In more detail
On 24 October, an updated version of the Catalan Guide was published. This guide serves as a reference to ensure that promotional messages of medical devices addressed to the general public in Spain comply with the applicable law and, therefore, that they can be authorized by the competent health authorities. We summarize below some of the most relevant novelties:
- The new version of the Catalan Guide now clearly and expressly states that promotional messages cannot promote violence against women nor present them in any degrading manner and, generally, prohibits any message that promotes any form of violence or discrimination.
- The promotional materials must specify if there is any restriction of age to be able to use the medical device, as well as if a prior consultation with a healthcare professional or a prior medical diagnosis is necessary to properly use the medical device.
- If the promotional materials include any reference to the sustainability of either the medical device, the packaging of the medical device or the promotional material itself, this reference needs to be duly substantiated and visually separated from any healthcare message related to the medical device.
- When the same promotional material include references to different types of products (e.g., cosmetics, medicines or medical devices), references to medical devices have to be clearly separated from references to the rest of products.
- Any reference to a medical device has to include the following mandatory information: contraindications, secondary effects, a representation whereby the medical device complies with the applicable law and the CPSP number. The following statement needs also to be included next to the CPSP number: "This CPSP number only authorizes the promotional messages related to medical devices".
- The new version of the Catalan Guide also includes a specific section referred to the location of the mandatory information regarding medical devices, which will vary depending on the format of the promotional material. In this regard, in case of websites, the CPSP number and the representation whereby the medical device complies with the applicable law must be placed next to the main image of the medical device. Additionally, if the main or primary website redirects to other websites, this information does not need to be repeated in these secondary websites, as long as the user can only access these secondary websites through the main or primary website.
In case of websites that include links to the specific website of the medical device, it is allowed to not include information regarding contraindications and adverse effects and to only include the CPSP number and the representation whereby the medical device complies with the applicable law, whenever the design of the main or primary website has space limitations and it does include a button tagged as "more information", which will redirect to the specific website of the medical device, where all mandatory information will be included.
- Importantly, the new version of the Catalan Guide includes two references to opinions or reviews of medical devices. On the one hand, it is clarified that opinions or reviews of notorious individuals may be considered promotion of medical devices if the message has a promotional nature. It is understood that there is a promotional nature or intent whenever this individual receives a compensation from the manufacturer or the distributor of the medical device.
On the other hand, the use of opinions or reviews from end users must be clearly differentiated from promotional messages of the medical device (e.g., highlighting the specific section of the website with the following title: "Opinions/Reviews from end users"). The section of opinions or reviews from end users will need to be accompanied by the following statement: "These opinions or reviews have not been evaluated nor authorized by the competent health authority". Lastly, the owner of the website must verify that the opinions or reviews hosted in its website are true with respect to the publisher of the review and with respect to the content of the review (which has to be compliant with the applicable law).
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We want to thank Adrià Masip, Associate at Baker McKenzie, for his contribution to this legal update.