Medicinal products advertisements can be addressed not only to the public, but also to specialists1. Since the autumn of 2020, the extent of online pharmacy purchases has doubled. Experts believe there would have been even more orders if buyers knew that home delivery of prescription medicinal products2 was indeed possible3. However, Latvian law allows the advertising of prescription medicinal products only to specialists.
If it can be established the consumer's choice is affected, the distribution of advertising of prescription drugs may constitute a violation of the Unfair Commercial Prohibition Practices law in Latvia4. The Latvian Health Inspectorate is also entitled to impose a fine of up to 10 % of its net turnover for EUR 100,000 for a violation of the rules5. Therefore, what should be kept in mind when advertising medicinal products to specialists so that the Latvian Health Inspectorate does not initiate an administrative case for unfair commercial practices?
1/What else should be taken into account, in addition to the regulatory requirements?
Section III of Cabinet Regulation No. 378 of 17 May 2011, “Procedures for the Advertising of Medicinal Products and Procedures by which a medicinal product manufacturer is entitled to hand over free samples of medicinal products to doctors” (the “Advertising Rules”) broadly sets out the requirements for advertising intended for specialists and the procedures for the distribution of advertising of medicinal products.
Firstly, it must be borne in mind the substance of the advertisement, or the way in which the information is presented, is decisive. Advertising of a medicinal product must be clearly aimed at specialists, with a neutral view of the medicinal product in question and the affiliation of the medicinal product to a group of prescription medicinal products. Therefore, the advertiser must carefully consider how the information is presented.
An advertisement should not contain promotional elements of a particular medicinal product. For example, if an advertisement for a medicinal product intended for specialists contains personal and emotional stories of patients, in which occurs tendency to refer only to the good properties of the medicinal product, the Health Inspectorate questioning the true addressee of the advertisement would be justified. The Latvian Regional Administrative Court also acknowledges that in a case like this, there would be the reason to believe that the true addressee of the advertising is the public.6
Secondly, it already follows from Paragraph 22 of the Advertising Regulations the advertiser must provide a warning at the source of the advertisement that the advertisement is intended for specialists. For example, on the website www.doctus.lv, before the selected article about the specific drug (for example, prescription drugs), a column appears in which it is necessary to confirm the reader is a specialist. This is important because, in the event of a dispute, the decisive question may be whether the advertising could have influenced the consumer's economic choice.
If the advertisement of prescription drugs did not have such a warning, the Latvian Supreme Court acknowledged the advertisements were addressed to the general public. In such cases, the Latvian courts will successively assess how such advertising influenced the consumer's choice. The Latvian Supreme Court in this case also emphasized the fact that the target audience of the advertisement were persons diagnosed with cancer. It further acknowledged that in this particular case, there was a high probability of influencing the economic behavior of consumers by inviting them to seek treatment with the advertised prescription medicinal product.7
2 / When is the marketing authorization holder responsible for the content of the advertisement?
Paragraph 30.2 of the Advertising Rules stipulate that the owner of the registration of a medicinal product or his authorized representative or another person who is an advertising agent or advertising distributor shall ensure the advertising of the medicinal product complies with the law. But what if the advertisement for specialists has been published on websites without an indication of the advertiser?
In such instances, the Latvian Regional Administrative Court indicated the Health Inspectorate is also entitled to prosecute the marketing authorization holder. On the other hand, if the advertiser and the distributor are indicated in the source of the advertisement, they must also be held primarily liable.8 The author recommends parties contractually separate the liability between the advertiser, the distributor and the producer of the advertisement.
To sum up, firstly, the owner of the registration of a medicinal product must have an agreement with the advertiser, the distributor and the producer of the advertisement on the rights, obligations, and responsibilities in developing, distributing, and publishing the advertising content. Secondly, when creating advertising content for specialists, attention must be given to the nature of the information presented. Advertisement information should be neutral, it must include a comprehensive description of the medicinal product and there must be indications that the advertising is intended for specialists.
1. Article 2.2. of Cabinet of Ministers Regulation No. 378 “Procedures for Advertising of Medicinal Products and Procedures for the Manufacturer of Medicinal Products to Have the Right to Provide Free Samples of Medicinal Products to Physicians”.
2. Article 11.1. of Cabinet of Ministers Regulation No. 378 “Procedures for Advertising of Medicinal Products and Procedures for the Manufacturer of Medicinal Products to Have the Right to Provide Free Samples of Medicinal Products to Physicians”.
3. Report on the increase in demand for home delivery of prescription medicines. Published March 29, 2021. Please see here: https://www.delfi.lv/news/national/commercials/audzis-pieprasijums-recepsu-medikamentu-piegadei-uz-majam.d?id=52998779.
4. Judgment of the Senate of the Supreme Court of 27 November 2020 in case no. SKA-407/2020 8.-9. points.
5. Section 15.2, Paragraph one of the Unfair Commercial Practices Prohibition Law.
6. Judgment of the Regional Administrative Court of 30 March 2021 in case no. A420139417, article 15
7. Judgment of the Senate of the Supreme Court of 27 November 2020 in case no. SKA-407/2020 article 10.
8. Judgment of the Regional Administrative Court of 30 March 2021 in case no. A420139417, article 17.