Case 335-92 and 359-92

This case was an unconstitutionality action brought by the Guatemalan Association of Pharmacists and Chemists et al. challenging the Liberalization of Importation of Medicines Act. The claimants argued that the Act’s elimination of requirements for imported medicines such as expiration dates, instructions in Spanish, and required government testing violated constitutional competition provisions, intellectual property and patent laws, and citizens’ rights to health and quality control of pharmaceuticals, among others.

The case was decided by the Constitutional Court in the first and only instance.

The Court considered that: a) the law sought to liberalize the importation of medicines to obtain better prices; b) the law made importers responsible for the quality of the products that they import; c) the law required that sale of such medicines be through authorized establishments; d) the law only required for importation the presentation of a copy of the health certificate and the certificate of free sale issued by the country of origin of the product; e) the importation and commercialization of drugs that may result in addiction must be authorized and controlled by the Ministry of Public Health and Social Assistance; f) the titleholder of the registry of medicines did not have the exclusive right over their importation, distribution and sale; g) the law established a single location for procedures related to the law; h) the law overturned those regulations that contradicted its provisions, as well as those regulations that prohibited the commercialization of medicines, or that imposed fees for the registration or analysis of medications.

Ultimately the Court held that the law 1) relieved the State of its constitutional responsibility to control products that could affect its citizens' health; 2) ignored the State's constitutional mandate to direct economic policies toward consumer defense, with protection of health as a priority; 3) and 4) imposed unacceptable limits on government control of imports and marketing of drugs; and 5) violated the principles of legal security and certainty by broadly overturning all laws in contradiction to it, without specifying which laws or provisions to which it referred.

The Court therefore ruled that the law was unconstitutional, and overturned it.

“The State’s activities in respect of the public health should be understood as a public service that is exercised in response to the constitutional provisions that establish the bounds of public power to regulate and protect the public health through preventative measures and through the provision of necessary services.”

“La actividad sanitaria del Estado debe concebirse como un servicio público que ejerce en atención a las declaraciones constitucionales que establecen la competencia del poder público para organizar y tutelar la salud por medio de medidas preventivas y de la prestación de los servicios necesarios.”

“In addition, it is necessary to consider that, according to Article 154 of the Political Constitution, public powers cannot be delegated, and this same article refers to all powers of the State, both administrative, as well as legislative and judicial, that are exercised under the State’s jurisdiction, and in accordance with the rules that limit the scope thereof.”

“Por otra parte, es necesario considerar que, según el artículo 154 de la Constitución Política, la función pública no es delegable y la misma comprende todas las funciones del Estado, tanto las administrativas como las legislativas y judiciales, cumplidas dentro de la competencia que les corresponda y conforme a las normas que las delimitan.”

“From the text and the context of the aforementioned constitutional provisions, it can be concluded that the protection of the public health is meant to be undertaken through the direct and decisive intervention of the State, given that it is the State’s non-delegable and essential obligation to take action in the different spheres of the protection and promotion thereof, as the supreme value underlying the social order. As a result, the constitutional framework confers to the State the ineludible power to control those alimentary, pharmaceutical, chemical and, in general, all other products that may affect the public health.

In accordance with the interpretation of the constitutional provisions that are alleged to have been violated, and the analysis of the provisions contained in the challenged Decree, this Court finds that the law in question violates the Constitution because: 1) it relieves the State of its constitutional obligation, as set forth in Article 96, to control those products that may affect the public health, which power the State has exercised through health certificates and through the application of, among others, the provisions of the Health Code; 2) it ignores the mandate contained in Article 119, paragraph i), which orders the State to direct its economic policies toward the defense of consumers and users, in respect of the safeguarding of the quality of consumer products, in order to guarantee, as the State’s highest priority, the health of the nation’s inhabitants; 3) by limiting the control that can be exercised by the Ministry of Public Health and Social Assistance only to those medicines that may result in addiction, the Decree also violates the aforementioned articles of the Political Constitution of the Republic, because it is the State’s ineludible obligation to control not only the aforementioned medicines, but all products that may affect the public health; 4) by accepting as the sole requirement for the importation of medicinal products the health certificate and certificate of free sale issued by the country of origin, the Decree undermines the constitutional mandate to control such products, which the aforementioned provisions, and specifically Article 96, impose upon the State; 5) when, in Article 5, in very broad terms, the challenged Decree overturns all regulations that oppose it, this violate Articles 171, paragraph a), and the 2^nd article of the Political Constitution, which establish, respectively, the power of Congress to decree, amend and overturn laws, and the duty of the State to guarantee, among other things, the security of the nation’s inhabitants, because when this entity overturns laws in the abstract, as in the case at hand, without specifying the provision or provisions to be overturned, this contradicts the principles of legal certainty and security, which are basic pillars of the Guatemalan constitutional framework.”

“Del texto y del contexto de las normas constitucionales referidas se desprende que la protección a la salud se pretende realizar mediante una intervención directa y decisiva del Estado, en cuanto a que es su obligación, indelegable y fundamental, el actuar en los diferentes campos de prevención y promoción de la misma, como valor supremo dentro de la organización social; consecuentemente, la normativa constitucional establece para el Estado una función, ineludible, de controlar los productos alimenticios, farmacéuticos, químicos y en general, de todos los que puedan afectar la salud.

De conformidad con la interpretación de las normas constitucionales que se estiman infringidas, y del análisis de las normas contenidas en el Decreto impugnado, esta Corte advierte que la mencionada Ley viola la Constitución porque: 1) releva al Estado de su obligación constitucional, contenida en el artículo 96, de controlar los productos que puedan afectar la salud, que ha venido realizándose mediante el registro sanitario y mediante la aplicación, entre otras, de las normas del Código de Salud; 2) ignora el mandato contenido en el artículo 119 inciso i), que ordena al Estado orientar la economía en defensa de consumidores y usuarios en cuanto a la preservación de la calidad de los productos para garantizar, como primera prioridad, la salud de los habitantes del país; 3) al limitar el control que debe ejercer el Ministerio de Salud Pública y Asistencia Social sólo a la importación y comercialización de medicinas que produzcan adicción, también viola los mencionados artículos de la Constitución Política de la República, porque es obligación ineludible del Estado el controlar no sólo las referidas medicinas, sino todos los productos que puedan afectar la salud; 4) al aceptar para la importación de los productos medicinales únicamente la copia del registro sanitario y el certificado de libre venta en el país de origen, tergiversa el mandato constitucional de controlar tales productos, que las normas citadas y, específicamente el artículo 96, imponen al Estado; 5) cuando en su artículo 5, en una redacción amplísima, el Decreto impugnado deroga las normas que se opongan al mismo, viola los artículos 171 inciso a) y 2o. de la Constitución Política que establecen, respectivamente, la facultad del Congreso de decretar, reformar y derogar las leyes y el deber del Estado de garantizar, entre otros valores, la seguridad de los habitantes de la Nación, porque cuando este Organismo deroga las leyes en abstracto, como en el caso de mérito, sin especificar la norma o normas que quedan sin vigor, contradice los principios de certeza y de seguridad, pilares básicos del régimen constitucional guatemalteco.”