Educational guide
IDENTIFYING DATA 2023_24
Subject LEGAL AND SOCIAL ASPECTS OF BIOTECHNOLOGY Code 00208033
Study programme
0208 - GRADO EN BIOTECNOLOGÍA
Descriptors Credit. Type Year Period
3 Compulsory Fourth First
Language
Castellano
Prerequisites
Department DERECHO PUBLICO
Coordinador
PARDO PRIETO , PAULINO CÉSAR
E-mail pcparp@unileon.es
stars@unileon.es
mmorg@unileon.es
Lecturers
PARDO PRIETO , PAULINO CÉSAR
TARODO SORIA , SALVADOR
MORLA GONZALEZ , MARINA
Web http://
General description Study of: Biotechnology Law; Basics, constitutional principles and normative frame; Biomedical legislation and genetic technology; The embryos and the Spanish legislation on genetic engineering; Governmental policies on Biotechnology; Freedom of scientific investigation; Principle of precaution and measures of safeguard; Right to self-determination before the Biotechnology: constitutional implications; Regulation of the Vegetable Biotechnology; Legal protection of the environment; Confined utilization of genetically modified organisms; Legal regime of the biotechnological politics; Voluntary release and marketing of genetically modified organisms; Biosafety and risks; Patents
Tribunales de Revisión
Tribunal titular
Cargo Departamento Profesor
Presidente DERECHO PUBLICO GARCIA AMADO , JUAN ANTONIO
Secretario DERECHO PUBLICO SEIJAS VILLADANGOS , MARIA ESTHER
Vocal DERECHO PUBLICO BALLESTEROS MOFFA , LUIS ANGEL
Tribunal suplente
Cargo Departamento Profesor
Presidente DERECHO PUBLICO GONZALEZ GRANDA , PIEDAD
Secretario DERECHO PUBLICO TRAPERO BARREALES , MARIA ANUNCIACION
Vocal DERECHO PUBLICO ALEGRE MARTINEZ , MIGUEL ANGEL

Competencias
Code  
A14019
A14020
A14021
A14022
A14023
A14083
A14084
A14085
A14089
A14092
A14093
A14101
B3764
B3765
B3766
B3768
B3829
B3830
B3834
B3835
B3836
B3838
B3843
B3844
B3846
B3847
B3848
B3849
B3850
B3851
B3852
B3853
B3854
B3855
B3856
B3857
B3858
B3859
C1 CMECES1 That students have demonstrated possession and understanding of knowledge in an area of study that is based on general secondary education, and is usually found at a level that, although supported by advanced textbooks, also includes some aspects that involve knowledge from the cutting edge of their field of study
C2 CMECES2 That students know how to apply their knowledge to their work or vocation in a professional manner and possess the skills that are usually demonstrated through the development and defense of arguments and the resolution of problems within their area of study.
C3 CMECES3 That students have the ability to gather and interpret relevant data (normally within their area of study) to make judgments that include reflection on relevant issues of a social, scientific or ethical nature.
C4 CMECES4 That students can transmit information, ideas, problems and solutions to both a specialised and non-specialised audience
C5 CMECES5 That students have developed those learning skills necessary to undertake further studies with a high degree of autonomy

Learning aims
Competences
A14083
A14089
A14092
B3834
C1
C5
A14085
A14089
A14092
B3830
B3843
C1
C5
A14019
A14020
A14021
A14023
B3764
B3765
B3766
B3835
B3836
B3838
B3843
B3850
B3851
B3852
C2
C3
C4
A14023
A14084
A14093
B3829
B3835
B3836
B3850
B3852
C2
C3
C4
A14020
A14022
A14023
A14101
B3838
B3843
B3846
B3847
B3850
B3851
B3854
B3859
C2
C4
A14021
A14023
A14092
B3766
B3768
B3844
B3853
C1
C4
C5
A14020
B3848
B3849
B3850
B3851
B3855
B3856
B3857
B3858
B3859
C5

