses the details and implications of this change. Limitation on Compensation for Transition Payment The compensation scheme for the transition payment was introduced to support employers in paying the transition payment after 104 weeks of illness. For many employers, it felt unjust to have to pay a transition payment after two years of continued salary payment. This often led to ‘dormant employment contracts’, where the employment contract was not terminated to avoid payment of the transition payment. With the new bill, the government aims to limit the compensation scheme to small employers. Small employers are defined as those who have been active for less than two years or have a wage bill of no more than 25 times the average taxable wage per employee. In 2025, this threshold was set at a wage bill of no more than € 990,000 per year. Implications for larger employers For medium-sized and large employers, this change means that they will have to pay the transition payment themselves in case of dismissal due to long-term disability. This can have significant financial consequences. The question arises whether employers are still obliged to terminate the employment contract if they are not compensated. The legislator leaves this to the judiciary, but it is likely that existing case law will be maintained. The change is expected to take effect on July 1, 2026. No transitional law is proposed, meaning the new rules will apply immediately. Employers will only be eligible for compensation if the 104-week waiting period ends before the law comes into effect. No specific arrangements have been made for special employers, such as social development companies. Contact Do you have questions about the compensation scheme for the transition payment or would you like to discuss it? Please contact Gerard Zuidgeest, Rose Horstman, or one of our other employment law specialists.

On February 21, 2025, the Supreme Court ruled on the classification of employment relationships, specifically in the context of self-employed workers. As early as 2021, the Amsterdam District Court ruled that Uber drivers are employed under an employment contract, meaning that Uber must comply with the Taxi Transport Collective Labour Agreement (CAO). On appeal, the Amsterdam Court of Appeal asked preliminary questions to the Supreme Court regarding the role of the criteria ‘entrepreneurship’ in assessing the employment relationship. The Supreme Court has now provided answers to these questions. No hierarchy in criteria In the Deliveroo ruling, the Supreme Court ruled that the assessment of whether an agreement constitutes an employment contract depends on all the circumstances of the case. This includes the nature and duration of the work and the way the work and working hours are determined. In the Uber ruling, the Supreme Court clarified that there is no fixed hierarchy among these criteria. This means that all nine criteria must be equally weighed. For employers, this means that the classification of an employment relationship can be more complex, as every aspect of the working relationship must be assessed. This can lead to different outcomes, even if two workers perform the same work under the same conditions. Entrepreneurship: external aspects matter An important aspect emphasised by the Supreme Court is the entrepreneurship of the self-employed worker. The Supreme Court considers that the entrepreneurship criterium is not given more weight than the other criteria. This means that entrepreneurship can be decisive for the classification of the agreement. Not only does the general entrepreneurial situation of the worker in the relationship between the workers and the client play a role (internal entrepreneurship), but circumstances outside the relationship are also important (external entrepreneurship). In terms of external entrepreneurship, one might consider whether the worker is registered with the Chamber of Commerce, the number of clients the worker has outside the specific relationship, or the number of investments the worker makes for its own business. Retaining self-employed workers? Stimulate entrepreneurship! Employers are advised to encourage the external entrepreneurship of their self-employed workers. This can be done, for example, by encouraging them to take on assignments from multiple clients and ensuring that the worker clearly profiles themselves as an entrepreneur, for instance, with their own website. Contact Do you have questions about the classification of employment relationships or would you like to discuss this further? Please contact Gerard Zuidgeest, Rose Horstman, or one of our other employment law specialists.

