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European Medicines Agency Executive Director Claims that Smarter Regulation Could Control Rising Drug Prices
Guido Rasi, the European Medicines Agency Executive Director, has said that a smarter and faster pharmaceutical approval system is essential for controlling rising drug prices.
Guido Rasi, the European Medicines Agency Executive Director, has said that a smarter and faster pharmaceutical approval system is essential for controlling rising drug prices.
According to an article on Pharmaceutical Processing:
Specifically, Rasi indicated that society would expect drugmakers to reduce drug prices if the approval process is hastened. “As [a] regulator, we want to recommend innovative medicines for approval that are affordable,” Rasi commented, adding “that is why we are fostering a better model for the development of medicines.”
A key component of this goal is the EMA’s proposed “adaptive pathways” initiative, under which drugs would be approved for restricted populations based on smaller initial trials, with clearance expanded progressively as clinical data are accumulated. Similarly as the current system, drugs could be pulled from the market of unexpected problems are identified.
Rasi suggested that such an approach would be “leaner and more efficient,” consequently reducing the cost of drug development. The executive added that the approach could reduce “by years” the time needed for regulatory approval and could be applicable to many, although not all, new products in the future. “Our expectation is that companies will reflect this by reducing the price of medicines for the benefit of patients and for the sustainability of our healthcare systems,” Rasi remarked.
Click here to read the full article on Pharmaceutical Processing.
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