New law on the prescribing of medicines by their generic name

At the beginning of the year the difficult economic and financial situation prevailing in Argentina, with extreme levels of poverty and a crisis affecting the health system, obliged the Government to issue Decree No. 286/02 declaring a National Sanitary Emergency (1).

In this emergency situation, faced by the difficulty that the lower-income segment of the population (2) was experiencing in acquiring medicine, in recent months Congress has been addressing the need to introduce a nation-wide system for the prescription of drugs by their generic names.

According to the legislators themselves, the purpose of the initiative is to lower the cost of public and private spending on health (3). The writing of prescriptions using generic names allows patients to opt for the lowest price among "similar medicines" (4), which the pharmacist must offer at the request of the consumer. It is therefore expected that the prices of all medicines will tend to fall as a result of competition and the lower prices of the "similar medicines".

The bill received wide support from the Government and a large number of organizations and entities, including those in academic circles.

On the other hand, the three pharmaceutical chambers grouping local and foreign drug manufacturers (CILFA (5), CAEME (6) and COOPERALA (7) ) opposed the project, stating that: "there is no international experience of any similar policy that, against all scientific methods, lays down that medicines with the same active ingredient are equivalent and replaceable among themselves" (8).

For its part, the Asociación Médica Argentina (Argentine Medical Association) criticized the fact that pharmacists would be able to change the drugs prescribed by physicians as part of their technical, legal and ethical responsibility (9).

The new Law No. 25,642 entitled "Promotion of the use of the generic name of medicines" was passed on August 30, 2002 and published in the Official Gazette on September 19, 2002. Its main terms are as follows:

(i) All medical prescriptions must state the generic name of the medicine or standard international denomination being indicated, followed by the pharmaceutical form and dosage/unit, with a detail of the degree of concentration. All prescriptions not complying with these requirements shall be considered invalid.

(ii) The prescription shall also be able to indicate the name or commercial brand, but in this case the pharmacist, at the request of the consumer, may replace it with a lower price medicinal specialty containing the same active ingredients, concentration, pharmaceutical form and similar quantity of units.

Analysis of the requirements of the new law reveals the existence of difficulties in fact and in law that could threaten the life and health of the population.

We detail below the changes introduced by the law and its difficulties.

1.    Physician's obligation to prescribe on the basis of the generic name

The Argentine pharmaceutical market is made up of:

(i) "innovative drugs", which may be patented or not and which first receive authorization for sale on the basis of documentation regarding their efficacy, innocuousness and quality (10); and

(ii) "similar medicines", that contain the identical active ingredients, in the same concentration, in the same pharmaceutical form, with the same method of administration, dosage and therapeutic benefits, and which are equivalent to the specialty indicated as a reference and may differ in aspects such as size and format, excipients, primary container and useful life (according to Decree 150/92).

In the first place it should be noted that the concept of pharmaceutical equivalence that pharmaceutical products require to be considered as "similar medicines" by Argentine legislation is insufficient to guarantee interchangeability in all cases. Pharmaceutical equivalence does not necessarily imply therapeutic equivalence, as the differences in the excipients, manufacturing processes and other aspects could lead to disparities in the performance of the products.

Those products internationally known as "generic medicines" are the only ones that can guarantee interchangeability, because they have been subjected to pharmaceutical equivalence, bioavailability (11) and bioequivalence (12) studies for comparison against the original product.

These studies can be used to certify the efficacy, safety and quality of the products according to international standards, to guarantee that they relate to equivalent medicinal specialties in therapeutic terms; that is to say, that after administration of the same molar dose their effects regarding efficacy and safety are essentially the same.

Once the bioequivalence and industrial pharmaceutical quality studies have been performed and approved, the "similar medicine" can be denominated "generic medicine".

In Argentina there are no "generic medicines", only "similar medicines" that have not been submitted to bioequivalence trials and therefore it is not possible to know if they possess the same therapeutic benefits as the reference medicines (13).

