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![]() The Biotechnology Market in the NetherlandsJuly 2003Prepared by the © Department of Foreign Affairs and International Trade Report prepared by the Market Research Centre 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 SUMMARYThe Netherlands has the fifth-largest biotechnology industry in Europe. There are approximately 300 companies in the Netherlands involved in biotechnology; together, these companies saw a turnover valued at $150 million(1) in 2002. The open dialogue among government, industry and consumers has resulted in strict but effective legislation for biotechnology, which provides a high level of safety for animals, humans and the environment. Dutch consumers are generally well-informed about the pros and cons of biotechnology, particularly with regard to food. Environmental and consumer groups in the Netherlands judge issues on a case-by-case basis, as opposed to groups in other parts of Europe, which tend to reject biotechnology as a matter of principal. Dutch strengths include diagnostics and therapeutics, plant biotechnology and environmental biotechnology. By 2010, the health-care sector may account for 34% of all biotech output in the Netherlands, while the food and agricultural biotech sector should experience dramatic growth and may account for 25-30% of the sector. Currently, however, environmental biotech output exceeds agriculture. The most significant opportunities for Canadian biotech firms are in collaborative research partnerships and technology transfer agreements in these sectors. In addition, there will be a growing need for companies offering equipment, support services and technical experience to supply the market as the biotech industry in the Netherlands matures and expands. MARKET OVERVIEWWith an estimated value of $150 million, the Netherlands has the fifth-largest biotech industry in Europe behind the United Kingdom, Germany, France and Sweden. Approximately 300 companies in the Netherlands are involved in biotechnology, employing a total of 1500-2000 people. Dutch strengths include diagnostics and therapeutics, plant biotechnology and environmental biotechnology. By 2010, the health-care sector may account for 34% of all biotech output in the Netherlands, while the food and agricultural biotech sector may experience dramatic growth and account for 20-30% of the sector that year. Currently, however, environmental biotech output exceeds agriculture. Characteristic of Dutch industry in general is the spirit of collaboration between the public and private sectors. As a result, there is strong communication among industry, consumers, government and environmental groups. Indeed, the industry is known to have an open and constructive dialogue with social organizations and environmental groups concerning the introduction of new biotech products. The Netherlands has also developed strong regulatory structures, including strict but workable legislation for biotechnology that focusses on human and animal health safety, as well as environmental protection. The Dutch biotech industry is globally oriented in general and is highly supportive of forming international partnerships. Many foreign companies have based their European headquarters in the Netherlands, benefitting not only from a positive climate for biotechnology, but also the country's excellent transport and information technology infrastructures and its favourable tax climate. Agricultural and Food BiotechnologyThe agriculture and food biotech industry in the Netherlands is concentrated in the Wageningen Food Valley. This area is renown for strong government funding as well as quality research and educational institutions. Activity is focussed on plant genomics, agronomic research and, to a lesser extent due to public opposition, veterinary research, which is generally concentrated in Utrecht. Scientists in Wageningen have also developed expertise in functional foods, particularly sport-related food and drink, the role of anti-oxidants in food and human health, and the role of micronutrients. Unlike in other European countries, genetically modified (GM) crops and food products are not a significant topic of public debate in the Netherlands. The traditional Dutch "Polder model" of consultation has ensured that interested parties on both sides of the GM debate have amicable discussions and keep each other abreast of new issues. As a result, government and industry organizations actively encourage the development and marketing of novel foods, both in safety assessment and product labelling procedures. In response, Microscreen, a Dutch-owned biotech company, and TNO, a domestic research organization, have developed monitoring and testing systems for food products. Leading local companies include BaseClear, BioDetection Systems, CatchMabs BV, Cellscreen BV, Keygene N.V., Plant Research International B.V. and TNO. Agricultural biotechnology is also researched at Greenomics (a Plant Research International B.V. facility and part of Wageningen University and Research Centre), Groningen Biomolecular Sciences and Biotechnology Institute (GBB) and the Graduate School Vlag. Foreign participants in the agricultural and food sectors include Biotechnology Application Centre BV, a subsidiary of Unilever, and Bio-Rad Laboratories, a Dutch subsidiary of California-based Bio-Rad Labs. Chemical