When should an employee disclose information about chronic physical or psychological complaints during a job application? This was the subject of a recent ruling by the Court of Appeal in ‘s-Hertogenbosch. The disclosure of medical Information in the application procedure An applicant is not required to voluntarily provide medical information. This is only different if the applicant knows at the time of concluding the employment contract that their health condition would significantly and long-term hinder them in performing the job duties. Additionally, an employer may not ask questions about the health condition of a prospective employee, past sick leave, or any limitations during the application process, except in the context of a legally permitted medical examination. Ruling: the facts in the case before the Court of Appeal in ’s-Hertogenbosch The employee in this procedure had suffered from chronic psychological complaints (PTSD and an anxiety disorder) since 2011 following an unsuccessful surgery. The employee applied for a position as a security guard at a courthouse in October 2023 and did not disclose his medical situation during the application process, nor the fact that he was currently unfit for work as a security guard at the Department of Transport and Support (DV&O) of the Ministry of Justice and Security. The employee was hired and was declared fully recovered by the DV&O company doctor at that time. Shortly after starting at the courthouse, the employee fell ill. The employer requested the termination of the employment contract due to gross misconduct, arguing that the employee had failed to disclose his medical situation. The employer’s requests were denied in the first instance. Court’s judgment: no disclosure obligation for employee The Court of Appeal, like the subdistrict court, ruled that there were no grounds to terminate the employment contract. The court ruled that the disclosure obligation only exists if the illness or disability makes the applicant unfit for the position and the applicant knew or should have understood this. In this case, the employee had fallen ill several times at his previous employer, but this was not due to the specific job requirements, and the employee had always fully recovered. The position at the courthouse was less demanding than the position at DV&O, leading the employee to believe that his chronic illness would not be an issue. The employer argued that an applicant must also disclose their illness if the illness does not absolutely prevent the performance of essential job requirements, but the applicant will experience significant hindrances in fulfilling the role. The court dismissed this argument, as it would mean that every chronically ill person would have to disclose their chronic illness during a job application, which is contrary to the protection provided by the Dutch Equal Treatment Act on Grounds of Disability or Chronic Illness (Wgbh/cz). Practical tips As an employer, do not ask questions about the health condition, past sick leave, or any limitations of the applicant during the application process, unless it concerns a legally permitted medical examination. Additionally, ensure that the job requirements are detailed and are clearly stated in the job application and/or job profile. Discuss these requirements during the application process and ensure written documentation. If possible ask the former employer for references. Contact Do you have questions about the disclosure obligation during job applications or would you like to discuss further? Please contact Gerard Zuidgeest, Rose Horstman, or one of our other employment law specialists.

Under the Dutch Working Conditions Act, employers are obliged to provide a safe working environment. In this context, employers sometimes implement a strict alcohol and drugs policy. But how far can that go? Can an employer test an employee for alcohol or drug use? The Limburg District Court recently ruled on this issue. What can employers do in this regard? Ruling Limburg District Court – 20 February 2025 The case concerned SIF Netherlands B.V., a manufacturer of foundations for offshore wind farms, which had introduced a zero-tolerance policy regarding alcohol and drug use. One of its employees, employed since 2008 and responsible for quality inspections, tested positive for cannabis during an unannounced saliva test on 25 September 2024. Several colleagues also reported red eyes and strange behaviour. While the employee admitted to having used cannabis the previous evening, he denied being under the influence while at work. Nevertheless, SIF sought permission to terminate the employment contract on the basis of serious culpable conduct (ground e), a disrupted employment relationship (ground g), or a combination of grounds (ground i). The court rejected the request for termination. Although the question of drug use was considered legitimate, the court ruled that the test did not establish that the employee had been under the influence during work hours. Moreover, the test had been conducted unlawfully, breaching the employee’s right to a private life and privacy. As a result, the test results were excluded. Moreover, the witness statements from colleagues were deemed insufficiently substantiated to justify termination. The Legal Landscape Employers have a legal duty to ensure a safe working environment. The question is under which circumstances they may take a specific measure to test for drugs and/or alcohol. There is ample case law involving employees appearing at work under the influence of drugs or alcohol, where disciplinary actions were upheld. Yet, this employer’s request for termination was not upheld. Why is that? Employment Law Consequences If an employer suspects an employee of being under the influence in a way deemed unacceptable, disciplinary measures may be taken. Although Dutch law does not list exhaustive employment-related sanctions, potential measures include a formal warning, suspension, wage withholding, a fine, or even dismissal (including summary dismissal). The challenge of evidence Any sanction must be justified and proportionate to the alleged misconduct. The employer bears the burden of proving both the conduct and the proportionality of the measure. Courts also assess whether the evidence was lawfully obtained. Unlawfully obtained evidence may be excluded. In the context of alcohol or drug testing, courts will weigh the interest in truth-finding against the employee’s right to a private life and