An estimated 1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified, according to new research from WHO.
This means that people are taking medicines that fail to treat or prevent disease. Not only is this a waste of money for individuals and health systems that purchase these products, but substandard or falsified medical products can cause serious illness or even death.
“Substandard and falsified medicines particularly affect the most vulnerable communities,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Imagine a mother who gives up food or other basic needs to pay for her child’s treatment, unaware that the medicines are substandard or falsified, and then that treatment causes her child to die. This is unacceptable. Countries have agreed on measures at the global level – it is time to translate them into tangible action.”
Since 2013, WHO has received 1500 reports of cases of substandard or falsified products. Of these, antimalarials and antibiotics are the most commonly reported. Most of the reports (42%) come from the WHO African Region, 21% from the WHO Region of the Americas, and 21% from the WHO European Region.
This is likely just a small fraction of the total problem and many cases may be going unreported. For example, only 8% of reports of substandard or falsified products to WHO came from the WHO Western Pacific Region, 6% from the WHO Eastern Mediterranean Region, and just 2% from the WHO South-East Asia Region.
“Many of these products, like antibiotics, are vital for people’s survival and wellbeing,” says Dr Mariângela Simão, Assistant Director-General for Access to Medicines, Vaccines and Pharmaceuticals at WHO. “Substandard or falsified medicines not only have a tragic impact on individual patients and their families, but also are a threat to antimicrobial resistance, adding to the worrying trend of medicines losing their power to treat”.
Prior to 2013, there was no global reporting of this information. Since WHO established the Global Surveillance and Monitoring System for substandard and falsified products, many countries are now active in reporting suspicious medicines, vaccines and medical devices. WHO has trained 550 regulators from 141 countries to detect and respond to this issue. As more people are trained, more cases are reported to WHO.
WHO has received reports of substandard or falsified medical products ranging from cancer treatment to contraception. They are not confined to high-value medicines or well-known brand names and are split almost evenly between generic and patented products.
In conjunction with the first report from the Global Surveillance and Monitoring System published today, WHO is publishing research that estimates a 10.5% failure rate in all medical products used in low- and middle-income countries.
This study was based on more than 100 published research papers on medicine quality surveys done in 88 low- and middle-income countries involving 48 000 samples of medicines. Lack of accurate data means that these estimates are just an indication of the scale of the problem. More research is needed to more accurately estimate the threat posed by substandard and falsified medical products.
Based on 10% estimates of substandard and falsified medicines, a modelling exercise developed by the University of Edinburgh estimates that 72 000 to 169 000 children may be dying each year from pneumonia due to substandard and falsified antibiotics. A second model done by the London School of Hygiene and Tropical Medicine estimates that 116 000 (64 000 – 158 000) additional deaths from malaria could be caused every year by substandard and falsified antimalarials in sub-Saharan Africa, with a cost of US$ 38.5 million (21.4 million – 52.4 million) to patients and health providers for further care due to failure of treatment.
Substandard medical products reach patients when the tools and technical capacity to enforce quality standards in manufacturing, supply and distribution are limited. Falsified products, on the other hand, tend to circulate where inadequate regulation and governance are compounded by unethical practice by wholesalers, distributors, retailers and health care workers. A high proportion of cases reported to WHO occur in countries with constrained access to medical products.
Modern purchasing models such as online pharmacies can easily circumvent regulatory oversight. These are especially popular in high-income countries, but more research is needed to determine the proportion and impact of sales of substandard or falsified medical products.
Globalization is making it harder to regulate medical products. Many falsifiers manufacture and print packaging in different countries, shipping components to a final destination where they are assembled and distributed. Sometimes, offshore companies and bank accounts have been used to facilitate the sale of falsified medicines.
“The bottom line is that this is a global problem,” says Dr Simão. “Countries need to assess the extent of the problem at home and cooperate regionally and globally to prevent the traffic of these products and improve detection and response.”
Insecurity and bureaucracy hampering aid to Ethiopia’s Tigray region
Nearly three months after the start of conflict in Ethiopia’s Tigray region, hundreds of thousands of people have yet to receive assistance, the United Nations reported on Wednesday, citing information from its humanitarian coordination agency, OCHA.
“Humanitarian assistance continues to be constrained by the lack of full, and safe, unhindered access to Tigray, caused by both insecurity and bureaucratic delays”, UN Spokesperson Stéphane Dujarric told journalists.
“The UN and its humanitarian partners in Ethiopia urgently call on all parties to allow the immediate safe passage of humanitarian personnel and their supplies to the Tigray Region to be able to reach all people who desperately need assistance.”
Over two million in need
Mr. Dujarric said the UN continues to receive alarming reports of civilians being injured and killed in rural areas in Tigray, as well as of violations against civilians, though verification remains a challenge.
“Aid workers have been able to deliver assistance in some areas, mainly in cities, where access has been granted by the authorities. However, the number of people reached is extremely low compared to the 2.3 million people we estimate are in need of life-saving assistance”, he said.
The situation is particularly critical for newly displaced people and refugees, especially those who were living in two camps that remain inaccessible, according to OCHA.
Humanitarians further warn that the majority of the 270,000 people receiving benefits through the Government’s Safety Net Programme have also been without assistance as banks in most rural areas have been closed since before the crisis began.
“These are extremely vulnerable people who rely on monthly cash transfers to meet their basic needs,” said Mr. Dujarric.
