“Sorry, but you are unable to donate blood today.”
“Can I ask why?”
“On your application, you noted that have received CRISPR therapy in the past.”
“Yeah, I was diagnosed with leukemia two years ago and I was treated with a CRISPR-based drug.”
“I am glad you are cured; however, when receiving CRISPR treatments, you gave up the rights to the edited genes in your DNA. Basically, the researchers who developed the gene you were treated with own a patent over this gene, which they inserted into your genome to replace the mutated version.”
“What do you mean? It’s still my body and my DNA. Shouldn’t I be able to donate my own blood if I want to?”
“Once you obtain documented permission from the pharmaceutical company, you can donate blood.”
When the CRISPR/Cas9 system was first successfully tested as an effective gene editor in human cells, the government imposed strict regulations on this new therapeutic. They required that a library of “approved” genes be created, and only genes from this library could be inserted into a patient’s genome. The main reason for this was to ensure the safety and health of patients; only genes that have been extensively studied and shown to work in clinical trials can be added to the gene library. The government incentivized researchers to develop new, healthy genes by granting them patents over genes that are added to the library. When pharmaceutical companies use genes from the library, the researchers are paid royalties.
“I still don’t understand why I need permission. Are there forms that I have to fill out?”
“When your doctor gave you the CRISPR therapeutic, they engineered your genome to contain a patented gene. Because of this, pieces of your DNA are considered the intellectual property of the researchers who developed your new gene. Technically, you could donate blood, but I would have to inform the company and you could risk being sued for patent infringement.”
“Does this mean I would have to pay the pharmaceutical company in order to donate blood?”
“It depends on the terms of your agreement with the company and how it’s negotiated. The main reason why permission is required is so that we can monitor your modified DNA. When we collect blood from CRISPR-treated patients, we have to specially label the bags with the specific edited gene that it contains. This way we will know who received your blood, and can regulate the transmission of the DNA and study the long-term effects of CRISPR drugs.”
This was only one of many incidents related to the intellectual property rights over genomes that had been edited by CRISPR-based drugs. Besides donating blood, treated patients who wanted to donate organs, sperm or eggs were subjected to a similar, but more complex process. Furthermore, If a CRISPR-treated patient wanted to have children, these children would be monitored by government regulatory agencies to determine if they inherited the edited gene. If so, the child would be subjected to numerous tests and would be studied over the course of their lifetime to determine if CRISPR has any evolutionary effects. So far no adverse effects have been found, but this regulation will have to continue through many generations.