privacy. The Right to private life The right to a private life, protected under Article 8 of the European Convention on Human Rights (ECHR), shields employees from unwarranted intrusions. Alcohol and drug testing constitutes an infringement of this right. Such an infringement is only permitted under strict conditions. The court will assess whether the infringement serves a legitimate goal and is suitable to achieve that goal (necessity criteria), whether the infringement is proportionate (proportionality criteria) and whether there is a less intrusive alternative (subsidiarity criteria). GDPR considerations When an employer processes personal data of a employee, the General Data Protection Regulation (GDPR) applies. The results of alcohol and/or drug testing constitute a special category of data. Processing of such data is in principle prohibited, unless one of the exceptions under the GDPR applies. According to the Dutch Data Protection Authority (AutoriteitvPersoonsgegevens or ‘AP’), processing such data requires a specific legal basis. Currently, such a basis exists only for certain sectors (e.g. aviation and maritime and public transport). Practical recommendations for employers Testing for alcohol or drugs in the workplace is legally complex. Employers should verify whether their sector has a statutory basis allowing testing. Its advisable to consider adopting a written zero-tolerance policy outlining potential disciplinary measures in the case of a breach, including (immediate) dismissal. If you suspect an employee is under the influence during working hours, take them aside privately with a witness present. Ask the employee directly whether alcohol or drug use is involved and stress that this is a safety matter. If you are reasonably convinced that substance use is at play, suspend the employee and send them home. Document the incident and the meeting as thoroughly as possible and confirm your findings to the employee in writing, inviting a response. The appropriate sanction will depend on the specific circumstances. Seek legal advice as soon as possible before initiating further steps. Contact Would you like to introduce or update your alcohol and/or drugs policy? Do you suspect an employee has appeared at work under the influence? Do you have another related question? Please do not hesitate to contact Gerard Zuidgeest, Rose Hortsman or one of our other employment law specialists. We would be happy to assist.

On 14 March 2025, the Dutch Supreme Court (‘Hoge Raad’) issued an important ruling in the context of the Act on the Resolution of Mass Claims in Collective Actions (“WAMCA”) (ECLI:NL:HR:2025:388). One of the key questions the Supreme Court addressed was whether an extension of the so-called three-month period for serving a writ of summons, pursuant to Article 1018d(2) of the Dutch Code of Civil Procedure (“Rv”), has general effect or applies only to the legal entity that requested the extension. The Supreme Court’s decision is clear: an extension of the three-month period does not have general effect—it applies only to the legal entity that requested it. Background of the Case The case concerns collective claims brought by various foundations against Apple. Apple was summoned on October 4, 2021, by the Right to Consumer Justice Foundation (“Stichting RCJ”). Pursuant to Article 1018d(1) Rv, other foundations wishing to file a similar collective claim had three months to do so – until January 4, 2022, in this case. Article 1018d(2) Rv provides that a court may extend this three-month period upon request by another legal entity seeking to initiate collective proceedings. In this case, the court granted an extension of three additional months at the request of another foundation, the App Stores Claims Foundation (“Stichting ASC”), extending the deadline to April 4, 2022. This procedural decision was published in the central register for collective claims on November 29, 2021. Stichting ASC summoned Apple within this extended period. Another foundation, the Consumer Competition Claims Foundation (“Stichting CCC”), also summoned Apple within the extended period – on March 31, 2022. However, this meant that Stichting CCC had issued its writ of summons outside the original three-month period. The question in the proceedings was whether Stichting CCC could be deemed admissible in its collective claims, given that its summons was served after the initial three-month period had expired. At first instance, the court declared Stichting CCC inadmissible because it had not served its writ of summons within the statutory three-month period. The court ruled that an extension of the period under Article 1018d(2) Rv does not have general effect—the extension granted to Stichting ASC applied only to Stichting ASC. Stichting CCC disagreed and an appeal was files directly with the Supreme Court (‘sprongcassatie’). Supreme Court Decision The Supreme Court upheld the lower court’s ruling. It confirmed that an extension of the three-month period under Article 1018d(2) Rv does not have general effect. The Supreme Court noted that, according to the legislative history of the WAMCA, a court’s decision on an extension request must be tailored to the specific circumstances of the legal entity making the request. This, according to the Supreme Court, implies that an extension applies solely to the requesting legal entity and does not have a general effect. The Supreme Court also pointed out that this interpretation aligns with the absence of a requirement for extension decisions to be registered in the central register for collective claims. Conclusion For foundations seeking to initiate similar collective claims, it is crucial to closely monitor the collective claims published in the central register for collective claims. While it is understandable that Stichting CCC also considered the court’s procedural decision granting an extension to Stichting ASC, the publication of a summary of the initial summons in the central register remains decisive for determining the start of the three-month period. If an organization needs more than three months to prepare its case, it must submit a reasoned request for an extension of the three-month period to the court within one month. Organizations cannot rely on procedural decisions regarding extensions granted to other foundations that may be published in the central register for collective claims. Questions about the WAMCA? Please contact Lennart Hoeksema, Arnout Koeman or one of our other WAMCA specialists.

