Implementing the
The Case of Agriculture*
Iraides Romero Montoya**
Indice
1. Introduction
2. The Venezuelan Legal System
3. Agencies
Responsible for Implementing the
4. The Agreements on the Application of Sanitary and
Phytosanitary Measures (SPS Agreement), on Technical Barriers to Trade (TBT)
and on Trade Related Intellectual Property Rights (TRIPs). A Brief Overview
5. Implementation of the Agreement on the Application of
Sanitary and Phytosanitary Measures (SPS Agreement)
5.1 The
“Andean Agricultural Health System”
5.2 Andean
Community Instruments to Guarantee Food, Animal and Plant Health
5.3 Institutions for Sanitary and Phytosanitary
Protection
5.4 Law on Sanitary Protection of Plants and
Animals
5.5 Measures Amended in Order to Comply with the
SPS Agreement
6. Implementation of the Agreement on Technical Barriers to
Trade (TBT)
6.1 Decision
562 on Directives of Technical Regulations for the Andean Member Countries
6.2 The
Recognition and Acceptance of Certificates
6.3 The
Andean System of Standardization, Accreditation, Testing, Certification,
Technical Regulations and Metrology
6.4 Laws,
Decrees and Resolutions
6.5
Institutions
a) Autonomous National Service for Standardization, Quality,
Metrology and Technical Regulations (SENCAMER)
b) Fund for Standardization and Quality Certification
(FONDONORMA)
c)
The Venezuelan Commission for
Industrial Standards (COVENIN)
d) The National Autonomous Metrology Service (SANAMET)
e) The Bureau for Standardization and Quality Certification
(SENORCA)
7. Implementation of the Agreement on Trade Related
Intellectual Property Rights (TRIPS)
7.1 The
Andean Legislation on Intellectual Property and its Relationship with TRIPS
7.1.1 Common Industrial Property Regime
7.1.2 Common Regime for Access to Genetic Resources
7.1.3 Common Regime for the Protection of the Rights of
Breeders of New Plant Varieties
7.2 National
Laws, Decrees and Regulations Created and Amended in Order to Comply with the
TRIPS Agreement
7.2.1 The
2000 Law on Biological Diversity
7.2.2 The
Organic Law on Science, Technology and Innovation (LOCTI)
7.2.3 Decree
3136 Implementing Decision 345 of the Andean Community
7.3 The Institutions Created in Order to Protect
Intellectual Property Rights
7.4 Implementation of Enforcement Obligations
7.5
Cooperation with the TRIPS Council
8. Conclusion
References
1. Introduction
The Uruguay
Round marks the first time that the agricultural sector was included in the
General Agreement on Tariffs and Trade (GATT) system. The inclusion of
agriculture within GATT reflects the changes that the global economy is
undergoing towards a market orientation with a clear priority for efficiency
and competitiveness in all sectors. In order to comply with the Uruguay Round
objectives member countries have adopted several commitments such as improving
market access by eliminating unnecessary trade barriers in accordance with the
Agreement on the Application of Sanitary and Phytosanitary Measures (SPS
Agreement) and the Agreement on Technical Barriers to Trade (TBT Agreement). Member countries have also agreed to provide
for a system to protect plant varieties in accordance with Article 27.3 (b) of
the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPs).
The commitments
made by member countries in this multilateral context have to be implemented in
their territories, in most of the cases, through reforming domestic law and
national institutional or administrative structures. This implementation has
been particularly difficult for developing countries, e.g. those in
This paper will
explore the case of
This paper will
address the SPS, TBT and TRIPs Agreements within the general context of how they
are implemented to facilitate the cross border agricultural trade of
2. The Venezuelan
Legal System
The Constitution is the foundation of
the
According to the Constitution,
international treaties have to be implemented by domestic regulations or
statutes[17].
Once the necessary domestic regulations are published in the Official Gazette
of the
The general framework established by the
new Constitution promotes regional integration within Latin America and the
Regarding agriculture, it should be said
that the new Constitution contains extensive provisions on Agriculture[34].
Article 305 of the 1999 Constitution states that the State shall promote
sustainable agriculture as the strategic basis for rural development, thereby
assuring the population’s food security. In order to reach this purpose, the
State shall enact financial measures, commercial measures, support
infrastructural works and take other relevant measures related to national and
international agricultural trade[35].
The objective of agricultural policy is rural development and consequently the
improvement of living standards of the rural population. It is hoped that this
will generate jobs and higher incomes, and will also ensure food security, the
sustainable management of the environment and natural resources[36].
The Decree on the Status and Force of
Law on Land and Agricultural Development (Land Law, Decree No. 1.546 of 9
November 2001)[37]
may be one of the main legislative modifications. Enacted by the President of
the Republic[38]
the Law on Land and Agricultural Development basically seeks to reduce the Latifundios[39], guarantying land to those who worked
it[40].
Article 236.8 of the Constitution authorizes the President to enact decrees
having the status and force of law concerning exceptional economic and
financial measures in the public interest through an Enabling Law[41].
Many
of the legal changes made since the new Constitution have been introduced by
means of such decrees[42].
After the entry into force of the
Marrakesh Agreement Venezuela adopted laws, decrees and programs to support
agriculture activities, such as the “2000 Law on Biological Diversity”[43],
“Law on Credits for the Agricultural Sector”[44],
“Law on Fishing and Aquiculture”[45],
“Law on Silos, Warehouses and Agricultural Deposit”[46],
“Law of Land and Agricultural Development”[47],
Law on Agricultural Trade”[48],
“Law on Credits for the Agricultural Sector”[49].
The most relevant decrees are “Norms for
classification and control of the water quality, liquid assets”[50];
“Norm about Evaluation of Activities tending to degrade the Environment”[51];
“Decree with the Status and Force of Law on Development of Livestock Farming,
Fishing, Forests and related Issues (FONDAFA)”[52].
Some of the programs are “The Strategic
Food Program (PROAL)”, the “Channeling of Credits to the agricultural sector”;
the latter program being oriented in particular to small farmers, the
“Irrigation Systems Program” and the “Development and Sanitation Program”. The
State has also provided agricultural production with support services through
strategic alliances between the Agricultural Supply and Services Corporation (Corporación de Abastecimiento y Servicios
Agrícolas) (CASA).
Venezuelan law is comprised of national
legislation and regional legislation passed by the Andean Community as a
consequence of the direct applicability of CAN law[53]. As mentioned supra, Art. 3 of the
Treaty establishing the Court of Justice of the CAN provides that decisions and
Community regulations must be directly and equally applicable in the Member
Countries[54].
They must have simultaneous and uniform effect in the entire CAN-region. The
Cartagena Agreement, its protocols and complementary treaties have the status
of constitutional provisions in the Andean countries in accordance with their
own national constitutions[55].
In Andean-Community law,
supranationality takes the form of two basic principles that must serve as the
basis of the legal structure of integration, namely, direct application and
preeminence[56].
Direct application consists of the possibility for a regulation to produce
legal effects in a country Member without the need for any supplementary
regulations in domestic legislation[57].
Preeminence refers to the fact that a community regulation prevails over a
contrary provision of domestic law, irrespective of the status of the latter[58].
3. Agencies
Responsible for Implementing the Uruguay
There are mainly three ministries
responsible for implementing the WTO Agreements related to Agriculture in
The MFA represents
Trade policy is formulated and
implemented by the MPT[62].
Created in 1999 the MPT plays an active policy-making role in the areas
relevant to the WTO Agreements. It is responsible for formulating and
monitoring the activities of the national executive power that concern domestic
and foreign trade[63].
It is also responsible for activities relating to all aspects of international
trade negotiations or trade relations, in coordination with the MFA, in
particular in the following areas: domestic and foreign investment,
agriculture, services, intellectual property, technical standards, quality
control and certification, the promotion and encouragement of competitiveness
and free competition, and the participation in the formulation of customs and
tariff policies in coordination with the Ministry of Finance, etc.[64].
The body responsible for developing and
implementing agricultural policy and for administering the legal framework for
the agricultural sector is the Ministry of Agriculture and Land (MAL)[65].
Agricultural policies are those related to development of production and
commerce in the agricultural, plant, livestock, aquacultural, fisheries and
forestry sectors.
The Ministry of Finance and the Central
Bank of Venezuela (BCV) are also involved in trade matters. The Ministry of
Finance is responsible for tariff policy[66].
Foreign exchange and monetary policies are formulated by the Central Bank of
4. The Agreements on the Application of Sanitary and Phytosanitary
Measures (SPS), on Technical Barriers to Trade (TBT) and on Trade Related
Intellectual Property Rights (TRIPs). A Brief Overview
Two of the GATT/WTO 1994 Agreements
address special government standards applied to restrict imports; the Agreement
on the Application of Sanitary and Phytosanitary Measures (SPS Agreement)[68]
and the Agreement on Technical Barriers to Trade (TBT Agreement)[69].
The Agreements confirm the right of WTO Member countries to apply measures that
are trade restrictive when they are necessary to protect human, animal and
plant life and health or enhance the safety of food[70].
The measures must be implemented in a manner that does not constitute arbitrary
or unjustifiable discrimination between member countries where the same
conditions prevail[71].
Sanitary, phytosanitary and technical
measures are among the most complex possible trade barriers as there is rarely
an obvious distinction between legitimate product standards and protectionist
measures[72].
National measures restricting market access of imported goods may or may not be
intended to act as protectionist measures favoring domestic industry to the
detriment of imports[73].
States remain free to protect important values[74]
and to adopt levels of protection superior or different from those of
international standards[75].
But technical requirements can similarly be used to disguise trade restrictions[76].
The agreements on the use of SPS and technical standards in regulating imports
help prevent these types of measures from undoing the results of tariff and
other market access concessions.
The agreements require Members to ensure
that the measures are based on scientific principles[77].
While the SPS Agreement explicitly demands such a scientific basis, the TBT
Agreement only implicitly does so by imposing necessity, proportionality or
other standards. Hence, the TBT requirements can be expected to be
significantly less rigorous than the requirements of the SPS Agreement[78].
Accordingly, the agreements require that
SPS and technical measures be based on international standards[79]
or guidelines where they exist[80],
be made transparent[81],
be applied only to the extent necessary to achieve the objective in question[82],
and be subject to dispute settlement procedures of the WTO[83].
Least developed country Members are entitled to more favorable treatment, such
as through eligibility for time-limited exceptions from obligations under the
agreements[84].
Both agreements also embody the principle of equivalence[85],
meaning that a Member shall accept the measures of another Member as equivalent
to its own and an exporting country must be given the opportunity to show that
its SPS or technical standards are equivalent to those of the importing
territory, even though they are different (and, presumably, appear to provide
less stringent standards)[86].
Despite their similarities, the TBT and
SPS Agreements have to be distinguished. While the scope of application of the
TBT Agreement hinges on the nature of the measures in question[87],
the applicability of the SPS Agreement depends on the purpose of measures[88].
The TBT Agreement relies primarily on whether a given measure discriminates
among imported products (most-favored nation principle) or between imported and
domestic products (principle of national treatment)[89].
As to discrimination, the SPS Agreement requires only that SPS measures not
“arbitrarily or unjustifiably discriminate” between importing countries “where
identical or similar conditions prevail”[90].
The Agreement on Trade-Related Aspects
of Intellectual Property Rights (TRIPS) was adopted as one of the WTO
Agreements in 1994[91].
The TRIPS Agreement includes detailed standards on the protection of seven
types of intellectual property: copyright and related rights[92],
trademarks[93],
geographical indications[94],
industrial designs[95],
patents[96],
trade secrets[97]
and layout-designs (topographies) of integrated circuits[98].
In general, TRIPS provides a minimum standard of protection; members may
provide for greater protection as long as they do not violate provisions of the
agreement[99].
The TRIPS Agreement is the treaty with the greatest impact on national laws on
intellectual property rights related to agriculture[100].
This paper will focus on three relevant areas:
Firstly, TRIPS contains provisions on
patent protection, which are also relevant for agricultural chemical products.[101]
According to Article 27.1 TRIPS, Member are obliged to make patents available
for any inventions, whether products or processes, in all fields of technology.
Recognizing the controversial nature of this topic[102],
Article 70.8 provides for transitional periods for pharmaceutical and
agricultural chemical products[103].
Article 70.9 commits Member to grant exclusive marketing rights to parties who
make use of the transitional periods under Article 70.8 TRIPS[104].
Secondly, TRIPS contains provisions on
geographical indications[105].
Geographical indications are extremely important for agricultural products[106].
Thirdly, TRIPS contains provisions on
plant varieties protection[107].
Under Article 27.3(b) TRIPS Member countries are obliged to provide for the
protection of plant varieties either by patents, an effective sui generis system, or a combination
thereof. The patents have to be available for any invention, whether products
or processes, in all fields of technology, including biotechnology[108].
The sui generis option provides
valuable policy space for developing countries to draft national legislation
that is in accord with their national agricultural development priorities and
at the same time meets their WTO commitments[109].
5.
Implementation
of the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS
Agreement)
The Venezuelan
legal regime for sanitary and phytosanitary protection consists of a set of laws
and resolutions of the Andean Community, as well as national regulations.
Now, the main
laws covering the area are the Decision 515 of the Commission of the Andean
Community about the “Andean Agricultural Health System”, as, and the Venezuelan
“Law on Sanitary Protection of Plants and Animal Health”[113].
In general, it should be noted that
exports and imports of plants, animals and their products and by-products
require phytosanitary and zoosanitary certificates, which are issued by the
Autonomous Agricultural Health Service (SASA) before shipment[114].
5.1 The Andean Agricultural
Health System
The Decision 515, adopted on March 8,
2002 by the CAN Commission, establishes the Andean legal framework for sanitary
and phytosanitary measures to be applied to trade within the Andean Countries
and with third countries in plants, plant products, regulated articles, animals
and animal products[115].
It replaces the Decision 328 and Regulation 241 of the Commission of the
Cartagena Agreement and Secretariat respectively, which were passed on 22
October 1992 and 1999[116].
Decision 515 brings Community provisions
into line with the new priorities of Andean integration and international
agricultural health requirements by incorporating the principles established in
the SPS Agreement[117].
It incorporates the National Agricultural Health Services into the Andean
Health System (Andean-SASA) in order to ensure better administration, execution
and observance of CAN provisions, adjusts the time limits and procedures for
updating and maintaining the Regional Register of Health all the while giving
priority to the protection of human, animal and plant health[118].
The Andean-SASA is defined as a set of
principles, elements and institutions for harmonizing sanitary and
phytosanitary provisions; improving plant and animal health; contributing to an
improvement in human health; facilitating trade in plants, plant products,
regulated articles and animals and animal products; and ensuring the
observation of provisions on the subject[119].
Decision 515 also contains, as part of the Andean-SASA, the procedures whereby
a Member Country or a part of it can declare itself free from a pest or disease
and the establishment of the Andean Systems of Animal Health Information and
Epidemiological Surveillance and of Plant Health Information and Surveillance[120].
The most important regulatory Andean-SASA instruments are the Community
sanitary and phytosanitary provisions; the subregional register of national
sanitary and phytosanitary regulations; plant and animal health import permits
or documents and plant and animal health export certificates. Furthermore it
provides for a mechanism of technical consultations between the Andean
Technical Committee on Agricultural Health and the National Plant and Animal
Health Protection Bodies to exchange experiences and relevant applicable
technical criteria and thereby contribute to perfecting proposed provisions[121].
The institutional structure of the
Andean-SASA consists of the CAN Commission[122],
The CAN General Secretariat[123],
The Andean Technical Committee on Agricultural Health (COTASA)[124],
and The Member Countries’ Official Agricultural Health Services[125].
The Andean System of Animal Health Information and Epidemiological Surveillance
and the Andean System of Plant Health Information and Surveillance, as well as
a Joint Action Program in Agricultural Health have also been set up by the
Andean-SASA[126].
5.2 Andean Community
Instruments to Guarantee Food, Animal and Plant Health
In formulating the Andean provisions on
food, animal and plant health the national laws of the Member Countries and
some relevant international agreements have been considered, such as FAO’s
International Convention on Plant Health Protection (ICPHP), and measures taken
by the International Epizootics Office (IEO) and the FAO/WHO Codex Alimentarius[127].
The Andean Community’s accomplishments
in food, animal and plant health include the approval of Decision 436 and
Decision 483[128].
These Decisions establish harmonized requirements and procedures for
registering and controlling chemical pesticides for agricultural use and
regulations for registering, controlling, marketing and using veterinary
products, permitting their proper use and handling in order to avoid and
minimize damage to health and to the environment and facilitating trade in
those items in the Andean region[129].
Resolution 431[130]
and Resolution 451[131]
establish a set of common requirements for facilitating trade within the Andean
Region and with third countries in 31 specific agricultural products (14
products through Resolution 431 and 17 via Resolution 451)[132],
which represent a significant percentage of the trade between the Andean
Countries[133].
These requirements include phytosanitary
certificates, controls, quarantine requirements, etc. Finally, to boost
trade in animals among Members and with third countries while protecting the
region from negative effects on animal health, the CAN has approved the
Resolutions 347 and 449, containing common requirements for the trade in all
species of domestic animals and products and byproducts of animals covered by
the classification of the Common Tariff Nomenclature for the member countries
of the CAN (NANDINA)[134].
