Ministry of Health considers granting data exclusivity to biological drugs

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 may grant exclusivity with respect to data filed in order to obtain regulatory approval to market biological drugs.

The Pharmacists Ordinance regulates the marketing, labelling and distribution of pharmaceuticals in Israel. Section 47D, the Protection of Confidential Information Provided in Registration of Pharmaceutical Preparations, was introduced in 2005 and de facto grants marketing exclusivity to innovative chemical drugs. The ordinance limits the Ministry of Health’s authority to authorise the marketing of generic drugs that rely on data filed by their innovative equivalents for a given period from the date of registration of the original drug, regardless of whether the new chemical entity is protected by a patent.

According to Section 47D, subject to certain exceptions, the Ministry of Health will not permit the marketing of a ‘new pharmaceutical preparation’ (ie, a drug that is registered based on the safety and efficiency data of a previously registered drug) for either six years from the registration date of the original drug in Israel or six-and-a-half years from the registration date of the original drug in another jurisdiction – whichever is earliest.

The data exclusivity period of six to six-and-a-half years is especially important for drugs that are not protected by a patent in Israel. 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 patent’s life.

According to its Call for Action (released on 31 July 2018), the Ministry of Health has invited individuals, organisations and stakeholders to participate in the examination process for the need to amend Section 47D with regard 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 may have significant implications on the biosimilar drug market. As the authorisation procedures of chemical generic drugs cannot serve as a basis for the approval of biosimilar drugs, many changes must be made to the regulation regarding biological preparations. Since the spatial structures of the proteins in biological preparations depend on the conditions during various production stages, it is almost impossible to produce a biological product identical to the original source drug. Therefore, it is problematic to rely on data regarding the efficacy and safety of another biological drug for the authorisation of a biosimilar drug. However, the authorisation 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 may pose an additional barrier to their entrance into the market.

For the amendment examination, a team of representatives from several government ministries was set up to carry out the regulatory impact analysis in accordance with Government Resolution 2118. The public was invited to participate in the process by submitting its position in writing and, if requested, present it orally.

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