BN 305 - Lecture notes- Mtui

Biosafety, Biopolicy and bioethics

Course Assessment Quiz/test 5 marks Mid-term test -15 marks Oral presentations - 10 marks Test (2) - 10 marks Final exam – 60 marks

Lectures outline• Introduction to Biosafety• International agreements on

biosafety• National Biosafety framework• National Biosafety Guidelines• Biotech policy development• TZ Biotechnology policy

Introduction to biosafety in biotechnology applications

Preamble Biosafety refers to the risk assessment,

management, communication and mitigation in regards to the safe dev. & application of biotechnology.

The Cartagena Protocol on Biosafety (CPB) requires all governments to formulate guidelines and build capacities to develop guidelines and transboundary movement of genetically modified organisms (GMOs) and products.

Potential GMOs RisksConcern for human health Toxicity: GM foods may contain novel protein

toxins arising from introduction of foreign genes.

Allergens: Some proteins in GM foods may cause harmful immunological responses such as allergic hypersensitivity.

Antibiotic resistance (AR): Antibiotic-resistance genes used as markers in gen. eng. may induce large scale evolution of drug resistant bacteria.

Potential GMOs Risks (cont’d)

Concern for animal health GM feed for poultry, pigs & ruminants:

Concern on chem. composition, nutritional parameters, digestibility, etc.

Quality of milk from cattle on GM feed: Risks on cattle fed on herbicide-tolerant or insect-protected crop silage.

Effect on bacteria on chicken gut: Concern on the effect of GM feed on the bacteria present in the chicken gut (AR concern).

Potential GMOs Risks (cont’d)

Concern for the environment Ecological impact: Loss of biodiversity due to the dominance of

GM strains; emergence of ‘superweeds’, gene escape/trans genes effect, etc.

Side effects on life support systems such as water, soil, air, etc.

NB: So far there are no compelling scientific evidence to verify the validity of all these concerns!

Biosafety risk asssessment procedures

1. Identification of characteristics associated with the GMOs that may result in potential risks.

2. Identification of the likelihood & degree of harm.3. Considerations of the consequences should the hazards be

realized.4. Identification of risk management strategies to minimize

harm.E.g. a) Precautions to minimize or prevent pollen or seed dispersal. b) Precautions to keep inedible and untested GMOs out of food chain. c) Description of mechanisms to deal with accidental releases during the GM activity. d) Estimation of the overall potential environmental impact, including impacts that will be beneficial to to health or environ.

Controversies surrounding biotechnology :

Human safety Products Labeling and consumer choice Intellectual property rights Ethics Food security Poverty reduction Environmental conservation.

Some arguments of GM food opponents: “There is more than enough food and other

conventional products in the world; no need of tempering with nature”.

“Genetic modifications might have unforeseen consequences, both in the initially modified organisms and their environments”.

“In the current recombinant technology there is no way to ensure that genetically modified organisms will remain under control; and the use of this technology outside secure laboratory environments carries potentially unacceptable risks to both farmed and wild ecosystems”.

Some arguments of modern biotechnology supporters: “Modern transgenesis-based genetic engineering is

capable of delivering changes faster than traditional breeding methods”.

“Genetically-engineered products are not significantly different from those modified by nature or humans in the past, and are as safe or even safer than such methods”.

“Species or genera barriers have been crossed in nature in the past even before the era of genetic engineering”.

“ Modern Biotechnology skepticism is politics, not economics or science”.

Modern biotechnology will alleviate poverty, hunger, malnutrition, environmental destruction, improve industrial productivity, etc in problematic areas of the world, especially Africa!

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Safety of biotechnology to human health, environment and trade.

Sharing of genetic resources Responsible use of biotechnology to

satisfy and improve human social welfare.

