Parallel import of medicines into Switzerland

New rules and their practical implications

The import of medicines authorised abroad into Switzerland can have various motives. The most important are ensuring cross-border medical care, balancing overstocks in foreign warehouses or exploiting price differences.

Since 1 January 2024, new regulations have been in force in Switzerland that simplify the parallel import of medicinal products already authorised in Switzerland with regard to labelling and product information. This article explains these new regulations and their practical implications, especially in the context of patent-protected medicines.

1. Recent regulatory changes

The revision of the Therapeutic Products Act (“TPA“) in 2022, which came into force at the beginning of 2024, brought changes that simplify parallel imports of medicinal products into Switzerland. In particular, the new provision in Art. 14 para. 3 TPA simplifies the import of medicinal products from countries whose authorisation system is equivalent to that of Switzerland (cf. Art. 14 para. 2 TPA). At present, these are the EU and EFTA-EEA Member States, Australia, Japan, Canada and the USA.

Under the new Art. 14 para. 3 TPA, Swissmedic is authorised to issue simplified rules for the labelling and information of medicinal products imported in parallel. These simplified rules can be found in Art. 28 et seq. of the Swissmedic Ordinance on the simplified authorisation of medicinal products and the authorisation of medicinal products in the notification procedure (“VAZV“).

It should be emphasised that the new rules can only be applied to medicinal products that are authorised both in the exporting country and in Switzerland and which essentially meet the same requirements as the medicinal product (original preparation) already authorised in Switzerland. In addition, the importer must meet the same safety and quality requirements for the parallel imported medicinal product as the marketing authorisation holder of the original medicinal product.

2. Impact of the new rules

Whereas under the previous regulations the repackaging of the products and a detailed description of the repackaging process were mandatory, under the new regulation the packaging used abroad may be retained.

It is now possible to place simultaneously imported medicinal products on the Swiss market in the foreign packaging with a non-removable label containing the Swiss requirements in at least two official languages. In addition to the indication of the excipient composition, the non-removable label must bear the note “Composition according to foreign package leaflet“.

If the package size of the imported medicinal product does not correspond to the package size authorised in Switzerland, this must not be relevant to safety, i.e. the imported package size must not contradict the dosage recommendation of the original Swiss preparation. Different package sizes must be specified in the drug texts (patient and prescribing information).

In addition, the information of the importer of the parallel imported medicinal product (including the marketing authorisation number and the packaging code) and the information on the marketing authorisation holder of the original medicinal product (including the marketing authorisation number) must be indicated and clearly distinguishable from each other.

3. The new rules in the context of patent law

With the revision of the Patent Act (“Patent Act“) in 2008, Switzerland unilaterally introduced the principle of regional exhaustion within the EEA. This principle, which is enshrined in Art. 9a paras. 1-4 in conjunction with Art. 8 para. 2 German Patent Act, states that the exclusive rights associated with a patent expire in Switzerland as soon as a patent-protected product is placed on the market in an EEA country with the consent of the patent proprietor. Consequently, patent-protected goods from EEA countries can be imported into Switzerland in parallel without the need for the consent of the Swiss patent holder.

However, according to Art. 9a para. 5 German Patent Act, there is an exception to regional exhaustion for the marketing of patent-protected goods, the price of which is determined by the state. The principle of regional exhaustion does not apply to such price-administered patent-protected goods, so that such goods may continue to be placed on the market in Switzerland only with the consent of the patent holder. This applies to medicinal products that are reimbursed by health insurance companies and are therefore listed in the list of specialities (“SL”) with a factory selling price and a public price. The patent holders of medicinal products listed in the SL can therefore also defend themselves against parallel imports into Switzerland under the new, simplified provisions.

Finally, it should be noted that the above-mentioned authorisation for parallel import is granted regardless of the patent situation. Since the revision of the Patent Act in 2008, the clarification of the patent situation is no longer the responsibility of Swissmedic, but must be clarified by the market participants themselves.

By Vischer, Switzerland, a Transatlantic Law International Affiliated Firm.

For further information or for any assistance please contact switzerland@transatlanticlaw.com

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