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National Medical Academy ,ANM) And 48 medical institutions he interrogated sternly Change In prescription drugs Which establishes Decree of Necessity and Urgency (DNU) 70/2023, published on 20 December.
In a statement from ANMDoctors gave this warning ban on inclusion in recipes Suggestion of commercial brands of medicines before common name “harms patients” And “Limits doctor’s liability,
In the section dedicated to health, D.N.U. Amends Article 2 of Law No. 25,649 on the Use of Medicines by Generic Name and indicates that “every prescription or therapeutic prescription must be made in the manner specifically expressing the generic name or international non-proprietary name of the drug Indicated, followed by details of the pharmaceutical form and dosage/unit, degree of concentration.
One of the axes of discussion is in Argentina Bioequivalence and bioavailability studies are not required For most generic pharmaceutical products and therefore cannot be Guarantee the same level of effectiveness and safety This is especially sensitive in cases of oncology patients, for example, in generic medicine compared to the original medicine recommended by the doctor.
advised by infobaedoctor Juan Antonio Mazzei, President of ANM, “In Argentina, it is not mandatory for most generic drugs to submit to bioavailability and bioequivalence testing,” he said. If the doctor is prevented from prescribing the medicine, There is no guarantee that the patient receives a product that matches his quality of therapeutic action,
“The situation that will be created by this amendment negative health consequences of population,” the AMN noted in a statement backed by 48 prestigious medical institutions. These include the Argentine Association of Clinical Oncology, Argentine Society of Cardiology, Argentine Cardiological Federation, Argentine College of Cardiology, Argentine Society of Infectology, Argentine Society of Hematology, Argentine Society of Urology, Argentine Society of Mastology. ., Argentine Society of Dermatology, Argentine College of Interventional Cardioangiologists, Argentine Society of Plastic and Reconstructive Surgery, Argentine Society of Child and Adolescent Gynecology, Argentine Society of Emergency and Emergency Pathologies, Argentine Society of Pediatric Neurosurgery, and others.
Doctors asked the executive branch and legislative branch to review this change Technical and scientific evidence of bioequivalence and bioavailability“To ensure that the doctor continues to have the freedom to prescribe medicines at his own discretion.”
with Existing rules before DNU The names of both were included in the medical prescription General as medicine Health professional’s advice regarding specific medication,
Faced with this change, National Medical Academy issued a harsh release In which he warned: “There are no bioequivalence and bioavailability tests in Argentina in the great Most pharmaceutical products, These tests guarantee that a pharmaceutical product with the same active ingredient retains its potency through its different forms on the market and can be interchangeable.”
mazei Clarified a point that commonly causes confusion: “When talking about generic drugs Law No. 25,649 Applicable from 2002, We talk about prescriptions by their generic name, which is the international common name, that is, the medicine. (or active ingredient). But, strictly speaking, generic drugs are those that are supported by evidence that shows they have the same Power And Effectiveness Compared to the original product and in Argentina in most cases this does not happen.
The pulmonologist stated that, since 2002, “there were laboratories (generic manufacturers) that did the test, but not all.”
With regard to responsibility towards the patient and the effectiveness of the medicines, the ANM stressed the need and urgency of removing the commercial name suggested by the doctor. “To whoever distributes the drug, transfer primary responsibility to Displacing the treating doctor in the said work and modifying his professional responsibility.
ANM President considered doctors They should retain the power to prescribe medicines And, secondly, in the future a common law should be debated and established “which should cover all products.” Bioavailability and bioequivalence testingSince then unapproved Of the thousands of pharmaceutical products available in the market today, this is required for only 68 generic products.
Medical Society raised questions on changes in drug prescription
infobae Consulted the top officials of some medical institutions supporting the declaration of National Medical Academy And those who questioned changes in drug prescriptions.
“Being in Argentina, I don’t agree with the prohibition of suggesting commercial names in recipes We do not have genuine generic medicines but copies of medicines, With a few exceptions,” he told infobae doctor Ana SalvatiPresident of Argentine Cardiological Foundation (FCA).
“The unapproved It does not require bioequivalence and bioavailability tests, which can Make sure the generic drug has a biological response Salvati said- It should be same as the original medicine. By not performing these tests, copies may contain the same amount of the required active ingredient, but with low biological impact with a greater number of adverse effects in the patient.”
For your part, doctor Diego Caine, President of the Argentine Association of Clinical Oncology (AAOC)he insisted infobae That there was already a law on generic medicines. “We agree that generic drugs exist because they can improve the cost and patient access to cancer treatment. But there needs to be a bioavailability study Ensure the quality and effectiveness of each product, We also think it is important that health professionals can prescribe according to the brand of the medicine.”
from the board of directors of Argentine Diabetes Societydoctor carolina gomez martin commented on infobae That article 2 of the DNU promoted by the government of Xavier Miley “Will ban prescriptions Only for the generic name of the medicine.”
“The change being made does not take into account that most of the products approved by the National Administration of Medicines, Food and Medical Technology (ANMAT) are not subjected to bioequivalence and bioavailability tests compared to the reference brand. “The difference between copies and generics, in terms of quality and reliability, represents an important factor in medical decision making.”Said the expert from the Argentine Diabetes Society.
In case of chronic diseases like diabetes, reliability and effectiveness of drugs is essential. “Our concern lies in ensuring that any legal amendments maintain high standards of quality and therapeutic equivalence between treatments,” he explained. gomez martin,
For his part, Ruben Sazem, Director of the Center of Argentine Pharmaceutical Professionals (SEPROFER)expressed his agreement to the changes in DNU, telling Infobae that “Pharmacists have the responsibility Inform the patient about all available brands and their respective prices, allowing you to make an informed decision about your purchase.”
“Bioavailability and bioequivalence studies require some complexity, They are not made for all medications, There are 17,000 different pharmaceutical products in Argentina and the bioavailability and bioequivalence of not all of them have been studied,” Sagem said.
