SESSION III: ETHICAL ISSUES


• GENETIC ENGINEERING ETHICAL AND PUBLIC POLICY CONSIDERATION
  Father B. MacGarry, S.J.

• IMPACT OF GENETIC ENGINEERING ON HUMAN HEALTH - DISCUSSION
  RAPPORTEUR'S REPORT: E. MWENJE.

• WORKING GROUP REPORTS
  RAPPORTEUR: P. TONGOONA

  • GROUP 1: CROPS (AGRICULTURE)
    FACILITATOR: K. MTINDI

  • GROUP 2: (ANIMALS - AGRICULTURE)
    FACILATATOR: P. MANYUCHI

  • GROUP 3: REPORT (HUMAN HEALTH)
    FACILITATOR: C.B. NHACHI

  • GROUP 4 REPORT: ETHICS
    FACILITATOR: D. MNYULWA

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SESSION III: ETHICAL ISSUES

GENETIC ENGINEERING
ETHICAL AND PUBLIC POLICY CONSIDERATION

Father B. MacGarry, S.J.
Zimbabwe Catholic Bishops Conference, P.O. Box GD100, Greendale, Harare, Zimbabwe

Where I come from, vakuru vanoti, When God made time, He made plenty of it and that makes me a bit uncomfortable with the air of haste that exists about this meeting. Unfortunately, out world seems to be run by people who do not share the Divine attitude to time and to change. I am not being flippant. This may be the most important point I have to make on today's issue.

Christian (and indeed, Muslim and Jewish) ecological principles are powerfully influenced by the biblical image of our first parents being placed in the garden of Eden to tend it: to be caretakers not rulers. The temptation they are said to have succumbed to, which led to their expulsion from their initial idyllic situation, was the desire to 'be like Gods'. This is a temptation that presents itself to humanity again and again with every advance in our knowledge. That biblical story further described the temptation as offering 'knowledge of good and evil'. It is fair to say that knowing what is good and what is evil is not undesirable, but 'knowing ' good and evil is in the language of the Bible, a different matter. "knowing' in Hebrew is not a purely intellectual thing , but experimental, as to take one example, only a few verses after the story of origins, it is said that Adam 'knew his wife' and she conceived. A valid gloss on that for our day is to say that we need to take time to consider and know intellectually what is good and what is evil that we do not fall into experiential 'knowledge of evil' that we could have avoided.

I will try in the few minutes I have been given to indicate the main ethical and policy questions concerning the topics of this meeting. Unfortunately, moralists find it easier to say what is wrong that what is right, and the short time available may seem to force me into that mode. Considerations will be offered under three headings: those concerning agriculture, those concerning animal rearing and those concerning human and eugenics.

GENETIC ENGINEERING IN AGRICULTURE:

1) CROPS

It is too early to know whether the benefits will outweigh the disadvantages, but meanwhile the technology raises new questions of science, law, ethics and economics which should be thoroughly debated around the world before hasty action is taken.

The Industry case:
Benefits claimed from modifying crop plants are:
Drought tolerance

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Reducing the need for herbicides:
Reducing soil erosion
Insect resistance
Better storage qualities
Monsanto the world's largest GM seed company, foresees three waves of beneficial products: The first consists of genetically modified crops which are resistant to insects and disease, or tolerant of herbicides. These will allow farmers to meet the growing demand for food.

The second wave ,due to begin in five year's time will see genetically induced 'quality traits' in food, such as high fibre or high -starch potatoes, some of which will help doctors to fight disease.

And in the third wave, plants will be used as environmentally friendly 'factors' to produce substances for human consumption.

