This is a guest blog by Marloes Meddens-Bakker, Founder of MOON legal & compliance.
Rules and regulations
Medicinal products and medical devices can be life-changing. However, before a life sciences product can be life-changing, it must be developed, and demonstrably effective and safe. Whether it’s a medicine or a medical device, you will have to jump through many regulatory hoops to get your product on the market. But that’s not the end of it. Legal and compliance govern the marketing as well.
Marketing prescription medicines
Very strict rules apply to the marketing of prescription medicines. One of the most important rules is that it is forbidden to direct advertise for prescription medicines to the general public. This often raises the question: Where does one draw the line between advertising (prohibited) and information (allowed)? Advertising for prescription medicines directed at certain healthcare professionals is allowed but governed by a vast set of rules.
Marketing OTC medicines
Advertising of OTC medicines directed at the general public is allowed but also governed by a lot of rules. Several codes of conduct based on self-regulation apply to OTC medicines, self-care medical devices and health products.
Marketing other life sciences products
But other life sciences products aren’t off-limits. Basic advertising rules apply to all kinds of products, such as medical devices and apps. Misleading advertising is always prohibited. That includes false comparisons with other products, misrepresentation of the characteristics of the product or greenwashing.
Risks of non-compliance in marketing
With so many rules and regulations applying to so many aspects of your product, it might be easy to overlook the legal aspects of your marketing campaign. Why bother? You’re already there, your product is on the market, now…go!
Non-compliance in marketing can be fined. Other measures can also be imposed, such as a prohibition on the advertisement, recall of materials or rectification. So that’s certainly something to take into account. But is that all?
The benefit of compliance in marketing
C.S. Lewis said: “Integrity is doing the right thing, even when no one is watching.”
There’s no debate about the importance of abiding by the rules. But sometimes the rules aren’t clear. In that case, you have to follow your moral compass. The will to comply – integrity – should be interwoven with your products and everything that surrounds it.
That’s what really makes the world a better place.