Lawyer - Pharmaceutical law
Articles prepared by lawyers from our Pharmaceutical Law Firm:
PHARMACEUTICAL LAW OFFICE
- here business and health collide with law, integrity and accountability
Our priority is to provide the highest quality legal service to the pharmaceutical industry, while maintaining an acceptable price level.
Why our pharmaceutical law firm?
The law firm we lead is distinguished by its unquestionable specialisation in pharmaceutical law. Members of our team are able to demonstrate a total of more than 200 successfully completed administrative and judicial proceedings in this field.
As pharmaceutical lawyers, we offer effective legal services to every person and entity in the industry: from individual pharmacists and pharmacy owners to pharmacy chains, wholesalers and small and large pharmaceutical companies. However, do not be fooled, contrary to common associations - we do not always operate in Warsaw, Krakow, Wroclaw or Szczecin, working exclusively for large chains. We carry out a significant proportion of projects for smaller entities, in small towns.
We proactively advise clients all over Poland, so that our Principals are legally and business-wise one step ahead of their competitors. We meet both stationary in our offices and online, and if necessary we travel to where our clients need us. We are available 7 days a week. We respond to clients' emails within a guaranteed timeframe.
Substantively, we also strive to be clearly superior to others. We have a sizable proprietary, database of decisions of pharmaceutical inspection authorities, which allows us to predict the outcome of proceedings with high probability and to build an effective argumentation. As pharmaceutical lawyers with many years of experience, we are able to anticipate trends and effectively protect our clients' interests in a dynamically changing legal and business environment.
Above we described how our pharmaceutical law lawyers, it is time to describe the key areas of our practice:
- Inspections and proceedings of WIF, GIF, OIA, NFZ: We offer support during inspections and investigations by the supervisory authorities, effectively representing the interests of our clients, including in cases of licence revocation or refund reimbursement.
- Transactions purchase and sale of pharmacies: We assist in the purchase and sale of pharmacies - minimising legal risks and carrying out projects for the rapid transfer of the pharmacy licence or the sale of shares - for clients from all over Poland. In this respect, we provide comprehensive business support services on a day-to-day basis with regard to, among other things, the valuation of pharmacies and assistance in finding potential buyers.
- Sale of other businesses - pharmaceutical wholesalers, small pharmaceutical manufacturers or pharmacy outlets, as well as shares in companies in the sector.
- New pharmacy openings - Among the projects we are carrying out, there are also those involving the conduct of pharmacy licensing proceedings without regard to geographic-demographic criteria.
- We are leading innovative projects in the pharmacy environment: We have behind us, for example, the opening of pharmaceutical care offices or the successful relocation of a pharmacy under AdA 2.0.
- Registration of medicines, medical devices and dietary supplements, as well as, within the scope of the law, advertising of pharmacies and pharmaceutical products: We advise on the registration of medicinal products, medical devices and dietary supplements, as well as on the creation of compliant information and advertising campaigns.
- Drug reimbursement and penalties from the National Health Service: We represent clients in drug reimbursement disputes, helping to avoid contractual penalties and similar legal problems.
- Import and export of pharmaceutical and veterinary products: We provide support in the import and export processes, ensuring compliance with applicable regulations.
- Pharmacists' disciplinary cases. In the pharmaceutical industry, disciplinary proceedings can unfortunately have serious consequences for a pharmacist's career. Our law firm offers comprehensive legal services in defending against disciplinary charges, providing full support at every stage of the proceedings before the pharmacy court. With our experienced pharmacy lawyers who are well versed in the specifics of these cases, we help to effectively protect a pharmacist's rights and reputation.
Who do we work for?
As lawyers specialising in pharmaceutical law, we primarily advise and represent the interests of individual pharmacists, and pharmacy owners.
We also frequently cooperate with representatives of small and large pharmaceutical companies, pharmaceutical wholesalers, manufacturers of medicines and medical devices and importers and exporters of medicinal products and veterinary medicinal products. We treat each client individually, building long-term relationships based on trust and mutual respect.
Our approach as lawyers from a pharmaceutical law firm:
What distinguishes pharmaceutical law from other areas of law and the economy is the fact that the rules and regulations governing the pharmaceutical business change up to a dozen times a year. This is why it is so important to have a lawyer on your side who not only keeps up with the changes, but also anticipates them, including by monitoring the pending draft amendments. We monitor the trends in case law from both the courts and administrative bodies. In this industry, the fact that something is impossible today does not mean that it will not be possible in a few months and vice versa - opportunities that exist for pharmaceutical companies today may disappear in a month or two. It is worth taking advantage of these changes appropriately - both legally and in terms of business - to achieve a competitive advantage.
- Proactivity: We constantly analyse changes in the law so that our clients are always prepared for new challenges.
- Practicality: Our advice is not just about interpreting regulations, but also about concrete, practical solutions adapted to market realities. We solve real problems that pharmacists and pharmacy owners face every day, as well as manufacturers, exporters and importers of pharmaceutical products.
- Partnership: We rely on long-term relationships that are built on trust and mutual respect.
Additional services:
- Mediation of pharmacy sales transactions
- Pharmacy audits and valuations
- Transactional negotiations
- Audits of pharmaceutical companies
- Resolution of disputes between shareholders
- Strategic advice
- Staff matters
If you want to join the group of our clients, then contact us or book an initial consultation date.
Previously I ran a pharmaceutical lawyer legal department at one of the largest in this part of Europe international pharmacy chains - Euro - Apteka.
I was responsible for the effective resolution of legal problems. This meant not only fighting in court or defending pharmacists in disciplinary courts, the traditional places for lawyers. Equally important were the day-to-day contacts with regulators such as the WIF across Poland and the overarching one, the GIF. Wherever possible we try to avoid a direct clash, although of course we do not shy away from fighting for our clients' interests if necessary, but to serve them as best as possible we always try to find a consensual solution first. And although this cooperation with the authorities regulating the pharmaceutical market is not always easy, such a model of cooperation with authorities and regulators is still practised by the law firm I run.
I was also responsible for the development and optimisation of the pharmacy network, among other things, by purchasing individual pharmacies as well as entire chains, co-designing the franchise programme and opening pharmacies in new locations. I also prepared strategies for the (possibly legal) advertising of pharmacies from the legal side and dealt with the defence of pharmacists in disciplinary cases. Again, to this day, as a pharmacy lawyer, I primarily handle such cases.
As part of my corporate career, I have also led projects concerning the registration of medical devices and dietary supplements, or the creation of a franchise programme and bonus system for a pharmacy chain.
For the way I led the legal department of Euro-Apteka, implementing uniquely simple and transparent, solutions and procedures and, above all, their results, I was awarded in the Rising Stars Lawyers - Leaders of Tomorrow competition in 2016. On many occasions to date, I have supported with my knowledge and made public appearances 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 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.
Each case requires an individual approach and an update of detailed knowledge, the latest jurisprudence - and with transactions - business conditions. An additional feature - making pharmaceutical law so interesting - are the dynamically changing legal conditions related to the implementation and enforcement, the changing provisions of the Pharmaceutical Law and new interpretations thereof. We strive to approach each problem as comprehensively as possible, i.e. to solve your problems and cases as efficiently as possible.
You can give us your case and forget about it. Our primary mission is to make it possible for everyone to do their job in peace.
I cordially invite you to contact and reservation the date of the initial consultation.