Abstract
Introduction:
The government of Indonesia has established a commitment to the provision of affordable medicines. The retail price of unbranded generic cannot exceed the maximum retail price set by the Ministry of Health. The generic medicine pricing policy that has been implemented by the Indonesian government must be evaluated.
Objectives:
To evaluate the impact of the generic medicine pricing policy on the price of selected medicines and to measure the differences between the prices paid by patients for unbranded generic medicines and the maximum retail price.
Method:
The study design was a cross-sectional survey and policy evaluation. Medicine prices were measured in 2010 at nine public hospitals, 64 private pharmacies, and nine non-governmental organisation hospitals in four provinces in Indonesia. The price of the lowest price generic (LPG) and innovator brand (IB) medicines in 2010 was compared to the price of the medicines before policy implementation. The results from a 2004 survey conducted by the Indonesian National Health Research Institute and Health Action International were used as the baseline data for the comparison. The price of unbranded generic medicine paid by patients was compared to the price in the generic medicine pricing policy 2010 edition.
Results:
The results indicated that the price of LPG and IB medicines was lower in 2010 than in 2004. The decline was approximately 40% to 2200%. Wide variations were observed in the excess of the unbranded generic medicine price paid by patients compared with the maximum retail price from the Ministry of Health, exceeding the maximum price by approximately 2% to 600%.
Conclusion:
Generic medicine pricing policies have succeeded in lowering the price of unbranded generic medicines. The price of IB medicines has declined but remains high compared to the international reference price. The prices paid by patients for unbranded generic medicines are more expensive than the maximum prices in the policy.
Introduction
The price of medicines can affect health outcomes and access to care. People have more opportunities to treat their health problems if medicines are available at an affordable price. 1 In fact, one-third of the population lacks access to medicines and faces financial constraints in paying for them. 2 High medicine pricing can lead to impoverishment, especially in low- and middle-income countries (LMIC). 3
As a middle-income country, the price of medicines in Indonesia is high in the public and private sectors. Survey results from 2004 showed that the price of medicines in Indonesia in both the public and private sectors was high. 4 The price of innovator brand (IB) medicines was 22 to 26 times higher than the international reference price (IRP) in the public and private sectors in 2004. Although generic medicines were priced lower than IB medicines, they still cost nine times the IRP. Moreover, a one-day global snapshot survey conducted in 2010 showed that the price of a vial of soluble insulin injection in Indonesia was nearly as high as the price in developed countries such as the United Stated and Austria. 5 These high prices affect people’s access to the medicines they need, especially when the average income is much lower than in the United State or Austria. In Indonesia, most people (60% to 85%) purchase medicines through out-of-pocket payments. 6 The government only subsidizes. Branded generic medicines dominate Indonesia’s pharmaceutical market, although IB medicines also have a significant market share. 7 Thus, people have to pay more for medicines.
The Indonesian government has long been aware of the high price of medicine. To solve this problem, the government has implemented several policies to regulate medicine prices. The policies issued by the government regulate the price of unbranded generic medicines (generic medicines using international non-proprietary names). The retail price of unbranded generic medicines in the public, private, or other sectors cannot exceed the maximum price set by the Ministry of Health (MoH). The effectiveness of the medicine pricing policy should be evaluated by assessing the impact of the policy in the field through reliable and valid data on processes and outcomes. 8 Unfortunately, there is little reliable information on the effectiveness of mark-up regulation in LMIC. 9
In Indonesia, reliable and up-to-date data on the impact of the medicine pricing policy are scarce. A study on medicine prices, availability, and affordability was conducted prior to the implementation of the generic medicine pricing policy. Between 2005 and 2010, several medicine pricing policies were launched by the government. The implementation of the policies may have influenced the price, availability, and affordability of medicines. Therefore, the objective of this study was to assess the impact of the generic medicine pricing policy on the LPG medicine price and to measure the differences between the prices paid by consumers for unbranded generic medicines and the maximum retail price of the MoH.
Methods
A cross-sectional survey was conducted from April to September 2010 to measure medicine prices using the WHO/HAI methodology. 10 The study was conducted in the provinces of South Sumatera, Jakarta, Yogyakarta, and South Sulawesi, which represent three out of four regions in Indonesia. Price data were collected from nine public hospitals. Additionally, 64 private pharmacies were surveyed, and nine non-governmental organisation (NGO) hospitals were surveyed in the other sector.
Policy evaluation was conducted to determine the impact of the policy on price, the results of the 2010 study were compared with medicine price data from the 2004 study (which also used the WHO/HAI methodology). 4 The findings from 2004 were used as the baseline. We also measured differences between the prices paid by patients for unbranded generics and the maximum retail price of the MoH 2010 edition.
Ethical clearance and endorsement of the survey
Permission to conduct the study was received from the Indonesia Ministry of Internal Affairs. Ethical clearance was granted by the National Ethics Committee under the National Institute of Health Research and Development.
