PUBLIC HEALTH

Law 26,688

Declare of national interest the research and public production of medicines, raw materials for the production of medicines, vaccines and medical products. Sanctioned: June 29, 2011 Enacted in Fact: July 29, 2011

The Senate and Chamber of Deputies of the Argentine Nation, meeting in Congress, etc., are sanctioned by law:

Article 1-State of national interest in the research and public production of medicines, raw materials for the production of medicines, vaccines and medical products, understanding them as social goods.

Article 2-It is the object of this law to promote the accessibility of medicines, vaccines and medical products and to promote scientific and technological development through laboratories of public production.

ARTICLE 3-It is the application authority of this law the Ministry of Health.

Article 4-They are considered laboratories of public production for the purposes of this law, the laboratories of the national, provincial, municipal and Autonomous City of Buenos Aires, of the forces located and of the institutions State management university.

ARTICLE 5-A regime of public production of medicinal products, raw materials, vaccines and medical products is hereby established.

ARTICLE 6-The regime established by this law shall have among its objectives the following: (a) to establish a register of public production laboratories, which must contain as minimum data operational status, installed capacity and registration conditions; (b) establish as a reference framework for the production of medicinal products the proposal for essential medicines of the World Health Organisation; (c) Define priorities in strategic production lines taking into account the epidemiological and seasonal profiles of the regions of our country; provision of medicinal products, vaccines and medical products for the first level of (e) Promoting research, development and production of orphan drugs; (f) Promoting its articulation with academic and scientific institutions and organizations of the European Union. workers and

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(g) Promoting a better use of the resources available at each institutional level, avoiding overlapping of production; (h) Promoting centralised purchases of inputs, in so far as they allow more favourable conditions for the (i) Promoting research and teaching, as well as training and training of human resources; (j) Promoting research, production and development of plant-based active principles and phytomics, prioritizing indigenous species of the country.

Article 7-The Ministry of Health should promote agreements with other national ministries and within the framework of the Federal Health Council (COFESA-) with the competent authorities of the jurisdictions, in order to establish criteria and priorities in the the allocation of budgetary resources and the coordination of the implementation of the scheme provided for in this Act for the purpose of developing the following actions: (a) Outline and develop operational bases; (b) Establish an operational procedure for the effective distribution of medicinal products, vaccines and medical products authorised for interjurisdictional transit; (c) Implement the Register of Public Production Laboratories; (d) Establish guidelines to ensure the quality, accessibility and traceability of medicines, vaccines and medical products; and) Promote mechanisms to grant preferences in the procurement of the medicines, vaccines and medical products of the laboratory public production by the national, provincial, municipal and municipal government of Buenos Aires; (f) to prepare an annual report on the actions carried out and their evolution and publish it by all means of dissemination available.

ARTICLE 8-Public production laboratories may conclude agreements with universities or other relevant state entities to carry out quality control of medicines, vaccines and medical products.

ARTICLE 9-The National Administration of Medicinal Products, Food and Technologies (ANMAT), which is decentralized in the field of the Ministry of Health, in its capacity as the authority of Comptroller and Enablement, must require the production laboratories (a) the implementation of good manufacturing and control practices.

ARTICLE 10. -This regulation does not limit the manufacture of medicinal products in hospital pharmacies under the control of the respective jurisdictions.

ARTICLE 11. -The Ministry of Health should promote the necessary agreements with state university institutions that have laboratories of public production, to coordinate their activity with the aims pursued by this law.

ARTICLE 12. -The regime established by this law should be solved with the specific items corresponding to the jurisdiction 80-Ministry of Health, according to the General Budget for the National Public Administration.

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ARTICLE 13. -Invite the provinces and the Autonomous City of Buenos Aires to adhere to this law.

ARTICLE 14. -Contact the national executive branch. GIVEN IN THE SESSION HALL OF THE ARGENTINE CONGRESS, IN BUENOS AIRES, AT THE TWENTY-NINE DAYS OF THE MONTH OF JUNE OF THE YEAR TWO THOUSAND ELEVEN. -REGISTERED UNDER NO. 26,688-JULY C. C. COBOS. -EDUARDO A. FELLNER. -Enrique Hidalgo. -Juan H. Estrada.

Date of publication: 02/08/2011

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