March 27, 2020

CJEU Advocate General says that samples of pharmaceutical products cannot be provided to pharmacists

On 30 January 2020, the conclusions of CJEU Advocate General Giovanni Pitruzzella were published on a preliminary ruling from the Bundesgerichtshof, the German Federal Court of Justice, in case C-786/18 (Ratiopharm v Novartis Consumer Health) regarding the free distribution of samples of medicines by the pharmaceutical companies.

The Advocate General provides a restrictive, literal interpretation of Article 96(1) of Directive 2001/83 according to which the delivery of samples of drugs free of charge constitutes an exceptional advertising measure which can only concern persons authorized to prescribe medicines or doctors.

Specifying that “advertising for medicinal products can harm public health whose protection constitutes the essential objective of Directive 2001/83” (see judgment of the Court of Justice of 5 May 2011 in case C-249/09) and although it is true that doctors and pharmacists have the same need to be informed, this information can come through different channels and it is equally true that the economic interest in the supply can be more immediate than the interest in the prescription and that the risk of spreading to consumers is more present among pharmacists, as consumers know that pharmacists have medicines available; the exclusion of pharmacists from this distribution would, at the same time, eliminate any risk of circumvention of the prohibition against the public referred to in recital 46 of the Directive 2001/83.

In conclusion, the Advocate General proposes that the Court of Justice should reply as follows to the questions referred for a preliminary ruling by the Bundesgerichtshof (Federal Court of Justice, Germany):

Article 96(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, must be interpreted as meaning that pharmaceutical companies may distribute free samples of medicinal products, on the conditions laid down by that article, only to persons qualified to prescribe them”.

This interpretation of the Advocate General is consistent with the rules currently applicable in Italy. Indeed, article 125, paragraph 1, of Legislative Decree no. 219/2006 (the Italian Code of Medicines) expressly provides that free samples of a medicine for human use can only be distributed to doctors who are authorized to prescribe it and must only be delivered through scientific informants; and therefore it prohibits the distribution of samples to pharmacists.

Considering the above, if the Court of Justice follows the opinion of the Advocate General, nothing will change in the current Italian legal framework.

< Back to blog
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
Read more
Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
Search by...
Follow us on
Follow us on