Medicine selection and data analysis
Seventeen medicines found in both the 2004 and 2010 surveys with the same strength and dose form were included in the analysis. Data for two product types were analysed: IB and LPG. Prices are expressed as median price ratios (MPR), i.e. the median local price (in rupiah) divided by the median IRP. The source of the IRP was the Management Sciences for Health’s (MSH) International Drug Price Indicator Guide. 11 The MSH price was converted into rupiah using the exchange rate on the first day of data collection (1US$ = 9172 IDR).
A previous study in Indonesia using the WHO and HAI methodology was conducted in 2004. To accurately compare the results between the 2010 and 2004 surveys, the MPR from 2010 was adjusted for inflation using Consumer Price Index (CPI) data. 12 The data from the current study were adjusted from the 2009 IRP to the 2003 IRP because a previous study in Indonesia was conducted in 2004 using the 2003 IRP. The world economic outlook database included the following data for Indonesia: the CPI in 2004 was 75.04 and the CPI in 2010 was 120.968. 13
The price of unbranded generics found in the health facilities were compared with the price in the policy. The price of medicines was calculated in Indonesian rupiah (IDR). Wilcoxon signed ranks or paired T-tests were used to assess differences in prices between 2004 and 2010 and in the comparison of prices with set MRPs.
Results
The impact of the generic medicine price policy on the price of LPG and IB
The median price ratios (MPRs) in 2010 vs 2004
After adjusting with IRP 2003 and CPI, CPI in 2004 was 75.04, CPI in 2010 was 120.968.
Wilcoxon signed-ranks test at α = 0.05.
Paired T-test at α = 0.05.
The decline of IB medicine prices was not as drastic as the LPG (90% to 297%). There were significant differences between IB prices in the private sector in 2010 and 2004 (p value <0.001). The MPR of IB medicines was 5 to 35 times more expensive than the IRP.
Comparisons of a patient’s medicine prices with the maximum retail price of the MoH
Comparison of the median price of lowest price generic (LPG) medicines with the MRP of Ministry of Health (MoH) in 2010 in the public sector
Wilcoxon signed-ranks test at α = 0.05.
Comparisons of the median price of lowest price generic (LPG) medicines with the MRP of Ministry of Health (MoH) in 2010 in the private sector
Wilcoxon signed-ranks test at α = 0.05.
Comparisons of the median price of lowest price generic (LPG) medicines with the MRP of Ministry of Health (MoH) in 2010 in the NGO sector
Wilcoxon signed-ranks test at α = 0.05.
In the public sector, the differences between the median price and maximum retail price ranged from 5% to 202%. In the private sector, the difference between the median price and the maximum retail price was approximately 4% to 661%, whereas in the NGO sector, the difference was between 2% and 453%. The highest number of medicines that exceeded the maximum retail price was found in the private sector. In all sectors, phenytoin was consistently observed as the most expensive medicine compared with the maximum retail price (200% to 600%). However, some medicines (e.g. phenobarbital 30 mg cap/tab, salbutamol 2 mg cap/tab, and dexamethasone 0.5 mg cap tab) were sold lower than the price in the policy.
Discussion
In 2010, the price of LPG medicines was lower than it was in 2004 in all sectors. From 2005 to 2010, six generic pricing policies were implemented to regulate LPG prices. This means that medicine pricing policies might have impact on decreasing LPG prices. Most LPG medicines in the 2010 survey were unbranded generic medicines, whose price is set by the government, whereas in 2004, some of the LPGs were branded generic medicines. 4 In 2004, the government had not regulated the price of unbranded generic medicine (because the generic medicine pricing policy began in 2005). Therefore, the price of unbranded generic medicines was occasionally higher than the price of branded generic medicines. Some evidence shows that the price control on medicine in European countries has led to decreased medicine prices.14–16 In the developing countries, India has implemented a cost-plus pricing method for essential medicines, which cannot exceed twice the cost of their production. 17 Therefore, the price of essential medicines in India is reasonable. 18
In addition to the policy that lowered the price of generic medicines, a drastic decline occurred due to the adjustment for inflation during the five-year period. Price changes in the policy might not consider inflation, as evidenced by the fact that the prices of medicines in the policies for the 2008–2010 period remained relatively stagnant.
