Language can be misleading. And when it comes to advertising medicine and medical products, pharmaceutical companies are held to strict account about how they describe what they’re putting on the market. In plain terms, what we’re ultimately talking about here is false advertising and the rules in place to protect the public from something ending up in their medicine cabinet that doesn’t do what it says it does.
Let’s first tackle the name RIP: the very ominous sounding title stands for a person who is responsible for the information and publicity of medicine. It’s a designation given for the purpose of overseeing the advertising and marketing of a medical product, be it prescription medicine (Rx) or over-the-counter (OTC) medicine, and its sale or supply (read: free samples).
The Belgian laws and restrictions that govern what a pharmaceutical company can and can’t say about a product is elaborate and extensive, as they have to follow the 2001/83/CE EU directive concerning medical products throughout Europe. Making sure a particular product intended for release passes these legal constraints can be quite the task.
This is where an RIP comes in – they’re hired to make sure that when the product is ready to hit the market, it complies with all the rules set out by the local authorities to the letter.
The Marketing Authorization Holder (MAH) – a distinction given to a company that’s been given the okay to promote medicine and medical products – is obliged by law to hire RIPs to vet their marketing material and cross-check it with the long list of do’s and don’ts in order to get official approval. These particulars are spelled out in the relevant summary of product characteristics (SmPC), an official document issued by the marketing authorization holder. This document is regularly kept up to date to take into account any change of information or new scientific data about the product, such as safety.
The regulations cast a wide net over who can market a product, whether directly to the public (only in the case of OTC) or to doctors or pharmacists (both OTC and prescription medicine) and covers everything from visits by a medical representative to sponsorship of promotional meetings or events or scientific congresses, and the payments given to the speakers and advisors at these events. As said, it needs to be exhaustive in order for member states to ensure there are adequate and effective methods to monitor this type of advertising.
The MAH has to appoint a RIP to respect the legal provisions. It’s a substantial role the RIP takes on because when there is an inspection, routine monitoring or investigation in the event of a formal complaint, the RIP assumes individual responsibility.
This means that when you are hiring an RIP as an MAH, you are guaranteed that the RIP will make sure, to the best of their ability, training and qualifications that the decision or approval he or she makes falls within the law.
Q-support can provide a Responsible for Information and Publicity for your company.
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