Podcast: Health Care Compliance Check-up: Belgium
The Ropes & Gray Global Health Care Compliance Initiative’s virtual trip around the world podcast series highlights our collaboration with our local counsel contacts, in particular the Local Law Comparison Guide. The Local Law Comparison Guide (the “Guide”) is a resource tool providing country-specific surveys that analyze legal, regulatory and industry requirements governing industry interactions with health care professionals. As part of this series, Ropes & Gray attorneys interview our local counsel partners, who are based around the world and helped develop the Guide. These discussions highlight notable health care regulations and developments impacting compliance in our various countries.
In this episode, we are joined by Stéphanie De Smedt, counsel at Loyens & Loeff CVBA in Belgium. Alison Fethke, counsel at Ropes & Gray, discusses with Stéphanie the regulatory framework in Belgium and key risks for life sciences and health care clients. They also discuss emerging trends, such as the new medical device regime and how COVID-19 is changing practices and presenting new challenges.
Alison Fethke: Hello, and welcome to Ropes & Gray's virtual trip around the world podcast. I'm Alison Fethke, counsel in the health care group in our Chicago office. And together with my colleagues, I'm really excited to share with you the launch of our new Local Law Comparison Guide. This was developed as part of our Global Health Care Compliance Initiative, which is a cross-practice group initiative at Ropes & Gray built upon our strong relationships with local counsel. This new Local Law Comparison Guide summarizes requirements and standards for typical activities that health care and life sciences companies will encounter across 19 key international jurisdictions, and we partnered with law firms on six continents to develop the guide. Today, I have with me Stéphanie De Smedt from the law firm of Loyens & Loeff. Stéphanie is resident in the Brussels office and is here today to discuss with us compliance and regulatory considerations in Belgium. Welcome, Stéphanie. Let's get started—if you could tell us a little bit about your practice and the practice of Loyens & Loeff with respect to health care and regulatory considerations in Belgium.
Stéphanie De Smedt: Loyens & Loeff is a Benelux law firm—that means that we're active in the Netherlands, Luxembourg, and Belgium. Within those offices, we have a life sciences and health care team. It's an industry team, so we focus not only on the regulatory matters and the compliance matters, but also on any type of legal or tax issues that clients in this industry may face. As part of that, I am part of the Belgium team, and I focus mostly on compliance, regulatory, GDPR matters, and also litigation for life sciences companies.
Alison Fethke: Great. Could you start by walking us through at a high-level the regulatory framework in Belgium? What laws or guidelines do health care and life sciences companies really need to be concerned about when operating in Belgium?
Stéphanie De Smedt: In Belgium, we have a legislative framework that's mostly composed of federal laws. The federal government enacts the basic laws, and those are then further implemented by royal decrees. The most important rules are set out in the law. We have a law on medicinal products, a law on medical devices. Then more specifically, we also have legislation on the exercise of health care professions that regulates how companies, how health care professionals can actually conduct their activities and how their relationship with the industry should be regulated and managed. On that topic specifically, we also have codes of conduct that are established by the professional bodies, the professional associations that lay down more detailed guidelines and rules. But the basic laws and also the laws that impose criminal sanctions or administrative sanctions for noncompliance are the federal laws and the royal decrees.
Alison Fethke: What are, from your perspective, the three most important hot topics or evolving areas of risk for health care and life sciences companies?
Stéphanie De Smedt: I think one that's common for most European companies is the medical device regulation that has become applicable quite recently. We've seen a lot of clients that are really struggling a bit with applying those new rules on medical devices in particular in relation to software, artificial intelligence, all kinds of new technologies that are really up and coming in the life sciences industry. It's still not entirely clear to which extent these kind of new technologies would qualify as a medical device under regulation and what type of requirements they must meet. So that's the first hot topic. Another one that was a hot topic the past year was of course Brexit. Companies were still adjusting to Brexit with all types of compliance issues that are linked to that in terms of export, in terms of licenses, taxes. So we received quite a lot of questions in that respect. Then a third one, specifically also for the life sciences industry, is clinical research. Belgium is really a hub for clinical research. We see that the legislation and the regulatory requirements are not really adapted to reality. In particular, in case of processing of personal data for clinical research, for example, the laws are not really adapted to the practice yet, which means that there are conflicts from time to time and companies are struggling how to apply this legislation in their clinical research, how to make sure that they are compliant when working with sensitive health data of patients. So that's really a hot topic, and also a topic where we hope that the Belgian legislature will really jump on this and also take some measures to help companies there.
Alison Fethke: Specific to interactions with health care professionals, which is one of the areas we focus in our Local Law Comparison Guide, where would companies look specifically for guidance on these types of interactions in Belgium? Would it be the statutory framework or more the trade association codes of conduct?
Stéphanie De Smedt: It would be both. On the one hand, we have anti-inducement laws that are quite strict and we have a general prohibition in the federal law that applies to both producers of medicines and producers of medical devices. This legal statutory prohibition actually provides that manufacturers of medicines or of medical devices cannot give gifts, or benefits, or premiums to health care professionals—only when they're in very small value or as a fair remuneration to certain consultancy services, for example. But the possibilities are very limited there. That legal prohibition is actually supplemented by the codes of conduct of the industry, where they determine in a bit more detail, "Okay, what is a small gift that is acceptable? In case you organize as a pharmaceutical company a scientific event or a conference, how far can you go in terms of hospitality for medical practitioners?" So those things are laid down in principle in the law, but they're detailed in more guidelines in the codes of conduct. What's also more specific for Belgium is that we have a law also on transparency that actually has put into place a transparency platform online—it's called beTransparent. Basically, any company or any industry player that offers some kind of value, or gift, or premium to a health care professional or even to a patient organization has to report this to beTransparent. When you look at the website, you can actually see there and you can look for any type of premiums or benefits that have been granted by specific pharmaceutical companies to specific practitioners—those can all transparently be consulted online.
