BREAKING NEWS: The Israeli Ministry of Health is considering amending the Israeli law and possibly introducing marketing exclusivity to biological drugs registered in Israel; therefore, it has recently published a "call for action" inviting the public to take a stand.
On 31 July 2018, the Israeli Ministry of Health (MoH) published a "call for action", inviting the public to participate in the process of examining the need to amend Section 47D of the Pharmacists' Ordinance, so it will also cover the protection of confidential data submitted in connection with the registration of biological drugs.
Section 47D of the Pharmacists' Ordinance already provides marketing exclusivity. However, the MoH took the position, in its letter, that the current regime applies to new chemical entities only.
As indicated in the MoH letter, a team has been assembled, which includes representatives from several government offices, that will conduct a regulatory impact analysis (RIA) procedure, all in accordance with a formal...