News Update
Shorting Counterfeits
In a post for the UBS Asset Management blog, Senior Portfolio Manager Richard Kolb argues the investments his organization makes in anti-counterfeiting companies are aligned with the financial services provider’s core values:
“Fake drugs threaten people’s health and wellbeing....[and] can pose a health hazard to the entire society. But with every challenge comes an opportunity: we believe the health prevention theme within our safety & security offering is a compelling investment opportunity. Consequently, we are invested in leading companies that provide solutions needed to mitigate the risks of counterfeit medicines, for example in the field of track-and-trace technologies or drug analytics.”
Kolb's writeup is a clear reminder that all sectors and industries have a role to play in curbing the harms of substandard and falsified medicines.
The Epicenter of the Track & Trace Revolution
The Medicine Maker has a fascinating Q&A with Alf Goebel, CEO of Advanco, a leading track and trace technology provider. In the piece, Goebel explains why the Asia Pacific region has embraced these tools as a method for combatting counterfeiting:
“Governments across the world are understanding that track and trace is one of the most effective methods to provide a guarantee to consumers that a particular medicine is genuine. We are now seeing mandatory regulations evolving in APAC, with India, China, and South Korea already having them in place; Indonesia and Malaysia are expected very soon, and other countries are working on their strategies. Increasing demand for serialization solutions worldwide and the emergence of Singapore as a pharmaceutical research and development hub are important factors in their own right that influenced our decision to expand in the APAC region.”
Identifying Key Enablers: New FTFA White Paper
Our very own Fight the Fakes Alliance just released a new white paper that explores key enablers in the ongoing fight against substandard and falsified medicines. Here’s a quick excerpt:
Actions against SFs require the cooperation of various stakeholders, including policymakers, healthcare professionals, international organizations but also academia, the public, and civil society.
The need for education and awareness among policymakers, healthcare providers, the public, and private sector must remain a priority and a necessary foundation in the fight against SFs. Enhanced training for law enforcement authorities, but also health professionals is essential to improve the detection of SFs and enforcement capabilities more broadly.
You can read the full report off our website here.
Demand-Side Challenges
Writing for Swiss Info, Jessica David Pluss and Pauline Turban take a closer look at the multitude of factors driving ongoing demand for counterfeit medicines:
“Fake medicines are still widely available, especially in developing countries that don’t have the infrastructure or funding to carry out the kind of checks that are now standard procedure in Europe. Sky-high prices and a growing shortage of many drugs and medical supplies are compounding the problem. While the pandemic is over, factors including trade barriers, manufacturing problems and the war in Ukraine have perpetuated shortages nearly everywhere.
Prices for some new drugs are also so high that insurance providers have refused to reimburse them, leading patients to look for alternative suppliers. The rise of online pharmacies has made it much ‘easier for counterfeit medications to reach consumers’, said Mario Ottiglio, a spokesperson for Fight the Fakes, an alliance of organizations raising awareness of falsified medicine.”
The story also features an in-depth look at some of the measures European regulators have taken in recent years to protect patients from the perils of counterfeit drugs.
The Compounding Threat
Katherin Eban offers an incredibly detailed peek at seedy underworld of counterfeit weight loss drugs. In addition to covering the major challenges regulators must confront, Eban also surfaces the issue of drug compounding:
“A less obvious risk arises from the proliferation of ‘compounded’ versions of GLP-1 drugs of uneven quality. State-licensed compounders…serve as an important stopgap in the US drug supply, and are allowed to make small amounts of commercially available medicines that are in short supply under certain conditions. But their products don’t undergo the same testing and scrutiny as FDA-approved drugs.”
In 2022, the FDA placed both Ozempic and Wegovy on its shortage list, enabling compounders to ramp up production. The result has been a quality control disaster. Some compounders are seeking out active ingredients from unregistered foreign sources who evade customs review by shipping their wares inside cat food bags or rolled-up rugs, says an attorney and former FDA official with expertise in compounding.”
Eban goes on to explain the devastating impact these drugs have had on patients:
Between February 2019 and December 2023, 352 reports of adverse events from compounded GLP-1 drugs rolled into the FDA, most submitted by patients and health care providers. Four people died, and many others suffered life-threatening reactions. One woman, who had obesity but was otherwise healthy, died suddenly from blood clots the day after injecting a dose of compounded semaglutide. The report submitted to the FDA says that a nurse practitioner felt the death was “possibly related” to the use of compounded semaglutide, due to the “proximity of product use.”
New Technologies to Combat Counterfeiting
Several articles this past month dig in to some emerging innovations that are improving traceability across the counterfeit medicines supply chain. In a paid piece in the Pharmaceutical Times, US-based startup Micro-Tracers Inc. touts the benefits of using on-dose authentication tools:
“Given the current limitations of tracking systems and packaging solutions, the pharmaceutical industry must consider on-dose authentication. One effective method involves the use of tracers or taggants, also known as physical chemical identifiers (PCIDs), which do not alter the drug’s identity, strength, quality, purity, potency, or bioavailability. Examples of PCIDs include inks, pigments, flavors, and molecular taggants, which can be incorporated into or on the coating of solid oral dosage form drugs. The presence or absence of the desired PCID allows for verification of a drug’s authenticity.”
And in a post for eHealth, Manoj Kochar, President of the Authentication Solution Providers’ Association, argues that deploying a range of technologies will be critical to successfully counteracting counterfeiters:
Pharmaceutical companies must leverage a multi-faceted approach that integrates both physical and digital authentication measures. One promising strategy is the “phygital” approach, which seamlessly combines tangible features such as holograms, security printing, and nano-engraving with digital technologies like RFID, QR codes, and blockchain. Holograms, in particular, have emerged as one of the most effective physical authentication technologies, offering multi-dimensional, eye-catching security features that are not only difficult to replicate but also provide a user-friendly means for consumers to verify a product’s authenticity quickly and easily.
Looking Beyond the Cartels
InSight Crime writer Marley Markham argues the DEA’s most recent ‘National Drug Threat Assessment’ – which primarily lays blame for the fentanyl crisis at the feet of two Mexican drug cartels – misses the mark.
[The DEA] analysis overlooks the complex nature and other operators in the fentanyl industry, as well as the vast global supply network behind the drug’s production, transportation, and distribution.
Mexican cartels are only one piece of a much larger, more nuanced network behind the production, transportation, and distribution of illicit fentanyl. As highlighted by InSight Crime in previous investigations, the fentanyl industry relies on a multi-layered global industry of legal and illegal actors.
Websites We Follow:
International Society of Pharmacovigilance
Scientific NGO working to promote safe medicine use around the world
CADCA
Global NGO supporting a coalition model to tackle substance misuse; provides resources and trainings to organizations to create safer, drug-free communities
European Alliance for Access to Safe Medicine
Leading cross-sectoral organization focused on protecting European consumers, including through bolstering medicines supply chain
Feeds We Follow:
Medicines for Africa
@MedicinesforAfrica
African non-profit organization working on drug safety and access
Magnus Ekelo
@MagnusEkelo
Pharmacovigilance specialist at Uppsala Monitoring Centre
Adebayo Alonge
@adebayoalonge
Innovator; CEO of RxAll, anticounterfeiting health-tech startup
USAID MTaPS Program
MTaPS_Program
USAID initiative focused on Pharmaceutical Systems Strengthening and facilitating access to safe, affordable medicines in LMICs