BIOTECHNOLOGY LAW NOTES

INTRODUCTION

Definition

This refers to the manipulation (as through genetic engineering) of living organisms or their components to produce useful usually commercial products (as pest resistant crops, new bacterial strains, or novel pharmaceuticals). It is the use of living systems and organisms to develop or make useful products.

A more complex definition follows. Biotechnology is the research and development in the laboratory using bioinformatics for exploration, extraction, exploitation and production from any living organisms and any source of biomass by means of biochemical engineering where high value-added products could be planned (reproduced by biosynthesis, for example), forecasted, formulated, developed, manufactured and marketed for the purpose of sustainable operations (for the return from bottomless initial investment on Research and Development) and gaining durable patents rights (for exclusives rights for sales, and prior to this to receive national and international approval from the results on animal experiment and human experiment, especially on the pharmaceutical branch of biotechnology to prevent any undetected side-effects on safety concerns by using the products), for more about the biotechnology industry.

It is relevant in Kenya on mainly agricultural areas. This includes, low technology applications like biofertilizer, biopesticides, micro propagation (Tissue culture) and Marker Assisted Selection (MAS) and also high tech biotechnology like transgenic sweet potato, Bt maize and rDNA vaccines and diagnostics and finally GMO maize.

Biotechnology has generated a lot of controversy in Kenya.

Why the Controversy?

There is overwhelming evidence and knowledge that the needs and drive for biotechnology in Africa are quite different from those of industrial countries. Africa’s agenda is based on the urgent needs for technological change to enhance food production and to alter the course of widespread poverty, hunger, and starvation. Industrial countries are driven by market and profit.

These distinctions must be understood and appreciated at the national, regional, and global levels. In Kenya civil society and other misinformed persons have created fear, mistrust, and general confusion to the public, and have failed to seek the views of African policymakers and stakeholders. There is need to understand the goals of biotechnology separately in the different countries.

The debate about biotechnology for Kenya should not be whether or not the country needs biotechnology, but how biotechnology can be promoted, supported, and applied in safe and sustainable ways that contribute to improved agriculture and to the social and economic welfare of the Kenyan people. The need for biotechnology in Kenya is very clear, and should not be confused with the marketing/food surplus driven forces of the industrial countries.

BIOSAFETY REGULATION IN KENYA: HISTORICALLY

The major legal concern in biotechnology is safety. In 1987, the Government through the then Ministry of Research Science and Technology set up a committee under the National Council for Science and Technology (NCST), to determine the priorities for research in biotechnology. The committee known as the National Advisory Committee on Biotechnology Advances and their Applications (NACBAA) made the first reference to the need for a policy on biosafety. The committee, consisting of the directors of Research Institutes, produced a report which recommended that the NCST develops a policy on biohazards and ethics in biotechnology.

Kenya signed the Convention on Biological Diversity (CBD) on 11th June 1992 and ratified it on 26th July 1994. The same year i.e. 1994, the Kenya National Environment and Action Plan (NEAP), which was approved by Cabinet, made the following recommendations pertaining to biosafety:

ü  Establish a National Commission on biotechnology and biosafety.

ü  Formulate a scientific criteria for the safe use genetically modified organisms including methods of hazard identification and exposure assessment before GMOs are released into the environment and also design measures for biological and Physical containment of GMOs and mechanisms to monitor the organisms, genetic material and processes exposed to GMOs.

ü  Make Prior Informed Consent a Pre-requisite for all field-testing.

ü  Formulate a biosafety policy and regulations.

In 1997, The Kenya Agricultural Research Institute produced Biosafety Guidelines and formed

the Institutional Biosafety Committee. In 1998, the National Council for Science and Technology produced the regulations and guidelines for safety in biotechnology which provided a base for the establishment of the National Biosafety Committee (NBC) and Institutional Biosafety Committees as well as identifying the competent authority as the National Council for Science and Technology. In 1999, under the framework of the UNEP/GEF Biosafety Enabling Activity, a National Biosafety Framework was produced based on an assessment of the status of biotechnology and biosafety in the country. A draft Biosafety Law was also prepared. In 2000, the National Biodiversity Strategies and Action Plans (NBSAP), published by the Ministry of Environment and Natural Resources, identified biosafety as an important area that required support for its advancement. On 15th May, 2000, during the Fifth Conference of Parties to the CBD, the President of Kenya signed the Cartagena Protocol on Biosafety. Kenya was the first country to sign the Protocol. Kenya fully ratified the Protocol in 2003.

