The Finance Committee of the Legislative Assembly accepted Amcham and Inquifar this Monday, just before accepting the National Pharmaceutical Directorate. / Video capture of the Legislative Assembly.
Representatives of El Salvador’s pharmaceutical companies today presented to the Finance Committee of the Legislative Assembly a counterproposal to the draft Special Law on Prices for Services of the National Pharmaceutical Directorate, proposed by Health Minister Francisco Alabi on August 25. Arrived. .
This regulation increases or updates the fees charged by the Directorate General for Medicinal Products (DNM) for services provided to pharmaceutical companies. This project includes a $3,000 health registration fee and a $3,000 marketing authorization fee. DNM offered to reduce the price to $1,500.
Currently, drug registration costs $300 for citizens and $500 for foreigners, plus $52 for a manufacturing permit and $86 for import.
DNM has included a new fee for market surveillance in the project, which was set at $240, but today proposes to keep it at $100.
The price list is outdated, but the response time has improved…to be honest, the process is subsidized.
Noe Garcia Iraheta
Director General of the National Drug Administration.
Carmen Aida Muñoz, executive director of the Salvadoran American Chamber of Commerce (AmCham), assured that pharmaceutical companies represented by the union have told them that DNM provides “agile and efficient services.” However, he proposed that the law be applied in stages.
Sergio Campos, AmCham’s legal coordinator, also said that the fee is set for “asset differentiation” and that the effectiveness of the payment is “an investment in human resources that must be made in this type of registration.” “Yes, and it will be extended to 12 months.”
Deputy Geovanny Zaldaña of Nuevas Ideas expressed openness to analyzing the requested one-year extension. “It will be evaluated by this committee for entry into force in 2024, which I see as being quite achievable,” he said.
Subsequently, the National Drug Directorate proposed that the collection of these duties begin in January 2024, a postponement of three months.
Carmen Pérez, president of El Salvador’s Association of Pharmaceutical and Chemical Manufacturers (Inquifar), also suggested that “changes be carried out in a gradual and step-by-step manner.”
Inquifar’s presentation revealed that the cost of the new fees will be borne by businesses.
Since we are subject to regulations regarding maximum selling prices, any additional costs that may arise will be absorbed by the company in any case. ”
carmen perez
President of Inquifar.
Due to the increased product offering, the company does not have to increase costs, which in turn increases the efficiency of domestic medical institutions, which in turn becomes a greater resource for the company. ”
carmen aida muñoz
CEO of AmCham.
The Legislative Assembly’s Finance Committee will continue debating the bill this Monday.
The National Drug Directorate also proposed that the collection of investigation and renewal fees be phased in starting from 50% of the amount in 2024 and 75% in 2025.
DNM has made several suggestions to fix the fees.
Source: Diario Elmundo
