Health Law and Bioethics FDUNL 2.Nd Semester Prof. Helena Pereira de Melo 2010/2011

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Oct 23, 2013 (3 years and 1 month ago)

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Health Law and Bioethics

FDUNL

2.Nd Semester

Prof. Helena Pereira de Melo

2010/2011


*
Joana Magalhães

n.º 002328

*
*
The use of living organisms or their products to
modify human health and the human
environment.


*
Biotechnology is booming.


*
Produce new medicines, treatments and
processes with the potencial to save or
transform the lives of millions

*
*
As new technological fronteirs are crossed, our
expectations continue to rise





*
Increase the complexities of the associated
bioethics

*
Concerns the way in which biotechnological
inventions are protected


or excluded from
protection


by intellectual property (IP)


*
The central debate on bioethics and IP revolves
around the morality of what is referred to as
“patenting life”

Human
Genes
Patents

*
*
Is it morally acceptable to grant exclusive
rights over a particular technology, such as
isolated DNA?



*
What ethical concerns arise regarding the way
exclusive rights over a technology are
exercised, such as patents on diagnostic tools?




*

“(…) we will soon enter an anxious era, in which
many of the current antibiotics will become
partly useless, the systematic study of
pathogenic mechanisms and discovery of new
antibiotics through the study of the genome will
be absolutely crucial especially now that we
know that microorganisms are highly dissimilar”

Santiago Grisolía

*
*
Are exclusive rights, limited in time, to exploit
an invention.

*
Others may not use the invention without
permission of the patent owner.

*
The underlying ideia of the patent system is
that the exclusive rights are given in exchange
for the disclosure of the invention.

*
Gene patents comprises:


*
Genetic technologies;

*
Natural genetic materials;

*
Isolated genetic materials;

*
Genetic products (such as proteins);

*
*
1873



Louis Pasteur received a patent on isolated
yeast

*
1953



the foundation for modern genetics was laid
when the scientific journal
Nature

published Watson
and Crick
´
s hypothesis about the double hellix
structure of DNA.

*
1973



Cohen, Boyer and Chang developed a
technique that allowed sections of DNA to be
transferred from one life form into another.

*
1976



Boyer and Swanson established the first
known biotechnology company, Genentech Inc., in
Berkeley, California.

*
1977



Genentech reported the production of the
first human protein manufactured in a bacterium.

*
*
1977



Sanger identified a method for reading DNA
consequences.

*
1980s



onward, the debate intensified when
patents began to be filled on human genes.

*
1980s



Mullis and others at Cetus Corporation
developed PCR, a quick and easy method for
selective amplification of DNA fragments, removing
the need for cloning in micro
-
organism.

*
1980



USA Supreme Court Decision in
Diamond v
Chakrabarty

allowed a patent to be granted for a
recombinant bacterium, thus determining that life
forms are patentable subject of matter.

*
*
1
980



US Congress passed the
Bayh
-
Dole Act.

*
1982



US Food and Drug Administration approved
the first recombinant DNA drug for market.

*
1988



first patent over an entire animal “Harvard
Mouse”.

*
2001 to 2003


Human Genome Project and the
Celera Genomics Group
-

draft of the human
genome sequence, completed in April 2003, bringing
a new array of problems for gene patents.

*
*
These include concerns about social impact of
gene patents on the conduct of research and
the provision of healthcare;

*
Ethical concerns about sharing the benefits of
genetic research, respect for human dignity
and consent to the use of genetic material in
research that leads to commercial outcomes.

*
*
The goals of a patent system, whether applied
to genetic materials and technologies, or other
patentable suject matter, are fundamentally
economic.

*
Biotechnology field is dominated by
commercial research and private industries.

*
The purpose of existence of a company is profit
making.

*
*
*

Human genome as the common heritage of
humanity:



patents on human genetic materials grant
exclusive rights over this common heritage to a
limited number of entities;



concern of fair distribution of the benefits of
genetic research;

*
Disrespect for human life and dignity:

*

patents on genetic materials commodify parts
of human beings by treating them as objects,
or as something to be placed in the stream of
commerce for financial gain;

*

genetic materials have a unique significance,
which requires them to be treated with special
respect;

“Our genetic code is our heritage. It deserves this
degree of respect. It is not merely a commercial
resource”

Dr. Graeme Suthers

*
Incompatible with respect for human dignity
because it reduces human being to things to
which no respect is owed and is ethically
unacceptable because it precludes respect for
individual autonomy;


*
Incompatible with respect for an individual
´
s
self
-
determination (and self
-
ownership) because
they grant ownership rights over genetic
material, and consequently over parts of human
beings, to someone other than the person from
whom the genetic material was taken;

*

Gene patenting may have an adverse impact
on the cost and quality of healthcare services


*

The economic rewards of patenting may
channel investment into the more profitable
areas of research and away from other
important goods and services, such as medical
treatments for rare diseases.

*
*

Human worth


including the genetic basis for
life


derives from the divine aspect of
creation.

