Publication date: January 08, 2025

Undertaking clinical trials plays a fundamental role in the development and marketing authorisation of medicinal products. The aim of clinical trials is to test the safety and effectiveness of the products being studied. A trial sponsor is an individual, company, institution or organisation that is responsible for undertaking, managing and organising the financing of a clinical trial.

Bioethics Commission

The composition and functioning of the bioethics commission are specified in Article 29 of the Act of 5 December 1996 on the professions of physician and dentist (consolidated text: Journal of Laws of 26 March 2018, item 617) and in the Regulation of the Minister of Health of 11 May 1999 on the detailed principles of establishing and financing and the mode of operation of the bioethics commission (Journal of Laws No. 47, item 480).

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Publication date: January 08, 2025

The classification of business activity is a system used to classify types of business activity and is regulated by the Regulation of the Council of Ministers on the Polish Classification of Activities. This system plays a key role when starting a business, because entrepreneurs are required to assign appropriate business activity codes, which precisely define the scope of the business activity conducted. In practice, however, as shown by the judgment of the Supreme Administrative Court of 7 July 2016 (ref. II GSK 342/15) [1], assigning the appropriate business activity code is not always unambiguous. The court ruled on a case in which the entrepreneur had doubts as to which category of activity he should choose to best reflect the actual nature of his company. What seems like a simple formality – assigning one of the many available business activity codes – in practice can become a problematic issue, with serious legal consequences. In this particular case, the entrepreneur indicated a code that he believed best suited his business, but the administrative authorities found that the assigned business activity code may not correspond to the actual activity, which led to the need to correct the registration. This judgment emphasizes how important it is for the business activity code to accurately reflect the scope of the business activity conducted. Correct classification is the foundation for the correct settlement of business activities in terms of tax liabilities, such as VAT or income, as well as other administrative obligations. Correct assignment of the business activity code affects what regulations will apply to the entrepreneur, and thus what VAT rates apply to his services or goods, or what group of tax reliefs he falls into. In the discussed judgment, the Supreme Administrative Court pointed out that incorrect assignment of the business activity code may result not only in problems with tax settlement, but also in negative consequences in the context of tax audits. In practice, the tax administration may question the incorrectly assigned code, and as a result of such verification, the entrepreneur is forced to correct tax returns, which is associated with additional costs and formalities. Moreover, the court indicated that entrepreneurs may be forced to re-verify their activities, which in the long term may lead to unnecessary administrative complications. An equally important aspect that appeared in the ruling is the issue of the ambiguity of some business code categories. In many cases, business activities may cover different areas that fit several business activity codes, which is why the entrepreneur may encounter difficulties in choosing the right one. The Supreme Administrative Court ruling shows that in such situations, the entrepreneur must demonstrate great diligence in choosing the code so as not to mislead the administrative authorities, and thus avoid potential consequences. For this reason, it is so important for entrepreneurs to take special care to correctly assign the appropriate business activity code already at the stage of registering the business.

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Publication date: January 07, 2025

What is the prohibition of discrimination?

The prohibition of discrimination at work is included in Article 18^3a) of the Labour Code and in the Constitution in Article 32, which requires equal treatment in all aspects, including those related to work.

Discrimination may be related to;

• gender,
• age,
• disability,
• race,
• religion,
• nationality,
• views,
• origin,
• religion or sexual orientation
• either due to employment for a fixed or indefinite period or on a full-time or part-time basis.

The above criteria are not socially acceptable and any unjustified unequal treatment of employees is considered discrimination.

Direct and indirect discrimination

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Publication date: January 07, 2025

Legal regulations

The issue of the European order for payment procedure is regulated in the provisions from Article 505¹⁵ to Article 505²⁰ of the Act of 17 November 1964 – the Polish Code of Civil Procedure (consolidated text: Journal of Laws of 2024, item 1568), hereinafter referred to as the Civil Procedure Code. The introduction of the above provisions into the Polish legal order was dictated by the entry into force of Regulation (EC) No 1896/2006 of the European Parliament and of the Council of 12 December 2006 creating a European order for payment procedure (OJ EU. L. of 2006, No. 399, p. 1, as amended), hereinafter referred to as the Regulation. If the conditions resulting from the Act and the Regulation are met, the court issues a European order for payment. Pursuant to Article 2 paragraph 1 of the Regulation, its provisions apply in cross-border civil and commercial cases, regardless of the type of court or tribunal. The definition of a cross-border case can be found in Article 3 Regulation: a cross-border case should be understood as a case in which at least one of the parties is domiciled or habitually resident in a Member State other than the Member State of the court seised.

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Publication date: January 06, 2025

Introduction

The modern economy based on knowledge and innovation makes intellectual property rights (IPR) a key element in protecting the interests of creators, inventors, and entrepreneurs. Infringement of these rights by illegally introducing counterfeit goods to the market poses a serious threat to both fair competition and consumer safety. The European Union has introduced systems aimed at detaining such goods at the time of their attempted import into the Community, which is regulated by detailed legal provisions, as well as procedures related to the protection of intellectual property rights. This article discusses the mechanisms for detaining goods suspected of infringing IPR, with particular emphasis on the legal regulations in force in the European Union.

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