The Critics' Case

Bad science: Ecosystem dangers
The appearance of Bt-resistance insect pests
The Bt gene may be an imprecise weapon which affects beneficial insects as well as pests
Introduced genes may 'jump' into other organisms, with unpredictable and probably uncontrollable results.
Concerns about the transfer of engineered resistance genes to related wild plants, producing new 'superweeds'

Greater reliance on chemicals

The introduction of herbicide-resistant varieties will alter the pattern of herbicide use but will not significantly change the overall amounts used
Planting of GM herbicide-resistant crop may lead to over-reliance on a single herbicide

Loss of biodiversity

Plant species disappearing
Plants being patented and taken out of control of the communities that have always used them.

Health Risks:

The risk of transplanted gene-producing proteins in the plants which may cause allergic reactions in people eating the food, and the presence of genes which cold produce resistance to antibiotics.
If genetically engineered crops were aimed at feeding the hungry, then the companies would be developing seeds with certain predictable characteristics:

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1. ability to grow on substandard or marginal soils
2. plants able to produce more high-quality protein with increased per-acre yield, without increasing the need for expensive machinery, chemicals, fertilizers, or water
3. they would aim to favour small farms over large farms
4. the seeds would be cheap and freely available without restrictive licensing and
5. they would be for crops that feed people not meat animals

None of the genetically engineered crops now available, or in development (to the extent that these have been announced) has any of these desirable characteristics. Quite the opposite. This leads to deeper questioning of the motives of the few large companies that dominate this field. If the genetically-modified crops on offer so far do not provide higher yields on poor soil or with less water, what benefits do they offer and to whom? The most obvious answer would gain much tighter control of the market than we have yet seen. There is even the possibility of the 'terminator gene' which, although we are told it does not exist yet Monsanto has secured all the rights to develop.

2. ANIMALS

The risks of escape of genetic material seem to be less in the case of genetically modified animals since animal reproduction is more controllable than that of plants. However, the risks involved in unexpected side effects or introduced genes is still present. One should be just as careful of introducing genetically modified meat into the food chain (not only into human diets) as we should be with genetically modified plant material. We must not exaggerate the extent of our knowledge. How far can we (a) identify the function of any specific gene, (b) be sure that this gene has only one function and (c) know whether that function depends on more that one gene?

One interesting use of genetic modification of animal is the use of pigs with an introduced human gene to provide organs for transplanting into humans. The argument for this, however, is merely that the supply of human organs for transplanting is insufficient. No reduction in the problems of organ rejection or in overall cost of the procedure, is promised by technology at present available. Even should it become possible to produce organs that would suffers less rejection, great care would need to be taken that there are not other harmful side effects.

3. HUMAN GENETIC ENGINEERING

The possibility is held up before us eliminating a number of genetically transmitted diseases. The problems arise:

1. Concerning when in the development of a fertilized egg or foetus it actually becomes a new human individual, with all the rights to life that a human individual enjoys

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2. Problems of equity

At present, at least, eliminating undesirable characteristics involves in vitro fertilization and discarding one or more ' sub-standard' fertilized ova, which raises the question as to whether these are to be considered as possessing the right to life as human individuals. In some procedures, ova are fertilized and allowed to develop for maybe a week or two for experimental purposes. At least in the present state of our knowledge of the point at which a new human individual emerges, there is no safe point at which we can allow such potential human beings to be destroyed once they have been brought into existence. Such criteria as have been devised by experimenters and government regulators elsewhere have proves uncertain and difficult to apply in practice once any latitude is allowed.

Equity: The procedures involved, even it they did not face these problems, are expensive. They run the risk that those who can afford it will use the methods to ensure that their children are free hereditary diseases and even that they have desirable physical and psychological traits (some people even suggest genetic causes for moral characteristics). This creates the danger that the rich will become a physically and psychologically improved type, more handsome, more intelligent, more psychologically balanced, maybe even 'better examples of their racial type', exacerbating the differences between the rich and poor in ways that could enshrine caste differences and eventually produce what are almost two human species. That is a scenario in which we here in Zimbabwe can be expected to lose out. If future methods were developed which escaped the first objection, the question would therefore remain as to whether these methods would escape the second objection: i.e. could they be economically within reach of all patients who could benefit?

