There are very few lawyers who can – genuinely – claim to offer unique expertise to clients, but Hanneke Later-Nijland is one of them. The founder of Genome Lawyers is trained in law and pharmacy, which means her unique expertise can be crucial in deals involving biotech or pharma companies.
Law and pharmacy may seem like two disparate subjects, but they combine two of Hanneke’s main interests.
Initially, Hanneke studied pharmacy at university but admits that the lab wasn’t her favourite place to spend her time. As a result, she looked to other subjects. “I had some friends who were studying law, and I really liked the abstract way of thinking,” she says. “I also liked thinking about case law, and how that is applied.
“So, I was interested in the practical part of pharmacy and how the body works, all the enzymes in the body, etc. On the other hand, I loved the more abstract, philosophical, ethical topics that were discussed in law.
In the end Hanneke decided that if she had a law degree, along with a few modules in pharmacy, it wouldn’t add much to her profile, “I decided to go for it and carry on with pharmacy as well”.
Carry on she did – Hanneke eventually studied for a PhD in pharmacy, on optimising treatment for tuberculosis. While this is no longer a problem in the EU, it’s still deadly in plenty of other populations around the world, including Indonesia, where she spent time studying during her PhD track. Once that finished, Hanneke had to think about a career. While she found pharmacy interesting, she didn’t want to become a full-time pharmacist. Academia was definitely an option, but not as a main career and not for now. She currently teaches pharmaceutical law at the University of Leiden. Initially, she worked as a healthcare inspector, inspecting clinical trials and pharmacovigilance, which is where, after a product has gone to market, it is monitored for any adverse events.
This gradually led Hanneke into practicing law in the pharma sector. She started off working at an international law firm before moving onto a boutique firm and eventually setting up her own practice, Genome Lawyers.
Genome Lawyers is based in Amsterdam and specialises in Dutch and EU regulatory life sciences law, advising clients from across the world, including the Netherlands, Switzerland, UK, US, Canada, Germany, Japan, China, and Italy.
Hanneke’s experience gives her a perspective on biotech and pharma legal issues that few others in the Netherlands have. “It helps me very much because I know if someone calls me from a pharmaceutical company, I know how they work and what their priorities are,” she says.
Hanneke prefers to work with entrepreneurs in these sectors: “I come from an entrepreneurial family, so maybe that’s the reason why, but I really like working with that type of person because they are flexible and think very quickly.”
Hanneke advises mostly on Dutch and European laws and how to comply with or implement certain provisions. She also works in litigation, mostly on the administrative side such as with marketing authorisations.
In addition, she assists in M&A and investment deals, but from a regulatory side: “I don’t do the deals myself, let’s say the work I do is a building block in the whole deal. For instance, advising on issues with marketing authorisations, pharmacovigilance, clinical trials.
“My task is to check and to be sure that what the buyer is buying is indeed there – and is how it has been presented by the vendor.
“In some cases, you have to check to see if the right people are working at the business. If they are not, then the business is not operating under good manufacturing practices. For instance, as a company you need a certificate that shows you can manufacture medicinal products and if you don’t have that then the product is not allowed to be brought to the market.
“If you breach that then you immediately have a problem with your customers because they expect that what they buy from you is something that is produced under specific circumstances.”
Hanneke adds that pharma and biotech regulatory law is becoming more central to many deals and will continue to increase in importance in the coming years.
Mise en réseau
This is also where being part of the IR Global network helps. While her firm has only been a member for a short time, having been introduced by another Dutch lawyer, former colleagues Rachida el Johari and Madeleine Molster. She has embraced it and found it a good source of new appointments, attending various networking events in recent months.
“I have spoken to so many interesting people and made a lot of appointments with people because we’re going to try to set up things together,” she says. “I have already been instructed for work through colleagues in the network.”
Hanneke believes this workload will only increase further as the biopharma sector throws up more business opportunities for entrepreneurs and corporations worldwide.
“When you look at newer medicinal products, I think there’s going to be much more what we call ATMP – advanced therapy medicinal products – which include gene therapy products, cell therapy products or therapy tissue engineered products, which are used for serious diseases such as cancer,” she says.
“These are very specific high-tech medicinal products. This is really what we’re going to see in the coming years and decades. It’s really interesting to work with. I also think that normal healthcare will also go in that direction.
“With this bio-revolution, I deeply understand the technology and can put on my legal glasses, detecting where I think the legal, regulatory and perhaps IP problems will be and where the focus needs to be.
Through IR Global, Hanneke has already connected with law firms across the EU, UK and into the US: “We have very good connections with US law firms to ensure that if there are biotech companies that wish to come to Europe, and more specifically the Netherlands, we can serve them, not just through this firm, but also by connecting them to the right people.”
Away from the office, Hanneke enjoys spending quality time with her family. She recently moved to an area with beautiful woodlands nearby, and they all regularly head off to the nearby mountain bike tracks on biking holidays: “There are great MTB tracks here.”
“We also like to go skiing in Italy because I love the food and the language, which I’m learning. I like to be in Italy as often as I can. History in cities like Rome is ubiquitous and the weather is lovely.”