An attempt by the Manufactures’ Association of Israel to broaden the requirements was thwarted
The Israeli Registrar has recently cancelled all existing PTE guidelines and circulars (“PTE Practice”) and issued a new circular, no. 36/2019, which refers to the scope and extent of reporting requirements imposed on PTE applicants under regulation 5 of the Israeli PTE Regulations.
In short, regulation 5 refers to reporting requirements of any change, cancellation, expiry or renewal of a drug registration in the Israeli Pharmaceutical Register, on the basis of which a PTE application is submitted.
The reconsideration of the existing PTE Practice was initiated by a petition of the Manufactures’ Association of Israel (MAI), which mainly represents the local generic industry. In its petition, MAI requested the Registrar to amend one former circular so it will impose much broader and extensive reporting requirements on PTE applicants. As a result of said petition, the Israeli Registrar has commenced a public hearing relating the PTE Practice at the ILPO.
The Reinhold Cohn Group, through our law firm of Gilat, Bareket & Co., took an active part in said public hearing. During the hearing, the RC group argued, inter alia, that the MAI petition should be refused, as it was previously refused in the framework of the amendment of the Israeli PTE Regulations. We also argued, inter alia, that (a) the data required by MAI extends beyond the conditions of the relevant Israeli Law and Regulations for the grantexpiry of PTE orders. Therefore, since the data is not required to examine a PTE application or to cancel a PTE order, there is no legal merit to have it reported; (b) the data, required by generic companies, may also include confidential, proprietary information of the innovative companies, which is not to be disclosed unless required explicitly by Law; and (c) the requested data imposes unnecessary, baseless burden on PTE applicants.
After a hearing was held at the ILPO, in which parties from the innovative and the generic community attended, the Registrar issued a new circular in which it was determined that the reporting requirements under regulation 5 will only include changes which may have effect on the validity or registrability of a PTE order. A cancellation, expiry or renewal of a drug registration are to be reported in any event.
The Circular applies to all PTE applications, new or pending, as well as to PTE orders already in force.
 Represented by partners Eran Bareket and Chen Ben Dori-Alkan, who were also involved in the legislation procedure relating to the amendments of the Israeli PTE provisions and PTE Regulations.
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