Medicines Activity Of The Public Production Laboratories - Full Text Of The Norm

Original Language Title: MEDICAMENTOS ACTIVIDAD DE LOS LABORATORIOS DE PRODUCCION PUBLICA - Texto completo de la norma

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ACTION

Law 27.113

The activities of public production laboratories should be described in national and strategic interest. National Public Laboratory Agency. Creation.

Sanctioned: December 17, 2014

Enacted: January 20, 2015

The Senate and Chamber of Deputies of the Argentine Nation assembled in Congress, etc. sanction with force

Law:

ARTICLE 1 — The activities of public production laboratories dedicated to the research and public production of medicines, raw materials for the production of medicines, vaccines, inputs and medical products are described in national and strategic interest.

ARTICLE 2 The purpose of this law is to promote the activity of the public production laboratories, understanding for them those belonging to the national, provincial, municipal and the Autonomous City of Buenos Aires, the armed forces and the university institutions of state management.

ARTICLE 3 — This law has the following objectives:

(a) Promoting research and scientific, technological and industrial development of public production laboratories;

(b) Strengthen the role of public production laboratories in the health system;

(c) To promote public programmes and policies that prioritize the accessibility of medicines, raw materials for the production of medicines, vaccines, inputs and medical products, considered as social goods;

(d) To guide the production and supply of medicines, vaccines, inputs and medical products to the public health subsector and to non-profit agencies or institutions;

(e) Promoting exchange and cooperation among public production laboratories at the regional and international levels.

ARTICLE 4 Créase la Agencia Nacional de Laboratorios Públicos (ANLAP), organism decentralised in the orbit of the Ministry of Health of the Nation, with economic, financial autarchy, its own legal entity and capacity to act in the field of public and private law. Its heritage is made up of the goods that are transferred to it and by those that acquire in the future for any title.

ARTICLE 5 — The ANLAP has the following functions and powers:

(a) Ensure compliance with the objectives set out in law 26,688 and its regulation;

(b) Design public policies for research and public production of medicines, raw materials for the production of medicines, vaccines, inputs and medical products and their distribution in the health system;

(c) Define priorities in strategic production lines, as provided for in law 26,688 and its regulation;

(d) Provide technical assistance, propose actions and conclude agreements to ensure the training and training of human resources that are developed in public production laboratories;

(e) Coordinate, within the framework of the Federal Health Council, national and provincial public policies for public production laboratories;

(f) To promote the conclusion of agreements between public production laboratories and universities or other relevant State entities for the quality control of medicines, vaccines, inputs and medical products and their distribution in the health system;

(g) To promote public-private partnerships of mutual convenience in the area of research and development;

(h) Carry out actions between the National Administration of Medicines, Foods and Technologies (ANMAT) and public production laboratories to ensure compliance with the current regulatory framework;

(i) Promote actions within the framework of COFESA to ensure the best conditions in the centralized supply and purchase of inputs and in the development of the components of the distribution logistics, as well as to facilitate access to sources of financing for investment;

(j) Promote investments to expand the installed capacity, infrastructure and equipment of public production laboratories that adhere to this law;

(k) Carrying out public production laboratories in accordance with the provisions of Act No. 26,688 and its regulations.

ARTICLE 6 The ANLAP is managed and managed by a board composed of three (3) members, one (1) president, one (1) vice president and one (1) secretary. The board members must be selected from a technical and professional background and designated by the national executive branch, one of them on the proposal of COFESA.

Its mandate will last five (5) years and can be renewed for once. The directory must issue the internal regulations.

Members of the board must have full dedication in their role, affording them the incompatibility set by law for public officials and can only be removed from their posts on the basis of the national executive branch. The members of the board will receive the retribution set by the national executive branch.

ARTICLE 7 The directory is responsible for the management and supervision of the activities and functions of the ANLAP, and are the powers of the same:

(a) Develop the ANLAP operational plan for the coordination of the production, research and development of medicines, raw materials for the production of medicines, vaccines, inputs and medical products;

(b) Promote the institutional relations of ANLAP, national and international and, where appropriate, propose agreements between public production laboratories, universities or other relevant state entities to promote the research and public production of medicines, vaccines, inputs and medical products;

(c) Develop and approve ANLAP investment plans, programmes and plans;

(d) Proposing the annual cost budget, resource calculation and investment accounts;

(e) To approve the overall memory and balance at the end of each exercise;

(f) To require the various agencies of the national civil service the transitional commission of appropriate personnel in the matter necessary for the operation of the agency;

(g) Designate the members of the Advisory Committee and the Executive Committee.

