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
Rich countries impose serialization and tracing requirements, but that only helps to keep the legitimate supply chain clean. Many countries Continue reading Sponsored: Anti-counterfeiting Successes and Failures Around the World
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One of the focuses of RxTrace is to explore global pharma serialization and tracing regulations in an attempt to discover some of their implications. Some implications turn out to be obvious, but some turn out to be surprising. Identifying the implications early provides us with a better understanding of what to expect from our investments in time to fine-tune those investments. If company leaders have a realistic understanding of what to expect from different investments, they will make better decisions for their stakeholders. Can they expect to be fully compliant? Only partly compliant, thus needing to spend more down the road? Will they be fully compliant with the law, but disappoint their primary customers and thus find that their business takes a hit? If they have a good idea of what to expect before they Continue reading Sponsored: Will Global Serialization Mandates Result In Less Counterfeiting?
While writing last Monday’s RxTrace essay I ran out of time before I could get to the point I originally intended to make, so here is the conclusion to my thoughts on the topic.
The point I wanted to make is that there is a big difference between the goal of serialization and that of most other anti-counterfeiting technologies. Most anti-counterfeiting technologies covered in Mark Davison’s essential book on the topic, “Pharmaceutical Anti-Counterfeiting, Combating the Real Danger from Fake Drugs“, are technologies that a given manufacturer chooses to place in or on their drug, or on their drug’s packaging so that they can later differentiate it from potential counterfeit versions. That is, so that they can later “authenticate” only the drugs that they truly manufactured.
The decision a given manufacturer makes about which anti-counterfeiting technology(ies), if any, to use for a given drug for a given market is Continue reading The Different Goals of Anti-Counterfeiting Technologies and Serialization
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.
Last Thursday a bipartisan group of U.S. Senators and Representatives jointly introduced a bicameral bill that would significantly increase the criminal penalties for drug counterfeiting to as much as 20 years in prison, as reported by Phil Taylor in SecuringPharma (see the article for the details). The house bill is called H. R. 3468, The Counterfeit Drug Penalty Enhancement Act. The group of legislators include U.S. Senators Patrick Leahy (D-VT), Chuck Grassley (R-IA), Michael Bennet (D-CO), and Richard Blumenthal (D-CT) and U.S. Representatives Patrick Meehan (R-PA) and Linda Sánchez (D-CA). Not surprisingly the responses from the Pharmaceutical Research and Manufacturers of America (PhRMA) and Pfizer were swift and supportive.
Raising the penalties for counterfeiting drugs to the point where they adequately reflect the widespread harm they can cause the public is a very good thing. It should have the effect of making people think twice about selling counterfeit drugs to Americans through the internet or attempting to introduce them into the legitimate supply chain (brick-and-mortar and legitimate internet pharmacies). It may even cause more people in the legitimate supply chain to Continue reading STEP #1: Raise Penalties For Drug Crimes To Reflect The Widespread Harm They Can Inflict