Abstract
This paper critically analyzes the basic models for the development and financing of orphan drugs, i.e. medicines for the treatment of rare diseases, starting from the principle of equality in health care proclaimed within the framework of the World Health Organization and to the protection of the rights of vulnerable categories of the population as well. A comparative and normative method has been applied. On the basis of the regulations of the European Union and the national laws of the member states, the paper emphasizes the possible solutions for the development of domestic law in the context of ensuring access to patients and exercising the right to health care. The opinion of the European Court of Human Rights in the case of Nitecki v. Poland is, specifically, analyzed from the aspect of refunding the price of an orphan medicinal product and exercising the right to access to health care services for patients. The model of public-private partnership was identified as the most adequate one in the conditions of limited public resources, taking into account the interest of the state, and the need for expressing social responsibility considering the interest of the (pharmaceutical) companies. The model is based on the (bio)ethic principle of justice, conceptualized as assistance to those people who suffer from bad health condition and who are economically worse off.
Highlights
PRAVNA PITANJA RAZVOJA I FINANSIRANJA**Apstrakt: U radu se kritički analiziraju osnovni modeli razvoja i finansiranja orfan lekova, odnosno lekova za lečenje retkih bolesti, polazeći od principa jednakosti u zdravlju, proklamovanog u okvirima Svetske zdravstvene organizacije, i zaštite prava ranjivih kategorija stanovništva
This paper critically analyzes the basic models for the development and financing of orphan drugs, i.e. medicines for the treatment of rare diseases, starting from the principle of equality in health care proclaimed within the framework of the World Health Organization and to the protection of the rights of vulnerable categories of the population as well
On the basis of the regulations of the European Union and the national laws of the member states, the paper emphasizes the possible solutions for the development of domestic law in the context of ensuring access to patients and exercising the right to health care
Summary
Apstrakt: U radu se kritički analiziraju osnovni modeli razvoja i finansiranja orfan lekova, odnosno lekova za lečenje retkih bolesti, polazeći od principa jednakosti u zdravlju, proklamovanog u okvirima Svetske zdravstvene organizacije, i zaštite prava ranjivih kategorija stanovništva. U vezi s tim, zastupa se model deobe rizika između javnog i privatnog sektora, odnosno uspostavljanje javnoprivatnog partnerstva sa ciljem finansiranja kako istraživanja tako i obezbeđenja dostupnosti orfan lekova licima obolelim od retkih bolesti.. Primena modela javno-privatnog partnerstva sa ciljem obezbeđenja finansijske dostupnosti pacijentima podrazumeva da se finansiranje orfan i ultra orfan lekova obezbeđuje delom iz budžeta, odnosno iz sredstava nacionalnog sistema zdravstvene zaštite, u okvirima regulative kojom se predviđa osnivanje ekspertskih centara za retke bolesti, a delom iz sredstava privatnog sektora, odnosno predviđanjem obaveznog izdvajanja, na godišnjem nivou, određenog procenta od profita farmaceutskih kompanija. Dostupnost orfan lekova je pitanje odgovornosti koje je društvene i političke prirode, a njihovo obezbeđenje pacijentima od strane država je više etički imperativ nego pravni, što je potvrđeno i pravom Evropske unije, gde se u oblasti zdravstvene zaštite primenjuje princip koordinacije, ne i harmonizacije prava. P., Battistella, C., Pinel, J., Pecuol, B., 1999, Is orphan drug status beneficial to tropical disease control? Comparison of the American and future European Orphan Drug Act, Tropical Medicine and International Health, Vol 4, No 6
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