Masterarbeit

Switzerland: Article 13 Act on Therapeutic Products - A Review ***

José Rodríguez Sánchez (2011)

Language: English

Article 13 ATP is part of the ATP and has remained unchanged since this act came into force in 2002. However, its construction was unclear until 2008, when Ordinance VV1 became effective. In 2010, the construction of Article 13 ATP underwent changes, which were implemented with Ordinance VV2. The essence of this article is that Swissmedic can grant an MA in the ideal scenario without performing a scientific assessment of the submitted data. Swissmedic needs to verify if the AR of the reference authority is plausible and what other authorities have decided. If the AR of the reference authority is not compelling or if contradictory decisions have been taken by other "high-standard countries", or if other conditions apply, Swissmedic can decide to perform a partial or complete assessment of the submitted data. In no case is Swissmedic bound by a foreign decision. Ordinance VV2 introduced parallel assessment with the EMA. This procedure constitutes one of the major amendments that came into force in 2010. Another one is that an MA granted under Article 13 ATP is now not linked to the reference MA, so different life cycles are possible. In addition to that, the applicability to new active substances has been limited. The objectives of Article 13 ATP are to increase Swissmedics efficiency and to facilitate market access. The incentives for the applicant can be higher revenues through earlier market access, shorter assessment periods and reduced assessment fees. However, the special requirements regarding the documentation to be submitted involve extra effort which must not be underestimated. Although most kinds of MPs are eligible for the Article 13 ATP procedure, and although most kinds of pharmaceutical companies could benefit from this stipulation, experience shows that mostly large companies make use of this procedure. Innovative and generic MPs have been authorized in this way to approximately the same extent. The Article 13 ATP procedure is mostly used for human MPs. One vaccine obtained an MA in a matter of days during the pandemic phase of “swine flu”; in this way, Swissmedic was able to make treatment available in a very short time. In situations of interest, Swissmedic can request the Article 13 ATP procedure. In this way, regulators have also found a way of making MPs available earlier to patients in Switzerland.

The data available show that this procedure has been used with an annually increasing frequency since Ordinance VV1 came into force in 2008. This trend seems set to continue, at least in the near future. The amendments to Ordinance VV2 prove that Swissmedic aims for further simplification and increases of efficiency. This will probably lead to even greater interest among applicants.

Pages 65
Annexes: 1, pages: 1