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Mexican border issue

About 15 years ago that the owner of one of the manufacturers of plasma derived medicinal products wrote me a letter and asked me to personally close the plasma collection centers along the Mexican border in the USA. Mexican citizens who were in the possession of an US issued Visa, were able to cross the border and donate their plasma and received a compensation for it. The reasons for the letter were not very clear since that company had no centers in that area. A copy of that letter was sent to the regulatory authority FDA and several patient organizations. Obviously, they raised questions that I had to answer.

I did not have the authority to make such a decision, but more importantly I wanted to have a good understanding of the practices in these centers before arriving at any conclusion. I decided to do a few things:

  • Personally visit and observe the plasma collection in some centers
  • Require an extra audit by an independent auditor to verify that correct procedures were followed
  • All companies collecting plasma had one center audited and had no input on the decision about what center was going to be audited

The results were excellent. All Mexican donors had the required Visa, were very committed, came back on a regular basis, had good health records and the donated plasma was of very high quality. 
This was communicated to the FDA and the patient organizations, and the issue was over.

In 2021, the US Customs and Border Protection Agency (CBP), amid the COVID pandemic, decided to block the entry of Mexican individuals into the USA when their purpose was to donate plasma. CBP considered as “labor for hire” and therefore the compensation for the donations (in their opinion) violated the rules of the Visa. That decision caused a further reduction of collected plasma, beyond the reductions because of COVID. Needless to say, that many were very concerned by this unexpected and unilateral action of CBP.

A lawsuit was filed by the manufacturers who had collection centers along the border to challenge this decision. On September 19, 2022,  a judge in the Federal District Court of the District of Columbia issued a preliminary injunction that bars CBP from enforcing its policy of barring Mexican nationals from crossing the border to donate plasma in the U.S. until the case is litigated on its merits. It is impossible to say what the final outcome will be, but normally a decision like this is a reliable predictor for the final decision.

This is an enormous success for the affected companies (such as CSL Behring and Grifols) who were challenging the CBP decision. Also, PPTA supported that case with several statements and provided calculations about the impact on the volume of US plasma collection because of that decision.

Since I retired from my position as President & CEO of PPTA, I have refrained from making comments about the activities of the organization or its members. I have given my best to help this industry to get to the place where they are today. Others have taken over that responsibility and I have given them all the freedom to ensure that patients have access to the many plasma derived medicinal products they clinically need. Fighting this irresponsible CBP decision is one of the things that needed to  be done. PPTA  had a very competent legal officer that was able to do that. I recruited him many years ago and he has never disappointed me or the companies with the quality of his work. One of the companies that benefits from this legal outcome is CSL Behring.

It is very unfortunate that this company decided to leave PPTA as of 2023. Until the moment of writing this column I have not heard what the reasons are. What I know is that this decision was communicated by the CSL Behring representative on the Board. She gave up her role as Chairman and soon after that she went into retirement. PPTA had no other choice than to make personnel cuts because of the budgetary consequences. One of the persons affected was the legal officer that helped this case. I am always uncomfortable when people are losing their position when they did nothing wrong.

Jan M Bult