In 2000, the National Environment Co -ordination and Management Act was enacted. This Act also emphasizes the need to set regulatory framework for biosafety issues.

The government published a National Biotechnology Development Policy in 2006. The Biosafety Act was enacted in 2009. It was assented to by President Kibaki on February 12, 2009.cThe National Biosafety Authority (NBA) was launched in May 2010 to administer Biosafety Act and Biotechnology Policy, NBA is to grant approvals for GMO testing, import and export and commercialization.

Legal Framework (summary)

National Biotechnology Development Policy in 2006

Biosafety Act of 2009

Biosafety Regulations, 2011

Convention on Biological Diversity (CBD)

Cartagena Protocol on Biosafety of 2000

LEGAL FRAMEWORK FOR BIOTECHNOLOGY REGULATION IN KENYA

NATIONAL BIOTECHNOLOGY POLICY, 2006

The policy charts the vision of the Kenyan government towards the development and safe application of biotechnology. It provides those developing and applying the technology with a clear framework under which to operate. The policy commits the government to give priority to the provision of relevant institutional, infrastructural and legislative framework and, in particular, the enactment of new legislation on biosafety.

What are the objectives of the Policy?

Some of the key objectives of the policy are to:

• Prioritize, promote, and coordinate research in basic and applied bio-sciences.
• Promote sustainable industrial development for production of biotechnology derived products.
• Create enabling administrative and legal frameworks for biotechnology development and commercialization.
• Develop mechanisms for the provision of sustainable funding for biotechnology research and products development.
• Support and facilitate capacity building on all aspects of biotechnology including intellectual property access and protection, biosafety and bioethics.
• Support the development and retention of human resources in science, innovation and biotechnology.
• Stimulate collaboration among public, private sectors and international agencies in order to advance biotechnology both locally and internationally.
• Promote public understanding of the potential benefits and address stakeholder concerns/issues on modern biotechnology.

Scope of the policy

The policy covers all biotechnology applications, including tissue culture and micro-propagation, biopesticides and biofertilizers, livestock technology, DNA Marker technology, and genetic engineering. It also covers research, development and use of biotechnology in various key fields such as agriculture, environment, human and animal health and industry. The policy takes cognizance of international instruments, such as the Cartagena Protocol on Biosafety.

Key Features of the Policy

The policy outlines six priority areas of focus

1. Agricultural Biotechnology

Under this, the Government will focus on the following priority areas:

• Biotechnologies to develop new plant varieties with beneficial genetic traits for pest and disease resistance, improved nutritional value, tolerance to drought and salinity. Special attention will be paid to conservation of germplasm of traditional and wild crop plants.  
• Animal reproductive biotechnologies such as artificial insemination, embryo transfer, genetic improvement of local breeds, and somatic cell nuclear transfer (cloning) techniques. Special attention will be paid to the development of livestock that are resistant to diseases, have improved meat, milk or wool quality, can increase proteins in their milk or meat (biopharm animals), or which have characteristics that are environmentally friendly.  
• New plant and animal diagnostic products, improved animal vaccines, biological pesticides, herbicides and fertilizers

2. Education

The government will pay particular attention to:

• Reviewing of curricula at all levels to promote the spirit of scientific inquiry by encouraging independent student projects, exposing students and teachers to biotech activities in Kenya and internationally through study tours, expert guest lectures; and promoting acquisition of entrepreneurial skills.  
• Strengthening the teaching of biosciences at the formal education level.  
• Attracting and retaining talent in biosciences.  
• Developing scientific and related infrastructures.  
• Spearheading formal and informal public education and awareness creation programs.