The medicine control body ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica or National Administration of Medicines, Food and Medical Technology) approves "similar medicines" without guaranteeing their therapeutic equivalence.

The "generic name" to which the new law refers is in reality only an active ingredient or an association of active ingredients. However, the active ingredient alone is not enough to ensure the same therapeutic effect as an original medicine, as there are various other factors that could cause clinically determinable differences between drugs with a similar chemical composition.

In short, what appears to be a simple question of terminology between generic and similar medicines is in fact at the heart of the matter, as generic drugs require studies that guarantee their therapeutic equivalence to the original medicine, while the latter only have a pharmacological equivalence.

Thanks to the new law, consumers may opt with the assistance of a pharmacist for a medicine that is similar to that prescribed by the physician, although without a guarantee that it will have the same therapeutic equivalence.

This endangers the right to health and life as well as the right to adequate and truthful information enabling the exercise of valid options, in violation of articles 33 and 42 of the National Constitution.

2.    Obligation of the pharmacist to replace, at the request of the consumer, the physician's prescription for a lower priced medicinal specialty that contains the same active ingredients, concentration, pharmaceutical form and similar quantity of units

The obligation that the new law imposes on the pharmacist to substitute, at the consumer's request the medical prescription for a less expensive medicinal specialty constitutes a transgression of the existing legal regime.

On the one hand, the law that regulates the exercise of medicine (Law No. 17,132) imposes on the physician the responsibility for the prescription of medicine, while on the other the law governing the exercise of the pharmaceutical activity (Law No. 17,565) prohibits its members from encouraging their customers to purchase a given medicine (section 32, cl. h).

From the new law however, it appears that the choice of the active ingredient will be made by the doctor, but the medicine (the identity of which is made up of the active ingredient, the excipients, the dosage and the chemical pharmaceutical process) will be chosen between the consumer and the chemist, both of whom lack the appropriate means for a sound diagnosis and the technical training to enable them to medicate.

In the first place, when the physician prescribes by generic name, he does not indicate precisely the medicine that is considered appropriate for the patient in terms of therapeutic effect, because as explained, the active ingredient is not the only element involved.

Similarly, the physician is totally unaware of the therapeutic effect of the substitute medicine to be recommended by the pharmacists on the basis of the active ingredient indicated by the physician.

It can be seen that the law has put together a puzzle whereby the physician prescribes a generic name without knowing the therapeutic effect of the medicine, and on the other hand the pharmacist will substitute the item prescribed by the physician without knowing the patient's pathology and without knowing whether the "similar medicine" will provoke the therapeutic effect necessary for that patient in particular.

It might be possible to uphold the argument that the physician is also not competent to certify the difference in quality of medicine between a branded and a similar product.

However, the physician is the most suitable person to prescribe a given medicine because he is the professional in the art of curing, he best knows the pathology of the patient and he is the person who will monitor the patient's reaction to the drugs as well as that of other patients, and also because as a result of his own experience and the information provided by the pharmaceutical laboratories he is aware of the features that make one medicine more effective than another in the treatment of a given pathology.

It is true that the law allows the physician to suggest a brand name if he considers it necessary, but unfortunately it has been left to the criteria of the consumer and the pharmacist to decide whether or not to accept the physician's indication, which would seem to be unacceptable.

It is also a fact that in many cases it is not the pharmacist himself who serves the public, but an employee, further aggravating the risks derived from such a substitution.

The foregoing is intended to serve as a warning regarding the difficulties and risks that will arise as a result of the new practices required by this law.

To conclude, it should be considered that this law has come about as a result of the national health emergency in which the country is immersed, requiring the facilitating of access to medicine by the population, particularly the poorer segments.

It can also be considered that this matter is not an Argentine invention, as in many countries "generic medicine" has been used to lower the price of prescription drugs.

However, as we have explained, "generic medicine" requires the performance of bioavailability and bioequivalence studies to verify that their therapeutic effects are identical to those of the original medicine, and these are not performed in Argentina.