BiotechnologyThe chemicals sector is also embracing biotechnology, as evidenced by the growing number of companies focussing production on high added-value products such as raw materials for agro-chemicals and drugs. Research in the Netherlands with regard to chemicals tends to focus on enzymes. Dutch-owned DSM, for example, is using GM moulds as a cost-saving measure in the production of raw substances used to make antibiotics. Biocatalysis research is also broad, ranging from basic to applied research. In 2002, researchers from five universities and several publically funded institutes were engaged in biocatalysis research. The chemicals sector had an estimated value of $35.4 billion in 2000. Biotechnology accounted for 12-18% of turnover that year, a percentage that is expected to increase to 25% by 2010. Environmental BiotechnologyThe Netherlands is highly susceptible to pollution. The country is densely populated (16 million people) and has both a huge chemical industry and an intensive agriculture and livestock farming industry. The fact that much of the Netherlands is below sea level makes it vulnerable to pollution, as does its position at the estuary of the Rhine and Meuse rivers, which bring contaminants from the highly industrialized countries of Germany, Switzerland, France and Belgium. Pollution control and environmental protection are key national priorities and the population has a high level of environmental awareness. Environmental biotechnology is one of the most advanced areas of research in the Netherlands. Dutch universities are conducting research into various types of bacteria with the ability to break down pollutants. Research also focusses on the recovery of primary raw materials. Soil cleaning in the Netherlands has also achieved worldwide recognition, with its reputation founded on expertise in cleaning up highly complex "cocktails" of pollutants, often reducing them to undetectable levels. Polluted ground, including dredged material from rivers, is a major problem in the Netherlands, however - one that invites solutions from Canadian companies with new and innovative technologies. Leading domestic companies include BioDetection Systems, CatchMabs BV, Cellscreen BV and TNO. The public research infrastructure consists of a network of research schools and institutes including the Graduate Research School of Biotechnological Sciences Delft Leiden, BioCentrum Amsterdam (joint venture of the University of Amsterdam and the Vrije Universiteit), Hubrecht Laboratorium (Utrecht University), Noordelijke Hogeschool Leeuwarden and the Van Hall Instituut. Bio-Rad Laboratories is also active in the field. Medical/Pharmaceutical BiotechnologyBiopharmaceuticals are the primary strength of the Dutch biotech industry. As the science behind biotechnology develops, many traditional pharmaceutical companies are turning their attention to the potential of biotech processes and biopharmaceuticals. The industry, however, does not distinguish between biopharmaceuticals and pharmaceuticals. In 2001, the Dutch pharmaceuticals market was valued at $7.8 billion or $469.48 per capita. Average annual growth in the Dutch pharmaceuticals markets is approximately 10%. The generics market grew at a faster rate than the pharmaceuticals market as a whole, at 15% in 2001. The slowest-growing segment of the market was hospitalprescribed drugs, which grew by only 2% in 2001. Prescription drugs accounted for the vast majority of the market, with over-the-counter (OTC) drugs accounting for approximately 12%. Most medicines consumed in the Netherlands are imported. The Netherlands has a strong position in the global market for niche, biotech-related pharmaceuticals. Although the Netherlands has no major pharmaceutical companies, there are over 50 biotech companies active in health care. Of these, 40 companies use biotech approaches for their human health-care products, while the remaining 10 companies use biotech for veterinary applications. Over 60 biotech medicines are on the market currently. An important source of knowledge for medical biotechnology is the rapidly developing field of genomics. At present pharmacogenomics is the main focus for Dutch biotech companies. This focus could lead to genetically customized medicines. Of the 50-plus biotech companies active in health care, AkzoNobel, along with its subsidiaries Organon, Diosynth and Intervet, is the leading domestic leader in the development of biotech pharmaceuticals. Other leading domestic companies include Crucell, IsoTis, Gene Pharming, Primagen Holding, Rhein Biotech NV, Quiagen and Jari Pharmaceuticals BV. Key Factors Shaping Market GrowthCurrently, the Netherlands ranks tenth in Europe in total number of biotech start-up companies. The Dutch government would like to see the Netherlands rise to the top few countries and is, therefore, encouraging growth in the biotech sector. This encouragement includes a $94-million R&D investment in the sector. The Ministry of Economic Affairs2 has also set up initiatives such as the BioPartner Network to facilitate and stimulate the growth of the industry. The BioPartner Network assists spin-off and start-up companies by providing funding, through subsidies and risk capital, as well as facilities to new companies. The BioPartner Network currently supports groups and individuals focussed on molecular diagnostics, production of medicinal proteins in