Setterwalls successfully represented Abboxia vs. the Medical Products Agency

Setterwalls has successfully represented Abboxia in an administrative dispute against the Medical Products Agency concerning marketing authorisation for parallel import of pharmaceuticals. The judgement of the Administrative Court of Appeal concerns when a difference between reference products and parallel imported pharmaceuticals can afffect safety and establishes that assessment shall be based on the their normal use.

In April 2019 the Medical Products Agency decided to reject Abboxias’ application for marketing authorisation for parallel import of pharmaceuticals with the dosage form oral drops. The decision was justified by the fact that the parallel imported pharmaceutical did not contain a blue dye included in the reference product on which the application was based. The Medical Products Agency was of the opinon that the dye was important to reduce the risk of misuse of the product. Abboxia appealed the decision to the Administrative Court who upheld the appeal and remanded the case to the Medical Products Agency for granting of a marketing authorisation. The Medical Products Agency appealed the judgment of the Administrative Court to the Administrative Court of Appeal.

The Medical Products Agency stated in its appeal that the difference between the parallel imported pharmaceutical and the reference product was important to reduce the risk of misuse and that the lack of the dye under all circumstances entailed a risk to public health. The Administrative Court of Appeal judged that the new circumstance referred to by the Medical Products Agency (risk to public health) in the Administrative Court of Appeal did not imply any change of the subject-matter of the case. Thus, it was not a question of an unauthorized amendment of action, but the Administrative Court of Appeal was unhindered to assess whether the lack of dye implied a risk to public health. The Administrative Court of Appeal then proceeded and tried the grounds presented by the Medical Products Agency on the basis of the judgement by the European Court of Justice in case no. C-94/98 Rhône-Poulenc Rorer, establishing that differences between parallel imported pharmaceuticals and reference products shall be accepted if they do not affect the quality, efficacy or safety of the pharmaceutical and that this assessment shall concern the normal use of the pharmaceutical.

The Administrative Court of Appeal stated that even the assessment of a pharmaceutical’s risk to public health shall be judged based on its normal and intended use. With reference to the judgement of the European Court of Justice in case no. C-270/02 The Commission vs. Germany, the Administrative Court of Appeal emphasised that the Medical Products Agency had an obligation to justify on scientific grounds its position that a pharmaceutical is a risk to public health. The Administrative Court of Appeal established that the Medical Products Agency had not claimed that the difference between the parallel imported pharmaceutical and the reference product constituted a safety risk during normal use but only during misuse or abuse. Thus, the difference was irrelevant.

Further, it was established by the Administrative Court of Appeal that the Medical Product Agency had not explained in more detail any serious safety risks that could appear if the pharmaceutical was used for its intended purpose. Absence of the dye could thus not constitute such a safety risk that entailed that the parallel imported pharmaceutical and the reference product were not sufficiently similar to each other or constituted a serious risk to public health. Consequently, the Administrative Court of Appeal rejected the Medical Products Agency’s appeal.

The decision by the Administrative Court of Appeal is welcome, especially as it clarifies that safety risks shall be judged based on the pharmaceutical’s normal use and that the Medical Products Agency has to justify its positions on scientific grounds.