Market Information
Europe

The Bio-Medical Market
in Italy

November 2000

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

© Department of Foreign Affairs and International Trade
(FaxLink no. 42570)

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:
- the FaxLink Domestic service (613-944-4500); and
- 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

With approximately 20 biomedical products on the market and as many as 100 more in advanced stages of development, the Italian biotechnology market represents emerging opportunities for Canadian companies. The market is currently valued at $3.7 billion¹ and is forecast to grow to $9.1 billion by 2005. As more traditional pharmaceutical companies develop biotechnology products and processes, the distinction between pharmaceutical companies and biotechnology companies will continue to blur. There are 285 pharmaceutical companies in Italy, 70% of which are controlled by foreign multinationals.

The Italian pharmaceutical market was valued at $23 billion in 1999. However, despite the size of the market, there is limited government financial support for research and development in the industry. Growth in the market is also hampered by poor collaboration between academia and industry and a lack of R&D infrastructure.

A vibrant subsector of Italy's pharmaceutical industry is the active pharmaceutical ingredient (API) industry. Italy is the leading country in western Europe for the production of APIs, manufacturing about 30% of all products in the region with exports of $3 billion in 1999. The API industry is characterized by small and medium-sized, family-owned companies. One of the key trends facing the API industry is consolidation to meet the increased demand for sophisticated intermediate chemicals.

Opportunities exist for Canadian biomedical companies to import innovative drugs to Italy and to establish strategic partnerships through licensing and technology transfer arrangements. There are also strong opportunities for generic manufacturers in Italy. There are very few generics currently on the market, but the demand is expected to increase.

TABLE OF CONTENTS

EXECUTIVE SUMMARY

MARKET OVERVIEW

Key Factors Shaping Market Growth
Opportunities

COMPETITIVE ENVIRONMENT

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

PRIVATE-SECTOR CUSTOMERS

PUBLIC-SECTOR CUSTOMERS

Government Procurement Regulations

MARKET LOGISTICS

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

APPENDIX A

PROMOTIONAL EVENTS

KEY CONTACTS AND SUPPORT SERVICES

BIBLIOGRAPHY 

OTHER REFERENCE MATERIALS 

Useful Internet Sites

MARKET OVERVIEW

The Italian biotechnology market is currently valued at $3.7 billion and is forecast to grow to $9.1 billion by 2005. The biomedical industry in Italy is relatively underdeveloped, and has been hampered by a lack of regulations. However, the recent integration into national legislation of European Union Directive 98/44 EC - dealing with patenting biotechnology products - has stimulated the industry. As the science behind biotechnology develops, many traditional pharmaceutical companies are turning their attention to the potential of biopharmaceuticals.

The Italian pharmaceutical market is the fifth-largest in the world (after the United States, Japan, Germany and France) and is currently growing at a rate of 5% per year.

The industry was valued at $23 billion in 1999, with imports accounting for approximately 35% of all sales. Human and veterinary pharmaceuticals account for 79% of sales, and bulk products for the pharmaceutical industry account for the remainder. Per-capita consumption of pharmaceuticals in Italy is below average when compared to other western markets, including the United States, France and Belgium.

The president of the Italian Biotechnology Association, Assobiotec,² estimated in 1999 that there were 20 biotechnology-based pharmaceuticals on the market in Italy, with as many as 100 more in advanced stages of development.

As of August 1999, there were 285 pharmaceutical companies in Italy, 70% of which were controlled by foreign companies. Production in 1997 was valued at $18.33 billion, with finished products accounting for 80.5% and pharmaceutical ingredients for 19.5%.

Investment in the pharmaceutical industry totaled $1.4 million in 1998. Although this money represents one of the largest sectoral investments in Italy, it is considerably lower than in other EU countries.

Source: Survey of the Italian Pharmaceutical and Medical Devices Market, October 1999.

State-reimbursed products under the national universal health-care authority, the Servizio Sanitario Nazional (SSN), are the most important part of the market. In 1998, spending on reimbursable drugs rose 9.1% to $14.04 billion. As of January 1998, there were 2118 reimbursed products on the Italian market in 3954 formats. Of these, 3631 were fully reimbursed and the remainder required a 50% co-payment by the patient. Since 1994, Italy has had a three-tiered classification system for medicines: Class A drugs are fully reimbursable by the SSN, Class B drugs are 50%-reimbursable and Class C drugs must be paid for in full by the patient. Over-the-counter (OTC) drugs are included in Class C and are the only drugs that may be advertised. Class A products accounted for 58.92% of the Italian pharmaceutical market by value in 1997, Class B for 6.04%, Class C for 21.02%, non-prescription for 5.9%, and OTCs for 8.12%.

Generics are largely missing from the Italian market. Doctors are not encouraged by government regulations to prescribe them, and pharmaceutical manufacturers and distributors enjoy the profit margins of branded pharmaceuticals. Analysts predict that this trend will change as the Italian government continues to rationalize health-care costs and more generic companies become active in the market.

As in other countries in the European Union and North America, the Italian government is struggling with rising health-care costs and the medical demands of an aging population. The reorganization of the Italian national health system to focus on cost rationalization has introduced financial accountability to the local level, and has increased competition in the pharmaceutical industry. The Italian government introduced a pricing strategy in 1994 that resulted in pharmaceutical prices being, on average, 30% lower than in the rest of Europe. Most manufacturers of innovative drug products chose not to market their products in Italy under this pricing system. In 1996, a "same price for the same drug" principle was introduced, which saw drug prices reduced to the level of the cheapest product in each therapeutic category. Companies could reduce their prices or have their products de-listed from the reimbursed health insurance program. The industry was highly critical of this system as well.