4. PUBLIC POLICY CONSIDERATIONS

Making ethical decisions is the easy part of our problem. Carrying them out in the face of the few powerful companies that dominate the new gene technology and their political friends will be more difficult.

The commercial development of genetically modified crops is dominated by Monsanto and five other major agrochemical companies. The efforts of these companies have so far been concentrated in high volume crops which offer the most opportunity for sales large enough to recoup research costs and generate profits. The main targets have been Soya beans, maize, cotton, oilseed rape (Canola), potatoes and tomatoes. Now public funding for agricultural research institutions is dwindling, and the private sector is taking the lead in research and development of new seeds using the new genetic engineering technology.

Monsanto, the biggest of the companies concerned, has in the past few years bought out Cargill's African interests. Cargill's intervention in our local cotton market is the one example of liberalization that offered unambiguous benefits to peasant producers. Now however, Monsanto are bidding for a majority share in CottCo. This threatens peasant

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producers, not only with the price effects of the loss of a competitive market, but loss of choice as to what they grow, when Monsanto offer them only a strain tied to a particular Monsanto pesticide or fertilizer, or one containing the terminator gene.

Are the government regulatory authorities aware of how far we have already been invaded by this technology? And do they have the power to act, even if they have the will? The new world economic order, directed by the World Bank and IMF, enforced by the World Trade Organization , which included rules on 'intellectual property' and possibly in the near future a revised Multilateral Agreement on Investment, while using the language of the free market, does not allow much freedom for anyone except multinational corporations.

WTO rules disallow all 'non-tariff' controls on trade. This means that the USA has used WTO procedures to force the European Union to import beef containing growth hormones. They are now trying to get the WTO to rule that labeling genetically modified foodstuff and genetically modified is a 'non-tariff restriction on free trade' and thus forbidden.

In the USA,
No public records need be kept of which farms are using genetically-engineered seeds;

Companies that buy from farmers and sell to food manufactures and grocery chains do not need to keep genetically-engineered crops separate from traditional crops

No one needs to label any crops or any food products with information about their genetically engineered origins.

The USA is trying to force everyone else to reduce controls to the same slack levels as their own. Unfortunately, under WTO rules sanctions are imposed by the winner of a dispute against a losers or even if we should win a case against them, all we would be allowed to do would be to impose unilateral sanctions on the USA.

We must watch not only what comes into out country but what goes out. Companies racing to claim patents on genetic materials from all over the world on which they hope to reap large profits - in order they argue to fund research and innovation. But the new technologies raise many new questions of science, law, ethics and economics and patent and intellectual property laws have not kept up. The World Trade Organization (WTO) will be under pressure in 1999 from the agricultural biotech industry side to globalize and strengthen patent protection - meaning the right of foreign companies to patent whole plants, not just specific genes or materials they may contain, while opponents will argue that plant varieties should be excluded and new mechanisms found for sharing the benefits of genetic material with communities and farmers who may have nurtured and used it for generations.

Governments must be prepared for companies to act beyond even the very broad limits allowed by the WTO. What Monsanto can do to maximize its profits and control the market Monsanto will do. Last October, they forced the printers to destroy a whole issue of The Ecologist Magazine, a British Periodical with a reputation for academic rigour as

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well as principles reporting built up over thirty years. Monsanto did not challenge their facts, did not sue. They just put pressure on the printers.

The threat is not distant. Foods reaching us that now genetically engineered include Kraft salad dressings and Nestle's chocolate. It is estimated that 60% of products on British supermarket shelves already contain GM crop products.

Government regulators will need to be very alert to every possibility that remains to us to control our own environment. Our consumers will need to be equally alert to what slips through government regulatory nets.

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IMPACT OF GENETIC ENGINEERING ON HUMAN HEALTH - DISCUSSION

RAPPORTEUR'S REPORT: E. MWENJE.

