Regulatory law firms ranking

Boutiques dominate pharmaceutical law services

Ranking 2017-03-30
The winners in PI's ranking* were DZP and KRK. The firms in this industry will be advising pharmacy networks on how to prepare for restrictions in medicine sales.

 

REGULATORY LAW FIRMS RANKING - PHARMACEUTICAL INDUSTRY
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.

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Justyna Jawor
Fmr. Legal Affairs Analyst
Justyna Jawor
PI Alert
10:00
28.06.2024

EU summit: Member States launch discussion on financing joint defence initiatives

State of play

Leaders approved appointments to top posts. At the EU summit that ended on Thursday night, they nominated Ursula von der Leyen for a second term as head of EurCom, former Portuguese Prime Minister António Costa as head of EurCou and Estonian Prime Minister Kaja Kallas as head of EU diplomacy. Italian Prime Minister Giorgia Meloni abstained from voting for von der Leyen and voted against Costa and Kallas. This means that Meloni is preparing for tough negotiations and may demand a high political price in return for his party's support for von der Leyen in her approval in the EurParl. Prime Minister Viktor Orbán voted against von der Leyen and abstained on Kallas.

They adopted the Union's strategic agenda for 2024-2029. Over the next five years, the Union's goals include a successful digital and green transformation by "pragmatically" pursuing the path to climate neutrality by 2050. Another objective is to strengthen the EU's security and defence capabilities.

Von der Leyen spoke of EUR 500 billion for defence over a decade. This was the EurCom estimate of needed EU investment presented by its head at the EurCou meeting. Poland and France were among the countries that expected the EurCom to present possible options for financing defence investments before the summit, such as EU financing of common expenditure from a common borrowing. This idea was strongly opposed by Germany and the Netherlands, among others. In the end, von der Leyen decided to postpone the debate until after the constitution of the new EurCom, i.e. in the autumn. And the summit - after von der Leyen's oral presentation - only launched a preliminary debate on possible joint financing of defence projects.

Poland has submitted two defence projects. These might be co-financed by EU funds. On the eve of the summit, Poland and Greece presented in writing a detailed concept for an air defence system for the Union (Shield and Spear), which Prime Ministers Donald Tusk and Kyriakos Mitostakis had put forward - in a more general form - in May. In addition, Poland, Lithuania, Latvia and Estonia presented the idea of jointly strengthening the defence infrastructure along the EU's borders with Russia and Belarus. Poland is pushing for the EU to go significantly beyond its current plans to support the defence industry with EU funds and agree to spend money on defence projects similar to the two proposals. But EU states are far from a consensus on the issue.

Zelensky signed a security agreement with the Union. The document, signed by President Volodymyr Zelensky in Brussels, commits all member states and the EU as a whole to "help Ukraine defend itself, resist efforts to destabilise it and deter future acts of aggression". The document recalls the EUR 5 billion the EU intends to allocate for military aid and training in 2024 (in addition to bilateral aid from EU countries to Kyiv). It says that "further comparable annual increases could be envisaged until 2027, based on Ukrainian needs" i.e. it could amount to up to EUR 20 billion. Ukraine's agreement with the EU comes on top of the bilateral security "guarantees" Ukraine has already signed with a dozen countries (including the US, UK, Germany, France, Italy). As Prime Minister Donald Tusk confirmed in Brussels, talks are also underway between Ukraine and Poland on the text of mutual commitments on security issues.

PI Alert
21:00
09.06.2024

KO wins elections to the European Parliament

KO received 38.2 per cent of the vote and PiS 33.9 per cent, according to an exit poll by IPSOS. Konfederacja came in third with 11.9 per cent, followed by Trzecia Droga with 8.2 per cent, Lewica with 6.6 per cent, Bezpartyjni Samorządowcy with 0.8 per cent and Polexit with 0.3 per cent. According to the exit poll, KO gained 21 seats, PiS 19, Konfederacja 6, Trzecia Droga 4 and Lewica gained 3. The turnout was 39.7 per cent.

According to the European Parliament's first projection, the centre-right European People's Party (EPP), which includes, among others, PO and PSL, will remain the largest force with 181 MEPs in the 720-seat Parliament. The centre-left Socialists and Democrats (S&D), whose members include the Polish Lewica, should have 135 seats, whereas the liberal Renew Europe club (including Polska 2050) will have 82 seats. This gives a total of 398 seats to the coalition of these three centrist factions (EPP, S&D and Renew Europe) on which the European Commission under Ursula von der Leyen has relied on so far. The Green faction wins 53 seats according to the same projection, the European Conservatives and Reformists faction (including PiS) 71 seats and the radical right-wing Identity and Democracy 62 seats.

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