Civil society organizations, professional associations, patient associations and experts in Health They have issued a national health alert against a law approved by the Congress of Peru that could allow the entry of medicines to the country without adequate health control.
According to the pronouncement, addressed to President Dina Boluarte, the standard represents a direct threat to public health by weakening the mechanisms of technical evaluation and quality control of medicines. The congressman Ernesto Bustamanteof Popular Force, leads the legislative initiative that has generated this controversy.
In accordance with the pronouncement, the law in question, which encompasses Law No. 1422/2021-CR, 1880/2021-CR, 2273/2021-CR and 4995/2022-CR, establishes that if the General Directorate of Medicines, Supplies and Drugs (Exemmem) does not evaluate a file within 45 days, the sanitary record will be granted automatically.
This means that medications could be approved without an exhaustive technical review, which, according to the spokesmen of organizations, puts the safety of patients at risk. “Never before in Peru it had been intended to register medications by administrative silence. Not even countries with high Health surveillance They allow such irresponsible measure, ”they said.
The pronouncement also warns that the standard would allow the entry of products manufactured in any part of the world, provided that they are marketed in countries considered high sanitary surveillance. However, it is not guaranteed that these products come from regulated plants under the same quality standards, which could expose Peruvian patients to medications without real guarantees of efficiency or safety.
In addition, organizations denounced that the law ignores recently approved norms, ignores the constitutional framework and eliminates minimal sanitary safeguards, without providing a technical regulation for its implementation.
Victor Dongorepresentative of the Medical College of Peru and general manager of the Institute of Management and Evaluation of Health Technologies, emphasized that the health of Peruvians is at risk if this law is promulgated. According to the pronouncement, access to treatments cannot be achieved by sacrificing lives or reducing public health to a simple administrative procedure.
Organizations have asked President Boluarte to observe the law autograph and immediately summon a multisectoral technical table. This table should include representatives of DIGEMID, the Ministry of Health (Minas), the National Institute of Neoplastic Diseases (Inen), Professional Colleges, Universities, Patient Associations and the Pharmaceutical Industry, with the objective of building a technical, viable and responsible standard.
The spokesmen also pointed out that the approval of this law could open the door to high -risk products that have not undergone adequate review. According to the pronouncement, this situation not only violates the rights of patients, but also calls into question the state’s ability to guarantee health safety.
“The health of Peruvians is at stake. If this rule is promulgated, medicines could enter the country without any real filter,” they warned.
The debate on this law has generated a strong opposition by various sectors, which consider its implementation It could have devastating consequences for public health. Organizations have insisted on the need for a technical and rigorous approach to ensure that medicines that enter the country comply with the necessary quality and safety standards.
