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Biotechnology. Promotion.

Original Language Title: Biotecnologia. Promocion.

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Legislative Power/ Eastern Republic of Uruguay
Published D.O. 2 mar/015-NAº 29161

Law No. 19,317

BIOTECHNOLOGIES

NORMAS FOR YOUR PROMOCIA " N

The Senate and the CA of Representatives of the Eastern Republic of Uruguay, meeting in General Assembly,

DECREE:


CAPATULO I

GENERAL PROVISIONS

ArtAculoA 1Aº. For the purposes of this law it is understood by BiotechnologA any technological application that uses biological systems and living organisms or their derivatives for the creation or modification of products or processes for specific uses.

Also, it is understood by New Entrepreneurship the creation of a company or an existing business unit in the area of the biotechnology industry in the national territory destined to produce goods or services in a creative way, method, responsible and ethical.

ArtAculoA 2Aº.A (Declaratory of national interest).-The development of Biotechnologies and its applications as fundamental factors for technological innovation, productivity, the development of biotechnology, competitiveness, sustainable development and the well-being of the population.

ArtAculoA 3Aº.A (Object of the law).-The purpose of this law is to promote research, technology transfer and application and development of national and departmental Biotechnologies.

The limitations and scope of the activities covered will be governed by these provisions and by the regulatory norms (in the framework of the international obligations that the State has assumed).

ArtAculoA 4Aº.A (Finality of the Law).-The purpose of this law is to promote the economic and sustainable development of the country. To this end, it will tend to increase productivity and competitiveness in the framework of the national interest according to the law. And, likewise, it preserves biological diversity without affecting the health of the population and the environmental balance.

ArtAculoA 5Aº.A (Activities included).-The following activities are considered to be included in this law:

a) scientific research and everything related to the development of the biotechnology area.

b) the technological transfer to the productive sector of goods and services.

c) those aimed at developing new biotech ventures and their marketing.

d) the incorporation of Biotechnologies in every production process.

e) the demand stack through a public purchasing system that encourages the development of Biotechnologies.

f) education at all levels and the dissemination of biotechnology in all population.

g) all other industry-related activity.

ArtAculoA 6Aº.A (Subjective Application Scope).-The persons or legal, public and private persons who develop at national and departmental level the activities mentioned in the previous article shall be covered by the provisions of this law.

ArtAculoA 7Aº.A (Investment Promotion).-The inclusion of the activities of Biotechnologies and their applications defined in the article 5Aº of this law in the promotion of promotion and its applications is made. protection of investments, set in Law No 16,906of 7 January 1998 and other relevant regulatory standards.

CAPATULO II

COMPETENT AUTHORITIES

ArtAculoA 8Aº.A Crate the Inter-Ministerial Group of the Biotechnology Industry, which will be integrated by the Ministries of Industry, Energaa and MinerAa (MIEM), of Livestock, Agriculture and Fisheries (MGAP), of Education and Culture (MEC), Public Health (MSP) and Housing, Territorial Ordinance and Environment (MVOTMA), which will function in the first one, with the advice of the Sectoral Council of Biotechnologies (CSB) with the following tasks:

a) prior and precept advising the various Ministries on the approval of regulatory standards necessary for the application of this law;

b) design and coordinate public policies to promote research, innovation, development, production, Technology transfer and application of Biotechnologies;

c) evaluate the initiatives presented by the CSB and promote the approval of the regulatory instruments needed for its apply

d) define the strategic guidelines of the CSB's work, how to approve its annual action plan;

e) designate the Executive Power representatives in the CSB.

In the case of biotechnological provisions or initiatives applicable to human health, the advice of the MA©dic College of Uruguay should be obtained in advance to ensure the congruence of the same with the code of A%tica MA©dica.

ArtAculoA 9Aº.A Crése the Sectoral Council of Biotechnologies (CSB) in order to promote the recognition of the paAs in the global biotechnology market derived from the increase of innovation and the promotion of the Scientific knowledge; and in particular, its ability to articulate education and technological and productive advancement in the search for sustainable development.

The CSB will participate in the harmonisation of sectoral policies in the field of biotechnologyAsadvising the Inter-Ministerial Group or the Authority of Implementation, as the case may be, in:

a) the design, development and implementation of sectoral policies, which are summarized in the Sectoral Strategic Plan, with Definition of targets, strategic objectives and corresponding policy tools, as well as action plan and indicators that allow adequate monitoring of the results achieved;

b) the monitoring and evaluation of the development of the Sectoral Strategic Plan, based on the instruments defined in the Previous literalA;

c) the adjustment or revenue of the Sectoral Strategic Plan and the adaptation of the policy tools in the Industry evolution;

d) identifying constraints, market imperfections, and productive development needs that are presented In turn, the proposal for palliative measures to support medium and long-term objectives.

ArtAculoA 10Aº.A (Composition).-The Sectoral Council of Biotechnologies (CSB) will function as a coordination between government, employers, workers and the academic sector and as A Advice from the Inter-Ministerial Group and the Authority of Application, and may propose with a recommendation of the measures that it is relevant to adopt, with the aim of achieving the tasks defined in Article 11 of this Law.

The CSB shall be coordinated by the Authority of Application established according to Article 12 of this Law, which shall assume the Technical Direction of this Law.

The Authority of Implementation will also convene representatives of the public, business, workers and academia sector in agreement with the general coordinator and the member institutions of the CSB.