Human cloning and gene therapy
(C.B. Nhachi)

The technology of cloning is well advanced that there is no doubt as the ability of scientists to clone humans. The important question is should it be done or not. There are clear benefits of this technology especially in studies of embryonic development and in correction of diseases (gene therapy) such as thalaceamia and schizophrenia. Some of the strong arguments against human cloning are the dangers of loss of uniqueness of individuals. As a result the director general of UNESCO is against human cloning.

A number of developed countries have banned research on cloning. These include China (May, 1997), Germany (1990), Russia (1998) and the United Kingdom. The United Kingdom seems flexible - while the US has no position. There is a feeling that although people may attempt to prevent human cloning now, with time it will happen. Presently there is no evidence of human cloning that has taken place. Some of the scientific setbacks include trying to match donor with recipient and also the low survival rates of embryos. It was felt from the floor that time and research is required before any attempts can be made on humans as there were problems with "Dolly." It has been reported that Dolly was aging fast. There are some other concepts about cells and their development we have to understand before progressing to cloning humans.

Biosafety issues threats, risks and public concerns.
(J. Gopo)

Biosafety is concerned with the safe application of biotechnology which include both GMOs of LMOs products. Biosafety issues want to ensure safe research methods and the morality of research agendas. There are important questions which have to be addressed before this technology can be adopted. What happens to the gene constructs that are inserted in crops or animals? There are possibilities of gene transfer especially horizontal transfer as has been reported elsewhere. The effect or possible effect of marker genes e.g. for antibiotic resistance is not well understood. There is need for us to try to answer or address these questions.

If the technology is to be useful the products should have immediate utility in Agriculture, industry and medicine.

The content and scope of Biosafety Protocol has been a major debate internationally. The world is divided into two groups, the Miami group and the developing countries. The Miami group is composed of US and a few countries. It was agreed that countries must be provided with International rights under the Biosafety Protocol to give the Advance Informed Agreement (AIA) products. There is a concern that the Biosafety

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Protocol should not be subservient to established laws or other protocols such as TRIPS or WTO.

There are dangers and public concern that have arisen as a result of GMOs or LMOs. Many issues deal with transgene, horizontal transfer. There is no ample evidence that the transgene is destroyed in the processing e.g. cooking for maize products. The effect on animals such as baboons which feed on non-processed maize cobs is not known.

The effect of Bt on the Monarcho butterfly has raised public suspicion on the science. There is therefore public concern in Europe pertaining to products of GMOs on environment, bio-diversity, human health, ethics, impact on indigenous and local communities.

In India there have been mass demonstrations against Monsanto while Brazil has banned Monsanto. The EU is coming up strongly against GMOs. The issue of labeling is still a problem however countries such as Australia and New Zealand have taken initiatives.

The questions from the floor:

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Moral issues and Public concerns
(Father B. MacGarry)

If we are to do this technology we have to make or take time. There is a concern as to the effect of altering a gene and the resulting characteristics. Some other things may be affected, the human being is complex. The area of side effects and escape of genetic material is of public concern and moral concern.

The developments especially by Monsanto do not seem to address the developing countries problems. There is a likelihood of developing superweeds or superhumans. The rich will have all the good characteristics. Important questions are raised by this science. Are we improving the health of individuals or eliminating unhealthy individuals? Are we engineering caste or putting a race structure? We will, with this science increase differences between rich and poor.

Question 1: do we have the power to act? Or WTO, TRIPS will bind us?

Question 2: Is there any merit in changing the genotype of a human being?

From the floor: Monsanto representative: the terminator gene does not exist as a product and could be 5 years away. Before release the issue will be debated by NGOs and all interested parties. Monsanto has interest to feed people and farmers go to them because of perceived benefits

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WORKING GROUP REPORTS

RAPPORTEUR: P. TONGOONA

GROUP 1: CROPS (AGRICULTURE)
FACILITATOR: K. MTINDI

The Group noted that there were no problems with traditional biotechnology such as fermentation, plant tissue culture and micropropagation which has facilitated the production of disease and virus free material used extensively in horticulture, medical pharmacology where the technology was employed in the production of drugs.

