Technological change in the global supply chain is driving a new era of productivity and creativity with far-reaching implications for global development and security. However, beyond adopting new, non-binding frameworks, all countries must work together to manage new and emerging technologies, better leveraging their benefits while mitigating risks.
A recent UN report has referred to the current evolving cycle. Analyst Maximilian Malawistahas pointed out that medicines contaminated by toxic excipients used as solvents or antifreeze are resulting in multiple deaths and health complications. The contamination of pharmaceutical medicines through toxic excipients is killing many and harming others. The UN agencies for health, drugs and crime warn that systemic vulnerabilities in the global supply chain have been exploited to introduce industrial-grade toxic chemicals into medicines, harming thousands of people, including children.
On July 24, the United Nations Office on Drugs and Crime and the World Health Organisation released a 120-page report on the persistent but preventable threat of contaminated medicines that have claimed lives and compromised health. The report, titled "Contaminated Medicines and Integrity of the Pharmaceutical Excipients Supply Chain", reveals illegal substitutions of pharmaceutical-grade substances like glycerin, propylene glycol, and sorbitol with toxic excipients. Industrial-grade chemicals like diethylene glycol and ethylene glycol, typically used as solvents and antifreeze, can cause serious health issues, yet they are entering pharmaceutical supply chains.
Over the past few decades, twenty-five documented incidents have revealed over 1300 deaths worldwide. Over the past few decades, twenty-five documented incidents have caused over 1300 deaths worldwide, many of them children, due to excipient contamination. More recently, incidents in Gambia, Indonesia, and Uzbekistan resulted in 334 deaths and drew further attention to the issue, prompting more investigations. In the report, case studies have also found that some pharmaceutical manufacturers have been "quick to produce the medicine, as market demand has been very strong in some countries, outstripping the ability for oversight".
The first reported case was in 1937 in the United States, where DEG used as an excipient for sulfanilamide, killed 105 people. These once-considered anomalies have continued through 2022, with over 300 people in Africa dying in October of that year. The highest number of deaths from one case occurred in Bangladesh, where DEG used in Paracetamol syrup killed 339 people from 1990 to 1992.
The report also revealed that criminal networks exploit market volatility and regulatory gaps to introduce toxic excipients into the supply chain. This includes using falsified labels, substituting toxic chemicals for excipients, marketing falsified excipients online, lack of regulatory oversight, and inadequate coordination among regulators, law enforcement, and customs, which hinders timely investigations and prosecutions.
Experts have noted that to regulate the pharmaceutical supply chain for development, production, distribution, and inspection, principles known as GxP or cGxP are used to set guidelines. These systems are meant to ensure quality, safety, efficacy, and risk management across the supply chain. However, delays in certain areas can increase the risk of failure.
Observers have also noted that a main issue is the fact that excipient manufacturers are not subject to regulatory oversight. Nevertheless, WHO is now calling for an "appropriate" level of Good Manufacturing Practice (GMP) guidelines to be in place for the production, packaging, repackaging, labelling, quality control, release, storage, and distribution of excipients intended for pharmaceutical use.
So, there is a need for collaboration at all levels. This includes international organisations such as the WHO and UNODC, member states, regulatory authorities, criminal justice and law enforcement agencies, manufacturers, and excipient distributors, to take appropriate measures to prevent further harm. We must remember that a healthy life is better than death. Logical progress and the course of human history have advanced together; more recent technological innovations have emerged at unprecedented speed and reach, deeply influencing many areas of human activity.
Advances in artificial intelligence (AI) and machine learning, including neural networks, enable machines to process new information in real time. As federated learning becomes more widespread, machine learning models can collaborate without sharing sensitive data, enhancing privacy and security. These and other recent developments will find applications in sectors such as healthcare, where advanced algorithms can support personalised diagnosis and treatment.
New and emerging technologies, including nanotechnology and human enhancement, have implications for international peace, healthcare, and security.
With disruptive global forces creating new challenges, risks, and opportunities for development, security, and the global order, the need for effective tech-governance involving all countries through existing global institutions has never been more urgent.
In short, effective tech-governance would help countries employ common principles (including safety and transparency), codes of practice, and regulations to implement shared values and protect basic human rights, especially in healthcare and medicines. However, successful governance of new and emerging technologies globally will require the UN's 193 Member States to adopt new, non-binding frameworks and build on them by pursuing targeted innovations in global governance.
This sensitive situation in the health sector and pharmaceutical industry requires updated global governance tools and mechanisms to keep pace with technological advances. Benefits can then reach millions worldwide while also mitigating misuse of technology.
Muhammad Zamir, a former Ambassador is an analyst specialised in foreign affairs, right to information and good governance.
muhammadzamir0@gmail.com
