1. Biosafety and Bioethical issues
in Biotechnology

2. BIOSAFETY
‘Biosafety’ means the need to protect human and animal health and environment from the possible adverse effects of the products of modern biotechnology

3. How is Genetic Engineering (GE) different from conventional breeding (CB)?
Combining DNA in new combinations and introducing it into a new organism are the GE tools.
Main differences between CB and GE
Ability to move across sexual barriers
Amount of change: a specific gene embodying a particular trait or thousands of genes embodying desirable and undesirable traits
Occurrence of change in one or several generations.

5. Genetic engineering:Recombinant DNA technology

6. Is GE inherently unsafe?
Two diametrically opposite trends of thought
US-Canada
No new risks associated with GM crops
New regulations not considered necessary
Safety assessments
‘Product’ rather than ‘process’ based
In comparison and contrast to their ‘familiarity’ and ‘substantial’ equivalence to conventional crops

7. …Is GE inherently unsafe?EU
GE crops considered new and special
Existing legislation not considered sufficient
Safety assessment
Process based
Principle of ‘substantial equivalence’ beginning rather than the end
Adoption of ‘Precautionary Principle’ as guide

8. ….Is GE inherently unsafe?
GE technology carries certain inherent unpredictability
Some facts
Isolation of a gene from its natural environment and integration into entirely different organism
Possible transgenic instability due to triggering of the inbuilt defense mechanisms of the host organism leading to inactivation or silencing of foreign genes.

9. ….Is GE inherently unsafe?
Possibilities of integration of foreign gene at a site predisposed to silencing of genes (position effect).
Variance in the levels of expression of the transgene in different environmental conditions (heat, humidity, light…..)
Possibilities of silencing of genes arising in subsequent generations
Case by case sound scientific
assessment is of utmost significance

10. Rigorous Scientific Assessment Precautionary Principle
Relate to environmental, human and animal health consequences
Both can have short and long term implications
Biosafety risks involve the entire spectrum of biodiversity
A universal ‘true for all’ approach may not be applicable
Biosafety issues in transgenic crops
Risks
Known Probability
Unknown Probability
Rigorous Scientific Assessment
Risk Mitigation
Precautionary Principle

11. ..Biosafety issues in transgenic crops -
Biosafety concerns arise from:
Horizontal gene transfer
Genetic contamination
Transfer of allergens and toxins from one life form to another and creation of new toxins and allergenic compounds

12. ..Biosafety issues in transgenic crops -
Main Concerns
Development of aggressive weeds/ wild relatives by transfer of transgenic traits
Erosion of land races/wild relatives by genetic pollution in centres of origin/ diversity
Harm to the non-target organisms
Development of pest resistance by prolonged use
Monoculture and limitations to farmers’ choice in crop management
Hazard to human and animal health by transfer of toxins and allergens and by creation of new toxins and allergenic compounds
..Biosafety issues in transgenic crops -

13. ..Biosafety issues in transgenic crops
Assessment
GE venturing into an unknown biological territory
ASILOMAR Conference (1975): No research till safety guidelines in place
Initially, focus on laboratory safety procedures
Wider definition of biosafety with possibilities of commercialization of GM products
The broad format of biosafety parametres essentially the same in all regulations

14. ..Biosafety issues in transgenic crops
Two main stages:
Laboratory/green house stage
Confined Trial Stage
IMPORTANT
Prevention of the spread of genetically
engineered material outside lab/field

15. Laboratory/green house stage
Different biosafety levels as per the degree of risk involved
Two methods of containment
Physical
Biological

16. A confined trial is a small scale release of a transgenic plant species for research purposes conducted under conditions that prevent spread of the organism and mitigate its impact on the surrounding environment
Objective is to collect data to evaluate the crops’ performance
Confined Trial Stage

17. Focus on Risk Mitigation
Risk mitigation – the terms and conditions that are necessary to conduct the trial safely.
Prevent Gene Flow
Prevent entry of GMOs into food chain
Prevent Persistence of GMOs in the field

18. Bio-pharmaceutical therapeutics
Biosafety risk
Survival, multiplication and dissemination of GMOs in contained/ open environment
Interaction of GMOs with biological systems
Routes of dissemination: physical; biological
Risk depends upon
Nature of organism invovled
Extent of use of LMOs
End product LMO or not?