In 1998, the Ministry of Health announced "co-responsibility" for pharmaceutical spending and raised the prices of many reimbursed products. The government determined that 60% of spending beyond the national budget for pharmaceuticals would have to be paid back by the pharmaceutical industry. The remaining 40% of overspending would be absorbed by the government. The issue was controversial, raising questions of how payment would be distributed among companies and arguments that a limited number of products were responsible for the overshoot.

Although large overspendings were registered both in 1998 and 1999, the industry has not yet been asked to pay back their share and discussions are underway among the industry associations and the Italian Government to determine how and whether the refund should actually take place. The prevalent interpretation is that industry will not have to pay back any amount in exchange of a two year freeze on price increases.

Further changes were introduced in 1999 that met European Commission demands for a more equitable pricing scheme. Generics are no longer considered in price comparisons, and a number of de-listed products have been reinstated. The prices for biotechnology-based pharmaceuticals are negotiated between manufacturers and the government under Interministerial Economic Planning Committee (CIPE) criteria.

Criteria include cost-benefit analysis, therapeutic value, price elsewhere in Europe, sales forecasts and estimated patient numbers.

Although the Italian market is large, Italy relies heavily on pharmaceutical imports, principally from Switzerland, Germany, France and the United States. Between 75% and 85% of drugs consumed in Italy are wholly imported, contain imported ingredients or are produced under foreign patents. Italy has a negative trade balance for pharmaceuticals, with imports outweighing exports by approximately $1.1 billion, making Italy the only other major industrialized country, together with Japan, with a pharmaceutical trade deficit.

The Italian government launched a national development plan for biotechnology and genetic engineering in the fall of 1999. Sites were established throughout the country as centres of excellence in biotechnology R&D, as well as industrial incubators to develop projects resulting from the research. The government allocated $7 million in 1999 and $14 million in 2000 for infrastructures and equipment necessary to create and support a network of excellence centres. Centres are selected on a three year basis by the Italian Ministry of Universities and Research (MURST), based on a bid calling for projects from Universities and Colleges. Deadline for the presentation of the projects was June 30, 2000. The final list of projects should be made public on October 31. Despite the size of the Italian pharmaceutical market, there are limited government financial or taxation provisions in support of R&D in the industry. In addition to this lack of support through government-funded initiatives, there is also a lack of R&D infrastructures. According to a recent study, only three out of 15 multinational companies had R&D development in Italy. The majority of companies focused on clinical registration, or had a market orientation. Although there has been recent improvement in the collaborative efforts between industry and academia, overall, the Italian industry's commitment to R&D is low.

A vibrant subsector of Italy's pharmaceutical industry is the active pharmaceutical ingredient (API) industry, which was established in the 1940s. Today, Italy is the leading API-producing country in western Europe, manufacturing about 30% of all products in the region. Italy has developed an export-oriented mentality, exporting almost $3 billion in APIs in 1999. From 1990 to 1998, Italian production of APIs grew by 80%, reaching a value of $4.7 billion in 1998. Unlike the pharmaceutical industry, the API industry is not characterized by multinational corporate ownership. The majority of companies in the industry are small and medium-sized, largely family-owned operations. However, one of the key trends facing the API industry is consolidation to meet increased demand for sophisticated intermediate chemicals.

Over-the-Counter Drugs

Similar to other European countries, OTCs in Italy are sold primarily through pharmacies. While the Italian market is growing, it is behind those of its European counterparts. The OTC market in Italy was valued at $1.5 billion in 1997, and is expected to top $2.8 billion by the end of 2000. Sold without a prescription and not subject to reimbursement under the Italian health system, there are 1175 preparations on the market.

Italy's OTC manufacturers' association - Assosalute - is currently lobbying for a simplification of the drug classification system to two classes of drugs: prescription and non-prescription. Opposition to the proposal by both government officials and healthcare professionals suggests that a two-tier system is unlikely in the near future. OTC manufacturers have also begun a political campaign against proposed price cuts to OTC drugs. Manufacturers want to see the market remain competitive with other markets in Europe.

Key Factors Shaping Market Growth

An ever-increasing proportion of the Italian population is over 65, resulting in increased health-care costs associated with geriatric care. With one of Europe's highest longevity rates (women's life expectancy is 78 years and men's is 72 years), the growth rate will translate to 40% of the population being over the age of 60 by 2038. The last 10 years have seen the Ministry of Health work to rationalize the health-care system, and this trend is likely to continue, particularly as innovative drugs and treatments become more expensive.

In 1998, Italy, along with the Netherlands, opposed the European Union Directive 98/44 on the legal protection of biotechnology inventions, and challenged it in the European Court of Justice. Italian biotechnology industry associations, including Farmindustria and Assobiotec, were outspoken against this action by the government and claimed that the move threatened the state of biotechnology R&D in Italy. The associations urged the government to reconsider its position. By October 1999, the Italian government dropped its legal challenge of the directive, and drafted a bill to incorporate it into national legislation. The bill did contain an additional clause to meet the government's concerns that no damage would be caused to humans, animals or the environment as a result of commercializing any biotechnology products. Analysts forecast new energy for Italy's biotechnology industry as a result of these patent protection changes. The lack of a harmonized patent protection system with other EU countries had reduced the potential for expansion of product lines. It is now expected to play an important role in enabling the European biotechnology industry to compete against non-EU companies, and to create new jobs in the European Union.

While Italy is experiencing a significant movement toward privatization of various government-controlled industries, the capital market is still underdeveloped, making investment in R&D difficult and venture capital virtually non-existent for small and medium-sized enterprises (SMEs). Since the majority of pharmaceutical companies in Italy are multinationals, SMEs must share R&D costs or join together to seek out venture capital. Moreover, analysts believe that the current level of investment in research and innovation is not high enough to support an adequate strengthening of the biotechnology industry. Currently, the tax on capital gains from high-risk investments is the same as the tax on low-risk investments, and is therefore preventing growth in venture capital investment in biotechnology.

A further barrier to growth in biomedical technology is the lack of co-operation and, therefore, technology transfer between universities and the industry. Along with increased collaboration, Italy also needs a single body to co-ordinate biomedical research activities throughout the country and to assist with the creation of publicly funded research facilities.

Opportunities

Working with Italian SMEs through strategic partnerships is the most promising route for potential entry into the Italian market. Generally speaking, SMEs are looking for business partnerships to broaden their product lines and assist with expansion into foreign markets for new business opportunities. Joint ventures, strategic partnerships, technology transfer arrangements or licensing agreements offer Italian companies a competitive edge to other companies in the European Union. Opportunities exist for Canadian companies to import innovative drugs to Italy. Those already registered for sale in the European Union will be most easily introduced to the Italian market. Demand will increase for cardiovascular treatments, cancer preparations, allergy medications, AIDS-related drugs, as well as treatments for conditions associated with the aging population.

The are also significant opportunities for generic manufacturers in Italy. There are very few generics currently on the market, but the demand is expected to increase. Companies, including Apotex Canada, have begun to form alliances with Italian companies to take advantage of this opening in the market.

COMPETITIVE ENVIRONMENT

Local Capabilities

There are 285 pharmaceutical companies in Italy, 70% of which are controlled by foreign companies with subsidiary branches or manufacturing plants. Almost all pharmaceutical companies are concentrated in and around Milan. The Italian market leader in pharmaceuticals is the Menarini Group, based in Florence, with a total of 10 production facilities, four of which are abroad. Other key players in the market include Istituto Biochimico Italiano, Zambon Group SPA, and Chiesi Farmaceutici SPA. Italy is among the world leaders in the production of antihistamines, vitamins, alkaloids and antibiotics.

Italian companies are the principal suppliers of bulk pharmaceutical chemicals and active pharmaceutical ingredients to the U.S. market - about 58% of U.S. imports from Europe are from Italy. The Italian industry is dominated by SMEs, most of which are located in northern Italy. The vast majority of these companies employ less than 100 people.

International Competition

By far, the largest biotechnology industry in the world is the United States, which is followed by Germany, the United Kingdom, France and Canada. The dominant international players in the Italian market include: Roche (Switzerland), Glaxo Wellcome (United Kingdom), Novartis (Switzerland) and Pfizer-Pharma (United States). The market is concentrated, with 25 companies sharing almost 60% of the entire market.

Despite the presence of multinationals, there is still a need for SMEs to do critical earlystage work in the area of drug discovery. More than 90% of advanced biotechnology products on the world market are health related, and it is expected that about three quarters of the total world demand for biotechnology will continue to be in the health sector. World sales of biopharmaceuticals have grown more than sevenfold over the past decade, and should exceed $26 billion by 2003. The biopharmaceutical portion of world prescription drug sales is expected to triple from 5% to 15% by 2005.

Canadian Position

The Canadian biotechnology industry has flourished over the last several years. With almost 500 companies, collective revenues of more than $1.9 billion and research expenditures of more than $1.5 billion, Canada is poised to become a world leader in pharmaceutical research and production. Canadian exports to Italy are estimated to be close to 0.5% of the market and, in 1997, represented $1.4 billion.  

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. In 1999, the federal government announced a $550 million increase in health research funding over three years and reinforced biotechnology as an important growth sector for the future. The funding announcement included the creation of the Canadian Institutes of Health Research, $200 million in additional funding for the Canadian Foundation for Innovation and $150 million in additional funding for Technology Partnerships Canada. This commitment to biotechnology was strengthened in the federal budget in February 2000 with the announcement of $160 million to fund five genomic science centres across Canada, $900 million for university and hospital research infrastructure and $900 million for additional research chairs at Canadian universities. The government has also allotted $90 million to strengthen Canada's regulatory capacity in the area of biotechnology.

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 is well positioned to provide joint-venture partnerships and commercialization expertise as well as a broad range of products resulting from Canada's research and development efforts.

Examples of Canadian collaboration in the Italian market include Apotex, based in Toronto, who have a joint-venture partnership with Chiesi and Zambon of Italy in marketing generic pharmaceuticals. The new company, DOC Generici, is based in Milan and produces a range of 20 pharmaceutical products. As well, Patheon Inc. of Toronto, Canada's largest contract pharmaceutical manufacturer, concluded its purchase of a large pharmaceutical plant near Milan in December 1998. Patheon purchased the $15 million facility from the Italian affiliate of Hoffmann-La Roche Ltd. This was Patheon's first purchase outside of Canada.  

