NIHR HPSR-CA: Prevalence, health impact and economic cost of substandard and falsified medicines in Indonesia Affordable, good quality medicines are a bedrock of strong health systems, something governments aspire to deliver as they expand health care to more citizens, especially the poorest. But budgets don't always match political aspirations or patient demand, and health authorities have to squeeze down spending on medicines or services. If prices are pushed too low, drug manufacturers sometimes cut corners, compromising quality. Hospitals also protect profits by pushing patients towards medicines not covered by insurance. Poor patients then buy on the internet or in street markets, where they are easy targets for criminals who sell fake medicines. So while expanding health systems are delivering more medicines, poorer people may be getting "medicines" that don't actually work, and which can cause real harm.
The World Health Organization says substandard and falsified medicines are a major problem in poorer countries with rapidly-growing markets, but no-one knows how bad the problem really is. Some prefer to turn a blind eye, worrying that quality enforcement could reverse progress towards wider access. And with no reliable numbers, it's easy for politicians to ignore the threat, at least for a while. Over time, though, bad quality medicines hurt patients, waste money, drive out responsible companies and undermine confidence in the whole health system. And if sub-par antibiotics don't deliver full doses to patients, they'll kill only the weaker bugs, allowing resistant infections to spread.
We want to help countries understand and measure the problem, so that they can plan effective action and track change over time. That's hard to do, because the market for medicines is huge and complex. We've been working in Indonesia to use information about price, sales outlet and company history to try and predict which medicines are most likely to be substandard or fake. We believe our model could be used to improve the efficiency of surveillance systems, helping governments to save money by sampling from the market and testing the medicines most likely to be poor quality. We also want to build simple tools to estimate the overall size of the problem in a country, and the toll it takes on health and on the economy.
We'll work with WHO to make these methods useful for many countries. First, we want to try the system in Indonesia, the world's fourth most populous country, where 106 million people live on less than £1.25 a day. In the last 5 years most of them have joined another 116 million citizens as members of the national health insurance scheme, which carries a deficit of £1.9 billion. Medicine prices have been slashed, and several recent scandals, as well as our research, suggest that poor quality medicines are common.
Working with the regulator, we plan to sample and test medicines from categories our model predicts are at risk (e.g. expensive medicines with recent shortages sold on the internet; or products sold for under 20% of a benchmark price). We'll work in 9 districts in 4 market regions, and use the results, together with assumptions based on market volumes, insurance claims and discussion with our policy partners, to estimate the prevalence, impact and cost of poor quality medicines in Indonesia. Those policy discussions can provide a springboard for action needed to ensure that quality is built in to medicine procurement, while the methods we develop will provide a blueprint for other countries facing similar challenges. We aim to support national efforts to ensure that Indonesians, especially the poorest who rely on
insurance or informal markets, have consistent access to quality medicine. We will do this by working
with the medicine regulator and intersectoral partners to better understand and quantify the prevalence
and distribution of substandard and falsified medecines nationally. In the process, we will:
1. Trial new methods for risk-based sentinel surveillance for substandard and falsified medecines.
2. Develop robust, adaptable tools to estimate the prevalence, health impact and cost of substandard and falsified medecines.
3. Pioneer the use of the tools, making the first national estimates of substandard and falsified medecines in any low and middle-income country (LMIC).
4. Engage continuously with policy partners to facilitate appropriate intersectoral responses in Indonesia, and to adapt tools for other LMICs.
5. Promote institutionalisation of academic-policy partnerships to support the ongoing production and use of medicine policy research in Indonesia.