Lawyer - Pharmaceutical law
Articles prepared by lawyers from our Pharmaceutical Law Firm:
PHARMACEUTICAL LAW FIRM:
this is where business collides with law, integrity and accountability
Why our pharmaceutical law firm?
The law firm we lead is distinguished by its unquestionable specialisation in pharmaceutical law. We can boast a total of more than 250 (mostly successfully) completed administrative and judicial proceedings in this area.
As pharmaceutical lawyers, we provide an effective legal service, providing services to, among others:
individual pharmacists, individual pharmacy owners, pharmacy chains, pharmaceutical wholesalers, small and large pharmaceutical companies....
But don't be fooled, contrary to common associations - we don't always operate in Warsaw, Krakow, Wroclaw or Szczecin, working for the big chains. We carry out a significant proportion of projects for smaller entities, in small towns and cities, all over Poland. We meet with clients both stationary at our offices and online, and if necessary - we can easily travel to wherever we are needed.
Substantively, we also strive to be better than others. We have a large, proprietary database of decisions of pharmaceutical inspection authoritieswhich allows us to predict the outcome of proceedings and build an effective argument for our clients.
Above we described how we operate as 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 supervisory authorities, effectively representing the interests of our clients. Also in cases for reimbursement of refunds, for the withdrawal of a licence to operate a pharmacy or wholesale, as well as in disciplinary cases.
- 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: Defending against disciplinary charges, we provide full support at every stage of pharmacy court proceedings. With our experienced pharmacy lawyers who are well versed in the specifics of these cases, we help you successfully protect your rights as a pharmacist and your reputation.
Our approach as lawyers from a pharmaceutical law firm:
What differentiates pharmaceutical law from other areas of law and the economy is the fact that the regulations affecting 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 by analysing draft amendments under consideration at any given time. We monitor the trends in case law of both courts and administrative authorities.
In this industry, what is impossible today does not mean that it will not be possible in a few months' time and, conversely, opportunities that exist for pharmaceutical companies today may disappear in a month or two. It is worth exploiting these changes appropriately - both legally and in terms of business - to gain an advantage over competitors.
Additional services:
- Transaction mediation purchase and sale of pharmacies
- 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.
I ran as a pharmaceutical lawyer legal department at one of the largest international pharmacy chains, Euro-Apteki.
It is a position where it is not necessary to merely recommend what can and cannot be done. I was primarily responsible for proactively and effectively solving legal problems. This meant not only fighting in court or defending pharmacists in disciplinary courts, the traditional places for lawyers. Equally important were, and still are, market knowledge, looking for unique ideas, solutions to problems as well as ongoing contacts with regulators such as WIF throughout Poland and the overarching one - GIF.
To this day, where we can think of a better way, we try to avoid a direct clash. Although, of course, we do not shy away from fighting for our clients' interests if necessary, to serve them as best as possible, we always try to find a cleverer or conciliatory solution in the first place.
Properly running the legal department also means being responsible for the development and optimisation of the pharmacy network, including by purchasing individual pharmacies as well as entire chains, co-designing the franchise programme, creating clear rules for incentive systems, private label registration and opening pharmacies in new locations. I have repeatedly analysed strategies for (possibly legal) advertising of pharmacies and have been involved in defending pharmacists in disciplinary cases. To this day, as a pharmacy lawyer, I still handle such cases.
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.
On several occasions, I have also been asked to take a public stand and act as an expert, assessing proposed changes and implementations of EU directives in the field of pharmaceutical law. I have taken part in several television debates on successive amendments to the Pharmaceutical Law. I have published my analyses on these issues in Rzeczpospolita and Dziennik Gazeta Prawna, and my words have been quoted many times in industry articles. Furthermore, I have been asked to support the legislative process by being invited several times as an expert to sittings of the Parliamentary Health Committee to provide an opinion on successive draft amendments to the Pharmaceutical Law. In addition, I also provided substantive support during meetings at the 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.
You can give us your case and... try to 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.