*

Patents on genetic materials attribute
ownership of the basis of life to someone other
than God.

*
*

Encouregement of inventiveness, development of new
products and processes with important healthcare
applications

*

Disclosure of the research

*

F
air reward for their investments

*

I
nvolving private companies may lead to a greater
amount of total knowledge and a more rapid
completion date

*

Principle of autonomy


if I invest in something, I have
the right to use that knowledge first

*

Patents grant intangible intellectual property rights
and not physical property rights

*
*
*


Reflects

The insterest of the
biotechnology industry

The interest of various
constituencies concerned
about human dignity and
the commercialization of
life

*
*
The regulatory framework responds to these
competing interest in two ways

Morality clauses,
principles and specific
exclusions

Biotechnology is to be
treated no differently
from any other
inventive science that
comes forward with
patents claim

*
*
In the patent law of most countries, the same
basic rules and principles govern the patenting
of biotechnological inventions as other
technologies.

*
Requirements:




Inventive step;



Novelty;



Industrial application;

*
*
1
.

For

the

purposes

of

this

Directive,

inventions

which

are

new
,

which

involve

an

inventive

step

and

which

are

susceptible

of

industrial

application

shall

be

p
atentable

even

if

they

concern

a

product

consisting

of

or

containing

biological

material

or

a

process

by

means

of

which

biological

material

is

produced,

processed

or

used
.


*
2
.

Biological

material

which

is

isolated

from

its

natural

environment

or

produced

by

means

of

a

technical

process

may

be

the

subject

of

an

invention

even

if

it

previously

occurred

in

nature





Article 3.º

*

*
1
New inventions
involving
inventive activity
can be patented
if they have an
industrial use
, even
if they apply to a product consisting
of or containing biological material
or to a process that produces, treats
or uses biological material.

*
2 Patents may be obtained for any
inventions, be they products or
processes, in all fields of technology,
provided that these inventions
comply with the previous paragraph.

*
3 New processes for obtaining known
products, substances or
compositions may also be
patented.

*
(…)



Article 51 .º

*

*
1 An invention is considered
new if it does not form part of
the state of the art.

*
2 An invention shall be
considered as involving an
inventive step if, having regard
to the state of the art, it is not
obvious to a person skilled in
the art.

*
3 An invention shall be
considered as susceptible of
industrial application if it can
be made or used in any kind of
industry or in agriculture.

Article 55.º

*
*

It is sometimes argued that the isolation of
proteins and the cloning of genes represents a
discovery (since the product already existed),
not na invention and so is excluded from
patentability.

*
*

Demand a specific regulation;


*

Deeper analysis of the traditional patents
criteria throughout principles and morality
clauses;



*
*
The human genome
underlies the fundamental
unity of all members of the
human family, as well as the
recognition of their inherent
dignity and diversity. In a
symbolic sense, it is the
heritage of humanity.


Article 1.º

*
(a) Everyone has a right to
respect for their dignity and
for their rights regardless of
their genetic
characteristics.


(b) That dignity makes it
imperative not to reduce
individuals to their genetic
characteristics and to
respect their uniqueness
and diversity.


Article 2.º

*
*
The human genome in its
natural state shall not give
rise to financial gains.

Article 4.º

*
*

Practices
which are contrary
to human dignity, such as
reproductive cloning of
human beings, shall not be
permitted. States and
competent international
organizations are invited to
co
-
operate in identifying
such practices and in taking,
at national or international
level, the measures
necessary to ensure that the
principles set out in this
Declaration are respected.

Article 11.º

*
*
(a) Benefits from advances in
biology, genetics and medicine,
concerning the human genome,
shall be made available to all,
with due regard for the dignity
and human rights of each
individual.


(b) Freedom of research, which
is necessary for the progress of
knowledge, is part of freedom of
thought. The applications of
research, including applications
in biology, genetics and
medicine, concerning the human
genome, shall seek to offer
relief from suffering and
improve the health of individuals
and humankind as a whole.


Article 12.º

*
*
*
The human body and its
parts shall not, as such, give
rise to financial gain.


Article 21.º

*

*
1. The human body, at the various
stages of
its formation
and
development, and the simple
discovery
of one
of its elements,
including the sequence or
partial
sequence
of a gene, cannot
constitute
patentable
inventions
.

*
2. An element isolated from the
human body
or otherwise
produced
by means of a technical
process,
including
the sequence or partial
sequence of a gene,
may constitute
a patentable invention, even if the
structure
of that
element is identical
to that of a natural element.

*
3. The industrial application of a
sequence or a
partial sequence
of a
gene must be disclosed in the
patent
application
.

Article 5.º

*
*
1. Inventions shall be considered
unpatentable

where their
commercial
exploitation would be contrary to
ordre

public
or morality; however, exploitation
shall not
be deemed
to be so contrary
merely because it is
prohibited
by
law or
regulation.