Without these studies, the medicines can be said to be pharmacologically similar but not necessarily interchangeable in therapeutic terms. Hence the grave risk that the new law represents for the health of persons.

In conclusion, a law that permits the interchangeability between medicines that are not interchangeable places the life and health of the country's citizens and their right to adequate and truthful information, in violation of articles 33 and 42 of the National Constitution.

For this reason we argue that this law should apply only to the substitution of "original medicines" by "generic medicines" that have been duly approved by the ANMAT, once the necessary tests have been performed to establish their equivalent therapeutic effect.

This is technically feasible, the costs are reasonable, it would provide a source of employment and has enormous health implications. The protection of the health and life of its citizens is the Government's moral and legal obligation.

(1) It should be clarified that section 10 of Decree No. 150/92 governing the registration, manufacture, fractionating, prescription, sale and import of medicine had already established the mandatory use of generic names in labels, medical prescriptions, etc. In addition, prior to the issue of the law under review, in June 2002, the National Ministry of Health and Social Action had issued Resolution No. 326/02 establishing the prescription of medicines using their generic names.

(2) According to the latest Permanent Household Survey, 18.5 million Argentines are poor and 8,700,000 fall into the category of indigent. The price of medicine has risen 200% since January. Currently 5,000,000 Argentine have lost their welfare fund coverage because of unemployment or the crisis in the health system (data obtained from the statements of Senators debating the bill).

(3) The National Ministry of Health and Social Action spends a total of 24 billion pesos, and 30% of this amount goes on medicine (7 million pesos) according to the Ministry itself. It has been estimated that the law on the prescription of medicine using generic names will result in a reduction in this cost of approximately 2 billion pesos (data extracted from statements by Senator Alperovich during the session of Congress when the new bill was being debated).

(4) These are described as similar medicines because they are pharmaceutically equivalent. It does not mean that they necessarily guarantee an equivalent therapeutic benefit. Similar medicines have lower prices because they do not require research and development, they are not protected by patents allowing them to set monopolistic prices, they must adapt their prices to market levels, and their advertising and marketing strategies are less aggressive.

(5) CILFA (Centro Industrial de Laboratorios Farmacéuticos or Industrial Center of Pharmaceutical Laboratories).

(6) CAEME (Cámara Argentina de Especialidades Medicinales or Argentine Chamber of Medicine Specialties).

(7) COOPERALA (Cooperativa de Laboratorios Argentinos de Especialidades Medicinales or Cooperative of Argentine Laboratories of Medicine Specialties).

(8) The Argentine Consumer Protection Association (ADECUA) also filed an injunction for the suspension of decrees 486/82 and 326/02 as a preventive measure until such time as adequate mechanisms and controls have been put into place to ensure that the substitution and sale of medicine is carried out under secure conditions by suitable professionals involving interchangeable medicines expressly authorized by the ANMAT.

(9) See note by the president of the Argentine Medical Association, Prof. Elías Hurtado Hoyo in the magazine "Gracias Doctor" included with the VIVA magazine in the Clarín newspaper on September 8, 2002.

(10) To approve an original drug the regulatory authority requests pharmaceutical and industrial quality studies, in vitro studies and clinical trials that support its efficacy and safety.

(11) Bioavailability: This is the quantity and speed at which the active ingredient in a pharmaceutical form reaches the bloodstream, determined by means of the concentration/time curve or urinary excretion (WHO/disp 3185/99 ANMAT).

(12) Bioequivalence: Two medicinal specialties are bioequivalent when, while pharmaceutically equivalent, their bioavailability after administration in the same doses is sufficiently similar that it can be expected that their effects will be essentially the same. This can only be corroborated by means of clinical research to determine the plasmatic levels of both medicines in healthy volunteers or in patients, as the case may be. The performance of these trials is possible in Argentina in both public and private institutions and can cost around US$10,000, depending on the degree of complexity.

(13) "Reference medicines" are patented pharmaceutical products, the first to be sold or the market leaders.