Doctors reject the reform in the DNU, which prohibits prescribing drugs by brand

With the changes to the DNU, “there is no guarantee that the patient will receive a product of therapeutic quality,” Dr. Jorge Mazzei, president of the National Academy of Medicine, told Infobae (Getty).

National Academy of Medicine (ASM) And 48 medical institutions They harshly questioned changes V prescription for medicine which establishes the Decree of Necessity and Urgency (DNU) 70/2023, published on December 20th.

In a statement from ASMdoctors warned that ban on inclusion in recipes offer of commercial brands of medicines next to the general name “harms patients” And “limits the doctor’s liability

In the section dedicated to health, DNU amends Article 2 of Law No. 25649 “On the use of medicines by their generic name.” and states that “every prescription or medical prescription must be issued without fail.” exclusively expressing the generic name of a medicinal product or international nonproprietary name indicated by the pharmaceutical form and dose/unit indicating the degree of concentration.”

One of the axis of the discussion is that in Argentina Bioequivalence and bioavailability studies are not required for most generic pharmaceutical products and therefore cannot guarantee the same level of effectiveness and safety in a generic drug there is more than in the original drug recommended by a doctor, this is especially sensitive, for example, in the case of cancer patients.

consulted Informationdoctor Juan Antonio Mazzei, President of the IDA, He noted that “in Argentina, bioavailability and bioequivalence tests are not required for most generic drugs. If the doctor is not allowed to offer medicine, There’s no guarantee that the patient receives a product that is appropriate quality of therapeutic action

The ANM statement emphasized that the changes to the DNU “shift the primary responsibility to the one who dispenses the medicines, replacing the attending physician in this task and changing his professional responsibility.”

“The situation created by this modification may have negative health effects population,” AMN noted in a statement supported by 48 prestigious medical institutions. Among them are the Argentine Association of Clinical Oncology, the Argentine Society of Cardiology, the Argentine Federation of Cardiology, the Argentine College of Cardiology, the Argentine Society of Infectious Diseases, the Argentine Society of Hematology, the Argentine Society of Urology, and the Argentine Society of Mastology. , Argentine Society of Dermatology, Argentine College of Interventional Cardiac Angiologists, Argentine Society of Plastic and Reconstructive Surgery, Argentine Society of Pediatric and Adolescent Gynecology, Argentine Society of Emergency and Emergency Pathology, Argentine Society of Pediatric Neurosurgery and others.

Doctors asked the executive and legislative branches to consider this change “based on technical and scientific evidence of bioequivalence and bioavailabilityto ensure that the freedom that a physician has to prescribe at his own discretion continues to be exercised.”

WITH current rules before DNU was included in the medical prescription as a name universal medicines like suggestion from a healthcare professional regarding a specific drug.

Faced with this change, National Academy of Medicine made a stern sound release in which he warned: “Bioequivalence and bioavailability tests are not performed in Argentina. in great most pharmaceutical products. These tests ensure that a pharmaceutical product with the same active ingredient retains its potential in different forms on the market and can be used interchangeably.”

The National Academy of Medicine (ANM) and 48 medical organizations expressed disagreement with DNU 70/2023, which prohibits doctors from offering commercial brands in prescriptions (Getty)

Mazzei clarified a point that usually causes confusion: “When it comes to generics in Law No. 25649 has been in operation since 2002, We are talking about prescribing by generic name, which is the internationally accepted name, that is, the drug. (or active substance). But strictly speaking, generics are drugs supported by evidence demonstrating that they have the same effect. power And efficiency than the original product, and in Argentina in most cases this does not happen.”

The pulmonologist stated that since 2002, “there have been laboratories (generic drug manufacturers) that have performed tests, but not all.”

Regarding patient responsibility and the impact of drugs, the ANM emphasized that the decision on necessity and urgency by eliminating the commercial name proposed by the doctor, “transfers primary responsibility to the person dispensing the medicine” displacement of the attending physician in the specified task and change in his professional responsibility.”

The President of the ANM considered that doctors They must retain the right to offer prescription drugs. and that, secondly, a general law should be discussed and adopted in the future “whereby all products must represent bioavailability and bioequivalence testsBecause the ANMAT Today, it is required for only 68 generics out of thousands of pharmaceutical products on the market.”

Medical societies question changes to drug prescriptions

The country’s most prominent cardiological societies also questioned the DNU.

Information consulted with senior officials of some medical institutions who supported the declaration National Academy of Medicine and who questioned changes in drug prescriptions.

“I do not agree with the ban on using a commercial name in a recipe, because in Argentina We do not have real generics, but copies of drugs. with some exceptions,” he said. Information doctor Ana Salvatithe president Argentine Heart Foundation (FCA).

Physician concerns are especially high in the treatment of chronic diseases or in cases such as cancer and heart disease where drug effectiveness and safety are critical (EFE).

ANMAT does not require bioequivalence and bioavailability tests, which may ensure that the biological response of the generic be the same as the original drug, Salvati said. If these tests are not performed, copies may contain the same required amount of active ingredient, but with less biological effect in the patient or with a large number of side effects.”

For his part, the doctor Diego Caen, President of the Argentine Association of Clinical Oncology (AAOC)he emphasized Information that there is already a law on generic drugs. “We agree that generic drugs exist because they can reduce the cost and accessibility of cancer treatments for patients. But bioavailability studies are needed to guarantee the quality of each product and its effectiveness. We also believe it is important that healthcare providers can prescribe medications based on brand.”

From the company’s board of directors Argentine Diabetes Societydoctor Carolina Gomez Martin commented Information that Article 2 of the DNU, promoted by the government of Javier Miley “will limit the prescription only to the generic name of the drug.”

“This change being made does not take into account that most products approved by the National Authority for Medicines, Food and Medical Technology (ANMAT) are not subject to bioequivalence and bioavailability tests compared to the reference brand. “The difference between copies and generics in terms of quality and reliability represents a critical factor in medical decision-making.”said an expert from the Argentine Diabetes Society.

In the case of chronic diseases such as diabetes, the reliability and effectiveness of medications are important. “Our concern is that any legal changes maintain high standards of quality and therapeutic equivalence of treatments,” he explained. Gomez Martin.

From my side, Director of the Center for Argentine Pharmaceutical Specialists (Ceprofar) Ruben Sademexpressed agreement with the changes in the DNU and informed Infobae that “the pharmacist is responsible for inform the patient about all available brands and pricing to match, allowing you to make an informed purchasing decision.”

“Bioavailability and bioequivalence studies require some complexity, They are not intended for all medications.. There are 17,000 different pharmaceutical products in Argentina, and not all of them have been studied for bioavailability and bioequivalence,” said Sayem.

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