Biotechnology. Promotion.

Original Language Title: Biotecnologia. Promocion.

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BIOTECHNOLOGY regulations to his promotion the Senate and the Chamber of representatives of the Republic East of the Uruguay, gathered at General Assembly, Decree: chapter I General provisions article 1. For the purposes of this Act biotechnology means any technological application that uses biological systems, living organisms, or derivatives to make or modify products or processes for specific uses. New entrepreneurship also means the creation of a company or a business unit already existing in the area of the biotechnology industry in the country to produce goods or services in a creative, methodical, responsible and ethical way. Article 2º. (Declaration of national interest)-declared of national interest the development of biotechnology and its applications as fundamental factors for technological innovation, productivity, competitiveness, sustainable development and the well-being of the population. Section 3. (Purpose of the law).-the purpose of this law is to promote research, technology transfer and the application and development of biotechnology at the national and departmental levels. The limitations and scope of included activities shall be governed by these provisions and the regulations (in the framework of international obligations that the State has assumed). Article 4. (Purpose of the law)-the purpose of this law is to promote the sustainable and economic development of the country. To do this, it will tend to increase productivity and competitiveness within the framework of national interest according to law. And, in addition, it will preserve biodiversity without affecting the health of the population and the environmental balance. 5 article. (Actividades comprendidas).-are considered covered in this law the following activities: to) scientific research and everything related to the development of the biotechnology area.

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

(c) develop new ventures biotechnology and its marketing-oriented.

(d) the incorporation of biotechnology in all production process.

(e) the stimulation of demand through a procurement system that fosters the development of biotechnology.

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

(g) any other activity related to the sector. 6 article. (Scope of subjective).-physical or legal, public and private persons that develop national and departmental activities mentioned in the previous article shall be covered by the provisions of this law. 7 article. (Investment promotion)-declared of general interest including the activities of biotechnology and its applications defined in article 5 of this law in the promotion and protection of investments regime, established in the law No. 16,906, of January 7, 1998 and other relevant regulations. Chapter II competent authorities article 8. Create group Interministerial the industry biotechnology, which will be integrated by the ministries of industry, energy and mining (MIEM), livestock, agriculture and fisheries (MGAP), education and culture (MEC), public health (MSP) and housing, Territorial Planning and environment (MVOTMA), which will work on the orbit of the first, with the advice of the Sectorial Council of biotechnology (CSB) with the following tasks (: a) prior and mandatorily advising various ministries with regard to the adoption of regulations necessary for the implementation of this law;

(b) designing and coordinating public policies to promote research, innovation, development, production, technology transfer and application of biotechnology;

(c) evaluate the initiatives presented by the CSB and promote the adoption of policy instruments necessary for its implementation;

(d) defining the strategic guidelines of work from the CSB, as well as approve its annual action plan;

(e) appoint the representatives of the Executive power in the CSB. In the case of provisions or applicable to human health biotechnology initiatives must be obtained previously the advice from the medical school of the Uruguay that ensures consistency with the code of medical ethics. 9 article. Create the Sectorial Council of biotechnology (CSB) in order to promote the recognition of the country in the global biotech market resulting from the increase in innovation and the promotion of scientific knowledge; and in particular, its capacity to articulate education and technological and productive progress in the quest for sustainable development. The CSB will participate in the harmonization of sectoral policies in the field of biotechnology advising the inter-ministerial group or the enforcement authority, as the case may be, in: to) design, development and implementation of sectoral policies, which are summarized in the sector Strategic Plan, definition of goals, strategic objectives and corresponding policy tools, as well as plan of action and indicators that allow appropriate follow-up of the results achieved;

(b) the monitoring and evaluation of the development of the sector Strategic Plan, on the basis of the instruments defined in the previous paragraph;

(c) the setting or redesign of the sector Strategic Plan and the adequacy of the policy tools in function of the evolution of the sector;

