Pharmaceuticals and Healthcare
Pressure is mounting with the anticorruption law
With the impending law aimed at tackling corruption in the healthcare system, there is an increasing amount of pressure on the industry to ensure that compliance regulations are up to scratch. The need for advice is clearly on the rise. The German Federal Government’s plan to introduce criminal provisions to deal with bribery and corruption in healthcare is a response to the ruling passed by the Federal Court of Justice (Bundesgerichtshof) in 2012 declaring that acts of corruption committed by physicians and pharmacists in private practices are not punishable at present. It will now become apparent which firms already advising on pharmaceuticals and healthcare compliance are also well set up at the interface with criminal law.
The issue of transparency has long since been gaining ground with the FSA Code of Conduct. The FSA is an association for voluntary self-regulation in the pharmaceutical industry and 2016 will see a tougher stance being taken on this voluntary commitment in the industry as cooperations between physicians and pharmaceutical companies will first have to be announced online. The collection of such data already boosted the significance of data protection in 2015.
This will become ever more important to pharma companies and medical products manufacturers from another angle: health apps are moving into the market and shining the spotlight on authorization and demarcation issues.
Law firms woo medical products manufacturers
Firms are trying to appeal to medical products manufacturers on this and other topics – the sector is not yet as clearly divided as pharma.
However, regardless of the client, one thing is for sure: expertise beyond traditional pharma law is essential to making a name for oneself in the advisory market. Dierks + Bohle, for example, acted with particular foresight – the firm was one of the first to appoint its own criminal lawyer focused on corruption.
Public procurement and corporate expertise in demand
With regard to the numerous health insurance tenders, on the other hand, firms with a good setup at the interface to public procurement are doing especially well.
Corporate competencies, esp. concerning the in- and out-patient healthcare sector, are also increasingly sought after. Transactions and restructuring, especially as regards medical centers, will be in higher demand in the future. This will make business more interesting for major firms such as Hengeler Mueller, but also for specialized boutiques such as Möller & Partner.
Small, specialized outfits penetrate the market
The shift in advisory needs in the pharmaceuticals and healthcare industry poses a challenge to all firms advising in the field. Several specialist boutiques do not yet possess the necessary expertise across all the various interfaces, while several major firms still have to expand their industry-specific expertise. Specialist outfits such as Sträter and Dierks + Bohle are best equipped for these changes, as are major firms such as Baker & McKenzie and Gleiss Lutz. In contrast, smaller outfits such as Ampersand, Wachenhausen and Meisterernst score points through their specialist expertise, which are the envy of many competitors.
The following comments deal with firms which provide advice to the German pharmaceutical and healthcare sector. The German healthcare system is undergoing huge changes which challenge all players in the sector. Advice in this area covers an increasing number of legal fields. 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 ?dispute resolution (product liability), ?distribution, trade and logistics and ?trademarks and unfair competition.
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