Resolution 566 of the Cartagena
Agreement contains an inventory of pests and diseases existing in the Andean
region[135].
The Basic Catalogue of Animal Pests and Diseases contains a list of pests and
diseases - and its causal agents - that cause considerable damage to
agricultural production, spread easily, are costly to control, difficult to
eradicate, and pose a high risk for the region[136].
The Catalogue also lists the countries that are affected by these pests and
diseases[137].
It is forbidden to import animals, plants and any product capable of
propagating the pests and diseases listed in the catalogue from affected third
countries into the region[138].
5.3 Institutions for Sanitary and Phytosanitary
Protection
The institution responsible for
developing and implementing agricultural policy and for administering the legal
framework for the agricultural sector until 1999 was the Ministry of Agriculture
and Livestock “Ministerio de Agricultura
y Cria”. Since the beginning of 2002 its responsibilities have been
transferred to the Ministry of Agriculture and Land “Ministerio de Agricultura y Tierras” (MAL). Animal products and
livestock-farming inputs require a sanitary health permit with a non-renewable
period of validity of 60 calendar days from the date of the issue. The Ministry
of Agriculture and Land (MAL) and the Autonomous Agricultural Health Service
(SASA)[139]
are accredited to represent
The SASA was created with the purpose to
ensure the country’s food security and its ability to compete in international
markets with optimal agricultural health standards. One of the missions of SASA
is to ensure the implementation in
In 2001 was established the Codex
Alimentarius Committee. The main functions are to review the standards and
coordinate the mechanism relating to the protection of consumer health, to
facilitate trade in foods and to ensure the application of fair commercial
practices in respects of foods[141]. The Committee also acts as a
coordinator of the work of the MAL, MSDS and MPT[142].
5.4 The Law on Sanitary
Protection of Plants and Animals
The law on sanitary protection
of plants and animals of August 15, 1941[143],
regulates the prevention of diseases and pests that affect plants and animals
and their respective products[144]. The MAL is
authorized to take the necessary measures to improve plant and animal health[145]. Article 4 states
that the importer of animals, animal products, plants and plants products into
5.5
Measures Amended in
Order to Comply with the SPS Agreement
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Source: WTO,
Policy Review |
6. Implementation of the Agreement on Technical Barriers to Trade
(TBT)
The Agreement on
Technical Barriers to trade (TBT) seeks to ensure that technical negotiations
and standards, as well as testing and certification procedures, do not create
unnecessary obstacles to trade[147].
At the same time it acknowledges that countries have the right to determine the
level of protection for human, animal or plant life or health or the
environment they consider appropriate, and shall not be prevented from taking
measures necessary to ensure that level of protection[148].
The TBT Agreement covers process and production methods related to the
characteristics of the product itself and encourages countries to use
international standards where appropriate, but it does not require them to
change their level of protection as a result of standardization[149].
The Agreement includes a Code of Good Practice for the Preparation, Adoption
and Application of Standards by standardizing bodies, which is open to
acceptance by private sector bodies as well as the public sector[150].
The basic instruments with which
Venezuela formally fulfilled its obligations under the TBT Agreement are
Decision 562, Decision 506, Decision 419, Decision 376 of the CAN; The Andean
Quality System; The Law on Technical Standards and Quality Control; The Organic
Law on the Venezuelan Quality System; the Decree No. 989 of 29 December 1995
and amendments and Resolution of the Ministry of Industry and Trade No. 044 of
24 March 1998.
6.1 Decision 562 on Directives on the
Elaboration, Adoption and Application of Technical Regulations for the Member
Countries of the Andean Community and at a Community Level
Decision 562 was approved by the
Commission of the CAN on Jun 25, 2003. It establishes directives on the
elaboration, adoption, application of technical regulations for the Member
Countries of the CAN in order to avoid technical barriers to trade in the
Andean region[151].
It contains general principles that govern the elaboration and adoption of
technical standards in the region. These principles are national treatment,
most-favored nation treatment, non-discrimination, transparency and equivalency[152].
The Decision also elaborates on its purpose and defines certain terms used such
as “technical regulations”, “Certificate”, “Process for evaluation of
conformity”, “technical norm”, etc.[153].
Technical regulations have to be notified, registered and revised in accordance
with Articles 10 to 15 of the Decision.
6.2 The Recognition and Acceptance of
Certificates of Products Marketed within the Andean Community
The Decision 506 on the Recognition and
Acceptance of Certificates of Products Marketed in the CAN[154]
is an important step toward removing unnecessary technical obstacles to trade.
Decision
6.3 The Andean System of Standardization, Accreditation,
Testing, Certification, Technical Regulations and Metrology
The purpose of Decision 419[157]
on the Andean System of Standardization, Accreditation, Testing, Certification,
Technical Regulations and Metrology is to perfect the Andean system of standardization,
with the objective of facilitating intra-regional trade by improving the
quality of products and services and by eliminating technical restrictions to
trade[158].
Decision 419 creates the Subregional Committee on Standardization,
Accreditation, Testing, Certification, Technical regulations and Metrology[159]
and the Andean Network of National Accreditation Bodies that are competent to
authorize laboratories, certification bodies, inspection entities and persons
whose services shall be subregionally accredited. According to Chapter III of
Decision 419 the Andean countries shall gradually harmonize the national
standards in force in each country.
The Andean System of Standardization,
Accreditation, Testing, Certification, Technical Regulations and Metrology,
(AQS)[160]
is the quality system of the CAN. The application of the AQS is intended to
shore up institutions in the member countries that are responsible for
monitoring the fulfillment of the conformity evaluation provisions, technical
regulations, and procedures of the TBT Agreement. The AQS covers all elements
of the infrastructure for quality control: standardization, accreditation,
testing, certification, technical regulations, and metrology for all of the
products and services of the CAN, except for those having to do with
phytosanitary and zoosanitary matters[161].
