INTRODUCTION Every clinical trial has to meet all ethical criteria in addition to the scientific ones. The basic ethical principles in the clinical trials are the following: nonmaleficence, beneficence, respect for autonomy and the principle of justice. OBJECTIVE The aim of the study was to analyse clinical cases with the outcomes leading to the changes in regulatory-ethical framework related to the clinical trials, as well as the outcomes of key clinical trials that influenced the introduction of the ethical principles into clinical trials. METHODS This was a descriptive research (methods of analysis and documentation; desk analysis of the secondary data). RESULTS By analysing the cases from the secondary sources as well as clinical and ethical outcomes, it may be noticed that the codes, declarations and regulations have been often preceded by certain events that caused their adoption. Moral concern and public awareness of the ethical issues have initiated not only the development of numerous guidelines, codes, and declarations, but also their incorporation into the legislative acts. CONCLUSION It is desirable that ethical instruments become legally binding documents, because only in this way will be possible to control all phases of the clinical trials and prevent abuse of the respondents.

Rare diseases (RD) are very heterogenic group of disorders affecting less than 5 out of 10.000 people in the European Union (EU), at the same time putting them in danger or disabling them chronically. It is estimated that only in Serbia almost half a million people suffer from some RD. In spite of rarity, they represent an important medical and social problem. The aims of this pilot project were to evaluate the pharmacists` general knowledge and specific knowledge regarding RD, regulatory requirements and availability of drugs for the RD in the Republic of Serbia as well as pharmacists` attitudes and understanding of the health public importance of RD and drugs` availability. The prospective crosssectional KAP study was conducted during 2012, on a convenient sample of the community pharmacists from the territory of the Nis branch of Pharmaceutical Chamber of Serbia. The questionnaire was fully completed by 139 pharmacists; 89.2% were females with mean age of 43.4±9.1 years. More than half of the respondents (66.9%) knew that there was no Register of RD in Serbia, but did not know the estimated percentage of the EU population suffering and the prevalence of RD (67%, 51.8%, respectively). Insufficient information about the problem points to insecurity in basic epidemiology and regulatory knowledge. The majority of the respondents supported the establishment of the regulatory instruments for the promotion of the research and development of the orphan drugs for RD. Acta Medica Medianae 2013;52(2):23-32.

Introduction: According to legal provisions and moral and ethical principles, pharmacists are required to contribute to improving the level and quality of health care services of their professional duties. Modern pharmaceutical practice in a community pharmacy setting presumes a pharmacist faced to many situations, when is required to see the right decisions to concern for the welfare of the patient. It carries a new kind of professional expectations and obligations, but may produce serious conflicts and ethical dilemmas as well. Objective: To describe the importance of professional ethics and knowledge of ethical codes, ethical principles and moral principles by pharmacists, and the ways of making decisions in situations where pharmacists encounter to the ethical problems in terms of contemporary pharmacy practice. Content analysis was performed and ethical problems solving was analyzed. Methods: We used a descriptive approach with desk research method of reviewing available data from different sources and literature. Results: Data from the literature say about the legal interpretation of the ethical problems in practice and poor knowledge of the codes by pharmacists. By the analysis of codes, four basic principles were established: beneficence, safety, justice and autonomy. In ethical situations, pharmacists are in the state of moral anxiety based on agitation and moral conflict. There are several ways of making moral decisions. Conclusion: It is necessary to educate pharmacists in terms of knowledge of ethical codes and making distinctions with legal problems. It is necessary to develop an awareness of the importance of professional ethics and how to improve the moral decision-making.

