Country Focus
Biotechnology in Sweden
The biotech scene in Sweden can consider itself lucky: Great Britain aside, no other country has such a liberal attitude towards scientists. A swirling debate about stem cell research, as experienced in Germany, is simply not conceivable in Sweden. Largely owing to these basic conditions, the majority of Swedish biotech companies concentrate on medical applications, which are developed for the market with the assistance of outstanding research facilities. Nevertheless, fresh capital is increasingly hard to find in this small northern country. This is particularly true for companies in early development phases, for whom almost no investors are forthcoming. Tax breaks for research-intensive companies have therefore been demanded for some time. Many have been alarmed by the example set by Cellartis: The stem cell lines manufacturer recently shifted its production location from Sweden to Scotland. And why? For tax purposes.
Legal Foundations
Sweden is generally open to the development of biotechnology. This is reflected in a general acceptance of stem cell and embryonic stem cell research and, since April 2005, permission to carry out therapeutic cloning. Swedish legislation regarding research into human embryonic stem cells is among the most liberal in the world. Thereby, Sweden is in accordance with the In-vitro Fertilisation Law NR.115 on surplus embryos from 14 March 1991, which permits research using human embryonic stem cells from so-called surplus embryos. However, these embryos must be destroyed 14 days after production and may not be implanted into the uterus. Donor consent is also required.
Embryonale Stammzellen werden aus einer Blastozyste gewonnenSource: Advanced Cell Technology, Inc.
Sweden's Gene Technology Advisory Board began work on 1 June 1994. This ethics commission is occupied with the effects on the environment and health of gene-technological applications as well as providing ethical guidance on new developments in the area. These ethical guidelines were emphasised in January 2004 by a law that specifies the observance of human dignity as a precondition of approval for stem cell research projects. In May 2007, the Central Office of Health and Social Welfare caused some animation In Sweden with the decision to permit, for the first time, the use of genetic tests during in-vitrofertilisation in three specific cases. These tests were aimed at the selection of a ' suitable ' embryo, which would be later available to family members for the transplantation of stem cells. This decision was made possible by change in the law that became effective just over a year ago and which makes it generally possible to use targetedly selected, artificially fertilised embryos. Nevertheless, in the future, every new case will be examined individually as to whether alternative possibilities remain for the treatment of the serious disease in question.
The Laekemedelsverket, the Swedish Medical Products Agency (MPA), is responsible for the approval of medical and/or pharmaceutical products, as well as the supervision of clinical studies. The MPA is one of the most established medicines authorities in the European Union.
Agrobiotech: Laws on coexistence regulations required
Genetically modified organisms (GMO) are permitted in Sweden; conforming to European Union regulations, foods that contain GMO must be clearly labelled. The Central Food Office is working on the development of a control system to examine compliance. However, the appropriate laboratory analyses are not yet available. The cultivation of genetically modified (GM) plants is legally permitted in all European Union countries and thus also in Sweden. The new European legal framework, which regulates the approval of GM-plants, fodder and foodstuffs, has EU-wide authority. Sweden has begun the legislative processes that regulate the cultivation of GM-plants and compiled a draft of coexistence rules, whereby a distance of 15-150 meters for GM maize and two meters for GM potatoes is stipulated. Handling of the genetically modified organisms is regulated by the Swedish Environmental Code; practical use and supervision is divided among various authorities, depending upon the area of application as well as the end utilisation. Thus, for example, the use of GM-fish is dealt with by the National Board of Fisheries and the approval of GM-wood is supervised by the National Board of Forestry. In 2004, a genetically modified, particularly starch-rich potato for use in the Swedish paper industry and which is intended to improve paper quality, was approved for scientific field tests in Sweden. Commercial cultivation is planned for 2007. So far, no confirmed data are available on GM commercial cultivation locations in Sweden. According to press reports, the Central Office for Agriculture, which approves the cultivation of GM-plants, is planning to permit the test cultivation GM-rapeseed, a controversial topic in Sweden, as of 2010.
2004 saw the first hesitant steps towards the iIntroduction of GM food products to Sweden. As New Scientist magazine reported that year, the first GM-beer hit the shelves in a test run of consumer attitude. The specially brewed beer contained fifteen percent GM maize, which had been grown in Germany, replacing ordinary barley. The beer, named "Kenth", was the first GM food product on the Swedish market and was developed together with "Bioteknikcentrum", a PR agency, to test the Swedish market for GM foods. In May 2007, a study was published in Nature Biotechnology, in which consumer behaviour in Sweden, among other countries, was examined when shoppers were given a choice between conventional, organic and GM fruit. The picture that emerged was that 43% of the observed Swedes were open to GM-food, if these were also clearly cheaper (-15%) and offered some other consumer advantage (e.g. "no pesticides").