Market Information
Europe

Biotechnology Sector Profile: Sweden

May 2002

Christian Ekström
Business Development Officer
Canadian Embassy
PO Box 16129
SE-10323 Stockholm, Sweden
Tel.: (011-46) 8453-3022
Fax: (011-46) 8453-3016
E-mail: christian.ekstrom@dfait-maeci.gc.ca
Internet: http://www.canadaemb.se 

Market Overview

A fast and internationally respected registration procedure for medicinal products assists this growing industry, which has innovative startups generated from Astra and Pharmacia. There is easy access to seed and venture capital, and a large number of unique patient databases (e.g. the world-famous twin database), as well as high patient compliance. This market includes world-class researchers and health professionals, as evidenced by the number of scientific publications (which are globally ranked the highest, given the per capita). There is a clear regulatory framework, and a good environment for Contract Research Organizations (CROs) and clinical research. For these reasons, Sweden ranked first in the world for per-capita investment in research and development (R&D).

Sweden has access to many large markets: the EU (with 370 million), the Baltic (with 100 million) and Scandinavia (with 25 million). Now, Swedish companies are seeking partners to explore the North American market.

Opportunities

There are opportunities for Canadian companies looking for knowledge and technology transfer, biotechnology joint ventures, research and clinical trials, particularly in telemedicine and e-health, cancer research, genomics/proteomics, allergology, molecular endocrinology and metabolism, neuro-degenerative diseases and cell signaling, physiology and bio-informatics.

Opportunities are also available for sales, distribution and licensing of other innovative Canadian biomedical products.

Market Access Considerations

For the marketing of medical products and the distribution of pharmaceutical and natural remedies, a local partner or distributor is essential. Although the majority of Swedes speak fluent English, product labelling must be in Swedish. Also, all medical devices and diagnostic products intended for use by human patients must carry a CE mark before being marketed or sold in Sweden. As in other European countries, there is a very strong bias in Sweden against genetically modified organisms (GMOs).

Major Competition

As is the case in Canada, Swedish biotechnology firms work in complex collaborative networks with both academia and industry, and Swedish biotechnology companies may have greater and easier access to this network than their foreign counterparts.

There has been an abundance of biotechnology spinoffs over the past five years as a result of Astra and Pharmacia mergers with Zeneca and Upjohn respectively.

Unlike in Canada, discoveries made by a researcher while employed by a company remain the property of the researcher, not the company. This is true even if the discovery is made in company labs and on company time.

Other Useful Information Sources/Web Sites

Pharmaceutical

Medical Products Agency: http://www3.mpa.se/nn_engindex.html
(Läkemedelverket-The Swedish MPA, equivalent to the FDA in North America, is one of the most highly respected and fastest pharmaceutical regulatory bodies in the world.)

Swedish Association of the Pharmaceutical Industry: http://www.lif.se/info/English/english.asp
(Facts on the Swedish pharmaceutical industry, including rules governing drug information in Sweden. English pages.)

Swedish Association for Small and Medium-sized Pharmaceutical Companies 
(20 companies, all active internationally): http://www.iml.nu 

Kronans Droghandel (KD): http://www.kronans-droghandel.se/English/kdgroup/index.htm
(A comprehensive logistics company that supplies the Scandinavian health-care and medical markets with distributive and logistical services)

Medical Devices

Medical Devices-CE-Marking (comprehensive information about regulations and procedures in English): http://www.sos.se/sose/nt/medtekn/cemark.htm 

In Vitro Diagnostic Devices-CE Marking : http://www.sos.se/NT/Medtekn/invitro/newleg.htm
(New legislation for CE marking of in vitro diagnostic devices commencing 2003, as well as current regulations. English pages.)

Natural Remedies : http://www.mpa.se
(On July 1, 1993, a new drug law came into force in Sweden. Natural remedies must now be approved by the Medical Products Agency before sale. A permit from the Agency is also required for the production or wholesale trade of natural remedies. The requirements for documentation of the quality of natural remedies are as rigorous as for regular medicinal products. Requirements for safety and efficacy are, on the other hand, usually lower. Applications for approval of natural remedies must be made by those who wish to sell these products in Sweden. Applicants who are not located within the EU or European Economic Area (EEA) area must engage a local agent.) 

Chemicals

National Chemicals Inspectorate: http://www.kemi.se/default_eng.htm
(Kemikalieinspektionen-information about classification and labelling, legislation and product registers)