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PUBLICA HEALTH

Law 26.588

Health care, clinical and epidemiological research, vocational training in early detection, diagnosis and treatment of celiac disease are described in national interest.

Sanctioned: December 2, 2009

Cast: December 29, 2009


ARTICLE 1 O Deplore national interest in medical action, clinical and epidemiological research, professional training in early detection, diagnosis and treatment of celiac disease, its dissemination and access to gluten-free foods and medicines.

(Article replaced by Article 2 of the Act No. 27.196 B.O. 18/11/2015)

ARTICLE 2 O The authority to implement this law shall be the Ministry of Health of the Nation.

ARTICLE 3o O The application authority must determine the amount of wheat gluten, oats, barley or rye (TACC) that contain by unit of measure food products and medicines to be classified gluten-free or gluten-free. To the extent that the detection techniques permit the application authority will fix the gradual decrease in toxicity.

(Article replaced by Article 2 of the Act No. 27.196 B.O. 18/11/2015)

ARTICLE 4o O Food products and medicines that are commercialized in the country, and that comply with the provisions of Article 3 of this Law, to be considered gluten-free, must be printed in their packaging or wrapping and in their labels and prospects respectively, in a clearly visible way, the legend of gluten free and the symbol that establishes the authority of application.

All medicines or medicinal specialties included in the Register of Medical Specialties that cannot dispense with gluten as an integral part of its formula should substantiate its presence and quantify it by „certainty of pharmaceutical doses according to the provisions of Article 3 of this Law.

Medicines that use ingredients that contain gluten should clearly include the legend: This medicine contains gluten.

(Article replaced by Article 2 of the Act No. 27.196 B.O. 18/11/2015)

ARTICLE 4o bis O The institutions and establishments listed below should offer at least one food option or a gluten-free menu (without TACC) that meets manufacturing conditions and nutritional requirements per serving, which certifies the application authority:

(a) Places for persons in situations of deprivation of liberty;

(b) Health facilities with public, private and social security boarding;

(c) Places of residence and/or temporary or permanent coexistence offering food;

(d) Trainers and kiosks of educational institutions;

(e) Air, terrestrial and aquatic transport companies offering food on board;

(f) Restaurants and bars;

(g) The kiosks and food dealers of terminals and transport stoppers;

(h) Fast food facilities;

(i) Those who determine the enforcement authority in coordination with the jurisdictions in accordance with the availability of those already established in this article.

(Article 1 of the Act No. 27.196 B.O. 18/11/2015)

ARTICLE 5o O The Ministry of Health must keep a record of foodstuffs and medicines that are commercialized in the country and that comply with the provisions of article 3 of this Act, which will update on a bimonthly basis and publish once a year, by means determined by the implementing authority.

(Article replaced by Article 2 of the Act No. 27.196 B.O. 18/11/2015)

ARTICLE 6o O The application authority should promote compliance with the conditions of good manufacturing practices for the development and control of food products and medicines that are commercialized in the country and that comply with the provisions of Article 3 of this Law, coordinating actions with the laboratories of brothology and medicinal specialties.

(Article replaced by Article 2 of the Act No. 27.196 B.O. 18/11/2015)

ARTICLE 7o O Producers and importers of foodstuffs and medicines intended for celiacs must credit for their marketing in the country the status of gluten free, as provided for in Article 3 of this Law.

(Article replaced by Article 2 of the Act No. 27.196 B.O. 18/11/2015)

ARTICLE 8o O Producers, importers or any other natural or legal person who commercializes foodstuffs and medicines, as provided for in Article 3, must disseminate, publish or promote them by accompanying to advertising or dissemination the legend „Free of gluten“ or ”This gluten medicine contains gluten content accordingly. If the form of diffusion, advertising or promotion allows it, the legend must be informed visually and soundly.

(Article replaced by Article 2 of the Act No. 27.196 B.O. 18/11/2015)

ARTICLE 9o O The social works under the laws 23,660 and 23.661, the social work of the judiciary of the Nation, the Directorate of Social Assistance for the staff of the Congress of the Nation, the prepaid medical entities and the entities that pay attention to the personnel of the universities, as well as all those agents that provide medical services to their affiliates regardless of the legal figure they possess, must provide preclassical coverage to the people with celia.

(Article replaced by Article 2 of the Act No. 27.196 B.O. 18/11/2015)

ARTICLE 10. The Ministry of Social Development should promote agreements with the jurisdictional authorities, for the provision of gluten-free flours and premixtures to all persons with celiac disease who are not covered by article 9 of this Act, as provided by the regulations.

