Changes in the DNU: the Government modified the article that prevented doctors from prescribing specific brands of medicines - Infobae
Source:
www.infobae.com
January 22, 2024
Through a new decree that was published this morning in the Official Gazette, the regulations that forced professionals to indicate generic drugs and not from a particular laboratory were made more flexible.
The modification would be published in the Official Gazette (Getty)
After listening to the claim of the sector's business chambers, medical associations and the National Academy of Medicine itself, the Government finally modified the article of the Decree of Necessity and Urgency (deregulation of the economy) that prevented health professionals from health prescribe specific brands of remedies.
In this way - as anticipated Infobae- although doctors will continue to be obliged to tell their patients the generic name or international common name of the drug to be administered, they may suggest that it be from a particular laboratory.
The retreat of the Executive Branch was confirmed through Decree 63/2024, published early this Monday in the . There it was also established that, in the event that the electronic prescription system is used, the pharmacist "must return to the acting professional the information in case of substitution in the pharmacy" of the medication in question, "to preserve adequate monitoring of the clinical treatment." of the patient.”Official Gazette. It also established that, in the event that the electronic prescription system is used, the pharmacist "must return to the acting professional the information in case of substitution in the pharmacy" of the drug in question, "to preserve an adequate follow-up of the patient's clinical treatment".
Beyond the suggestion of the professional who prescribed the drug, the consumer has the right to “replace it with a lower-priced medicinal specialty that contains the same active ingredients, concentration, pharmaceutical form and similar number of units as that prescribed.”
Another point that modifies the new Decree has to do with the possibility that establishments that are not authorized as pharmacies can sell remedies, which will be maintained, although it will be limited “to antacids and painkillers”.
These places must “have a space to store medicinal specialties, separate and independent from other products sold by the establishment, kept under lock and key and that meets the conditions of hygiene, safety, cleanliness, spaciousness, light and adequate ventilation.”
Finally, it was clarified that “drugstores may exclusively dispense to the public prescriptions in which oncological medications or special treatments that are listed by the enforcement authority are prescribed.”
The Government decided to move forward with these changes, after criticism from the National Academy of Medicine (ANM) and 48 medical entities to the norms established in the presidential DNU of December 20.
At that time, the Executive Branch ordered that “every prescription or medical prescription must be made in a mandatory manner expressing exclusively the generic name of the medication or international non-proprietary name indicated, followed by pharmaceutical form and dose/unit, with details of the degree of concentration.”
If the measure is published, doctors will be able to suggest brands
For entities in the sector, the prohibition of including in prescriptions the suggestion of commercial brands of medicines by doctors, together with the generic name, “harms the patients” and “limits the doctor's responsibility.”
According to them, in Argentina, in most pharmaceutical products, the same level of efficacy and safety between both drugs cannot be guaranteed (the so-called mother and the generic), which they pointed out as especially sensitive in the cases of oncological patients.
“In Argentina it is not mandatory for most generic medications to present bioavailability and bioequivalence tests. If the doctor is prevented from suggesting the medication, there is no guarantee that the patient will receive a product that meets the quality of the therapeutic action,” he explained to Infobae, doctor Juan Antonio Mazzei, president of the ANM.
The Industrial Chamber of Pharmaceutical Laboratories (CILFA) and representatives of the doctors of the Argentine Lipid Society and the Argentine Federation of Endocrinology Societies expressed themselves in a similar way.
In the recitals of the decree published this Monday in the Official Gazette, the Government explained that in relation to deregulation, by article 2 of DNU 70/23 “it is established that the National State will promote and ensure the effective validity, throughout the national territory, of an economic system based on free decisions, adopted in an area of free competition, with respect for private property and the constitutional principles of free circulation of goods, services and work; and that to achieve this goal, the broadest deregulation of commerce, services and industry will be established throughout the national territory and all restrictions on the supply of goods and services, as well as any regulatory requirement that distorts the prices of goods, will be void. market, prevents free private initiative or prevents the spontaneous interaction of supply and demand.
