Council of Ministers Regulation No.388/2016
Council of Ministers Regulation to provide for the establishment of the Ethiopian Biotechnology
Council and Biotechnology
This Regulation is issued by the Council of Ministers pursuant to Articles 5 and 39 of the Definition of Powers and Duties of Executive Organs of the Federal Democratic Republic of Ethiopia Proclamation No. 916/2015.
1. Short Title
This Regulation may be cited as the “Ethiopian Biotechnology Council and Biotechnology Institute Establishment Council of Ministers Regulation No. 388 /2016”.
In this Regulation unless the context otherwise requires:
1/ “biotechnology” means any technology application that uses biological systems, living organisms, their cells or derivatives thereof, to make or modify products or processes for specific use to benefit man in several ways including in agriculture, health, industry, environment and other related activities;
2/ “research” means a scientific study to discover new things and methods and applications by employing intellectual knowledge and an activity which improves or advances human knowledge to solve community and development problems and improve quality of life;
3/ “biotechnology research and development” means scientific investigation to transform knowledge of biological systems and processes to useful products or services and apply the same to promote productivity in agriculture, health, environment, industry and other sectors through the useful application of modern technology;
4/ “national biotechnology research system” means a collection of institutions engaged in biotechnology research within the country;
5/ “institution” means a Federal, Regional or Higher Education Institution, or public or private enterprise authorized by law to conduct biotechnology research and development;
6/ “technology transfer” means the process of sharing/exchange of skills, knowledge, technologies, methods of manufacturing, products and samples among industries, universities, government and other institutions to ensure scientific and technological developments are accessible to a wider range of users who can then develop and exploit the technology into new products, processes, applications, materials or services;
7/ “knowledge economy” means an economy founded on scientific knowledge;
8/ “related science” means science which has physical, chemical or computational basis such as information technology, nano-biotechnology, biomaterial science and bio-automation that can be implemented in close interaction with bio-technology or that can accelerate product development and enhance productivity in combination with biological processes;
9/ “emerging technology” includes nano- technology, materials science, reverse engineering, artificial intelligence and the like fields that depend on new, existing or improved knowledge; can build greater capacity to compete for rapid development; can help register tangible and sustainable growth in economic, social and political sphere; have multifaceted purpose and increasing acceptance; and technologies that create opportunity in terms of solving existing and upcoming national or international problems;
10/ “nanotechnology” means a field of study of matters phenomenon like molecular, physical and biological properties and structures at nano-scale (billionth meter dimensions), to provide novel products, equipments and systems through investigating and altering at atoms and molecule level;
11/ “materials science” a field of science which studies about different materials’ structure, classifications (metals, polymers, ceramics and composites), properties, applications, and other relevant characteristics of materials in order to make it applicable based on their studied properties;
12/ “reverse engineering” means a field of technology which focuses in a process of reworking and duplicating a system or a product in an easier and efficient way through studying carefully how it is made;
13/ “artificial intelligence” means developing systems and computer programs so that machines and services can conduct in human like thought process;
14/ “financial support” means any additional fund allocated by the government for sector government offices for research and development purposes other than the regular budget;
15/ "region" means any regional state referred to under Article 47 of the Constitution of the Federal Democratic Republic of Ethiopia and includes the Addis Ababa and Dire Dawa city administrations;
16/ “Ministry” and “Minister” means the Ministry and Minister of Science and Technology;
17/ “person” means any natural person or juridical body;
18/ any expression in the masculine gender includes the feminine.
ETHIOPIAN BIOTECHNOLOGY COUNCIL
The Ethiopian Biotechnology Council (in this Regulation referred to as “the Council”) is hereby established.
4. Members of the Council
The Council shall have the following members:
1/ the Prime Minister …………Chairperson
2/ Minister of Education………….. ....... Member
3/ Minister of Agriculture and Natural Resources ………………………………………….. Member
4/ Minister of Health ……………….........…"
5/ Minister of Environment, Forestry and Climate Change.............………………….."
6/ Minister of Industry. ……..........……….. "
7/ Minister of Livestock and Fisheries..………"
8/ Minister of Science and Technology..........."