nectar and honey and bioresolutions for the fine-chemical industry. Factors shaping the consumption and pricing of pharmaceuticals in the Netherlands include growing government pressure to contain health-care costs, an ageing population, the emergence of new products, the shift from curative to preventative health care, and the shift from institutional to out-patient care. As a result of these factors, the market is expected to change significantly over the next several years. For example, by 2005, the number of persons over the age of 65 will increase by over 20%; the number of persons over the age of 80 will increase by 33%. By 2005, fully one third of the population will be over 50 years of age. As the population ages, demand for pharmaceuticals will likely increase. Public Opinion IssuesUnlike in other European countries, there has not been a strong public outcry against biotechnology and genetically altered food products in the Netherlands. There has been some resistance to the introduction of food products without labels, but the industry has not faced the violence and negative publicity seen in other countries. In general, the Dutch accept biotech products that are beneficial to human health or the environment, but have a strongly negative opinion of technology that raises ethical issues or involves the modification of humans or animals. Studies indicate that consumer and environmental groups in the Netherlands judge biotechnology on a case-by-case basis. In contrast, groups in other European countries tend to reject biotechnology outright, based on "a matter of principle". The Dutch agriculture industry, however, is sensitive to the demands for non-GM food products. To date, retailers have protected themselves from public backlash against GM products by ensuring GM-free alternatives are available and by supporting compliance with labelling regulations. OpportunitiesAs a result of strong government support for biotechnology, the industry is in a growth and development phase, providing significant opportunities for strategic alliances between Canadian and Dutch firms. Canada is, traditionally, a major supplier of food products to the Netherlands. The Dutch marketplace is changing: affluence and changing lifestyles have created a larger demand for variety, including for convenience foods and high-value specialty foods. Increasingly, Canada is becoming an important source for the Dutch consumer of both technology and value-added food products. Significant potential exists for collaborative research opportunities in the area of functional foods - foods designed with specific health benefits. The finished biotech product market for agriculture is also expected to expand in a number of areas in the coming years, including industry supplies (e.g. processing aids), microbial crop protectants and herbicides, and genetically engineered pest-resistant agricultural products. Due to strict environmental legislation and increased public pressure, the environmental biotech industry in the Netherlands has strong potential for growth. Applications include conversion of waste into useful products, more compact reactors and treatment centres for waste water, as well as process control and monitoring techniques. There are also large areas of the country that require soil remediation to reclaim and return the land to useful production. There are strong opportunities for Canadian exporters of bio-medical products. Pharmaceuticals, diagnostics, vaccines and antigens offer the best sales prospects for at least the next three years. The licensing and milestone market is also expected to have openings for drug-discovery, gene-sequencing and gene-mapping services. Canadian firms with expertise in these areas could find opportunities for collaboration with Dutch firms. As the biotech industry in the Netherlands matures and expands, there will be a growing need for companies offering equipment, support services and technical experience to supply the market. There are good export prospects for cell- and tissue-cultivating equipment, fermentation equipment, bioreactor systems, high-performance liquid chromatography equipment, columns and accessories, electrophoresis instruments, pilot plant systems and process analysis systems. COMPETITIVE ENVIRONMENTLocal CapabilitiesThe Dutch biotech industry is supported by a strong legislative framework and government programs. These programs, which first supported R&D, are now geared toward product marketing, new company start-up and the commercialization of research results. The Netherlands has a strong public research infrastructure. It is home to 22 universities with biotech expertise. Moreover, one quarter of research schools in the country are engaged in biotech research. Dutch biotech firms enjoy a worldwide reputation for excellence, as evidenced by the high level of Dutch participation in EU research projects as well as the quantity and quality of publications issued annually. The Netherlands also files more patent applications per capita than the global biotech leaders and is among the 10 most productive countries for obtaining copyrights and patents. Over 90% of domestic biotech firms have offices or subsidiaries abroad. International CompetitionStrong competition is felt from larger industries in the United Kingdom, Germany, France, the United States, Canada and, increasingly, Japan. Several leading biotech multinationals have established branches in the Netherlands including Novartis (Switzerland) and Unilever (U.K.). U.S.