A recent ruling by the Trade and Industry Appeals Tribunal (CBb) highlighted the importance of the notion of an “undertaking” within state aid law. This particularly with regard to the situation where several entities are considered to be one undertaking. In such cases, all aid received by these entities should be added up, as they qualify as one undertaking and thus one aid beneficiary. This may have implications for, for example, application of aid ceilings. The ruling therefore offers important insights for companies that are part of a group and may receive state aid. CBb’s ruling In the judgment of February 20, 2025 (ECLI:NL:CBB:2025:76), the CBb dealt with a case in which a company (hereafter: Company X) appealed against a decision of the Minister of Economic Affairs in which a TVL subsidy (Reimbursement Fixed Costs) of Company X was revised and lowered. Based on this decision, an amount of €333,831.48 of the TVL subsidy received as an advance was recovered from Company X for exceeding the aid ceiling. The Minister reached this decision as Company X was part of a group which until December 1, 2021 consisted of Company X, Company Y and Company Z. Company Z was dissolved on December 1, 2021. All three companies received subsidies under the TVL scheme over different periods. This TVL scheme gave financial support to enterprises with loss of turnover due to COVID measures from June 2020. According to the Minister, in the present case, the TVL subsidy to Company X had exceeded the aid ceiling of €2.3 million applicable until Q1 of 2022. Company X believed that the recovery of part of its subsidy was unlawful, as the subsidies received by Company Z should not be added to the total subsidies received by the group. This is because Company Z had been dissolved as of December 1, 2021, which meant that it was not part of the group at the time of both the award and review of the subsidy given to Company X. The CBb did not follow Company X’s position and upheld the Minister’s judgment. The court ruled that the three companies qualify as one undertaking under state aid law, and that the total aid granted to them may not exceed the aid ceiling. Exceeding the aid ceiling would result in unlawful state aid. The fact that Company Z was no longer part of the group due to dissolution at the time of award and review of the subsidy does not change this. Because Company Z ceased to exist, the TVL subsidies granted to it (earlier) were not withdrawn from the group. They benefit the group (in)directly. This is also the case if the balance of dissolution has been used to pay a tax debt of Company Z. Even then, the subsidy received by Company Z prior to dissolution can provide (in)direct benefit to the rest of the group. In view of the above, the CBb held that the revision and lowering of the subsidy to Company X was justified. Determination of a higher amount would constitute unlawful state aid, according to the CBb. Definition of an enterprise within state aid law Under state aid law, an undertaking is defined as any entity engaged in an economic activity, regardless of its legal form and method of financing. Based on Union law jurisprudence, carrying out economic activities is defined as offering goods and/or services on a market. The concept of undertaking within state aid law is thus very broad, and can include virtually any legal form, regardless of whether the entity in question is profit-making or not. Any provider of a good or service on a market is, in theory, an undertaking within state aid law. Multiple entities as one company Within state aid law, several separate legal entities may be deemed to constitute a single economic entity for the purposes of state aid rules. They then qualify as a single undertaking, for the purposes of State aid reviews. This was also the case for the companies that were part of the group in the CBb ruling. In assessing whether multiple entities qualify as a single undertaking, a number of factors are considered which have been developed in Union law jurisprudence. In particular, the following factors are considered: Economic, organizational and functional links between entities; Degree of say and control; Joint performance on the market. Impact on state aid The classification of multiple legal entities as a single undertaking under state aid law may have negative consequences for the amount of aid granted. In such cases, the aid received by these separate legal entities must be added together to determine whether the aid remains below applicable aid ceilings. In the CBb ruling, this worked out negatively for Company X, which received a lower subsidy due to a past group composition. Indirect aid should also be taken into account in such cases. Conclusion For companies that may receive state aid, it is crucial to carefully analyse the interrelationships between different entities. Failure to pay sufficient attention to this may lead to unlawful state aid and recovery risks. This is the case, for example, when aid ceilings are exceeded because aid granted to different entities must be added together within the frameworks of state aid law. Do you have questions on this topic? Would you like to learn more about the qualification of multiple entities as a single enterprise for state aid purposes? Please feel free to contact Monika Beck or one of our other state aid specialists.