To fulfill its objectives, the Ministry of Industry, Energaa and MinerAa will provide the CSB with the necessary infrastructure and financial resources to ensure its proper functioning. The CSB shall draw up a regulation determining its operating system.

ArtAculoA 11Aº.A (Committed of the Sectoral Council of Biotechnologies-CSB).-The Sectoral Council of Biotechnologies will have the following objectives:

a) propose to the competent political authority, plans and strategies for development and strengthening of the biotechnology sector and propose the necessary corrective measures in this regard;

b) advising the competent authority on biotechnology and articulating sectoral, regional and institutional proposals With the economic, social, environmental and cultural development plans of the paAs;

c) promoting a regulatory framework that encourages the adoption of Biotechnologies in the paAs;

d) strive for active cooperation between the public and private sectors in the field;

e) promoting outreach, awareness and education activities regarding research and development promotion biotechnological;

f) strengthening the articulation between academia and the public and private productive sector, generating exchange of exchange information and opportunities for the development as a whole of new ventures.

ArtAculoA 12Aº.A Habra ¡ una Autoridad de Aplicação, whose headline will be designated by the Executive Branch, and must meet conditions of recognized suitability in biotechnology.

The following tasks should be:

a) propose the regulatory rules of this law;

b) collecting and administering the information required for the performance of the tasks of the Inter-Ministerial Group and the CSB;

c) run how much they have;

d) bring the National Registry of Technical Emrollups, and

e) perform any other task that is entrusted to you.

ArtAculoA 13Aº.A (National Register of Biotechnology Enterprises).-The National Register of Biotechnology Enterprises will be registered that will depend on the Ministry of Industry, Energy and Mineraa (MIEM), who provide the material and human resources necessary for the performance of their tasks.

The said Registry shall have the purpose of the registration of national biotechnological undertakings which carry out activities covered by Article 5Aº, who wish to obtain the benefits of the scheme provided for in this Law and their regulatory and amending decrees.

The form of registration, its content, costs and other necessary elements will be established in the regulation of this law. This regulation will clearly specify the process to be followed by companies to register. The non-pronouncement by the competent authority within the period of thirty days from its presentation shall be considered to be a sign of the inscription, without prejudice to the obligation to pronounce on the part of it.

CAPATULO III

ESTAMUA FUND TO BIOTECHNOLOGA

ArtAculoA 14Aº.A (Fund for the Research and Development of Biotechnologies).-As of the promulgation of this law, the Fund of the Research and Development Fund, whose ownership and administration will correspond to the competent authority defined in Article 8Aº of this law. The Fund will be used to finance initial capital contributions to new ventures.

The regulation dictated by the Executive Branch will establish the ways and conditions in which the Fund will be awarded and the possibility of reimbursements for the support received.

The Fund created will be funded by:

a) general revenue allocated items;

b) the funds generated by conventions that are held with public or private organizations, national or foreign;

c) what is raised by the application of the penalties provided for in Article 15 of this law;

d) donations, inheritances, and legacies you receive;

e) the other income that is assigned to you by legal or regulatory.

The form of administration of this Fund will be defined by the Executive Branch, in consultation with the Sectoral Council of Biotechnologies (CSB), according to the provisions of Articles 10 and 11 of this Law.

CAPATULO IV

VIOLATIONS AND PENALTIES

ArtAculoA 15Aº.A Failure to comply with the obligations arising from the benefits granted under this law will give rise to the penalties that are provided below:

a) admonition;

b) fines up to 40,000 IU (forty thousand indexed units);

c) suspending or revoking the record created by item 13 of this law.

The penalties will be graduated according to what is available in the regulation. The penalties shall be applied without prejudice to the suspension or cessation of the benefits granted or the sums contributed and the corresponding return of the equivalent to those benefits or contributions, duly adjusted in accordance with the rules in effect.

ArtAculoA 16Aº.A The amounts obtained by applying pecuniary penalties will be allocated to the Biotechnologa EstAmulus Fund, in accordance with the provisions of Article 14 of this Law.

CAPATULO V

FINAL " N DEVICE

ArtAculoA 17Aº. The Executive Branch will regulate this law within one hundred and eighty days from the day following its promulgation.

A A A A A Sala de Sessions de la CA ¡ mara de Reps, en Montevideo, a 10 de febrero de 2015.

ANABAL PEREYRA,
President.
José Pedro Montero,
Secretary.

MINISTRY OF INDUSTRY, ENERGY AND MINERAA
TO MINISTRY OF ECONOMICS AND FINANCE
A TO MINISTRY OF EDUCATION " N AND CULTURE
A TO MINISTRY OF HEALTH PAsBLICA
A A A A A MINISTRY OF GANADERAA, AGRICULTURE AND FISHERIES
A A A A MINISTRY OF HOUSING, TERRITORIAL PLANNING AND ENVIRONMENT

Montevideo, 18 February 2015.

CA-Mplase, achosese recibo, comunaquese, publáquese e inséltese en el Registro Nacional de Leitos y Decretos, la Ley por la que se lían el Marco normative para la promoción de la Biotecnologáa.

JOSA% MUJICA.
EDGARDO ORTUA 'O.
MARIO BERGARA.
RICARDO EHRLICH.
SUSANA MUA' IZ.
TABARA% AGUERRE.
FRANCISCO BELTRAME.

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Montevideo, Uruguay. Legislative Power.