A big problem for certain clinics is how to bring the paying American customer (i.e. the patient) and the biological product that they are selling derived from the patient’s stem cells together outside the reach of the FDA so a lucrative stem cell transplant can occur.
These clinics realize that exporting a human stem cell biological product out of the US with the intention of clinical use without regulatory permission is almost certainly illegal. In addition, to do it legally, US Customs would likely require an export fee.
But the clinics just want to make money and not deal with rules.
Shift the risk to their own patients.
Certain clinics based at least in part outside the USA are asking their American patients to pack an unusual kind of luggage when they travel out of the USA to the clinic: human stem cell biological products made from the patients’ stem cells.
What do I mean?
Some clinics apparently are asking patients themselves to carry stem cells across the US border into other countries or areas such as Mexico, Latin America, and Asia.
It’s a nasty, double-cross by the clinics to their own paying customers, who are most often vulnerable patients.
Carrying human stem cells out of the US without the permission of several federal agencies (FDA, CDC, and Customs) most likely is illegal in most circumstances.
Export of Drugs and Biologics Under the FDA Export Reform and Enhancement Act of 1996
A draft guidance document is available that summarizes and explains the basic requirements and procedures for exporting human drugs (also drug components) and biologics that may not be sold or distributed in the United States. This guidance document also summarizes and explains the requirements for exporting drugs that are approved for marketing in the United States, but which are being exported for an unapproved use. The draft guidance document is available online: Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996. It also provides contacts for additional information.
Export Certificates for Drugs/Biologics
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the Act. An export certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status.
The clinics and perhaps some of their patients may argue that since the cells “belong” to the patient that they can do whatever they want with them, but that’s not the way the law works.
Sure you are “taking” endogenous stem cells with you inside your body wherever you travel including across international borders.
However, once cells are removed from a patient’s body and particularly once they are made into a biological product with market value, those cells now belong to the company and are subject to many federal laws related to export amongst other things.
Even if the clinic gives the patient the rights in writing to complete ownership of the cellular product (which I have never heard of actually happening), that still does not make it legal for the patient (or the clinic for that matter) to transport the biological product from the US without regulatory permission.
The FDA must give pre-approval, in most cases I believe the CDC must also approve, and Customs may well have export fees to be paid since the cellular product likely has value in the thousands of dollars.
What should patients do?
If a clinic asks you to carry your own stem cells across the US border, what should you do?
The wise thing to do would be to ask the clinic if the FDA, CDC, and Customs have given permission for you to do so.
Also ask–have any export fees already been paid?
If they answer “yes” to these questions, ask to see documentation.
If indeed everything seems kosher, please also let me know in that case as I’d like to highlight in a positive way a company for conducting compliant export of human biological stem cell products intended for clinical use.
If the clinic cannot answer these questions comfortably, it seems to me that the wisest thing for you to do is not to proceed as you could find yourself in legal hot water.
Talk to your lawyer and your doctor for advice.
Even they may not be sure about the law as export law as it pertains to human biological products intended for clinical use is extremely complex.
Don’t let the clinic try to trick you into shouldering the legal and potential financial risks of sketchy exports. You could be charged with smuggling. There have been criminal cases related to stem cell smuggling both in the US and one still under investigation in Korea.
Of course another risk is that during transport the stem cell product may be compromised putting you at risk from a future transplant involving it.
How are the clinics asking patients to carry the stem cells across the border? If they are asking you to do it with the cells at room temperature that is a recipe for disaster as cells are not stable. That seems unlikely.
If they are asking you to carry them inside of cryovials with dry ice or liquid nitrogen that may keep the cells more stable, but there are no guarantees that the stem cells won’t be compromised.
Also, I believe that if you are hiding the liquid nitrogen container in your car, for example, as you drive into Mexico, and you do not declare that you have the stem cells in your possession to the US Border Agents or to Mexican officials, you must know that you are doing something wrong. Thus, not all the responsibility is on the clinic. You are knowingly putting yourself in legal jeopardy.
Finally, I’ve tried to look into it, but countries such as Mexico, Korean, and others often have their own very complex human biologics import laws. The clinic could be putting you at risk to break the laws in those countries as well.
Bottom line? Don’t do it.