The group therefore discussed genetic engineering or genetically modified organisms as defined in the Biosafety guidelines and Regulations. Two separate aspects were debated:

• 1.1 All on-going research was to be brought under the fold of the Biosafety Board. All institutions carrying out biotechnology research would have to register their laboratories, researchers and the nature of the research has to be approved by the Biosafety Board.

• 1.2 All intended new research needed to be approved by the Biosafety Board.
  The group were relieved to note that the Biosafety guidelines and regulations have in fact addressed the above concerns and the trialling testing, debating and finally approval of the genetic material will happen through the current existing infrastructure used for conventional breeding.

• 1.3 The group recommended strongly that the Biosafety Board ought to do more to publicize itself, its guidelines and regulations and inform the public of the technology in general.

• 1.4 Collaborative partnerships between local and external researchers were seen as a way forward as it is mutually beneficial and strengthens capacity building.

• 1.5 The group felt transgenic material available in the region and suited to our environment should not be unnecessarily delayed by time for release but however agreed that the entry point was still the Biosafety Board.

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2. Commercialization

• 2.1 An institution wishing to commercialize a genetically modified organism
  (GMOs) should make an application to the Biosafety Board providing all tests results, cost/benefit analyses and risk assessments, absolutely ensuring environmental safety.

• 2.2 Enforcement of the regulations was emphasized.

• 2.3 Consumer awareness and labeling of products of GMOs was essential so that consumers made informed choices.

• 2.4 Transgenic products should be handled on a trait to trait basis and a cautious step by step release to the commercial environment was emphasized to save on costly failures.

• 2.5 Scientific institutions, consumer council and other relevant bodies should function as watchdog bodies.

• 2.6 The group recommended that at all phases of commercialization, mechanisms for monitoring and evaluation should be in operation.

Discussion (Crops - Agriculture)

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GROUP 2: (ANIMALS - AGRICULTURE)
FACILATATOR: P. MANYUCHI

The group discussed current issues including cloning, embryo transfer, vaccines, Bio-farming, administration of products of recombinant DNA and replacement gene therapy.

1. Concerning cloning, it was recommended that:

   • measures should be taken to prevent loss of biodiversity,
   • it could be useful in conservation farming, and
   • there is need to be careful on cloning which produces chimeras because there is need to be clear if new species are being produced or not. There are ethical issues to be addressed.

2. Embryo Transfer and Artificial Insemination

   After noting that these techniques are acceptable in Zimbabwe and that regulations exists for quarantine and testing, the meeting recommended the need for regulations to control exports of embryos and ownership of products from such exports.

3. Vaccines

   Concerning genetic and sub-unit gene vaccines, the group recommended

   • The need for more data on mode of operation and persistence in animal products.
   • The need to monitor any horizontal transfer.
   • The need to evaluate possible impact on import/export conditions e.g. the EU market.

4. Biofarming:
   • The group recommended that this should be controlled, e.g. slaughter of animals for human consumption.
   • The group recommended careful consideration of animal welfare, environmental and ethical issues.

5. Administration of Products of Recombinant Technology

   The group noted that the long-term effects of administration of such products was not understood. The group therefore recommended a precautionary attitude in administration of products of recombinant technology.

   • On BST, there is need for more data on current status on use and socio-economic impacts.

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   • GMO crops may find their way into animals via feed. There is need to assess the impact of this on export markets e.g. beef exports to EEC.

6. Replacement Gene Therapy

   No recommendations were made.

Discussion (Animal-Agriculture)

Concerning the export of germplasm, it was recommended that there is need for agreement on any GMOs produced from the germplasm particularly in relation to payment of royalties. There is need for protection agreement in export of genetic materials.