Alison Fethke: That sounds somewhat similar to the structure we have in the U.S. and the transparency law we have in the U.S. So how does the enforcement or adherence to the industry trade codes, how does that happen? Is it a self-regulating regime? Has there been any enforcement or fines or penalties under those codes?
Stéphanie De Smedt: In Belgium, enforcement is not always very public. The laws as such, they are enforced by the government regulator and the federal service for health—so they enforce the legal requirements, and they can impose fines. But the regulator often just first starts by sending a warning to a company saying, "Okay, this is what we see. We think this is not compliant," and they issue a warning and ask the company to comply. Then you get the opportunity to respond to that and to enter into some sort of settlement discussions with the regulator. Very often, that is where it actually ends. There is a confidential settlement that may or may not involve the payment of a certain settlement amount. Only when no settlement is reached the case will be further prosecuted and it may eventually become public. But it's really not that common for enforcement decisions to be published in Belgium. The same goes for the industry codes—those are enforced by the industry bodies themselves, and they see also more as an internal type of enforcement. For the health care professionals, they are regulated also by the professional body—Association of Health Care Professionals—those do publish their enforcement decisions online. For example, when a doctor receives a certain benefit from a pharmaceutical company that's not compliant with the doctor's professional code of conduct, then he may be sanctioned or his license can be suspended, and those kind of decisions are published online.
Alison Fethke: Often, there is an overlap between a health care professional and a government official. Are there particular regulatory or compliance considerations you would highlight when interacting with a government official, whether or not he or she may be a health care professional as well?
Stéphanie De Smedt: Yes. For government officials, the rules are even stricter. They have general anti-bribery legislation that applies to them. As a rule, they're not allowed to accept any type of compensation—they cannot accept small gifts, they can't accept any type of compensation or gift. They have to remain completely impartial and independent. So they cannot solicit, demand, or accept any gifts or benefits either in the performance of their duties or in the performance of any kind of side duty.
Alison Fethke: Obviously, COVID-19 has been a big topic for everywhere in the world in the last year. Has there been anything specific to COVID-19 in Belgium in terms of regulatory risks or developments that you would highlight for our listeners?
Stéphanie De Smedt: Of course, yes, in the past 12 months the focus of the regulators has really been on the approval process of the COVID-19 vaccines—getting the vaccines approved, also looking at approvals of COVID-19 tests, and also home kits for testing. That's really where the main focus of the regulator is for the moment. In terms of other risks, there was a bit less this year, but what has become a very important issue for our clients actually in the life sciences industry is any type of remote operating. Having COVID forced them to work remotely and also to share confidential and sensitive business information remotely. So it's not just about patient data, and personal data, and GDPR, but actually, pharmaceutical companies, life sciences companies, they as well, they start using remote tools, virtual meetings to discuss or exchange confidential information. Topics like cybersecurity and cyber fraud have really become key points of attention because we do see more and more cyber attacks because of the remote working, and companies are really faced with that as a big threat these last few months.
Alison Fethke: Interesting. In the U.S., we've of course also seen a shift to more interactions happening online or in a virtual format, as you mentioned. One of the things that I have counseled my clients on in the U.S. is how to conduct marketing interactions or sales interactions in a virtual or online format. Are there any key considerations for health care or life sciences companies in conducting marketing interactions in a virtual or online format?
Stéphanie De Smedt: Yes, I think a very important consideration is to make sure that the tools that you're using, that those are safe and secure, and make sure that there's no leaks of confidential information. We've seen as well that companies have become more and more vulnerable to hacking attacks, to phishing attacks just because they're sharing much more information virtually. So, use safe data sharing platforms. If you're communicating about sensitive information, for example, marketing information about a new product that has not been launched yet—that you still want to keep confidential—share it through secure means and think about the tools you're using.
Alison Fethke: Stéphanie, what's on your radar for the next 12 months in Belgium? What should companies keep on the top of their list to think about?
Stéphanie De Smedt: As I mentioned in the beginning, what's on top of the list for a lot of clients is GDPR and clinical research, and really getting more guidance from the authorities on how to conduct clinical research and how to carry out their clinical trials in a GDPR-compliant manner, because we do see more and more GDPR enforcement—we see more fines. But specifically, for life sciences companies, there is just still a lot of things that are unclear, and they do require more guidance to know exactly how to apply these rules in practice. So that's definitely something to keep an eye out for. Another thing that's on our radar is of course, as I mentioned as well, the medical device regulation, and specifically, its impact on software and health apps. In Belgium also, there's a big community of health app developers and projects working with artificial intelligence to predict someone's health status or monitor someone's health status. We see that there are more and more health apps and software being developed. Having more guidance on that and how to comply with the medical device regulation, that's also still something that will be further developed I think in the next 12 months. Because of COVID-19 of course, production capacity had to be upscaled by many manufacturing sites—some companies had to re-orientate their business focus. We see a lot of movement in the sub branches, I would say, of laboratories, distributors of personal protective equipment, players also in the food supplement or vitamins market. There will be a lot of movement on the M&A market, therefore, in Belgium in the next 12 months, with of course also important regulatory angles.
Alison Fethke: What a helpful overview to help our clients start thinking about key areas of risk and evolving hot topics in Belgium. I want to thank you so much for joining me today and for your firm's partnership with us at Ropes & Gray in developing the Local Law Comparison Guide. We really are sure this is going to be a terrific tool for our clients as they work through the complex regulatory and compliance environments across the globe. You can also subscribe and listen to this series wherever you regularly access your podcasts, including Apple, Google, and Spotify. Thanks everyone for listening, and thank you so much, Stéphanie, for joining us today.