Mansilla Cristián, Cárdenas Jorge, Kaplan Warren A, Wirtz Veronika J, Kuhn-Barrientos Lucy, Ortíz de Zárate Matías, Tobar Tatiana, Herrera Cristian A
Ministerio de Salud, Gobierno de Chile, Santiago, Chile.
Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.
BMJ Glob Health. 2019 Mar 4;2(Suppl 3):e000922. doi: 10.1136/bmjgh-2018-000922. eCollection 2017.
Chile implemented a generic substitution policy in 2014 to improve access to medicines. This study aims to measure if the generic substitution policy had an effect on the sales volume and prices of referent and the branded generic products with demonstrated bioequivalence (BEQ) in the private pharmaceutical market.
The volume and total private sales of medicines sold at private sector retail outlets between November 2011 and October 2016 were considered in the analysis. We calculated the total number of daily defined doses (DDD) by adding up the number of DDDs of different presentations with the active pharmaceutical ingredient (API). We determined the ratio of the median prices of all BEQ per DDD presentations compared with the median price of the corresponding referent presentations per DDD in 2011 and 2016. Sixteen APIs representing 231 different conventional-release presentations were included in the analysis.
Overall, the volume of sales of the referent products decreased over time after the intervention. However, this reduction was not mirrored by an increase in the corresponding branded generic BEQ volumes overall. In all cases, the median price per DDD of the referent was higher than its BEQ counterpart in 2011 and 2016.
Since referent products are more costly than branded BEQ generic products, reducing their consumption-and increasing the BEQ availability-should improve access to medicines in Chile. However, this must be accompanied by promotion of BEQ products to ensure savings for consumers in the long term. Future research should focus on identifying facilitating and inhibiting factors of generic substitution.
智利于2014年实施了仿制药替代政策，以改善药品可及性。本研究旨在衡量仿制药替代政策是否对智利私营药品市场中对照产品以及具有生物等效性（BEQ）的品牌仿制药的销量和价格产生影响。
分析纳入了2011年11月至2016年10月期间在私营部门零售网点销售药品的销量和私营销售总额。通过将含有活性药物成分（API）的不同剂型的限定日剂量（DDD）数量相加，计算出每日DDD总数。我们确定了2011年和2016年所有BEQ剂型每DDD的中位数价格与相应对照剂型每DDD中位数价格的比值。分析纳入了代表231种不同常释剂型的16种API。
总体而言，干预后对照产品的销量随时间下降。然而，相应的品牌仿制药BEQ销量总体上并未随之增加。在所有情况下，2011年和2016年对照产品每DDD的中位数价格均高于其对应的BEQ产品。
由于对照产品比品牌BEQ仿制药成本更高，减少对照产品的消费并增加BEQ产品的可及性应能改善智利的药品可及性。然而，这必须伴随着对BEQ产品的推广，以确保从长远来看为消费者节省费用。未来的研究应侧重于确定仿制药替代的促进因素和抑制因素。
