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Drafting medical product labels only in the state language violates the principle of equality

Recently, the Council for Preventing and Eliminating Discrimination and Ensuring Equality spoke out on the case of restricting the access of Russian-speaking persons to information on the medical product labels. The institution appealed to the Ministry of Health, Labour and Social Protection with a request to activize a change in the normative act (art. 4(4) and (5) of the Law on Medicines No. 1409/1997) so that the labels with instructions of medical products, as well as the information on the packages of medicines authorized for use in the Republic of Moldova (especially ones that are sold in pharmacies) could be available in both Romanian and Russian languages.

The case was investigated due to the complaint submitted to the Council, where the applicant referred to the fact that persons who do not speak the state language face an inequality in access to the labels with instructions of medical products, which restricts their right to life and health

In response, the Ministry of Health, Labour and Social Protection noticed that medicines labelling is performed according to the provisions of art. 4 of Law on Medicines No. 1409/1997, where the inclusion of Russian version of medical product labels is mentioned as optional. At the same time, the Medicines and Medical Devices Agency stated that the labels approved in the state language in the Republic of Moldova comply with the provisions of normative acts and do not derogate the right of persons to health. According to the Agency, the medical doctor is responsible for prescribing treatment and regulating it, and the pharmacist is responsible for providing pharmaceutical information.

As a result, the Council found an indirect discrimination in access to information in instructions of medical products. The Council also mentioned that the optional drafting of medical product labels in Russian disadvantages persons who belong to linguistic minorities. This disadvantage adds complexity to the use of medicines purchased. In addition, the Council notes that the lack of Russian version of medical product labels has a negative impact on the right to health of the language group. The negative impact occurs despite the fact that Russian language is recognized as the official language in two administrative territories of the Republic of Moldova.

The change in the legislative framework required by the Council will ensure equal right to health through free access to information in instructions of medicines for persons who are the parts of linguistic minorities and who do not speak the state language.