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?

In a judgment from 12 January 2018, the Higher Regional Court of Cologne (Oberlandesgericht Köln) has now decided that, when facing a – the following term is a quote from the decision – “shitstorm” in the internet, a pharma company may defend its Rx-drug with public statements even if these statements qualify as promotional. In this case, the manufacturer of a veterinary medicine became victim of defamations in the internet. Several posts with allegations about a flea and tick repellent were published on Facebook. As the allegations lacked a factual basis, the manufacturer reacted with own posts about the product to counter this “shitstorm”. Additionally, a webpage was linked where the company responded to the inaccurate allegations and informed consumers and veterinarians.

A competitor of the company applied for a preliminary injunction to prohibit these statements and referred to the legal ban of public advertising for Rx-drugs as set forth in Section 10 (1) of the Act on Advertising for Therapeutic Products (Heilmittelwerbegesetz). In the first instance, a lower court in Cologne in fact prohibited these posts. However, on appeal the Higher Regional Court allowed those statements that aimed at defending against the shitstorm. The higher court considered that in such a situation an overall assessment of the involved rights and interests is necessary. The ban of public advertising for Rx-drugs needs to be weighed against the constitutional rights of the affected manufacturer. Hereby, the court took the view that, as long as the promotional statement can be clearly linked to the shitstorm and responds to the comments made against its product in this campaign, the legal assessment may be in favour of the manufacturer. Then, the manufacturer may exceptionally be allowed to make such statements even if their content could be qualified as promotional.

The decision has a significant practical impact for drug companies: It acknowledges an exception from the ban of public advertising for Rx-drugs and allows companies to defend their products against defamation and false information.

Actually, this new decision of the Higher Regional Court of Cologne is a continuation of the “Sortis”-decision of the German Supreme Court (Bundesgerichtshof) from 2009 (case: I ZR 213/06) in which the court expressed a similar view but for a different scenario. In that case, Pfizer was facing negative public comments on its product Sortis® (Atorvastatin) made by institutions of the German healthcare system. The controversy arose in the context of the drug’s evaluation under the German reference pricing and reimbursement rules. Pfizer had reacted by posting own public statements about Sortis® in nationwide newspapers. The new decision of the court in Cologne continues this judicature for the scenario of an internet shitstorm.

Conclusions: in Germany, drug manufacturers are allowed to publicly defend their products against shitstorms. In so doing, they may exceptionally make public statements about Rx-drugs even if these can be qualified as promotional. However, this exception is still subject to quite strict legal requirements with respect to both the type and content of the allegations (shitstorm) against the drug and the scope and limits of the defense statements that the company may publish. Therefore, the individual case scenario and the envisaged defense statements should undergo a very careful legal review.

What does this German judicature mean for the rest of the EU? So far, the Court of Justice of the EU has not issued a decision on this particular issue. As the ban of advertising for Rx-drugs applies in the entire EU and as a shitstorm can hit a company anywhere, a consistent judicature should apply in the EU. There are good arguments in favor of the legal view of the German courts. Hence, sooner or later this German judicature may also be adopted in other EU countries.

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Photo of Dr. Dr. Adem Koyuncu Dr. Dr. Adem Koyuncu

Adem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & Device” practice group and also a member of our Compliance practice. Adem is…

Adem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & Device” practice group and also a member of our Compliance practice. Adem is recognized as a “leading lawyer for pharma and medical devices law” (JUVE 2021).

Adem helps clients on a wide range of EU and German law issues, including regulatory, compliance, privacy and liability matters. He also provides strategic advice. He knows the life sciences sector also from his earlier work in the pharmaceutical industry and as a medical doctor. He represents clients before courts and authorities and assists them in contract negotiations, investigations and transactions. For years, Adem is listed in various lawyer rankings.

See some Accolades from Clients and Surveys:

  • “He is one of the most detail-oriented and client-focused partners I have ever encountered.” (Client, Chambers 2021)
  • „Great professional and human competence, good team player.“ (Client/Adverse Party, JUVE 2022)
  • “I find him to be one of the most pragmatic regulatory lawyers. He was a doctor before a lawyer, has been in-house, worked on lots of stuff that I have to handle in-house, which helps when getting advice. He is really good at saying it’s a complex situation and your best option is to do this.” (Chambers 2022)
  • “He always comes through with extremely helpful advice. He brings a unique understanding and experience to his practice as both a lawyer and medical doctor.” (Chambers 2021)
  • “Adem Koyuncu is not only a lawyer but also a doctor and has worked in industry. He knows the perspectives that also move in-house lawyers.” (Legal 500 2022)
  • “He is very sharp and quick, while at the same time having a good sense of humor and nerves of steel. Very pleasant to work with.” (Legal 500 2022)
  • He is described as “versatile competent, reliable and high quality” (JUVE 2021) and “incredibly fast.” (JUVE 2018)
  • Provides advice at “an outstanding level.” (Legal 500 2015)
  • “Very strong negotiation skills.” (JUVE 2011)
  • Clients appreciate his “very broad knowledge and long-standing expertise” (JUVE 2021/22) and that “he is approachable, knowledgeable and really easy to talk to over the various issues. He is calm and has seen most problems before.” (Chambers 2020)
  • Peer lawyers described him as “highly competent” and a “very good and pleasant lawyer” (JUVE 2014) and as “the off-label-guru, substantively very good, creative.“ (JUVE 2022)

Adem is the author of numerous publications (e.g., in leading books on pharma law, product liability and clinical trials) and frequent speaker at different events. As such, he will soon speak at following events:

  • “Medical Device Liability and Risk Transfer 2.0 | A liability issue for the Management?!,” BVMed, Webinar (3/24/2023)
  • “Data Protection Requirements and Open Issues in the Pharma Sector – Status quo,” Speech at conference, 26. Marburger Gespräche zum Pharmarecht, Marburg (3/16/2023)
  • “Vendor Oversight & Vendor (Quality) Management in the Pharma Industry,” FORUM-Institut, Online Seminar (4/19/2023)