Pharmaceutical Companies

On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act.  The Sunshine Act entered into force on 26 June 2022.  However, it will become fully enforceable once the Ministry of Health sets up the Public Register where companies will have to disclose their data and issues the necessary implementing acts.  This means that realistically the new transparency system will not be operational before 2023.  Nonetheless, it is critical that companies operating in Italy make sure that they are ready when the time comes.  Here, we outline some of the key features of the new Sunshine Act and the steps that companies could take in preparation.Continue Reading The New Italian Sunshine Act: What Companies Should Know And How To Get Ready

Following the federal election in September 2021, Germany will soon be led by a new three-party coalition, the so-called “traffic light coalition”, composed of the Social Democratic Party (SPD), the Liberal Democrats (FDP) and the Green Party (Die Grünen). This new federal government led by the new chancellor Olaf Scholz from the Social Democrats will replace the Merkel administration and will be in office for four years. On November 24, 2021, the new coalition has presented their coalition agreement with their plans for the next 4 years. The agreement needs to be approved by the respective party committees and it is expected that all three parties will approve it.Continue Reading New German Government plans significant changes with Impact on the Healthcare, Life Sciences and Food Sector

On 6 May 2021, the European Commission published its “EU Strategy on COVID-19 Therapeutics” (the “Strategy”).  With the vaccination programme now under way, the EU is shifting focus towards the development, approval and procurement of COVID-19 therapeutic products.  The Commission intends to build on the experience from the EU vaccines strategy.  In particular, the aim is to have three new therapeutics available by October 2021 and possibly two further products by the end of the year.

The Strategy touches on a number of key areas for both biotechnology and pharmaceutical companies operating in the space:
Continue Reading European Commission outlines Strategy on COVID-19 Therapeutics

On January 30, 2021, the European Commission published the Regulation establishing an export authorization and notification scheme relating to COVID-19 vaccines and their active substances.  It applies “for a limited duration” to COVID-19 vaccines covered by Advanced Purchased Agreements (“APAs”) concluded with the Union.  As regards APAs contracted by third countries, “the Commission will endeavour that the expectations of these countries to obtain their deliveries will be met as much as possible.”  This post briefly outlines the key elements of the export authorization and notification scheme that require further scrutiny.
Continue Reading EU Adopts Export Authorization Scheme for COVID-19 Vaccines and their Active Substances

French “anti-gift” rules strictly regulate the relationship between the life sciences industry and healthcare professionals (“HCP”) and the possibility for companies active in the health sector to offer benefits, in cash or in kind to healthcare professionals, medical students or associations representing them.  This includes a general prohibition against offering such benefits.

To strengthen the

On 21 February 2019, the European Commission wrote to the European Medicines Agency (“EMA”) and the Heads of Medicines Agencies of the EU-27 Member States concerning the acceptability of UK batch testing after Brexit (see the letter here).  The letter seeks to address concerns that a number of pharmaceutical companies will not have been

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…

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

Raj Gathani, a Trainee Solicitor in Covington’s London office, contributed to this post.

On 1 September 2015 the General Court issued an interim order in favour of Pari Pharma GmbH (“Pari”) to suspend the European Medicines Agency’s (“EMA”) decision to grant a third-party, Novartis Europharm Ltd (“Novartis”), access to certain documents prepared during the Marketing Authorisation (“MA”) application process (the “MA Documents”).  The MA Documents at issue included EMA Assessment Reports on similarity and superiority between Pari’s product (Vantobra) and Novartis’ product (TOBI Podhaler), which has an EU MA as an orphan medicine.  Novartis made the request to the EMA for access to the MA Documents under the Transparency Regulation 1049/2001.  The main case is currently pending before the General Court (Case T-235/15).

The thrust of Pari’s argument before the General Court was that the MA Documents contain Pari’s regulatory strategy for obtaining MA approval, disclosure of which might cause Pari serious and irreparable financial damage.  The President of the General Court acknowledged that the case raised complex issues in the area of confidentiality and stated that the main proceedings (rather than an interim hearing) is the appropriate forum to address such issues..  As such the President considered that the MA Documents fell under a presumption of confidentiality  and ordered the EMA not to disclose the MA Documents.
Continue Reading General Court Makes Interim Order to Protect Confidentiality in Pari Pharma Transparency Case