The Genetically Modified Organisms and the Law of Moratorium to their entry and commercialization in Peru

Biotechnology is a science that involves several disciplines and sciences (biology, biochemistry, genetics, virology, agronomy, engineering, chemistry, medicine and veterinary, among others). It has been used by man since the beginning of history in activities such as the preparation of bread and alcoholic beverages or the improvement of crops and domestic animals. Historically, biotechnology involved the use of organisms to perform a task or function. If this definition is accepted, biotechnology has been around for a long time.

Modern biotechnology is comprised of a variety of techniques derived from research in cellular and molecular biology, which can be used in any industry using microorganisms or plant and animal cells. This technology allows the transformation of agriculture. It is also important for other carbon-based industries such as energy, chemicals and pharmaceuticals, and waste or waste management. It has a huge potential impact because life sciences research is making a fast progress and the results not only affect a broad range of sectors but also facilitate linkage between them. For example, successful results in fermentation of agricultural wastes could affect both the energy sector and agribusiness sectors and also have a favorable environmental effect.

Un ejemplo de la biotecnología moderna son los «Organismos Genéticos Modificados» (OGM). El Dr. Carlos Andaluz, en su libro «Manual de Derecho Ambiental» define los OGM de la siguiente manera:

«Los OGM son plantas o animales creados a partir de la manipulación genética, que contienen genes transferidos de otro organismo. Este procedimiento puede realizarse entre plantas de la misma especie, entre especies no relacionadas o incluso transferir genes de una planta a un animal y viceversa. (…) Un OGM es aquel que ha incorporado un gen extraño de otro organismo, gracias a la manipulación genética que permite la transferencia de un gen de un organismo y lo inserta en otro.

 Esta técnica ha roto las barreras naturales para la reproducción y creación de seres vivos, porque bajo condiciones naturales sólo es posible cruzar plantas o animales de la misma especie «[1]

Durante miles de años, los agricultores han estado alterando la estructura genética de los cultivos que siembran. La selección hecha por el hombre para obtener características tales como crecimiento más rápido, semillas más grandes o frutas más dulces ha modificado significativamente las especies vegetales en comparación con los parientes silvestres. El desarrollo en los últimos años de las técnicas de biología molecular ha proporcionado al hombre herramientas que le permiten acceder y manipular el ADN de los organismos. Una de las aplicaciones de lo que se ha llamado «ingeniería genética» es el desarrollo de técnicas moleculares para la modificación genética de una variedad de plantas, animales y microorganismos utilizados como alimento o involucrados en el proceso de obtención de alimentos. Estos alimentos se llaman alimentos «transgénicos» porque provienen de organismos que transportan material genético pertenecientes a especies no relacionadas que han sido transferidos a través de la ingeniería genética.

But during the last years, some groups of people (mainly ecological activists) oppose the creation of GMOs, arguing that some dangers of transgenic products include: genetic pollution, soil pollution, loss of biodiversity, development of pest resistance, effects on ecosystems that may be irreversible and unpredictable. They can increase the allergies produced by the proteins that generate the new introduced genes, resistance to antibiotics as these crops carry unnecessary genes that inactivate or render ineffective the antibiotics in the human health and animals that consume it.

In Peru, there is no issue that generates more debate, controversy and even passion than that of transgenics and their entry, use or release in the territory of our country. It is pointed out that when we refer to transgenics the debate may refer to: (i) its use in manufactured products and the need to find in the labeling sufficient information for the consumer to make their own decision; (ii) its use in pharmaceutical, veterinary or other uses; and (iii) their entry and liberation in our territory.

The main reason for this debate in our country is because Genetically Modified Organisms are absolutely new in the planet and no one knows how they will behave when they enter the environment. When inserting a genetically modified plant in a location that is center of origin of the relatives species that originated it can be generated negative impacts.

As a consequence of this concern, rules and mechanisms to prevent and control the impact and negative effects of research, production, release and introduction of new species or genetically modified products developed by conventional biotechnology were first drafted. This is known as BIOSECURITY.

The reason for this is, as noted above, that GMO´s can affect environmental, technological, socioeconomic and cultural aspects and, moreover, on food security and the present and future quality of life.

