The digital environment is always changing. Legal compliance at home and abroad is becoming more demanding and complicated. This is especially true in the highly regulated healthcare space.
In the United States, websites are treated much more casually than in other countries. With a cultural emphasis on consumerism, individual choice, and private healthcare, the U.S. has relatively relaxed laws on what can be said and marketed to the public. This is not the case in other countries, which often presents unexpected challenges for healthcare marketing teams, strategies, and solutions. In Europe, there are a variety of country specific regulations that control medical device marketing. Some countries are very strict, with expansive regulations and steep fines. As marketing partners to companies in this space, it is critical that we work with our clients to understand the rules, risks and penalties.
Let’s Start with GDPR
When most people think of European regulations impact on marketing, they think of GDPR. GDPR’s official guide, which includes a lot of great information, provides this basic explainer:
GDPR stands for General Data Protection Regulation, and it was designed by the EU to protect the personal details of its citizens. Despite being passed in Europe, it has an impact on businesses worldwide. Privacy regulations, such as GDPR, CCPA, and HIPPA, deal mainly with the collection and storage of personal information. They also address options for management and remediation. In today’s digital environment, marketers address these concerns primarily through cookie management. Basically, people can choose to contribute their data or not. If not, cookies get blocked and data collection efforts become hindered.
However, medical device marketing in the EU involves more hurdles than managing privacy and data collection.
Each Country is Different
Although the EU does have some shared regulations, each country also has its own regulations, and these can vary widely. Because of this, in many cases regional websites are not enough.
For example, medical devices can be marketed widely in Norway. However, look south to France and you’ll find that medical devices can only be marketed to healthcare professionals.
In France, medical devices that are reimbursed by French public insurance may not be advertised to the public. Websites are considered marketing. Complying with this regulation means not only understanding which devices are reimbursed and, therefore, restricted, but also understanding who is viewing the website and marketing materials.
A simple “Yes, I am a healthcare professional” statement certifying the person is not enough. France’s National Agency for the Safety of Medicines and Health Products requires positive verification of the identity and good standing of any person accessing the website as a medical professional. This, of course, is difficult, as it requires accessing the national registry of health professionals and is an almost-certain blocker.
France proves it’s serious by imposing some of the stiffest penalties in the EU for violations. A company can be fined up to 750,000 Euros for allowing public access to medical marketing information and up to 1.5 million Euros if that information is misleading. By misleading, French authorities mean leading people to believe there’s a way they can purchase medical devices.
This extends to country-specific websites outside of France as well. If a non-healthcare professional in France views medical device marketing collateral on the Norwegian website of a company that also does business in France, then that company could be fined for violating the regulations. More punitive measures can occur if that product is offered for purchase on the Norwegian website, because that could be considered misleading information (the French person could not purchase it from Norway).
Obviously, geo-based audience blocking becomes critical. More problems are created with search engine indexing and the potential for the wrong site to rank well for the wrong country.
While France may be the strictest EU country in this regard, it’s not alone. Overall, 11 out of 22 countries reviewed had EU healthcare regulations that require restricting medical device marketing to healthcare professionals only. While details and penalties vary, this is generally a significant risk to corporate marketing for the healthcare industry in the EU.
How to Plan For EU Healthcare Rules
More than ever, legal guidance is needed when doing work in the healthcare industry outside of the US because regulations go well beyond privacy, data collection, and cookie management. It’s critical that global healthcare organizations looking to launch websites in European countries understand the regulatory environments they are about to enter, receive clear guidance from their legal counsel, and maintain precise documentation on decisions that could expose risk.
The EU is a big market with much opportunity. As in the US, the healthcare industry is experiencing rapid digital transformation across the globe. Global healthcare organizations can create lots of great work, but they need to know the rules and manage risk for themselves.
Learn more about our expertise within the healthcare sector.