Life Science & Healthcare

About this practice area

Our experts in this area work with Clients in the pharmaceutical, cosmetics, food, and medical sectors, and advise on any marketing authorization matters for:

  • medicinal products,
  • dietary supplements,
  • borderline products,
  • cosmetics,
  • nutritional products,
  • plant protection products,
  • medical devices.

We assist Clients in Poland and elsewhere. Our extensive knowledge of the true climate in these sectors enables us to advise strategically and propose interim solutions. We advise Clients at each stage of product or service development, from obtaining marketing authorization through financing and protecting intellectual property rights to providing representationin any litigious or administrative proceedings.

By taking an interdisciplinary approach to Client matters we can provide a broad range of services stretching beyond ‘normal legal advice’.

What we do?

We advise on a full range of issues relating to marketing authorization for new products in the pharmaceutical, cosmetics, food and medical sectors.

  • We assist with advertising and promotion, and protection of a brand,
  • We devise a professional strategy for protecting industrial property rights,
  • We provide assistance with combating acts of unfair competition such as product and brand imitation and unfair advertising,
  • We handle cases before the Office of Competition and Consumer Protection,
  • We provide specialized personal data protection services tailored to the specific nature of the pharmaceutical, cosmetics, food, and medical sectors,
  • We make proposals for distribution of pharmaceutical products, medical devices, and cosmetics, taking account of the current regulatory climate,
  • We handle cases conducted under the Public Procurement Law,
  • We handle disputes before common courts, the Supreme Court, the Domain Name Dispute Resolution Centre, arbitrational tribunals, and administrative courts,
  • We represent Clients before state authorities such as the Minister of Health, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, the Chief Pharmaceutical Inspectorate, the President of the Personal Data Protection Office, the Office of Competition and Consumer Protection, and European authorities and courts,
  • We conduct training and workshops on legal and commercial issues for the pharmaceutical, cosmetics, food, and medical sectors.
Cooperation benefits

The Life Sciences sector is subject to increasing oversight from regulatory authorities, while growing pressure to cut prices, and rapidly advancing technology are an additional problem. Life Sciences firms and organizations now need professional legal advice covering a range of aspects.

The thorough market practice knowledge that our experts have spent years developing means that we can provide Clients with legal safety.

At the same time, we can implement solutions that are commercially effective. We can provide long-term advice, or interim advice, where necessary. We have a partnership style approach to our work, and communicate with Clients in a transparent and comprehensible way.

Our Clients can expect proposals for measures to mitigate any risk that may arise while also achieving the envisaged commercial objectives. We appreciate business needs and ensure legal safety.

Why choose us?
  • assistance with a full range of matters covering highly diverse areas of law,
  • a thorough understanding of the specific nature and true market climate in the medical, pharmaceutical, cosmetics, and food sectors,
  • a high success rate,
  • convenient forms of contact,
  • rapid assistance in matters needing urgent attention.


Related articles

11 Apr 2024

NGT plants: what future for crop, food, and feed protection in the EU?

The European Union is in the process of drawing up a regulation on plants and foods obtained through the so-called new genome techniques (NGT). According to the proposed new regulation, NGT plants are those obtained through specific genetic modifications: guided mutagenesis, cisgenesis or a combination thereof.

14 Sep 2023

The EMA has released official guidance on the protection of personal data and commercially confidential information in the Clinical Trials Information System (CTIS)

It is compulsory to use the Clinical Trials Information System (CTIS) when filing any new applications for clinical trials from 31 January 2023. The CTIS is a website designed for the implementation of Regulation 536/2014 on clinical trials. Although the regulation was adopted almost ten years ago, there is still uncertainty surrounding the implementation of the regulation’s requirements concerning greater transparency of clinical trials and, in particular, the scope of information to be published in the CTIS.

27 Jul 2022

Advertising of dietary supplements: the more charges, the harsher the penalty?

At the end of April, the President of UOKiK announced initiation of proceedings for practices infringing the collective consumer interest against a trader dealing in dietary supplements. The list of allegations is considerable. And for each of these — under a new debatable fining method — the authority can impose a separate severe financial penalty.

05 Jun 2022

Cannabis in Poland – significant changes in legislation, jurisprudence and on the market

The cannabis plant contains many different cannabinoids. The most popular one is THC, (Tetrahydrocannabinol), a substance triggering a narcotic effect. CBD (Cannabidiol) is the second most known cannabinoid  identified in cannabis. It is believed not to have negative psychoactive effects and indicates calming effects. As of 2019, clinical research on CBD included studies related among other things to anxiety and pain, but there is insufficient high-quality evidence that cannabidiol is effective for these conditions. Nevertheless, CBD can be and is used in many countries as an ingredient in food, especially dietary supplements and cosmetics.

02 Jun 2022

New rules on advertising medical devices

There has been a major change to laws regarding advertising of medical devices in Poland due to another Act on Medical Devices being passed, of 7 April 2022.

14 Mar 2022

New proposal for a Polish act on clinical trials

Work is in progress on a proposal for an act on clinical trials of medicinal products for human use. The main purpose of the act is to transpose Regulation (EU) No. 536/2014 into Polish law and enforce it. The bill was first published for public consultation in April last year, and as of 17 January 2022, following the publication of statements submitted during the consultation process, has been forwarded to the European Union Affairs Committee.

24 Dec 2021

Advertising of dietary supplements - trends in recent case-law in Poland

Administrative authorities and courts are clarifying the scope of health claims considered unacceptable.

19 Oct 2021

Significant changes to Polish reimbursement law are on the way

A proposal for an amendment to the Reimbursement Act was published on 30 June 2021. The bill is currently undergoing public consultations and will be submitted to the Sejm for debate next year.

30 Jun 2021

Legal developments concerning medical devices

On 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices (MDR) came into force, and this means revolutionary changes in many areas of the medical devices industry. The regulation changes current regulations concerning clinical trials for the most technologically advanced products. It also introduces major amendments to rules on regulatory compliance of a device post marketing authorization and on classification of software as a medical device.