II.

Biotechnology’s
Advantages, clusters and laws
 Learning goals (Topic 2):

• Describe the trends and prospects • Document the • Analytical.

Concepts:

Attitudes:
Performance:
for the development of Reflexive. Critical.
biotechnology according to its area development
trends of the Deductive.
of ​application and social needs at Observer.
the global and national level. areas of
Relate trends and prospects for biotechnology Creative.
biotechnology development with applied at the Ecological
the solution of current social regional level and awareness.
problems and needs at the comment on the Socially
regional level. Identify new areas leading prospects responsible.
of application of biotechnology in Proactive.
regarding the
the innovation of the benefits Systematic.
sought in the short and medium national and
global level. Ethical. Objective.
term.
2.1 Comparison between chemical
and biotechnological
products/processes
 Biological/Biotechnological vs. Chemical Products
Significant Differences In:

Production Handling Reference Expiration

Raw Materials Physicochemical Formulations Stability Profile Specifications
Processes Conditions Standards Dating

Methods Storage
of Analysis Conditions
 E.g. CHEMICALS VS
BIOLOGICALS

DRUG BIOLOGIC
Statin IgG
MW 405 MW 150,000

© 2015 N. Ritter, Ph.D.

E. g. Comparison of biopharmaceuticals vs chemical pharmaceuticals

Characteristics Chemical pharma Biopharmaceuticals

products
When ingested Not easily destroyed More prompt to be
destroyed
Route of ingestion Orally (less efficacy) Parenteral (more
efficacy, but less safety)
Issues Might have undesirable Might have cross
chemicals (e.g quirals, contamination (host-
solvents) cell proteins,
microorganisms)
Generics More available Less common
2.2 Factors shaping Biotech’s trajectory

They are
economical,
social and
political

BIOCONVERGENCE 2040.PNG
Economical: In 2019, global bioeconomy
An increased accounted for $5 trillion (6% global
GDP).
investment and By 2030 could exceed $20 trillion,
decreasing cost: when decreased costs.
Political: When regulatory Reduces funding, production or public
acceptance.

restrictions: In response to accidents, unintented

consequences or public pressure.

Which could increase funding, production

When international and public acceptance.

acceptance: International agreements, recognition of

international issues or advocacy by
influential voices may foster this.

Open, normatively and legally guided

Large-scale collaboration.

collaboration and Also, collaborations less visible, among

cooperation: researchers, start-ups and hobbyists.
 Key necessities, like pandemics or food shortages.

Social: Changes in consumer

demands:
Healthier and environmentally friendly products.

Agriculture and livestock alternatives.

Increasing attention for land and water usage related

Responses to to carbon emissions.

environmental change: Policies that prefer carbon neutral technologies.

2.3 Biotech’s clusters
Worldwide clusters of biotechnology

https://www.mbbnet.umn.edu/scmap/biotechmap.html
Worldwide locations of biotechnology employers. Source Biotech-Careers.org
2.4 Biotech in Mexico
Mexico towards biotechnology
MegaBiodiversity Skilled Competitive
(10% of global biodiversity ) workers costs

Free trade pacts Geography Friendly legal and

(Climate and ecosystem regulatory
(45 countries) diversity) framework

• Innovative Solutions to global and local challenges

• Sustainable use of thebiodiversity
 Human and veterinary health

Agricultural modernization
Potential
Biotechnology Protection of environment
Applications in
Mexico Biofuels

Other areas
http://www.salaryexplorer.com/salary-survey.php?loc=139&loc
type=1&job=41&jobtype=1
Biotech clusters in Mexico
2.5 International and National Law on
Biotechnology
Mexican LAWs in accordance with
global recommendations
 NOM´s, e.g:
NOM-257-SSA1-2014, En materia de medicamentos biotecnológicos

Legislación y Políticas Públicas en Biotecnología en México, Centro de Estudios para el Desarrollo Rural Sustentable y la Soberanía Alimentaria de la Cámara de Diputados, LXI Legislatura, México,2009.
 International Law on Biotechology
To set standards for biotechnology on health, the environment, agriculture, trade, ethical and socio-economic aspects.

These organizations include:

Codex Alimentarius Commision

World Health Organization (WHO),

United Nations Food and Agriculture Organization (FAO),

United Nations Environmental Programme (UNEP),

United Nations Educational, Scientific and Cultural Organization (UNESCO)

United Nations Industrial Development Organization (UNIDO), among others

 International Law on Biotechology

A first approach:

The Food and Drug Administration (FDA) issued a policy statement in 1992, in which:

“Biotech products were generally considered to be as safe as

conventional food and that pre-market approval was only
necessary under certain conditions”.
 The great majority of countries have, so far, adopted some form of regulation on
biotechnology and biotech products.

The core elements for regulation:

Socio-economic Other
considerations monitoring
Laboratory Environmental
Risk analysis, for pre- Labeling, Traceability measures for
control, release,
marketing post-approval
authorization; surveillance.
The potential of biotechnology to contribute to the alleviation of some problems associated with
development and the environment was recognized by the:

1992 UN Conference on Environment and Development (the “Earth Summit”),

which devoted

Chapter 16 of Agenda 21 to “Environmentally sound management of biotechnology.”

https://www.un.org/en/conferences/environment/rio1992
Activity 1, research:
• Look for 5 INTERNATIONAL and 5 MEXICAN biotechnology companies and
their main products.
• At least one of those must be from Puebla.

• Look for 5 INTERNATIONAL and 5 MEXICAN LAWS on biotechnology and

explain what are them about in short and who (instance) published them.

• You will expose them (10 mins)

• In teams
• English
• Do not copy!
Questions,
comments
feedback?
Many international agreements relating to biotechnology are legally binding or strongly
political consensus, including, inter alia,

• UN Convention on the Law of the Sea (UNCLOS, 1982),

• Convention on Biological Diversity (1992),
• WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS
Agreement, 1994),
• WTO Agreement on Technical Barriers to Trade (TBT Agreement, 1994),
• International Plant Protection Convention (1997),
• UNESCO Universal Declaration on Human Genome and Human Rights (1997),
• Aarhus Convention (1998), (the UNECE Convention on Access to Information, Public
Participation in Decision-making and Access to Justice in Environmental Matters)
• Biosafety Protocol (2000),
• UNESCO International Declaration on Human Genetic Data (2003), and
• UNESCO Universal Declaration on Bioethics and Human Rights (2005).
• Convention on Biological Diversity, June 5, 1992

As of October 2000, 178 states have ratified or acceded to the Convention, an extraordinary level of adherence
by any measure. The overall objectives of the Convention are:
The conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing
of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic
resources and by appropriate transfer of relevant technologies, taking into account all rights over those
resources and to technologies, and by appropriate funding.

• The Cartagena Protocol on Biosafety (2000)

https://bch.cbd.int/protocol/

• In Mexico:

“Ley de Bioseguridad de Organismos Genéticamente Modificados”

Última reforma: DOF06-11-2020