Health Care Compliance Check-up: Netherlands

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 local counsel partners’ respective countries.

In this episode, we are joined by our partner in the Netherlands, Jacobine van Beijeren. Jacobine is a senior associate at Loyens & Loeff. Alison Fethke, counsel at Ropes & Gray, discusses with Jacobine the regulatory framework in the Netherlands 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.

Transcript:

Alison Fethke: Hello, and welcome to Ropes & Gray's virtual trip around the world podcast. I'm Alison Fethke, a counsel in the health care group in our Chicago office. And together with my colleagues across the globe, 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 based on our cross-practice group collaboration at Ropes & Gray and 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've partnered with law firms on six continents to develop the comparison guide. Today, I have with me Jacobine van Beijeren from the law firm of Loyens & Loeff. Jacobine is resident in the Amsterdam office and is here today to discuss with us compliance and regulatory considerations in the Netherlands. Welcome, Jacobine.

Alison Fethke: Please do, yes. If you could tell us a little bit about your practice and a little bit about the health care compliance and regulatory practice at Loyens & Loeff, that would be terrific.

Jacobine van Beijeren: Yes, of course. I'm a senior associate working at the Benelux and Swiss law firm, Loyens & Loeff, as you mentioned. So I'm an attorney at law working at our Amsterdam office. I'm a member of our competition and regulatory practice group, and I'm specialized in regulatory pharmaceutical law, health care law, and data protection and privacy law. And I'm also litigating in administrative proceedings with, for example, several Dutch authorities such as the Dutch Healthcare Authority and the Food and Consumer Product Authority.

Alison Fethke: Wonderful. It sounds like you have a really broad base of experience in the Netherlands. Could we start by having you describe for us, what is the regulatory framework in the Netherlands? What laws or industry codes would a health care or life sciences company be contending with?

Jacobine van Beijeren: Yes, of course. We have a legal framework applicable in the Netherlands. For medicinal products, there's the Dutch Medicine Act, and it also includes rules on the inducement and advertising of medicinal products. And next to that, we have of course the Medical Device Act that also includes similar rules on inducement and advertising. But besides that, we also have industry guidelines and the self-regulation system. So we have a code of conduct for medical devices, as well as for pharmaceutical products. A large number of umbrella organizations for manufacturers or importers of medical devices do participate in this self-regulating system, and also, umbrella organizations for health care professionals or hospitals are included in this self-regulation system. So both frameworks are important. Of course, the law is most important and is enforced by the Dutch Healthcare and Youth Care Inspectorate, so that's the competent authority that also can impose fines, for example. On the other hand, we have those self-regulation systems, which has the code authorities, so that's the authority that is enforcing compliance with these self-regulation codes on the advertisement rules or inducement rules. And it's very easy for consumers or competitors to file a complaint with these code commissions, so we also see that consumers or competitors do so to keep each other sharp. The Inspectorate is also quite active in the field of compliance with these rules. So for example, the Dutch Inspectorates published a report the end of last year, and they announced that various pharmaceutical companies, communication agencies, and even newspapers have been fined or warned for advertising medicine between—it was quite a broad range in years—2013 until 2019 that was covered in this research. But a total of 14 investigations have been carried out by the Inspectorate, and they established 15 violations of the Medicines Act with this research. And that was just only published last year, so they are quite active in enforcing these rules.

Alison Fethke: So Jacobine, for let's say a pharmaceutical company or a medical device company, it sounds like there are layers of regulatory authority and enforcement risk, both as you mentioned from the Inspectorate, but also some self-policing between companies who might file complaints about the conduct of other companies. Is that correct?

Jacobine van Beijeren: Yes, definitely—that’s correct. And filing a complaint is, of course, much easier than going to court and to start civil proceedings. So yes, filing a complaint is that easy, that companies are doing that, and consumers, of course.

Alison Fethke: Are the complaints between companies, do they tend to be focused on advertising activity or does that also encompass activities with health care professionals, such as educational presentations or sponsorships?

Jacobine van Beijeren: Yes, the latter can be the case, as well. But I think when competitors are complaining about each other, it's more about advertisement, and then especially comparative advertising.

Alison Fethke: In the Netherlands, I think, like many countries in Europe, direct-to-consumer-advertising is completely prohibited. So these are primarily advertisements directed to health care providers?

Jacobine van Beijeren: That's correct. So indeed, it's not allowed to advertise to the public. To health care professionals it is allowed, but it is, of course, subject to certain limitations.

Alison Fethke: In terms of a company's interactions with health care providers, which is an area of high-risk, generally, in the United States, so if a company is presenting an educational training or perhaps sponsoring a medical conference, in the event of concerns arising from those types of activities, would that be the Inspectorate who would be taking action against the companies? What would be the regulatory authority that companies would be most concerned about with those types of health care professional interactions?

Jacobine van Beijeren: Yes, that will definitely be the Inspectorate, because that's also the authority that is entitled to impose fines, for example. So I think that is the authority that is most important to be aware of.

