Opinion on Directive 98/44/EG on the legal protection of biotechnical inventions and its implementation in Sweden

Swedish National Council on Medical Ethics
Date: 2002-02-25

The Department of Justice
SE-103 33 Stockholm

Opinion on Directive 98/44/EC on the legal protection of biotechnical inventions and its implementation in Sweden.

The Swedish Department of Justice is proposing changes to the Swedish patent 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 protection of biotechnological inventions (in the following referred to as “the Directive”). The proposal, like the Directive, has implications for health care and medical research, as well as for biotechnical research with applications within the fields of agriculture and food production. The Swedish National Council on Medical Ethics, below referred to as ”the Council”, is primarily concerned with issues that have bearing on health care and medicine. We will focus our critical discussion on the proposed implementation of Articles 5 and 6 of the Directive (1 a § and 1 b §).

The Council strongly opposes that the proposed changes be made to the Swedish patent law.

Patents may play an important role in stimulating research, innovations and development. The possibility to protect biotechnological inventions through 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 unacceptable commercialisation and monopolization. The human body, and elements thereof, should under no circumstances be patentable. Health care and ethically justifiable medical research must not be limited. A fundamental guiding principle must be that innovations, not mere discoveries, can constitute patentable inventions.

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

1. The Department of Justice claims that the Directive does not introduce any new demands on Sweden, but is essentially in agreement with what is stipulated by current Swedish law, as well as with praxis developed by the European Patent Office (EPO). It is argued that the law changes are motivated merely by a need for clarity in the regulatory framework. A completely different conclusion is as reasonable: if Swedish law and praxis are already in agreement with the Directive, there should be no need for additional adjustments.

2. In its present from, the Directive itself is unacceptable. Article 5, paragraph 2 (1 a § 2 paragraph of the Swedish law proposal) is incompatible with the important and fundamental principle which is laid down in the first 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 elements, including the sequence or partial sequence of a gene, cannot constitute 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 the Directive, particularly its Article 5, which refers to innovations that involve the human body and its elements. We wish to remind the reader of the very strong statements made independently by the French National Ethics Committee (June 8, 2000), the Danish Ethical Council (November 15, 2001) as well as by the governments of the Netherlands, Italy and Norway in their application before the Court of the European Union for annulment of the Directive. 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 genome, 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. Likewise, we wish to consider three recommendations of the Parliament of the Council of Europe, 1425 (1999), 1468 (2000) and 1512 (2001), all of which criticize the Directive.
Article 5, paragraph 2, of the Directive challenges fundamental ethical principles, such as human dignity, integrity and justice. If elements isolated from the human body are patentable, the genetic integrity of individuals may be violated. The Directive leaves the door open for broad patents, which may lead to increased costs for medical and health services and put restrictions on research.

3. A third and final objection concerns Article 6 of the Directive (1 b § of the law proposal). With the good intent of defining certain ethical constraints, the formulation of the article is such that the lawmaker would definitively 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 promising directions that were completely unknown when the Directive was formulated. In this respect, the law proposal is in opposition to opinions expressed by the Swedish Research Council and by the Swedish National Council on Medical Ethics. It is also in opposition to a joint statement by the Swedish Minister of Health and Social Affairs and the Minister of Education (published in the daily newspaper Dagens Nyheter on January 29, 2002). In its statement of opinion, the Swedish National Council on Medical Ethics has pointed out some questions that e.g. nuclear transfer give rise to, and that need further investigation and ethical analysis. However, the Council firmly 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 the Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.

The law proposal from the Swedish Department of Justice was considered by the Council during its regular meetings on December 7, 2001 and January 24-25, 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

Ann-Charlotte Smedler
Council Secretary, Ex officio