Late last month the World Health Organization (WHO) published a draft “policy brief” for comments by February 28, 2020. The draft is aimed at regulators of medicines around the world who might be considering the development of new medicines traceability mandates. That pool of countries shrinks each year as more and more new mandates are announced, but considering the wide variations in the quality of the existing regulations, guidance aimed at those who would create new mandates is welcome. Let’s take a look at the draft.Continue reading WHO Publishes Draft Policy Brief for Medicines Traceability Regulations
Counterfeiting of drugs has become a favorite activity of organized criminals and it negatively impacts the citizens of every country in the world. The pharma industry is multi-national, the criminals are multi-national, the patients that are harmed are multi-national. What we need now more than ever before is a multi-national approach to fighting these crimes.
That’s why I was deeply disappointed last week to read that the World Health Organization (WHO) has barred a group of people with certain global crime fighting ideas from participating in their “member state” meeting on substandard/spurious/falsely-labelled/falsified/counterfeit medical products being held today through Wednesday in Buenos Aires, Argentina. See the Reuters article “Row flares over global fight against fake medicine” and see Roger Bate’s introduction to the group’s position “How to achieve international action on falsified and substandard medicines” and don’t miss the full PDF containing the group’s well-stated position.
There was a flurry of discussion last week over a recent Wall Street Journal blog by their “Numbers Guy”, Carl Bialik, regarding the often quoted “estimate” that 10% of drugs worldwide are counterfeit. On September 10, Bialik posted an essay titled, “Dubious Origins for Drugs, and Stats About Them“. The next day he published an article on the topic called “Counterfeit Drug Count Is Tough to Swallow“. Both essays call into question the origins and the accuracy of the “estimate”. On September 13, Dr. Adam Fein posted an essay titled, “The Counterfeit Counterfeit Drug Count” on his DrugChannels blog, citing the WSJ essays and providing some additional insight.
Don’t miss the many comments left by readers of Bialik and Fein’s postings. It’s surprising how Continue reading Stop Claiming that 10% of Drugs Worldwide are Counterfeit