pharmaceutical industry

On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog

Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices

The CMA issued an infringement decision today fining GlaxoSmithKline (“GSK”) and two other pharmaceutical companies a total of £45 million for delaying market entry of generic versions of GSK’s blockbuster anti-depressant Seroxat (paroxetine) in the UK.
Continue Reading CMA Fines GlaxoSmithKline and Several Generic Companies £45 million for Delaying Market Entry of Generic Paroxetine in the UK

On 9 July 2014, the European Commission’s Directorate General for Competition imposed fines totalling € 427.7 million on innovative pharmaceutical company Servier and generic companies Niche/Unichem, Matrix (now Mylan), Teva, Krka and Lupin.  The Commission’s decision was the result of proceedings opened in 2009 and follows a Statement of Objections sent to the parties involved in 2012, accusing Servier of abusing its dominant position in the market of antihypertensive medicines and entering into anticompetitive agreements with generic competitors.  According to the Commission’s decision, Servier aimed to prevent entry into the market of cheaper versions of Servier’s blockbuster drug perindopril.

The Servier investigation was a new case in the long series of Commission investigations into the pharmaceutical sector, which started in essence with the Commission’s Competition Inquiry into the Pharmaceutical Sector (Sector Inquiry).  The 2009 Final Report of the Sector Inquiry revealed practices that could have an impact on generic competition in the pharmaceutical market and initiated a monitoring exercise by the Commission of anticompetitive patent settlements.  The Commission concluded four monitoring exercises, covering the periods from mid 2008 – end 2009, 2010, 2011 and 2012.  The latest monitoring has shown that the number of patent settlements is increasing but the number of potentially problematic agreements from an antitrust perspective is low.  In the period after the Sector Inquiry, the Commission sanctioned pharmaceutical companies for anticompetitive patent settlements in two major instances, i.e., the citalopram and the fentanyl decisions of 2013.
Continue Reading European Commission Fines Servier and Five Generic Companies For Preventing Entry Of Generic Versions Of Blood Pressure Control Drug