Approval of Proposed Invented Names for Medicinal Products in Slovenia

Article by Tatjana Simović, Trademark and Patent Agent and PETOŠEVIĆ Slovenia Director, first published in Law, Lore & Practice, December 2014

The regulatory framework in Slovenia allows prescribing of medicines by their international non-proprietary name (INN). However, as INN prescribing is not compulsory, physicians mostly prescribe medicines by their invented names. Pharmaceutical branding thus plays an important role in marketing of pharmaceuticals in Slovenia.

The competent authority in Slovenia responsible for granting marketing authorisations through the national, decentralised or mutual recognition procedure is the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (hereafter referred to as the JAZMP). Part of its role in evaluating the safety of medicinal products is to approve their proposed (invented) names. In that regard the JAZMP issued the Guideline governing the acceptability of names for human medicinal products (hereafter referred to as the JAZMP Guideline).

The JAZMP Guideline mostly follows the requirements for approval of proposed (invented) names in the process of granting Community marketing authorisation for human medicinal product through the centralised procedure that is in the competence of the European Medicines Agency (hereafter referred to as the EMA). A Community marketing authorisation for human medicinal product is valid throughout the European Union and the invented name of the medicinal product is an integral part of the authorisation. According to Article 1(20) of Directive 2001/83/EC, as amended, the name of the medicinal product “may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder”. Article 6(1) of Regulation (EC) No 726/2004 stipulates that a single name is used to identify a medicinal product authorised under the centralised procedure.

For the purpose of reviewing proposed (invented) names of medicinal products, the EMA established the (Invented) Name Review Group (NRG) composed of representatives from the EU Member States. The group’s main role is to consider whether the invented name proposed by the applicant(s) or marketing authorisation holder(s) could create a public-health concern or potential safety risk. When assessing the acceptability of the proposed (invented) names, the NRG applies criteria based on public health concerns and, in particular, safety.
Specifically, the invented name should not:

• convey misleading therapeutic or pharmaceutical connotations;
• be misleading with respect to the composition of the product;
• be liable to cause confusion with the invented name of an existing medicinal product in print, handwriting or speech.

The criteria applied by the NRG when reviewing the acceptability of proposed (invented) names are detailed in the Guideline on the acceptability of names for human medicinal products processed through the centralised procedure (EMA/CHMP/287710/2014 – Rev. 6), hereafter referred to as the EMA Guideline.

In reviewing the proposed (invented) names of medicinal products authorised through the national, decentralised or mutual recognition procedure, the JAZMP takes into consideration safety issues and possible confusion with existing medicinal product names or names pending approval. As of late 2011 an increase in the rejection rate with respect to the names
proposed to the JAZMP is noticeable. The JAZMP decisions on the proposed (invented) names often seem arbitrary, which is evident from the situation on the market.

The JAZMP Guideline introduced a requirement not comprised in the EMA Guideline, prescribing that the names of medicinal products should differ in at least three characters. This criterion is vague and may be interpreted in different ways. According to one possible interpretation, the names of two medicinal products must differ in more than three letters, whereas the letters are compared in the sequence as they appear. The same requirement may also be interpreted in a way that the names of two medicinal products must differ in three or more letters, whereas the positioning of the individual letters is not taken into account. The JAZMP has not made publicly available its official standpoint on this issue. There are examples of name pairs that have been approved by the JAZMP that do not fulfill the aforesaid requirement, regardless of the interpretation applied, e.g. TOBREX and TOBRADEX, ZALDIAR and SELDIAR. The applicants for marketing authorisations often face rejections of the proposed invented names of medicinal products due to the alleged similarity to the applied/registered invented name, even though the conflicting names are more distant visually and phonetically than the aforesaid name pairs.

Furthermore, trade mark registration priority is not a determining factor in the JAZMP assessment of the acceptability of the proposed name for a human medicinal product. Since the first-come, first-served rule is applied, the proposed name enjoining the trade mark registration priority can be rejected during the marketing authorisation granting procedure on the basis of a name that obtained trade mark protection later, but for which marketing authorisation was requested earlier.

The applicants have the possibility to consult with the JAZMP as regards the acceptability of the proposed (invented) name prior to filing an application for marketing authorisation. However, the opinion given beforehand is not binding in the granting of marketing authorisation, and it neither helps in anticipating the outcome of the assessment of each proposed name nor does it remedy the JAZMP’s strict and inconsistent practice.