title: Off-label prescription of genetically modified organism medicines in europe: emerging conflicts of interest?
abstract: Recently, the first human medicine containing a genetically modified organism (GMO medicine) was authorized for use in the European market. Just as any medicinal product, the market authorization for a GMO medicine contains a precise description of the therapeutic use for which the medicinal product is intended. Within this use, the application of the GMO medicine is permitted, without the need for the institution to obtain a specific permit. In practice, however, medicinal products are also frequently prescribed for treatment outside the registered therapeutic use, a practice that is referred to as "off-label use." While off-label use of conventional medicines is permitted and has been very useful, the off-label use of GMO medicines is not covered in the European Union (EU) legislation or guidelines and falls under each member state's national environmental legislation. This implies that in the Netherlands and most other EU member states, an environmental permit will be required for any institution that uses the GMO medicine outside the registered application(s). In the Netherlands, this permit is identical to the permits required for the execution of clinical trials involving nonregistered GMOs. The application procedure for such permit is time-consuming. This process can therefore limit the therapeutic options for medical professionals. As a consequence, desired treatment regimens could be withheld for certain patient (groups). To make future off-label use of GMO medicines permissible in a way that is acceptable for all stakeholders, regulators should adopt a proactive attitude and formulate transparent legislative procedures for this. Only then the field can maintain the public acceptance of GMO medicines, while maintaining the freedom to operate of medical professionals.
authors.affiliation: 1 Netherlands Commission on Genetic Modification (COGEM) , 3720 AN Bilthoven, The Netherlands .
authors.forename: Frederik H E
authors.initials: FH
authors.lastname: Schagen
authors.forename: Rob C
authors.initials: RC
authors.lastname: Hoeben
authors.forename: Geke A P
authors.initials: GA
authors.lastname: Hospers
mesh_terms: D005060:Europe; D015316:Genetic Therapy; D006801:Humans; D007880:Legislation, Drug; D009426:Netherlands; D056687:Off-Label Use / Q000331:legislation & jurisprudence / Q000592:standards; D030781:Organisms, Genetically Modified; D004364:Pharmaceutical Preparations / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations