Market Information
Europe

The Biotechnology Market
in Germany

April 2002

Prepared by the Market Research Centre and the Canadian Trade Commissioner Service

© Department of Foreign Affairs and International Trade
(FaxLink no. 42578)

Report prepared by the Market Research Centre
Market Support Division (TCM)
Department of Foreign Affairs and International Trade
125 Sussex Drive, Ottawa K1A 0G2
Fax: (613) 943-1103
E-mail: mrc@dfait-maeci.gc.ca

The Market Research Centre produces a wide range of market reports by region and sector for Canadian exporters. These reports are available from:
- DFAIT's InfoExport Internet site (http://www.infoexport.gc.ca).

The Government of Canada has prepared this report based on primary and secondary sources of information. Readers should take note that the Government of Canada does not guarantee the accuracy of any of the information contained in this report, nor does it necessarily endorse the organizations listed herein. Readers should independently verify the accuracy and reliability of the information.

EXECUTIVE SUMMARY

As a result of government support at all levels and strong research institutions, the biotechnology industry in Germany is doubling in size every 18 months. Germany's biotechnology sector is the second largest in Europe, following the United Kingdom. There are approximately 1300 companies (600 of which can be considered "core" biotechnology companies); by 2005, the number of core companies is predicted to grow to 700. Seventy-five percent of all companies are involved in human health and therapeutic applications.

Germany's drive to lead Europe in the biotechnology industry began in earnest in 1995 with the creation of BioRegio, a competitive research and development initiative for the private sector. BioRegio projects have been enormously successful, attracting additional venture capital funding and spawning the establishment of regional offices and support programs to encourage further growth in the industry. Further programs have been added to assist in the development of the biotechnology industry in Germany.

Germany's biotech industry has developed in clusters, built around centres of research excellence. The German biotechnology industry is maturing with an increasing number of products ready for commercialization. The industry is undergoing a consolidation phase with mergers and collaborations. Simultaneously, the availability of seed capital from government funding programs is continuing to fuel the number of startups. The strength of the German biotechnology industry is research. Strong research and academic institutions support biotechnology in areas including genomics, agricultural biotechnology, environmental applications and medical research.

The industry is still in a strong growth phase accompanied by the consolidation of the smaller firms. This offers significant opportunities for strategic alliances between Canadian and German firms. 

TABLE OF CONTENTS

EXECUTIVE SUMMARY

MARKET OVERVIEW

Key Factors Shaping Market Growth
Opportunities
Actual and Planned Projects

COMPETITIVE ENVIRONMENT

Local Capabilities
International Competition
Canadian Position
Competitive Advantage through Canadian Government Policies and Initiatives

MARKET LOGISTICS

Suggested Business Practices
Import Regulations
Intellectual Property Protection
Local Standards, Certificates or Registrations 

PROMOTIONAL EVENTS

KEY CONTACTS AND SUPPORT SERVICES

BIBLIOGRAPHY

OTHER REFERENCE MATERIAL

Useful Internet Sites

MARKET OVERVIEW

The German federal government began its support for biotechnology in the mid-1970s with the creation of the German Research Center for Biotechnology Ltd. (Gesellschaft für Biotechnologische Forschung mbH [GBF])¹. The government renewed its commitment by creating Biotechnology 2000, a national program designed to encourage research and development, as well as commercialization of results. In 1993, the government amended the Genetic Engineering Act (Gentechnikgesetz) to liberalize Germany's legal framework around biotechnology and genetic engineering. The amendments improved the application requirements for biotechnology companies, thereby encouraging research, international co-operation, and an increase in venture capital funding. These amendments also stemmed the growing number of scientists, production facilities, and research funding from leaving Germany.

The industry was valued at an estimated $6 billion² in 2000 and is expected to grow to $12 billion by 2005. There are approximately 1,300 biotechnology companies in Germany (600 of which can be considered "core" biotechnology companies). Of these, 75% work in the biopharmaceutical industry while the remainder work in agricultural and environmental biotechnology.

The strength of the German biotechnology industry is research. Corporate research and development expenditure in the pharmaceutical sector alone was $4.25 billion in 2000. The federal budget for the Ministry for Education and Research (BMBF) allocated to biotechnology is approximately $1.1 billion, spread over five years (2001-2005) for all programs. The federal programs cover all areas of gene research and biotechnology, with an emphasis on health-care and environmental research. The country has a strong research and academic community, including a highly skilled and educated workforce to support world-renowned institutions. As is characteristic of the industry worldwide, the biotechnology industry in Germany has developed in clusters, built around centres of research excellence.

The biotechnology sector in Germany is both growing and consolidating. It is approaching the United Kingdom in terms of size and number of companies, with an increasing number of products ready for commercialization. The German industry is experiencing mergers and collaboration typical of a maturing biotechnology sector. Germany has a increasing number of management teams prepared to make the switch from traditional pharmaceutical products to the promising future of biopharmaceuticals. This alone may help Germany grow beyond the United Kingdom in industry size. The German government is a strong supporter of biotechnology. The Federal Ministry for Education and Research (BMBF), Robert Koch Institute-Central Committee for Biological Safety, Federal Environment Ministry, and the Federal Ministry Consumer Protection, Food and Agriculture (BML) are particularly concerned with bio-industries and support various research institutions across the country. Regional governments, as well, look to this sector as one for potential long-term growth and high-technology employment. Federal and state governments support biotechnology through direct funding, investment incentives and the creation of research centres of excellence. The federal and state governments are advised on biological safety issues by the Central Biological Safety Commission (ZKBS).

Medical Biotechnology

Biopharmaceuticals are the most significant sector of the German biotechnology market. However, the distinction between traditional pharmaceutical firms and those which employ biotechnology in the development of medical products is difficult to establish. As the science behind biotechnology develops, many traditional pharmaceutical companies are turning their attention to the potential of biopharmaceuticals in both product development and manufacturing technologies. The pharmaceutical market in Germany is one of the world's largest and was valued at $57 billion in 2001. There are approximately 1100 pharmaceutical companies in the market, 45% of which are small to medium-sized enterprises. There are as many as 40 multinational firms active in this sector. Key players include Aventis Pharma AG, Bayer AG, Abbott Laboratories, Merck Group, Schering AG, and Boehringer Ingleheim GmbH. In other markets, and increasingly in Germany as the industry matures, the biotechnology industry is characterized by mergers and partnerships. Instead of investing the millions of dollars required to take a product through testing, clinical trials and to market, smaller firms typically develop drug compounds and then sell the rights to the compound, or license the technology to a larger firm for further development. In this way, large biopharmaceutical firms are able to keep a number of products in the research pipeline without supporting extensive drug discovery departments.  

There were 50 genetically engineered pharmaceuticals available in Germany in 1999, and four more received marketing authorization in 2000. These biopharmaceuticals represent approximately $1.6 billion in sales. The Association of Research-Based  Pharmaceutical Companies estimates that one in four drugs currently in clinical trials in Germany is based on gene technology. The focal point for gene therapy work in Germany is the German Treatment and Research Centre for Gene Therapy of Tumors (Deutsches Behandlungs und Forschungszentrum zur Gentherapie von Tumoren), located at the Free University of Berlin and established in 1995. Germany also began work on the human genome project in 1995. As well, almost 30% of the $582 million German diagnostics market consists of products based on biotechnology processes.

