SF Pulse
Issue 2, May 2024
News Update
The Case for Letting African Experts Lead
Writing in the Daily Maverick, Lenias Hwenda, Farai Masekela and Wayne Muller reflect on the challenges African governments face in stemming the tide of falsified and substandard medicines flowing into their countries; in their piece, they also call on African leaders to be at the forefront of collectively implementing robust anti-SF programs:
African nations must develop a fit-for-purpose reliance framework that accounts for the continent’s unique challenges and ensures that all medicines, regardless of their origin, meet the highest standards of quality, safety and efficacy.
Development of such a framework cannot and should not be left to the World Health Organization or to any other international organisations only. This is a task that African regulatory experts with an in-depth understanding and experience of Africa’s unique challenges should lead.
Thankfully, just last month, a continental group was convened to help advance regulatory reform and harmonization efforts. As part of its remit, leaders from the newly formed First Continental Heads of Medicine Registration and Marketing Authorization Forum, an initiative of the AU’s NEPAD African Regulatory Harmonization Programme, will work with national regulatory authorities to standardize approval frameworks, which in turn will help improve overall safety and access.
On the Road with Interpol
Blogger Jennifer Huxta has just shared a fascinating recap of her time as a photographer embedded with an Interpol anti-counterfeiting unit in 2014. Huxta joined the Interpol team as they conducted their operation across six West African countries. She writes:
In the Grand Marché, in a covert warehouse at the end of a long and twisting corridor, we found a cache of fake Coartem. The investigators showed me the minuscule discrepancy in the packaging; it’s almost impossible for the untrained eye to tell the difference between legitimate and counterfeit boxes of this critical medicine. Pharmaceutical companies create ever more complex holograms and other distinguishing marks to prove the veracity of their products, but counterfeiters are becoming more adroit at copying this packaging for their fake drugs. “They can copy a hologram within a month,” a Kenyan investigator told me.
In the Inkstick post, Huxta blends some of the photographs she took during her journey with her own doodles and sketches to form a sort of linear, visual scrapbook narrative.
Understanding Counterfeit Purchasing Behavior
In a piece for Hopkins Bloomberg Public Health, Kellie Schmitt writes about BESAFE (Behavioral and Educational Strategies for Avoiding Falsified Medicine Exposure), a joint initiative run by Bloomberg School of Medicine and Pfizer, which aims to better understand why consumers evade regulations to access potentially dangerous substandard or falsified medicines.
Schmitt notes the initiative, which also helps educate patients about the risks associated with purchasing substandard drugs, will expanding in the coming years, with programs tailored to the unique challenges countries are facing.
Synthetic Opioid Wreaks Havoc Down Under
In Australia, federal authorities are sounding the alarm about the emergence of Nitazenes, a newer type of synthetic opioid associated with 20 overdose cases in western Sydney last month. Experts warn the drug, which is being illegally imported into the country, could lead to a further spike in overdose cases and deaths in the coming months.
And even more troubling is that fact that Nitazenes have been detected in counterfeit medicines entering the country, including pain medications and sleeping pills.
Penalties Commensurate with the Crime
The Editors of the Philippines’ Business Mirror call for the passage of HB 3894, which expands the number of criminalized counterfeiting offenses and strengthens overall penalties for selling falsified drugs:
One of the critical aspects of HB 3984 is its comprehensive definition of “counterfeit pharmaceutical products.” By including products that do not contain the claimed ingredients, possess the wrong ingredients, lack active ingredients, or have reduced efficacy due to expiration, the legislation covers a wide range of deceptive practices. This broad definition is crucial in countering the increasingly sophisticated methods used by counterfeiters.
The proposed administrative and criminal penalties outlined in the bill are essential for deterring counterfeiters and ensuring the integrity of the healthcare system. The fines and license revocations will hit counterfeiters where it hurts the most—their pockets. Additionally, the prison terms prescribed for those found guilty of counterfeiting, ranging from not less than six months and one day to 15 years, send a strong message that such crimes will not be taken lightly.
Rep. Brian Raymund Yamsuan, the bill’s sponsor, told the Manila Standard that existing laws were not sufficient for dealing with the spike in counterfeit drugs being sold nationwide.
Websites We Follow:
European Medicines Verification Organization
Information on the organization responsible for ensuring European patients are protected from falsified medicines
Interpol - Pharmaceutical Crime Operations
Details on how the international law enforcement agency tackles counterfeit medicines
Feeds We Follow:
@AshleighFurlong
Ashleigh Furlong
Bloomberg Health
Reporter who has recently covered SFs
@GPHF
Richard Jähnke
Global Pharma Health Fund
Non-profit focused on combatting SFs in LMICs
@ACNAfrica_Org
Anti Counterfeit Network Africa
Ugandan organization working to convene stakeholders to tackle counterfeits, including SFs
@FDAGhana
Ghanaian Food and Drug Authority
Agency feed sharing info on national efforts to combat SFs