Potential of misuse of biotechnology in biological warfare and bio-terrorism

Ethical and social concern on biotechnology

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Food and Agriculture Organization (FAO)

World Health Organization (WHO) United Nations Environment Program

(UNEP) International Center for Genetic

Engineering and Biotechnology (ICGEB)

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United Nations Education, Scientific and Cultural Organization (UNESCO)

United Nation Industrial Organization (UNIDO)

Global Environmental Facility (GEF) Office International des Epizooties

(OIE) also popularly known as World Organization for Animal Health

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World Trade Organization (WTO) Cartagena Protocol on Biosafety

(CPB) – 2000/2003 International Plant Protection

Convention (IPPC) – 1997 Codex Alimentarius Commission

(CAC) - 1963 formed by FAO and WHO

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Organization for Economic Cooperation and Development – (OECD)

Africa Union (AU) Southern African Development

Community (SADC) East African Community (EAC) Individual countries

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What is the outcome?

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Raised the issue of safe application of biotechnology and safeguarding the environment from impact of biotechnology

Resulted in formation specific institutions or organ to deal with global environmental issues known as UNEP.

Resulted in development of active in environmental policies and regulations in developing countries including building capacity in developing biosafety policies and regulatory systems

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United Nations Conference on Environment and Development (UNCED) – 1992 Agenda 21 was followed by Convention on Biological Diversity (CBD) –

1992 Cartagena Protocol on Biosafety (CPB) –

2000/2003 International Plant Protection Convention

(IPPC) – 1997 Office International des Epizooties (OIE)

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Other International Treaties and Agreements

International Treaty on Plant Genetic Resources for Food and Agriculture (PGRFA) -2001

European Union Directive on Deliberate Release into the Environment of GMOs -2001

Codex Alimentarius Commission (CAC) - 1963

Organization for Economic Cooperation and Development – (OECD)

International Centre for Genetic Engineering and Biotechnology – ICGEB

a) The General Agreement on Tariffs and Trade (GATT)

b) The Agreement on Application of Sanitary and Phytosanitary Measures – SPS

c) The Agreement on Technical Barriers to Trade – TBT

d) The World Trade organization (WTO) Agreement - Trade-Related Aspects of Intellectual Property Rights – TRIPS

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ETHICAL, LEGAL AND SOCIAL ECONOMIC ISSUES

Background What is Intellectual Property (IP)? Patents in biology and biotechnology Kinds of inventions that can be protected

patent laws Intellectual Property Right (IPR)

Intellectual Property Right (IPR) as Applied to Biotechnology Applications

Historical Trends in Patenting of Biotechnology Innovations.

Characteristics of Patentable Biotechnology Innovations

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Concerns of Patenting Biotechnology Innovations

Intellectual Property and Protection of Plant Variety

Protection of Undisclosed Traditional Knowledge and Biodiversity with Biotechnological Applications

International Frameworks for Protection of Intellectual Property at International Level

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CBD is based on three key objectives: (i) conserving biological diversity;

(ii) sustainable use of its components, and

(iii) equitable sharing of benefits arising out of utilization of genetic recourses.

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CBD recognizes the benefits of biotechnology and call for safe management of biotechnology to ensure its safety to human health and the environment.

Article 19.3 raises the concerns on potential impact of biotechnology application and demands the precautions in safe handling of biotechnology products.

The article has been the basis for the international biosafety regulatory systems, through the CPB

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This is an agreement adopted from the CBD. Was adopted in 2000 and enforced in 2003.

CPB is an international regulatory mechanism to regulate transboundary movement of GMOs.

CPB is an international regulatory device specific for regulating trade and use of GM crops and derived foods

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The main objective of CPB“ To contribute to ensuring an adequate level of protection in the field of safe transfer, handling and use of GMOs resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account also of risk to human health and especial focusing on transboundary trade”.

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Sets procedures on provisions of information during export and carrying out tests to assess the safety of GM crops, microorganisms and animals.

Requires the identification and documentation shipments containing GMOs for food or feed and processing.

The recipient countries should be given this information in advance to make decision on accepting and managing the potential risks.

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The Protocol is the use of the precautionary principle** as a policy tool of regulation of GMOs especially in risk management.

Requires products to be proven safe before release to the market or into the environment.

The protocol excludes products of medical biotechnology application.

** “If an action or policy has suspected risk of causing harm to the public or environment, in the absence of scientific consensus that harm would not arise, the burden of proof falls on those who would advocate taking the action”.

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Promotes labeling of food containing GM products for people to make choice.

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Developed through the initiative of FAO, to emphasize the need of protecting and conserving genetic resources associated with food and plant crops.