19. …Bio-pharmaceutical therapeutics
Risk categorization of micro organisms:
determining factors
Capability to cause disease
Hazard to laboratory workers
Risk of spread to community
Availability of effective treatment
Health risks
Toxigenicity Pathogenicity
Allergenicity Antibiotic resistance

20. ..Bio-pharmaceutical therapeutics
Environmental risks
Outcrossing between GMOs and pathogens
Negative effects on populations of non target organisms
Risk assessment
Access
Expression
Damage
Risk management and communication
Physical
Biological

21. GM foods: need for safety assessment
Expressed proteins generally not a part of regular food supply
Food complex mixtures e.g. nutrients, anti-nutrients and natural toxins
Directly enter human system
Assume different forms
Involve storage, processing, transportation

22. .. Safety assessment of GM foods comprise
Guidelines by Codex Alimentarius Commission
Assessment of possible allergenicity
Assessment of possible toxicity
Compositional analysis of key components
Food processing
Nutritional modification

23. ….GM foods: Allergenicity; Toxicity
Allergy
It is a hypersensitive reaction initiated by immunologic mechanisms caused by specific substances called allergens.
Assessment
Is the gene source allergenic?
Expression level of introduced gene
Unintended effect
Digestibility and heat stability
Toxicity
New proteins as a result of intended modification
Unintended new proteins as a result of the modification
Natural constituents beyond their level of normal variation

24. ….GM foods: nutritional aspects; unintended effects
Intended and unintended changes in nutrient levels
Bioavailability of nutrients, stability and processing
Presence and effect of anti-nutrients
Impact of individual changes on overall nutritional profile
Unintended effects
Random integration of transgenes
Insertional mutagenesis
Disruption of gene functions
Production of new proteins
Changes in
Phenotype Metabolites
Enzymes Toxins
Genotype

25. Concluding Note…… Biosafety is integral to modern biotechnology
The adoption of modern biotech products needs to be balanced with adequate biosafety safeguards
Case by case scientific risk assessment and cost benefit analysis
Greater acceptance of health care applications
Need based adoption in GM crops and foods
Participation of various stakeholders
Dissemination of knowledge and information

26. bioethics? as against ethics, moral issues writ large?
what is distinctive about life sciences?
is it about outcomes?
a moral judgement as to right and wrong?
who decides, and on what basis?
is it about a way of making policy choices?
consultation, consent, a broader framework?
is it a judgement on behaviour?
what kinds of research activities, ways of doing business do we favour?

28. IP and bioethics: law or ethics?
IP systems largely a creature of statute
Law vs. ethics: what is ethical aspect of lawmaking guided by public policy?
Ethically neutral? Or policy space for ethical considerations?
Law vs. morality: question of patentability of morally questionable technologies
‘Natural rights’ basis for [some] IP laws and principles
Article 15.1(c) ICESCR, Art 27.2 UDHR
but strong utilitarian flavour to IP law and policy, increasingly emphasized in current debate on IP as a tool of public policy
Article 7, TRIPS

29. distinguish… ethical aspects of a technology as such
ethical aspects of national authorities granting IP
ethical aspects of an individual seeking exclusive IP
ethical aspects of the forms of exercising IP rights

30. distinguish… ethical aspects of a technology as such
e.g. the ethics of stem cell research
ethical aspects of national authorities granting IP
ethical aspects of an individual seeking exclusive IP
ethical aspects of the forms of exercising IP rights

31. distinguish… ethical aspects of a technology as such
ethical aspects of national authorities granting IP
e.g. ethics of a patent office granting patents on life forms
ethical aspects of an individual seeking exclusive IP
ethical aspects of the forms of exercising IP rights

32. distinguish… ethical aspects of a technology as such
ethical aspects of national authorities granting IP
ethical aspects of an individual seeking exclusive IP
e.g. ethics of a public funded agency patenting research)
ethical aspects of the forms of exercising IP rights

33. distinguish… ethical aspects of a technology as such
ethical aspects of national authorities granting IP
ethical aspects of an individual seeking exclusive IP
ethical aspects of the forms of exercising IP rights
e.g. ethics of licensing patents key medical technologies).

34. distinguish… ethical aspects of a technology as such
e.g. the ethics of stem cell research
ethical aspects of national authorities granting IP
e.g. ethics of a patent office granting patents on life forms
ethical aspects of an individual seeking exclusive IP
e.g. ethics of a public funded agency patenting research)
ethical aspects of the forms of exercising IP rights
e.g. ethics of licensing patents key medical technologies).

35. ?

