Category: Poland

1 January 2023 brought a major change to medical device advertising in Poland. From this date, the new national regime for medical device advertising applies. Therefore, all promotional activities associated with medical devices in Poland need to comply not only with the European Union regulations, but also with the new national requirements.

At the EU level, the legal regime consists of two regulations: Regulation 2017/745 on medical devices (the MDR) and Regulation 2017/746 on in vitro diagnostic medical devices (the IVDR). The MDR applies from 26 May 2021, while the IVDR started to apply from 26 May 2022. They both stipulate a prohibition of misleading advertising in Article 7.

In Poland, the advertising of medical devices must also abide by the Polish Medical Devices Act of 7 April 2022 (the MDA). The MDA came into force on 26 May 2022. Nevertheless, the provisions on medical device advertising started to apply on 1 January 2023. The MDA regulates issues such as restrictions related to advertising to the public, entities responsible for advertising, obligations to keep templates of released advertising, surveillance of competent authorities and sanctions.

Additionally, on 28 July 2022, a draft Regulation of the Minister of Health on the medical device advertising was published (the Draft). The Draft is intended to clarify technical requirements for medical device advertising that have been introduced at the statutory level. The Draft is currently at the public consultation stage.

The general rules on advertising must also be taken into account with respect to medical device advertising. In Poland, these are in particular: Act combating unfair competition, which regulates unfair advertising of goods, including unfair comparative advertising, and Act on radio and television broadcasting, which sets rules for advertising of goods in radio and television.

By Agnieszka Majka, Partner, Celina Bujalska, Senior Associate, Paulina Roslon-Horosz, Junior Associate, NGL Legal

Clifford Chance has advised Polish apartment rental company Resi4Rent on obtaining EUR 50 million in financing from the EBRD. DLA Piper reportedly advised the lender.

“The funds are being provided under the EBRD Resilience and Livelihoods Framework, which aims to support Ukraine and countries affected by the Russian invasion of Ukraine,” Clifford Chance informed.

Resi4Rent is an apartment rental company operating in Poland. The company offers rental services in Lodz, Gdansk, Warsaw, Poznan, Wroclaw, and Kracow, with 3,000 units in 11 locations.

The Clifford Chance team included Poland-based Partner Andrzej Stosio, Senior Associate Maksymilian Jarzabek, Associates Aleksandra Bialyszewska and Krzysztof Burda, and Trainee Joanna Korycinska, as well as lawyers from the firm’s Luxembourg office.

Gessel has advised Pure Biologics on its public offering of shares carried out under an accelerated book-building program and the private offering of new company shares. Jonak i Partnerzy advised the managers.

According to Gessel, the public offering included new series G shares and existing sold shares, offered to qualified investors and selected retail investors. The private offering included new series H shares. The total value of both offerings amounted to approximately PLN 30 million.

“The transaction was carried out based on the investment and offering agreement concluded by the company with Ipopema Securities and the placement agreement,” Gessel informed.

Pure Biologics is a Warsaw Stock Exchange-listed biopharmaceutical company that operates in the field of immuno-oncology, autoimmunity, and neurological rare diseases, conducting research using technological platforms for the selection of active particles – antibodies and aptamers.

The Gessel team included Partner Krzysztof Marczuk, Managing Associate Magdalena Szeplik, Senior Associates Michal Wielinski and Jakub Rowicki, and Associates Maciej Kowalski and Piotr Blank.

The Jonak i Partnerzy team included Managing Partner Jacek Jonak, Partner Szymon Banach, and Associate Danuta Pociecha.

Clifford Chance has advised Ipopema Securities on the establishment of an up to PLN 500 million bond issuance program for Echo Investment and Echo’s first PLN 180 million issuance of bonds under the program.

Ipopema Securities is a Poland-based company specializing in investment banking services.

Echo Investment is a Polish real estate company.

According to Clifford Chance, “the company placed the inaugural issue of five-year bonds with a total value of PLN 180 million, under a new up to PLN 500 million bond issuance program. Their interest rate was determined based on the variable WIBOR 6-month rate increased by a margin for investors. As part of the program and in relation to the issue, Ipopema Securities acts as the organizer and exclusive dealer of the issue.”

“The money obtained from the bond issue will be used to redeem existing bonds maturing in 2024 and, consequently, to further finance business development. The bonds issued are not secured and will be introduced to trading in the alternative trading system of the Warsaw Stock Exchange,” the firm informed.