The German bio-medical industry has proven research strength, but must focus more on product development if it is to continue to compete with other industries. For example, there are only six biotechnology-based drugs undergoing clinical trials among all of Germany's publically traded companies, while in the United Kingdom almost 130 drugs are in the trial process. In response to the need for larger product pipelines, companies are working to develop non-patent genetic drugs and are seeking partnerships and alliances. Analysts suggest that generics occupied just over 50% of all prescriptions covered by the statutory health insurance program in 1999.  

German law banned all genetic research on embryos in 1990, but did not deal directly with the issue of stem cell research or lay any legal framework for the importation of human embryonic stem cells for research purposes. In January 2002, a motion was passed that restricts the import of human embryonic stem cells to existing stem cell lines which were established prior to the passing of the motion. The cut-off date ensured that, for the purpose of importing human embryonic stem cells to Germany, the killing of further embryos for the production of stem cells would be avoided. This motion reflects the original intention of the Embryo Protection Act: To prevent the killing of embryos for research purposes.

Agricultural Biotechnology

The agricultural biotechnology market in Germany was valued at $9 million in 1998 and is expected to grow to $36 million by 2005. While no genetically altered agriculture products have been approved for commercial production in Germany, there is a large research community working particularly in plant genetics and crop improvement.

In 1989 and 1990, the Max Planck Institute for Cultivation Research (MPIZ) performed the first field tests in Germany of genetically altered plants (specifically, petunias). Since that time, the institute has grown to over 350 research personnel throughout four departments. MPIZ is a member of Bio-Gen-Tec-NRW association. The University of Hamburg has conducted field trials of genetically modified (GM) canola on the island of Poel since 1995. At this and other sites throughout Germany, protesters have attempted to destroy test crops of genetically altered foods, with limited success.

In 1994, Canada exported almost $500 million in canola seed to the European Union. The market for this product, of which 60-70% is GM, has collapsed in recent years  because Canadian producers do not segregate their crops. Until the European Union becomes more receptive to products of biotechnology, or Canadian producers segregate organic from genetically altered seed, the market will remain closed.

Key Factors Shaping Market Growth

European Union

In April 1998, the European Union stopped approving GM products in response to public concerns. The 11 products approved prior to the moratorium have not been marketed and 13 others were suspended in the approval process. In June 1999, EU environment ministers agreed not to approve any GM product until a new approval and monitoring system was put into place. The new set of regulations, outlined in 2001, includes labelling and traceability requirements, a mandatory review of all genetically modified organisms (GMOs) after 10 years, tighter safety regulations, and an increased role for an ethics committee in the decision-making process.

The moratorium is expected to be lifted throughout the European Union in October 2002 in order to avoid a trade dispute with the United States. However, analysts expect that an agreement on the new approval system may take even longer to achieve, given the variety of opinion within the European Union on the various issues surrounding GM food. All 15 member states must ratify the new directives prior to the ban being removed in practice.

Of particular interest to Canadian export firms are the labelling standards and traceability requirements currently being discussed. The proposal is for complete transparency for the consumer and the ability to trace every GMO back to the farm on which it was grown. Canadian firms interested in direct export of GM food products to Germany should keep abreast of developments in these areas. 

Germany

Most biotechnology companies in Germany work in the area of bio-medical technology rather than agricultural and environmental biotechnology. Analysts predict that agricultural biotechnology companies may experience difficulty obtaining federal research grants, particularly if the government in power has strong opposition to genetically modified organisms.

A true test of the strength of the industry will come in two to three years as more products reach the end of their trials and seek marketing approval. Current debate within the World Trade Organization and the European Union over genetically altered foods will also affect the German industry.

Academic institutions support biotechnology research in areas including genomics, agricultural biotechnology, environmental applications, and medical research. All levels of government in Germany provide funding to these research centres to support industry growth. Key institutes include:

• Hermann von Helmholtz Association of National Research Centres (HGF):

The 16 HGF pursue long-term governmental research goals with a concentration of financial and staff resources, and a sophisticated scientific and technical infrastructure. The Helmholtz centres perform scientific and technical as well as biological and medical research and development. The centres receive 90% of their basic funding from the federal government and 10% from the respective host state. They have a total budget of about $3.3 billion and a staff of roughly 22 000. HGF has established its own technology transfer office to make research results available to medium-sized enterprises.

• National Research Centre for Biotechnology Ltd. (GBF).

GBF is a national research institute for biotechnology, funded with the support of BMBF and the State of Lower Saxony. Research interests include gene function and genome analysis; infection and immunity; bioactive compounds and disease targets; and environmental biotechnology. GBF, which is one of the 16 Helmholtz laboratories, has about 450 research staff and an annual budget of approximately $62 million. It has established links with Canada's National Research Council, as well as the University of Toronto.

• Max Planck Institutes conduct basic research in areas of natural science, social science, and the arts and humanities. In particular, the Max Planck Society takes up new and promising directions in research that may not be feasible at smaller institutions. There are 81 institutes, research centres and laboratories and at least 27 institutes are involved in biological and medical research. The society's budget is estimated at $1.8 billion. Ninety-five percent of financial support comes from public funds provided by the federal and state governments. More detailed information on specific Max Planck centres working on biotechnology research may be obtained the Max Planck Institutes Web site at http://www.mpg.de.
• Fraunhofer Gesellschaft is the leading organization of applied research in Germany with a staff of around 9000 employed at 47 research establishments. International collaboration is promoted through Fraunhofer branches in the United States and Asia. The research performed at the institutes is often done in conjunction with private enterprises with the object of developing marketable products (see http://www.fhg.de/english/profile/index.html). Biotechnology research institutes include the Institute for Biomedical Engineering, the Institute for Interfacial Engineering and Biotechnology, and the Environmental Safety and Energy Technology Institute.
• Federal Biological Research Centre for Agriculture and Forestry (BBA): Engaged in plant pathology, entomology, plant protection and related fields, the BBA concerns itself with the effect of pesticides on humans, animals and the environment. The German Plant Protection Act defines the majority of the BBA's duties. The Centre employs 700 people and has an annual budget of approximately $58 million.

Public Opinion Issues

Liberalization of the Genetic Engineering Act in 1993 did not receive overwhelming public support, and public education of the benefits of biotechnology remains a government priority.

There is a striking contrast in Germany between the public acceptance of biotechnology with medical applications as compared to biotechnology with agricultural applications. Resistance to genetically altered pharmaceutical and health-care products is minimal, with as much as 80% of the population supporting the development, production and use of these medications. No other market in Europe has as many genetically engineered medicines on the market. However, public resistance is much stronger against genetically engineered agricultural products, with as much as 65% of the population opposed to these products. Similar to the situation in the United Kingdom, protesters have attempted to destroy genetically modified plants in field trials.

Before labelling requirement discussions were initiated by the European Union early in 1999, the majority of German citizens supported mandatory labelling of all genetically modified food products.

Opportunities

As a result of strong government support for biotechnology, the industry is in a growth and development phase, with significant opportunities for strategic alliances between Canadian and German firms. Few products have reached the commercialization stage, presenting opportunities for technology licensing and mergers. Small German firms are also seeking larger partners to provide funding to take products into trial phase and, finally, commercialization.

There are strong opportunities for Canadian exporters of bio-medical products. However, given the large number of domestic suppliers of pharmaceutical and biopharmaceutical products, the competition to supply medications is stiff. Competition focusses primarily on price, but also on product quality, new developments and valueadded services provided by the company. Canadian firms should address these issues in their marketing strategies.