Bioniche Life Sciences Inc. of London Ont. recently announced the signing of a distribution agreement with Zambon Italy for exclusive marketing and distribution rights of Cystistat, the company's innovative product for the treatment of interstitial cistitis.  

Axcan Pharma, based in Quebec, recently entered into a new 10 year (renewable) agreement with Eurand International SpA of Milan, Italy, which grants Axcan the right to market a new generation of the ULTRASE pancrelipase minitablets to be manufactured by Eurand with a new coating, on an exclusive basis in the US, Canada, Mexico, Central and South America. In July, Axcan also obtained marketing approvals for their product PHOTOFRIN in Sweden, Ireland and Italy.

Competitive Advantage through Canadian Government Policies and Initiatives

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 devices and pharmaceuticals, among other sectors, entered an evaluative phase in October 1999. A subsequent phase will involve the mutual acceptance of regulatory decisions based on results from preliminary reviews. The final stage of the MRA's implementation was extended past the original projection of 18 months as a result of its inherent complexity. For further information, contact the Department of Foreign Affairs and International Trade (DFAIT), European Union Division (REU).

In relation to the pharmaceuticals sector, the MRA establishes mutual recognition of each country's regulations on the manufacturing of pharmaceuticals, based on good manufacturing practices (GMPs). The MRA makes certification for regulatory compliance faster and cheaper. Efficient certification procedures, in turn, help to open doors for smaller firms that were formerly unable to enter European markets because of prohibitive regulatory costs. It is also expected that Canada-EU co-operation will continue to reduce and eliminate tariff and non-tariff barriers, which will further ease Canada's penetration of EU markets. For further information, contact Health Canada, Therapeutic Products Program Office. 

Canada-EU Co-operation in Science and Technology Agreement

An amendment to the existing Canada-EU Agreement on Co-operation in Science and Technology was signed in December 1998 extending coverage of the agreement to include pharmaceuticals. Intended to encourage collaborative R&D activities between the signatories, it allows reciprocal access to research programs funded by either the Canadian government or European Union. For further information, contact DFAIT's European Union Division (REU).

Export Development Corporation

Export Development Corporation (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.

Canadian Commercial Corporation

The 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.

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 fairs, incoming buyers, product testing for market certification, legal fees for international marketing agreements, transportation costs of offshore company trainees, product demonstration costs, promotional materials, 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 Project Bidding) and, for trade associations, developing international marketing activities for their membership. For additional information visit http://www.infoexport.gc.ca/pemd-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/menu-e.asp 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. Contact the Department of Foreign Affairs and International Trade, European Business  Development Section (RENB) or visit http://www.infoexport.gc.ca/nexos-e.asp for more information about NEXOS.

Technology Partnerships Canada

Industry Canada's Technology Partnerships Canada is an investment loan fund of $250 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 1-800-266-7531 or consult the Internet at http://tpc.ic.gc.ca.

PRIVATE-SECTOR CUSTOMERS

Although Italy's health-care system is primarily public, private-sector spending is on the rise. Dissatisfaction with the quality of public health care, an increase in patient co-payments, and the introduction of prescription charges has led to relatively high spending on private health services in Italy. About 10% of the population is covered by some form of health insurance or belongs to a mutual assistance organization.  

The private sector consists of approximately 799 hospitals - most of which are located in southern Italy where public services are not as prevalent - that operate under contract to the public sector. While the vast majority of the private hospitals seek accreditation by the SSN, some elect not to seek accreditation (107 in 1996), instead working through private insurers, company or industrial health funds, or mutual assistance organizations. Each privately owned hospital has its own purchasing procedures.

In 1998, there were 16 317 pharmacies in Italy. A recent trend in the pharmaceutical industry has been the mass privatization of publicly owned pharmacies. Previously, the distribution of pharmacies was regulated by law, with a specific number licensed to each municipality based on population considerations. In April 1999, Gehe AG, a large German pharmaceutical wholesaler, acquired AFM Bologna, a prominent public pharmacy group, and is now turning its attention to municipal councils in Milan, Florence and Rome to negotiate further pharmacy purchases. In May 1999, Moss Chemist partially acquired Amfa, a publicly owned Italian pharmacy and pharmaceutical wholesaling business. Moss Chemist, a subsidiary of Alliance UniChem, acquired 73.8% of Amfa. Based in Rimini, Amfa is one of the larger pharmacy/pharmaceutical groups, with reported sales of $21.2 million in 1998.

PUBLIC-SECTOR CUSTOMERS

Italy's universal health-care authority, the SSN, was implemented in 1978 and guarantees mostly free as well as co-payment access to health care, preventive medicines and rehabilitation. The SSN is made up of 21 regional and 295 local health authorities. In addition, there are 81 hospitals operating as "hospital trusts," which provide facilities to the SSN through a complex reimbursement system.

Regional authorities are responsible for the provision of all health-care services and negotiating contracts with hospitals in the private-hospital sector. In addition, there are 1090 public hospitals in Italy that follow government-tender procurement procedures.