The main goal of the IPPC is to ensure common and effective actions to prevent the spread and introduction of pests of plants and plant products and to promote measures of their control in order to protect plant health.

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Develop international standards for phytosanitary measures that identify the plant pest’s risks and assessing these risks.

Sets standards for biosafety assessment of risks associated with GMOs

IPPC standards for phytosanitary measures serve as basis for national phytosanitary measures for countries which are parties to this convention.

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Responsibilities include setting of sanitary standards for the international movement of animals or animal products.

Setting regulations on the use of reproductive biotechnologies in animals to prevent potential transmission of pathogens through embryos especially those which can transmit zoonotic diseases to humans.

Drafting guidelines for biosafety risk assessment and risk management of risks associated with such of reproductive biotechnologies in animals.

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Maintains agreement with other international organization like CBD, CPB, WHO, FAO and WTO on matters related to biosafety and animal trade regulations especially on trans-boundary movement of animals.

Responsible for developing and implementing enforceable international rules and standards to contain threats, limit harm, and impose liability for damages resulting from biotechnology.

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This directive sets out regulatory measures such as: Requirement of following scientific principles

of risk assessment in evaluating safety. Mandatory post-market monitoring of long

term effects that may arise from GMO. Mandatory information to the public on

commercialized GMOs and derived products. Ensure that labeling and traceability of GMO

at all stages of the market is done.

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Commission formed by FAO/WHO experts that set standards, guidelines and procedures for risk analysis and assessment of safety of food, including foods derived from or produced from transgenic food crops and microorganisms.

The Codex standards are recognized by the WTO as an international reference point for the resolution of disputes concerning food safety and consumer protection.

The goal of CAC is to protect the health of consumers and ensure fair practices in the food trade.

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Protecting health of the consumers and ensuring fair trade practices in the food trade.

Promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations.

Sets code of ethics which aims to encourage food traders to adopt voluntarily ethical practices to protect human health and to ensure fair practices in food trade.

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This is a treaty of FAO member countries which arose out of concerns for food security and access to seed germ plasma under the concept of “farmer right”.

The aim of this treaty is to enhance policies on conservation and sustainable use of plant genetic resources for food and agriculture, and ensure fair and equitable sharing of benefits derived from their use in food crops.

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This involves use of “Material Transfer Agreement- MTA” which is an aspect related to intellectual property (IP) issues related to CBD.

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Produces Code of Conduct on Biotechnology, with the aim of maximizing the positive effects, and minimizing the possible negative effects of agricultural biotechnology.

The “Code of Conduct on Biotechnology” is to ensure that the aspects of biosafety relevant to genetic resources for food and agriculture are covered in product development.

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IPPC and PGRFA share the same goal of conservation and sustainable use of biodiversity with the CBD.

Tanzania, has policies and laws on protecting plant genetic resources and has gene banks of food crops in compliance with these global initiatives.

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WTO has four international agreements with direct implications on biotechnology and biosafety issues, including dealing with international policies related to trade in GMOs safety.

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GATT allows governments to act on trade in order to protect human, animal or plant life or health, provided they do not discriminate or use this as disguised protectionism.

GATT advocate fair trade requires “like products” to be treated in the same manner whether produced domestically or imported.

GMOs and other products derived from them should be treated like conventional counterparts as long as they are safe.

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The source of the two specific WTO agreements dealing with food safety and animal and plant health and safety, and with product standards in general (SPS and TBT).

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Deals with regulating of the quality of foods and other goods which could harm life human health, animals and plant life.

SPS is responsible for harmonizing international food and feed standards set by other international regulatory systems like: Codex Alimentarius Commission International Plant Protection Convention Other WHO/FAO initiatives on food and

human safety

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The SPS Agreement recognizes the right of countries in setting up rules to protect food safety and health of animals and plants from and biological agent that could course harm or diseases.

Biosafety regulation of Trade in GMOs is covered under biological agents

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Deals with trade regulatory issues which are not covered by SPS Agreement.

Obliges members of the WTO to ensure that their national regulations do not unnecessarily restrict international trade.

This principle has also influenced the guidelines for regulation of trade of GMOs by the Cartagena Protocol on Biosafety.

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TBT covers some technical measures that seek to protect consumers from economic fraud and deception and measures concerning human, animal and plant life and health not covered by the SPS Agreement, and the environment.

Codex Alimentarius food safety provisions concerning quality and compositional requirements, labeling, nutrition and methods of analysis are relevant to the TBT Agreement.

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TRIPS Agreement provides a set of minimum standards for intellectual property rights protection to which all member countries must conform.

The IPRs here referred to are in the form of: copyrights, trademarks, patents industrial designs, geographical indicators, integrated circuits and trade secrets.

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The TRIPs allows temporary exclusion from patentability when necessary to protect human, animal or plant life or health or to avoid prejudice to the environment.

These provisions have an implication on biosafety regulation of GMOs.

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THE CASE OF DEVELOPING COUNTRIES

Modern biotechnology is considered under the UNCED/CBD to be a key in developing sustainable production of food, feed, improved medical application, and provides new ways of environmental protection.


Countries planning to develop their capacity in application of biotechnology are required to have: a guiding policy on meeting the

challenges associated with the technology development and managing its impact.

There is a need to know challenges to biotechnology development.


The controversies and concerns on safety of biotechnology applications.

Meeting the global governance of biotechnology.

Global political economy issues. Security concerns on misuse of

biotechnology - biosecurity issues. Meeting these challenges the need

for biopolicy


Policy which will promote its acquisition and safe use.

Ensure that the benefits to the public and potential negative impacts are regulated.

The policy has to have a vision and a set of guiding principles, and a defined set of specific goals.


Having political will to embrace biotechnology revolution.

Promoting the responsible use of economic benefits of biotechnology to improve public livelihood. This includes the linking of research and development to meet societal demands.

The policy has to incorporate the ability of the society to use ethical consideration into biotechnology regulatory systems.


Identifying the key stakeholders who will be part of biotechnology development process and regulation.

Setting clear goals of biotechnology applications and adoption.

The policy has to be linked to national and global developmental policies including the governance of biotechnology and biosafety regulatory systems.


Identify of scientists and institutions to be involved in making scientific policy.

Determine at what point in technology development the biotechnology policy and related policies are to be made.

Building mechanisms and processes of decision making.

Creating plans for biotechnology capacity building.


Establish factors to be considered in policy formulation such as:

Setting clear goals to be achieved by the policy.

Defining clear problems to be solved by biotechnology application.

Evaluating relevant experiences and options to be used to achieve the objectives.


Establish factors to be considered in policy formulation such as:

Defining means of selecting partners to be involved in decision making on matters related to research and development in biotechnology.

Identifying institutions to promote R&D in biotechnology and those responsible for management the risks.


The development of biotechnology policy also requires the existence of other relevant or cross-cutting policies


Science and technology policies Agriculture and food security Food laws and regulations Environmental policies Industrial development Trade Health


Renewable energy Biosafety policies Technology transfer Intellectual property right Occupational Health National Security Conservation of biodiversity Research and development Sustainable development


Biotechnology policy is influenced by societal demands and market forces. The policy to be effective requires the following actions: Setting up advisory bodies to advice on

means of developing and implementing the biopolicy.

Evaluating impact on ELSI, as well as environmental sustainability. This also requires biosafety and bioethics advisory committees to the government.



IMPLEMENTATION OF BIOSAFETY REGULATORY

SYSTEMS.


Developing National Biosafety Framework

In general terms this National Biosafey Framework is a combination of policy, legal, administrative and technical instruments that are developed to address safety issues with respect to environment and human health in the context of developing and applying modern biotechnology or other biohazardous biological agents.


According to UNEP, a National Biosafey Framework is a system of legal, technical and administrative mechanisms put in place to address safety in the field of modern biotechnology– often focus on living modified organisms (LMOs).


Regulatory system: Consisting of legally binding regulations and non-binding guidelines. These should include procedures for GMOs release, biosafety review system, risk assessment and management, and feedback mechanisms.

Means of implementing the regulatory systems: These should be based on scientific expertise.

Decision-making system: This should include capability to conduct risk assessment of different impacts.


Information communication system: This is required, both to maintain public acceptance of the biosafety regulation system and ensuring that the decisions are made based on knowledge.