Rare diseases are a heterogenic group of disorders with a little in common except of their rarity affecting by less than 5 : 10.000 people. In the world is registered about 6000-8000 rare diseases with 6–8% suffering population only in the European Union. In spite of rarity, they represent an important medical and social problem due to their incidence. For many rare diseases have no treatment, but if it exists and if started on time as being available to patients, there is a good prognosis for them to be able for normal life. The problems of patients affected by rare diseases are related to the lack of diagnosis and timely undergoing as well as their treatment or prevention. Orphan drugs are products intended for treatment, diagnosis or prevention of rare diseases, but for their development and marketing the industry has not been interested in yet because of their marketing reasons. Patients suffering from a rare disease although belonging to the vulnerable group for their specific health needs,is becoming invisible in the health care system due to their additional needs unproperly recognized. Ethical problems faced by patients, but also health care professionals are related to the allocation of medical diagnostics, unequal approach to health care, inappropriately specialized social services as well as therapy and rare orphan drugs unavailability. Ethical questions related to clinical trails on orphan drugs, population screening and epidemiology testing on rare diseases will also be discussed in this paper.

The first state-owned pharmacy in Serbia dates back to 1836. At first its title was Dvorska i voena apoteka (Court and Military Pharmacy), which later changed to Pravitelstvena apoteka (Government Pharmacy). The pharmacy moved from Kragujevac to Belgrade on two occasions along with the government seat, to finally settle in Belgrade on 8 december 1841 Pravitelstvena Apoteka fostered the development of the pharmaceutical science in the country and acted as a public healthcare institution. It had a state-of-the-art laboratory, equipped for chemical analysis of mineral water and for toxicological and biochemical analysis of water containers. It is the cradle of the applied chemistry in serbia and it operated as a controlling centre for other pharmacies. In 1853, Pravitelstvena Apoteka opened a branch Filijala Pravitelstvene Apoteke, which was run by the Central Pharmacy in Belgrade and the appointed administrator Đorđe Bogdanović, MPharm. On 10 June 1859, both pharmacies were privatised by the decree of the Prince of Serbia, Duke Miloš Obrenović.

Aim To analyze the pharmacy network (structure and resources) in Bulgaria, Croatia, Serbia, and Slovenia and its relation to public expenditures for medicines. Methods We performed a cross-sectional study using the officially published data for the period 2003-2008 in four selected countries. Data sources were relevant national institutions. Results In 2008, Serbia had 27.5, Bulgaria 66.8, Croatia 59.5, and Slovenia 71.2 pharmacists per 100 000 inhabitants. There was a significant difference in the number of pharmacists per 100 000 inhabitants between all countries except between Bulgaria and Slovenia. The number of inhabitants per one pharmacy was significantly different between all observed countries. The expenditures for medicines per capita in 2008 were between €30.34 in Bulgaria to €137.03 in Slovenia, with a significant difference between all countries except between Bulgaria and Serbia. The number of pharmacists per 100 000 inhabitants and expenditures for medicines per capita were positively correlated in all observed countries, except in Bulgaria. Conclusion There were significant difference in the structure and availability of the pharmacy service in all selected countries. Expenditures for medicines were positively correlated with the number of pharmacists in all countries, except in Bulgaria. Our findings could be valuable to national regulatory bodies for the creation of national drug policies.

Rare diseases are a heterogenic group of disorders with a little in common except of their rarity affecting by less than 5 : 10.000 people. In the world is registered about 6000-8000 rare diseases with 6-8% suffering population only in the European Union. In spite of rarity, they represent an important medical and social problem due to their incidence. For many rare diseases have no treatment, but if it exists and if started on time as being available to patients, there is a good prognosis for them to be able for normal life. The problems of patients affected by rare diseases are related to the lack of diagnosis and timely undergoing as well as their treatment or prevention. Orphan drugs are products intended for treatment, diagnosis or prevention of rare diseases, but for their development and marketing the industry has not been interested in yet because of their marketing reasons. Patients suffering from a rare disease although belonging to the vulnerable group for their specific health needs, is becoming invisible in the health care system due to their additional needs un properly recognized. Ethical problems faced by patients, but also health care professionals are related to the allocation of medical diagnostics, unequal approach to health care, inappropriately specialized social services as well as therapy and rare orphan drugs unavailability. Ethical questions related to clinical trails on orphan drugs, population screening and epidemiology testing on rare diseases will also be discussed in this paper. [Projekat Ministarstva nauke Republike Srbije, br. 41004: Rare diseases: Molecular pathophysiology, the diagnostic and therapeutical modalities, social, ethical and legal aspects]