9/ Heads of Sectors, as may be necessary, to be assigned by Government decision………... "
10/ researchers assigned by Government considering their knowledge in the field of biotechnology ………………………...……"
11/ Director General of the Ethiopian Biotechnology Institute...............member and secretary
5. Powers and Duties of the Council
The Council shall have the powers and duties to:
1/ issue policy on biotechnology research and development, set national strategy, define major national priority programs for biotechnology research and development; follow up and evaluate their implementation in each sector and set directions;
2/ set directions for biotechnology research and development, in particular, in the fields of agriculture, health, industry and environment, to contribute to the country’s rapid and sustainable economic and social growth by creating partnership, coordinating, leading and directing and building capacity in technology transfer and research;
3/ provide leadership to build and strengthen sustainable national capacity which focuses on the national goals of biotechnology research and development, which is led by plan and is executed in synergy and in a coordinated manner, which gives priority to improvement of products and services, is competitive in quality and level of effectiveness, benefits the public and grows by incorporating those appropriate from among emerging technologies;
4/ set directions for the establishment and proper management of the specialized research and service centers to strengthen education, training, research and development in biotechnology; and issue directives to guide their effective management;
5/ recognize excellence and award exemplary achievers in biotechnology research and development, and industries caused economic benefit;
6/ provide guidelines to identify key biotechnology product development which needs to be transformed into production based on developmental needs of each sector; and set standards for the appropriate selection of technologies from among emerging and future technologies to be integrated into biotechnology research and development; design strategies for synergy and integration of related technologies in building capacity towards knowledge economy; ensure that directives to encourage innovation are implemented;
7/ establish committees necessary for dis- charging its responsibilities.
6. Meetings of the Council
1/ The Council shall have a regular meeting in every quarter of a year; provided, however, extraordinary meetings may be held when called by the Chairperson.
2/ There shall be a quorum when more than half of the members are present at a meeting.
3/ Without prejudice to the provisions of this Article, the Council may, adopt its own rules of procedure.
Ethiopian Biotechnology Institute
1/ The Ethiopian Biotechnology Institute (hereinafter the "Institute") is hereby established as an autonomous Federal Government office having its own legal personality.
2/ The Institute shall be accountable to the Ministry.
8. Head Office
The Institute shall have its head office in Addis Ababa and may have branch offices elsewhere, as may be necessary.
The objectives of the Institute shall be to:
1/ establish a system that coordinate research and research infrastructures on bio- technology and emerging technologies which are dispersed in various sectors so as to make it contribute to the Development of the country;
2/ enable the country benefit from biotechnology development by coordinating and leading biotechnology research and through transfer, adaptation and promotion of appropriate technology, creation of conducive environment for local development of indigenous new technologies by building enabling capacities;
3/ conduct research and development activities on biotechnology and emerging technologies which have the potential to contribute to the development of the country and support similar research;
4/ establish, strengthen, lead and coordinate research and development support centers to strengthen biotechnology research and development needed for rapid progress in agriculture, industry, health, environment, and other related sectors and make the products and services accessible to the public; and create opportunities and an enabling environment for researchers;
5/ put in place an all-round support system that fosters an enabling work environment in terms of attitudes, work culture, organizational structure and execution capacity to rapidly build capacity for biotechnology research and development; to enable environment safety protection and maintain international standards in product quality and ensure the sustainability of research and development; to create conditions for making use of the output in the interest of economic and social benefit of the public;
6/ ensure research and development activities conducted on biotechnology and emerging technologies respect the societal values and morals.
10. Powers and Duties of the Institute
The Institute shall have powers and duties to:
1/ formulate policies and strategies on biotechnology and emerging technology and submit to the Council; and implement same upon approval by the Council;
2/ prepare the country’s short term and long term biotechnology and emerging technology development plan, and implement the same upon approval by the Council;
3/ establish a system to coordinate the dispersed biotechnology researches and research infrastructures of the country in a manner that can contribute for the development of the country;
4/ build capacity of, provide support to, and coordinate the organs of the national biotechnology research and development system to carry out biotechnology research and development in collaboration, coordination and synergy in the quest for enhanced effectiveness; in accordance with the directions given by the Council;
5/ conduct problem solving researches on bio technologies and emerging technologies which are designated as priority areas by the Government and encourage and support similar researches; facilitate conditions necessary for provision of different supports and incentives for researches conducted on the field of bio and emerging technologies;
6/ in accordance with the biotechnology research and development policy and strategy, issue guidelines and create framework for key biotechnology programs and technology transfer and collaboration agreements with foreign countries in accordance with the directive issued by the Council, coordinate the efforts made by implementers and stakeholders to ensure technology transfer; provide technical, and as needed financial support to facilitate selection and transfer of technology;