Means of enforcing the compliance: It is required for any decision made and to allow the monitoring of GMOs or any other hazardous biological agents after accepting the release into the environment.


Means of validation of presence and concentration of GMOs in the environment or products. This includes having competent scientists and institutions to make analysis of contested products to verify the presence and concentrations of GM products.


National Biosafety Decision Making Body (National Biosafety Committee (NBC)

National Biosafety Administrative Office Science Advisory Committee(s) Institutional Biosafety Committees (IBC) Pool of Scientists for Reviewing Applications

of releasing GMOs Public Consultation Process Appeal Process Inspection and Monitoring Body


National Biosafety Guidelines NB: This is part of class

assignment.

The development of an effective national biosafety system is important on many reasons: Encourage the growth of domestic

biotechnologies

Ensure ability of the public and private sectors to invest in biotechnology and to make the products of biotechnology available

Build public confidence that biotechnology products which are produced under regulated condition are safe.


The Tanzania’s National Biotechnology Policy (NBP)

The policy was approved in 2009 Justification for the policy:- Tanzania is faced with mass poverty and

remains to be among the poorest countries of Sub-Saharan Africa and the second poorest in the world with over 30% of its population living below the international poverty line, earning less than 1 USD per day.

- The burden, and incidence of poverty is more widespread in rural than urban areas, where over 60 percent of the people live and agriculture forms the main stay.

Justification for the TZ NBP (contd)

- In promulgating the Vision 2025, the Govt of TZ has postulated that by the year 2025, "The economy of TZ would have been transformed from a low productivity, predominantly rural based subsistence agriculture, to diversified semi industrial economy with a modern rural sector and high productivity agriculture, which ensures food security and food self sufficiency".

- TZ considers S&T to be central to creating wealth and improving the quality of life and bringing sustainable dev in the society.

NBP Vision “To achieve significant investment in

harnessing biotech tools for generation of products, processes and technologies that shall enhance the efficiency and productivity in food and agriculture, nutrition and health, which are also cost effective and environmentally friendly in conservation of biodiversity and the development of a viable biotechnology industry”.

NBP Mission Creation of a strong infrastructure

both for research, development and commercialization in biotechnology so as to ensure a steady flow of bio- products, bioprocesses and new biotechnologies for social and economic development of Tanzania.

NBP General Objectives The general objective of this policy is

to ensure that TZ has the capacity and capability to capture the proven benefits arising from health, agriculture, industry and environmental applications of biotechnology while protecting and sustaining the safety of the community and the environment.

POLICY ISSUES, SPECIFIC OBJECTIVES AND POLICY STATEMENTS

Policy issue # 1: Coordination in the application of Biotechnology

- TZ will require a complete inventory of the existing human and institutional capacities in order to identify the available strength to build upon.

- It will also require identification of various stakeholders from research institutions and the industry.

Policy issue # 1: Coordination in the application of Biotechnology Contd

TZ will promote biotechnology dev and utilization at the following levels:

- Basic research and technology development.

- Translation of research results into products.

- Commercialization and marketing of biotechnology products.

Policy issue # 1 Objectives

a) To coordinate biotechnology research and development activities between relevant stakeholders in the country.

b) To forge linkages between institutions within and outside the country.

Policy issue # 1: Coordination in the application of Biotechnology (contd)

Policy statements a) Provide adequate financial resources

for coordination of activities of the National Biotechnology Advisory Committee (NBAC).

b) Encourage institutions involved in biotechnology research and development.

c) Foster close institutional collaboration between institutions conducting research under similar themes.

Policy issue # 2:Funding of Biotechnology Programmes The Government needs to allocate

adequate financial resources for R&D activities related to biotechnology.

Other biotech stakeholders should also complement the Government's effort.

Policy issue # 2: Funding of Biotech Programmes (contd)

Policy objectives (a) To ensure adequate availability of

funds from sustainable sources for biotech research and development programmes.

(b) To institute other innovative sources of financing biotechnology programmes.

Policy issue # 2: Funding of Biotech Programmes (contd)

Policy statements a) Provide sustainable funding for

enforcement of biotechnology programmes.

b) Promote and attract the participation of the private sector investors in biotechnology.

c) Facilitate capacity building of research scientists in biotechnology.

d) Promote multidisciplinary research in all sectors.

