Marín Gustavo H, Polach María Andrea
Dirección Nacional de Relaciones Internacionales, Ministerio de Salud, Argentina.
Rev Panam Salud Publica. 2011 Aug;30(2):167-76.
Determine how the Mercosur countries access, regulate, and finance costly drugs and propose joint selection and financing strategies at the subregional level.
Qualitative design, using content analyses of primary and secondary sources, document reviews, interviews, focus groups, and case studies. The variables selected included: selection criteria, access, financing, and regulations in the various countries. Costly drugs were divided into those that do not alter the natural course of the disease and those with demonstrated efficacy, using the defined daily dose to compare the costs of classical treatments and those involving costly drugs.
The Mercosur countries generally lack formal strategies for dealing with the demand for costly drugs, and governments and insurers wind up financing them by court order. The case studies show that there are costly drugs whose efficacy has not been established but that nonetheless generate demand. The fragmentation of procurement, international commitments with regard to intellectual property, and low negotiating power exponentially increase the price of costly drugs, putting health system finances in jeopardy.
Costly drugs must be regulated and rationally selected so that only those that substantively benefit people are accepted. To finance the drugs so selected, common country strategies are needed that include such options as flexible in trade agreements, the creation of national resource funds, or joint procurement by countries to enhance their negotiating power.
确定南方共同市场国家如何获取、监管和资助高价药物,并在次区域层面提出联合遴选和资助策略。
采用定性设计,对一手和二手资料进行内容分析、文献综述、访谈、焦点小组讨论和案例研究。所选变量包括:各国的遴选标准、获取途径、资助方式和监管措施。根据限定日剂量比较传统治疗和使用高价药物治疗的成本,将高价药物分为不改变疾病自然病程的药物和已证明有疗效的药物。
南方共同市场国家普遍缺乏应对高价药物需求的正式策略,政府和保险公司最终只能通过法院命令来资助这些药物。案例研究表明,有些高价药物的疗效尚未得到证实,但仍产生了需求。采购分散、知识产权方面的国际承诺以及谈判能力低下,都使高价药物价格呈指数级上涨,危及卫生系统的财政状况。
必须对高价药物进行监管并合理遴选,只接受那些能给人们带来实质性益处的药物。为资助这些所选药物,各国需要制定共同战略,包括在贸易协定中采取灵活措施、设立国家资源基金或各国联合采购以增强谈判能力等选项。