-based companies active in the market include Amgen, Biogen, Centecor, EuroCefcus and Gene Pharming. Canadian PositionCanada'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 European markets. Canadian companies are wellpositioned to provide joint-venture partnerships, public education initiatives and commercialization expertise to the Dutch biotech industry, as well as a broad range of products resulting from Canadian R&D efforts. Canada's strengths in applying biotechnology to agricultural commercialization may be of interest to Dutch producers and researchers. The Canadian agricultural biotech industry has already received government approval for a number of genetically altered products. Canadian experience in this area will be valuable to the Dutch biotech industry as Dutch approval and monitoring processes are put into place. Several Canadian companies are active in the Dutch market. Montreal-based ProMetic Life Sciences Inc., for example, concluded a licensing agreement in early 2002 with PharmAAware SEPSIS B.V. to develop both diagnostic kit and a therapeutic protein for the treatment of sepsis and septic shock. PharmAAware has obtained rights to ProMetic technology for purification of the enzyme alkaline phosphatase, and plans to exploit its endotoxin-neutralizing properties. Competitive Advantage through Canadian Government Policies and InitiativesCanadian Commercial CorporationThe Canadian Commercial Corporation (CCC) gives Canadian companies access to financing and better payment terms under the Progress Payment Program (PPP). The PPP concept was developed as a partnership between major Canadian financial institutions and the CCC. It enables the exporter's bank to open a project line of credit for the exporter's benefit, based on CCC approval of the project and the exporter's ability to perform. The CCC will also act as a prime contractor on behalf of Canadian small and medium-sized enterprises, giving those businesses increased credibility and competitive advantage. Export Development CanadaExport Development Canada (EDC) offers export financing and insurance to Canadian exporters. Additionally, insurance can be provided for larger transactions that are subject to the terms and conditions established by the buyer. EDC prefers to work through letters of credit, bank credits or bank guarantees. Approval for financing is considered on a case-by-case basis. New Exporters to OverseasThe 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 a Canadian 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. Canadian firms must be registered in the WIN Exports database to be eligible to participate. Contact the Department of Foreign Affairs and International Trade (DFAIT), European Business Development Section (REB) for more information about NEXOS. Virtual Trade CommissionerThe Virtual Trade Commissioner (vTC) is a new on-line service offered by Canada's Trade Commissioner Service of the Department of Foreign Affairs and International Trade. Through a personalized and password-protected Web page, vTC-registered Canadian exporters will receive timely and relevant information on contacts and business opportunities in targeted foreign markets. The vTC offers registered users direct on-line access to market information, including market reports, business news, events and business leads related to the companies' industry sectors and markets of interest. Users can request services on line from a trade commissioner responsible for their industry sector in their target markets. They will also automatically receive new information as it becomes available. Canadian exporters can register for a Virtual Trade Commissioner at http://www.infoexport.gc.ca. PRIVATE-SECTOR CUSTOMERSThe Netherlands is home to internationally renown research institutions and scientists in the area of biotechnology. There is strong interest in technology transfer and collaborative research ventures in the Netherlands. As is typical in the biotech industry, companies often require partnerships in order to help finance product development. Collaborative research work is also beneficial to help penetrate a new market. In 2001, there were approximately 2200 pharmacies in the Netherlands. Over 1600 of these were operated by pharmacists; the remainder were operated by physicians. OTC products represent 12% of the total pharmaceuticals market. Both pharmacies and druggists sell OTC medications and are therefore important customers for pharmaceutical manufacturers. Approximately 5.8% of OTC products are sold through supermarkets. PUBLIC-SECTOR CUSTOMERSGovernment OrganizationsThe Government of the Netherlands is a strong supporter of biotechnology. The ministries of Economic Affairs, of Education, Culture and Sciences, and of Agriculture, Nature Management and Fisheries are particularly concerned with bioindustries, biomedical research and agricultural biotechnology. These ministries support various research institutions across the country. Regional governments also look to this sector as one for potential long-term growth and high-tech employment. Federal and regional governments support biotechnology through direct funding, investment incentives and the creation of research centres of excellence. Canadian companies interested in targeting