Policy issue 3: Intellectual Property Rights (IPR) regimes on

Biotechnology TZ is yet to have policy guidelines on

access and exchange of genetic resources.

Material Transfer Agreements (MTAs) are in existence but these are largely not standardized.

Therefore, In order to encourage and promote biotech, IPR policy has to be in place.

Policy issue # 3: Intellectual Property Rights (IPR) regimes on Biotechnology (cont’d)

Policy objectives a) To establish Intellectual

Property Rights on biotechnology inventions, innovations and services.

b) To develop policy guidelines on exchange of genetic resources.

Policy issue 3: Intellectual Property Rights (IPR) regimes on Biotechnology (cont’d)

Policy statements a) Strengthen the institutions

responsible for IPR issues. b) Encourage R&D institutions to

develop their Institutional IPR frameworks.

c) Facilitate the devt of policy guidelines on exchange of genetic resources.

d) Identify and designate competent sectoral authorities to handle the processing and issuing of standardized MTAs.

Policy issue # 4: Conservation and utilization of

genetic resources Conservation and utilization of plant,

animal and microorganism genetic resources is of great economic importance:

- These resources comprise a significant sector in economic terms in a country.

- Relatively few varieties or species have been utilized over the centuries for production.

- Modern utilization practices tend to concentrate on the dev of a very small portion of the available genetic resources.

Policy issue # 4: Conservation and utilization of genetic resources (cont’d)

Policy objectives a) To effectively integrate relevant

international agreements on conservation and utilization of genetic resources in respective national sectoral policies.

b) To develop national programmes for sustainable conservation and utilization of genetic resources.

Policy issue # 4: Conserv &

utiliz of genetic resources (cont’d):

Policy statements

a) Enact a law on conservation of genetic resources both in-situ and ex-situ.

b) Surveying and making inventory of genetic resources in all responsible sectors.

c) Create sectoral designated centers for conservation and utilization of genetic resources.

d)Promote sustainable utilization of genetic resources.

e) Create public awareness on the value of genetic resources for food and agriculture.

f) Enter into bilateral and regional agreements on conservation and utilization of bio-diversity.

g) Establish a data bank of both indigenous and exotic genetic resources available in the country.

Policy issue # 5: Improved public perception and creation of

awareness on biotech There is poor public perception

about the safety and efficacy of new and emerging technologies, including biotech, in problem solving.

There is inadequate awareness and understanding among the public, policy markers, decision makers and research managers on practical applications, research and dev opportunities of biotech.

Policy issue # 5: Improved public perception and creation of awareness on biotech

Policy objectives a) To create awareness and improve

perception of the public on biotech.

b) To enable policy and decision makers as well as the general public make informed decisions on the potential application of biotech for the socio-economic dev of the country.

Policy issue # 5: Improved public perception and creation of awareness on biotech contd

Policy statements a) Promote and support public

education initiatives for accurate and balanced information on biotech.

b) Foster debates and discussions about benefits and risks, environ and ethical implications on biotech appl.

c) Designate a National Biotechnology Day.

Policy issue # 6: Setting up priority areas for biotech in

relevant sectors The need to attain improved

agriculture, health, industrial production, trade as well as environmental protection must be governed by a priority setting process.

In recognition of the meager human and financial resources available, priority must be given to those activities that hasten national development.

Policy issue # 6: Setting up priority areas for biotech in relevant sectors (cont’d)

The need to attain improved agriculture, health, industrial production, trade as well as environmental protection must be governed by a priority setting process.

In recognition of the meager human and financial resources available, priority must be given to those activities that hasten national development.


Policy objectives a) To set up priority areas for

biotech applications in relevant sectors of the economy.

b) To provide improved goods and services from biotech products for social and economic development.

Policy statements a) Carry out regular biotech appl review. b) Dev of new varieties of high quality and

disease/pest resistant plants and animals.

c) Promote the prodn of vaccines, diagnostic kits as well as new medicines.

d) Encourage the design and appl of techniques for environ bioremediation and biodiversity conservation.

e) Encourage research activities, which are demand driven and adhere to natl priorities.


