ISRAEL Law and Practice Contributed by: Lior Glassman, Matan Kovacs, Alexandra Cohen and Tamar Morag Sela, Reinhold Cohn Group
7.5 Trade Blocs and Free Trade Agreements
the importation of specific medical devices with- out MoH import authorisation under certain con- ditions. The Pharmacists Ordinance of 1981 permits the parallel import of a product equivalent to a regis- tered preparation by entities other than the regis- tration holder, provided it is identical to the reg- istered item and meets regulatory storage and delivery conditions. Except for the requirement of registration itself, all rules applicable to the registered preparation also apply to the imported equivalent on a comparable basis. As of January 2025, and according to Amend- ment to the Pharmacists Ordinance (Amend- ment No 37) of 2024, Israel’s “What is Good for Europe is Good for Israel” reform allows import- ers (registered as “proper importers” ) to bring in cosmetic products legally marketed in EU member states, Switzerland or the UK through a streamlined process. The reform aims to facili- tate imports, increase competition, and reduce consumer prices while maintaining product safe- ty standards. From an IP perspective, importing a product protected by a local patent for purposes such as production, use, sale, or offering for sale is regarded as exploitation of the invention. There- fore, if a medical device or pharmaceutical has a related registered patent/s in Israel, the importer is obligated to obtain consent from the patentee prior to importing the product. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports The Import and Export Ordinance of 1979, the Customs Ordinance of 2014, and the Free Import Order of 2014 include various non-tariff regula- tions and restrictions imposed upon importation.
Israel has signed many free trade agreements and trade pacts with multiple countries and eco- nomic blocs, including the USA, the EU (includ- ing the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA)), the European Free Trade Association (EFTA), the UK, South Korea, China, the Eurasian Economic Union, India, Mercosur (a South American trade bloc comprising Argentina, Brazil, Paraguay and Uruguay), and neighbouring/regional countries such as Jordan, Egypt, Turkey, and UAE. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Although the prices of medical devices are not controlled, the prices of pharmaceuticals are. Specifically, the Supervision of Prices of Com- modities and Services (Maximum Prices for Prescription Preparations) Order of 2001 deter- mines maximum prices for prescription prepa- rations, as elaborated on in 8.2 Price Levels of Pharmaceuticals or Medical Devices . As for preparations sold without prescriptions, the Supervision of Prices of Commodities and Services (Application of the Law on Preparations) Order of 2001 provides that the prices of such preparations may not be raised without their sell- ers first obtaining governmental approval. When it comes to GSL preparations, the same order provides that the registrants of such are to provide a biannual report to the MoH in which they are to detail the prices of all preparations they are selling, as well as provide an annual
181 CHAMBERS.COM
Powered by FlippingBook