Pharmaceutical Law Office

Pharmaceutical Law Law Firm

pharmaceutical law lawyer
Piotr Kłodziński - lawyer, specialist in pharmaceutical law

Pharmaceutical Law Firm Practice

pharmaceutical law firm
Piotr Kłodziński - lawyer, specialist in pharmaceutical law

Our priority is to provide clients from the pharmaceutical industry with the highest quality legal services, while maintaining prices at an acceptable level.  

For which clients and what types of pharmaceutical law cases does the Law Firm handle? 

The pillar of our activity is legal services for pharmacies, but we also provide our services to other entities from the pharmaceutical industry, which means that we also serve pharmaceutical wholesalers, individual pharmacists, small producers, as well as importers and exporters of medicinal products, medical devices and veterinary medicinal products . As a pharmaceutical law firm, we provide comprehensive services to all these entities in the field of legal and business consulting - not only based on our legal knowledge, support of scientific authorities, but also extensive experience and negotiation skills.

First of all, we conduct transactions, cases and disputes regarding:

sale and acquisition of pharmacies
– other cases of transfer of the license to operate a pharmacy
– opening new pharmacies, also in “difficult” or potentially impossible locations
– requests for reimbursement from the National Health Fund 
– contractual penalties imposed by the National Health Fund
– inspection proceedings in which there is a risk of withdrawal of the permit to operate a pharmacy or wholesale store
– advertising proceedings
– disciplinary liability of pharmacists
– proceedings regarding the withdrawal of a license to operate a pharmacy
– registration and notification proceedings, including those relating to producers and wholesalers
– purchasing pharmacies from the bankruptcy estate

Our specialization in pharmaceutical law matters

The activities of lawyers specializing in advising pharmacies, wholesalers and manufacturers require not only experience, but also constant monitoring of changes in legal regulations. The Pharmaceutical Law Act and the most important implementing provisions thereof are amended even more than 10 times during a calendar year. Therefore, as lawyer-practitioners handling matters related to pharmaceutical law, we emphasize the need for people who want to specialize in these matters to be fully involved in this field. We are proud that the team of our Pharmaceutical Law Firm has gained experience that distinguishes us on the market. So far, acting for clients from the pharmaceutical industry, we have participated in over two hundred administrative proceedings. 

Own database of WIF and GIF decisions, useful in key proceedings in the field of pharmaceutical law

As a law firm specializing in Pharmaceutical Law, we have an independently created database of several hundred decisions issued by pharmaceutical inspection bodies, one of the largest in Poland and constantly developed, allowing us to better predict how specific proceedings will end. Thanks to the collected knowledge and materials, we have grounds to claim that we often know better than others how to convince supervisory authorities that we are right. We also add experience in representing pharmaceutical entities (pharmacies, wholesalers, importers, manufacturers) before, among others, Provincial Pharmaceutical Inspectorates, the Chief Pharmaceutical Inspectorate, the Ministry of Health, the National Health Fund, the Office for Registration of Medicinal Products and the Chief Sanitary Inspectorate.

Additionally, we have a strong team in the field of civil law and company law - this also helps in many matters.

Who do we represent most often? 

Today, as a Pharmaceutical Law Firm, we cooperate with large entities (pharmacy chains, manufacturers, pharmaceutical wholesalers) and with small entrepreneurs running - often with great success - single pharmacies. Not only do we help them find legal solutions and represent clients in all types of matters as part of legal services, but we also help with valuations, audits and provide business advice. Thanks to a wide network of contacts, we connect our clients where it can bring them potentially significant benefits. For example, such support often turns out to be very useful when selling pharmacies and wholesalers.

Although we do not purchase pharmacies or wholesalers, in fact the sale of a pharmacy to a pharmacist, as well as orders involving the need to look for buyers for a pharmacy or wholesaler, are the tasks with which customers usually approach us. We also accept orders for the valuation of pharmacies. All this so that our clients receive a fair payment for their pharmacy, or when we represent pharmacy buyers - they pay the market price.

If you want to join the group of our clients, then contact us or book an initial consultation date.

Together with our law firm's team, we constantly monitor subsequent changes in pharmaceutical law to help our clients predict how amendments to these regulations will affect their business.

158E7DD1-7A5D-4A28-81EA-A2BB0A41E59F

Corporate and other experience in supporting entities operating in the pharmaceutical industry 
— a word from the founder of Legal Advisor Piotr Kłodziński:
 

I ran the legal department of one of the largest international pharmacy chains - Euro-Apteka. In this corporation, I was responsible for all legal issues and contacts with regulators such as WIF and GIF. An equally large scope of my responsibility was also the development and optimization of the pharmacy network, including by co-creating a franchise program and opening new pharmacies. Comprehensively conducting a number of transactions involving the purchase and sale of individual pharmacies and their entire chains was equally important for achieving this goal. I also prepared legal (possibly legal) advertising strategies for pharmacies and defended pharmacists in disciplinary cases. I also led projects such as the registration of medical devices and dietary supplements, and the creation of a franchise program. 

For the way I ran the legal department of Euro-Apteka, implementing uniquely simple and transparent solutions and procedures, and above all, their effects, I was awarded in the Rising Stars Lawyers - Leaders of Tomorrow competition in 2016. So far, I have supported many times with my knowledge and acted on behalf of the Association of Pharmacy Employers PharmaNET or as an expert of the Business Center Club.

I was also asked several times to take a public position and act as an expert assessing proposed changes and implementation of EU directives in the field of pharmaceutical law. I took part, among others, in several television debates on subsequent amendments to the Pharmaceutical Law. So far, I have published my analyzes on these matters in Rzeczpospolita and Dziennik Gazeta Prawna, and my words have been quoted many times in industry articles. In addition, I was asked to support the legislative process by inviting me as an expert several times to the meetings of the Parliamentary Health Committee, aimed at giving opinions on subsequent draft amendments to the Pharmaceutical Law. Additionally, I also provided substantive support during meetings Ministry of Health and Chancellery of the President of the Republic of Poland.

We continue to keep up to date with current changes in the industry. We constantly cooperate with pharmaceutical entities and the industry environment, and we conduct (sometimes difficult) dialogue and correspondence with the authorities supervising this market on many issues. If you need expert legal assistance in the field of pharmaceutical law, please contact me. 

Regardless of whether you want to use help within:

– conducted in our office legal services for companies 

– are you an individual pharmacist who needs the assistance of a lawyer in the field of pharmaceutical law or a related field of law, 

this with our Team within Pharmaceutical Law Office within our time limits, we are happy to take on new challenges. Each case requires an individual approach. An additional feature that makes pharmaceutical law so interesting is the dynamically changing legal conditions related to the implementation and implementation of the changing provisions of the Pharmaceutical Law Act and their new interpretations. We try to approach each case comprehensively. You can give us your case and forget about it. Our basic mission is to ensure that each of us can do our job in peace.

Currently, in our specialized practice as part of the Pharmaceutical Law Firm, we are handling several cases regarding:
– pharmacy sales
– opening new pharmacies (also in areas where it seems impossible),
– inheritance of pharmacies and transfer of pharmacies to pharmacists' children upon retirement,
– taking over pharmacies from bankruptcy estate,
– sales of pharmaceutical wholesalers.
– WIF control in pharmacies and wholesalers,
– disciplinary proceedings for pharmacists,
– disputes over reimbursement from the National Health Fund,
– registration of medical devices, dietary supplements, medicinal products.

I cordially invite you to contact and reservation the date of the initial consultation.