> If a medicine kills someone who should the responsibility fall on?

Medication, regulated or unregulated, is a risk the patient takes. I don’t think we’re optimizing for the right thing if the goal of regulation is to avoid death by medication. I’d rather die trying to cure my illness than die from inactivity/inability to try while the scientists go through the motions in the laboratory.

So to answer your question, we should empower patients to seek treatment, and live or die by their choices. Because it turns out no one cares about them more than they do. Also, this has been the law of the land in most African countries where natural/unlicensed medicine is heavily sought after, and no one is asking about who should be blamed for deaths during treatment.

And how can they be properly informed of the risks without empirical data from trials? Regulations exist to prevent malicious sellers from taking advantage of sick patients, who are making decisions under duress, about things way more complex than they can handle.

I realize it sounds paternalistic, and I can appreciate your point about giving people freedom to make the choice, but sometimes it’s not really a choice in the true sense you describe (no pressures from failing health; proper time to research everything; ability to weigh benefits and risks correctly).