7/ based on the development needs of sectors, identify through studies key biotechnology research outputs that need to go into product development based on the development needs of sectors, conduct research, coordinate and support product development research; identify partner institutions to support knowledge and skill transfer and capacity building in biotechnology training, research and development;
8/ provide the necessary support for human resource capacity building for biotechnology and emerging technology research and development; organize training in collaboration with concerned institutions; facilitate mechanisms for financial support for research conducted by postgraduate students; evaluate quality standards of education, training and research; assist in maintaining quality;
9/ work in collaboration with concerned institutions to realize an effective human resource retention and motivation mechanism for biotechnology education, training and research workforce; undertake required studies and present its proposals to the Council for approval; follow up its implementation;
10/ undertake national biotechnology education and research infrastructure needs assessment; develop short and long term capacity building plans and submit same to the Council for approval; create conditions for and facilitate establishment of specialized research and service centers to strengthen biotechnology research and development; assist implementation; follow up and provide support for same as necessary; exert effort to fulfill infrastructure needs of research institutions;
11/ strengthen, coordinate and make accessible specialized research and service centers to be established to strengthen biotechnology education, research and development; in collaboration with concerned institutions; strengthen the participation of institutions capable of providing support promote their coordination and synergy;
12/ create conducive conditions, as may be necessary, for the acquisition of ownership of intellectual property rights for technologies, knowledge, process and information generated from the national biotechnology research system;
13/ investigate and assess the capacity of biotechnology research and development institutes and centers, evaluate their quality and competence level based on criteria it develops; submit its findings to responsible authorities as input;
14/ collect and organize national data and scientific publications generated by the biotechnology research system and create conducive conditions for utilization of same; ensure their accessibility to researchers, students and other users;
15/ establish a system which enables and ensure any research and development activities conducted on biotechnologies and emerging technologies respect the cultural and moral values of the society, the necessary ethics of the research area and could contribute for the economic development of the country;
16/ in collaboration with relevant organs, examine and issue permit, regulate and, when necessary suspend the importation and exportation of the bio and emerging technologies products which are subject to import and export control by law;
17/ prepare and implement directives, standards, guidelines, manuals on biotechnologies and emerging technologies; implement same upon approval by the Council;
18/ establish cooperation with foreign entities, benchmark and implement best practices and experiences to the country; and facilitate the acquisition of technology, technical and material support necessary for undertaking research activity;
19/ own property, enter into contract, sue and be sued in its own name;
20/ carry out such other activities necessary for the fulfillment of its objective.
11. Organization of the Institute
The Institute shall have:
1/ a Director General, as may be necessary, Deputy Director Generals to be nominated by the Minister and appointed by the Prime Minister and,
2/ senior professionals drawn from the various biotechnology sectors and other necessary staff.
12. Powers and Duties of the Director General
1/ The Director General shall be the Chief Executive Officer of the Institute and shall, subject to the general directions of the Council, direct and administer the activities of the Institute.
2/ Without prejudice to the generality of sub-article (1) of this Article, the Director General of the Institute shall:
a) exercise the powers and duties of the Institute stipulated under Article 10 of this Regulation;
b) employ and administer employees of the Institute in accordance with directives approved by the Government following the basic principles of Federal Civil Service laws;
c) prepare and submit to the Council work plan and budget of the Institute and implement same upon approval;
d) effect expenditure in accordance with the approved budget and work plan of the Institute;
e) develop strategy and detail programs of the Institute; organize the Institute;
f) represent the Institute in its dealings with third parties;
g) prepare and submit performance and financial report of the Institute to the Council;
3/ The Director General of the Institute may delegate part of his powers and duties to officers and other employees of the Institute to the extent necessary for the efficient performance of the activities of the Institute
13. Powers and Duties of the Deputy Director Generals
The Deputy Director Generals shall have:
1/ assist the Director General in planning, organizing, leading and coordinating the activities of the Institute;
2/ execute other duties specifically assigned by the Director General;
3/ represent the Director General in his absence, when specifically delegated by the Director General.
The Budget of the Institute shall be allocated by the Government.
15. Books of Accounts
1/ The Institute shall keep complete and accurate books of accounts.
2/ The books of accounts and financial documents of the Institute shall be audited annually by the Auditor General or by other Auditors designated by him.
The Institute shall, on matters of biotechnology related to biodiversity and bio-safety, work in cooperation with other concerned bodies.
17. Effective Date
This Regulation shall enter into force on the date of its publication in the Federal Negarit Gazette.
Done at Addis Ababa this 8th day of June, 2016.
PRIME MINISTER OF THE FEDERAL DEMOCRATICREPUBLIC OF ETHIOPIA