The human genetic code has received a great deal of attention since gene technology as a science emerged from Watson's and Crick's discovery of the structure of the DNA molecule (for which they received the 1962 Nobel Prize). Today, researchers have in principle mapped the entire set of human genes. Many expect that an increasing number of applications of this new knowledge will bring a revolution within, for example, medicine and plant development. With gene technology's rapid growth - and increasingly bold predictions concerning what can be accomplished with its help in the near future - a number of ethical issues have also appeared, concerning things such as ownership or patentability of genes and what gene technology means for people's private lives and integrity.
What is gene technology?
Gene technology is primarily a technology for mapping genes - humans' genetic makeup. Genes consist of a certain sequence of nucleotides (A, G, T, or C). Using this knowledge, we can further analyze hereditary diseases, change an organism's genetic makeup so that its characteristics are changed, and perform gene therapy (correcting or exchanging pathogenic genes in an individual). Another application of this knowledge is the possibility to match medicines directly to an individual's genome, his/her specific set of genes. For example, if 5% of a population does not react to a medicine it may be possible to find a gene common to this group that explains this, which can lead to the development of an effective treatment. In short, gene technology in the broadest sense entails using knowledge about the human genetic makeup and its functions to solve problems or manufacture products. In this wider conception, biotechnology concerns using qualities of cells or their parts in a technical context (SOU 2000:103). Biotechnology have a long succession of applications, e.g. computer technology, chemistry, materials development and the judicial system. This is a development of which we have yet only seen the beginning.
The fundamental regulations concerning genetically modified organisms can be found in Chapters 13 and 14 of the he Swedish Environmental Code, which replaced the previous gene technology law. Ordinance 2000:271 on the contained use of genetically modified organisms provides detailed regulations regarding application. These regulations rest on the EU directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and 2009/41/EEC on the contained use of genetically modified micro-organisms. In Sweden, Arbetarskyddsstyrelsen (the National Board of Occupational Safety and Health - now Arbetsmiljöverket, the Swedish Work Environment Authority) has also published corresponding regulations (AFS 2011:02). Kemikalieinspektionen (the Swedish Chemicals Inspectorate) has issued regulations on chemical products and biotechnical organisms. Additionally, there are The Swedish Agency for Marine and Water Management's regulations on genetically modified aquatic organisms (FIFS 2004:2).
In Sweden, the government authority the Gene Technology Advisory Board has the tasks of following national and international development in the area of gene technology, monitoring ethical questions and, via its advisory position, promoting an ethically defensible and secure use of gene technology so that people's and animals' health and environment are protected. The board notifies the government if a field of application or planned use of gene technology is questionable from an ethical or humanitarian viewpoint.
Experiments on humans are regulated foremost by the The Genetic Integrity Act (SFS 2006:351), the main idea of which is that experiments on fertilized eggs are allowed during the first 14 days after fertilization. The eggs must then be destroyed. Most countries, including Sweden, (through laws or moratoria) do not allow research involving gamete therapy (by which the cells’ altered character would be inherited by future generations).
There has surfaced strong apprehension that the new gene technology can, for example, trespass on people's right to integrity and a private life, or be discriminatory. Not least worrisome are what have been seen as threats regarding genetically improved humans and cloning. Such issues have brought about a number of documents. The year 1997 saw the publication of the Council of Europe's Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine, which was supplemented with a protocol concerning the Prohibition of Cloning Human Beings. In 2004, the Article 29 Working Party has developed a Working document on Genetic Data. The Council of Europe's Parliamentary Assembly published Order No. 534 (1997) on research and the cloning of human beings and in Recommendation 1468 (2000) they call for more care and suggest that the EU renegotiate many of its fundamental texts. Recommendation 1512 (2001) again addresses the protection of the human genome, while Resolution 1352 discusses research on human stem cells.
The European Commission has developed 25 recommendations on the ethical, legal, and social implications of genetic testing (2004). There is a statement from the European Group on Ethics in Science and New Technologies (EGE): Ethical Aspects of Human Stem Cell Research and Use. The European Parliament created a resolution against human cloning 15 January 1998. Due to Great Britain's proposal to allow 'therapeutical cloning' (cloning with a medical aim other than reproduction), the Parliament again presented a strongly critical resolution on human cloning. In practice, the European Union has adopted a rather restrictive position. European scientists have had a voluntary moratorium on human reproductive cloning since 1999, through their organisation The European Society of Human Reproduction and Embryology (ESHRE).
For its part, the United Nations presented a declaration on the human genome and human rights, which was further developed into UNESCO's Declaration on the Human Genome and Human Rights of 11 November 1997.
The Council for International Organizations of Medical Sciences (CIOMS) has authored The Declaration of Inuyama on Human Genome Mapping, Genetic Screening and Gene Therapy. The World Medical Association (WMA) published a Statement on In-Vitro Fertilization and Embryo Transplantation. They have also taken a stand on Genetics and Medicine. The Human Genome Organisation (HUGO) has its own ethics committee that, in addition to a Statement on Cloning, has written a Statement on the Principled Conduct of Genetics Research. They have also issued a Statement on Benefit-Sharing and a Statement on Human Genomic Databases.
Lately new techniques like CRISPR have caused concerns, as they enable gene editing with great precision. In an international meeting the following view was adopted: On Human Gene Editing: International Summit Statement.
The international Biotechnology Industry Organization (BIO) has formulated policy documents and recommendations on issues such as genetic discrimination, integrity, cloning and genetic testing. The corresponding European organisation, Europabio, also has core ethical values as well as a collection of various position papers. The European Society of Human Genetics has a number of policy documents on genetics. International Society of Nurses in Genetics has published various position statements. An initiative is The Budapest Meeting 2005: Intensified Networking on Ethics of Science - The Case of Reproductive Cloning, Germline Gene Therapy and Human Dignity. Finally, we can mention that the Indigenous Peoples Council on Biocolonialism has contributed the Ukupseni Declaration (as well as a number of similar initiatives; see here for a list), which expresses strong criticism of attempts to map differences between different populations' genomes. Regarding this isse, see also the article The ethics of characterizing difference: guiding principles on using racial categories in human genetics.
For specific questions about, for example, biobanks or stem cell research, see the pages elsewhere in CODEX on those topics. Another debated question concerns xenotransplantation. Research involving such work is allowed in Sweden. WHO has issued recommendations concerning xenotransplantation. The Council of Europe's Committee of Ministers has issued its Recommendation No. (2003) 10 on xenotransplantation.
Last updated: 2016-03-29