JUVE Law Firm of the year

Pharmaceuticals and Healthcare

New regulations are driving the sector

The anticorruption law is still creating a great deal of uncertainty among all players in the sector, meaning a lot of work for the respective specialists. Companies are exercising extreme caution in cooperations with hospitals and are waiting to see how the public prosecution departments will implement the new law.

Besides this, digitalization projects are resulting in a high demand for advice. The interface with data protection is gaining in significance with the emergence of more telemedicine methods. Pharmaceutical legislation is being Europeanized following the introduction of new regulations affecting medical devices and clinical trials: stricter controls have led to a noticeable increase in the need for advice, esp. for medical product manufacturers. Firms are going all out to canvass for these clients, partly because this newer market does not yet have the same structure as that of classic pharmaceutical companies.

Ruling on AMNOG pricing causes uproar

Another hot topic is the new German law to increase the provision of drugs under statutory health insurance (AMVSG), effective since April 2017: surprisingly, neither the much discussed price cap nor the confidentiality of reimbursement amounts have been incorporated. Furthermore, legislation has failed to ensure legal certainty about the topic of mixed prices. The preliminary decision made by the Superior State Social Court of Berlin-Brandenburg in March 2017, which has the potential to turn the current pricing practice in the AMNOG proceedings on its head, has therefore thrown the entire sector into turmoil.

Other pioneering judgements included the decision made by the Federal Public Procurement Tribunals on open-house agreements, which could increase the number of review proceedings, and the European Court of Justice’s (ECJ) judgement on price fixing, which is causing uproar among pharmacies. Besides this, the ECJ has now come to a decision on the sensational dispute concerning breast implants: it ruled that TÜV Rheinland, in its capacity as appointed test center, is under no explicit obligation to conduct its own examinations of medical devices.

Furthermore, transactions are still plentiful in the industry, such as the €1.3bn biotech deal which saw Astellas acquire Mainzer Ganymed Pharmaceuticals. In the currently trending biosimilars segment, Fresenius paid up to €670m to acquire the respective division from Merck.

Boutiques facing generation change

The law firm landscape is progressing along two tracks, with boutiques still occupying a strong market position. The new firm Novacos Heil Hübner Natz Oeben Stallberg was able to boast a niche position after just one year, with a more international setup and a greater focus on transaction advice than other boutiques such as Sträter and Dierks + Bohle. In the medium term, these firms are faced with a huge challenge internally as they have to actively organize the generation transition from their highly reputed name partners to those next in line.

Large firms focusing on international work

Major firms, on the other hand, are occupied with a different development. As in previous years, Baker & McKenzie, Clifford Chance, Freshfields Bruckhaus Deringer and Hogan Lovells are focusing on international instructions and advising on cross-border compliance investigations and complex e-health projects, often at the interface with the chemistry and food industries.

 

The following comments deal with firms which provide advice to the German pharmaceuticals and healthcare sector. The focus still remains on providing legal advice to manufacturers of pharmaceuticals and medical products – and thus on regulatory, social and unfair competition issues – which helps mold the reputation of firms active in this sector.

Expertise in ?patents, ?antitrust and ?public procurement also continues to play a decisive role. Other chapters that may be relevant are ?IT, ?dispute resolution (product liability), ?distribution, ?trademarks and unfair competition, ?food law, ?banking and regulatory law, ?insurance and telecommunications ( ?media).


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