This National Academy of Medicine (ANM) and 48 medical institutions They made serious inquiries changes in Drug prescription which establishes Decree of Necessity and Urgency (DNU) 70/2023 published on 20 December.
In a statement from ANMDoctors warned Prohibition on inclusion in recipes Suggestion of commercial brand of medicines next to the generic name “Harms patients“and”Limits the doctor’s liability“
In the Department dedicated to Health, D.N.U Amending Article 2 of Law No. 25,649 on the Use of Medicines by Their Common Name and suggests that “every prescription or medical prescription must be made compulsorily Expressing specifically the drug’s generic name or international non-proprietary name followed by the pharmaceutical form and dose/unit, with details of the degree of concentration.”
One point of discussion is that in Argentina Bioequivalence and bioavailability studies are not required For most generic pharmaceutical products and so cannot Ensures the same level of efficacy and safety This is particularly sensitive in the case of oncology patients, for example, in generic medicine rather than the original medicine recommended by the doctor.
Consulted by InfobayDoctor Juan Antonio Mazzei, President of ANM, He pointed out that “in Argentina it is not mandatory to submit bioavailability and bioequivalence tests for most generic drugs. If a doctor is prevented from prescribing the drug, There is no guarantee that the patient receives a product that fulfills Quality of therapeutic action“
“This could be a situation created by change Negative consequences on health AMN noted in a statement supported by 48 reputable medical organizations. They include the Argentine Clinical Oncology, the Argentine Society of Cardiology, the Argentine Cardiological Federation, the Argentine College of Cardiology, the Argentine Society of Infectology, the Argentine Society of Hematology, the Argentine Society of Urology, the Argentine Society of Mastology. , Argentinean Society of Dermatology, Argentinean College of Interventional Cardioangiologists, Argentinean Society of Plastic and Reconstructive Surgery, Argentinean Society of Child and Adolescent Gynecology, Argentinean Society of Emergency and Emergency Pathologies, Argentinean Society of Pediatrics Society of Trick and Neuro, Argentina. other
Doctors said the executive branch and legislative branch should review the change “based on this Technical and scientific evidence of bioequivalence and bioavailabilityTo ensure that the freedom a doctor has in prescribing medicines at his own discretion is used.”
along with Existing rules prior to DNU Both names were included in the prescription of medical prescriptions common as medicine A health professional’s prescription with a specific medication.
Faced with this change, the National Academy of Medicine issued harsh liberation In which he warned: “There are no bioequivalence and bioavailability tests in Argentina In the great Most pharmaceutical products. These tests are a guarantee that a pharmaceutical product with the same active ingredient retains its potency through its various 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 In force since 2002, We talk about the prescription by the generic name, which is the international generic name, that is, the drug. (or active ingredient). But, strictly speaking, generic drugs are supported by evidence that shows they have the same Power And Effectiveness than the original product and it does not occur in Argentina in most cases.
Since 2002, “there were laboratories (generic manufacturers) that did the tests, but not all,” the pulmonologist said.
Regarding the responsibility towards the patient and the effects of the drugs, the ANM emphasized that the decree of necessity and urgency by abolishing the trade name prescribed by the doctor, “Transfers primary responsibility to the dispenser of the drug Transferring that function to the treating doctor and changing his professional responsibility.”
President of ANM Dr They should retain the power to prescribe drugs And that, secondly, a general law must be discussed and established in the future “in which all products must be present Bioavailability and bioequivalence testsSince then ANMAT Today it is required only for 68 generic products available in the market along with thousands of pharmaceutical products.”
Medical societies questioned the changes in drug prescriptions
Infobay Consulted top officials of several medical institutions supporting the announcement of National Academy of Medicine and who questioned changes in drug prescriptions.
“I don’t agree with the ban on indicating the commercial name in the recipe because in Argentina We do not have true generics but copies of medicines, With some exceptions,” he said Infobay Doctor His salvationPresident Cardiological Foundation of Argentina (FCA).
“The ANMAT There is no need for bioequivalence and bioavailability tests, which it can do Ensure biological response to generic drug Same as the original medicine – said Salvati. By not doing these tests, copies may contain the same amount of the required active ingredient, but with Low biological impact in a patient or with a greater number of adverse effects.”
For his part, Dr Diego Cain, President of the Argentine Association of Clinical Oncology (AAOC)He emphasized Infobay There was already a law on generic drugs. “We agree that generic drugs exist because they can improve cost and patient accessibility to cancer treatment. But there should be bioavailability studies Ensure the quality of each product and its effectiveness. We also believe it is important for a health professional to be able to prescribe by brand of drug.
From the Board of Directors of Argentina Diabetes SocietyDoctor Carolina Gomez Martin commented on Infobay Article 2 of the DNU promoted by the government of Javier Millán “Would restrict prescription For the generic name of the drug only.
“The change being made does not take into account that most of the products approved by the National Administration of Medicine, 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.”An expert from the Diabetes Society of Argentina said.
In case of chronic diseases like diabetes, reliability and efficacy of medicines is essential. “Our concern is to ensure that any legal change maintains high quality standards and therapeutic equivalence between treatments,” he clarified. GOMEZ MARTIN.
For its part, the Director of the Center of Argentine Pharmaceutical Professionals (Saprofar), Ruben Sajemexpressed his agreement with the changes in DNU and told Infobae that “Pharmacists have a responsibility Inform the patient about all available brands and their relative prices, allowing you to make an informed decision about your purchase.”
“Bioavailability and bioequivalence studies require certain complexity, They are not made for all medicines. There are 17,000 different pharmaceutical products in Argentina and the bioavailability and bioequivalence of all of them have not been studied,” Sajem noted.