Policy issue # 7: Fostering public-private sector partnership (PPP)

and linkages Most private firms have import

goods or have industries that neither use locally available raw materials nor require research investments in Tanzania.

This has denied collaboration with public research institutions in the country with regard to tech dev and commercialization of research results in the relevant sectors of economy.

Policy issue # 7: Fostering PPP and linkages (cont’d)

Policy objectivesa) To foster public - private sector

partnerships and linkages in technology development and transfer.

b) To increase participation of stakeholders from the private sector in commercialization of research results from the public sector.

Policy issue # 7: Fostering PPP and linkages (cont’d)

Policy statements a) Encourage the private sector to invest

and adopt scientific innovations from the public R&D institutions.

b) Creation of a conducive environment for biotech application in all sectors.

c) Encourage exploitation of the 3rd generation biotechnology.

Cross-cutting issue # 1. Dev of institutional and human

resources Tanzania has a shortage of

scientists specialized in diverse areas of biotechnology.

Specialized labs for advanced biotech research such as DNA sequencing and molecular cloning do not exist in the country.

Considering the potentials of biotech in dev, TZ has to to develop institutional and human resources in this area.

Cross-cutting issue # 1. Dev of institutional and human resources (cont’d)

Policy objectives a) To develop and sustain optimum

institutional and human resources capacities in biotech.

b) To improve the current curriculum in basic sciences at all levels of education in order to generate a pool of human resources who can work in the field of biotech.

Cross-cutting issue # 1. Dev of institutional and human resources (cont’d)

Policy statements

a) Creation of a conducive working environment to educators and researchers in biotechnology.

b) Establish a succession programme for biotechnology experts.

Cross-cutting issue # 2. Strengthening national and international

collaboration

For a successful tech transfer process, it is crucial for institutions in TZ to develop strong collaborative links with relevant Natl & Intl research centers.

Currently, TZ is a member to the ICGEB since May 2001. It also participates in regional and intl networks, which include the Eastern Africa Regional Programme and Research Network for Biotechnology, Biosafety and Biotechnology Policy Development (BIO-EARN), Program for Biosafety Systems (PBS) and Association for Strengthening Agricultural Research in Eastern and Central Africa (ASARECA).

Cross-cutting issue # 2. Strengthening national and international collaboration (cont’d)

Policy objectives a) To develop new and strengthen

existing national and international collaboration, with relevant research centers.

b) To establish networks between relevant research and development institutions for regional collaboration.

Cross-cutting issue # 2. Strengthening national and international collaboration (cont’d)

Policy statements a)Develop and maintain a reliable

Information Communication Technology (ICT) system for biotechnology institutions in Tanzania.

b) Establish an environment conducive to support national and international initiatives in biotechnology.

c) Promote collaboration through national, international and bilateral agreements.

Cross-cutting issue # 3. Ethical Ethical consideration relating to

biotechnology Ethical issues are important when research

touches the lives, welfare, interests, privacy of people and their properties that can stimulate different public opinions.

Ethical issues include disclosure and use of genetic information, gene therapy and human cloning for medical purposes; the potential impact of GMOs on the environment, horizontal gene transfer from GMOs to other organisms, trans-species gene transfer and participation in research and clinical trials.

Cross-cutting issue # 3. Ethical Ethical consideration relating to biotech (cont’d)

Policy objective To ensure that ethical aspects relating

to biotech applications are taken into considerations.

Policy statements a) Set-up a national strategy to address

ethical issues associated with biotechnology.

b) Encourage institutions to form ethical clearance committees.

INSTITUTIONAL FRAMEWORK A National Centre of Excellence for Biotech and

Genetic Eng need to be created in order to build the technology platforms required to support biotech industry.

The Centre will need to be aligned with national priority areas, market demands and will have a major focus on agriculture, human management, health, livestock, food processing and environmental management.

At present, the biotech industry in TZ is at embryonic stage of dev with inadequate strategic research being carried out within domestic industries.

Institutional Framework (cont’d)

Policy objective To create a “Centre of

Excellence” for the development of adequate capacities in industrial biotechnology within the country.

