Much has been written in favor and against the obligation to guarantee the supply of the investigational product (IP) once the clinical trial has concluded. The National Ethics Committee (CONEP) establishes as a prerequisite to approve a clinical trial that the Sponsor guarantees unrestricted, free of charge access to the IP if the investigator prescribes so at the end of the study.
In 2017 and implemented last year, the Ministry of Health (MOH) approved Resolution 563 limiting post-study drug supply to 5 years for Ultra-Rare diseases, those with an incidence equal or less than 1 in 50,000. Bill 7082 is now considering extending the limitation to all therapeutic areas something that is viewed by local investigators and industry as a breakthrough ruling that will set the basis for a deluge of clinical trials to the country. Moreover, the bill goes a step further and the proposed change establishes that post-study supply should be based on a clinical assessment of the patient condition that justifies the risks of an experimental drug versus an existent therapeutic.
Despite being a top recruiter in all multicentric studies, highly skilled investigators, world renowned hospitals and competitive pricing the rank is dismal, and industry and policy makers are finally aligned to make it into the top 10 of clinical research.
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