Ah, so we should just get rid of those regulations and let the little guy compete!
Not so fast. Maybe the first new market entrants are motivated by altruism as much as by profit. They do everything carefully but charge prices closer to cost. Patients pay less and there are hardly any downsides, except to the financials of legacy pharma companies.
But by year 3 there are people who have learned that you can buy barrels of technical-grade active pharmaceutical ingredients off of Alibaba and make pills from them without any quality control in between. Sometimes the products are contaminated with carcinogens. Sometimes they vary widely in potency across lot numbers. In the absence of regulations, fraudulent and shoddy products become widespread. It would be like the supplements industry, except that people actually die if they don't take real prescription drugs they need (this is less common for people who are sold fake herbs.)