government-funded research institutions for technology transfer agreements, licensing or partnering opportunities should continue their market research by perusing the company information offered through the contacts and Web sites listed at the end of this report. Furthermore, the vTC and the Canadian Embassy in the Hague can provide guidance on how to enter this market. Government Procurement RegulationsProcurement regulations in the Netherlands comply with the World Trade Organization's Agreement on Government Procurement and EU procurement directives. Tenders are issued in Dutch and English, although all technical documents will be in Dutch only. All bids should be submitted in Dutch, unless otherwise indicated; there are some highly technical fields where English submissions are accepted. Canadian firms should inquire before submitting an English-language bid. All public tenders over €5 million (approximately $8 million) are published in the Tenders Electronic Daily (TED) database, a supplement of the Official Journal of the European Communities and the Dutch government gazette (Staatscourant). There is a growing tendency in the Dutch market to purchase from a company located in the Netherlands or, alternatively, in Europe. Therefore, local representation is recommended before, during and after the procurement process. This is particularly important if the successful company is providing services or equipment. MARKET LOGISTICSChannels of DistributionWith Rotterdam as the largest seaport in the world, Amsterdam as the fourth-largest cargo airport in Europe, and an intricate network of river barge and highway transportation systems, the Netherlands is strategically located as a distribution centre for other EU countries. A variety of importers, sales agents and distributors in the Netherlands have expertise in international trade; however, because of strong competition, most will insist on an exclusive distributorship. Legislation exists to protect agents from dismissal and breach of contract. Most Dutch have a working knowledge of English, but Canadian companies should make the effort to translate promotional materials into Dutch. Distributors and WholesalersCanadian manufacturers who are new to the market are advised to appoint a distributor or wholesaler to represent their interests in the Netherlands. The leading wholesale pharmaceutical distributor in the Netherlands is Apothekers Cooperatie OPG U.A. (OPG). Other major distributors include Euromedica, Brocacef Holding and Interpharm Group BV. Joint Ventures and PartnershipsJoint ventures between Canadian and Dutch companies are quite feasible since Dutch researchers are increasingly interested in forming strategic alliances with foreign firms. Canadian companies involved in joint ventures with Dutch companies can take advantage of their partner's knowledge of the local market, cultural and technological differences, existing customer-base and dealer network, marketing and sales experience and support services. A local partner can further establish valuable connections with government and local officials. The most important step is to find a good local partner who is well-connected in the industry. Assistance in identifying appropriate Dutch business partners may be obtained by contacting the Canadian Embassy in the Netherlands. It is advisable that Canadian companies check the background of a potential partner company. All Dutch companies must be listed with their local chamber of commerce and the Netherlands Foreign Trade Agency. Market-entry ConsiderationsSuggested Business PracticesDutch companies often operate in a complex business culture in which consensus is sought among government bodies and industry associations - all of which are often in close consultation. Egalitarianism is a central tenant of Dutch society and everyone affected by a decision will be consulted, no matter their position in the company. Generally, the Dutch are known to speak their minds and will not waste time if they are not interested in a product or service. Punctuality is very important for all business and social meetings, and all appointments should be made well in advance. Import RegulationsAs an EU member, the Netherlands follows the Community Integrated Tariff (TARIC) system, which applies duties to all imports from non-EU countries. Dutch import duties for pharmaceuticals range from 3% to 6% and are based on the cost, insurance and freight (c.i.f.) value of the shipment. The receiver of the goods must pay a 6% valueadded tax (VAT) for necessities of life including food, medicines and transportation, and a 17.5% VAT on most other goods including OTCs (note that the VAT is based on the c.i.f. value). Pharmaceuticals may be imported only by qualified pharmaceutical companies located in the Netherlands or other EU countries. For this reason, Canadian companies must negotiate with a company within the European Union to license pharmaceuticals for sale, to purchase a Dutch company or to establish a corporate subsidiary in the European Union. Intellectual Property ProtectionPatentsThe Netherlands is a signatory to the Paris Convention, the World Intellectual Property Organization, the Patent Co-ordination Treaty and the European Patent Convention. This means that any person applying for a patent in one of the signatory countries enjoys a one-year priority right to register the same patent in