As the biotechnology industry in Germany matures and expands, there will be a growing need for companies offering equipment, support services and technical experience, including process-related solutions, to supply the market. There are also good export prospects in the market for analytical techniques and equipment. Germany is one of the largest countries in Europe with just over 80 million people and is centrally located for access other EU countries as well as the Eastern European market.

Actual and Planned Projects

The German Government is proceeding with a number of funding programs to further biotechnology development. To assist the biotech industry, funding programs such as BioChance were introduced to provide seed capital for startups. The BioProfile program was designed to support regions that are developing a specialised biotech network.

Two other funding programs include BioInformation, for the development of information technology based systems to analyze and evaluate large amounts of genomic data, and BioFuture, which is meant to assist German and foreign scientists in researching new topics and approaches in biotechnology. These programs are the follow-ups to the successful BioRegio.

The Federal Ministry for Education and Research has also identified a number of S&T biotech targets that are eligible for funding. The comprehensive list was subdivided into basic innovations, applied research and preventive research.

Basic Innovations

• Genome Research
• Technologies and methods for genome and proteom research
• Structural molecular biology
• Bioinformatics
• Nanobiotechnology
• Neurosciences
• Research for Applications
• Tissue Engineering
• Environmental friendly bioprocesses
• Nutrition
• Preventive Research
• Biological safety
• Biodiversity
• Animal Protection

COMPETITIVE ENVIRONMENT

Local Capabilities

There is strong support for biotechnology by the German government, who sees biotechnology as a key technology for the future. The government currently spends approximately $800 million annually on biotechnology and is determined to overtake the United Kingdom as industry's European leader. This process began in earnest in 1995 with the creation of BioRegio. BioRegio was a competitive, research and development initiative that provided the impetus for the German biotechnology industry to collaborate and commercialize research results. Sponsored by the Federal Ministry for Education and Research (BMBF), BioRegio awarded funding through a competitive process that stressed collaboration among academic institutions, industry, government laboratories, and financial institutions.

The three selected BioRegio projects have been enormously successful, attracting additional venture capital funding and spawning the establishment of support programs to encourage further growth in the industry. In fact, in 2000, German biotechnology companies received 40% of all European venture capital funding, compared to 20% in the United Kingdom. The result has seen the German biotechnology industry develop in clusters, built around research centres of excellence and with smaller regions of biotechnology concentration throughout the country. The five top biotechnology regions in Germany in order of number of companies are (1) Berlin and surroundings; (2) Munich and surroundings; (3) North Rhine-Westfalia; (4) Lower Saxony and (5) the Rhine-Necker Triangle. A short description of some of the regions follows:

• BioTOP Berlin-Brandenburg pursues broadly based biotechnological research activities including medical diagnostics, therapeutics, and new forms of treatment. Within the last 5 years about 70 biotechnological enterprises were founded in Berlin and Brandenburg alone (presently there are over 90). With four Universities, two applied science universities and two dozen non-academic research institutes, there is considerable cooperation between disciplines such as engineering sciences, informative technology, chemistry and automated technology. There are 6 technology parks for biotechnology in the region. BioTOP has also been active in setting up financing seminars to assist new startups in acquiring capital.
• Initiativkreis Biotechnology of Bavaria, based in Munich, assists biotechnology companies by providing development space to new start-ups within the Munich Biotechnology Park, as well as assistance with technology transfer and financial agreements. The Martinsried incubator, known as Bio-M, collaborates with the state government to promote contact between academic researchers and industry to encourage spin-offs. There are as many as 85 biotechnology-related firms in and around Munich, 62 of which are small and medium-sized  enterprises. Genetic engineering is a particular strength in the area, and a number of leading U.S. biotechnology companies have established subsidiaries here.
• North Rhine-Westphalia established BioRegio Rheinland, managed by a nonprofit association (Bio-Gen-Tec-NRW) as a network of 40 collaborators and over 120 associates that have established as many as 15 new biotechnology firms. The region is particularly strong in the production of genetically engineered substances for medicines and plant breeding, and has also been commended for the strength of business and organizational potential for biotechnology growth. The BioRegio Rhine-Necker Triangle assists companies with start-up funding, venture capital, and technology transfer. The industry is concentrated around Heidelberg and the Heidelberg Technology Park and is an international leader in biomedical research. Companies and research institutions in the area hold a large number of patents and are involved in collaborative projects with international companies.
• Lower Saxony, which has a number of renowned research centres and academic institutions specializing in biotechnology. Through the Co-ordinating Centre for Biotechnology (Fachkoorrdinierungsstelle fur Biotechnology), the state government offers a number of support services, including market links. The first field trials of genetically modified sugar beet were conducted here in 1993.  
• BioRegio Freiburg has research strength in medical and pharmaceutical biotechnology. State initiatives include a special range of services for new biotechnology companies. BioRegio Freiburg is rapidly linking with French and Swiss neighbours to form BioValley Upper Rhine, which will continue to grow in importance in the coming years.
• BioRegio Greifswald Rostock is conducting initial, practical research activities in areas of biotechnology. The region offers specific development opportunities in marine biotechnology, environmental biotechnology and plant biotechnology. There is a considerable knowledge base in areas of biomaterials and animal health.

Key domestic players in the German biotechnology market include Evotec Biosystems AG, Morphosys AG, Atugen AG, Lion Biosciences, MediGene AG and Artemis Pharmaceuticals.

International Competition

The biotechnology industry in Germany is the second largest in Europe after the United Kingdom based on capitalization; Germany leads the UK in the number of biotech  companies. The industry in the United States, however, remains the global leader. Multinational biotechnology corporations, based primarily in the United States, have operational offices in Germany and tend to dominate the industry. Forty-one percent of the German pharmaceutical industry is German-owned. The German pharmaceutical market had a total value of $22 billion in 2000, an increase of 6% over the previous year. Companies from the United States had a market share of 23%, followed by the Swiss with 10%. The most important market for German pharmaceutical exports is the US.

Canadian Position

Canada is well-positioned to provide joint-venture partnerships, public-education initiatives, and commercialization expertise to the German biotechnology industry, as well as a broad range of products resulting from Canada's research and development efforts.

Canada's strengths in applying biotechnology to agricultural commercialization may be of interest to German producers and researchers. The Canadian agricultural biotechnology industry has already received Canadian government approval for a number of genetically altered products, including canola, soy beans and corn. Canadian experience in this area will be valuable to the German biotechnology industry as approval and monitoring processes are put into place. On a recent visit to Canada, the CEO of a regional biotechnology organization indicated that he was particularly impressed with the way Canadians have accepted biotechnology and hopes to use this experience as a model to help win support for these technologies in Germany. Bio-Gen- Tec-NRW is another organization that has a number of contacts in Canada, including a letter of intention with Ag-West Biotech Inc. of Saskatoon in the area of agricultural biotechnology.

Competitive Advantage through Canadian Government Policies and Initiatives

Canada's biotechnology industry has flourished over the last several years. With over 300 companies and collective revenues of over $1.9 billion, the Canadian industry is poised to become a world leader in biotechnology research and production. Fostering growth in the Canadian biotechnology sector is consistent investment in research and development, financial support by private and public agencies, a solid regulatory framework, strong human resources, and general public acceptance of biotechnology-derived products. Canada's positive relations with the world's most prominent economies, as well as its global reputation for scientific excellence, give Canadian companies an advantage in expanding their businesses to overseas markets. 

