Post-trial access to medicines is an interesting topic to pharmaceutical companies. A treatment is provided to trial participants at cost to the company in the hope that the treatment will be proved effective for a later market access. However, trials come to an end, and patients experiencing benefit from the treatment may no longer be able to use it. In countries with rules allowing participants to continue to have access to the treatment, the cost is usually borne by the manufacturer.
The bill currently under discussion in the Brazilian House of Representatives argues that Phase III trial participants should be provided with the treatment, at cost to the company, indefinitely, or until suitable stopping points are reached.
This will be an interested story to follow, so please check back on MAP soon for more updates.