In personalised medicine, patients are treated with medicinal products according to their individual characteristics, such as genetic background, instead of a traditional one-size-fits-all approach. Genetic screening of patients for effective and safe treatment with medicinal products is performed using in vitro diagnostic devices (IVDs), including genetic tests. Therefore, in personalised medicine, medicinal products and IVDs are linked. However, different regulatory frameworks exist for these two components of personalised medicine. The current RIVM report states that in order to adequately control the risks of personalised medicine, the legislation of medicinal products and that of IVDs should be linked. Also, RIVM research reveals that the training of healthcare professionals in the use of personalised medicine techniques needs to be improved.
The report describes the gaps between two sets of legislation. One of these gaps is the incompleteness and lack of uniformity of information in the summary of product characteristics (SPC) of medicinal products, the instructions for use of the IVDs and Dutch clinical practice guidelines. The need for comprehensive and uniform information across these documents was confirmed by Dutch healthcare professionals. A potential hazard resulting from lack of (uniform) information occurs when in daily practice an IVD is used that differs from the one applied in the pivotal clinical trials of the medicinal product. A difference in IVD tests may result in a different selection of patients, and thereby different, and potentially less optimal, treatment. In addition, legislation does not cover the simultaneous development of a medicinal product and IVD. Finally, the results of vigilance activities (the monitoring of adverse drug reactions, product defects, etc.) are not exchanged between the authorities responsible for medicinal products and those responsible for IVDs. In the European Commission's September 2012 proposal for revised IVD regulation, both medicinal products and IVDs are mentioned; however, gaps remain.