For small and sporadic purchases of less than $8,000, hospitals are not obliged to issue a tender and products can be acquired as necessary. While public tenders are open to both domestic and foreign companies, the cumbersome bureaucratic procedures of public procurement make it almost impossible to bid successfully without having a base in Italy. Moreover, companies participating in the public-tender system should be well-known by hospital management.

Despite privatization trends, a significant number of public pharmacies are still run by individual town councils. A number of pharmacists have voiced a concern over privatization, claiming that it will negatively affect competition. Some believe that these acquisitions will result in large distribution groups offering discounts that smaller pharmacies will not be able to match. Accordingly, public pharmacies are not expected to be phased out completely. As is the case with the regional health authorities, individual town councils maintain a considerable level of autonomy. This is particularly true with respect to public pharmacies in their jurisdiction. However, individual pharmacies are not obliged to procure supplies through the town council. 

Government Procurement Regulations

While some progress has been made in making procurement laws and regulations more transparent, Italy has neither fully updated its government procurement code nor completely implemented the World Trade Organization Agreement on Government Procurement and the EU directives. Following the discovery of kickbacks to drug-pricing officials, legislation enacted in 1994 (known as the Merloni Law) aimed at providing more transparent procurement procedures and establishing a central body to monitor implementation.

There are three types of bidding procedures:

• Asta pubblica (public tender): the most common method involving purchases of more than ECU200,000 and open to companies meeting criteria outlined in the bid specifications;
• Licitazione privata (private bidding): open to companies that have been pre-screened; and
• Trattativa privata (private contract): involving direct negotiations with the supplier of choice.

Since there is a preference for local suppliers and the government and its agencies do not normally purchase abroad, Canadian companies are encouraged to use Italian agents and distributors. Companies are also advised to submit product information and company details, written in Italian, to various government departments and procuring bodies, including hospital management boards, as proof of professional expertise. All Italian and foreign companies supplying goods and services to the Italian government or any government-controlled organization must present an Anti-Mafia certificate certifying that the owners and principals have no past convictions and are not defendants in current criminal proceedings.

MARKET LOGISTICS

Italy is divided into 94 provinces and 20 regions. The quality of Italy's transportation infrastructure is inconsistent, particularly between the north and south. Despite modern port and railway infrastructures, most merchandise (over 60%) is transported by the road network, which is vast, but in need of repair.

There are 1729 health-care facilities in Italy, including public and private hospitals, and approximately 77 000 doctors. Advertising of prescription drugs, distribution of free samples to the general public and inducements to prescribe a particular medicinal product are forbidden in Italy. Restrictive advertising regulations apply to OTCs and, more importantly, advertising rates in Italy are extremely high. As a result, only multinational companies are typically able to advertise their products, which adversely affects domestic manufacturers as their brands become less visible. While a large number of products are imported, the complexity of the market and the priority given to domestic suppliers means that foreign companies must seek a local partner in order to succeed at penetrating the market.

The Ministry of Health supervises the promotion of all prescription drugs. While the promotion or advertising of prescription pharmaceuticals to the public is against the law, companies are permitted to promote their products with doctors and pharmacists through visits, literature and advertising in trade publications.

Channels of Distribution

Distributors and Wholesalers

To ensure efficient distribution, exporters are encouraged to retain the services of a distributor/wholesaler dealing specifically with pharmaceuticals and biopharmaceuticals. In 1998, almost 300 wholesalers and pharmaceutical dealers operated in the Italian market. Distributors and wholesalers with stocking facilities must meet Ministry of Health requirements and be authorized by the Ministry. Given that distributors and wholesalers have varying degrees of market coverage - some serve only urban centres while others cover larger regions of the country - it is most advisable to become established on a regional basis before attempting national distribution. The Canadian Consulate in Milan can provide Canadian companies with a list of possible distributors.

Agents and Sales Representatives

Negotiating the rules and regulations of the Italian bureaucracy can be difficult. The central government is more pervasive than in Canada, and it is advisable to get assistance from someone familiar with the intricacies of the system. While agents solicit business and enter into agreements on behalf of the Canadian exporter, they do not take ownership of the product. Accordingly, a number of factors must be considered - from reputation, product knowledge, experience, commission, track record and size - and Canadian companies are advised to seek legal advice when drawing up a representation agreement.

All agents in Italy are required by law to be listed in a register maintained at the regional Chamber of Commerce. Agreements should be in writing, specifying the agent's marketing area and exclusivity arrangements. Italian agency law now conforms with EU requirements. Companies interested in seeking a distributor for their products are encouraged to contact the Canadian Consulate in Milan for assistance.

Suggested Business Practices

Canadians are not generally known in Italy as an entrepreneurial or business-minded people. Another challenge for Canadian exporters entering the Italian market is that it is a more formal business environment, requiring frequent visits to clients, distributors and agents. Neither English nor French are widely spoken in Italy; it is, therefore, advisable to determine in advance whether an interpreter will be available for business meetings.

Titles on business cards are taken seriously and are important in establishing initial contacts. Business relations are formal but gracious and attempts to understand the Italian language and culture are appreciated.

Protection of Intellectual Property

Italy is a member of the World Intellectual Property Organization and a party to the Berne and Universal Copyright conventions, the Patent Co-operation Treaty, and the Madrid Agreement on International Registration of Trademarks. Italy is also a signatory to the European Patent Convention, but has not yet ratified it.  

