EU law on medical devices: New transition periods and other changes
Amendments to the EU’s provisions on medical devices were published in the Official Journal on 9 July 2024. The new rules will begin to apply six months after publication (i.e. from 10 January 2025). In vitro diagnostic devices are gaining extended certificate validity and longer transition periods. The EUDAMED database can be launched in steps, which should speed up the mandatory use of the modules that are now ready. Meanwhile, manufacturers and other participants in the distribution chain have a new obligation to report problems with availability of medical devices.
KNF’s new Recommendation U includes guidance for bancassurance and insurance distribution channels
On 26 June 2023, the Polish Financial Supervision Authority (KNF) adopted the new Recommendation U on good bancassurance practices, which will replace the previous Recommendation U of June 2014.
Pay Transparency Directive: Strengthening the principle of equal pay in the European Union
Directive (EU) 2023/970 of the European Parliament and of the Council to strengthen the application of the principle of equal pay for equal work or work of equal value between men and women through pay transparency and enforcement mechanisms was adopted on 10 May 2023. What new obligations will employers face? How does EU law understand equal pay
Public procurement: Once again, a criminal record certificate should come from the contractor’s home country
In public procurement proceedings initiated on or after 22 September 2023, contractors may again submit criminal record certificates according to the residence of the person referred to in the certificate.
Sale of energy drinks to minors will be banned
On 28 August 2023, an amendment to the Public Health Act was published, including an important change impacting the food industry. After lengthy debate, it was decided to impose an absolute ban on the sale of energy drinks to minors. Ultimately, proposed advertising restrictions were dropped, but new labelling requirements for beverages containing caffeine or taurine remain. Starting 1 January 2024, the new regulation will force manufacturers and vendors to adjust their internal procedures for marketing energy drinks in Poland.
Will pharmacy M&A still be possible?
On 17 August 2023 the parliament held its final vote on a bill to tighten the section of the Pharmaceutical Law known as “Pharmacies for Pharmacists.” Now the act will be sent to the President of Poland, who will decide whether to sign it into law. The amendment (known as “Pharmacies for Pharmacists 2.0”) is stirring a lot of controversy. Its entry into force would significantly restrict the possibility to buy and sell pharmacies, and would require the Pharmaceutical Inspectorate to scrutinise franchise agreements. Pharmacy chains are concerned that the new provisions will lead to expropriation.
The benefits from starting a family foundation
The Family Foundations Act, entering into force on 22 May 2023, introduces the family foundation into Polish law as a new legal entity designed for collecting property and managing assets in accordance with the founder’s will and paying benefits to beneficiaries. Therefore, the objectives of a family foundation are different from those of existing foundations, which are non-governmental organisations operating for public benefit and not for profit.
Running a business through a family foundation
In just a few days, it will be possible to carry out intergenerational succession in Polish companies through the vehicle of a family foundation. This new legal entity is designed to meet the needs of business owners, who until now have been condemned to relatively limited choices under general provisions, or could choose foreign jurisdictions to set up a family foundation (e.g. in Austria, Liechtenstein, Malta, or the Netherlands).
Taxes and the family foundation
Along with the provisions allowing for establishment of a family foundation, entirely new tax provisions are being introduced, with attractive rules for taxation of asset transfers and foundation activities, but also a slightly too varied patchwork of tax rates.
Reducing the risks of setting up a family foundation
Like any other legal form, a family foundation may also involve the risk that the management of assets will be delegated to incompetent persons, the foundation will act in a manner contrary to its stated purpose or the interests of its beneficiaries, or it will conduct business activity in areas not permitted for a family foundation. However, in the Family Foundations Act, the Polish parliament has provided certain tools to prevent such situations.
Advertising of medical devices: Currently only with warnings
On 13 May 2023, a new regulation with detailed requirements for advertising of medical devices enters into force. Advertisers of such products, including influencers, must include warnings in advertising messages, similar to those familiar from drug advertisements.
Intellectual property: Changes in interim injunction and enforcement proceedings
Soon, another major amendment to the Polish Civil Procedure Code will enter into force, particularly affecting holders of intellectual property rights. The amendment will change the existing rules on interim injunction proceedings, which are typically used in intellectual property cases prior to filing a statement of claim. These changes will come into effect on 1 July 2023. Significant changes have also been made in the provisions on judicial enforcement, already in force since 15 April 2023.