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Withholding tax and beneficial owner identification – practical comments on Polish and EU law

Publication date: October 10, 2024

Withholding tax is one of the essential elements of the international tax system, which aims to ensure that countries have the right to tax income earned on their territory by foreign entities. In the context of increasing globalization and dynamic capital flows between national borders, the issue of identifying entities entitled to use preferential tax rates is becoming increasingly complex and important. The key concept in this discussion is the so-called “beneficial owner”, i.e. the actual owner of the income.

The concept of beneficial owner is fundamental in the context of applying double taxation treaties. These treaties often provide for reduced withholding tax rates or exemptions from withholding tax for specific categories of income, such as dividends, interest or royalties. However, in order to benefit from these preferences, the recipient of the income must meet the criterion of beneficial owner of the income. In practice, this means that it is not enough to have a formal right to receive the income; a number of other requirements must also be met.

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Comments for companies in Poland with international shareholding structure

Publication date: October 10, 2024

Lack of facilities in Poland and deduction of VAT – views of Polish tax authorities

There are a number of companies being established in Poland with foreign shareholding structure. In this respect, the conditions that must be met by entities in order to be able to develop their business are important. This is particularly important in the context of the company’s background and the deduction of VAT, in accordance with the applicable Act on the tax on goods and services. In Poland, more and more judgments of the Supreme Administrative Court are being issued, which indicate the need to have an appropriate background in a given company.

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Digital Therapeutics – Polish legal environment and practical issues

Publication date: October 10, 2024

What applications will the Polish Ministry of Health promote?

The Polish Ministry of Health will promote free applications that allow monitoring of the health of patients. Applications will be able to receive the title of “MZ Certified Application” (Software certified by the Ministry of Health) for a period of 24 months. According to the regulations for awarding applications the title of Ministry of Health Certified Application, the aim of the competition is not only to find applications that will provide information on health, but will also store data safely and their software will be a medical device.

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Compassionate Use under Polish law

/legal status as of September 2024/

Publication date: October 10, 2024

There were attempts to introduce into the Polish legal system the compassionate use procedure, when implementing the amendments to the Polish Clinical Trial Act and Pharmaceutical Law. The changes were to enter into force in 2022, however, ultimately, the Act did not include any mention of the so-called compassionate use procedure. This procedure, also known as the use of medicines in exceptional situations, allows patients to access therapies that have not yet been registered on the market. This is particularly important in the context of rare and serious diseases, where available treatments are insufficient or ineffective. In many European countries, including in EU law, compassionate use is regulated and is an important tool in protecting public health. Unfortunately, in Poland, the implementation of this procedure encounters numerous obstacles, which is a serious problem for patients and doctors.

What is the compassionate use procedure?

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Named Patient Programs – Polish and European perspective

Publication date: October 10, 2024

The concept of a named patient concerns the access to the supply of a medicinal product that is excluded by a Member State from the provisions of Directive 2001/83/EC, in accordance with the applicable provisions and in order to meet special needs [based on Article 5(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ EU L 311, 2001, No. 311, p. 67, as amended)].

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