Monitoring Framework for Medicine Wholesalers (AF0026)
Action Plan: Afghanistan Action Plan 2019-2021
Action Plan Cycle: 2019
Lead Institution: The Ministry of Public Health (MoPH)
Support Institution(s): Relevant civil society organizations
Policy AreasE-Government, Health, Local Commitments, Public Participation, Public Service Delivery
What is the public problem that the commitment will address?
Existence of open borders with neighboring countries, illicit imports, smuggling of medicines, corruption in customs department, insufficient monitoring on medicine markets and low literacy rate among public caused that expired medicines in some cases can be at the disposal of public and patients in the market.
Lack of appropriate storage condition for some medicines is another major challenge in the medicine market of Afghanistan which requires special temperature, humidity and other special conditions. Failure to comply with medicines’ storage conditions can result to amputation of curative nature of medicine in many cases, adverse medication effects on the health of consumer.
What is the commitment?
To address this problem, MoPH is committed to conducting regular monitoring of the medicine`s market in partnership with civil society. MoPH will not only limit its activities to the collection and dumping of expired medicines, but it will also monitor the storage conditions of medicines in wholesale stocks and pharmacies. All expired medicines and the medicines stored in non-standard conditions have to be collected and dumped. In addition, it shall make wholesalers and pharmaceutical companies provide standard conditions for standard storage of the pharmaceutics.
How will the commitment contribute to solving the public problem?
Strict market monitoring can improve the storage conditions of medicines and prevent the supply of substandard and expired medicines. Serious scrutiny of the pharmaceutical market, collection and disposal of poor quality medicines will force all market actors to respect and adhere to the principles and regulations of MoPH for pharmaceutical market.
Why is this commitment relevant to OGP values?
This commitment is related to accountability and CSOs scrutiny from medicine market ensures civic participation.
National Health Policy
National Health Strategy.
IRM Midterm Status Summary
13. Prepare Monitoring Framework for Medicine Retailers and Wholesalers to Stack Up Expired Medicine in Partnership with CSOs
To address this problem, MOPH is committed to conducting regular monitoring of the medicine`s market in partnership with civil society. MOPH will not only limit its activities to the collection and dumping of expired medicines, but it will also monitor the storage conditions of medicines in wholesale stocks and pharmacies. All expired medicines and the medicines stored in non-standard conditions have to be collected and dumped. In addition, it shall make wholesalers and pharmaceutical companies provide standard conditions for standard storage of the pharmaceutics.
Strict market monitoring can improve the storage conditions of medicines and prevent the supply of substandard and expired medicines. Serious scrutiny of the pharmaceutical market, collection and disposal of poor-quality medicines will force all market actors to respect and adhere to the principles and regulations of MOPH for pharmaceutical market.
- Form a joint working committee of experts from Ministry of Public Health and CSOs to prepare and finalize a monitoring checklist for pharmacies, medicine stocks, and develop a database for continual scrutiny and follow up of pharmacies and stocks whose monitoring is completed.
- Monitoring of stock of 15 wholesale stocks and 30 pharmacies in one quarter also the collection and dumping of expired medicines as well as monitoring of standard conditions for storing temperature-sensitive medicines at the pharmaceutical market in Kabul.
- Monitoring of stock of 15 wholesale stocks and 30 pharmacies in one quarter also the collection and dumping of expired medicines as well as monitoring of standard conditions for storing temperature-sensitive medicines at the pharmaceutical market in Herat.
- Monitoring of stock of 15 wholesale stocks and 30 pharmacies in one quarter also the collection and dumping of expired medicines as well as monitoring of standard conditions for storing temperature-sensitive medicines at the pharmaceutical market in Nangarhar.
- Monitoring of stock of 15 wholesale stocks and 30 pharmacies in one quarter also the collection and dumping of expired medicines as well as monitoring of standard conditions for storing temperature-sensitive medicines at the pharmaceutical market in Kandahar.
- Monitoring of stock of 15 wholesale stocks and 30 pharmacies in one quarter also the collection and dumping of expired medicines as well as monitoring of standard conditions for storing temperature-sensitive medicines at the pharmaceutical market in Balkh.
- Prepare a comprehensive report, present specific recommendations for continuous monitoring, present challenges/lessons learned of performed monitoring, and share findings with public through photos, video and statistics.
Editorial Note: For the complete text of this commitment, please see Afghanistan’s action plan at https://www.opengovpartnership.org/wp-content/uploads/2020/01/Afghanistan_Action-Plan_2019-2021_EN.pdf.
IRM Design Report Assessment
Access to Information, Civic Participation
This commitment aims to curb the circulation of substandard and/or expired medicines, often channeled to market through illicit imports or smuggling, and compounded by corruption in the customs department. Many pharmaceutical and wholesale stores also do not have standard or appropriate storage facilities for medicines, and there is currently insufficient monitoring from the authorities in this regard. The Ministry of Public Health will lead the implementation of this commitment, in collaboration with civil society stakeholders.
Afghanistan has a relaxed border policy with neighboring countries such as Pakistan, from where 95 percent of pharmaceutical products originate.  Afghanistan has around 13,500 pharmaceutical and wholesale stores across the country.  The fluid border policy has led to more trade but has also created space for illicit activities, including the smuggling of medicines and the trade of substandard and expired medicines. At the same time, many vendors in Afghanistan do not have the appropriate facilities to store medicines, which are often affected by temperature, humidity, and other storage conditions.
The National Medicines and Healthcare Products Regulatory Authority, established in 2016, ensures the availability of safe medicine at fair prices in the market. It also manages and controls the production, import, delivery, and distribution of medicines.  In 2018 alone, the authority disposed of 70 tons of substandard, expired medicines found in the market—a significant increase from the 62 tons disposed of in 2017.  The overall process of inspecting, collecting, dumping, and disposing of bad and expired medicines from the market follows the protocols set by multiple regulatory frameworks. Such frameworks include the National Policy for Waste Management and Safe Disposal of Pharmaceutical Products,  the National Pharmacovigilance Policy,  and the Law on Medicine.  A draft Law on Safe Disposal of Medicine has also been in development since 2013. 
According to the Ministry of Public Health, between 50 and 60 percent of wholesale medicine stocks in Afghanistan are not stored in proper conditions.  Even in Kabul, almost no pharmaceutical store complies with standard conditions, which comprise controlled humidity and temperature; availability of ventilation, standard coolers, and fridges; and prevention of direct exposure to sunlight.  Cross-border transportation of medicines exacerbates the problem, as most transporters do not follow the protocol to keep the medicines away from direct sunlight exposure.  This means that medicines are likely in bad or unsafe condition before they even make it to the stores.
This commitment aims to address these problems by conducting regular monitoring of medicines sold in the market. In doing so, the ministry would not only be inspecting for expired medicines, but also continuously monitoring the quality of storage facilities in pharmaceutical and wholesale stores. This is in line with the National Medicines Policy,  which outlines Afghanistan’s general policy on regulating the pharmaceutical industry. Implemented over a five-year period, the 2014–2019 National Medicines Policy focuses on ensuring the availability and accessibility of safe, efficacious, cost-effective, good quality, and affordable medicines.  It also aims to strengthen the quality assurance system to guarantee the safety and efficacy of medicines in the market. 
In implementing this commitment, the Ministry of Public Health will form a joint working committee to supervise and monitor the regulation of the pharmaceutical sector. Civil society organizations will play a role, especially in capturing and reflecting feedback from citizens,  which can then inform decision-making processes. The committee will focus on monitoring and inspecting pharmacies in Kabul, Herat, Nangarhar, Kandahar, and Balkh. At the end of the implementation period, the committee will deliver an implementation report with recommendations, lessons learned, and evidence collected through the joint monitoring process.
This commitment is relevant to the OGP values of access to information and civic participation. It aims to institutionalize the participation of civil society stakeholders in the monitoring of medicines in the market.
If fully implemented as written, this commitment is expected to result in a minor potential impact on the quality and reliability of medicines in circulation across the public health service. While many pharmaceutical laws and regulations exist, there are major gaps in their implementation. Civil society participation could make a positive contribution to addressing these gaps. However, the commitment, as written, will provide an opportunity for civil society stakeholders to be part of a committee and provide input to the ministry in relation to monitoring and inspecting the quality of medicine in the five selected cities. The commitment does not directly address the critical problem of corruption in the health procurement process.  It also does not address the lack of accountability in this process,  as reiterated by civil society stakeholders during interviews for this report.
Currently, the Ministry of Public Health conducts regular quality control checks of wholesale medicine stocks and checks their quality against a standard checklist.  Any medicines that are of bad quality, or that have expired, will then be dumped safely.  This process is carried out entirely by the ministry, amid constant public criticism over the circulation of low-quality medicines in the market. In other words, there are currently no accountability mechanisms to allow civil society or citizens to monitor the government’s efforts to keep poor-quality medicines off the market.
Apart from circulation of expired or poor-quality medicines, the lack of independent oversight leaves the pharmaceutical sector highly vulnerable to corruption.  Civil society stakeholders allege that corruption extends from the customs officers at the border to the regulatory body at the Ministry of Public Health.  The Independent Joint Anti-Corruption Monitoring and Evaluation Committee has reported similar findings.  Specifically, in assessing the vulnerability and capacity of the pharmaceutical importation process, the committee found that illegally imported products make up at least 50 percent of Afghanistan’s pharmaceutical import market—at a value of around 700–800 million USD. 
It is also relevant to note that significant dumping of medicines is already occurring, so there are existing efforts to address the issue of expired medicines being circulated in the market. However, the dumping of tons expired medicines—particularly in the context of essential medicines being in short supply—points to a broader concern in the medicines system that this commitment also does not adequately address.
Going forward, the government is encouraged to pursue broad, sustainable reform of the medicines system, to ensure that the critical issues that hamper the quality and availability of medicines are addressed, beyond controlling the circulation of expired medicine. The Ministry of Public Health could, for instance, consider enlisting civil society participation to identify the gaps in existing regulations that have led to low compliance with storage facility standards among pharmaceutical and wholesale stores. This is important, as this commitment goal to constantly inspect market stocks would exhaust both the ministry’s and civil society’s resources in the long run. Given that the pharmaceutical industry is essential to public health, it is important to think of solutions that could impact the industry in a sustainable way.
During the co-creation of the action plan, civil society stakeholders also raised concerns over the lack of accountability in the government’s health procurement process.  However, this issue was not included in the scope of the final commitment. Therefore, in future action plans, the government could also consider exploring opportunities for citizens and civil society to play a central role in monitoring the healthcare procurement system and overseeing pharmaceutical licenses. Civil society could, for instance, help the government identify issues with the healthcare procurement system and/or help provide a basis for firm action against unlicensed pharmacies. The latter measure would be in line with data reported by the Ministry of Public Health in 2017. That data showed an overwhelming gap between the number of pharmacies in Afghanistan (14,000) and the number of pharmacists or drug specialists (4,000). 
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