Pharmacies, do your websites selling medicinal products comply with the legislation?
About a year after the authorisation of the online sale of medicinal products, pharmacies have had to change their general terms and conditions following an important reform in consumer law, established by the French law n°2014-344 dated 17 March 2014, also known as the Hamon law. The publication of this legislation has also been an opportunity to remember that the online sale of medicinal products is subject to specific legislation related to health law, namely the bylaw of 20 June 2013, relating to good practices of online distribution of medicinal products, on the basis of article L.5121-5 of the French Public Health Code.
The implementation of the bylaw concerning good practices of online distribution of medicinal products
When reading the general terms and conditions available on various websites, it is clear that the bylaw is not always respected. Even if the bylaw’s provisions are numerous, closer attention must be paid to some points. For example, the internet page “Who are we?” imposed by the bylaw (article 1.1 relating to the administrative identification of the website and of the pharmacy) is heavily regulated and it will be easy to comply with these provisions. Concerning the general terms and conditions of sale, care must be taken to ensure that the application of the provisions relating to the right of withdrawal be exact. Indeed, due to the medicinal product’s specificities, the bylaw strictly forbids the right of withdrawal. In the same way, websites must include links to the form page of the ANSM’s (the National Agency for the Safety of Medicine and Health Products) pharmacovigilance and to the professional indemnity cover (RCP in French).
The implementation of non-health law specific provisions
Online pharmacies must also respect the French law n°2004-575 of 21 June 2004 concerning confidence in the digital economy (known as the LCEN law in French); this law, amongst others, obliges websites to include certain references, often displayed on a page called “legal notices”. Pharmacists must therefore clearly define the pages “legal notices” and ‘Who are we?”. Another important aspect is the respect of the French law n°78-17 of 6 January 1978 relating to computing, files and liberties (known as the Data Protection Act). Notably, pharmacists have to ensure that they correctly declare that which they must to the CNIL (French National Commission of Data Protection). Besides, since the recent reform on consumer law, the CNIL can operate remote controls to check that websites are complying with the Data Protection Act. The consequent report can then be used to sanction the websites’ editors.
If you want to ensure that you are doing your part as a pharmacist in guaranteeing the distribution of medicinal products, making your patients trust you and stopping the online distribution detractors, make sure your website is impeccable!
Verify that the “standard” general terms and conditions that are proposed by computer service providers are valid for your specific medicinal product.
Do not forget that if you have already created a website for the online sale of parapharmacy products, you need to adapt your general terms and conditions!
Verify the formalities that you have accomplished on behalf of the CNIL.
After putting so much effort into this activity and having invested in its development, it would be a shame to risk not receiving the health authority’s authorisation needed for the online sale of medicinal products.