REGULATORY LAW FIRMS RANKING - PHARMACEUTICAL INDUSTRY
Key points
Pharmaceutical lawyers advise clients in dealing with regulators. These include the Chief Pharmaceutical Inspector (GIF), the Office for Registration of Medicinal Products and MinHea. In relations with the health ministry, law firms help manufacturers to obtain drug reimbursement decisions, and in contacts with GIF they support wholesalers and distributors in obtaining permissions to run a pharmacy. Lawyers are also involved in adjusting companies' internal regulations to compliance. Some focus on advice connected with marketing and advertising of medicines, they can also help with patenting the drugs.
Three types of law firms stand out. These are international networks, large and mid-sized domestic law firms and the so-called boutiques. Unlike larger law firms, boutiques focus on representing clients before regulators, courts and on preparing legal opinions. They are rarely able, for example, to offer comprehensive advice on pharmaceutical mergers or acquisitions. Although the boutiques do not offer all the legal services that may be needed by the companies operating in this market, their representation in pharmaceutical law is the largest of all the fields of the "Polityka Insight's Law firms' ranking".
Lawyers transfer to law firms from regulators. An example is Dentons, who offered a senior lawyer's position to Magdalena Wojciechowicz from GIF, as well as to Barbara Rybińska-Kruszyńska and Łukasz Pera from MinHea. In 2015, the law firm was joined by former Chief Pharmaceutical Inspector Zofia Ulz as a managing consultant. There were also reversed situations, Daria Zygmunt from DZP transferred to the Office of Consumer Protection and Competition (UOKiK). In September 2016, Kieszkowska Rutkowska Kolasinski was strengthened by a senior lawyer Maciej Konarowski from DLA Piper and Marta Skomorowska left Food & Pharma Legal for Czyżewscy.
Polish law firms dominate the market. The representatives of large and mid-sized domestic law firms - DZP, where the practice of life sciences is directed by Marcin Matczak and Kieszkowska Rutkowska Kolasiński led by Paulina Kieszkowska-Knapik and Ewa Rutkowska–were at the forefront of pharmaceutical law, similar to last year. Dentons and Czyżewcy also remained in the second group. In turn, DFL Legal fell to the third group. Among the newcomers was the law firm of Monika Duszyńska (awarded), who headed the life sciences practice at CMS in the past and was senior lawyer at Wierzbowski Eversheds Sutherland.
Pharmaceutical transactions are usually confidential. Due to non-disclosure agreements (NDAs), particularly in pharmaceutical matters, law firms are reluctant to boast about their cases. In 2016, lawyers advised on amendments to reimbursement law and the pharmaceutical law. Czyżewscy prepared comments and proposals for amendments to these laws on behalf of the Chamber of Commerce "Farmacja Polska", and Kieszkowska Rutkowska Kolasinski advised INFARMA, an organisation of the largest foreign drug manufacturers. In turn, DZP supported USP Zdrowie, specialising in diet supplements, in the takeover of the Polish-Swedish Naturell Group.
WHAT'S NEXT
In 2017, the law firms in the pharmaceutical market will focus on distribution of medicines. The health ministry plans changes that include a limitation of sales channels of medicines and dietary supplements. The ministry also intends to increase the market share of small and mid-sized pharmacies, for example, by implementing restrictions limiting the ownership to no more than four outlets. Law firms could advise owners of large networks to transform pharmacies into a franchise format, which would allow them to avoid the planned restrictions. 
Maciej Czapluk contributed to this analysis.
*The ranking covers law firms involved in regulatory consulting or related to public economic law enforced by the authorities such as the Office of Competition and Consumer Protection (UOKiK), the Energy Regulatory Office (URE) and the Polish Financial Supervision Authority (KNF). The gala awarding diplomas to the outstanding law firms took place on March 23. This is the first ranking of law firms in Poland taking into account qualitative data. The results are based on the survey data collected by PI's analysts among the largest companies in the regulated sectors and the law firms themselves.
