[Ip-health] E.C. on: Ethical aspects of patenting inventions involving human stem cells

Tue Apr 10 04:21:04 2007

This 2002 opinion by the E.C. Europe Group on Ethic's addressed
larger issues of patents on stem cells, but it's statements on
patents and access to health care have broader implications.

*  2.9. PATENTS AND ACCESS TO HEALTH CARE
The patent creates a control regarding commercial use. This raises
questions as to the uses which are covered by the patent. To secure
that patent holders do not misuse their rights for example by
charging unreasonable fees for the use of their inventions, EGE finds
that the recourse to compulsory licence should be encouraged when the
access to diagnosis and treatment is blocked by misuse of patent
rights. The EGE stresses the fact that it is the responsibility of
the states to establish legal procedure for the delivery of
compulsory licence and to examine if fair access to health care
justifies such a procedure.

[Note the broad application of this statement, which is not limited
to particular diseases or health problems.  jl].

http://ec.europa.eu/european_group_ethics/publications/docs/
avis16_complet_en.pdf

The Text of the Opinion No 16
ETHICAL ASPECTS OF PATENTING INVENTIONS INVOLVING HUMAN STEM CELLS
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D
Delivered by the European Group on Ethics
In Science and New Technologies
To the European Commission
On 7 May 2002

Reference: Request by the European Commission on 18th October 2000
Rapporteurs: Linda Nielsen and Peter Whittaker
************************************************************************
*****************************************************
The European Group on Ethics in Science and New Technologies (EGE),

2. OPINION
2.1. SCOPE OF THE OPINION

According to the 1998 EU Directive on the Legal Protection of
Biotechnological Inventions article 7: =AB EGE evaluates all ethical
aspects of biotechnology =BB.

The Group has, in its Opinion No. 15 of 14th November 2000 on the
ethical implications of human stem cell research and its uses, made
recommendations, namely:

- to set up a strict public control by centralised authorities, on
human embryo research where it is allowed;

- to take measures to prevent commercialisation of human embryos or
cadaveric foetal tissue;

- to ensure the respect of ethical principles through the control of
public authorities, concerning import of human stem cells, where
allowed.

This present opinion deals with the specific ethical questions
related to patenting of inventions involving human stem cells. The
Group is aware of the fact that patents also involve many difficult
and different questions of an economic and political nature, which
may influence the way of dealing with patents, but has seen its task
as providing an ethical focus on the question. The rapid development
of biotechnology, especially the promise of stem cell research, makes
it appropriate to consider and clarify some questions which could not
have been taken into account when the 1998 EU Directive was drafted,
given the state of the art at that time.

One option would have been to forbid patenting of stem cells or stem
cell lines. The consequence of such an option would be the major
slowing of this research field (except in case of a very unlikely
large public investment), and the EGE opinion is that it would be
contrary to public (and especially patients=92) interests. Moreover,
the Group considers that it would be contrary to the EU choices as
expressed by the 1998 EU Directive on patenting. The Group finds that
it is crucial to define the conditions required to patent, the limits
of the patenting of human stem cells in relation to ethical
considerations and the relevant processes securing ethical evaluation.

2.2. THE BASIC ETHICAL DILEMMA
EGE recognises the importance of patents as an incentive to
innovation and as a reward to the inventor for openness and
publishing the results.

One ethical dilemma arises due to the fact that patents can encourage
scientific progress which can be used to the benefit of better health
care, and at the same time, patents can also impair access to the
health care due to the need of a licence to use them and to the fees
that will have to be paid to the patent holder.

It is then necessary to secure the right balance between the
inventor=92s interests and the society=92s interest =96 in the sense that
one task for the community is to secure ethical principles and values
in the context of possible conflicting interests of stake-holders,
namely: patients and patients=92 associations, inventors and other
researchers, donors, industry, investors, healthcare providers, and
social insurance providers.

In order to be able to specify ethical limitations, a number of
problems are to be considered, including:

- content of patents (process or product);
- various sources of stem cells;
- methods used to derive stem cells;
- protection of the donor;
- possible socio-economic consequences and philosophical implications
of the patent system as applied to stem cells (further research,
access to health care).

2.7. PATENTS AND FURTHER RESEARCH AND DEVELOPMENT
Although the appreciation of the patentability of an invention in
biotechnology as in other fields is a matter of a case by case
evaluation by a patent office and eventually by a court, the
Group again insists on the necessity to avoid the granting of too
broad patents that would impair further research and development.

In the new area of stem cell research, the potential use is hoped to
expand over time and stem cell lines may provide very important
research tools. In addition to the academic exemption, it is
essential to secure that patents on stem cell lines are not too
broad, as this may have adverse effects on the aim to support further
innovation to the benefit of health care.

It is therefore the opinion of EGE that patents shall only be
granted, when the patent claim refers to a specific and a
sufficiently accurately described stem cell line and its industrial
application. That involves a consistent relationship between a patent
claim and the description of the invention.

2.9. PATENTS AND ACCESS TO HEALTH CARE

The patent creates a control regarding commercial use. This raises
questions as to the uses which are covered by the patent.

To secure that patent holders do not misuse their rights for example
by charging unreasonable fees for the use of their inventions, EGE
finds that the recourse to compulsory licence should be encouraged
when the access to diagnosis and treatment is blocked by misuse of
patent rights.

The EGE stresses the fact that it is the responsibility of the states
to establish legal procedure for the delivery of compulsory licence
and to examine if fair access to health care justifies such a procedure.

----------------------------------------------
James Packard Love
Knowledge Ecology International
http://www.keionline.org
james.love@keionline.org
Washington, DC +1.202.332.2670

"If everyone thinks the same: No one thinks." Bill Walton"