When the choice is between poor quality drugs and no drugs at all


Poverty fuels the market for substandard drugs just as it fuels other instances of inequality. A socially integrated approach is needed to combat the problem.

“A patient wanted to buy antibiotics for a bruise. They want antibiotics even for the flu. Indonesian pharmacists have had alarming stories when researchers asked them about their experiences.

But the story gets even more alarming: 2021 to research shows that 70% of Indonesian pharmacies dispense antibiotics without a prescription. And many Indonesians who cannot afford proper health care buy prescription-only medicines, including antibiotics, from the informal sector to self-treatment.

In Indonesia, licensed pharmacies (which are different from pharmacies) often sell antibiotics, evading inspection by the authorities. The informal and formal sectors – licensed and unlicensed vendors, grocery stores and pharmacies – are intertwined. The Indonesian distribution channels because it is said that medicines are the most complicated in the world.

When prescription-only drugs are dispensed without a prescription in pharmacies, it seems that the regulations don’t work. When they are distributed by unlicensed sellers, it shows that there is a market beyond the reach of laws and regulations. Both are characteristic of a world in which poor quality medicines are prevalent. It remains to be seen whether the problem can be solved simply by tightening the regulations.

Substandard generic medicines are a major challenge for low- and middle-income countries in two ways. First, the widespread availability of low-quality antimalarials and antibiotics in these countries appears to be demand-driven: many consumers need these drugs. Second, the BRICS (Brazil, Russia, India, China and South Africa), an emerging group of low- and middle-income countries, need to develop their pharmaceutical business as an export industry.

A technological base is necessary to meet these two needs: to satisfy local demand and to succeed as an export industry. Standards are a central part of this foundation. Pharmaceutical efficacy and safety standards are driven by the need to protect human life. In other words, it is not possible to design pharmaceutical standards solely in terms of efficacy and convenience.

But the will to conform to the standards is not the same thing as reaching them. Cost is the main obstacle here. All stakeholders in a company must be motivated (encouraged) to comply with the applicable standards. Simply strengthening laws and regulations is not enough. The quality of medicines depends on a social system in which all stakeholders – including approval, manufacturing, distribution and marketing entities, as well as doctors and patients – receive appropriate incentives and benefits.

The public dispensary system in India is a social security system that benefits many poor people, but it is not a strong system in this regard. Officials were caught taking bribesand the negotiation process between suppliers and the government is a strong temptation for manufacturers of shorten productionmanufacturing low-quality drugs for greater profits.

By contrast, Japan’s public health service is a rare example of a system designed immediately after World War II that continues to function extremely well. The medical service provided under the universal health insurance system is equitable, reasonably inexpensive and of good quality for all. Providers and patients are strongly encouraged to use the services. For this reason, the problem of poor quality drugs in Japan is much less than in other countries.

Where standards are lax and incentives to meet them few, there is plenty of room for malicious criminals. Even legitimate providers can struggle to avoid the temptation to cut costs and deviate from standards and regulations. In this way, the market sees a mix of counterfeit products made by criminals and low-quality drugs made by legitimate vendors that do not meet specifications.

The World Health Organization (WHO) International Working Group on Combating Counterfeit Medical Products (IMPACT), established in 2006, defined and sought to eradicate counterfeit medicines, but remained silent on substandard ones. This has led to significant opposition from low- and middle-income countries.

Low- and middle-income countries consider counterfeit medicines to be different from substandard medicines. But the WHO definition does not clearly make this distinction and, internationally, the two types of poor quality drugs are confused. High-income countries like the United States and Germany supported IMPACT and sought to protect their intellectual property rights against emerging countries. This added to the backlash from low- and middle-income countries.

Intellectual property rights are the biggest barrier to converting new innovative drugs into generic drugs and adding them to the model list of essential medicines. Many of the drugs on the Model List are generic drugs, of which substandard drugs are common in low- and middle-income countries.

When IMPACT was created, antiretrovirals to treat HIV (AIDS) were the main candidates for inclusion in the Model List from a global public health perspective, but this challenged international human rights rules. intellectual property. The conflict between the two worlds – developed economies and developing economies – is evident here.

IMPACT lack because from the beginning, advanced economies and international organizations led the process, leaving aside the interests of a series of countries. The WHO needed to change course.

Tackling the proliferation of poor quality medicines is not just about strengthening pharmaceutical regulations, defining counterfeit medicines and making technical improvements. It is also a matter of international politics.

Public health policy must go beyond the quality of medicines and aim at the impoverishment of those who need them. Those who risk falling into poverty if they buy good quality drugs are forced to choose between poor quality drugs and no drugs at all. Paradoxically, even poor quality drugs can be a saving grace for many actors in the informal sector. At the same time, intellectual monopoly rights are not only the rights of a company or an industry, but also a source of economic growth for some countries.

Health care is a scarce economic resource, and countries around the world are struggling to correct the unequal distribution of this resource. But the situation is not structurally uniform in all countries, and their external considerations are even more individualized. The gap between the ideal objectives of regulation and the constraints of reality must be recognized.

The problem of poor quality medicines has the same source as the problem of economic inequality between people. It must be tackled at the same fundamental level.

Teacher Yasuhide Nakamura is Professor Emeritus of Osaka University, President of Friends of WHO Japan and Senior Professor at the National College of Nursing at the National Center for Global Health and Medicine in Japan.

He declares no conflict of interest in relation to this article.

Professor Nakamura thank you Doctor Satoru Kimura for his excellent work in adapting material from their book, Substandard Pharmaceuticals in Global Public Healthto become this article.

Image published under Creative Commons.

Originally published under Creative Commons by 360info™.

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