Canada-Germany Science and Technology Co-operation Agreement

Over the past 30 years, the driving force behind the Canadian/German science and technology (S&T) relationship has been the 1971 Bilateral S&T Co-operation Agreement. Under the aegis of the agreement, more than 500 projects in 14 sectors have been carried out to date, with more than 100 projects in the pipeline at any one time. The agreement assists in establishing links between Canadian and German researchers.

Germany is one of the largest contributors to the Fifth Framework Research Program. Similarly, considerable government resources are devoted to manage the bilateral international co-operation S&T programs.

This collaborative scientific relationship was re-enforced during the Team Canada Trade Mission to Germany in February 2002. The Max-Planck Institute for Molecular Genetics, the Canadian Health Institute for Genetic Research and the Canadian Genetic Diseases Network signed the Elucidation of Human Genetic Disease Using Genomic Technologies agreement. This five-year collaborative program is designed to encourage research and share capacity in all fields of human genetic disease research through joint research projects, scientific meetings, scientist exchanges and support for scientific trainees.

For additional information on the agreements, please contact the Canadian Embassy in Berlin.

Canada-EU Mutual Recognition Agreement

A Canada-EU Mutual Recognition Agreement (MRA), designed to facilitate trade between the two regions, was signed on May 14, 1998. The agreement, which covers medical devices and pharmaceuticals, among other sectors, entered an evaluative phase in October 1999. A subsequent phase will involve mutual acceptance of regulatory decisions based on results from preliminary reviews. The date of the final stage of implementing the MRA has not been confirmed.

Canada-EU Co-operation in Science and Technology Agreement

In December 1998, Canada and the European Union signed an amendment to the 1996 Canada-EU Agreement on Co-operation in Science and Technology. Coverage of the Agreement now extends to all sectors, including pharmaceuticals. Canadian and EU researchers are afforded reciprocal access to research programs funded by either the Canadian government or the European Union.

Program for Export Market Development

The Program for Export Market Development (PEMD) helps Canadian companies enter new markets by sharing the costs of activities that companies normally could not or would not undertake alone, thereby reducing risks involved in entering a foreign market. Eligible costs and activities include market visits, trade fair participation abroad, incoming buyers, product testing for market certification, legal fees for international marketing agreements, air transportation costs of offshore company trainees, product demonstration costs and other costs necessary to execute a market development plan.

Activity costs are shared on a pre-approved, 50/50 basis. The PEMD refundable contribution ranges from $5,000 to a maximum of $50,000. Preference is given to companies with fewer than 100 employees for a firm in the manufacturing sector and 50 in the service industry, or with annual sales between $250,000 and $10 million. Other components of the program include international bid preparation (Capital Projects Bidding) and, for trade associations, developing international marketing activities for their membership. For additional information visit http://www.infoexport.gc.ca/pemd/menu-e.asp or call 1-888-811-1119.

WIN Exports

WIN Exports, a database of Canadian exporters and their capabilities, is used by trade commissioners around the world and by Team Canada Inc partners in Canada to match Canadian suppliers with foreign business leads, and to share information on trade events. To register your company in WIN Exports or for more information, visit http://www.infoexport.gc.ca/winexports/home_e.html or call 1-888-811-1119.

New Exporters to Overseas

The New Exporters to Overseas (NEXOS) program helps Canadian companies that have not yet exported to Europe. NEXOS introduces the essentials of exporting and provides practical information and first-hand exposure to European markets. The program emphasizes information in areas such as customs procedures, market access, shipping, labelling, distribution channels and currency regulations. Flexibility and fast turnaround times are the hallmarks of this program. Each mission includes thorough briefings on how to find an agent, a distributor, an associate, in other words how to do business in the destination country.

NEXOS missions are arranged for groups of companies in the same general sector. Because of this, applications from individual firms cannot always be entertained. Individual companies are advised to work with an organization such as an industry association, chamber of commerce, international trade centre or provincial government to assemble a group of at least six companies on whose behalf a program can be arranged.

The mission is usually built around an event such as a national or international trade fair. Participants are responsible for their own transportation, accommodation and living expenses. NEXOS will cover associated program expenses such as meeting rooms, speakers and local transportation. Participants must be listed in WIN Exports. Contact the Department of Foreign Affairs and International Trade (DFAIT), European Business Development Section (RENB) for more information about NEXOS.

Technology Partnerships Canada

Industry Canada's Technology Partnerships Canada is an investment loan fund of $300 million that was created to assist the development and eventual export of hightechnology products. Investment loans must be fully repaid and are intended to help ensure that products with high potential actually reach the market. Sectors within bioindustries supported by the program include: therapeutics, including clinical trials in phases I and II; diagnostics, including clinical trials in phases I and II; agri-food; aquaculture; and bio-remediation. For further information, contact Technology Partnerships Canada at http://tpc.ic.gc.ca.

MARKET LOGISTICS

Suggested Business Practices

Germans have a reputation for being extremely precise when it comes to business. All aspects of conducting business-from arriving on time for a meeting to carrying out all details of a contract-are considered to be of utmost importance. Personal relationships tend to be conducted separately from business relationships, and Canadian exporters may need years of contact with German counterparts before more personal relationships are developed.

Business relationships also tend to be conducted with the utmost seriousness, rarely with humour and may appear cold. Germans generally do not appreciate exaggeration of any kind and insist on data to support all claims. This preference for facts over emotion is also seen in German advertising, where factual information dominates opinion.

Import Regulations

As a member of the European Union, Germany follows the Community Integrated Tariff (TARIC) system, which applies duties to all imports from non-EU countries. EU/German import regulations, duties, and tariff-rate-quotas protect domestic industries by limiting the range of foreign products entering the market. Combined with transportation costs, these factors usually result in higher-priced Canadian products.

Value-added tax (VAT) is applied on a non-discriminatory basis to all goods and most services. The tax is levied at the time of customs clearance for all imported goods and is currently 16%. Contrary to many other European countries, Germany applies VAT in full to all medicinal products. There is a reduced rate of 7% for some agricultural products. Canadian companies should consult with customs officials to confirm import tax rates on their products or services.

Pharmaceuticals may be imported only by qualified pharmaceutical companies located in Germany or other EU countries. Canadian companies must therefore negotiate with either a German or EU company to license pharmaceuticals for sale, purchase a German company, or establish a corporate subsidiary.

Germany uses the Harmonized System (HS) to classify goods for international trade. An importer must to have an HS number to determine the amount of duty required. In order to clear customs, goods must be accompanied by the proper shipping documents, bill of lading (or air waybill) and a detailed commercial invoice.

Intellectual Property Protection

Germany is a signatory to all international conventions on intellectual property including the World Intellectual Property Organization and the Paris Union International Convention for the Protection of Industrial Property (patents, trademarks, trade names, and industrial designs). The intellectual property laws in the Germany are comprehensive and rigorously enforced.

Patents

For an EU-wide patent, exporters must file an application with the European Patent Office in Munich. The patent will not be valid until a copy of the grant is filed with the Office.

The European Union regulates the length of patent protection of an original medicinal product developed within the European Union. Commercial research, the preparation of dossiers for filing, the application, and the authorization of a generic product are not permitted within 10 years after the first authorization of an original product. Patent protection can be extended for a further five years with the issue of a supplementary protection certificate.