ARTICLE 8 — The president of ANLAP has the following duties and functions:

(a) To exercise the administration of ANLAP by signing relevant administrative acts to that end;

(b) To convene and chair the meetings of the advisory committee and executive committee and participate in them with voice and vote;

(c) To convene the advisory committee at least one (1) time for every six (6) months and to submit to its consultation the planned and ongoing policies;

(d) Coordinate and conduct all of the agency ' s activities in order to achieve the best implementation of the objectives proposed in article 3;

(e) To sign agreements with public or private, national or foreign organizations for the achievement of the objectives of ANLAP in coordination with relevant agencies;

(f) Approval of the annual cost budget, resource calculation and investment accounts;

(g) Manage the funds of ANLAP and carry the inventory of all its assets, in accordance with the rules established by the directory and the legislation in force in the matter;

(h) To exercise the other powers and functions assigned to it by the directory;

(i) Dictate the regulations necessary for the operation of ANLAP;

(j) To exercise the representation and general direction of ANLAP, to act as an actor and respondent in matters of exclusive competence.

ARTICLE 9 — The Vice-President shall perform the functions assigned to him or her by the President, and shall replace him in the event of the absence, impediment or leave of office.

ARTICLE 10. - Board members may not be owners or have any direct or indirect interest in companies in the private sector of the pharmaceutical market or medicines, private health providers, or in their controlled or controlling companies.

ARTICLE 11. - ANLAP will be assisted by an advisory committee that will have the function of collaborating and advising in all matters concerning public policy of production, research and development of medicines, raw materials for the production of medicines, vaccines, inputs and medical products. The committee will be composed, on an ad honórem basis, by representatives of recognized human rights organizations, members of the multisectoral for the public production of medicines, by a representative of ANMAT, by a representative of INTI, by a representative of the Conicet, by a representative of the National Inter-university Council, by a representative of the trade unions, by a representative of the Ministry of Science, Technology and Productive Innovation, a representative of the Argentine Confederation

The functions of the advisory committee shall be:

1. Propose public policies on public production of medicines, raw materials for the production of medicines, vaccines, inputs and medical products and express opinion on which they are carried out by ANLAP.

2. Develop and raise biannually to the ANLAP directory public policy proposals on public production of medicines, raw materials for the production of medicines, vaccines, medical inputs and products, development and research.

ARTICLE 12. - The ANLAP will be assisted by an executive committee, which will have the function of coordinating the implementation of national policies in the field of public production of medicines, raw materials for the production of medicines, vaccines, medical inputs and products; research and development and will be integrated, on an ad honórem basis, by the representatives of the national, provincial, municipal, public production laboratories of the Autonomous City of Buenos Aires, the armed forces and the management of the state university institutions.

ARTICLE 13. - For the purposes of forming the executive committee of ANLAP, laboratories that decide to be incorporated as full members shall be subject to the rights and obligations set out in the framework of this law, those that emanate from its regulations and those established in the internal regulations.

ARTICLE 14. - ANLAP's operational resources will come from:

(a) Budget allocations allocated by the budget law to the Ministry of Health or special laws;

(b) Any income not provided for in the preceding paragraph, from the management of the agency itself;

(c) Property transferred to ANLAP by other State agencies;

(d) Any other income legally prescribed.

ARTICLE 15. - ANLAP is bound only and may require commitments to public laboratories that are part of its executive committee.

ARTICLE 16. - The Ministry of Health is implementing authority.

ARTICLE 17. - Invite the provinces, the Autonomous City of Buenos Aires and the municipalities to adhere to this law.

ARTICLE 18. - Contact the national executive branch.

IN THE SESSION OF THE ARGENTINE CONGRESS, IN GOOD AIRES, TO THE DECEMBER OF THE YEAR TWO MIL CATORCE.

— REGISTRATE BAJO #27.113 —

JULIAN A. DOMINGUEZ. - GERARDO ZAMORA. - Lucas Chedrese. — Juan H. Estrada.

(Note Infoleg: by art. 1 Resolution No. 2011/2015 of the Ministry of Health B.O. 9/11/2015 is transferred the ‘NATIONAL PROGRAMME FOR THE PUBLIC PRODUCTION OF MEDICAMENTS, VACUNAS AND MEXICO PRODUCTS’ created under Resolution No. 286 dated 9 April 2008 to the unit of the NATIONAL AUGUST OF PUBLIC LABORATORIES (ANLAP), a decentralized body in the orbit of the HEALTH MINISTERY)