The Israeli Ministry of Health has asked the public to comment on the need to expand the scope of section 47D of the Pharmacists Ordinance [New Version] 5741-1981. The amendment will possibly grant exclusivity with respect to data filed in order to obtain regulatory approval to market biological drugs.
The Pharmacists Ordinance regulates the marketing, labeling and distribution of pharmaceuticals in Israel. Section 47D, entitled “Protection of confidential information provided in registration of pharmaceutical preparations” was introduced to the Ordinance in 2005, and de facto grants marketing exclusivity to chemical innovative drugs. The Ordinance therefore limits the authority of the Ministry of Health to authorize the marketing of generic drugs that rely on data filed by their innovative equivalents for a certain period of time from the date of registration of the original drug, regardless of the question of whether or not the new chemical entity is protected by a patent.
According to Section 47D, The Ministry of Health will not permit the marketing of a new pharmaceutical preparation (“a new pharmaceutical preparation” is defined as a drug that is registered based on the safety and efficiency data of a previously registered drug) for 6 years from the date of registry of the original drug in Israel or 6.5 years from the date of registry of the original drug in another jurisdiction (the earliest), subject to certain exceptions.
The data exclusivity period of 6 to 6.5 years granted by section 47D is especially important for drugs that are not protected by a patent in Israel, for whatever reason. Section 47D, in its current form, has little effect on drugs that are protected by a patent, since the patent owner may enforce the patent and prevent the marketing of generic drugs throughout the life of the patent.
According to the Ministry of Health’s “Call for Action” (released on July 31, 2018), the Ministry of Health invites individuals, organizations and stakeholders to participate in the examination process on the need to amend section 47D with regards to biological preparations, and the appropriate scope of the proposed amendment, since section 47D provides data exclusivity only for new chemical entities.
The proposed amendment to section 47D may have significant implications on the biosimilar drug market. Considering the fact that the authorization procedures of chemical generic drugs cannot serve as a basis for the approval of biosimilar drugs, there are many regulatory changes to be made with regards to biological preparations. Since the spatial structures of the proteins in biological preparations depend on the conditions in various production stages, it is almost impossible to produce a biological product identical to the original source drug. It is therefore very problematic to rely on data regarding the efficacy and safety of another biological drug for the authorization of a biosimilar drug. However, the current authorization requirements for biosimilar drugs are relatively strict since the production requirements of biological preparations are far more detailed and complex than those of chemical preparations. Thus, granting a data exclusivity period for biological drugs might pose an additional barrier to enter the market.
For the purpose of the amendment examination, a team of representatives from several government ministries was set up to carry out the regulatory impact analysis (RIA) procedure in accordance with Government Resolution No. 2118. The public was therefore invited to participate in the process by submitting their position in writing, and, if requested, present it orally to the team.