3. Bioresources

The Government will support the following priority activities for fast-tracking economic exploitation of biodiversity:

• The development of a centrally managed database on species in different ecosystems and the traditional knowledge associated with the species.
• Creation of research fund to facilitate molecular characterization and bioprospecting for novel products for development and industrial production.
• Establishment of national culture collection centers for the preservation and utilization of economically beneficial microorganisms.  
• Accelerate the establishment of viable in situ and ex situ (Gene banks) conservation centers.  
• Focused exploitation of fauna, flora and microbes in marine and extreme habitats for novel genes for development of osmo tolerant crops, enzymes, biopolymers, marine pollution biosensors, bioactive molecules, etc.

4. Environmental Biotechnology

The Government will ensure environmental sustainability by developing and adopting appropriate biotechnologies to address:

• Monitoring of environmental pollution
• Eco restoration of degraded habitats
• Afforestation and reforestation
• Bioremediation of wastes
• Control of biological invasions
• The potential for value-added products from biomass

Applications requiring use of modern biotechnology for all purposes, will be subject to approval by the designated authority,

5. Medical Biotechnology

To realize fast and meaningful economic benefits from medical biotechnology, the government will focus on the following areas:

• Basic and applied research in bioinformatics, molecular and cellular biology, genomics, proteomics, stem biology (strictly using ethically obtained stem cells only), and other new platform biotechnologies as appropriate
• Development of molecular diagnostics, recombinant vaccines, and drug delivery systems.
• Development of traditional herbal medicines into superior industrial therapeutic products
• Screening of biodiversity components for bioactive compounds for value added therapeutic products.
• The policy outlaws any activities or research dealings involving human cloning, use of unethically procured stem cells, and the introduction, use or release of the “Terminator Technology” and associated products into Kenya.

6. Industry and Trade

Key priority areas will be to:

• Develop initiatives that will attract major investment in biotechnology research and product development from local and international companies or institutions.
• Promote industrial skills development.
• Provide a conducive environment for small and medium size biotechnology products businesses.
• Ensure high quality standards, competitiveness of products on local and international markets.

Key Policy Recommendations

I. Prioritization and Coordination of Research and Development

The policy recommends establishment of a National Biotechnology Enterprises Programme that will consist of a National Commission on Biotechnology, a National Biotechnology Education Centre and a National Biosafety Authority.

Functions of the National Commission on Biotechnology will be to consolidate and maximize on available resources of institutions engaged in training and R&D through:

• Identification and implementation of national priority areas for R&D
• Provision of advice/guidance on and/or supervision of the allocation of primary resources and responsibilities to public R&D institutes and universities
• Tracking and evaluation of inventions, patents and commercialization of discoveries
• Identifying and linking R&D centers of excellence and the private sector.

The National Biotechnology Education Centre will:

• Coordinate and facilitate training and knowledge-sharing
• Develop and maintain bioscience research, innovation and biotechnology database
• Develop and maintain a National culture collection

A National Biosafety Authority will be responsible for safe acquisition, development and commercialization of biotechnology and its products thereof. The authority will be the central coordinating and implementation body and will work together with other government regulatory bodies to ensure adherence to laws and regulations.

II. Public Education and Awareness Creation

There are four basic elements to the principle of public awareness and participation that the Government will adopt:

• Creation of public awareness on biotechnology issues and investment opportunities
• Access to information held by public authorities;
• Public participation in decision making process;
• Access to judicial and administrative provisions.

III. Public Protection and Support

Key recommendations

• Protecting Intellectual Property Rights (IPR) is a critical aspect of biotechnology innovation, and ensuring  effective public and private sector participation in research and product development.
• The Government recognizes the existing policies and legislation on protection of traditional knowledge and resources.

IV. Infrastructure, Facilities and Equipment

Key recommendations

• The National Biotechnology Enterprises Programme to put in place mechanisms to create linkages and networks among public research institutes and universities for optimum access and utilization of available resources.
• Enhancement of public/private partnerships.
• Support initiatives for the establishment of biotechnology parks at R & D institutions as incubators to stimulate the growth of small and medium size businesses with potential to mature into high technology companies.

