No. 07-00-431/2017-02  Date:  12 January 2018

OPINION

The present opinion was issued following a complaint procedure lodged upon a complaint filed by N.T. from B. against Republic of Serbia Health Insurance Fund (RSHIF), on account of discrimination on the grounds of genetic trait as a personal characteristic. In his complaint the complainant stated that he had metastasis of the melanoma caused by the mutation of BRAF gene, he also stated that the List of Drugs prescribed, issued and covered by mandatory health insurance include drug Keytruda (pembrolizumab) used in immunotherapy of patients suffering from melanoma, but that this drug can be covered by mandatory health insurance only for patients without BRAF gene mutation. In its declaration responding to allegations made in the complaint, the Republic of Serbia Health Insurance Fund stated that drug Keytruda had been included in the List of Drugs covered by mandatory health insurance based on a proposal contained in the expert opinion on pharmacotherapeutic justification given by the Republic of Serbia Expert Commission on Cytotoxic and Molecular Drugs. At the request of the Commissioner for the Protection of Equality, the Republic of Serbia Expert Commission on Cytotoxic and Molecular Drugs has submitted a communication to the Commissioner stating that there were no medical reasons for excluding patients with BRAF gene mutation from receiving Keytruda immune therapy drug, and that their proposal to the Central Commission for Drugs and the Republic of Serbia Health Insurance Fund was driven by financial reasons only. In the course of the complaint procedure it has been ascertained that there were no reasons for patients with BRAF gene mutation suffering from melanoma to be put in an unequal position on the grounds of their personal characteristic (genetic trait) with respect to patients without BRAF gene mutation suffering from melanoma, in terms of receiving Keytruda immune therapy drug covered by mandatory health insurance. It has also been ascertained that the expert opinion of the Republic of Serbia Expert Commission was not binding on the Republic of Serbia Health Insurance Fund and that the final proposal of the List of Drugs is determined by the Central Commission, i.e. the Rulebook is passed by the Managing Board of the Republic of Serbia Health Insurance Fund. The Commissioner for the Protection of Equality has issued its opinion stating that the Republic of Serbia Health Insurance Fund had, by mandating that Keytruda immune therapy drug covered by mandatory health insurance be available only to patients without BRAF gene mutation suffering from melanoma, put patients, as was the case with the complainant who was a patient with BRAF gene mutation suffering from melanoma, in an unequal (less favorable) position in comparison to patients without BRAF gene mutation suffering from melanoma, in terms of being eligible to receive this drug which would be covered by mandatory health insurance, thus violating Article 8 of the Law on the Prohibition of Discrimination. For this reason, the Commissioner for the Protection of Equality has issued a recommendation to the Republic of Serbia Health Insurance Fund to take all necessary actions and measures within its scope of authority aimed at ensuring that Keytruda immune therapy drug covered by mandatory health insurance be available to persons with BRAF gene mutation who suffer from melanoma, while meeting conditions based on medical parameters for prescribing and issuing this drug, and to refrain in the future from violating anti-discrimination legislation when performing its regular work and activities.