the Netherlands. Companies should contact the European Patent Office for inquires about registering patents. The Netherlands Industrial Property Office is responsible for granting national patents. Additional patent protection is available through EU Directive 98/44/EC for pharmaceutical products containing biological material or for processes involving biological material. TrademarksThe Uniform Benelux Law on Trademarks governs the registration of trademarks in the Netherlands, Belgium and Luxembourg. According to the law, a trademark must be registered for the entire territory - not only one or two countries. The first user of a mark is entitled to its registration. Applications should be filed with the Benelux Trademark Office. Trademarks are registered in the Benelux countries 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. 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 Interior Market Harmonizing Office in Spain. CopyrightsThe Netherlands currently recognizes a copyright for the life of the author/inventor plus 70 years. In May 1998, the European Union passed legislation that allows for copyright protection of biotech inventions, including artificial genes. Local Standards, Certificates or RegistrationsCanadian firms exporting to Europe are still confronted with both national and EU product standards. These regulations occasionally change to meet new technology and more stringent demands. Agricultural and Food BiotechnologyEuropean UnionIn an effort to rebuild public confidence in EU food safety regimes, the European Commission has proposed regulations on labelling and traceability. These regulations will require genetically modified organisms (GMOs) to be documented on a transformation event basis. Under the new proposal, all food and animal products imported by EU countries must bear a label alerting consumers of the presence of GM ingredients. The new regulations also include measures that impose the separation of GM and conventional crops. For further details, consult "Canadian Exporters' Guide to Food Labelling & Packaging Requirements of the European Union" at http://ats.agr.ca/info/europe/e1429.htm. The NetherlandsThe Ministry of Housing, Spatial Planning and the Environment (VROM) is responsible for implementing EU directives on both the release of GMOs into the environment and the contained use of GMOs. Decisions are made with the consultation and agreement of the Minister of Agriculture, Nature Management and Fisheries. Anyone wishing to conduct research or work with GMOs must receive a permit under the Environmental Protection Act and notify the VROM of their work. The Committee on Genetic Modification (COGEM) is an independent technical and scientific advisory committee in the Netherlands, appointed by VROM. Beyond advising on safety issues concerning biotechnology, COGEM is tasked with alerting relevant authorities to any possible ethical and social concern. The committee is composed of scientists who are subdivided into eight subcommittees concerned with plants, animals, microorganisms, viruses, large-scale activities, medical issues, education and information, and ethical and social issues. Medical BiotechnologyEuropean UnionCanadian prescription drugs must be approved by the European Agency for the Evaluation of Medical Products (EMEA) before they can be sold in the Netherlands. As of January 1995, registration in any EU state is recognized by all other EU members. EMEA approval must be obtained for all biotech and other high-tech pharmaceutical products, but is optional for other products. The EMEA application and approval process takes 300-400 days, and the cost is approximately $250 000 (20-40% less than the cost of obtaining a single, national approval). The EMEA is responsible for ensuring quality and safety of all medical products and monitoring compliance with specific guidelines. The NetherlandsThe Medicines Evaluation Board (MEB) is an independent administrative body comprising doctors and pharmacists who are appointed by the Crown and responsible for authorizing medical products for human use in the Netherlands. The MEB is also involved in granting European marketing authorization and works collaboratively with the EMEA. In order to obtain marketing authorization for new products, Canadian prescription drugs must be registered by a Dutch company (either a manufacturer or distributor) that is officially designated as being able to submit registration applications. This company must submit information related to the quality, safety and efficacy of the product, as well as a proposal for public product information leaflets. Once the file is reviewed by a panel of experts, the MEB decides whether to grant marketing authorization and, if such authorization is granted, finalizes product information texts. All product labelling must include the marketing authorization number, beginning with "RVG." Other EU members are expected to recognize this marketing authorization, unless there are serious objections related to public health. In such cases, manufacturers can apply for arbitration by the EU Committee for Proprietary Medicinal Products. The MEB is responsible for limiting conditions under which a product is authorized, as well as for suspending or revoking market authorization if new information is presented concerning adverse reactions. Determination of the legal status (prescription or