Alina Stoica – Draft order marks significant shift in medicine advertising and disease awareness campaigns on social media and mobile apps

In a previous article, we highlighted the role of social media platforms in disseminating disease awareness campaigns led by pharmaceutical companies[1].

Now, two years on, authorities have officially recognized social media platforms and mobile apps as suitable channels for advertising medicines, marking a pivotal change in policy.

On November 7, 2024, the Ministry of Health released a draft order for public consultation, proposing amendments to the annex of Ministerial Order no. 194/2015 on the approval of the Regulations for the evaluation and approval of advertising for human-use medicines[2].

This draft order marks a significant shift, explicitly permitting the advertising of medicines on social media platforms and mobile apps—a practice currently banned under existing regulations.

For advertising to medicines on social media and mobile apps to be permitted, two conditions must be met: The social media platform or mobile app must have an official website offering similar services and content. The “Like” buttons, comments, and sharing options must be disabled.

According to the initiator of the draft order, another key aspect is the increased responsibility placed on marketing authorization holders to monitor posts on social media platforms and mobile apps, ensuring compliance with regulations regarding advertising materials related to medicines in their portfolio.

While it may seem that the issue has been resolved, some ambiguities remain. The approval notice accompanying the draft order raises an important question: Is the dissemination of disease awareness campaigns on social media platforms and mobile apps permitted?

The issue arises because the approval notice refers only to advertising to the general public for OTC when discussing the introduction of social media and mobile apps, without mentioning disease awareness campaigns. Furthermore, the article in the draft order that addresses this topic explicitly refers to advertising to medicines.

However, there are arguments to support that, in the form published in transparency, the draft order should allow the dissemination of disease awareness campaigns on social media platforms and mobile apps. Specifically, the article in the draft order addressing this issue is part of the general section, which applies to both advertising to the general public and disease awareness campaigns.

This reasoning was also used by the competent authority to justify the prohibition of using social media platforms and mobile apps for disease awareness campaigns under the legislation in force.

Furthermore, the article introduced by the draft order, which outlines the marketing authorization holder’s obligation to provide the competent authority with proof of compliance regarding the prohibition of comments, evaluations, reactions, endorsements, distribution, or sharing by third parties, specifically mentions both advertising and educational materials.

In conclusion, the proposed draft order represents a significant step forward in modernizing the regulation of medicine advertising and disease awareness campaigns, particularly through social media and mobile apps.

While the draft order opens new possibilities, key clarifications are still needed regarding its scope, especially in relation to disease awareness campaigns.

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[1]https://www.gnp.ro/alina-stoica-disease-awareness-campaigns-developed-by-pharmaceutical-companies-why-should-such-campaigns-be-conducted-on-social-media-platforms/

[2]https://www.ms.ro/ro/transparenta-decizionala/acte-normative-in-transparenta/ordin-privind-modificarea-%C8%99i-completarea-anexei-la-ordinul-ministrului-s%C4%83n%C4%83t%C4%83%C8%9Bii-nr-1942015-privind-aprobarea-normelor-pentru-evaluarea-%C5%9Fi-avizarea-publicit%C4%83%C5%A3ii-la-medicamentele-de-uz-uman/

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