V. Financial and Business Support

Key recommendations

• Create incentives to encourage partnerships between public research institutes and universities, and the private sector for the purpose of attracting private sector investment in biotechnology based start up firms. Incentives include but not limited to subsidies on private sector capital investment and tax exemptions.
• Waiver of taxes on research materials and equipment
• Encourage specialized technological financing agencies to provide loans to firms or consortia and research institutions.
• Direct public budgetary allocation to biotechnology research and development.

Conclusion

The policy defines a road map for biotechnology and should effectively guide the country into a pre-eminent position of a knowledge-based economy for overall sustainable economic growth, poverty alleviation and wealth creation.

It pronounces the Government’s commitment to provide an enabling environment for the acquisition and development of biotechnology responsibly for speedy exploitation of the immense potential in agriculture, environment, bioresources, health and industry .

Furthermore, the Government will ensure that information on the development and use of the bio-technology is accurately and transparently disseminated to the public and industry to allow informed choices on its application while respecting their traditional methods of production.

BIOSAFETY ACT, 2009

This Act was passed on

National Biosafety Authority

The Act establishes a National Biosafety Authority, which shall be a body corporate. The Act sets up a representative Board of management comprising of regulatory agencies, consumers, industry & farmer’s rep. The objective & purpose for which NBA was established: “ To exercise general supervision and control over the transfer, handling and use of GMOs with a view to ensuring;

a) safety of human & animal health

b) provision of an adequate level of protection of the environment

Mandate of National Biosafety Authority

ü  Consider and determine applications for approval for the safe transfer, handling and use of GMOs;

ü  Co-ordinate research and monitor activities on all GMO work as per the Act;

ü  Strengthen national technical capacities and capabilities for biosafety;

ü  Develop regulations to operationalize the Biosafety Act;

ü  Establish and maintain a Biosafety Clearing House (BCH) mechanism – web based information sharing of national database that is linked to the international BCH;

ü  Promote public awareness on biosafety and biotechnology;

ü  Enforce the provisions of the Biosafety Act;

ü  Provide advisory services on matters of biosafety;

Regulatory Agencies

The NBA implements mandate through various regulatory agencies namely:

ü  Kenya Plant Health Inspectorate Service (KEPHIS)

ü  Directorate of Veterinary Services (DVS)

ü  Department of Public Health (DPH)

ü  Kenya Bureau of Standards (KEBS)

ü  National Environmental Management Authority (NEMA)

ü  Kenya Wildlife Service (KWS)

ü  Kenya Industrial Property Institute (KIPI)

ü  Pesticide Control Products Board (PCPB)

Role of Regulatory Agencies

• Monitor approved GMO activity to ensure compliance with conditions of approval

• Inform Authority of any significant new scientific information indicating that an approved activity poses biosafety risks not previously known

• Inform Authority of unintentional or unapproved introduction of a GMO into the environment and propose mitigation measures

Application for Licenses

1.      Any person wishing to undertake any activities using GMOs can only do so with the approval of the NBA. Activities envisaged under the Act include‐

a.       Research‐ contained use, confined use

b.      introduction into the environment

c.       Placing on the market

d.      Import, transit, export

2.      Applications are made to the Authority in a prescribed form

3.      Upon receiving an application, the Authority will screen the application for completeness.

4.      Screening involves both administrative as well as technical assessment of the form to ensure that all the relevant information needed to make a decision is availed

5.      If an application is complete, the Authority acknowledges the application, in writing.

6.      Where an application is not complete, the Authority must inform the applicant and request for additional information from the applicant

7.      Every application must be acknowledged within thirty days of receipt of the application

8.      Once an acknowledgement has been issued, the clock starts running. Every application must be determined within 150 days of receipt of the application

Review and Appeal Mechanisms

• The Act makes provisions for a review as well as appeal mechanism.