Institutional Framework (cont’d)

Policy statements a) Establish physical infrastructure for the

creation of a Centre of Excellence in Biotech. b) Create new and promote existing industries

for biotechnology products. c) Develop and retain human resources in

biotechnology fields and provide them with adequate finance, infrastructure, facilities and attractive schemes.

d) Fast-track the human resource needs for the biotechnology R&D.

e) Nurture talented students and researchers for biotech development in the country.

f) Designate a national reference laboratory for the detection of genetically GMO products and materials.

LEGAL FRAMEWORK

Implementation of the biotech policy will require having in place National bio-safety guidelines (NBG) that stipulate the regulation of risk assessment and management procedures and monitoring within the framework.

These guidelines are intended to protect individuals, communities, environment and biodiversity by minimizing potential hazards associated with biotechnology applications while facilitating beneficial utilization.

This involves not only the establishment of necessary guidelines and laws, but also the development of capacity to ensure that the regulations are enforced.

LEGAL FRAMEWORK (cont’d)

Policy objective To establish and implement bio-

safety regulations and guidelines

Policy statements a) Facilitate the development of bio-safety guidelines. b) Maintain transparency in the implementation

of bio-safety regulations. c) Empower the NBAC to handle its activities.

d) Enforce international regulatory frameworks.

ROLES OF STAKEHOLDERS IN IMPLEMENTING THE NB POLICY

In order to implement effectively the NBP in TZ, all sectors of the economy need to be involved. Responsibilities of some priority sectors include:

o Health: To search for alternative treatment and vaccination for various human and animal diseases.

o Agriculture and Food Security: To increase crop production by using high quality seed varieties that can resist pests and diseases and tolerate drought.

Role of stakeholders: Priority sectors (cont’d)

o Industry and Trade: To increase competition by selling products of good quality produced by biotech techniques.

o Research and Development Institutions in all relevant sectors (Public and Private): To carry out different research and development activities in biotech geared towards solving socio-economic problems of the country.

o Education and Mass Media: To educate the public at all levels on biotech issues and its importance on the application of biotech to socio-economic development.


O Religious Institutions: To provide education on the importance of the application of biotech to socio-economic development.

o Legal Affairs and Public Safety: To assist in developing and implementing the legal mechanisms for monitoring and evaluation of biotech programmes in the country.

Livestock Development: To increase production by using modern breeding techniques, and high quality fodder plant varieties that can increase productivity.


O Financial Institutions: To finance biotechnology programmes.

O Environment: to develop legal mechanisms for protection of the environment

o Natural Resources: To produce more seeds of rare species which are widely used for different purposes. purposes e.g. for medicinal and food

o Academic associations: Like the Biotech Association of Tanzania (BAT).

MONITORING AND EVALUATION

Monitoring and evaluation (M & E) processes are normally initiated and carried out by or together with relevant stakeholders, leading to action as the main purpose.

Elements to be monitored include the strategic policy options, the areas of priority and the principles of implementation.

The aim should be to monitor and assess the relevance of objectives, efficiency, effectiveness, impact and sustainability.

MONITORING AND EVALUATION (cont’d)

M&E tools include system analysis, biological and physical decision support models, computer simulation models and environ impact analysis. All these tools will facilitate communication among stakeholders and provide input into socio-political process of prioritizing alternative biotech appl.

To monitor the quantity and quality of biotech materials, variety of methods and systems are available. However, govt commitment and investments are needed to guarantee consistent and unbiased sources of both environmental and economical information.

MONITORING AND EVALUATION (cont’d)

In order to establish effective mechanisms for monitoring and evaluation, the following will have to be undertaken:

a) Facilitate the identification of areas and key actors to be responsible for carrying out monitoring and evaluation.

b) Facilitate the development of various indicators for monitoring and evaluation of the progress in bio-policy implementation.

c) Encourage the establishment of a comprehensive reporting and feedback mechanisms.

WAY FORWARD

a) A strategic action plan for implementation of the National Biotechnology Policy directives needs to be prepared.

b) The National Biotechnology Advisory Committee (NBAC) shall review the regulatory frameworks as need arises with the view of addressing gaps and weaknesses.

BN 305 - Lecture notes- Mtui

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Transcript of BN 305 - Lecture notes- Mtui