Physicians and other healthcare professionals
The rules concerning the status and the competences of the healthcare professionals belong to the core of health law. This field regulates among others the access to the various healthcare professions, the recognition of the different disciplines and their mutual areas of competence. This domain is dynamic and characterised by a strong European flavour. We support national and foreign healthcare providers and professional associations for the acquisition of a recognition, a special professional title, the right of establishment or an academic equalization. The interaction between the competences of the various healthcare providers actually causes a lot of conflicts. They are also addressed in this practice area. We also pay a lot of attention to the complex status of hospital physician and even more to his financial status when hospital financing is changed. Healthcare providers have to comply with a growing number of legal obligations. These legal obligations concern the professional practice, medical treatment, prescription of medication, communication with patients and third parties, advertising, etc. In health law, the breach of these obligations is very often subject to criminal prosecution. We assist healthcare professionals as from the first interrogation by the police or an investigating judge up to the possible defence before the courts. The enforcement of rights and obligations of healthcare providers passes through an impressive myriad of courts, disciplinary authorities and professional bodies. To this practice area certainly belongs the classic disciplinary law of the various professional bodies and of the provincial medical commissions. But also the procedures before the RIZIV/INAMI (national sickness and invalidity insurance institute) and the recognition commissions are included. Given the fact that all these bodies have their own procedural “characteristics”, even locally, experience is of a key importance here. As an extension of these procedures and after the appeal and annulation before the Council of State, the Court of Cassation and the Constitutional Court are exhausted, our clients often require initiation of proceedings before the European Court of Justice and the European Court of Human Rights. In this way it was achieved that in our country the advertisement ban for medical professionals was lifted.
Hospitals and care networks
It is well known that hospitals belong to the organisations which are the most difficult to manage. There is of course the legal framework which defines the governance structure of a hospital. An in-depth knowledge of this legal format is crucial, but far from sufficient. The internal relationship called hospital governance is after all different in each hospital given its respective history, culture and strategy. Structure follows strategy. The legal structure must be adapted to that strategy. For more than 25 years we have solid experience in this matter. Governance of care networks is the newest challenge and will set the agenda of the healthcare landscape for the coming years. We also take our responsibility in this field, as well as a leading position by presenting formats and structures ourselves which enable efficient work.
Medicinal products, medical devices and apps
Pharmaceutical law is applied in full width. When bringing medicinal products on the market pharmaceutical companies are supported through all the phases: from the experimental phase (clinical trials), through to registration, price determination, reimbursement, distribution and packaging to product liability and the possible (re)use and the off-label use. Our lawyers in this practice area also review certain business models (direct marketing) and sales techniques, such as publicity, via internet, and sale at a distance vis-à-vis Belgian and European standards. Indeed we also assist manufacturers and distributors of medical devices through all their Belgian and European deontological-legal pathways. We were also the first to be ready to support the developers of medical apps and 3D applications.
Health related data
Healthcare providers, care facilities, manufacturers of medicinal products, medical devices or medical applications are faced with privacy issues on a daily basis because of health data being in their possession. Especially the electronic transmission of health related data and the eHealth-world are a source of great concern and this requires subtle and consistent legal attention. Our law firm also adopted a unique position in this important niche of health law which is highly appreciated on an international level. In addition to the consulting practice we also perform privacy-audits of companies and care facilities and we support legislative initiatives and research for the government.
Full legal assistance of the life cycle of a “product” falls under this dynamic practice area. “Products” can be biotechnological products, but also cosmetics and foodstuffs. The border between medicinal products, medical devices, foodstuffs or food supplement, cosmetics or biotechnological products is ultra-thin and requires in addition to legal knowhow also a lot of product knowledge.
Medical liability law includes civil and criminal liability of the healthcare provider, care facilities or the manufacturer for their professional practice or for the use of defective medical supplies. The procedures of the 'Fonds Medische Ongevallen' (medical accidents trust) play an increasingly important role in this field. We are proud of our network of excellent and very renowned medical legal experts who can assist our clients. This is a critical success factor when conducting liability proceedings. By the large impact of the liability insurance (and its coverage) on the consequences of a judgement or arrest with regard to medical liability, healthcare providers and care facilities require more and more a periodic analysis of their policies. By our combined expertise on the subject of insurance law and medical liability, we consider these analyses as our core activity. The assessment of the quality of the informed consent of the patient has become a crucial part in medical liability proceedings. By an arrest of the Court of Cassation the burden of proof about the informed consent was ultimately moved to the practitioners. We assist professional associations, individual practitioners and hospitals when drawing up and especially keeping up to date informed consent forms.
The pharmacist is responsible for a good and efficient delivery of medicinal products and hence he traditionally is an important player in the healthcare sector. He must comply with several legal obligations guaranteeing the quality of his services. Also the practice of the pharmacist as well as the establishment of the pharmacy are regulated by law. We advise the pharmacist concerning his legal obligations, we support him in relation to his demand to transfer his pharmacy and we assist him during administrative, disciplinary, criminal and RIZIV/INAMI (national sickness and invalidity insurance institute) proceedings.
Government and healthcare
Under this practice area falls the legal assistance of care providers in their often complex relation with the government. It often concerns recognition, programming, accreditation and financing pathways. Next to the assistance through these civil pathways the appeal procedures also play an important part in this context. The successive state reforms also complicated the search to the competent authority. This subject is also part of this practice area.
Patients' rights and obligations
Medical law in the strict sense of the term comes under this large practice area. It includes the totality of rights and obligations of the medical profession. This contains all the regulations concerning the early beginnings of life (among others IVF, abortion, predictive screening, wrongful life), medical treatment (among others professional secrecy, information, consent, qualifications, fee) and end-of-life issues (euthanasia, organ donation, end-of-life care, post-mortem rights).