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Life Sciences & Healthcare

We work with and have established long-term relationships with the top 100 life sciences and healthcare companies in the areas of pharmaceuticals, medical devices, biotechnology, agriculture and food, including the top 20 global pharmaceutical companies and nine out of the top ten global medical device companies.

Our life sciences and healthcare teams in Central and Eastern Europe advise leading global business groups in the sector on transactions, commercial agreements, compliance, investigations and litigation, very often across multiple jurisdictions in the region and beyond. We can help you to navigate the regulatory landscape and to ensure compliance with both local laws and global policies.

Our co-operation with the team was delightful.

Chambers, 2016

With over 480 international specialist lawyers across CMS and the support of the Life Sciences & Healthcare Asia-Pacific Network (LAN), we understand the scientific and commercial as well as the legal imperatives affecting your life sciences and healthcare business. Our experts, many of whom have worked in-house in your sector, have developed a shared capability in the areas of pharmaceuticals, biotechnology, medical devices and diagnostics.

With active memberships in major industry associations such as the ABPI, ABHI, BIVDA, PAGB, EUCOMED and EFPIA, we help shape the legal frameworks impacting the life sciences and healthcare sector. We regularly advise our clients on their day-to-day operational needs such as support with advertisement and promotion of medicine, public sector procurement, pricing and reimbursement, patent enforcement, commercial and clinical trial agreements as well as regulatory advice.

In Poland we are one of the largest players in the market. The close cooperation of almost 150 lawyers in our Warsaw and Poznan offices allows the Life Sciences & Healthcare Practice to offer comprehensive industry-focused advice. Our clients trust us with their toughest business challenges, spanning from clinical trials, pricing and reimbursement, IP, to high profile compliance issues and M&A transactions.

Highlights of our experience in Lifesciences in Poland
A leading global medical device and pharmaceutical company on regulatory issues concerning both medical devices and medicinal products, in such areas as compliance, reimbursement, marketing, promotion...
29/11/2021
Global Life Sciences & Healthcare Festival 2021 - Virtual
Join us for this year's Global Life Sciences & Healthcare Festival 2021 - Virtual from 29 November to 2 December.  Day 1: Artificial Intelligence in Life Sciences & Healthcare: New business models in a changing legal en­vir­on­ment­Busi­ness models for AI

Feed

19/07/2024
A healthy balance between novelty and sufficiency for a claimed therapeutic...
The question of novelty and sufficiency of second medical use claims in light of clinical trial prior art has been addressed by the EPO Boards of Appeal on a number of occasions. In recent decision T...
11/07/2024
Cannabis law and legislation in Poland
Medical use Polish legislation does not generally allow the growing of cannabis that contains more than 0.3% THC in flowering or fruiting tops of plants from which the resin has not been removed ( Non-Fibrous...
10/07/2024
Polish inspectorate issues ruling on the import of medicinal products
On 8 July 2024, Poland’s Chief Pharmaceutical Inspectorate (GIF) published a decision interpreting the definition in Pharmaceutical Law regarding import of a medicinal product.The decision, published...
27/06/2024
Polish inspectorate rules pharma wholesalers can store commercial medicinal...
Poland’s Chief Pharmaceutical Inspectorate (Główny Inspektorat Farmaceutyczny or GIF) published a decision on its website in June 2024 that pharmaceutical wholesalers can legally store free commercial...
26/06/2024
Updated CMS Expert Guide to Cannabis law and legislation
CMS Expert Guide on cannabis law and legislation gives stakeholders detailed and updated information on the latest developments in cannabis regulation in key markets.  The Guide now covers 33 jurisdictions...
17/06/2024
When medical garment is a medical device – communication from the Polish...
In May 2024, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (President of the URPL) issued a Communication on the principles for determining...
13/06/2024
What’s in a name? The use of a product code in a clinical trial protocol...
The use of product or sponsor codes in clinical trial related documents is common practice in the pharmaceutical space. However, such codes may not always be sufficient to disregard a publication as relevant...
31/05/2024
Poland’s Advertising Council amends Code of ethics to include advertising...
In May 2024, the Union of Associations Advertising Council (Advertising Council), an NGO involved in corporate responsibility in advertising, developed a comprehensive self-regulation on ethical advertising...
21/05/2024
Consultation of the European Commission on Vifor's commitments concerning...
In response to the Preliminary Assessment stating the potential abuse of its dominant position, Vifor proposed several commitments to rectify the potential competition law infringement. The European Commission...
16/05/2024
A broader interpretation of "substance or composition" - good news for...
A recent decision from the EPO Boards of Appeal (T 1252/20) potentially paves the way for more diverse products to be patentable in Europe using the medical use claim format.The back­ground:Art­icle 53(c)...
08/05/2024
Pharmaceutical advertising regulation and medical device advertising in...
1. Which laws are applicable regarding advertising of medicines and medical devices? The main act providing the legal framework for advertising of medicinal products is the Pharmaceutical Law of 6 September...
11/04/2024
Navigating clinical trial disclosures: No reasonable expectation of success...
Recent EPO Board of Appeal decision T 1437/21 adds to a growing number of decisions concerning the patentability of second or further medical use inventions where the prior art relates to a clinical trial...