SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang and Djamila Batache, Bär & Karrer Ltd
(Article 55 of the MedDO and Article 48 of the IvDO) (see 5.1 Requirement for Authorisation for Manufac- turing Plants ). 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices In principle, only medicinal products that have been granted a marketing authorisation by Swissmedic can be imported into Switzerland (Article 9 of the TPA) and importation is subject to a specific licence (Article 18 paragraph 1 lit a of the TPA). Subject to certain excep- tions – in particular, in connection with an official batch release from a foreign control authority belonging to the Official Control Authority Batch Release Network (OCABR) – anyone wishing to import immunologi- cal medicinal products or blood and blood products generally requires a special licence for each individual shipment (Article 44 of the MPLO). Under certain cir- cumstances, ready-to-use medicinal products with- out a marketing authorisation in Switzerland may be imported in small amounts by persons for private use or by HCPs (cf Articles 48 and 49 of the MPLO). While no licence for the import of medical devices is required (see 7.2 Importer of Record of Pharmaceu- ticals and Medical Devices ), medical devices must – prior to their placing on the Swiss market – undergo a conformity assessment to ensure that general safety and performance requirements are met (Articles 6 and 21 et seq of the MedDO and Articles 6 and 21 et seq of the IvDO). Certifications of conformity (CE markings) issued by bodies from EU/EEA countries are unilater- ally recognised in Switzerland (Article 25 paragraph 4 of the MedDO and Article 21 paragraph 4 of the IvDO). 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports Non-tariff restrictions are set forth in the Swiss cus- toms tariff. The entries in the relevant Harmonised Tar- iff Schedule (HTS) line will determine which market surveillance authority is competent to examine and approve import. The product-related laws and imple- menting ordinances set out the restrictions in detail. 7.5 Trade Blocs and Free Trade Agreements Switzerland is a member of the EFTA and is, among others, signatory to the free trade agreement with the EU of 1972 as well as to a network of currently
33 free trade agreements with 43 partners. The EU has unilaterally ceased the application of the MRA as regards medical devices. As a result, exportation of medical devices from Switzerland into the EU has become more burdensome. Negotiations are currently taking place between Switzerland and the USA on a free trade agreement concerning the pharmaceuticals sector, which is intended to facilitate market access for Swiss pharma companies. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Under Swiss law, prices of therapeutic products are controlled to the extent that they are reimbursed by the compulsory health insurance. With regard to thera- peutic products not reimbursed by compulsory health insurance, manufacturers, wholesalers and retailers are, in principle, not restricted in their pricing. Pharmaceuticals are reimbursed subject to a listing on the Specialties List (SL) where ready-to-use medici- nal products are included. Medicinal products that are manufactured in a pharmacy are reimbursed if their APIs are included in the List of Medicines with Tar- iff (LMT). The requirements for price fixing are mainly contained in the HIA, the Health Insurance Ordinance (HIO), and the Ordinance on the Benefits under the Mandatory Health Insurance (OBHI). The SL deter- mines the ex-factory price as well as the public price, which is the maximum amount (including VAT) that must be reimbursed by health insurers. The FOPH decides on the inclusion of a medicinal product on the SL after consultation with the Federal Drugs Commission (Eidgenössische Arzneimittelkom- mission, or EAK), except in the case of certain medici- nal products, such as generics and new galenic forms or package sizes of already-listed medicinal products (Article 31 paragraph 2 lit a of the OBHI). An accel- erated procedure applies in the case of an acceler- ated market authorisation (Article 31a of the OBHI). The procedure is initiated by the market authorisa- tion holder (Article 31 paragraph 1 lit a of the OBHI). Medicinal products can only be included in the SL
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