The Andean Standardization Network (ASN)
is another part of the AQS. Its activities are aimed at establishing
"Andean standards" for products marketed in the region by harmonizing
the standards in effect in the Member States, also adopting international
standards considered to be of interest to the region[162].
The new regulations setting out the guidelines for the ASN to be followed for
adopting, harmonizing, publishing, and disseminating Andean standards have now
been approved and some 50 Andean standards are already in effect[163].
Institutions responsible for accrediting testing and calibration laboratories,
certification institutions, inspection bodies etc. are obliged to guarantee the
reliability of the results of the accredited bodies and conduct supervisory
audits for that purpose[164].
The AQS is also meant to expand the network of testing laboratories and
certification institutions in the Member Countries responsible for evaluating
the conformity of national products with applicable regulations, and to
encourage and provide guidance for the attainment of multilateral recognition
agreements[165].
The AQS is completed by the Andean Metrology Network, which has merged with the
ANDIMET Regional Group of the Inter-American Metrology System (IAMS) that has
the same membership and the same objectives and functions. The Andean
Standardization, Accreditation, Testing, Certification, Technical Regulations
and Metrology Committee (CAN) will continue to be responsible for defining
Andean policy in the area of metrology.
6.4
Laws, Decrees and Resolutions
In March 2002 was approved the Organic
Law on the Venezuelan Quality System. This law contains provisions relating to
standardization, certification, testing, accreditation, metrology, standards,
technical regulations and quality control in the areas of manufacturing and
trade in goods, the provision of services, the introduction, distribution and
marketing of imported goods, and the exportation of Venezuelan goods and
services. The National Assembly approved a new Draft Organic Law on the
Venezuelan Quality System, which will strengthen SENCAMER's mandate for the
coordination of activities relating to the administration and implementation of
the Agreement on Technical Barriers to Trade. The law is currently in the
process of being enacted.
The Decree no. 3.145, adopted in 1999[166],
establishes the Autonomous National Service for Standardization, Quality,
Metrology and Technical Regulations (SENCAMER), which governs and regulates,
coordinates and supervises activities relating to standardization, quality,
metrology and technical regulations. SENCAMER's rules of procedure were
published in the GO No. 37.125 of 23 January 2001 and specify the Service's
core functions and operating structure.
The law on technical standards and
quality control sets forth the basic guidelines in this respect. It was adopted
on 31 December 1979 and published on the same date in Special Official Journal
No. 2.529.
The Resolution
of the Ministry of Trade No. 044 of 24 March 1998 requires Venezuelan and
imported products for which mandatory Venezuelan COVENIN[167]
standards have been issued to be entered in the Register of domestic and
imported products subject to the mandatory standards regime (COVENIN). Except in emergency situations, a period
of 45 days is provided for the submission of comments on draft standards,
technical regulations and conformity assessment procedures. The period may be extended at the request of
an interested Member[168].
6.5 Institutions
a) Autonomous National Service for
Standardization, Quality, Metrology and Technical Regulations (SENCAMER)
The Autonomous Service for
Standardization, Quality, Metrology and Technical Regulations (SENCAMER) is
attached to the Ministry of Production and Trade (MPC) and operates under the
b) Fund for Standardization and Quality
Certification (FONDONORMA)
FONDONORMA was established as a private
partnership and received its mandate from the Ministry of Production and Trade
under Resolution No. 1450 of 21 June 1993[171].
It is responsible for developing technical standards, for promoting and
carrying out certification activities, participates in the framing of policies
and strategies in the field of standardization and quality certification and
advises the State on their implementation all standards are drafted by
FONDONORMA under the supervision of SENCAMER[172].
Official certification in
Certification of products undertaked for
FONDONORMA consists in a serie of systems consistent with the ISO
classification of certification systems. The “Marca Norven” official quality
seal has been developed, pursuant to Model 5, and 256 certifications have been
granted; and for the certification of lots, the “Certiven” system, as per Model
7 of the ISO. The Scheme for certification of quality systems is based on the
ISO 9000 series, and 79 certifications have been issued. Both certifications
are voluntary. The Ministry of Health and Social Assistance grants three types
of product certifications, which are compulsory and based on the Organic Law of
the National Health System and the General Regulation on Foods. There are the
certification of free sale and consumption, b) the certification of sanitary
guarantee and c) certification of analysis[174].
c) The Venezuelan Commission for Industrial
Standards (COVENIN)
Resolution No. 044[175]
establishes a register for domestic and imported products covered by mandatory standards
laid down by the Venezuelan Commission for Industrial Standards (COVENIN).
The COVENIN standards are drafted by
FONDONORMA They can be converted into a technical regulation if the draft
standard is accompanied by a document which makes a consistent case for its
being made mandatory, based on the protection of the health, safety and life of
users. It is follow for a procedure that involves FONDONORMA, SENCAMER and the
Legal Service of the Ministry of Production and Trade which at the end publishes
the new technical regulation in the GO under a Joint MPT/SENCAMER Resolution.
In addition to COVENIN standards, regulations prepared by other public entities
and designated resolutions or decrees may acquire the status of technical
regulations.
d) The National Autonomous Metrology Service
(SANAMET)
The National Autonomous Metrology
Service SANAMET was created on January 1, 1966. Under the Ministry of
Development, SANAMET, has as its objective to foster, develop, promote and
consolidate the metrological infrastructure so as to promote growth in the area
of measurements and guarantee their reliability and to facilitate
interrelations with the industrial sectors of health, research, commerce, and
education, so as to benefit the user and/or consumer[176].