Patents

The EU Commission is working to harmonize the intellectual property laws of EU member states, and has created a single patent and trademark system that regulates the length of patent protection of an original medicinal product within the European Union. The issues around the patent protection of biotechnology have been debated within the European Parliament and the Council of the EU since they were first proposed in October 1988 and remain controversial. The Biotechnology Patenting Directive (98/44 EC) allows for the patenting of biotechnology inventions and is granted to the original product or technology for a period of 20 years. Patents for pharmaceuticals for humans may be extended for an additional four years if the applicant can show insufficient revenues during the initial term. Commercial research, preparation of filing dossiers, application for and authorization of a generic product are not permitted during the patent protection time frame. A copy of the EU directive on biotechnology patents can be viewed at http://www.wuesthoff.de/c.htm. As mentioned above, Italy has incorporated the directive into national legislation, with one additional clause accounting for the health and safety of humans, animals and the environment. Before beginning the patent-application process, exporters should obtain detailed information and hire a patent attorney.

Trademarks

The European Community Trademark Act established a registration system that came into force in 1996 and co-exists with the national system of registration. Applications are filed with the EU Trademark Office in Alicante, Spain.  

Under the Italian trademark system, applications are examined for acceptability and consistency. Once the mark is registered, there is no opportunity for opposition.

Trademarks are registered for 20 years from the effective filing date, and are renewable for similar periods, but must be used continuously. Failure to use a trademark within three years after registration can result in cancellation. No prior use claim can be rendered after the mark is registered for five years.

Copyright

Italy is a member of the Universal Copyright Convention, under which authors receive automatic copyright protection in Italy for their works published and copyrighted in Canada. In January 1996, the Italian parliament extended the copyright term from 50 to 70 years.

The EU Commission is working to harmonize copyright protection in several areas, and in May 1998, passed legislation for copyright protection of biotechnological inventions, which, upon member ratification, is expected to be implemented by 2001.

Import Regulations

A 10% value-added tax (VAT) is added to the cargo, insurance and freight (CIF) value of pharmaceutical products on entering Italy. All foreign firms doing business in Italy are also required to register with the local Chamber of Commerce, Industry and Agriculture.

Local Standards, Certificates or Registrations

The Canada-EU Mutual Recognition Agreement (MRA) is currently in the second phase of implementation and has had a significant impact on the certification procedures for Canadian products entering the markets of any EU member state. It effectively removes the requirement for Canadian companies to undergo local European testing and certification procedures, provided that they have already been undertaken in Canada.

Since January 1995, the market entry of biotechnology-derived drugs has been eased. Products not covered by the MRA must be certified by the European Medicines Evaluation Agency (EMEA), which is responsible for the administration of common rules relating to the approval, quality and safety of prescription drugs in the European Union, as well as monitoring compliance with the guidelines. The Agency's endorsement of a new drug is binding in all EU member states. The application and approval process takes between 300 and 500 days, and costs approximately $250,000. Packaging must include the European registration number beginning with "EU."

The text of the regulations can be found in the Official Journal of the European Communities of July 22, 1993. It covers the procedures for the authorization of medicinal products for human and veterinary use and includes a list of products that pharmaceutical companies are compelled to register with the Agency, as well as application procedures and fees. Pharmaceuticals that cannot be registered through the EMEA - including established (non-innovative drugs) and products requiring re-registration due to changes in format or packaging - follow national procedures.

This centralized system for pharmaceutical registrations has raised concerns among manufacturers of generic products. In most cases, brand-named pharmaceutical products were not harmonized across the European Union before the EMEA was created. As a result, there are discrepancies and variations in the Summary of Product Characteristics between countries, resulting in the inability of generic manufacturers to apply one formula throughout Europe. As patents on brand-name products expire, approval for generics must be obtained on an individual basis for each country in the European Union.

Since the establishment of the EMEA in 1995, none of the 76 new biotechnology products have been registered under Italian manufacturers' names. 

National Marketing Authorization

National procedures for the registration of pharmaceuticals are governed under Law No. 178 dated May 29, 1991, which implements a number of EU directives. The Italian Ministry of Health, and the pharmaceutical committee - Commissione Unica Farmaco - are responsible for accepting applications and issuing marketing authorizations.

Approval of applications takes at least four months, and must be accompanied by all necessary documentation. The fee for filing this application is approximately one fifth of that applied by the EMEA.

With a backlog of 1495 dossiers requiring approval in 1998, products have been taking an average of 24 months to approve. However, mutually recognized and centrally approved products are reported to pass through the administrative procedures on a timely basis.

Labelling, Pricing and Other Requirements

Modifications to dosages or methods of presentation, such as tablets rather than liquid form, constitute a "new" product and require new Ministry of Health registration. In accordance with EU directives, Italy has regulations with respect to standardized packaging sizes and weights, and labelling must be in metric units for all products to be sold in Italy. The EU deadline for accepting metric only labels has been extended to 2010.

Export Credit Risks, Restrictions on Letters of Credit, Currency Controls

Credit terms are usually between 60 and 90 days, varying according to the size of transaction. Since delays for payments are frequent, Canadian exporters are advised to specify terms of payment in the contract and include clauses with respect to late payments.

On January 1, 2002, the withdrawal of national currencies will begin and businesses will be required to begin operating in the European currency (the Euro). By July 1, 2002, the Euro will be the only legal tender used in EU member countries.

