The new Law on Activities of Pharmacies which will regulate entire field of the pharmaceutical activity is in preparation
On 2nd February 2017 the public hearing related to the draft of the Law on Activities of Pharmacies (hereinafter: the “Law”) held by the Ministry of Health of the Republic of Serbia has been finished.
The Law (and bylaws which should be enacted on the basis of the Law) should reform activities of pharmacies (both state owned and private practices) by introduction of a number of novelties such as providing an intensified inspection, forming unique registry of pharmacies for the territory of Republic of Serbia, as well as introduction of new demographic and geographic criteria for opening of the pharmacies (such as the provision of Article 10 of the draft of the Law which prescribes that the minimum distance between pharmacies, measured on the basis of the distance on the map of the existing road network, is 300 meters). In addition, one of the main suggestions of the Pharmaceutical Chamber of Serbia with respect to the daft of the Law is that it should provide conditions for introduction of single retail medicines price, all in order to ensure availability of medicines under equal conditions to all patients in the Republic of Serbia.
However, the special attention has attracted the provision of the draft of the Law by which is forbidden to natural persons and legal entities who perform activities of the production of the medicines or medical devices, wholesale of the medicines and medical devices, as well as the holders of the marketing authorizations, directors, members of supervisory or management board, employees of that legal entity, as well as other persons with special authorization in that legal entity, directly or indirectly through their affiliated persons to establish pharmacies, all in order to avoid conflict of interests.
Additionally, one of the most important novelties introduced by the new draft of the Law represents the provision of Article 23 of the draft of the Law which prohibits transfer of founder’s rights over the pharmacies established by the Republic of Serbia or autonomous province to other legal entities or natural persons. However, certain organizational unit of the pharmaceutical facility may be leased to natural person or legal entity in the manner and under the conditions prescribed by the new draft of the Law.
The draft of the Law also prescribes new requirements related to equipment, size and number of employed pharmacists in pharmacies. Thus, the minimum size of state owned pharmacies is 60 m2 instead of the former 45 m2. On the other hand, when it comes to pharmacies private practices, the new Law prescribes the same size as the previous one (30 m2). However, if working hour of pharmacy private practice requires the presence of two employed pharmacists, then it must have at least 40 m2 of usable space.
In the legal system of the Republic of Serbia, activities of pharmacies have been so far regulated by many laws and by-laws (Law on Health Care, Rulebook on Detailed Conditions for Performing Health Activity in Health Facilities and Other Forms of Health Services etc.). Therefore, enactment of one unified legal act has the aim to significantly simplify legal framework of the whole activity of pharmacies, as well as other important questions related to it.
The provisions of the draft of the Law stipulate a period of 12 months from its coming into effect for harmonization of the activities of all forms of pharmacies (state owned and private practices). Therefore, state owned pharmacies and pharmacies private practises which fail to harmonize their activities with provisions of this Law within provided period shall cease to exist by force of the law.
Considering that the huge number of suggestions for amendments and modification of Law have been submitted and that analysis and implementation of stated suggestions in Law is in process, it is expected that the final text of the Law will be published soon on the website of the Ministry of Health of the Republic of Serbia.