La regulación de la bioseguridad en el Perú comienza en 1999, cuando el Congreso emite la Ley N ° 27104, denominada «Ley de Prevención de Riesgos derivados del Uso de la Biotecnología». Esta Ley se centra en la «biotecnología moderna». Este marco jurídico tiene por objeto promover «la investigación, la producción, la introducción, el transporte, el almacenamiento, la conservación, el intercambio, la comercialización, el uso confinado y la liberación con OGM en condiciones controladas» y proteger la salud humana, el medio ambiente y la diversidad biológica. (Artículos 1° y 2°).

Excluded from the law are activities in the human genome, vaccines applied to humans, GMOs obtained from traditional or conventional techniques, in vitro fertilization, among others (Article 4).

Three years later, through Supreme Decree No. 108-2002-PCM, the institutional framework was established and designates three Competent Sectoral Bodies (CSOs) whose role is to implement their respective Internal Sectoral Biosafety Regulations: the National Institute of Agrarian Innovation - INIA (for the agricultural sector), the Vice-Ministry of Fisheries (for the fishing sector) and the General Directorate of Environmental Health - DIGESA (for the health sector).

In 2004, through Legislative Decree No. 28170, Congress ratified the Cartagena Protocol on Biosafety (CPB), which aims to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biodiversity taking into account risks to human health and specifically focusing on transboundary movements.

One point that we must highlight from the CPB is that the signatory states may adopt more stringent regulations to the CPB, but are required to the realization of the Advance Informed Agreement, in which the country of import has the following rights: (a) Has to be notified of the proposed transboundary movement, (b) To receive information about the GMO´s and their proposed uses, (c) have the opportunity to decide whether or not to allow the import of GMO´s, and under what conditions.

In spite of the approved regulatory framework, the lack of sectoral regulations regulating the procedures represented a de facto moratorium on the entry and release to the environment of GMOs. In addition, the lack of information on the subject and the need to strengthen national capacities in biosafety generated a growing trend of opinion that demanded a moratorium aimed not only at controlling unwanted GMOs but also in preparing for the adoption of an informed and technical decision at the end on the same.

In this context, the Congress approved in November 2011, Law No. 29811, Law that establishes the Moratorium on the entry and production of GMOs in the national territory for a period of ten years, which aims to strengthen national capacities, develop infrastructure and generate the baselines in relation to native biodiversity.

It should be noted that GMOs, whether for direct use as food, for use in processing, for confined research-focused use, as well as for regulated pharmaceutical and veterinary products by the World Health Organization (WHO), are excluded from the Moratorium Act.

Finally, if we talk about protecting the rights of the plant breeders, we must mention that since 1996, our country has special legislation to protect new plant varieties, including transgenic, developed under any method of plant breeding (discipline responsible for creating new varieties or hybrids of plant species) thus promoting and encouraging technological development and agricultural research with the aim of consolidating a sustainable production system.

The problem is that with this law, is that it restricts the development of research, creation and development of better agricultural techniques for our country.

In conclusion we can say that:

a) Biotechnology in Peru has not been able to reach its potential, fundamentally because there is no incentive on the part of the government to develop the research activities and scientific creation in general nor access to proper modern biotechnology.

b) As we said, transgenics were patentable, but all the legal frameworks and laws that regulated the procedures to obtain the admission for using GMO´s were repealed by the new government, due to political reasons and rivalries with the previous government, to obtain a free way to enact anti-technological laws that restrict access to new technologies.

c) We agree with the position of former Minister of the Environment, Antonio Brack who pointed out that "Peru is one of the largest gene banks in the world, and its defense and projection is a task for all of us. If all biodiversity and traditional knowledge could obtain a patent right, our country would be in a better position to deal with GMOs and allow the consumer to make the final decision without moratorium laws restricting access to new technologies and knowledge".

Author: Jesús Cuba – Intellectual Property Specialist
Law Firm: OMC Abogados & Consultores

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[1] ANDALUZ WESTREICHER, Carlos, Enviromental Law Manual, Grijley, Lima, 2009, p. 185.