To attain this objective SANAMET has established national programs on metrology[177]
in order to ensure the use and dissemination of the International System of
Units (SI); to assay and seal weights and measures and inspect instruments of
measurement used in commercial, industrial, and health activities. SANAMET
provides technical assistance to industry[178].
e) The Bureau for Standardization and Quality
Certification (SENORCA)
The Autonomous Service, Bureau for
Standardization and Quality Certification (SENORCA), is an organization on
inspection and testing of products and materials. SENORCA was established on
February 4, 1993[179]
and works under the support of the Ministry of Development. It operates a
program to accredit testing laboratories and certification and inspection
entities that is open to all types and sizes of laboratories, covering all
areas of product and materials testing. SENORCA’s accreditation program is
operated in harmony with the guidelines of the ISO/IEC developed by ISO/CASCO
conformity with ISO/IEC Guide 58[180].
SENORCA performs evaluations for testing laboratories that wish to become
accredited, and audits already-accredited ones to ensure compliance with terms
of their accreditation[181].
Inspections and test are also performed by the various Ministries on a
compulsory basis that act in the field of health, hygiene and safety,
environment, farming, and stockraising[182].
7.
Implementation of the Agreement on Trade Related Intellectual Property Rights
(TRIPS)
In
In addition,
The Constitution
of 1999 contains several provisions[189] guaranteeing
the freedom of cultural, scientific, technological and humanistic creation and
the recognition and protection of intellectual property by the State, expressly
recognizing the relevant international treaties. The Constitution also includes
articles relating to the protection of the traditional knowledge of indigenous
communities[190].
The Constitution protects the intellectual
property of scientific, literary and artistic works, inventions, and
innovations, i.e. geographical indications, patents and trademarks[191].
The State also recognizes the public interest in the development of science,
technology and knowledge[192].
In order to promote these activities the Constitution creates the National
System on Science and Technology[193].
The State shall finance the system and guarantee the observance of ethical and
legal principles with respect to scientific activities.
The Constitution guarantees and protects
the collective intellectual property of indigenous communities, genetic
resources and the knowledge related to genetic resources[194].
Patents on these ancestral knowledge and resources are prohibited[195].
This issue is also regulated in the 2000 Law on Biological Diversity[196].
Biodiversity and environment are also protected by the Constitution by
prohibiting patents on the genome or germ plasma of any living being[197].
7.1
The Andean Legislation on Intellectual Property and its Relationship with TRIPS
7.1.1 The Common Industrial Property Regime. Decision
486
The Decision 486 of the CAN on Common Industrial
Property Regime contains two modes of protection for inventions: Patents for
Invention and Patents for Model of Unit[202]. The Members of the CAN shall grant
patents for inventions, whether products or processes, in all fields of
technology, provided that they are new, involve an inventive step, and are
capable of industrial application[203].
This
study focuses on patents for inventions which are relevant to agriculture.
Pursuant to
Decision 486, an invention shall be considered new when it is not included in
the state of the art[204].
An invention shall be regarded as involving an inventive step if, for a person
in the trade with average skills in the technical field concerned, the said
invention is neither obvious nor obviously derived from the state of the art[205].
Finally, an invention is regarded as industrially applicable when its
subject-matter may be produced or used in any kind of industry, meaning any
productive activity, including services[206].
Plants, discoveries, scientific
theories, all parts of living beings, animals and essentially biological
processes for the productions of plants and animals are excluded from
patentability[207].
Natural biological processes are not considered inventions[208],
thus implementing the exception contained in Article 27.3 TRIPS[209].
The genome or germ plasma of any living being is also excluded from
patentability[210].
Patent protection is available for micro-organisms, pending the adoption of
specific measures as a result of the ongoing review of Article 27.3 (b) of the
TRIPS Agreement[211].
The term of protection of a patent is 20
years from filing an application[212].
A patent may be subjected to compulsory licensing for reasons of public
interest, national emergency or national security but only as long as these
justifying circumstances continue to exist[213].
The grant of a compulsory license does not prevent the patent holder from
continuing to exploit the patent[214].
The rights of a patent holder are laid
down by Article 52(a) (ii), which provides that the owner of a patent has the
right to prevent third parties not having his consent from offering for sale,
selling or using the product, or importing it for any of these purposes.
Article 14 provides for the grant of patents for any invention, whether
processes or products. This naturally includes agricultural products, provided
that they are new, involve an inventive step and are capable of industrial
application[215].
Directive 486, which contains
regulations for the implementation of Decision 486, contains several provisions
protecting the technical knowledge associated with genetic resources. It is
meant to safeguard and respect the genetic heritage of member countries
together with the traditional knowledge of their indigenous, African American,
or local communities[216].
Decision 486 establishes that the grant
of patents on inventions that have been developed from genetic material from
the Andean Community shall be conditioned on the acquisition of that material
in accordance with international, Andean Community, and national law[217].
7.1.2 The Common Regime for Access to Genetic
Resources. Decision 391
The fundamental objective of
establishing an Access Regime to Genetic Resources (Decision 391)[218]
was to prevent the practice of “bioprospecting”, i.e. using native species of
the region and traditional knowledge to develop a product without permitting
the local population to benefit from that product[219].
Decision 391 regulates the equitable distribution of benefits derived from the
use of traditional knowledge, and recognizes the contributions of indigenous
people, not just by providing for mandatory mention of these people but by
requiring contracts for the use of the relevant knowledge[220].
Decision 391 also recognizes the
sovereign right of Member Countries over the use and development of their
biological[221]
and genetic[222]
heritage[223]
and promotes the consolidation and development of scientific, technological and
technical capacities at the local, national and sub-regional level[224].
It is important to note that the Common
Access Regime for Genetic Resources “Decision
Article 3 of Directive 486 states the
obligation of Andean Countries to ensure that any protection given to patents
has to respect the biological and genetic heritage as well as the traditional
knowledge of the indigenous, African-American, or local communities located in
their territories[226].
As patent applicants have to file a copy of the access contract where their
invention is derived from genetic heritage or traditional knowledge, the
Directive embodies the principle of prior informed consent.
