[Adaptive licensing - a threat to patient safety?].
In 2014, a pilot project of the European licensing authority EMA was launched to explore new ways to license medicinal products. The intention of this project is to open up gradual ("adaptive") licensing pathways, with pharmaceutical developing preparations gaining market authorization on the basis of clearly lower-level evidence of effectiveness and risk of damage than before. Their market authorization shall, initially, be restricted, for example, to subpopulations of patients or to selected indications. When new data from subsequent become available, the extension of the authorization shall follow in a stepwise manner. Data from investigations using less valid methodology shall also find consideration, such as, for example data from uncontrolled studies. The experience with accelerated market access, which is already being offered by several drug authorities, may give rise to concerns about the use of procedures that keep drugs with a negative benefit-risk relation for the patients in the market for many years - apart from the costs for the healthcare system. It is unacceptable that manufacturers will be exempt from (strict) liability for these adaptively licensed pharmaceuticals. If patients suffer damage from taking these medications, they cannot even expect material compensation.
Institut für Pharmakologie, Gesundheit Nord GmbH, Bremen, Germany. Electronic address: muehlbauer@pharmakologie-bremen.de.
Bernd
B
Mühlbauer
D003365:Costs and Cost Analysis; D017277:Drug Approval; D005858:Germany; D006801:Humans; D007880:Legislation, Drug; D008004:Licensure; D061214:Patient Safety; D010865:Pilot Projects
Accelerated market access; Arzneimittelzulassung; Beschleunigte Zulassungsverfahren; Patientensicherheit; Risiko; Transparenz; Unsicherkeit; adaptive Zulassung; adaptive licensing; drug approval; patient safety; risk; transparency; uncertainty