Regulatory & compliance

EMA Transparency Policy upheld by General Court: companies unable to show that submissions to EMA are confidential

Eveline Van Keymeulen

On 6 February 2018, the General Court delivered three very carefully considered judgments in cases brought by companies who objected to the disclosure in their entirety of documents submitted to the European Medicines Agency (EMA) for the purposes of gaining a marketing authorisation or additional market exclusivity (see our previous update (see our previous blog Read More

German Court rules that promotion of prescription-only medicines is justified to refute a “shitstorm” in social media

Stefanie Günther

The Higher Regional Court of Cologne held in a recent decision that a pharmaceutical company could defend itself against a so-called “shitstorm” via a post in social media, even though the post qualified as promotion of a prescription-only medicine. The promotion of prescription-only medicines vis-à-vis the public is prohibited in the EU. The German courts Read More

CJEU’s first ruling on the classification of software as a medical device: A predictable scenario with a possible cliff-hanger?

Eveline Van Keymeulen

In its judgment dated 7 December 2017 (Case C-329/16) the Court of Justice of the EU – rather unsurprisingly – confirmed that software which uses patient-specific data to aid prescription by detecting contra-indications, interactions with medicinal products and excessive doses falls within the definition of a medical device for the purposes of the Medical Devices Directive. Read More

Italian reform of clinical trial rules out of the starting blocks

Marco de Morpurgo

Today, Italian Law 3/2018 – mandating the governement to reform the Italian clinical trial rules – entered into force.  The Italian government now has 12 months to revise the regulatory framework applicable to clinical trials conducted in the country.  The legislative mandate to the government includes an alignment of the Italian clinical trial rules with the Read More

EU General Court rules on transparency of clinical trial data

Marco de Morpurgo

Today, the General Court delivered three landmark judgments relating to transparency of clinical trial data in the EU.  The long-awaited rulings clarify the scope of commercial confidentiality with regard to data pertaining to centrally approved medicinal products and included in the MA application dossier.  The three rulings uphold the European Medicines Agency (EMA)’s decisions to Read More