While harmonization of rules exists between EU member states, there are still some imbalances in the area of generic drug development during the patent protection time frame. There are national restrictions on scientific research and administrative processes required for generic drug approval applications. Most EU members prohibit commercial research during patent protection, and generic drugs cannot be marketed immediately after a patent expires.

German patents are issued for a term of 20 years, renewable in cases where there has been inadequate remuneration. Extensions are generally granted for products that are subject to lengthy approval processes, including pharmaceuticals and biotechnology products. The government, however, does not allow the patenting of animals or plants or any essentially biological process for their production. These rules do not include microbiological processes.

Trademarks

The European Community Trademark Act established the Community Trade Mark, with a registration system that came into force on April 1, 1996. The system co-exists with national registration systems: applications are filed with the Office for Harmonization in the Internal Market (Trade Marks and Designs).

The first user of a mark is entitled to its registration. Applications are published for three months to allow for challenges. Trademarks are registered in Germany for 10 years from the date of application and are renewable for 10-year periods. Before beginning the trademark process, Canadian exporters should consult professional agents.

Local Standards, Certificates or Registrations

Agricultural and Food Biotechnology 

European Union Regulations

The first EU-wide regulations concerning genetically altered food products were drawn up by the European Commission in 1991. As a result, 11 varieties of genetically modified products were approved, including corn and soybeans. In response to public concerns, the European Commission stopped approving genetically modified products in April 1998 and announced, in June 1999, that no other products would be approved until new evaluation and monitoring standards were established. All new GM food products have been prevented from entering the EU market. The moratorium should be lifted by the end of 2002 or early 2003, although product approvals may still be delayed as member states ratify the new directives.

The European Union's Novel Food Directive of November 1997 requires all GM food to be labelled, whether it is produced in Europe or abroad (as a result of the decisions described above, this also applies to GM food products approved between 1991 and April 1998.) The directive allows companies to label their food as GMO-free if it is has not been bio-engineered. Only GM tomato puree, corn and soya products are marketed in the European Union, although soya is an ingredient in almost 60% of all processed foods and there are currently no requirements for GM food derivatives to be labelled as such. As well, most animal feed now contains genetically altered corn and there are no requirements to label animal food. Industry and member countries have called for a more specific and streamlined approval process.

German Regulations

The Robert Koch Institute is the German authority responsible for approving biotechnological products/processes using micro-organisms at any stage in production or development, including the deliberate release of GM organisms. The Institute's terms of reference include:

• development of a safety evaluation of genetic operations;
• development of a safety evaluation of recombinant vaccine development and
• methods of genetic engineering in biotechnology;
• execution of authorization procedures for release projects and of procedures for
• the placing on the market of GMOs under the German legislation on genetic engineering;
• fulfillment of the tasks of a national competent authority for community authorization procedures of the European Union relating to the deliberate release or the placing on the market of GM organisms;
• acting as Secretariat of the Central Advisory Committee for Biological Safety (Zentrale Kommission für die Biologische Sicherheit [ZKBS]);
• provision of expertise for the federal government, the Länder (German parliament), and their bodies in questions of biological safety in genetic engineering; and,
• provision of a basis for the updating of regulations to reflect the current state of science and technology.

Once the Robert Koch Institute has approved a genetically altered product, a report is submitted to the Central Advisory Committee for Biological Safety for review and final approval. State health authorities are responsible for verifying all regulations for imported bio-medical and biotechnology products and are also responsible for all decisions regarding the contained use of GMOs.

Medical Biotechnology

European Union Regulations

Canadian manufacturers must have their prescription drugs approved before they can be sold in Germany. This process may be undertaken through the European Agency for the Evaluation of Medical Products (EMEA). As of January 1995, registration in any EU state is recognized by all other EU members. Canadian manufacturers should therefore establish a legal presence in the European Union before applying for marketing approval of their products.

EMEA approval must be obtained for all biotechnology and other high-tech pharmaceutical products, but is optional for other products. The application and approval process through the EMEA takes 300-500 days, and the cost is approximately $250,000 (20-40% less than the cost of single, national approval processes). Packaging of centrally approved medicines must state the European registration number, beginning with "EU." The EMEA is responsible for ensuring quality and safety of all medical products and monitoring compliance with specific guidelines.

German Regulations

Pharmaceuticals are classified into three categories: prescription drugs (verschreibungspflichtig) available only at pharmacies; drugs that do not require a prescription but are still only available at pharmacies; and drugs that are available through health food stores and supermarkets.

Generic pharmaceuticals must obtain approval in accordance with the German Drug Regulations Act (Gesetz ueber den Verkehr mit Arzneimitteln [AMG]), which includes all necessary EU directives. The AMG defines all standards of quality, safety, effectiveness, declaration of ingredients, labelling, packaging and marketing for pharmaceutical products. Marketing approval is granted by the Federal Institute for Drugs and Medical Devices.

The Federal Agency for Sera and Vaccines, Paul Ehrlich Institute (PEI) is responsible for national approvals for specific diagnostic products, particularly those pertaining to viruses and infectious diseases.

PROMOTIONAL EVENTS

Euro-Biotech Forum 2002
June 23-25, 2002
Hotel Inter-Continental
Paris, France

Organizer:
Windhover Information and Lehman Brothers
40 High St., Wimbledon
London, SW19 5AU UK
Tel.: (44-20) 8879-4000
Fax: (44-20) 8879-4099
E-mail: csutton@windhover.com
Internet: http://www.windhover.com

Global Biotech for European Investors
April 16, 2002
New Connaught Rooms
London, U.K.

Organizer:
Sachs Associates
Oldebourne House
46/47 Chancery Lane
London, WC2A 1JB UK
Tel.: (44-20) 7405-5544
Fax: (44-20) 7405-4411
Internet: http://www.sachsforum.com

BIO 2002
June 9-12, 2002
Toronto Convention Centre
Toronto, Ontario

Organizer:
Biotechnology Industry Organization
1625 K St. NW, Suite 1100
Washington, DC 20006
Tel.: (202) 857-0237
Fax: (202) 857-0244
E-mail: bio2002@bio.org
Internet: http://www.bio.org/events.html

6th International Conference on Agricultural Biotechnologies
July 11-14, 2002
Ravello, Italy

Organizer:
International Consortium of Agriculture
Biotechnology Research (ICABR)
Tel.: (39-6) 7259-5843
Fax: (39-6) 2020-500
E-mail: ICABR@economia.uniroma2.it
Internet: http://www.economia.uniroma2.it/
conferenze/icabr

Annual Meeting of the German Biotechnology Society
June 11-13, 2002
Rhein-Main-Hallen
Wiesbaden, Germany

Organizer:
Association of German Biotechnology Companies
Theodor-Heuss-Alle 25
60486 Frankfurt am Main, Germany
Tel.: (49-69) 7564-163
Fax: (49-69) 7564-169
E-mail: vbu@dechema.de
Internet: http://www.dechema.de/
veranstaltung/jahrestagungen02
deutsch/index.htm  

4th European Symposium on Biochemical Engineering Science
August 28-31, 2002
Delft, Netherlands

Organizer:
Secretariat ESBES-4
Kluyver Laboratory for Biotechnology
Delft University of Technology
Julianalaan 67
2628 BC Delft, Netherlands
Tel.: (31-15) 278-2342
Fax: (31-15) 278-2355
E-mail: esbes-4@tnw.tudelft.nl
Internet: http://www.esbes4.tnw.tudelft.nl