APPENDIX A

Recent Company Details

• Istituto Biochimico Italiano (IBI), based in Milan, announced in June 2000 an exclusive agreement with American Pharmaceutical Partners of California to market several antibiotics in Italy. IBI is one of the largest antibiotic producers in Italy and the European Union. The company has facilities for the production of penicillin-based products as well as active ingredients for other pharmaceuticals.
• Telethon Institute of Genetics and Medicine, previously based in Milan, announced its relocation to Naples in January 2000, enhancing that city's reputation as a centre for genetic research.
• Alfa Wassermann SPA signed an agreement in January 2000 with Ligand Pharmaceuticals Inc. for exclusive long-term marketing and distribution rights in Italy.
• Zambon Group SPA, a multinational pharmaceutical company based in Milan, has begun a clinical development program with Sheffield Pharmaceuticals Inc. of St. Louis. The program involves ipratropium bromide to be delivered through a metered solution inhaler. The two companies are strategic partners in the worldwide development and commercialization of respiratory drugs based on Sheffield's metered solution inhalers.
• Chiesi Farmaceutici SPA, based in Parma, announced a development and licensing agreement with EpiGenesis Pharmaceuticals Inc., for an antisense oligonucleotide therapy for the treatment of respiratory diseases. The agreement was announced in January 2000 as an expansion step for Chiesi into biotechnology products. The Chiesi Group is one of the largest Italian-owned pharmaceutical companies with marketing and sales staff in most European markets, and product distribution in over 40 countries.
• Eurand, a drug-delivery company based in Milan, announced the purchase of Vectorpharma, a former subsidiary of Recordati, in February 2000. The agreement was valued at US$7.4 million.
• Mipharm signed a strategic alliance agreement with Soltec Research Ltd. of Australia in December 1999 for exclusive access to Soltec drug-delivery platforms in Italy and other Mediterranean countries.
• Milan-based Antibioticos, part of the Montedison Group of companies, is one of the world's largest producers of penicillin and cephalosporine antibiotics for humans and animals.

PROMOTIONAL EVENTS

MEDICA
International Trade Fair with Congress
November 22-25, 2000
Dusseldorf Trade Fair Center
Dusseldorf, Germany

Organizer:
Messe Dusseldorf (in Canada)
480 University Ave., Suite 1410
Toronto, ON M5G 1V2
Tel.: (416) 598-1524
Fax: (416) 598-1840

CPHI - Pharmaceutical Ingredients Worldwide
November 7-9, 2000 (Annual)
Milan Fairgrounds (Feira di Milano)
Milan, Italy

Organizer:
Miller Freeman BV
PO Box 200
3600 AE Maarssen
Industrieweg 54, Netherlands
Tel.: (31-34) 655-9444
Fax: (31-34) 657-3811
E-mail: cphi@unmf.com
Internet: http://www.CPhI.com

BIOTECHNICA 2001
October 9-11, 2001
Hannover, Germany

Organizer:
Deutsche Messe AG
Messegelände
D-30521 Hannover
Tel.: (49-511) 89-0
Fax: (49-511) 89-326-26

BIO 2001
June 24-28, 2001
San Diego Convention Center
San Diego, California

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

BioEurope 2000
November 13-15, 2000
Hyatt Regency Hotel
Berlin, Germany

Organizer:
E.B.D. Group. Inc.
6120 Pseao Del Norte, Suite J-2
Carlsbad, CA 92009
Tel.: (760) 930-0500
Fax: (760) 930-0520
E-mail: Bioeurope2000@ebdgroup.com
Internet: http://www.ebdgroup.com/bio2000

MILANO SALUTE
October 19-22, 2000
Milan Fairgrounds
Milan, Italy

Organizer:
Milano Salute
Via Domenichino 11
20149 Milan, Italy
Tel.: (39-02) 481-5541
Fax: (39-02) 498-0330
E-mail: assoexpo@assoexpo.com
Internet: http://www.assoexpo.com

DIABIOTECH 2000
November 28-30, 2000
Fortezza da Basso
Florence, Italy
Biomedical and diagnostics industry

Organizer:
Italian Association for Biomedical and Diagnostic Technology
Via Olgettina 58
20132 Milan, Italy
Tel.: (39-02) 264-110-31
Fax: (39-02) 264-104-13
E-mail: assobiomedica@assobiomedica.it
Internet: http://www.assobiomedica.it

KEY CONTACTS AND SUPPORT SERVICES

Canadian Government Contacts

Department of Foreign Affairs and International Trade
125 Sussex Dr.
Ottawa, ON K1A 0G2
Market Support Division (TCM)
Tel.: (613) 996-1431
Fax: (613) 943-8820
Contact: Patricia Filteau, Trade Commissioner
E-mail: patricia.filteau@dfait-maeci.gc.ca
Internet: http://www.dfait-maeci.gc.ca

Southern Europe Division (RES)
Tel.: (613) 992-8022
Fax: (613) 995-8783
Contact: Lisa Helfand
E-mail: lisa.helfand@dfait-macei.gc.ca

European Business Development (RENB)
Tel.: (613) 996-3298
Fax: (613) 944-1008
Email: renb@dfait-maeci.gc.ca

European Union Division (REU)
Tel.: (613) 996-2727
Fax: (613) 944-0034
Email: reu@dfait-maeci.gc.ca