OTC) of a new drug is also set by the MEB. For details on product labelling, registration applications and fees, contact the MEB. Export Credit Risks, Restrictions on Letter of Credit, Currency ControlsThe most common method of payment from the Netherlands is by open account. Payments for large shipments are frequently done by irrevocable letter of credit. Payment on delivery is quite common, particularly on new accounts, but buyers will accept a discount of between 2% and 3% and payment is 30 days net. Otherwise, payment terms are either 30, 60 or 90 days from the date of the invoice. PROMOTIONAL EVENTSEvent: Organizer Event: Organizer Event: Organizer Event: Organizer Event: Organizer Event: Organizer KEY CONTACTS AND SUPPORT SERVICESCanadian Government ContactsCanadian Embassy, Netherlands Agriculture and Agri-Food Canada Business Development Bank of Canada Canadian Commercial Corporation Canadian Food Inspection Agency Department of Foreign Affairs and International Trade Market Support Division (TCM) Western Europe Division (REO) Export Development Canada Health Canada Industry Canada Trade Team Canada Bio-Industries Dutch Government ContactsRoyal Netherlands Embassy Benelux Trademarks Office (Merkenbureau) Council for Public Health and Care (Raad voor de Volksgezondheid en Zorg) Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen) Mailing address: Ministry of Agriculture, Nature Management and Fisheries Ministry of Economic Affairs Ministry of Education, Culture and Science Ministry of Health, Welfare and Sport Mailing address Ministry of Housing, Spatial Planning and the Environment Mailing address: National Institute for Public Health and Environment Netherlands Foreign Investment Agency Netherlands Industrial Property Office (NIPO) Netherlands Standards Institute (Nederlands Mailing address: Canadian Industry ContactsAssociation of Health Technologies Industry (AHTI) BioAtlantech BioEast BIONova BioQuebec BIOTECanada Biotechnology Alberta British Columbia Biotechnology Alliance Canadian Agri-Food Research Council Canadian Aquaculture Industry Alliance (CAIA) Canadian Manufacturers and Exporters Association (CME) Canadian Medical Association Toronto Biotechnology Initiative Dutch Industry ContactsBG Pharma (Federation of Wholesalers Pharmaceutical Industry) Dutch Association for the Innovative Dutch Association of the Pharmaceutical Industry for OTC Products Dutch Association for Pharmaceutical Marketers Dutch Homeopathic Manufacturers' and Importers Association International Pharmaceutical Federation Netherlands-Canadian Chamber of Commerce Netherlands Industrial and Agricultural Biotechnology Association (NIABA) Netherlands Biotechnological Society Dutch Research InstitutesAmsterdam-Leiden Institute for Immunology (ALIFI) Bijvoet Centre for Biomolecular Research Biocentrum Amsterdam Biotechnological Sciences, Delft Leiden Experimental Plant Sciences (EPS) Food Technology, Agrobiotechnology, Groningen Biomolecular Sciences and Groningen-Utrecht Institute for Drug Interuniversity Cardiology Institute of the Netherlands (ICIN) Leiden-Amsterdam Centre for Drug Research Medical Genetics Centre (MGC), South-West Netherlands Agricultural Research Department (DLO) Netherlands Organization for Scientific European Industry ContactsEuropean Agency for the Evaluation of Medicinal Products European Federation of Biotechnology European Patent Office (EPO) BIBLIOGRAPHYDun & Bradstreet. 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Overview," 2002. Downloaded from http://www.tradepartners.gov.uk/biotechnology/ Trade Team Canada Bio-Industries. "TTC-BIO031 Newsletter,"
April 2, 2002. Downloaded from http://strategis.ic.gc.ca/epic/internet/ - - - . "Canada's Biotechnology Industry," December 20, 2002.
Downloaded from http://ttcbio.ic.gc.ca/epic/internet/inbio.nsf/ United States Department of State. "World Factbook 2002. The Netherlands," 2002. Downloaded from http://www.cia.gov/cia/publications/factbook/geos/nl.html on January 28. 2003. OTHER REFERENCE MATERIALUseful Internet SitesBioExchange: http://www.bioexchange.com/index.cfm Biotechnology Regulatory Assistance Virtual Office (BRAVO): http://www.bravo.ic.gc.ca/biotech/main.htm CanadaEuropa: http://www.dfait-maeci.gc.ca/canadaeuropa EuropaBio: http://www.europabio.org/pages/index.asp European Patent Office: http://www.european-patent-office.org ExportSource: http://exportsource.gc.ca Health Canada: http://www.hc-sc.gc.ca Holland Biotechnology: http://www.hollandbiotechnology.nl Industry Canada: http://strategis.gc.ca InfoExport: http://www.infoexport.gc.ca Ministry of Health, Welfare and Sport: http://www.minvws.nl/english/index.html?folder=3 Netherlands Medicines Evaluation Board: http://www.cbg-meb.nl Netherlands Foreign Trade Agency Internet: http://www.hollandtrade.com Official Journal of the European Union: http://europa.eu.int/eur-lex/en/oj/index.html Scrip World Pharmaceutical News: http://www.pjbpubs.com/scrip Tenders Electronic Daily: http://ted.publications.eu.int Theta Reports: http://www.thetareports.co.uk 1 All monetary amounts are expressed in Canadian dollars, unless otherwise indicated. The conversion rate to Canadian dollars is based on IDD Information Services, Tradeline, February 2003. 2 For contact information regarding key organizations mentioned in this report, see Key Contacts and Support Services.
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