文摘
昂贵的药物成本,专利强制许可和药剂师的限制令
作者(年代):Hanneke Later-Nijland近来,药品的成本是一个反复出现的主题的辩论在欧洲和预计将讨论这个话题更强烈。在这方面,应用专利强制许可和复合(宽)应用程序的豁免(公式magistralis)认真调查荷兰部长医疗作为工具来抑制药物的成本。对后者,立法提案正在将免除药剂师专利侵权时复合医药产品为直接使用个案在药店医疗处方。本课程探讨了适用的立法和判例法的这些解决方案是否正确标识为昂贵的医药产品的解决方案。依如TRIPS协议,专利强制许可的总体利益是(至少)结合使用适当的报酬。然而,值得提醒的是,在公共利益最近被授予强制许可(在吸引和维持)在德国的HIV药物频道。可用的判例法对复合及其基本原理表明,仅仅是被利用作为一个例外,这使得它不适合作为一个通用的解决方案。病人不能保证同样的质量控制授权的医药产品,因此需要适当的证实这一偏差的理由。这样的理由可能当比较欧洲案例法可能不会寻求经济利益抛开这个影响了公平的竞争环境。本课程是非常相关的政党制造或销售成本较高的药用产品。 Recent Publications 1. Later-Nijland (2018) Annotation to e.g. ECLI:NL:RBDHA:2017:12046 ???The Alimta cases??? (Patent infringement cases concerning Alimta) Jurisprudentie Geneesmiddelenrecht (???Case law Pharmaceutical law???), (Apr 6) 2018, Sdu [in Dutch] 2. Later-Nijland (2018) Annotation to ECLI:NL:RVS:2017:1175 ???The Biodent case??? (The Dutch Council of State rules that this caries protection product should be classified as both a medicinal product by presentation as well as a medicinal product by function) Jurisprudentie Geneesmiddelenrecht (???Case law Pharmaceutical law???), Apr, 2018, Sdu [in Dutch] 3. Later-Nijland H. (2016) Statutory prohibition inducements concerning medical devices upcoming, Life Sciences & recht, Jan 26, DeLex [in Dutch] 4. Nijland H M J, Ruslami R, Stalenhoef J E, Nelwan E J, Alisjahbana B, Nelwan R H, Ven A J A M van der, Danusantoso H, Aarnoutse R E and Crevel R van (2006) Exposure to rifampicin is strongly reduced in patients with tuberculosis and type 2 diabetes. Clinical Infectious Disease 43(7):848-854. 5. Nijland H M J, L'homme R F A, Rongen G A P J M, Uden P van, Crevel R van, Boeree M J, Aarnoutse R E, Koopmans P P and Burger D M (2008) High incidence of adverse events in healthy volunteers receiving rifampicin and adjusted doses of lopinavir/ritonavir. AIDS. 22(8):931-5.
