RARE (ORPHAN) DISEASES: LEGAL REGULATION ABROAD
Rubrics: LABOR LAW AND SOCIAL WELFARE LAW
Authors:
1.
Russian Federation
Type:
Article
Pages:
from 1
to 1
Status:
Published
Received:
18.11.2018
Accepted:
18.11.2018
Published:
18.11.2018
Subject area:
UDK 34 Право. Юридические науки
BBK 67 Право. Юридические науки
BBK 67 Право. Юридические науки
Language:
Russian
Keywords:
redkie (orfannye) zabolevaniya, orfannye lekarstvennye preparaty, medicinskaya pomosch', medicinskoe strahovanie, lekarstvennoe obespechenie.
Abstract (English):
V stat'e rassmatrivayutsya voprosy pravovogo regulirovaniya redkih (orfannyh) zabolevaniy, predstavlyayuschih soboy hronicheskie, neredko zhizneugrozhayuschie zabolevaniya ili sostoyaniya, rasprostranennost' kotoryh sostavlyaet ot 0,65 do 1 promille na tysyachu zhiteley. Raskryvayutsya problemy regulirovaniya redkih zabolevaniy cherez prizmu otechestvennogo i zarubezhnogo opyta. V fokuse vnimaniya avtorov obschie problemy dostupnosti lekarstvennoy pomoschi licam, stradayuschim orfannymi zabolevaniyami; mehanizmy finansovogo obespecheniya etoy pomosch'yu; kriterii otneseniya zabolevaniy k redkim. Issleduyutsya istoricheskie predposylki vozniknoveniya pravovogo regulirovaniya redkih zabolevaniy i razrabotki lekarstvennyh preparatov dlya takih zabolevaniy; praktika rossiyskoy normativno-pravovoy regulyacii voprosov, svyazannyh s orfannymi zabolevaniyami, kak na federal'nom urovne, tak i na urovne sub'ektov Rossiyskoy Federacii. Vyyavlyayutsya nedostatki normativno-pravovogo regulirovaniya redkih zabolevaniy. Rassmatrivayutsya razlichnye podhody k opredeleniyu ponyatiya «redkoe (orfannoe) zabolevanie», soderzhaschiesya v zarubezhnom zakonodatel'stve. Cel' stat'i - vyyavit' sovremennoe sostoyanie normativno-pravovogo regulirovaniya orfannyh zabolevaniy kak v Rossii, tak i za rubezhom. V chisle zadach: issledovanie slozhivshihsya v mirovoy praktike podhodov k regulirovaniyu voprosov, svyazannyh s redkimi zabolevaniyami; izuchenie rossiyskoy praktiki regulirovaniya analiziruemoy sfery; vyyavlenie obschih problem normativno-pravovoy regulyacii orfannyh zabolevaniy. Odnim iz osnovnyh metodologicheskih priemov issledovaniya v stat'e yavlyaetsya komparativistskiy podhod. V sravnitel'no-pravovom klyuche analiziruetsya zakonodatel'stvo zarubezhnyh gosudarstv, reguliruyuschee sferu orfannyh zabolevaniy i orfannyh lekarstvennyh preparatov. Po rezul'tatam issledovaniya sdelany sleduyuschie klyuchevye vyvody: 1) v nastoyaschee vremya v zarubezhnyh stranah ne vyrabotan edinyy podhod k opredeleniyu orfannyh zabolevaniy; 2) dlya finansovogo obespecheniya lekarstvennymi preparatami lic, stradayuschih orfannymi zabolevaniyami, v bol'shinstve stran ispol'zuyutsya mehanizmy strahovaniya (sostrahovaniya) i (ili) instrumenty vozmescheniya grazhdanam zatrat na pokupku sootvetstvuyuschih lekarstvennyh sredstv; 3) dlya stimulirovaniya razvitiya farmacevticheskogo rynka orfannyh lekarstvennyh preparatov v razvityh stranah prinimayutsya special'nye mery, v tom chisle: isklyuchitel'noe pravo na prodazhu orfannyh lekarstvennyh sredstv v techenie opredelennogo vremeni; predostavlenie nalogovyh l'got i subsidirovanie razrabotok; uproschenie razreshitel'nyh procedur, vklyuchaya uskorennoe soglasovanie neobhodimoy dokumentacii; pomosch' v podgotovke dokumentacii; i dr.
