If you can cure the problem more simply, then you shouldn't put the patient at risk with gene therapy. Therefore, Wivel said researchers must consider a positive risk-benefit ratio with regard to the choice of disease and the choices of available therapies. Wivel said the U.S. Patent Office uses stringent criteria in considering patents on genes, as with stem cells. Wivel said the traditional business model for the pharmaceutical industry is to develop drugs that can be sold at a certain volume in order to receive return on the investment. However with gene therapy, theoretically one treatment would cure the disease.
Gene therapy has the potential to be a one-shot cure.
This is very much opposite of what drug companies want, which is to produce drugs that you have to take repeatedly so they can get their money back, not just one magic bullet that cures all. Wivel predicts that gene therapy won't gain significant use for another 20 years. The basis of gene therapy regulation is to minimize or eliminate potential biohazards from either potential new viruses or the transfer of animal viruses to humans. The public oversight system of gene therapy contains several peculiarities, Wivel said. Because gene therapy and its products have not been otherwise legally classified, the government considers them under drug statutes.