Bio-Europe
November 11-13, 2002
Liederhall / Maritim Hotel
Stuttgart, Germany

Organizer:
E.B.D. Group
Pettenkoferstrasse 35
D-80336 Munich, Germany
Tel.: (49-89) 5139-9803
Fax: (49-89) 5442-0214
E-mail: bioeurope@ebdgroup.com
Internet: http://www.ebdgroup.com/bioeurope

KEY CONTACTS AND SUPPORT SERVICES

Canadian Government Contacts

Canadian Embassy in Germany
Friedrich Strasse 95
Internationales Handelszentrum - 12th floor
Berlin, Germany D-10117
Tel.: (49-30) 2031-2365
Fax: (49-30) 2031-2142
Contact: Steffen Preusser, Technology Officer /Business Development Officer
E-mail: steffen.preusser@dfait-maeci.gc.ca
Internet: http://www.canada.de

Consulate of Canada in Düsseldorf
Benrather Strasse 8
Düsseldorf, Germany D-40213
Tel.: (49-211) 17-21-70
Fax: (49-211) 35-91-65
E-mail: ddorf@dfait-maeci.gc.ca
Internet: http://www.canada.de

Consulate of Canada in Hamburg
Ballindamm 35, 5th Floor
Hamburg, Germany
Tel.: (49-40) 46-00-27-0
Fax: (49-40) 46-00-27-20
E-mail: hamburg@dfait-maeci.gc.ca
Internet: http://www.canada.de

Consulate of Canada in Munich
Tal 29
Munich, Germany D-80331
Tel.: (49-89) 21-99-57-0
Fax: (49-89) 21-99-57-57
E-mail: munic-td@dfait-maeci.gc.ca
Internet: http://www.dfait-maeci.gc.ca/~bonn

Agriculture and Agri-Food Canada
Market and Industry Services Branch
Sir John Carling Building
930 Carling Ave.
Ottawa, ON K1A 0C5
Tel.: (613) 759-7744
Fax: (613) 759-7499
Internet: http://www.agr.ca

Canadian Food Inspection Agency
Office of Biotechnology
59 Camelot Dr.
Nepean, ON K1A 0Y9
Tel.: (613) 225-2342
Fax: (613) 228-6653
E-mail: cfiamaster@agr.gc.ca
Internet: http://www.cfia-acia.agr.ca

Department of Foreign Affairs and International Trade (DFAIT)
125 Sussex Dr.
Ottawa, ON K1A 0G2
Internet: http://www.dfait-maeci.gc.ca

European Business Development (REB)
Tel.: (613) 996-5568
Fax: (613) 944-1008
Contact: Robert Rutherford, Deputy Director
E-mail: reb@dfait-maeci.gc.ca

Northern Europe Division (REN)
Tel.: (613) 943-0893
Fax: (613) 995-6319
Contact: Yvonne Gruenthaler, Trade Commissioner
E-mail: yvonne.gruenthaler@
dfait-maeci.gc.ca

Market Research Centre (TCM)
Tel.: (613) 996-3535
Fax: (613) 943-1103
Contact: Michelle Van Dyk, International Market Research Officer
E-mail: michelle.van-dyk@dfait-maeci.gc.ca

Market Support Division (TCM)
Tel.: (613) 996-1431
Fax: (613) 944-0050
Contact: Patricia Filteau, Trade Commissioner
E-mail: patricia.filteau@dfait-maeci.gc.ca
Internet: http://www.infoexport.gc.ca

Health Canada
International Affairs Directorate
Brooke Claxton Building, Room 814A
Postal Locator 0908A
Tunney's Pasture
Ottawa, ON K1A 0K9
Tel.: (613) 941-3136
Fax: (613) 952-7417
Internet: http://www.hc-sc.gc.ca

Industry Canada
Life Sciences Branch
PO Box 940, Station M
1505 Barrington St., 16th Floor
Halifax, NS B3J 2V9
Tel.: (902) 426-9958
Fax: (902) 426-6094
Contact: Mark Craig, Industry Development Officer, Bio-Industries
E-mail: craig.mark@ic.gc.ca
Internet: http://strategis.ic.gc.ca

Canadian Industry Associations

Ag-West Biotech
101, 111 Research Dr.
Saskatoon, SK S7N 3R2
Tel.: (306) 975-1939
Fax: (306) 975-1966
E-mail: agwest@agwest.sk.ca
Internet: http://www.agwest.sk.ca

Alberta Biotechnology Association
1150, 10180 101 St.
Edmonton, AB T5J 3S4
Tel.: (780) 425-3815
Fax: (780) 423-3893
Contact: Myka Osinchuk, Executive Director
E-mail: myka@bioalberta.com
Internet: http://www.bioalberta.com

BioAtlantech
PO Box 636, Station A
Fredericton, NB E3B 5A6
Tel.: (506) 444-2444
Fax: (506) 444-5662
Contact: John Argall, Executive Director
E-mail: jargall@fundy.net
Internet: http://www.bioatlantech.nb.ca

BioEast
2nd Floor, Spencer Hall
220 Prince Philip Dr.
St. John's, NF A1B 3X5
Tel.: (709) 737-2682
Fax: (709) 737-4029
Contact: Margaret Miller, Managing Director
Internet: http://www.bioeast.ca

BIONova
c/o Innovacorp
101 Research Dr.
PO Box 790
Dartmouth, NS B2Y 3Z7
Tel.: (902) 424-8670
Fax: (902) 424-4679
Contact: Bill Mills, Executive Director
E-mail: bmills@innovacorp.ns.ca

Bio Quebec
6100 Mount Royal Avenue
Montreal, QC H4P 2R2
Tel.: (514) 733-8411
Fax: (514) 733-8272
E-mail: info@bioquebec.com
Internet: http://www.bioquebec.com

BIOTECanada
130 Albert St., Suite 420
Ottawa, ON K1P 5G2
Tel.: (613) 230-5585
Fax: (613) 563-8850
E-mail: info@biotech.ca
Internet: http://www.biotech.ca

British Columbia Biotechnology Alliance
3250 East Mall, Suite 225
Vancouver, BC V6T 1W5
Tel.: (604) 221-3020
Fax: (604) 221-3027
Contact: Paul Stinson, Executive Director
Internet: http://www.bcbiotech.ca

Canada's Research-Based Pharmaceutical Companies (Rx&D)
302-1111 Prince of Wales Dr.
Ottawa, ON K2C 3T2
Tel.: (613) 727-1380
Fax: (613) 727-1407
Internet: http://www.canadapharma.org

Canadian Agri-Food Research Council
Building 60, Heritage House
Central Experimental Farm
Ottawa, ON K1A 0C6
Tel.: (613) 234-2325
Fax: (613) 234-2330
Internet: http://www.carc-crac.ca

Canadian Drug Manufacturers Association
4120 Young St., Suite 606
North York, ON M2P 2B8
Tel.: (416) 223-2333
Fax: (416) 223-2425
Internet: http://www.cdma-acfpp.org

Non-Prescription Drug Manufacturers Association of Canada
1111 Prince of Wales Drive, Suite 406
Ottawa, ON K2C 3T2
Tel.: (613) 723-0777
Fax: (613) 723-0779
E-mail: ndmac@ndmac.ca
Internet: http://www.ndmac.org