V stat'e rassmatrivayutsya voprosy pravovogo regulirovaniya redkih (orfannyh) zabolevaniy, predstavlyayuschih soboy hronicheskie, neredko zhizneugrozhayuschie zabolevaniya ili sostoyaniya, rasprostranennost' kotoryh sostavlyaet ot 0,65 do 1 promille na tysyachu zhiteley. Raskryvayutsya problemy regulirovaniya redkih zabolevaniy cherez prizmu otechestvennogo i zarubezhnogo opyta. V fokuse vnimaniya avtorov obschie problemy dostupnosti lekarstvennoy pomoschi licam, stradayuschim orfannymi zabolevaniyami; mehanizmy finansovogo obespecheniya etoy pomosch'yu; kriterii otneseniya zabolevaniy k redkim. Issleduyutsya istoricheskie predposylki vozniknoveniya pravovogo regulirovaniya redkih zabolevaniy i razrabotki lekarstvennyh preparatov dlya takih zabolevaniy; praktika rossiyskoy normativno-pravovoy regulyacii voprosov, svyazannyh s orfannymi zabolevaniyami, kak na federal'nom urovne, tak i na urovne sub'ektov Rossiyskoy Federacii. Vyyavlyayutsya nedostatki normativno-pravovogo regulirovaniya redkih zabolevaniy. Rassmatrivayutsya razlichnye podhody k opredeleniyu ponyatiya «redkoe (orfannoe) zabolevanie», soderzhaschiesya v zarubezhnom zakonodatel'stve. Cel' stat'i - vyyavit' sovremennoe sostoyanie normativno-pravovogo regulirovaniya orfannyh zabolevaniy kak v Rossii, tak i za rubezhom. V chisle zadach: issledovanie slozhivshihsya v mirovoy praktike podhodov k regulirovaniyu voprosov, svyazannyh s redkimi zabolevaniyami; izuchenie rossiyskoy praktiki regulirovaniya analiziruemoy sfery; vyyavlenie obschih problem normativno-pravovoy regulyacii orfannyh zabolevaniy. Odnim iz osnovnyh metodologicheskih priemov issledovaniya v stat'e yavlyaetsya komparativistskiy podhod. V sravnitel'no-pravovom klyuche analiziruetsya zakonodatel'stvo zarubezhnyh gosudarstv, reguliruyuschee sferu orfannyh zabolevaniy i orfannyh lekarstvennyh preparatov. Po rezul'tatam issledovaniya sdelany sleduyuschie klyuchevye vyvody: 1) v nastoyaschee vremya v zarubezhnyh stranah ne vyrabotan edinyy podhod k opredeleniyu orfannyh zabolevaniy; 2) dlya finansovogo obespecheniya lekarstvennymi preparatami lic, stradayuschih orfannymi zabolevaniyami, v bol'shinstve stran ispol'zuyutsya mehanizmy strahovaniya (sostrahovaniya) i (ili) instrumenty vozmescheniya grazhdanam zatrat na pokupku sootvetstvuyuschih lekarstvennyh sredstv; 3) dlya stimulirovaniya razvitiya farmacevticheskogo rynka orfannyh lekarstvennyh preparatov v razvityh stranah prinimayutsya special'nye mery, v tom chisle: isklyuchitel'noe pravo na prodazhu orfannyh lekarstvennyh sredstv v techenie opredelennogo vremeni; predostavlenie nalogovyh l'got i subsidirovanie razrabotok; uproschenie razreshitel'nyh procedur, vklyuchaya uskorennoe soglasovanie neobhodimoy dokumentacii; pomosch' v podgotovke dokumentacii; i dr.
Keywords:
redkie (orfannye) zabolevaniya, orfannye lekarstvennye preparaty, medicinskaya pomosch', medicinskoe strahovanie, lekarstvennoe obespechenie.
redkie (orfannye) zabolevaniya, orfannye lekarstvennye preparaty, medicinskaya pomosch', medicinskoe strahovanie, lekarstvennoe obespechenie.
No data
1. No data