In 2020, Clifford Chance advised mBank on Echo Investment’s PLN 150 million bond issuance (as reported by CEE Legal Matters on July 13, 2020).

Clifford Chance’s team included Partner Milosz Golab and Lawyer Zuzanna Bartczak.

Greenberg Traurig has advised CVC Capital Partners on its sale of the PKP Energetyka power company to state-owned PGE Polska Grupa Energetyczna. Rymarz Zdort advised PGE.

The transaction remains contingent on regulatory approval.

PKP Energetyka is a Polish power company. The company’s business activities include the sale and supply of electricity, delivery of green energy to railways, and sale of fuel and electric power services.

CVC is an alternative investment manager focused on private equity, secondaries, and credit with a network of 25 local offices and EUR 137 billion of assets under management.

PGE Polska Grupa Energetyczna is a state-owned public power company in Poland and is listed on the Warsaw Stock Exchange.

Greenberg Traurig’s team included Senior Partner Lejb Fogelman, Partners Rafal Baranowski and Andrzej Wysokinski, Local Partners Michal Bobrzynski and Maciej Pietrzak, Senior Associate Joanna Kuc, and Associate Adam Andula.

Rymarz Zdort’s team included Partners Marek Maciag, Marek Durski, and Monika Kierepa and Senior Associate Malgorzata Derus.

Wardynski & Partners, working with Latham & Watkins, has advised Spider Investments Luxembourg on its EUR 1.88 billion sale of Transporeon to Trimble.

Closing is expected in the first half of 2023, pending regulatory approval.

Transporeon is a German company providing a cloud-based transportation management platform for shippers, forwarders, carriers, and retailers to move, manage, and monitor freight. The company has 18 offices worldwide and employs over 1,400 people in 27 countries.

Spider Investments is a US-headquartered investment hub. Trimble is an industrial technology company.

The Wardynski & Partners team was led by Partners Bartosz Kuras and Izabela Zielinska-Barlozek and included Partner Monika Gorska, Attorney-at-Law Joanna Dudek, and Junior Lawyers Lukasz Wasilenko and Marika Grzybowska.

Editor’s Note: After this article was published, CEE Legal Matters learned that Skadden Arps Slate Meagher & Flom advised Trimble.

Balicki Czekanski Gryglewski Lewczuk has advised Adamed on a minority investment in Apeiron Synthesis as part of a PLN 21 million round that also included Aper Ventures and Orlen VC. Lewczuk Lyszczarek i Wspolnicy advised Apeiron Synthesis.

Apeiron Synthesis is a Polish company developing a scalable olefin metathesis catalysis platform.

BCGL’s team was led by Partner Jacek Balicki.

The Lewczuk Lyszczarek i Wspolnicy team was led by Partner Lukasz Lyszczarek.

Act BSWW has advised Develia on its public placement of bonds worth PLN 15.4 million.

According to Develia, “the issue was carried out under a program worth up to PLN 150 million, based on the prospectus approved by the Polish Financial Supervision Authority on October 26, 2022.”

“Under the program, the first series of bonds with a total nominal value of over PLN 15 million was issued and allocated,” Act BSWW informed. “The bonds will be traded on the Catalyst regulated market.”

Develia is a Wroclaw-headquartered real estate development group, carrying out residential and commercial investments in Warsaw, Wroclaw, Krakow, Gdansk, Lodz, and Katowice.

The Act BSWW team included Managing Partners Piotr Wojnar and Piotr Smoluch, Partner Sebastian Sury, and Lawyer Katarzyna Krzykwa.

Greenberg Traurig has advised CBRE Investment Management on the acquisition of 24 logistics assets in Europe from Hillwood Investment Properties.

The 24 assets, located in Germany, Poland, and the UK, are part of a wider 57-asset CBREIM acquisition from Hillwood Investment Properties that was announced early this year and includes properties across Europe and the US.

CBRE Investment Management is a real estate investment management firm with USD 143.9 billion in assets under management. It operates in more than 30 offices and 20 countries around the world.

Greenberg Traurig’s team included Warsaw-based Partners Karol Brzoskowski and Agnieszka Stankiewicz and further team members in Berlin and London.

SSW Pragmatic Solutions has advised Letbek on the lease of an 8,400 square-meter production hall in Komorniki, near Poznan, from SEGRO.

Letbek is a Danish plastic recycling company.

SEGRO is a European developer and owner‐manager of industrial property.

According to SSW, the complex, which includes the space leased by Letbek, is under construction. The building will be completed in the second quarter of 2023.

SSW’s team was led by Partner Andrzej Wloch.