Mali transition presents opportunity to break ‘vicious circle of political crises’
The current political transition period in Mali offers an opportunity to “break out of the vicious circle of political crises followed by coups d’état”, the UN envoy in the country told the Security Council on Wednesday.
Following the 18 August mutiny that ousted President Ibrahim Boubacar Keïta, Special Representative and Head of the UN Stabilization Mission in Mali (MINUSMA) Mahamat Saleh Annadif, said the country was now four months in, to a planned 18-month transition period, leading to presidential and legislative elections.
“However, it is never too late to reach a minimum consensus on the essentials of peace and stability, because the future of Mali is at stake”, he stated.
Against this backdrop, Mr. Annadif said the UN, African Union, Economic Community of West African States (ECOWAS) and others have always stood ready to support Mali’s institutional transitions.
He said that several missions and meetings had taken place in Bamako since the August coup and described consultations between the Government and the signatories of the 2015 Agreement on Peace and Reconciliation “encouraging”.
The Malian Government has been seeking to restore stability and rebuild following a series of setbacks since early 2012 that fractured the country, including a failed coup d’état, renewed fighting between Government forces and Tuareg rebels, and the seizure of its northern territory by radical extremists. The weakening of central institutions, loss of confidence in political actors and the rise of religious leaders demanding change, were among the factors leading up to last August’s events.
As one positive example of political progress being made, the UN envoy drew particular attention to the “positive dynamics” of key officials who visited the restive city of Kidal to organize a “solemn swearing-in hearing of the new Governor” on 31 December, flagging that “such an event has not taken place in Kidal for almost ten years”.
Interim parliament at helm
Mr. Annadif said that despite a hold up in State appointments, the National Transitional Council (CNT) had been established on 3 December, with Transitional President Bah N’Daou having appointed 121 members who are now acting as a de facto government towards restoring full constitutional order.
Serving as an interim parliament that will vote on political, institutional, electoral and administrative reforms, the UN envoy called their role “crucial for the consolidation of democracy and the success of credible elections allowing a return to constitutional order, as provided for in the Transition Charter”.
Successes and challenges
While pointing to “successes” of the international force, the MINUSMA chief acknowledged that security in border areas of Mali – which remains the deadliest UN peacekeeping mission of all – and in the country’s centre, remains “worrying and unpredictable”.
However, he said that MINUSMA continues to “adapt” to these multifaceted challenges and “strengthen its capacity” to better respond.
Moreover, the missions “adaptation plan” to better protect civilians and promote community reconciliation in central Mali is producing “significant results” with additional temporary bases and the intensification of dedicated joint patrols “to advance the reconciliation processes between communities in local conflict zones”, said Mr. Annadif.
The MINUSMA head lauded the efforts of Malian forces to improve their rights performance and underscored that reforms are a key dimension in ensuring the legitimacy of the next elected government.
He reassured the Ambassadors that the foundation has been laid for a successful political transition in the country as well as reliable security arrangements for its diverse regions.
However, he stressed that the transition’s success depends upon “the successful completion of political, institutional, electoral and administrative reforms with the aim of inclusive, credible elections, the results of which will be accepted by the majority of Malians and Malians”.
UNICEF: Closing schools should be ‘measure of last resort’
The head of the UN Children’s Fund (UNICEF) underscored on Tuesday that “no effort should be spared” to keep children in school, as the coronavirus pandemic continues into a second year.
“Despite overwhelming evidence of the impact of school closures on children, and despite increasing evidence that schools are not drivers of the pandemic, too many countries have opted to keep schools closed, some for nearly a year”, Henrietta Fore said in a statement.
A high cost
The UNICEF chief highlighted that the cost of closing schools has been devastating, with 90 per cent of students globally facing shutdowns at the peak of the COVID disruptions last year, leaving more than a third of schoolchildren with no access to remote education.
“The number of out-of-school children is set to increase by 24 million, to a level we have not seen in years and have fought so hard to overcome”, she said.
“Children’s ability to read, write and do basic math has suffered, and the skills they need to thrive in the 21st century economy have diminished”, Ms. Fore added.
Closure a ‘last resort’
Keeping children at home puts their health, development, safety and well-being at risk – with the most vulnerable bearing the heaviest brunt, she said.
She pointed out that without school meals, children are “left hungry and their nutrition is worsening”; without daily peer interactions and less mobility, they are “losing physical fitness and showing signs of mental distress”; and without the safety net that school often provides, they are “more vulnerable to abuse, child marriage and child labour”.
“That’s why closing schools must be a measure of last resort, after all other options have been considered”, stressed the top UNICEF official.
Evaluating local transmission
Assessing transmission risks at the local level should be “a key determinant” in decisions on school operations, Ms. Fore said.
She also flagged that nationwide school closures be avoided, whenever possible.
“Where there are high levels of community transmission, where health systems are under extreme pressure and where closing schools is deemed inevitable, safeguarding measures must be put in place”, maintained the UNICEF chief.
Moreover, it is important that children who are at risk of violence in their homes, who are reliant upon school meals and whose parents are essential workers, continue their education in classrooms.
After lockdown restrictions are lifted, she said that schools must be among the first to reopen and catch-up classes should be prioritized to keep children who were unable to learn remotely from being left behind.
“If children are faced with another year of school closures, the effects will be felt for generations to come”, said Ms. Fore.
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