A big issue in the stem cell field is that firms increasingly are doing business in multiple countries.
Associated with the increasingly international nature of the stem cell for-profit industry are emerging legal and ethical issues related to the transport of stem cell-based biological drugs across international borders.
Think you can just FedEx human stem cells anywhere you want in the world? Think again. Transport of human stem cell materials across international borders is an exceedingly complex task if to be done lawfully and ethically.
Companies thinking of shipping their human biological drugs, such as stem cells, across international borders have an alphabet soup of governmental agencies that they must deal with in order for the export/import to be legal. In additions to Customs, in the U.S. just two of the agencies are the FDA and CDC. It is not a simple matter, illustrated by the 61 page set of guidelines just from the FDA on export of biologics (can be found here). I’m not an expert in this area, but a glance at this document suggests companies need FDA approval to export biologics/drug products.
Let’s take the case of the Korean stem cell firm RNL Bio, which also does business in the U.S. via subsidiary companies called Human Biostar and RNL Biostar. RNL is reportedly under investigation by the Korean government for alleged smuggling of stem cells from Korea across the border into Japan and/or China (see here and here). Here are the links to newspaper articles on this investigation that were published in the last month or so:
http://www.koreatimes.co.kr/www/news/nation/2013/01/116_128264.html
http://news.asiaone.com/News/Latest%2BNews/Health/Story/A1Story20121225-391519.html
http://english.chosun.com/site/data/html_dir/2012/12/24/2012122401244.html
In the Korea Times piece, the reporter mentioned a response by RNL:
RNL Bio claimed the current law requiring researchers to receive certification for stem cell treatments after undergoing three rounds of clinical testing was a violation of the right to conduct research.
The prosecution plans to restart its investigation dependent on the ruling from the Constitutional Court.
The company did not give an immediate response to whether the allegations were true, but said it would release a public statement today.
I have checked and been unable to find a press release by RNL on this issue and I also tried to contact the company, but got no response. RNL is of course innocent of all charges until or unless proven otherwise.
Given that stem cell drug products can have cost patients tens of thousands of dollars and hence have substantial value in the thousands of dollars, an additional issue is whether there would be major costs such as tariffs or taxes associated with transborder shipment of the items.
There are unsubstantiated rumors that some companies have already had their patients take stem cells across international borders on their bodies or in luggage without any government approval. If true, this kind of practice is unethical in my opinion. It would seem to put patients at legal risk should this be discovered and shift the risk away from the companies, raising serious ethical issues. Such stem cells also seem to have a high risk of being biologically compromised during this form of cross border transit.
Of course it is also possible that companies may simply FedEx or otherwise overnight ship cells on liquid nitrogen or dry ice without any governmental approvals at all, but eventually they are likely to get caught. I think this practice also puts patients at risk as samples could be compromised.
The issue on international transport of human stem cells is likely to come even more to the forefront this year and in 2014 as more and more companies are on track to want to transport human stem cells across international borders. For example, Celltex has now announced that it plans to try to set up treatments for its patients in Mexico, but all their stem cell samples are stored in the U.S. Interestingly, the Celltex patient samples are currently in possession of Human Biostar, a subsidiary of RNL Bio in Texas.
How would the Celltex samples get across the border into Mexico? Would the FDA or Customs or other agencies allow it? I don’t know. I queried Celltex about the plan for Mexico-based treatments, but they had no comment at this time. I hope it is something I can open a dialogue with them about in the near future.
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A valid point – I used to export hepatocytes for use in research and pre-clinical drug testing and you have to claim that there are no clinical or therapeutic implications of the cells in order to export and, even more challenging, in order to import into the US. The FDA has the authority to investigate both inbound and outbound and the “controversy” about whether the cells are “drugs” or not has no matter. FDA can seize a delivery without cause, just on suspicion something isn’t labelled or paperwork isn’t perfect. For that reason i is always a good idea to have a Customs broker knowledgeable in the import and export of biologicals. Most of these will be people in the horse/cow semen business or people trading in exotic animals – not many out there working on issues related to human or other types of cell culture product, let alone human therapeutically active stem cells. I believe most hospitals also have people to work on this, but private companies, many without clinical MD’s or Veterinarians, have a hard time which = more $$.