Despite the absence of regulations that govern IB medicines, the prices of IBs in 2010 were lower than the prices in 2004. Unfortunately, when compared to the international reference price, the price of IB medicines remains very expensive. This problem is due to the fact that the price of IB medicines in Indonesia is left to the market. 6 A free pricing system has led to expensive medicine prices.9,19 In contrast, Malaysia is a middle-income country that implements free pricing for medicines. Without a medicine pricing policy, in Malaysia, the mark-up for generic medicines is greater than for IBs. 20
In the implementation of the Indonesian generic medicine pricing policy, some health-care facilities have violated the maximum retail price. Most pharmacies, especially in the private sector, sell unbranded generic medicines at a price higher than the maximum retail price. Low prices for medicines leads to a lower profit margin; therefore, these facilities sell unbranded medicine at a price higher than the maximum retail price. The government does not punish the health-care facilities that sell medicine at a price higher than the maximum retail price. This situation shows that the implementation of the medicine pricing policy in Indonesia is not optimal. The policy is simply considered a formal document without strong law enforcement for violations. To achieve the optimal impact, the implementation of the policy should be followed by adequate law enforcement. 9
Medicine prices can be reduced by implementing a medicine pricing policy. However, such a policy may have unintended effects. In the Indonesian context, pharmaceutical industries ceased their production activity, especially for low-price medicines. 21 In turn, the availability of some unbranded generic medicines in Indonesia declined.
The problems with the Indonesian pharmaceutical industry’s response to the medicine pricing policy can be viewed from two perspectives. First, based on the process of the medicine pricing policy, a cost-plus pricing system has difficulty obtaining reliable information on the cost of production. Policymakers estimated prices using inadequate data. Another part of this study presents results showing that when setting the prices of medicines, policymakers relied on the opinions of an expert and the experience of an expert consultant. The use of the IRP as a reference was limited to the prices of some medicines and was only implemented in 2011; in fact, not all medicines in the policy have IRP data. Thus, the prices that were determined might be too low or too high. In addition to a decrease in medicine prices, this situation may decrease the profits of the pharmaceutical industry. 22 In this case, the pharmaceutical industry would not produce medicines whose prices did not provide an adequate margin or were harmful to the industry. In the long term, price control could decrease a company’s spending on innovation research.16,19,23
From the pharmaceutical side, if policymakers determined prices using an appropriate formula and all cost variables were included in the pricing, the problems may be due to production inefficiencies in the pharmaceutical industry, which would prevent the industry from fulfilling production at the price set by the government.The cost-plus pricing system often leads to problems between policymakers and the pharmaceutical industry. The pharmaceutical industry finds it difficult to adjust prices when there are changes in the market or economic situation. 24 The application of cost-plus pricing is quite effective if it is implemented in a country that has few pharmaceutical industry facilities. In developing countries with a large market segment and adequate pharmaceutical industry facilities, the price competition method is an effective strategy to obtain lower prices. 25 In practice, the application of a medicine pricing policy is dynamic; the medicine pricing system in a country can be changed or combined with other methods if the evaluation does not provide optimal results or generates unintended effects.
Nevertheless, the low price of generic medicines in Indonesia did not increase the use of unbranded generic medicines. The impact of the generic medicine pricing policy on generic medicine use in health-care facilities is not optimal. 26 According to the government, the use of unbranded generics in public health-care facilities remains low. Therefore, to increase the use of unbranded generic medicines, the government revitalised the policy on unbranded generic use in 2010. The policy stated that it is compulsory for public sector health-care facilities to procure and use unbranded generic medicines. However, the use of unbranded generics did not increase. This problem may have been caused by stakeholders’ perceptions of the quality of generic medicines.27,28 Stakeholders may have perceived that low medicine prices indicate low quality.24,29 The government should ensure the quality of the unbranded generic medicines, which would influence the effectiveness of the policy implementation. 30 The government could provide information regarding the quality of medicines for prescribers or consumers, such as the bioavailability profiles of unbranded generic medicines. Another strategy would be for the government to educate consumers to change consumers’ perceptions. In addition, consumers could be informed that medication costs could be reduced by the use of generic medicines.31,32
The findings of this study describe medicine prices after the government of Indonesia implemented a series of medicine pricing policies. The findings also provide data on the effects and the compliance of health facilities with the generic medicine pricing policy. The government can use this information to develop effective medicine pricing policies and implementation strategies in Indonesia. In addition, to optimise the medicine pricing policy, there is a need to implement adequate law enforcement and to regularly monitor price. The limitation of this study was that it did not use a time series and longitudinal study design and only compared the price pre- and post-policy intervention. The use of a longitudinal study design would more clearly capture the change in trends before and after policy intervention. 33
Conclusions
The government has been successful in regulating the price of unbranded generic medicines through the generic medicine pricing policy. However, many outlets sell unbranded generic medicines above the maximum retail price set by the government. The price of IB medicines remains high because no policy regulates these prices.
Footnotes
Acknowledgements
We thank the pharmacy directors of the Provincial Health Offices, the hospital directors, the pharmacy managers of the hospitals, and all pharmacists at the pharmacies in all four provinces who endorsed and provided medicine pricing information for this study. We would like to thank Martuti Budiharto and Selma Siahaan on behalf of the Indonesian National Health Research Institute for providing the data used as the baseline in the comparison before and after policy implementation.
Conflict of interest
The authors declare that they have no conflicts of interest to disclose.
Funding
The study presented in this paper was part of a PhD thesis sponsored by the Ministry of Education Republic of Indonesia and Faculty of Pharmacy Pancasila University, Jakarta Indonesia.