7.1.3 The Common Regime for the Protection of the
Rights of Breeders of New Plant Varieties. Decision 345
Decision 345 on the Common Regime for
the Protection of the Rights of Breeders of New Plant Varieties was enacted[227]
to recognize and ensure the protection of the rights of breeders of new plant
varieties by the grant of breeders’ certificates[228]. The scope of the Decision encompasses
all botanical genera and species insofar as the growing, possession or use
thereof are not prohibited for reasons of human, animal or plant health[229].
“Plant variety” is defined as the set of
cultivated botanical species that are distinguished by specific morphological,
physiological, cytological and chemical characteristics and can be perpetuated
by reproduction, multiplication or propagation[230].
A variety shall be deemed to be
essentially derived from an initial variety when it originated therefrom or
from a variety itself essentially derived from the initial variety and retains the
expression of the essential characteristics that result from the genotype or
combination of genotypes of the original variety, and which although
distinguishable from the initial variety, nevertheless conforms to it in the
expression of the essential characteristics that result from the genotype or
combination of genotypes of the initial variety, except with respect to
differences resulting from the derivation process[231].
A sample is defined as a sample of a
variety supplied by the applicant for a breeder’s certificate, which sample
shall be used for the testing of novelty, distinctness, uniformity and
stability[232].
The material is defined as the reproductive or vegetative multiplication
material in any form; harvested material includes whole plants and parts of
plants; any product made directly from harvested material[233].
Decision 345 guarantees that Member
Countries grant breeders’ certificates to persons who have created plant
varieties, insofar as the varieties are new, uniform, distinct and stable, and if
they have been given a denomination that constitutes their generic designation.
These requirements need to be fulfilled by an applicant to be entered in
national Registers[234].
A plant variety is deemed to be new if
reproductive or multiplication material or harvested material thereof has not
been lawfully sold or disposed of to others in another manner by or with the
consent of the breeder or his successor in title for purposes of commercial
exploitation of the variety[235].
A variety is considered distinct if it
is clearly distinguishable from any other variety the existence of which is a
matter of common knowledge on the filing date of the application or the date of
any priority claimed[236].
The uniformity of a variety results from its essential characteristics, special
regard is given to the variations that may be expected from the manner of its
reproduction, multiplication or propagation[237].
The variety is stable if its essential characteristics remain unchanged from
generation to generation[238].
The owners of breeders’ certificates may
be natural persons or legal entities[239].
The certificate shall belong to the breeder of the variety or the party to whom
it has been lawfully transferred[240].
The term of the breeders’ certificate shall be from 20 to 25 years in the case
of vines, forest trees and fruit trees, including their rootstocks, and from 15
to 20 years for other species, calculated in both cases from the date of the
grant, as determined by the competent national authority[241]. The variety has to have a denomination
that permits its identification. It should not be susceptible to mistakes as to
the characteristics, the value, or the identity of the variety or the breeder’s
identity[242].
7.2 Nationals Laws, Decrees and Regulations
Created and Amended in Order to Comply with the TRIPS Agreement
7.2.1 The 2000 Law on Biological Diversity
The 2000 Law on Biological Diversity was
adopted on May 24, 2000[243].
It regulates the protection of plant varieties in
Article 80
provides for the possibility to obtain a breeders’ certificate for those
persons who have created or obtained a plant variety, insofar as the variety
fulfils the following five criteria: novelty, homogeneity, distinctness,
stability and denomination of their genetic designation, in line with Articles
4 and 7 of Decision 345 of the Cartagena Agreement. The 2000 Law on
Biological Diversity also excludes from patentability all parts of living
beings, genome or parts of genomes, while the scientific and technological
inventions that lead to a new product are patentable[247].
7.2.2
The Organic Law on Science Technology and Innovation (LOCTI)
One of the primary
objectives of intellectual property policy[250]
is to promote innovation and scientific, technological, industrial and cultural
development and encourage the development of inventiveness[251].
The importance attached to innovation in Venezuelan industrial policy is evidenced
by the promulgation in 2001 of the Organic Law on Science, Technology and
Innovation (LOCTI)[252].
The aim of the law
is to develop science, technology and innovation policy and to provide an
organizational framework for all the players involved in scientific,
technological and innovative activities[253].
At the same time, the legal instrument is creating institutional and
operational mechanisms for the promotion and encouragement of research and the
dissemination of knowledge[254].
LOCTI is setting up
a National Science, Technology and Innovation Plan that obliges the Ministry of
Science and Technology to coordinate the financing necessary to implement the
activities[255].
Public and private enterprises that market intellectual property developed with
this financing must earmark between 0.5 and 5 per cent of the pre-tax profits
resulting from that activity for investment in training human resources and
R&D-related activities[256].
LOCTI also requires every large public or private enterprise in Venezuela to invest
between 0.5 and 20 per cent of its gross profits earned inside or outside
Venezuela in R&D. Enterprises[257]
set up abroad and domiciled in Venezuela must invest similar percentages of the
profits from their Venezuelan activities and activities carried out abroad that
are attributable to their permanent establishment in Venezuela[258].
7.2.3
Decree 3136 for implementing the Decision 345 of the Andean Community
Decree 3136 is
the administrative act[259] that implements
the Decision 345 of the CAN on Common Provisions on the Protection of the
Rights of Breeders of New Plant Varieties in
Decision 3136
designates SAPI as national Body appointed to apply the provisions on plant
variety protection[262].
It establishes the Committee of Protected Varieties, which is an advisory body
of SAPI[263]. The owner of a
breeder’s certificate in
An owner of a
breeder’s certificate, on a protected plant variety, shall replace the live
sample of the plant variety during the duration of the Certificate, in line
with Decision 345[266],
and shall comply with other requirements imposed in Decision 345. The term of
the breeder’s certificate shall be of 25 years in the case of vines, forest
trees and fruit trees, including their rootstocks, and of 15/20 years for other
species, calculated in both cases from the date of grant[267].
