Do laws hindering umbrella-wielding assassins also hurt Pharma?
The call for comment – which was issued in the Federal Register today – is an annual request intended to assess what impact, if any, the Chemical Weapons Convention (CWC) has had on industry in the past 12 months.
When the US ratified the CWC in 1997 it stipulated that the President must certify “legitimate commercial activities and interests of chemical, biotechnology, and pharmaceutical firms in the United States are not being significantly harmed by the limitations of the Convention.”
In 2004, President George W Bush delegated responsibility for making this assessment to the US Department of Commerce’s Bureau of Industry and Security, which has conducted a survey every year since.
The focus is on chemicals classified as “Schedule 1,” which countries that have ratified the convention are only allowed to produce for “protective purposes” in limited quantities at a maximum of two manufacturing facilities.
Dual use chemicals
The problem is that, in addition to being used to make weapons, some Schedule 1 chemicals are used in medicines.
For example, the mustard gas chemical Bis (2-chloroethyl) methylamine is also component of the chemotherapy agent Mustargen, which is sold by Recordati Rare Diseases, the US division of Italian drug and specialty chemical firm Recordati, and produced by Baxter’s oncology unit in Germany.
Recordati decline to comment. A spokeswoman for Baxter told in-Pharmatechnologist.com that: "We have not experienced any disruption in supply of materials we use in production."
The plant-derived poison ricin which, has been implicated in several murders - notably the assassination of Georgi Markov in 1978 - is also on the Scedule 1 list. Like Bis (2-chloroethyl) methylamine, Ricin also has potential therapeutic application, specifically as a cancer treatment.
Another Schedule 1 mustard gas variant, HN3 is also currently being examined as a potential treatment for non-hodgkin's lymphoma.
No ban
The US does not impose any limitations on the production of “Schedule 1” chemicals for non-military applications. However, the Department of Defense (DoD) is tasked with monitoring production.
In addition, the BIS inspects sites where “Schedule 1” chemicals are made for legitimate purposes and prohibits their export to countries that have not ratified the treaty.
Member of industry wishing to comment are invited to contact Williard Fisher via email. The comment period is open for 30 days.