ARTICLE 11. The Ministry of Health, in coordination with the Ministry of Science, Technology and Productive Innovation and the universities of the National University System, should promote research on celiacs, in order to improve methods for early detection, diagnosis and treatment of the disease. The Ministry of Health, in coordination with the Ministry of Education, should develop outreach programmes in the educational fields, in order to promote awareness of celiacs and relevant national public bodies to promote incentive measures for access to gluten-free food and medicines.

In addition, the Ministry of Health should promote and implement training activities for celiac patients and their family group in self-production and production of food suitable for consumption.

(Article replaced by Article 2 of the Act No. 27.196 B.O. 18/11/2015)

ARTICLE 12. The Executive Power must adapt the provisions of the Argentine Food Code and, from the Register of Medical Specialties of the ANMAT to the provisions of this Act within the period of ninety (90) days of its official publication.

(Article replaced by Article 2 of the Act No. 27.196 B.O. 18/11/2015)

ARTICLE 13. The following conducts shall be considered offences under this Act:

(a) The impression of the legends „Free of gluten“ or ” This medication contains gluten in packaging or packaging of food products and medicines that do not comply with the provisions of Article 3 of this Law; (Incision replaced by art. 2° Act No. 27.196 B.O. 18/11/2015)

(b) Failure to comply with good manufacturing practices established for the development and control of food products and medicines that are commercialized in the country and that comply with Article 3; (Incision replaced by art. 2° Act No. 27.196 B.O. 18/11/2015)

(c) Any form of dissemination, advertising or promotion such as gluten-free, food products and medicines that do not comply with Article 3; (Incision replaced by art. 2° Act No. 27.196 B.O. 18/11/2015)

(d) The lack of full or partial benefit of the assistance coverage provided for in Article 9 by the above-mentioned entities;

(e) The concealment or denial of information required by the enforcement authority in its control function;

(f) Lack of supply of gluten-free food options or menus in accordance with Article 4° bis; (Incision replaced by art. 2° Act No. 27.196 B.O. 18/11/2015)

(g) Actions or omissions to any of the obligations established, committed in violation of this law and its regulations not mentioned in the preceding paragraphs. (Included by Article 2 of the Act No. 27.196 B.O. 18/11/2015)

ARTICLE 14. Offences to this Act shall be punishable by:

(a) Perception;

(b) Publication of the resolution that provides for punishment in a medium of mass dissemination, as determined by regulation;

(c) A fine that must be updated by the national executive branch on an annual basis according to the official price index of the National Institute of Statistics and Censuses ,INDEC,, from pesos a thousand ($1.000) to pesos a million ($1.000.000), which can be increased to the decuplo in case of recidivism;

(d) Suspension of the establishment by the end of up to one (1) year;

(e) Closure of the establishment of one (1) to five (5) years; and

(f) Suspension of advertising until its adequacy with the provisions of this law.

These sanctions shall be regulated in a gradual and cumulative manner, taking into account the circumstances of the case, the nature and gravity of the offence, the background of the offender and the injury caused, without prejudice to other administrative, civil and criminal responsibilities, to which there is room. The proceeding of fines shall be used for the dissemination and training campaigns set out in this Act.

ARTICLE 15. The authority for the application of this law must establish the administrative procedure to apply in its jurisdiction for the investigation of alleged offences, ensuring the right of defence of the alleged offender and other constitutional guarantees. It is empowered to promote the coordination of this role with the national public bodies involved in their areas covered by this law and with the jurisdictions they have acceded to. It may also delegate to the jurisdictions that have acceded to the proceedings to give rise to the offences envisaged and to grant them representation in the handling of the judicial remedies against the sanctions imposed. Exhausted the administrative channel shall proceed to appeal in judicial headquarters directly to the Federal Appeals Chamber with jurisdiction in the place of the act. The remedies against the implementation of the envisaged sanctions will have a devolutionary effect. For substantial reasons, in order to avoid an irreparable levy to the person concerned or to safeguard third parties, the remedy may be granted with suspensive effect.

ARTICLE 16. Invite the provinces and the Autonomous City of Buenos Aires to accede to this law.

ARTICLE 17. Acts 24,827 and 24,953 are repealed.

ARTICLE 18. Contact the national executive branch.

IN THE SESSION OF THE ARGENTINE CONGRESS, IN GOOD AIRES, TO THE TWO DAYS OF THE TWO YEAR TWO MIL NEW.


JOSE J. B. PAMPURO. EDUARDO A. FELLNER. . Enrique Hidalgo. . Juan H. Estrada.