• A review may be done by the Authority on its own volition or upon the rquest of an applicant

• An appeal’s board has been established to consider applications from persons aggrieved by the decision of the Authority

Regulatory Agencies, Inspection and Monitoring

The regulatory agencies are tasked with inspecting and monitoring GMO activities on behalf of the Authority. The regulatory agencies are empowered to enter and inspect premises carrying out GMO activities to ensure compliance with the Law and any conditions imposed on the approval. Any person obstructing an officer from carrying out his/her functions under the Act commits an offence

Restoration and Cessation Orders

There are several orders that the Authority may invoke should the GMO activity pose harm to the environment. These orders are given if the Authority, in consultation with the relevant regulatory agency, determines that there is an imminent danger posed to the conservation and sustainable use of biological diversity, taking into account risks to the human health. These are:

• Restoration orders: to restore the environment to as near as it may be to the state in which it was before the release of a GMO

• Cessation Orders: issued for the immediate imposition of additional risk management measures with respect to such activity,

Offences and Penalties

Several offences have been created under the Act; one is guilty of an offence if he;

Ø  makes contained use of, releases into the environment, places on the market, imports or exports a genetically modified organism without the approval of the Authority;

Ø  contravenes any conditions attached to an approval under this Act;

Ø  fails to furnish any information as required by this Act;

Ø  uses any confidential information for any purpose not authorized under this Act;

Ø  uses a genetically modified organism in a manner inconsistent with the approval granted by the Authority or for unethical purposes;

Ø  obstructs or fails to assist the Authority or officers of the Authority in the performance of their duties under this Act;

The penalties range from fines of Ksh two million to Ksh twenty million and/ or imprisonment of up to ten years

BIOSAFETY REGULATIONS, 2011

The Law provided for gazzetment of regulations that would be important for the implementation of the Biosafety Act 2009. To date 3 regulations have been gazette. These are Regulations for;

– Contained Use

– Environmental Release

– Import, Export and Transit

– Regulations for Labeling (awaiting gazzetment)

Biosafety (Contained Use) Regulations

Context and Scope

These regulations cover activities involving GMOs under containment and confinement. They are typically applied during research on GMOs (LAB, Green house, Screen, house CFT)

Objective (Art. 3)

The objective of this Regulation is to ensure that potential adverse effects of genetically modified organism are addressed to protect human health and the environment when conducting contained use.

Requirements

• A person shall not conduct any activity involving GMOs without written approval from the Authority (Biosafety Act, 2009, Art. 18)

• A person shall not undertake contained use without the written approval of the Authority

(Art. 7. (1)

• An application for contained use shall be made to the Authority

Other Provisions

• Suspension/Revocation of approval (Art. 11)

• Institutional Biosafety Committee

• Classification of containment levels

• Handling of New Information (Art. 12)

• Contingency Plans/Emergency Measures (Art. 13)

• Miscellaneous (Register of Decisions, BCH, CBI)

• Offences, Schedules

Biosafety (Environmental Release) Regulations

Context and Scope

These regulations cover activities involving release of GMOs into environment; placing on market. They apply during commercialization

Objective (Art. 3)

• The objective of these Regulations is to ensure that potential adverse effects of genetically modified organisms are addressed to protect human health and the environment when conducting environmental release.

Requirements

They require a person not make an environmental release or place on market a GMO without the written approval of the Authority.(Art. 5(1); 6 (1). The application for environmental release/placing on market is to be made to the Authority in a prescribed manner with KShs 850,000 as fees.

Other Provisions

The regulations also cover other matters including;

Review of decisions

• Unintentional release

• Conditions of release

• Offenses and liability

• Monitoring for compliance

• Miscellaneous (Register of Decisions, BCH, CBI)

• Schedules etc

Biosafety (Import, Export & Transit) Regulations

Context and Scope

• These regulations cover activities involving importation into, exportation out of and movement of GMOs through Kenya

• Could touch on aspects of release or placing on market in which case Regulations on Release apply

Objective (Art. 3)

The objective of these Regulations is to ensure safe movement of genetically modified organisms into and out of Kenya while protecting human health and the environment

Requirements

They require a person wishing to import, export or transit a GMO to apply for and obtain written approval from the Authority (Arts. 4(1); 5(1) & 6 (1)

An application for import or export or transit of a GMO is made to the Authority in a prescribed manner with cover letter and application fees

Other Provisions

These regulations cover other matters including;

• Suspension/Revocation of approval

• Handling of New Information

• Contingency measures

• Miscellaneous (Register of Decisions, BCH, CBI)

• Offences, Schedules

• Public awareness and participation

• Monitoring