(d) the identification of constraints, market imperfections and needs of productive development presented conditionally and the proposal of palliative measures allowing to support medium- and long-term objectives. 10 article. (Composition).-the sectoral Council for biotechnology (CSB) will function as scope of coordination between Government, employers, workers and academia and advisory area of advice of the inter-ministerial group and the enforcement authority, and may propose measures to understand relevant with recommendatory adopted, with the aim of achieving the tasks defined in article 11 of this law. The CSB will be coordinated by the enforcement authority established under article 12 of this law, which shall assume the technical direction of the same. The enforcement authority will convene, in addition, representatives of business, public sector, workers and Academy in agreement with the general coordinator and the institutions members of the CSB. To meet its goals, the Ministry of industry, energy and mining will provide the CSB with infrastructure and financial resources to ensure its proper functioning. The CSB will develop a regulation determining its operating regime. 11 article. (Cometidos deel Consejo Sectorial de Biotecnología-CSB).-the sectoral Council of biotechnology will have the following objectives: to) propose to the competent authority policies, plans and strategies for development and strengthening of the biotechnology sector and propose necessary corrective measures in this regard;

(b) advise the competent authority in the biotechnology field and joint sectoral, regional and institutional proposals of biotechnology with the country's economic, social, environmental and cultural development plans;

(c) to promote a regulatory framework that encourage the adoption of biotechnology in the country;

(d) to ensure the active cooperation between the public and private sectors in this area;

(e) promote outreach, awareness and education concerning the research and promotion of biotechnology development;

(f) strengthen the articulation between the Academy and the public and private productive sector generating areas of exchange of information and opportunities to develop new ventures together. 12 article. There will be an enforcement authority, whose head shall be appointed by the Executive Branch, must meet conditions of recognized suitability in the biotechnology field. You will have the following tasks: to) propose the regulations of this law;

(b) collect and administer the information necessary for the fulfilment of the tasks of the inter-ministerial group and the CSB;

(c) run as they are equipped with;

(d) record the national technological ventures, and

(e) carry out any other task that is entrusted. 13 article. (National register of biotech ventures)-created the national register of biotech enterprises that depend on the Ministry of industry, energy and mining (MIEM), who will provide the human and material resources necessary for the fulfilment of its tasks. The referred registration shall the inscription of the national biotechnology enterprises that develop activities covered in article 5 °, who wish to obtain the benefits of the system provided for in this Act and its regulatory and amending decrees. The registration form, 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 the companies to register. The decision by the competent authority within a period of thirty days from its presentation shall be regarded as ficta approval of the registration, without prejudice to the obligation to speak out by that. Chapter III STIMULATION to biotechnology Fund article 14. (Stimulus Fund biotechnology).-create, from the promulgation of this law, the stimulus Fund to biotechnology, whose ownership and management will be up to the competent authority defined in article 8 of this law. The Fund is intended to finance contributions of seed capital to new ventures. Regulations issued by the Executive branch shall establish the forms and conditions in which the Fund and the possibility of repayment of the support received will be awarded. The created Fund will be financed with: a) headings assigned by general revenue;

(b) the funds generated by the conventions concluded with organizations public or private, national or foreign;

(c) the funds raised by the application of the penalties provided for in article 15 of this law;

(d) donations, inheritances and legacies received;

(e) other revenue assigned to it by law or regulation via. The form of administration of such fund will be defined by the Executive Branch, in consultation with the sector Council of biotechnology (CSB) pursuant to articles 10 and 11 of this Act. Chapter IV offences and penalties article 15. Failure to comply with the obligations arising from the benefits granted under the framework of the provisions of this law, will lead to the sanctions which are detailed below: a) reprimand;

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

(c) suspension or revocation of the registry created by article 13 of this law. The sanctions will graduate in accordance with what stated in the regulations. The penalties shall apply without prejudice of the suspension or cessation of the benefits granted or of the amounts contributed and the corresponding return of equivalents to these benefits or contributions, duly adjusted in accordance with the regulations in force. 16 article. The amounts obtained by the application of fines will be used for the background of the stimulation of biotechnology, pursuant to article 14 of this law. Chapter V article 17 FINAL disposition. The Executive branch shall regulate this law within the period of one hundred and eighty days from the day following its promulgation.     Hall of sessions of the House of representatives, in Montevideo, February 10, 2015. ANIBAL PEREYRA, President.
José Pedro Montero, Secretary. Ministry of industry, energy and mining Ministry of economy and Finance Ministry of education and Culture Ministry of health Public Ministry of livestock, agriculture and fishing Ministry of housing, ORDENAMIENTO TERRITORIAL and friendly Montevideo, 18 February 2015. Met, acknowledge receipt, communicate, publish, and inserted into the national registry of laws and decrees, the law by which establishes the regulatory framework for the promotion of biotechnology. JOSÉ MUJICA.