Ottawa Life Sciences Council
600 Peter Morland Dr., Suite 100
Ottawa, ON K1G 5Z3
Tel.: (613) 521-1008
Fax: (613) 521-3065
Internet: http://olsc.ca

Toronto Biotechnology Initiative
PO Box 446, Station A
Toronto, ON M5W 1C2
Tel.: (416) 392-4780
Fax: (416) 397-0906
Internet: http://www.torontobiotech.org

German Government Contacts

Embassy of the Federal Republic of Germany
1 Waverly St.
Ottawa, ON K2P 0T8
Tel.: (613) 232-1101
Fax: (613) 594-9330
E-mail: 100566.2620@compuserve.com
Internet: http://www.germanembassyottawa.org

Consulate General of the Federal Republic of Germany-Montreal
Marathon Building, 43rd floor
1250 Rene Levesque W
Montreal, QC H3B 4W8
Tel.: (514) 931-2277
Fax: (514) 931-7239
E-mail: 106167.425@compuserve.com

Consulate General of the Federal Republic of Germany-Vancouver
World Trade Centre, Suite 704
999 Canada Place
Vancouver, BC V6C 3E1
Tel.: (604) 684-8377
Fax: (604) 684-8334
E-mail: 106167.431@compuserve.com

Consulate General of the Federal Republic of Germany-Toronto
77 Admiral Rd.
Toronto, ON M5R 2L4
Tel.: (416) 925-2813
Fax: (416) 925-2818
E-mail: 106167.430@compuserve.com

Central Committee for Biological Safety:
Robert Koch Institute (Zentrale Kommission
fuer Biologische Sicherheit [ZKBS])
Wollankstr. 15-17
D-13187 Berlin, Germany
Tel.: (49-30) 4547-0
Fax: (49-30) 4547-3060
Internet:
http://www.rki.de/GENTEC/
GENENG/GENTEC_E.HTM

Federal Agency for Sera and Vaccines: Paul
Ehrlich Institute (Bundesamt fur Sera und
impfstoffe: Paul-Ehrlich-Institut [PEI])
Postfach 1740
D-63207 Langen, Germany
Tel.: (49-610) 3770
Fax: (49-610) 3771-234
Internet: http://www.pei.de/english/eninfo.htm

Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte [BFARM])
Friedrich-Ebert-Allee 38
53113 Bonn, Germany
Tel.: (49-22) 8207-30
Fax: (49-22) 8207-5207
E-mail: poststelle@bfarm.de
Internet: http://www.bfarm.de

Federal Biological Research Centre for Agriculture and Forestry (Biologische Bundesanstalt [BBA])
Königin-Luise-Strasse 19
D-14195 Berlin, Germany
Tel.: (49-30) 830-41
Fax: (49-30) 8304-2002
Internet: http://www.bba.de/english/bbaeng.htm

Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF])
Hannoversche Strasse 30
10115 Berlin, Germany
Tel.: (49-30) 1888-570
Fax: (49-30) 1888-575270
Internet: http://www.bmbf.de

Federal Ministry of Consumer Protection, Food and Agriculture (Bundesministerium für Verbraucherschutz, Ernährung und Landwirtschaft [BMVEL])
Wilhelmstr. 54
10117 Berlin, Germany
Tel.: (49-30) 2006-0
Fax: (49-30) 2006-4262
E-mail: internet@bmvel.bund.de
Internet: http://www.verbraucherministerium.de

German Research Institutes

Federal Biological Research Centre for Agriculture and Forestry (Biologische Bundesanstalt für Land - und Forstwirtschaft) 
D-14195 Berlin
Königin-Luise-Strasse 19, Germany
Tel.: (49-30) 8304-1
Fax: (49-30) 8304-2002
Includes: Institute for Plant Virology, Microbiology and Biosafety
Internet: http://www.bba.de/english/bbaeng.htm

German Research Center for Biotechnology Ltd. (Gesellschaft für Biotechnologische Forschung mbH [GBF])
Mascheroder Weg 1
D-38124 Braunschweig, Germany
Tel.: (49-531) 6181-0
Fax: (49-531) 6181-515
E-mail: info@GBF.de
Internet: http://www.gbf.de/index-uk.html

Hans Knoell Institute for Natural Substance Research (Hans-Knoell-Institute fuer Naturstoff-Forschung e.V.)
Beutenbergstrasse II
D-07745 Jena, Germany
Tel.: (49-364) 1656-611
Fax: (49-364) 1656-600
Internet: http://www.hki-jena.de/hki_hpe.htm

D-38104 Braunschweig
Messeweg 11-12, Germany
Tel.: (49-53) 1299-5
Fax: (49-53) 1299-3001
Includes: Institute for Plant Protection of Field Crops and Grassland, 
Institute for Plant Protection in Horticulture, Microbiology and Biosafety.

Hermann von Helmholtz Association of National Research Centres (Hermann von Helmholtz Gemeinschaft Deutscher Forschungszentren [HGF])
Wissenschaftszentrum
Ahr-Straße 45
D-53175 Bonn, Germany
Tel.: (49-228) 3081-80
Fax: (49-228) 3081-830
Internet: http://www.helmholtz.de (some English)

D-14532 Kleinmachnow
Stahnsdorfer Damm 81, Germany
Tel.: (49-33) 2034-80
Fax: (49-33) 2034-8425
Includes: Institute for Ecotoxicology in Plant Protection.

Max Planck Institutes
Main Office
Postfach 10 10 62
D-80084 Munich, Germany
Tel.: (49-89) 2108-0
Fax: (49-89) 2108-1111
Internet: http://www.mpg.de/english

Fraunhofer Institute for Interfacial Engineering and Biotechnology (Fraunhofer Institute Grenzflachen - und Bioverfahrenstechnik [IGB])
Nobelstrasse 12
D-70569 Stuttgart, Germany
Tel.: (49-711) 970-00
Fax: (49-711) 970-4200
E-mail: hb@igb.fhg.de
Internet: http://www.igb.fhg.de/home.en.html

German Cancer Research Institute
(Deutsches Krebsforschungszentrum)
Im Neuenheimer Feld 280
D-69120 Heidelberg, Germany
Tel.: (49-62) 2142-0
Fax: (49-62) 2140-2995
Internet:
http://www.dkfz-heidelberg.de/index_e.htm

Max Planck Institute for Molecular Genetics
(Max-Planck-Institute fuer Molekulare Genetik)
Ihnestr. 73
D-14195 Berlin, Germany
Tel.: (49-30) 8413-0
Fax: (49-30) 8413-1388
Internet: http://www.molgen.mpg.de

Max-Delbrueck Center for Molecular Medicine, Berlin-Buch (Max-Delbrück-Centrum für Molekulare Medizin, Berlin-Buch [MDC])
Robert-Rössle Strasse 10
D-13092 Berlin, Germany
Tel.: (49-30) 9406-0
Fax: (49-30) 949-4161
E-mail: presse@mdc-berlin.de
Internet: http://www.mdc-berlin.de

Max-Planck Institute for Plant Breeding Research
(Max-Planck-Institut für Züchtungsforschung)
Carl-von-Linné Weg 10
D-50829 Köln, Germany
Tel.: (49-221) 5062 - 0
Internet: http://www.mpiz-koeln.mpg.de

National Research Center for Environment and Health (Forschungszentrum für Umwelt und Gesundheit [GSF])
Ingolstaedter Landstrasse 1
D-85764 Neuherberg, Germany
Internet: http://www.gsf.de