Contents
Topic Sub-topic
I.- CONCEPTS, PRINCIPLES AND SOURCES I.1.- Basic concepts.
I.2.- Principles: personality, autonomy, non-discriminatio, pluralism, participation, secularity, caution and traceability.
I.3.- Sources: internacional, comunitary, state, autonomic and deontologic.
II.- BIOTECHNOLOGY, FUNDAMENTAL RIGHTS AND OTHER LEGAL ASSETS ADMINISTERED CONSTITUTIONALLY II.1.- Fundamental rights and Biotechnology. Identity and information protection right. Freedom of scientific research. Freedom of choice. Limits on fundamental rights.
II.2.- Other legal assets administered constitutionally. Users and consumers. Scientific progress, medical applications and potential benefits for society. Environment. Risks for nature and biodiversity. Animal welfare. Business and market interests: Intellectual property, patents and free movement of produce.
III.- BIOTECNOLOGY AND BIOMEDICINE LAW III.1.- The human body and the person against biotechnology: constitutional implications.
III.2.- Biotechnologic research regulation.
III.3.- Biomedic law, genetic technology, embryo and genetic engineering.
III.4.- Criminal legislative policy and leave from prison in relation with human biotechnology.
IV.- PLANT BIOTECNOLOGY LAW IV.1.- Legal regime of the contained use of genetically modified micro-organisms.
IV.2.- Legal regime of the intentional freeing of genetically modified micro-organisms in the environment with different purposes from those of its commercialization.
IV.3.- Legal regime of the market of food and fodder modified genetically. Authorization, supervisión, labelling, trackability and transfrontier movement.
IV.4.- Legal criteria for coexistence between genetically-modified crops and eco and conventional crops.

Planning
Methodologies  ::  Tests
  Class hours Hours outside the classroom Total hours
Case study 6 9 15
 
Seminars 8 12 20
 
Lecture 10 10 20
 
Objective short-answer tests 2 4 6
Practical tests 2 0 2
2 10 12
 
(*)The information in the planning table is for guidance only and does not take into account the heterogeneity of the students.

Methodologies
Methodologies   ::  
  Description
Case study
Seminars
Lecture

Personalized attention
 
Case study
Seminars
Description

Assessment
  Description Qualification
Objective short-answer tests 50%
Practical tests 30%
20%
 
Other comments and second call

Sources of information
Access to Recommended Bibliography in the Catalog ULE

Basic Mellado Ruíz, Lorenzo, Bioseguridad y Derecho. La Administración ante los riesgos de la tecnología de la vida, Comares, 2004
Tarodo, Salvador; y, Pardo, Paulino (coords.), Biotecnología y Bioderecho, Eolas, 2011
Romeo Casabona, Carlos María, Biotecnología y Derecho. Perspectivas en Derecho Comparado, Comares, 1998
Vives Vallés, Juan Antonio, Derecho de cultivos transgénicos. El conflicto entre el Derecho español y comunitario y el derecho a la libertad de empresa, a la luz de la nueva normativa opt-out, Dykinson, 2016
Mellado Ruíz, Lorenzo, Derecho de la Biotecnología vegetal. La regulación de las plantas transgénicas, INAP, 2002
Amat Llombart, Pablo, Derecho de la Biotecnología y los transgénicos, Tirant lo Blanch, 2008
Esteve Pardo, José, El desconcierto del Leviatán, Marcial Pons, 2009
Triviño Caballero, Rosana, El peso de la conciencia. La objeción de conciencia en el ejercicio de las profesiones sanitarias, Plaza y Valdés, 2014
Rodríguez Arias, David et al., Ética y experimentación con seres humanos, Desclée De Brouwer, 2006
Pérez Álvarez, Salvador, Incidencia de las nuevas biotecnologías en el derecho a la protección de la salud de los pacientes: ¿de vueltas al Estado liberal?, en Los Avances del Derecho ante los Avances de la Medici, Aranzadi, 2008
Fernández-Coronado, Ana; y, Pérez, Salvador (coords.), La protección de la salud en tiempos de crisis, Tirant Lo Blanch, 2014
Martín Uranga, Amelia, La protección jurídica de las innovaciones biotecnológicas, Comares, 2003
Morla González, Marina, Las patentes farmacéuticas y el comercio del medicamento, Revista Electrónica de Derecho y Ciencia, 2017
Tarodo Soria, Salvador, Libertad de conciencia y derechos del usuario de los servicios sanitarios, Servicio Editorial de la Universidad del País Vasco, 2005
Romeo Casabona, Carlos María, Principio de Precaución, Biotecnología y Derecho, Comares, 2004
Mir Puigpelat, Oriol, Transgénicos y derecho. La nueva regulación de los organismos modificados genéticamente, Civitas, 2004

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