A point was raised concerning the traceability of products and international agreements signed. The meeting recommended the harmonization of such signed agreements in local operations.

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GROUP 3: REPORT (HUMAN HEALTH)
FACILITATOR: C.B. NHACHI

The group discussed reproductive cloning and therapeutic cloning in human health.

1. On Reproductive cloning, the group recommended the following:

   • it should be exercised with caution in non-humans, and not in humans.

   • more basic research should be done e.g. health of clones, life span etc. in view of the rapid aging of "Dolly" the sheep.

   • cultural concerns should be taken into account.

   It was pointed out that one of the immediate benefits of cloning in animals was replenishment of species facing threat of extinction.

2. On therapeutic (non-reproductive) cloning, the group recommended that:

   • This should be endorsed because there are clear benefits in medical field in the terms of tissue transplant and organ replacement.

   • More resources should be directed towards basic research in this area and selected research Institutes, Universities etc. should be galvanized to take up this research.

Discussion (Human Health)

1. A question was posed on whether cloning can redress the huge attrition due to HIV/AIDS. No concrete recommendation was made due to unresolved ethical issues surrounding human cloning.

2. On the cautious application of reproductive cloning, it was noted that there are many unanswered questions about cloned animals e.g. the aging process in „Dolly" the sheep. When unanswered questions have been addressed, maybe human cloning can be justified in future of course after taking into account cultural aspects and concerns.

3. Concern was raised on the consumption of products of genetic engineering in medicine. For example a recombinant vaccine on HIV is being developed. What is the reaction in Zimbabwe? The meeting recommended that there should be monitoring and control of the consumption of GMOs in medicine. It was pointed out that this will be controlled by the Drug Control Council.

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4. On-going research an aging process has shown that it is due to processes on the chromosomes. It was suggested that it is possible to replace telomeres on chromosomes to reverse the aging process. Such issues can be addressed under gene therapy but the possibility of doing this on all cells is mammoth if not impossible.

5. The meeting pointed out the need for a strong local body to generate technologies rather that being used as guinea pigs by other nations/organization. There is very little monitoring of materials for clinical trials locally even at personal doctor level.

   It was mentioned that the public should be free to complain in aspects where they feel they have been mistreated. The Medical Control Council has punished individuals for unethical practices. Very often people do not come forward to complain.

6. A claim was made that under witchcraft a lot of "cloning" has taken place. Somehow it is now being accepted through genetic engineering. There is need for more research in traditional medicinal practices.

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GROUP 4 REPORT: ETHICS
FACILITATOR: D. MNYULWA

The group raised the following issues:

• does the use of GMOs favour those that can afford the technology at the expense of the poor?

• what are the possible side effects of GMO products?

• all GMOs and their products in the country (either imported or produced internally) should be labeled and monitored.

• our national stance on GMOs should take precedence over the international conventions e.g. WTO.

• consultations at national level before negotiations at international fora should be broader than it has been in the past including all stakeholders.

• there is need to explore more ethical alternative approaches to address problems e.g. indigenous science.

• our National stance should be in support of the position of the likeminded group under the biosafety protocol.

• we must adopt precautionary approach to the whole issue of GMOs and carry out comprehensive risk assessment before adopting any technology.

• Awareness campaigns should be carried out at all levels on the possible impacts of genetic engineering

• the Biosafety Board and Ministry of Lands and Agriculture must strictly enforce Biosafety and Phytosanitary regulations and customs regulations.

• Government should exert every effort to maintain local control of our local agricultural and Pharmaceutical companies.

• there is need to draw up a code of ethics for our scientists working with biotechnology including human cloning and an ethics committee should be established to enforce the code.

• the Biosafety Board in future should include all stakeholders.

• we need to link with global networks on information on GMOs and ensure that locally we set up a forum and spread the information objectively.

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• Government must increase its budget for research on GMOs.

Discussion (Ethics)