Pharmaceutical Issues

DR HENNY RACHDIATI
SENIOR LECTURE

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 LEARNING OBJECTIVE

Explain legal and ethical issues, economic

aspect and professional issues in
Pharmaceutical Biotechnology
Explain public acceptance biotechnology-
derived products

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 Biotechnology Feeds on New
Paradigms of Bioscience
1953 Structure of DNA as genetic material.
1973 Genetic engineering (gene splicing)achieved.
Mid ‘90 Widespread genetically modified (GM) crops in market.
1997 Animal cloning achieved.
2001 Human genome unveiled
New Maturing of stem cell research and genomics (gene chips,
Millennium proteomics, “transcriptomics”).
Technology is moving faster than understanding of implications to
society ???
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 ETHICS
the branch of philosophy that deals with
distinctions between right and wrong – with the
moral consequences of human action”
(Coughlin & Beauchamp, 1996)
Effort to create the positive reflection on
activities or intuition and moral choice which
decided by someone

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 ETHICS
Consists of three meanings :
Moral values or norms that used to be a guidance for individuals
or groups in their activities
A moral philosophy that deals with distinctions between right and
wrong
Collection of moral rules ethical codes

(K. Bertens, 2004)

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 Ethical Principles

Beneficence Non-maleficence

Justice Autonomy

Henny Rachdiati 6
 ETHICS
Autonomy
◦ Right of self-determination
◦ Related to ‘informed consent’
◦ Respect to person
Beneficence – to do well, to promote well-being, unconditional
goodwill and compassion.
Non-maleficence – do no evil or harm; risk-benefit analysis.
Justice – equity; fair treatment for all people

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 Issues for the New Millennium
Cloning:
◦ Therapeutic organ cloning (cost and equity>
technical>moral)
◦ Whole organism cloning (moral>technical)
◦ Deciding factors: embryonic vs adult stem cells, failure
rates, long-term issues

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 Issues for the New Millennium
Genomics:
◦ Pharmacogenomics (cost and equity)
◦ GMOs (biosafety vs benefits)
◦ Deciding factors: consumer benefits vs costs,
understanding of long-term effects of GMOs on the
environment

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 Technical Implications:
Agricultural Biotechnology
DNA information as guide to selective breeding: “Molecular markers”.
Development of transgenic plants and animals (Genetically modified
organisms, GMOs).
◦ Insect resistance (eg. Bt cotton), herbicide resistance (eg. round-up ready):
gene expression
◦ Genetic Use Restriction Technologies (GURT, “terminator”): control of gene
expression (by genes and chemicals).

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 Ethical, Social and Legal Implications:
Agricultural Biotechnology
Is it against “nature”? Risks vs benefits?
◦ Relative lack of religious objections.
◦ Transgenic intrinsically harmful to the environment? Environmental biosafety
concerns.
◦ Harmful to consumers? Health biosafety concerns.
Gap between haves and have-nots increased.
Intellectual property system in favour of already developed countries
(e.g. gene patents).
Production system in favour of the already efficient

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 Ethical, Social and Legal Implications:
Agricultural Biotechnology
Types of risks
◦ Technical risks (environment, consumers).
◦ Public perception risk.
◦ Market risk.
Principle of Substantial Equivalence: Equivalent product
regardless of process.
Precautionary Principle: Err on the side of caution

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 Ethical, Social and Legal Implications:
Agricultural Biotechnology
Ownership of, and sovereignty over, genetic resources:
natural and developed further by human efforts.
◦ Indigenous people (Farmers’ rights).
◦ Countries (Biodiversity Convention).
◦ “Common property of mankind” (free use of natural resources,
but restricted by patents for modifications).

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 Technical Implications:
Medical/Pharmaceutical Biotechnology
Gene-based diagnostics can give prenatal and long-range
predictions of illness and other human characteristics.
Genes of humans and other organisms are targets leading to
therapeutics.
Stem cells (embryonic and adult) can lead to spare organs or
tissues, or whole humans through cloning.

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 Ethical, Social and Legal Implications:
Gene-based diagnostics
The need to know vs. the right to privacy.
Illness is a burden to both individuals and society.
The right to life of the unborn child.
The need (right) of the society, employer, insurer to know
(social contract issues).
The right of the individuals to privacy, and the right not to
know (human rights issue).

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 Ethical, Social and Legal Implications:
Intelectual Property Rights
Should genes be patentable?
Who own the genes (biological materials)?
Who has the right to use the genes?
Special considerations for developing countries/poor
communities who cannot afford the treatment (e.g. compare
with AIDS drugs).

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Ethical, Social and Legal Implications:
Cloning
Is it ethical to use embryonic stem cells? In what
circumstances?
Is it ethical to clone spare organs? From oneself? From
another individual?
Is it ethical to clone human beings? Under what
circumstances?
The legal status of a human clone?

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 Fukuyama concern

F. Fukuyama: How far do we let biotech go?

Current regulatory bodies are inadequate to deal with
future choices, eg.
◦ Manipulating genes which modify behaviour.
◦ Using drugs which alter moral character.
◦ Extending life, impacting on economies, international
relations, and new ideas generation.
◦ Creating “designer babies”.

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 Future Directions:
Towards Good Governance in
Biotechnology
More concerns and discussions on bioethics by lay
people and scientists alike.
Voluntary Codes of Conduct on issues involving risks
or ethics by bioindustries, professional societies, etc. (cf.
1973 voluntary moratorium on genetic engineering).
New laws may be enacted, but a good sense of balance
is needed.

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 Future Directions:
Towards Good Governance in
Biotechnology
Role of government:
 Oversees development and capability strengthening in both technical and social,
ethical issues in biotechnology and life sciences.
 Set up regulations and laws as necessary, making sure of having a healthy
balance.
Role of civil societies (NGOs)
 Help to make the public understand issues in various aspects, not just lobby on
single issues.
Role of education/research institutes
 Acquire knowledge and understanding on issues interfacing between technology
and society.
 Help to generate healthy debates among various stakeholders and the public.
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THANK YOU

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