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The Cancellation of Health Norms and Possible Consequences

By Rafael Gual - CANIFARMA
Director General


By Rafael Gual | Director General - Tue, 07/11/2023 - 15:00

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Norms are legal instruments of foremost importance to ensure  the quality of the services provided or the products consumed.

Of course, standards are not a Mexican invention or a lucubration of the industry to preserve its privileges. On the contrary, standards oblige manufacturers and service providers to maintain optimum quality standards and represent fundamental safety parameters for consumers, since they are created precisely for their protection.

The norms are defined by the government, calling upon experts in the field and taking as a reference, in many cases, already established international standards.

In the case of health, there are several instruments at the international level that provide, by way of example and in a succinct manner, guidance on existing diseases, symptoms, diagnosis, and treatment.  The most important of these, which provides data on the causes of mortality and morbidity in the world, is the International Classification of Diseases (ICD), which is more than a century old and whose latest revision is the11th, carried out in 2019 during the 72nd World Health Assembly of the World Health Organization (WHO) and which came into force on Jan. 1, 2022.

This instrument provides data and statistics that support governments in establishing coverage, planning, administration, and quality of services and, of course, in the development and updating of standards*. 

In Mexico, the antecedents date back to the signing of the North American Free Trade Agreement, since it was at that time (1992) that the Federal Law on Metrology and Standardization was approved, which gave rise to the Official Mexican Norms of all kinds, including those specialized in health, which had been gradually updated.

In July 2022, the Federal Metrology and Standardization Law was repealed to give way to the Quality Infrastructure Law, which redefines the functions of the Mexican Official Norms (NOM), including the promotion of quality and consumer protection. This law also establishes the National Quality Infrastructure Program, which was approved at the beginning of this year and whose purpose is precisely to update the standards so that they are adapted to technological advances, without losing their relevance.

The Supplement to the National Quality Infrastructure Program that was published on June 1, 2023, reported on the development of the cancellation procedure, without any justification and without mentioning the reasons for the decision, of 34 norms related to health, of which  the most relevant due to their impact on the health of the population are the following:

- NOM-015-SSA2-2010, for the prevention, treatment, and control of diabetes mellitus.

- NOM-030-SSA2-2009, for the prevention, detection, diagnosis, treatment, and control of systemic arterial hypertension.

- NOM-014-SSA2-1994, for the prevention, detection, diagnosis, treatment, control, and epidemiological surveillance of cervical cancer.

- NOM-041-SSA2-2011, for the prevention, diagnosis, treatment, control, and epidemiological surveillance of breast cancer.

As we can see, the NOMs we are referring to related to highly prevalent diseases in our country and determine standards of care and quality for these diseases, from the establishment of preventive measures to combat them to providing certainty on the rights and obligations of the establishments that provide services, not only in the public sector but also in the private sector.

It is important to point out that the health sector programs were also based on the information provided by the compliance with the standards by the institutions whose observance was mandatory.

The guarantee and surveillance of regulatory quality standards provide legal certainty while protecting the population and the users of such services and products. As an example of the usefulness of one of these standards for the population, suffice it to point out what happened with the recent crisis from the lack of oncological medicines for children with cancer, where parents were able to obtain treatments via amparo lawsuits, making their argument around the standard established for the care of the disease.

As already mentioned, no justification or public motivation is expressed in this decision, so we can only conjecture what the reasons are, since the government is depriving itself of the right to demand that individuals comply with standards, but also depriving the general population of the possibility of exercising their right to receive quality care in these specific cases.

Although they are not exclusively applied by the health sector, we can say that a considerable part of the canceled norms does correspond to it, so that a possible hypothesis would be aimed at saving resources.  Without a standard that establishes the parameters of care for a disease, the treatments of choice and their follow-up, it will be impossible for patients to demand compliance with the authority, which could have disastrous consequences.

Let us hope that in the future the reasons for these radical decisions, such as these cancellations, can be clarified. This situation has been exposed by several actors of society, such as patients' associations, physicians, and legislators, with the hope that eventually the updating of the existing norms will be sought and not their cancellation.

Photo by:   Rafael Gual

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