The National Executive may declare, on the basis of national security reasons
or public interest, the free disposition of a protected plant variety granted
through a breeder’s certificate[268].
This declaration cannot be for more than two years[269].
The functions of
the SENASEM “Servicio Nacional de
Semillas”[270]
are listed in Article 5. SENASEM is the organ responsible for the testing of
the novelty, the distinction, the homogeneity and the stability, as well as the
approval of the generic designation according to Decision 345.
7.3 The Institutions
Created in Order to Protect the Intellectual Property Rights
Intellectual property rights holders
have administrative, civil and criminal remedies at their disposal. Where civil
procedures are concerned, the competent courts are the civil courts of first
instance or the municipal courts. Criminal proceeding must be initiated by the
Department of Public Prosecution.
The Autonomous Intellectual Property
Service (SAPI)[271] is the body responsible for the
administration of intellectual property rights in
a) The Industrial Property Registration
Directorate (DRPI), responsible for administering the grant of patents, utility
models, industrial designs, breeder’s certificates (for plant varieties)[274]
and integrated circuit certificates and the registration of trademarks, trade
names, commercial slogans and appellations of origin[275]
and
b) The National Copyright Directorate
(DNDA), with administrative responsibilities for registration, monitoring and
inspection in connection with copyright and related rights. SAPI provides a
number of services, subject to the payment of fees fixed by SAPI itself, such as
computerized data searches; the listing of trademarks, trade names and
commercial slogans granted; reports and patent search reports by specific areas
in accordance with the International Patent Classification, etc.[276].
All the documents relating to patents,
designs, trademarks, etc. are published in the Industrial Property Bulletin[277].
SAPI is responsible to consent the breeder’s certificates for plant varieties,
to issue technical reports on novelty, distinctness, uniformity and stability;
to advise in matters related to protection of plant varieties and to give
information about the technologies that have been patented (national and
international).
The SAPI can
declare the breeder’s certificate null and void, in cases where the
requirements of novelty and distinctness were not fulfilled at the time when
the certificate was granted; in cases where the conditions laid down in
Articles 11 and 12 of Decision 345 where not fulfilled, at the same time; and
in the case of a certificate being granted to a person who had no right to it[279].
The certificate
can be also cancelled by SAPI when it is established that the protected variety
has creased to meet the conditions of uniformity and stability; when the
breeder does not provide the information, documents or material necessary for
testing the maintenance or reconstitution of the variety; when the breeder
doesn’t suggest, after the denomination of the variety has been rejected,
another suitable denomination within the prescribed period, and when payment of
the fee has not taken place by the expiration of the period of grace[280].
With the aim to coordinating efforts in
the fight against piracy, counterfeiting and forgery, the Venezuelan government
has created a special unit for preventing and repressing infringements of
intellectual property rights (COMANPI)[281].
COMANPI works to establish a joint strategy both for purposes of repression of
infringement and to promote a culture of respect for intellectual property. It
coordinates efforts to combat piracy, counterfeiting and falsification. COMANPI
has jurisdiction in the whole national territory. There are also special
investigators familiar with the national intellectual property situation that
order inspections and serve administrative summons which may give rise to the
imposition of penalties in the event of copyright infringement. A prosecutor
with national competence for intellectual property offences is assigned to the
Department of Public Prosecution.
The National
Office of Biological Diversity, which is delegated by the Ministry of
Environment[282]
is responsible for the regulation, formulation, and execution of the
environmental policy of the Government[283].
Its concern are also the planning, coordination, execution of the Government
activities aimed at improving people’s
standard of living; the environment and natural resources; the
establishment and implementation of programs for scientific and technical
education and training in measures for the identification, conservation and
sustainable use of biological diversity; design, development and implementation
of educational and public awareness programmes, with respect to conservation
and sustainable use of biological diversity; the administration and management
of water and forestry resources; the generation and actualization of the
cartography; the evaluation and control over the sea cost area; the elaboration
of studies and projects related to environment[284].
7.4 Implementation of
Enforcement Obligations
Intellectual property rights holders
have administrative, civil and criminal remedies at their disposal. Article 26
and Article 49 of the Constitution of 1999 guarantee the effective protection of
individual rights. An administrative mechanism of conciliation and mediation is
available for the resolution of disputes over intellectual property rights, to
the benefit of right holders who can save both time and money by having
recourse to the process[285].
The State prosecution authority is the Fiscal Office “Fiscalía del Ministerio Público”. It employs special prosecutors
with nation-wide jurisdiction in the field of intellectual property[286].
The administrative authorities are responsible for inspections to prevent
infringements of intellectual property rights, which may give rise to the
imposition of penalties.[287]
Civil procedures are within the responsibility of the civil courts of first
instance or the municipal courts. Criminal proceedings must be initiated by the
Department of Public Prosecution.
7.5 Cooperation with the TRIPS Council
In conformity with
the TRIPS Agreement,
8. Conclusion
The agreements
on the Application of Sanitary and Phytosanitary Measures, and on Technical
Barriers to Trade set out detailed rights and obligations to enable members to
determine the food safety levels and animal and plant health protection
required in their respective country. At the same time under the Agreement on
Trade related Aspects of Intellectual Property Rights the member countries are
obliged to provide for the protection of plant varieties. This paper provided a
comprehensive overview of the Venezuelan legal and institutional framework
implementing those agreements. It identified the essential features of the
Venezuelan system, including the policies supporting food safety and plant and
animal health protection.
This paper
described in particular the different forms of legal protection that result of
the linkages between the Andean Community and the transformation of the
Venezuelan domestic policies. It highlighted that regional trade initiatives, like the direct
applicability principle of Andean Community legislation, played a strong role
in the Venezuelan system of implementation of WTO-Agreements.
This paper also highlighted the reforms
made in the agricultural sector that have been previously undocumented, and
presented useful information for national governments and for non-Member
countries that are considering or that are in the process of WTO accession.
It is important to address the
misperception of that
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