On 11 February 2025, the Court of Appeal of The Hague (“CoA”) rendered its decision in the PI proceedings between Janssen Biotech Inc (“Janssen”) and Samsung Bioepis NL B.V. (“Samsung”). The CoA upholds the decision of the Provisions Judge in first instance and denies the PI claimed by Janssen. Samsung can benefit from the SPC Manufacturing Waiver for production and stockpiling for export of its biosimilar product containing ustekinumab. This case is of particular interest as it is one of the few decisions on the application of the SPC Manufacturing Waiver and, more generally, provides clear answers to various questions raised on when a manufacturer can benefit from said waiver. What preceded In our Pharma Update of 31 January 2024 we have reported on the decision of the Provisions Judge of the District Court of 23 January 2024. In said decision the PI claimed by Janssen was denied as the Provisions Judge was of the preliminary opinion that Samsung could benefit from the production-for-export and stockpiling- for-export exemptions of the SPC Manufacturing Waiver. Facts Janssen holds EP 1 309 692 B1 (“EP 692”) for “ANTI-IL-12 Antibodies, compositions, methods and uses”. The medicinal product of Janssen is marketed under the brand name ‘Stelara’ and contains the active ingredient ustekinumab. EP 692 was granted on 13 May 2009 in, among others, Italy and Denmark. The patent expired on 7 August 2021. After expiration, Janssen was granted an SPC in Italy, Denmark and the United Kingdom (UK – ending on 19 January 2024). Similar Stelara patents in Canada and South Korea have also expired. However, Jansen has filed patent(s) (applications) in these countries that protect the treatment regimen approved for Stelara for ulcerative colitis disease. Samsung has developed a biosimilar of ustekinumab with Stelara as reference called SB17. The Dutch Samsung entity (the defendant) issued a notice to the Danish and Italian authorities respectively that it intended to manufacture and stock its biosimilar in Denmark and Italy for the purpose of exporting it to the UK, Canada and South Korea based on Regulation 2019/933 regarding the SPC Manufacturing Waiver “MW Regulation”) and to market the product in the European Union after expiration of the SPC (stockpile exemption). Samsung mentioned that it would submit the reference numbers of its market authorisations in said countries as soon as publicly available. Samsung additionally undertook towards Janssen that it would not manufacture its biosimilar products for the EU-market until 24 January 2024 in order to avoid discussion on the stockpile exemption in the PI proceedings. Assessment of the CoA In its decision, the CoA considers the full range of arguments put forward by the parties. In general, the CoA considers that the purpose of the SPC Manufacturing Waiver is to create a level playing field for generic and biosimilar manufacturers in the EU vis-à-vis competitors in third countries in order to promote EU competitiveness in global markets where protection expired, while at the same time ensuring protection for SPC holders in the EU. In particular, the CoA answers three legal questions: 1. Does a valid reliance on the production-for-export exemption require that the manufacturer has a MA for the intended country of export at the time of notification, or at least before production commences? The CoA answers this question by first analysing the wording of the MW Regulation and finds that article 5(5)(e) of the MW Regulation only requires that the reference number of an MA is provided in relation to the notice of the SPC Manufacturing Waiver once this is available. There is no obligation for the manufacturer to wait with giving notice or with starting production until the MA for the intended country of export is granted and a reference number is provided. 2. Does a valid reliance on the production-for-export exemption require that at the time of the notification, or at least before the start of production, there are no IP rights in force in the intended exporting countries that could oppose entry into that country’s market? The CoA is of the opinion that the MW Regulation does not contain a requirement that the manufacturer must wait with the production under the waiver until the IP rights have expired in the intended export country. Starting production before those rights have expired is not considered unlawful because manufacturing in the EU under the waiver does not automatically infringe an IP right in the country intended for export. This would only be the case if IP rights still exist when the product is imported into that country’s market. 3. Does a manufacturer have the right to stockpile for the intended export? The CoA considers that under article 5(2)(a)(ii) MW Regulation the EU manufacturer is also entitled to stockpile its products as this is strictly necessary for export to third countries in order to achieve Day 1 entry and for the manufacturer to benefit from the “first mover” effect. The CoA considers that this is in line with the intention of the Union legislator and that Day 1 entry is not only intended for the EU but also for Day 1 entry in third countries, giving the EU manufacturer a first mover effect. The CoA rejects Janssen’s concerns that stockpiling could create a risk that products destined for third countries would eventually enter the EU market. According to the CoA there are sufficient safeguards in the MW Regulation to prevent such products from entering the EU market.