Implications of the new regulations
The import of medicinal products authorized abroad into Switzerland can have a variety of motives, the main ones being to ensure cross-border medical supplies, offset excess stocks in foreign storage facilities or exploit price differences.
Since 1 January 2024, new regulations have been in force in Switzerland that simplify the parallel import of medicinal products that are already authorized in Switzerland in terms of labelling and medicinal product information. This article explains these new regulations and their practical implications, particularly in the context of patent-protected medicinal products.
1. Recent Regulatory Changes
The revision of the Therapeutic Products Act ("TPA") in 2022, entered into force at the beginning of 2024, brought about changes that simplify the parallel import landscape. A new provision, Art. 14 para. 3 TPA, was introduced, outlining a simplified authorization procedure for Swiss companies seeking to import medicinal products into Switzerland from countries with equivalent authorization systems to that of Switzerland (cf. Art. 14 para. 2 TPA). At present, these are the member states of the EU and EFTA-EEA, Australia, Japan, Canada and the USA.
Under the new Art. 14 para. 3 TPA, Swissmedic is empowered to legislate simplified rules with regard to labelling and the information of parallel-imported medicinal products. These simplified rules can be found in Art. 28 et seqq. of the Swissmedic Ordinance on the Simplified Authorization of Medicinal Products and the Authorization of Medicinal Products under the Notification Procedure ("SAMPO").
It is important to note that the new rules can only be applied to medicinal products that are authorized in the exporting country as well as in Switzerland and that essentially meet the same requirements as the medicinal product already authorized in Switzerland (original medicinal product). Furthermore, the importer must fulfill the same safety and quality requirements for the parallel-imported medicinal product as the marketing authorization holder of the original medicinal product.
2. Implications of the new regulations
While repackaging of the products and a detailed description of the repackaging process were mandatory under the previous regulation, the new regulation allows the packaging used abroad to be retained.
It is now possible to place parallel-imported medicinal products on the Swiss market in the foreign packaging with the supplement of a non-detachable label containing the Swiss requirements in at least two official languages. In addition to the indication of the excipient composition, the disclaimer "Composition according to foreign package leaflet" should be placed on the non-detachable label.
If the pack size of the imported medicinal product does not correspond to the pack size authorized in Switzerland, this must not be safety-relevant, i.e., the imported pack size must not contradict the dosage recommendation of the original Swiss preparation. Different pack sizes must be specified in the medicinal product texts (information for patients and for healthcare professionals).
In addition, the details of the importer of the parallel-imported medicinal product (including its authorization number and packaging code) and the details of the marketing authorization holder of the original medicinal product (including its authorization number) must be indicated and be clearly distinguishable from each other.
3. The new regulation in the context of patent law
With the revision of the PatA in 2008, Switzerland – unilaterally – adopted the principle of regional exhaustion within the EEA. This principle, which is enshrined in Art. 9a para. 1-4 in conjunction with Art. 8 para. 2 PatA, states that the exclusive rights associated with a patent expire in Switzerland as soon as a patented product is placed on the market in an EEA country with the consent of the patent holder. Consequently, patented products from EEA countries can be imported into Switzerland in parallel without the consent of the patent holder being required.
According to Art. 9a para. 5 PatA, however, there is an exception to regional exhaustion for the marketing of patented goods whose price is fixed by the state in Switzerland. The principle of regional exhaustion does not apply to such price-administered patented goods, so that such goods may only be placed on the market in Switzerland with the consent of the patent holder. In Switzerland, this applies to medicinal products that are reimbursed by health insurance and, therefore, are included in the list of pharmaceutical specialties ("LS") with a reimbursement price. The patent holders of medicinal products that are included in the LS list can therefore defend against parallel imports into Switzerland also under the new regulation.
Finally, it should be noted that the authorization for parallel import discussed above is granted irrespective of the patent situation. Since the revision of the PatA in 2008, the clarification of the patent situation is not anymore the responsibility of Swissmedic, but must be clarified by the market participants themselves.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.