By Dr. Dr. Adem Koyuncu, Covington & Burling LLP

In the EU, drug companies are not allowed to publicly promote prescription-only medicines. As courts also apply a broad interpretation of the term “promotional”, nearly all public statements that mention a prescription drug are likely to be qualified as illegal advertising. In certain circumstances, this may be the case even if no drug is mentioned.

But what should a drug company do if false statements about its product are distributed? What is allowed in case of a so-called shitstorm? What can the company do to counter negative public statements about its drugs by HTA bodies or other institutions of the healthcare system?


Continue Reading German court allows pharma company public promotional statements about Rx-drug to counter a “shitstorm” – a trend also for the rest of the EU?

On 11 November 2016, the German Parliament passed another new law amending different parts of the German Medicines Act (Arzneimittelgesetz) and the Act on Advertising for Healthcare Products (Heilmittelwerbegesetz). The law is titled “Viertes Gesetz zur Änderung arzneimittelrechtlicher und anderer Vorschriften“. The draft was deliberated in the health committee of the Federal Council (Bundesrat) on 30 November 2016 and it has become clear that the Federal Council will not object to it in its final deliberations later this month. Therefore, the new law will likely become effective at the beginning of 2017.

The new law especially amends the existing clinical trial rules so that German law will comply with the new Clinical Trials Regulation (EU) No 536/2014. The amendments  particularly affect the approval procedure for new studies and the competencies of the ethics committees and regulatory authorities. While currently, two full stand-alone approvals for a study are required (i.e., from the ethics committee and the competent authority), under the new law, certain parts of the ethics committee’s opinion may be overruled by the authority. In addition, a new federal ethics committee can be established by the regulatory authorities which would additionally lead to significant changes in the procedure.
Continue Reading Another round of upcoming amendments to the medicines laws in Germany – Clinical Trials, Advertising, Biologics and more…

On 28 November 2016, the Italian Chamber of Deputies approved the Draft Budgetary Law of 2017.  Among other things, the Draft Law introduces new rules on the substitutability of biologics and the procurement of biosimilars.

In particular, Article 59(11) of the Draft Law provides that:

  • two products enjoy a biosimilarity relationship only where this has been established by the European Medicines Agency (EMA) or the Italian Medicines Agency (AIFA);
  • the automatic substitution of an originator biologic with its biosimilars (and between biosimilars) is not allowed;


Continue Reading Upcoming Changes to Italy’s Biosimilar Landscape

Recently, the Italian Medicines Agency (AIFA) has published a new Concept Paper on Biosimilars.  The Concept Paper outlines the regulatory status of biosimilars in Italy as well as their importance for the Italian healthcare sector.

The new Concept Paper constitutes a revision of AIFA’s Position Paper on Biosimilars of 13 May 2013.  Overall, the Concept Paper does not differ significantly from the Position Paper of 2013.  In fact, both Papers indicate that it is for the physician to decide on a case-by-case basis whether to treat a patient with a biosimilar or with the innovative biologic.  They also exclude the automatic substitution between biosimilars and their originators.
Continue Reading Italian Medicines Agency Publishes New Concept Paper on Biosimilars

Recently, the German Federal Ministry of Health published a new draft law (“Viertes AMG-Änderungsgesetz”) which aims to amend several provisions of the German Drug Act (Arzneimittelgesetz) and other drug-related laws.

Most of the intended amendments result from an adjustment of German laws to the new European Clinical Trials Regulation (Regulation (EU) No. 536/2014). For instance, several provisions of the German Drug Act related to clinical trials (e.g., definitions) will then refer to the Clinical Trials Regulation or are amended accordingly. The German Ordinance on Good Clinical Practice (GCP-Verordnung) will cease to be in force. Furthermore, some amendments, particularly those that refer to the informed consent of study subjects, will go beyond the scope of the Clinical Trials Regulation.
Continue Reading Comprehensive Amendments of German Drug Laws upcoming