German Industry Associations

Association of German Biotechnology Companies (Deutsche Gesellschaft für Chemisches Apparatewesen, Chemische Technik und Biotechnologie e.V. [VBU])
Theodor-Heuss-Alle 25
60486 Frankfurt am Main, Germany
Tel.: (49-69) 7564-163
Fax: (49-69) 7564-169
E-mail: vbu@dechema.de
Internet:
http://www.dechema.de/biotech/vbu/vbu.htm

Association of the German Pharmaceutical Industry (Bundesverband der Pharmazeutischen Industrie e.V. [BPI])
Karlstrasse 21
D-60329 Frankfurt am Main, Germany
Tel.: (49-69) 2556-1266
Fax: (49-69) 2556-1603
E-mail: presse@bpi.de
Internet: http://www.bpi.de (German only)

Association of Research-Based Pharmaceutical Companies in Germany (Verband Forschender Arzneimittelhersteller [VFA])
Postfach 240143
D-53154 Bonn, Germany
Tel.: (49-228) 8199-90
Fax: (49-228) 8199-999
Internet: http://www.vfa.de/extern/e/index.html

Canadian German Chamber of Industry and Commerce Inc.
Head Office
480 University Ave., Suite 1410
Toronto, ON M5G 1V2
Tel.: (416) 598-3355
Fax: (416) 598-1840
E-mail: info.toronto@germanchamber.ca
Internet: http://www.germanchamber.ca

Canadian German Chamber of Industry and Commerce Inc. (cont.) Montreal
1010 Sherbrooke St. W, Suite 1604
Montreal, QC H3A 2R7
Tel.: (514) 844-3051
Fax: (514) 844-1473
E-mail: info.montreal@germanchamber.ca

Vancouver
750 West Pender St., Suite 1101
Vancouver, BC V6C 2T8
Tel.: (604) 681-4469
Fax: (604) 681-4489
E-mail: info.vancouver@germanchamber.ca

German Association of Biotechnology Industries (Deutsche Industrievereinigung Biotechnologie [DIB])
Karlstrasse 21
D-60329 Frankfurt, Germany
Tel.: (49-69) 2556-1481
Fax: (49-69) 2556-1620
E-mail: dib@vci.de
Internet: http://www.vci.de/dib

German Association of the Diagnostic Industry (Verband der Diagnostica-Industrie e.V. [VDGH])
Muenchner Strasse 49
D-60329 Frankfurt, Germany
Tel.: (49-69) 2556-1229
Fax: (49-69) 2366-50
Internet: http://www.vdgh.de

German Research Council (Deutsche Forschungsgemeinschaft e.V. [DFG]) 
Kennedyallee 40
D-53175 Bonn, Germany
Tel.: (49-228) 8851
Fax: (49-228) 8852-221
Internet: http://www.dfg.de/english/index.html

European Union Associations

EuropaBio
Avenue de l'Armée 6
1040 Brussels, Belgium
Tel.: (32-2) 735-0313
Fax: (32-2) 735-4960
E-mail: mail@europabio.org
Internet: http://www.europabio.org

European Agency for the Evaluation of Medicinal Products (EMEA)
7 West Ferry Circus
Canary Wharf
London E14 4HB UK
Tel.: (44-171) 418-8400
Fax: (44-171) 418-8416
Internet: http://www.emea.eu.int

European Diagnostics Manufacturers Association (EDMA)
Place Saint-Lambert, 14
1200 Brussels, Belgium
Tel.: (32-2) 772-2225
Fax: (32-2) 772-2329
E-mail : edma@edma-ivd.be
Internet: http://www.edma-ivd.be

European Federation of Pharmaceutical Industries and Associations (EFPIA)
Rue du Trône 108
B-1050 Brussels, Belgium
Tel.: (32-2) 626-2555
Fax: (32-2) 626-2566
E-mail: info@efpia.org
Internet: http://www.efpia.org

European Generic Medicines Association
PO Box 193
B-1040 Brussels 4, Belgium
Tel.: (32-2) 736-8411
Fax: (32-2) 736-7438
Internet: http://www.egagenerics.com

European Patent Office-Munich
Erhardtstrasse 27
D-80331 Munich, Germany
Tel.: (49-89) 23990
Fax: (49-89) 2399-2850
Internet: http://www.european-patent-office.org

Office for Harmonization in the Internal Market (Trade Marks and Designs)
Apartado de correos, 77
E-03080 Alicante, Spain
Tel.: (34-96) 513-9100
Fax: (34-96) 513-9173
Internet: http://oami.eu.int

BIBLIOGRAPHY

Canada. Department of Foreign Affairs and International Trade. "The Biotechnology Market in Germany," 1999. Available on line from: http://www.infoexport.gc.ca.

Chemical Business NewsBase. "Bayer: First Biotechnology Drug," November 1999.

---. "Biotechnology in Germany," November 1999.

Datamonitor. "Germany Biotechnology: Market Profile," November 2001.

Euromonitor. "Market Briefing: Germany Pharmaceuticals Market," July 2001.

Krause, Carey. "Germany Moves Closer to UK in Biotechnology," Chemical Market Reporter, November 2001.

Marketletter. "German Pharma Industry and Market Data for 2000," September 2001.

New Scientist. "Germany Bites the Biobullet (The Rise of Biotechnology in Germany)," September 2001.

OECD. "Regulatory Developments in Biotechnology in Germany," 2000. Available on line at: http://www1.oecd.org/ehs/gerreg.htm.

Schropp, Carola G. "Biotechnology in Germany-Five Years After BioRegio," September 2001.

United States. United States Department of Commerce. "German Biotechnology," September 1998.

---. "German Hi-Tech in Bavaria-Biotechnology," 1999.

OTHER REFERENCE MATERIAL

Useful Internet Sites

Association of German Biotechnology Companies: http://www.dechema.de/biotech/vbu/vbu.htm

Biotechnology Companies in Germany (map and directory): http://www.i-s-b.net/firmen/sme.htm

BioTrack Online-Biotechnology at OECD: http://www1.oecd.org/ehs/service.htm

Canada Business Service Centres: http://www.cbsc.org

(Note: Western Canada-based companies should see particularly the Agricultural Biotechnology and Biotechnology Loan Program, established by Western Economic Diversification Canada) CanadaEuropa site: http://www.canadaeuropa.gc.ca

Canadian Embassy in Germany: http://www.kanada.de

Canadian German Chamber of Industry and Commerce: http://www.germanchamber.ca

Department of Foreign Affairs and International Trade (DFAIT): http://www.dfait-maeci.gc.ca

EuropaBio: http://www.europabio.org

European Agency for the Evaluation of Medicinal Products: http://www.emea.eu.int

Export Development Canada (EDC): http://www.edc.ca

Industry Canada: http://strategis.gc.ca

InfoExport: http://www.infoexport.gc.ca

Health Canada: http://www.hc-sc.gc.ca

Max Planck Institutes: http://www.mpg.de/english

Robert Koch Institute: http://www.rki.de/GENTEC/GENENG/GENTEC_E.HTM

READER EVALUATION

1 For contact information regarding key organizations mentioned in this report, see Key Contacts and Support Services.

2 All monetary amounts are expressed in Canadian dollars, unless otherwise indicated. The conversion rate to Canadian dollars is based on IDD Information Services, Tradeline, January 2002.