In recent years, our lawyers have built a strong reputation with their extensive knowledge and experience in the field of law for Life Sciences and Health(care). They serve many clients in this market sector, including pharmaceutical companies, MedTech companies, companies that develop or provide biotechnological, therapeutic and diagnostic solutions, healthcare providers, healthcare institutions, and organisations that cater to this market in other ways.
Providing our clients with adequate and effective support in this ever-changing legal and uncertain environment is a multidisciplinary challenge. The strategic and solution-oriented approach of our lawyers is very well adapted to this market sector. It is precisely in this field that (healthcare) parties often cannot afford to allow issues to escalate. Despite a particular dispute, they must be able to continue their close collaboration with all stakeholders. Sound, substantive, legal and strategic advice is therefore essential.
For many years, healthcare providers have been among our regular clients to our office. These include, for example, primary care organisations (such as healthcare groups, emergency care organisations, innovative collaborations and regional or national collaborations), large diagnostic (laboratory) organisations, home care organisations, pharmacists (organisations), municipalities and network organisations, for which we provide adequate legal support for all legal challenges they face in their day-to-day operations. The kinds of challenges they encounter range from privacy and medical confidentiality, corporate law issues, due diligence, agreements (for healthcare purchasing and collaboration), pricing issues, market organisation and competition issues, preparing for new laws and regulations, problems with healthcare purchasing, etc.
As a professional working in the pharmaceutical industry, you are likely to work with the many different phases of the life cycle of a medicine such as the development phase, scientific research, registration, pricing/launch, communication and advertising about the medicine, reimbursement, preferential treatment by health insurers if applicable, distribution of the medicine to wholesalers and healthcare institutions and the patent. Each phase is characterized by specific laws and rules to abide by, different government bodies, different (potential) contractual partners, and various other relevant stakeholders in the market that need to be taken into account. For each phase and for each of these individual subjects (including the themes further specified below), we can provide legal-strategic guidance. Developmental, scientific research phase Various legal aspects already emerge as early as the development phase of a medicine. We can offer counselling, for example, for setting up (fundamental) research. Not only can we provide support by bringing together the right parties within our network, but we may also be able to arrange for the formalization of agreements in this phase, or prior to it (e.g. non-disclosure agreements, R&D agreements, donation and sponsorship agreements, various collaboration agreements with researchers and hospitals, clinical trial agreements, material transfer agreements). It is often also necessary to think about intellectual property rights at this stage and to make agreements in this regard. Registration (marketing authorization) and reimbursement/funding As soon as there is sufficient evidence that a medicine is effective and safe, the next step is to prepare/submit a registration file and adequate strategy to obtain reimbursement/funding for the new medicine. The legal services of LS&H Lawyers are frequently deployed for legal matters with regards to both obtaining marketing authorization and realizing the reimbursement/funding (conditional or not) for the medicine – including issues related to clustering of products that qualify for the Medicine Reimbursement System (GVS in Dutch). ‘Lock’ procedure, advertising, magistral preparation, preferential policies, etc. Apart from the regular pharma-topics, a pharmaceutical company may also run into a whole range of legal issues. Our lawyers advise on these and other matters, such as the so-called ‘lock’ procedure in the Netherlands (Sluisprocedure) applicable for expensive medicine, tackling unlawful advertising from competitors, and the implementation of preferential policies by health insurers. In addition, there is a special development underway in the Netherlands with regard to the forwarding and delivery of pharmaceutically prepared medicine. In all aforementioned cases, our lawyers are fully competent and have ample experience and expertise.
Companies active in the field of medical technology or medical devices are in a rapidly growing market sector, in which highly specialized issues arise. We advise both startups and very large MedTech companies on a wide range of topics such as partnering and joint venture agreements, distribution contracts, collaboration agreements, licences for the buying and selling of intellectual property, etc. Within Europe, we are currently faced with major challenges due to the introduction of the new European Regulations and the additional legal regulations issued by individual Member States. The new European Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) have consequences for manufacturers, importers and distributors of medical devices. Their products may fall into a different risk classification and need to meet stricter safety and quality requirements. The new regulations also greatly affect healthcare institutions, healthcare providers and (indirectly) patients. Our law firm provides guidance for various parties in the MedTech sector (in the form of both advice and training) in order to adequately prepare for the new situation, whereby the developments in how the regulations are interpreted at the European and national levels are closely monitored. Patient
organisations represent the (legal) rights of patients in the various healthcare systems, both nationally and internationally. Each group of patients with a particular condition typically has a unique and very wide set of issues to consider with regard to advocacy. For example, the undesirable effects of the “preferential policies” of health insurers (whereby patient organisations may be concerned about the unnecessary changes in medication). Other examples of an issue might be a rare condition that requires more prominence in daily care practices so that patients are even diagnosed at all and an international cooperation that should be established between professionals. Many issues are caused entirely or partially by situations that must be addressed and resolved (at least in part) from a legal perspective. The lawyers in our law firm have extensive experience when it comes to guiding patient organisations in advising on and realizing legal strategic options to generate a solution for patients.
In the United States, a fast-growing industry has emerged under the influence of the trend of legalization for the use and production of cannabis (hemp) products. This is a development that is by now spreading worldwide. The experiment of legalized cannabis cultivation will soon be introduced in the Netherlands. Where regular cultivation and sale of cannabis is concerned, the market in the Netherlands is still subjected to extremely strict regulation. Nevertheless, we also observe in the field of research & development in the Netherlands a rapidly growing practice in which (GMP) laboratories, research centers, investors and various other involved parties alike are in search of a legally responsible way forward in the world of developing cannabis products. The lawyers at LS&H Lawyers have been active for years in this area, have greatly expanded their expertise, and by now serve many clients in this unique market segment.
Privacy / Medical Confidentiality
Privacy in the healthcare sector is an extremely complex issue. The General Data Protection Regulation is of course applicable, as are the national additions thereto. When the privacy regulation is carefully assessed in its own right, its implementation in the healthcare is already complicated. However, when combined with all the regulations concerning medical confidentiality in the healthcare sector and the unique legislation that applies, the result is an incomprehensible framework intended as guidelines for the practice of healthcare professionals and organisations. Many issues in this area are dealt with by our office, whereby our key focus is on providing a solution for our clients to make it possible to apply this complex legislative framework in their daily practice. International Cooperation/International Privacy Dutch organisations are famous for their international approach and willingness to work with many parties from outside of the Netherlands. We provide assistance for both Dutch and foreign parties to form a close cooperation within the fields of healthcare and life sciences. Our firm pays attention to the flexibility and the adaptability of the legal advisor in realizing these international collaborations and the fact that at times a different strategy is required of the legal advisor than is customary in the Netherlands. A special point for consideration arises as an additional aspect for consideration arises here in the event that personal data are processed outside of the EU. Solutions for such matters are also needed and can be provided for by our lawyers.