[Ip-health] Swedish National Council on Medical Ethics - on patents

[Martin Frid]

Dear IP friends,
The Swedish National Council on Medical Ethics today published a strongly w=
orded critique of DNA patents in the largest Swedish newspaper, Dagens Nyhe=
ter. Thanks Jamie for alerting me to this timely op-ed piece, that supports=
 our campaign against "life patents" and states that Sweden should strongly=
 oppose that an element of the human body may constitute a patentable inven=
tion. Below is the full text of the Council's opinion on Directive 98/44/EC=
 on the legal protection of biotechnical inventions, and its implementation=
 in Sweden.

Kind regards,
Martin Frid






The Swedish National Council on Medical Ethics

2002-02-25
Dnr 30/2001

The Department of Justice
SE-103 33 Stockholm
Sweden

Opinion on Directive 98/44/EC on the legal protection of biotechnical inven=
tions, and its implementation in Sweden.

The Swedish Department of Justice is proposing changes to the Swedish paten=
t law (1967:837) that would harmonize it with the Directive 98/44/EC of the=
 European Parliament and of the Council of 6 July 1998 on the legal protect=
ion of biotechnological inventions (in the following referred to as "the Di=
rective"). The proposal, like the Directive, has implications for health ca=
re and medical research, as well as for biotechnical research with applicat=
ions within the fields of agriculture and food production. The Swedish Nati=
onal Council on Medical Ethics, below referred to as "the Council", is prim=
arily concerned with issues that have bearing on health care and medicine. =
We will focus our critical discussion on the proposed implementation of Art=
icles 5 and 6 of the Directive (1 a =A7 and 1 b =A7).

The Council strongly opposes that the proposed changes be made to the Swedi=
sh patent law.

Patents may play an important role in stimulating research, innovations and=
 development. The possibility to protect biotechnological inventions throug=
h patenting is an integral part of the dynamic scientific and technological=
 advancements of our time. Likewise, international harmonization of patent =
regulations is of great importance.

However, it is equally important to make a clear demarcation against unacce=
ptable commercialisation and monopolization. The human body, and elements t=
hereof, should under no circumstances be patentable. Health care and ethica=
lly justifiable medical research must not be limited. A fundamental guiding=
 principle must be that innovations, not mere discoveries, can constitute p=
atentable inventions.

The proposed changes to the Swedish patent law constitute a near verbatim t=
ranslation of applicable parts of the Directive. Nonetheless, the Council s=
ees reason to put the law proposal into question on three grounds.

1. The Department of Justice claims that the Directive does not introduce a=
ny new demands on Sweden, but is essentially in agreement with what is stip=
ulated by current Swedish law, as well as with praxis developed by the Euro=
pean Patent Office (EPO). It is argued that the law changes are motivated m=
erely by a need for clarity in the regulatory framework. A completely diffe=
rent conclusion is as reasonable: if Swedish law and praxis are already in =
agreement with the Directive, there should be no need for additional adjust=
ments.

2. In its present from, the Directive itself is unacceptable. Article 5, pa=
ragraph 2 (1 a =A7 2 paragraph of the Swedish law proposal) is incompatible=
 with the important and fundamental principle which is laid down in the fir=
st paragraph of the same article: "The human body, at the various stages of=
 its formation and development, and the simple discovery of one of its elem=
ents, including the sequence or partial sequence of a gene, cannot constitu=
te patentable inventions".
Naturally, our criticism also has bearing on praxis currently developing in=
 the patenting domain. The Swedish Ministry of Justice maintains that there=
 is a "Nordic consensus" regarding the directive and its implications, but =
this is hardly the case. On the contrary, ethical bodies seem to agree that=
 there is an imminent need for a renewed discussion and renegotiation of th=
e Directive, particularly its Article 5, which refers to innovations that i=
nvolve the human body and its elements. We wish to remind the reader of the=
 very strong statements made independently by the French National Ethics Co=
mmittee (June 8, 2000), the Danish Ethical Council (November 15, 2001) as w=
ell as by the governments of the Netherlands, Italy and Norway in their app=
lication before the Court of the European Union for annulment of the Direct=
ive. We also wish to point to the Universal Declaration of the Human Genome=
 and Human Rights, adopted by UNESCO in 1997, which states that the human g=
enome, in a symbolic sense, is the heritage of humanity and that the human =
genome in its natural state shall not give rise to financial gains. Likewis=
e, we wish to consider three recommendations of the Parliament of the Counc=
il of Europe, 1425 (1999), 1468 (2000) and 1512 (2001), all of which critic=
ize the Directive.
Article 5, paragraph 2, of the Directive challenges fundamental ethical pri=
nciples, such as human dignity, integrity and justice. If elements isolated=
 from the human body are patentable, the genetic integrity of individuals m=
ay be violated. The Directive leaves the door open for broad patents, which=
 may lead to increased costs for medical and health services and put restri=
ctions on research.

3. A third and final objection concerns Article 6 of the Directive (1 b =A7=
 of the law proposal). With the good intent of defining certain ethical con=
straints, the formulation of the article is such that the lawmaker would de=
finitively disclaim some urgent research. Certain aspects of embryonic stem=
 cell research, e.g. somatic cell nuclear transfer or therapeutic cloning, =
would be branded as contrary to ordre public and morality. This is an area =
where great progress has been made in the very recent years, pointing in pr=
omising directions that were completely unknown when the Directive was form=
ulated. In this respect, the law proposal is in opposition to opinions expr=
essed by the Swedish Research Council and by the Swedish National Council o=
n Medical Ethics. It is also in opposition to a joint statement by the Swed=
ish Minister of Health and Social Affairs and the Minister of Education (pu=
blished in the daily newspaper Dagens Nyheter on January 29, 2002). In its =
statement of opinion, the Swedish National Council on Medical Ethics has po=
inted out some questions that e.g. nuclear transfer give rise to, and that =
need further investigation and ethical analysis. However, the Council firml=
y opposes that such research a priori would be considered contrary to ordre=
 public and morality.

In conclusion, the Swedish National Council on Medical Ethics holds
- that the proposed changes to the Swedish patent law, corresponding to    =
  Articles 5 and 6 of the Directive, should be rejected
- that Sweden should strongly oppose that an element of the human body,    =
even if it has been isolated, may constitute a patentable invention
- that, consequently, Sweden should work actively for a renegotiation of th=
e   Directive 98/44/EC of the European Parliament and of the Council of 6 J=
uly  1998 on the legal protection of biotechnological inventions.


The law proposal from the Swedish Department of Justice was considered by t=
he Council during its regular meetings on December 7, 2001 and January 24-2=
5, 2002. A decision to leave the present statement of opinion was made per =
capsulam, and was unanimous.


On behalf of the Swedish National Council on Medical Ethics,


Daniel Tarschys
Chairman

Ann-Charlotte Smedler
Council Secretary, Ex officio