36. Some distinctions Ethics and IP law and practice
In the sense of guidance for right behaviour
e.g. When is consent regarding seeking IP an ethical question?
Morality and IP law and practice
In the sense of determining innate right & wrong
e.g. substantive references to ‘morality’ in IP laws
Exclude patent protection for technologies the exploitation of which would be contrary to morality
Trademarks contrary to morality
‘Moral rights’ in copyright and related rights

37. International law: States may exclude from protection inventions on morality grounds (Article 27.2, WTO TRIPS Agreement).
States agree to leave space for morality considerations to apply at the domestic level:
They then have the option to create a specific morality exception within their own national patent laws.
In exercising such an exception, a decision maker working within the national system may be required to undertake a specific ethical judgment about a particular technology.

38. distinguish… ethical aspects of a technology as such
e.g. the ethics of stem cell research
ethical aspects of national authorities granting IP
e.g. ethics of a patent office granting patents on life forms
ethical aspects of an individual seeking exclusive IP
e.g. ethics of a public funded agency patenting research)
ethical aspects of the forms of exercising IP rights
e.g. ethics of licensing patents key medical technologies).

39. the BRCA gene patent

40. IP and bioethics: some themes
Transparency
Consent
Benefit sharing
Crossover between law and morality
Accommodating different value systems

41. Transparency in the patent system
Transparency as the basis for ethical scrutiny of relevant technologies
Patent information systems used to monitor:
trends and background in key technologies
state of the art in key technologies
research and patenting activities of firms/institutes/individuals
But need for improved use/access of patent information, and value-added information products to guide policymaking

42. Traditional knowledge and IP
“indigenous peoples have rarely placed anything in the so called ‘‘public domain’’, a term without meaning to us the public domain is a construct of the IP system and does not take into account domains established by customary indigenous laws”
- Saami Council

43. Traditional knowledge and IP
misuse of TK can cause severe physical or spiritual harm to the individual caretakers of the knowledge or their entire tribe from their failure to ensure that the Creator’s gifts were properly used, even if misuse was used by others outside of the tribe, or by tribal members who were outside of the control of customary authority.
For this reason misappropriation and misuse [is] not simply a violation of ‘‘moral rights’’ leading to a collective offense, but a matter of cultural survival for many indigenous peoples.
Tulalip Tribes

44. IP and the sharing of benefits
UNBHR: equitable access to medical, scientific and technological developments as well as the greatest possible flow and the rapid sharing of knowledge concerning those developments and the sharing of benefits, with particular attention to the needs of developing countries;

45. IP in research agreements
UNBHR: When negotiating a research agreement, terms for collaboration and agreement on the benefits of research should be established with equal participation by those party to the negotiation. (art 21.4)

46. IP and bioethics in the innovation process
research policy and planning
the research phase
the acquisition of IP rights
the use of new technology, and exercise IP of rights

47. reviewing IP and bioethics issues throughout the technology development pipeline
Ideally: each stage guided by an overarching conception of workable, equitable and effective arrangements for innovation in the public interest, consistent with legitimate private interests -- the ethical basis of good public policymaking?

48. a concluding example
many have called for an ‘open source’ approach to biotechnology
what are the bioethics-IP implications?

49. “should”
protection of IP “should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.”
WTO TRIPS Agreement, art. 7

50. but what is the nature of that ‘should’?
“should” - as
ethical (deontological),
ethical (utilitarian),
legal (obligatory)
aspirational, or
predictive?
within legal text, guide to broader interpretation
within policy context, guide to policymaker – an heuristic?

51. what message to life science policymakers?
if one should encourage or adopt ‘open source’ innovation in the life sciences
prudential – it is good for you, it serves your objective interests;
ethical: any ‘right thinking person’ would do so;
social utilitarian: – it yields overall welfare outcomes;
legal – you must do it, whether or not it is in your real or perceived interests.
Each has been made for ‘open source’ approaches to life sciences innovation.
How does the nature of the ‘should’ depend on who and where you are?

52. two layers of ‘should’
essence of IP policymaking is setting what legally defined exclusivities over knowledge resources will advance innovation, fair competition and public welfare, and how those exclusivities should be shaped and governed.
some ‘open source’ ideas hard-wired at the legislative level (or can be)
individual holders of exclusive rights are also presented with a range of obligations – ethical and legal - and motivations.
when and how is there a convergence of the overall architecture of the IP system, the interests and behaviour of players within that system, and the kinds of modes characterized as open source in the life sciences?

53. some approaches to IP and bioethics…
bioethics within the law of patents: the scope for judgements about morality in assessments on patentability
bioethics considerations in consultations on policymaking
bioethics as a guide to practice in medical research and in business
bioethics and fundamental rights and responsibilities