Page 70 - Genomic Medicine in Emerging Economies

Genetics Laws and Regulations in Colombia 59

1. Genetic manipulation (Article 132): Whoever manipulates human
genes with a purpose other than treatment, diagnosis or scientific
research in Biology, Genetics and Medicine, oriented at alleviating
human suffering or at improving the health of the person of human
kind, will be imprisoned 1–5 years.
2. Human being reproducibility (Article 133): Whoever generates identical
human beings by cloning or other methods, will be imprisoned
2–6 years.
3. Fecundation and trafficking of human embryos (Article 134):
Whoever fertilizes human ovules with a purpose different than
human procreation or with prejudice to scientific research, treatment
or diagnosis of the person object of the research, will be imprisoned
1–3 years, as well as whoever traffics gametes, zygotes, and human
embryos obtained by any means.

Additionally, Colombian law (Ley 721 de 2001) regulates paternity and mater-
nity DNA tests and the authorized laboratories offering these genetic services
(Congreso de la República, 2001). However, other genetic tests are not men-
tioned in Colombian legislation.

A very important aspect, which is not contemplated in Colombian law is
genetic discrimination. Ideally, individuals should be protected, as is the case
with the Genetic Antidiscrimination Act (GINA) in the United States, against
insurance and work discrimination based on genetic conditions (U.S Con-
gress, 2008). Hopefully, this aspect can be addressed in the near future.
Orphan diseases are also addressed in Colombian legislation in the Law
1392/2010 and are defined as chronic, debilitating, and severe medical condi-
tions with prevalence lower than 1 in 5000 people (Congreso de la República
de Colombia, 2010). There is a list of all conditions considered orphan dis-
eases that is updated every 2 years (Resolution 0430/2013) and an informa-
tion system to report and collect information regarding these diseases (Decreto
1954/2012) (Ministerio de Salud y Protección Social, 2013; MSPS, 2012). A
special health regulatory commission (Comisión de Regulación en Salud—
CRES) was created to evaluate the diagnostic tests that should be included
in the benefits plan, POS. The services related to orphan diseases that are
not incorporated in the POS, should be financed by a fund called Solidar-
ity and Guarantee Fund (Fondo de Solidaridad y Garantía—FOSYGA) (Law
1392/2010) (Congreso de la República de Colombia, 2010). Newborn or pre-
natal screening diagnostic tests for genetic disorders are available in the coun-
try, but they are not regulated or financed by the health care system. The only
mandatory neonatal screening test is for congenital hypothyroidism (Reso-
lution 412/2001, of the Ministry of Health and Social Protection), however,
this is not always done, especially in rural areas without access to this test