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www.smh.com.au/business/companies/irr...‘Irreparable harm’: CSL clashes with US customs over Mexican donors
Emma Koehn
By Emma Koehn
November 1, 2021 — 12.01am
Local biotech giant CSL says a ban on Mexican plasma donors in the US could lead to a severe shortage of medicines, as it locks horns with the US Customs and Border Protection in court to overturn new rules which stop Mexican citizens from crossing the border to donate plasma.
CSL, valued at $137 billion, last month took the unusual step of partnering with rival plasma company Grifols to apply for an injunction against US Customs and Border Protection, prompting the agency to retort that the Australian company and its peers should offer US citizens more cash for donations instead of relying on foreign donors
Analysts and investors have been watching plasma collection volumes at companies like CSL closely throughout the pandemic as lockdowns affected collections.
Analysts and investors have been watching plasma collection volumes at companies like CSL closely throughout the pandemic as lockdowns affected collections. CREDIT:PAUL JEFFERS.
Plasma, which is the straw-coloured component of blood that holds proteins, is key to the creation of the specialist medicines that CSL and Grifols make. The companies collect donations in centres across the United States, where participants are offered around $US50 for their contributions.
Plasma collection volumes have been watched closely by investors over the past 18 months, with coronavirus shutdowns resulting in a drop in the volume of raw materials collected. CSL has confirmed it has had to increase the cash on offer to donors to entice them back to donate.
In June, new guidance from US Customs and Border Protection confirmed that Mexican citizens would no longer be able to cross the border to make donations.
Court documents seen by this masthead show that CSL and Grifols expect the cap on Mexican donors to make the task of recovering to pre-pandemic plasma collection levels more difficult. Donations from Mexico account for around five to 10 per cent of all plasma collected across the United States.
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“Such a disruption in plasma donations is especially critical now, when more plasma than ever is required to meet the growing need for plasma-based therapies, and when the United States is already suffering from a 20 per cent industry-wide drop in plasma donations due to the COVID-19 pandemic,” the companies said in their application for an injunction on the rules.
However, the US Customs and Border Protection agency has hit back hard in its defence documents, saying the US government has never had a formal policy on whether Mexican citizens could cross the border into the US to donate plasma.
The agency added that the B1 and B2 visas, used by many of the donors, are designed for short business stays that promote international commerce.
“Because selling plasma is a domestic fee-for-services transaction that takes place entirely in the United States, it lacks a nexus to international commerce, which is a defining feature of permissible B-1 visa activity,” it said.
With the agency’s formal guidance now preventing Mexican citizens from using the B1 or B2 visas to enter the US to give plasma, it has rejected the argument the policy would hurt the business interests of CSL and Grifols.
The agency has argued that the biotechs could increase their donor fees, so they are more attractive to US donors to cover the gap, but have not done so.
“Plaintiffs chose to offer compensation that is relatively unattractive to domestic plasma donors, and they are free to increase their rates to offset any drop in foreign donors,” it argued.
Back in August, CSL chief executive Paul Perreault said the pause in overseas donors also hurt border towns, which get significant economic activity from the passage of people across the border.
The application for an injunction against the ban was heard on October 20. A person with knowledge of the subject said the companies were awaiting a decision in the coming days.