Alison Fethke: So what are you seeing as you counsel your life sciences and your health care clients in terms of regulatory and compliance considerations? For our audience today who may be legal or compliance professionals working with their companies on these activities, what are you seeing in terms of hot topics?

Jacobine van Beijeren: I think one of the hot topics is the medical device regulation that is coming. It will be applicable from 26 May, 2021 in Europe. So it's of course important for our clients to be aware of the new rules, and we are working on a lot of questions about that, of course. And what we also see is that companies are focusing on what we call the “borderline products,” so these are the products that are a bit sometimes fake. Which legal framework applies? So as an example, food supplements, it is of course regulated by the Food Law, but if you present it as having properties (or making claims) for treating or preventing diseases, like food supplements, then the legal framework switches from the General Food Law to the Dutch Medicines Act. So we see that clients and companies are really struggling with these kinds of products, and the applicable legal framework. I think a lot of companies are not aware of this strange switch from legal framework only by presenting your products in such a way, or claiming a certain effect or property.

Alison Fethke: That makes sense. How about any other key risks you're seeing?

Jacobine van Beijeren: I think there's a lot to do, of course, about the online sales of medicinal products and the online prescription, also, of medicinal products. So this is also something we get questions about on a regular basis—whether or not is allowed to sell online. And also, the Inspectorates recently warned on its website, for example, the sale of illegal medicines on the internet. Also in view of COVID, people seem to think that there would be products available that might help against the coronavirus, and the Inspectorate warned about the health damages this could cause. So there are parties that want to offer medicinal products online, and of course not the illegal ones, but just authorized medicines. Then we get these questions about the regulatory requirements for offering those products online. For example, these so-called “cross-border pharmacies,” so pharmacies that are based in the Netherlands or online, based in the Netherlands and then want to deliver the products to, for example, Germany.

Alison Fethke: You mentioned COVID—obviously that's been something we've contended with across the globe in the last year. One of the risks you mentioned was advertising of potential treatments to assist in COVID. Have there been any other changes in practice that were caused by the COVID-19 pandemic that have resulted in a new regulatory risk that you've seen?

Jacobine van Beijeren: Yes, I think that some confusion can exist about the requirements, for example, for medical devices, because last year there were a few exceptions for the requirements of medical devices. For example, the CE mark because of the shortages due to the crisis. But in the meantime, the temporary exemptions are not in place anymore, so this can be confusing for parties. And to COVID, we also have questions about the VAT rates of products. So of course, I'm not an expert on the VAT, but we conferred with our tax colleagues about those questions. It's really a team effort, those kinds of questions, because whether or not the VAT exemptions apply are always very depending on the question, what kind of products we are talking about and whether the product, for example, complies with the medical device requirements. So that's also something we see related to COVID. I think also, other kinds of questions in view of the sponsoring and organizing of events came up, because a lot of events, of course, could not take place in the way that they did before, so they need to be organized online, for example. And the requests for advice to the Code Commission, if you want to organize something, you can ask them for advice as a company, but this will decrease very much due to the COVID crisis. But they got some questions about, for example, organizing online events and the sponsoring of online events, because also, especially when the COVID crisis just came in, they wanted to organize on a very short-term something online. Then it was hard for them to make sure that, for example, when there was non-health care professionals and also health care professionals that were participating in these events, to make the distinctions between these two groups, because of course, you are not allowed to advertise products to the non-health care professionals, but you are allowed, to a certain extent, to do so towards health care professionals. So there were some struggles about how to organize these things and how we can do that, and they needed to work with the existing platforms, for example. So yes, there was a risk in view of COVID that things changed very quickly, and parties were struggling with how to organize these things and how to participate in events like this.

Alison Fethke: Yes, we saw that in the United States, as well. That makes a lot of sense. You raise the point about appropriate interactions with health care providers, non-health care providers. In terms of health care providers who may also be government officials, what are any key questions or risks that our listeners should think about with respect to those officials?

Jacobine van Beijeren: I think we do not really have a very big difference in the rules for governmental officials. So the requirements that apply to inviting government officials to the events, for example, are not so different from the normal applicable rules. We have a rule that prohibits, of course, public bribery, and that is defined as getting a gift or making a promise to a government official with the intention of inducing them to act or not to act in the performance of their office. We have some academic hospitals in the Netherlands, and these are legal entities incorporated under public law. So just for example, the Academic Medical Center in Amsterdam or in Rotterdam. And they, the legal entities, are founded on a public law, and therefore, all the health care professionals working at such an academic hospital qualify as a governmental official. So they, of course, also have to comply with these rules. But yes, there's not a complete different framework for governmental officials in the Netherlands.

Alison Fethke: But of course, there would be just key basic considerations with respect to any interactions with health care providers, whether or not they also be government officials.

Jacobine van Beijeren: Yes, absolutely. You need to comply with these rules anyway, but these are the same for health care professionals, whether or not they are governmental officials.

Alison Fethke: So Jacobine, 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 think this will be an amazing 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 listen to podcasts, including Apple and Spotify. Thanks, everyone, for listening, and hope you have a good day.