Source:
Cambios en el DNU: el Gobierno modificó el artículo que impedía a los médicos recetar marcas específicas de remedios
A través de un nuevo decreto que se publicó esta madrugada en el Boletín Oficial, se flexibilizó la normativa que obligaba a los profesionales a indicar drogas genéricas y no de un laboratorio en particular
www.infobae.com
January 22, 2024
Through a new decree that was published this morning in the Official Gazette, the regulations that forced professionals to indicate generic drugs and not from a particular laboratory were made more flexible.
The modification would be published in the Official Gazette (Getty)
After listening to the claim of the sector's business chambers, medical associations and the National Academy of Medicine itself, the Government finally modified the article of the Decree of Necessity and Urgency (deregulation of the economy) that prevented health professionals from health prescribe specific brands of remedies.
In this way - as anticipated Infobae- although doctors will continue to be obliged to tell their patients the generic name or international common name of the drug to be administered, they may suggest that it be from a particular laboratory.
The retreat of the Executive Branch was confirmed through Decree 63/2024, published early this Monday in the . There it was also established that, in the event that the electronic prescription system is used, the pharmacist "must return to the acting professional the information in case of substitution in the pharmacy" of the medication in question, "to preserve adequate monitoring of the clinical treatment." of the patient.”Official Gazette. It also established that, in the event that the electronic prescription system is used, the pharmacist "must return to the acting professional the information in case of substitution in the pharmacy" of the drug in question, "to preserve an adequate follow-up of the patient's clinical treatment".
Beyond the suggestion of the professional who prescribed the drug, the consumer has the right to “replace it with a lower-priced medicinal specialty that contains the same active ingredients, concentration, pharmaceutical form and similar number of units as that prescribed.”
Another point that modifies the new Decree has to do with the possibility that establishments that are not authorized as pharmacies can sell remedies, which will be maintained, although it will be limited “to antacids and painkillers”.
These places must “have a space to store medicinal specialties, separate and independent from other products sold by the establishment, kept under lock and key and that meets the conditions of hygiene, safety, cleanliness, spaciousness, light and adequate ventilation.”
Finally, it was clarified that “drugstores may exclusively dispense to the public prescriptions in which oncological medications or special treatments that are listed by the enforcement authority are prescribed.”
The Government decided to move forward with these changes, after criticism from the National Academy of Medicine (ANM) and 48 medical entities to the norms established in the presidential DNU of December 20.
At that time, the Executive Branch ordered that “every prescription or medical prescription must be made in a mandatory manner expressing exclusively the generic name of the medication or international non-proprietary name indicated, followed by pharmaceutical form and dose/unit, with details of the degree of concentration.”
If the measure is published, doctors will be able to suggest brands
For entities in the sector, the prohibition of including in prescriptions the suggestion of commercial brands of medicines by doctors, together with the generic name, “harms the patients” and “limits the doctor's responsibility.”
According to them, in Argentina, in most pharmaceutical products, the same level of efficacy and safety between both drugs cannot be guaranteed (the so-called mother and the generic), which they pointed out as especially sensitive in the cases of oncological patients.
“In Argentina it is not mandatory for most generic medications to present bioavailability and bioequivalence tests. If the doctor is prevented from suggesting the medication, there is no guarantee that the patient will receive a product that meets the quality of the therapeutic action,” he explained to Infobae, doctor Juan Antonio Mazzei, president of the ANM.
The Industrial Chamber of Pharmaceutical Laboratories (CILFA) and representatives of the doctors of the Argentine Lipid Society and the Argentine Federation of Endocrinology Societies expressed themselves in a similar way.
In the recitals of the decree published this Monday in the Official Gazette, the Government explained that in relation to deregulation, by article 2 of DNU 70/23 “it is established that the National State will promote and ensure the effective validity, throughout the national territory, of an economic system based on free decisions, adopted in an area of free competition, with respect for private property and the constitutional principles of free circulation of goods, services and work; and that to achieve this goal, the broadest deregulation of commerce, services and industry will be established throughout the national territory and all restrictions on the supply of goods and services, as well as any regulatory requirement that distorts the prices of goods, will be void. market, prevents free private initiative or prevents the spontaneous interaction of supply and demand.
