Table 2 Pros and cons of making sponsors responsible

Avoid family expenses

Could weakens the local clinical research groups participating in the trials and decreases research

Protects the patient’s health

Could jeopardizes the financing of the tests

Immediate access to medication for the patient / Ensuring continuity of treatment (gives patient peace of mind - possibility of placebo effect)

Reduce industry investment in countries with high prevalence of rare diseases

The public health system would not pay

Could create an iatrogenic risk for the patient to whom the medication is given even without registration if there is no ongoing medical follow-up.

The cost to the industry would be defined more clearly, knowing the future (the cost is internalized, knowing that it will have to be paid)

Could make the treatment more expensive and unfeasible