*
2. On the basis of paragraph 1, the
following,
in particular
, shall be
considered
unpatentable
:

*
(
a) processes for cloning human beings;

*
(b) processes for modifying the germ line
genetic
identity
of
human beings;

*
(c) uses of human embryos for industrial
or
commercial
purposes;

*
(d) processes for modifying the genetic
identity of
animals which
are likely to
cause them suffering without
any
substantial
medical benefit to man or
animal,
an also
animals resulting from
such processes.

Article 6.º

*
*
European patents shall not
be granted in respect of
:

*
(
a
)

inventions the
publication or exploitation
of which would be contrary
to "
ordre

public" or morality,
provided that the
exploitation shall not be
deemed to be so contrary
merely because it is
prohibited by law or
regulation in some or all of
the Contracting States;

Article 53.º

*

*
1 Inventions whose commercial exploitation is against the law
or contrary to public policy, public health or morality are not
patentable and their exploitation may not be considered as
such due to the simple fact that it is forbidden by law or
regulations.

*
2 Under the previous paragraph, the following are not
patentable:

*
a) Processes for cloning human beings;

*
b) Processes for modifying the germinal genetic identity of
human beings;

*
c) The use of human embryos for industrial or commercial
purposes;

*
d) Processes for modifying the genetic identity of animals
which may cause them suffering without any substantial
medical benefit to man or animal and also animals resulting
from such processes.

*
3 The following are also not patentable:

*
a) The human body, at the various stages of its formation and
development and the simple decoding of one of its elements,
including the discovery of a sequence or partial sequence of a
gene, without prejudice to (1)(c) of the following article;

*
b) Plant and animal varieties and essentially biological
processes for obtaining plants or animals;

*
c) Surgical or therapeutic methods for treating the human or
animal body and diagnostic methods used on the human or
animal body, though products, substances or compositions
used in any of these methods may be patented.

Article 53.º

*
*
(…)

*
C)
A new invention that involves an
inventive step and is susceptible of
industrial application relating to any
isolated element of the human body or
produced in any other way by a technical
process, including a sequence or partial
sequence of a gene, even though the
structure of this element is identical to
that of a natural element, provided that
the industrial application of a sequence
or partial sequence of a gene is expressly
observed and specifically described in the
patent application;

*
e) A biological material isolated from its
natural environment or produced on the
basis of a technical process, even if it
pre
-
exists in a natural state;

*
f) An invention relating to a
microbiological process or other technical
processes or products obtained by means
of these processes.

Article 54.º

*
*

Relaxin is a hormone
which relaxes the uterus
during childbirth.

*

Medical application
reducing the need for
caesarean deliveries in
difficult pregnancies.

*

It was first described
from pigs back in 1928.

*

Only in 1973 the chemical
structure of human form
of the hormone was
isolated and determined.



*

The subsequent research
revelead a second form of
human insulin.

*

The structure of human
relaxin was found to differ
from another species, such
that only human relaxin
could be used for the
medical purpose envisaged.

*
A patent was issued in
Europe in 1991 but opposed
in 1992 by members of the
Green Party in the European
Parliament

Challenge by the opponents

Response by the EPO Opposition

Division




The claimed invention was not novel, since the gene
encoding
relaxin

had always been present in the female
human body.





• There was no

inventive step
, because a conventional
method was used to isolate the DNA.






oelaxin

wa猠a mere

discovery
, and as such “no more
patentable than the moon or a new animal found in a
remote area.”







• The patent was contrary to

morality

or

ordre

public
;





• Isolating a gene from tissue taken from a pregnant
women wa猠an offen捥

to human dignity
, as it used the
pregnancy for a technical profit
-
oriented process;





• Patenting human genes "amounts to a form of modern
獬avery 獩n捥 it involve猠the di獭emberment of women
and their piecemeal sale to commercial enterprises;”





• Patenting human genes was tantamount to

patenting
human life
, and would as such be intrinsically immoral.




This gene sequence was itself novel, as it was in the form of
complementary DNA, which

does not exist in nature
. The
form of
relaxin

that it coded for was also unknown until the
inventor isolated it for the first time.



• As the inventor was providing to the public for the first time a
product whose existence was previously unknown, the
method used to obtain it was

immaterial
.



• A discovery of a substance freely occurring in nature was not
patentable; but if the substance was

newly
isolated
and
characterized, then it was not a mere discovery;

it was an
industrially applicable technical solution to a technical
problem.



• It would not be viewed by the public as too abhorrent to be
patentable.



• The tissue was donated with consent within the framework of
gynaecological

ope牡tions. Many life
-
saving substances we牥
isolated in this way, patented and welcomed by the public;



• Gene patents do not confer any rights over individual human
beings. There was no dismemberment of humans since the
point of the invention was to synthesize the hormone;



• "The patenting of a single human gene has nothing to do
with the patenting of human life. Even if every gene in the
human genome were cloned it would be impossible to
reconstitute a human being from the sum of its genes". No
moral distinction was seen between the patenting of genes
and the patenting of other important human substances, such
as adrenaline.