The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data.

BACKGROUND: Affordability is a key barrier to access to medicines. Generic medicines policies can address this barrier and promote access. Successful uptake of generic medicines depends, in part, on ensuring that these products are interchangeable with reference products. Typically, bioequivalence certification is established in order to demonstrate such interchangeability. OBJECTIVE: To study the implementation of the bioequivalence certification policy in Chile. METHODS: We used Chilean Market Regulatory Authority data for analysis to study the number of products that obtained bioequivalence certification, the time until bioequivalence certification and associated factors to obtain bioequivalence. RESULTS: As of January 2017, out of 2,336 products with a valid market authorization containing at least one of the 167 APIs that required BE certification, 1,026 products actually have BE certification (1,026/2,336, 43.9% compliance). Where data were available, the time between submission of the market authorization as a bioequivalent product to final authorization by the national medicine regulatory authority for most products varied between 4-6 months. The fraction of all BE products containing a given API out of the total marketed products containing that API varies considerably, e.g. for the API olmesartan there was only a single BE product marketed, the API diclofenac had none. CONCLUSIONS: Although the implementation of Chile's bioequivalence policy increased the number of bioequivalent products, over 50% of generic products requiring bioequivalence that did not obtain this certification. Also for some of the API none or very few BE products are marketed which limits the success of a substitution policy. Further studies are required to identify the apparent lack of incentives to obtain bioequivalence certification. Studies of sales volumes and prices of the products are needed to identify whether generic products without bioequivalence certification either become bioequivalent or eventually exit the market.

The implementation of the bioequivalence certification policy in Chile: an analysis of market authorization data

Affordability is a key barrier to access to medicines. Generic medicines policies can address this barrier and promote access. Successful uptake of generic medicines depends, in part, on ensuring that these products are interchangeable with reference products. Typically, bioequivalence certification is established in order to demonstrate such interchangeability. To study the implementation of the bioequivalence certification policy in Chile. We used Chilean Market Regulatory Authority data for analysis to study the number of products that obtained bioequivalence certification, the time until bioequivalence certification and associated factors to obtain bioequivalence. As of January 2017, out of 2,336 products with a valid market authorization containing at least one of the 167 APIs that required BE certification, 1,026 products actually have BE certification (1,026/2,336, 43.9% compliance). Where data were available, the time between submission of the market authorization as a bioequivalent product to final authorization by the national medicine regulatory authority for most products varied between 4-6 months. The fraction of all BE products containing a given API out of the total marketed products containing that API varies considerably, e.g. for the API olmesartan there was only a single BE product marketed, the API diclofenac had none. Although the implementation of Chile's bioequivalence policy increased the number of bioequivalent products, over 50% of generic products requiring bioequivalence that did not obtain this certification. Also for some of the API none or very few BE products are marketed which limits the success of a substitution policy. Further studies are required to identify the apparent lack of incentives to obtain bioequivalence certification. Studies of sales volumes and prices of the products are needed to identify whether generic products without bioequivalence certification either become bioequivalent or eventually exit the market.

Evaluation of the effects of a generic substitution policy implemented in Chile

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.

Evaluation of the effects of a generic substitution policy implemented in Chile.

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.