BUENOS AIRES (Reuters) -Argentina’s government said on Monday that it will review the use of fast-track authorizations for high cost drugs, as well as requiring future vaccine trials to include a placebo test group, as part of a broader revision of its healthcare policy. “The Ministry of Health will propose to discuss the use of […]
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Argentina to review use of fast-track authorizations for costly drugs
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BUENOS AIRES (Reuters) -Argentina’s government said on Monday that it will review the use of fast-track authorizations for high cost drugs, as well as requiring future vaccine trials to include a placebo test group, as part of a broader revision of its healthcare policy.
“The Ministry of Health will propose to discuss the use of this type of authorization for very high-cost drugs, especially those intended for children and rare diseases,” the government said in a statement. “Innovation cannot justify hasty decisions without solid evidence.”
It said it would open technical discussions on approval criteria that prioritize patient safety and system sustainability.
The government also said vaccines would be subject to clinical studies with a placebo group “as a minimum standard.”
“To review is not to deny,” it added, saying the approach aimed to improve scientific rigor and boost public confidence.
(Reporting by Lucila Sigal and Peter Henderson; Editing by Kylie Madry)