Agriculture and Agri-Food Canada
Market and Industry Services Branch
Sir John Carling Building
930 Carling Avenue
Ottawa, ON K1A 0C5
Tel.: (613) 759-7744
Fax: (613) 759-7499
Contact: Jo-Anne Stewart
E-mail: stewartja@agr.gc.ca
Internet: http://www.agr.ca

Business Development Bank of Canada
5 Place Ville Marie, Suite 400
Montreal, QC H3B-2G2
Tel.: 1-888-463-6232
Fax: (514) 283-0617
Internet: http://www.bdc.ca

Consulate General of Canada in Milan
Via Vittor Pisani 19
Milan, Italy 20124
Tel.: (39-02) 675-81
Fax: (39-02) 675-83-900
Contact: Sandra Marchesi
Email: sandra.marchesi@dfait-maeci.gc.ca

Industry Canada
Life Sciences Branch
P.O. Box 940, Station A
1801 Hollis Street
Halifax, NS B3J 2V9
Tel.: (902) 426-9958
Fax: (902) 426-2624
Contact: Mark Craig, Bio-Industries
E-mail: craig.mark@ic.gc.ca
Internet: http://strategis.ic.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
Therapeutic Products Program Office
Holland Cross, Tower "B," 2nd Floor
Address Locator: 3102D1
1600 Scott St.
Ottawa, ON K1A 1B6
Internet:
http://www.hc-sc.gc.ca/
hpb-dgps/therapeut

Export Development Corporation (EDC)
151 O'Connor St.
Ottawa, ON K1A 1K3
Tel.: (613) 598-2500 or 1-888-332-3320
Fax: (613) 237-2690
E-mail: export@edc-see.ca
Internet: http://www.edc.ca

Canadian Commercial Corporation (CCC)
50 O'Connor St., Suite 1100
Ottawa, ON K1A 0S6
Tel.: 1-800-748-8191 or (613) 996-0034
Fax: (613) 995-2121
Internet: http://www.ccc.ca

Italian Government Contacts

Italian National Institute of Health (Istituto Superiore di Sanità - ISS)
Viale Regina Elena, 29
00161 Rome, Italy
Tel.: (39-06) 499-01
Fax: (39-06) 493-87-118
Internet: http://www.iss.it (Italian)

Ministry of Health (Ministero della Sanità)
Department of Medical Products and Pharmaceuticals Evaluation (Dipartimento per la valutazione dei medicinali e la farmacovigilanza)
Via della Civiltà Romana, 7
00144 Rome, Italy
Tel.: (39-6) 599-41
Fax: (39-6) 599-44-142
E-mail: g.guglielmi@sanita.it
Internet: http://www.sanita.it (Italian)

Italian Pharmaceutical Committee (Commissione Unica del Farmaco - CUF)
Piazzale dell'Industria, 20
00144 Rome, Italy
Tel.: (39-06) 599-41
Fax: (39-06) 599-4532-8
Internet:
http://www.sanita.interbusiness.it/
sanita/farmaci/normativa/
29%5F10%5F97.htm

Ministry of Trade (Ministero Commercio L'Estero)
Viale America, 341
00144 Rome, Italy
Tel.: (39-06) 599-31
Fax: (39-06) 596-4750-7 or 596-4749-4
Internet: http://www.mincomes.it

Ministry of Foreign Affairs
(Ministero Degli Affari Esteri)
P.le Farnesina, 1
00194 Rome, Italy
Tel.: (39-06) 369-11
Fax: (39-06) 322-2850
Internet: http://www.esteri.it

Italian Trade Commission in Canada
Montreal:
Délégation Commerciale d'Italie
1501, -a) venue McGill College, bureau 520
Montreal, QC H3A 3M8
Tel.: (514) 284-0265
Fax: (514) 284-0362
E-mail: it-trade@italytrade.com
Internet: http://www.italcomm.com/e/index.html
Toronto:
438 University Ave., Suite 1818
PO Box 112
Toronto, ON M5G 2K8
Tel.: (416) 598-1566
Fax: (416) 598-1610
E-mail: ice@italcomm.com

Italian Associations

Farmindustria - Italian Association of Pharmaceutical Industries (Associazione Nazionale dell'Industrial Farmaceutica)
Largo del Nazareno 3
00187 Rome, Italy
Tel.: (39-06) 675-801
Fax: (39-06) 675-802-59
Internet: http://www.farmindustria.it (Italian)

Federfarma - National Pharmacy Association (Federazione Nazionale Unitaria dei Titolari di Farmacia Italiani)
via Emanuele Filiberto, 190
00185 Rome, Italy
Tel.: (39-06) 703-801
Fax: (39-06) 704-7658-7
Internet: http://www.federfarma.it (Italian)

Assobiotec - Italian Biotechnology Association (Associazione Nazionale per lo sviluppo delle biotecnologie)
Via Academia 33
20131 Milan, Italy
Tel.: (39-02) 268 103 06
Fax: (39-02) 268 102 84
Internet:
http://italytech.com/htc/Directories/index.html

Association of Pharmaceuticals Distributors
(Associazione Distributori Farmaceutici - ADF)
via Milano 58
00184 Rome, Italy
Tel.: (39-06) 487-0148
Fax: (39-06) 478-2494-3
E-mail: adf.roma@agora.stm.it

Italian Association of Hospital Suppliers
Associazione italiana fornitori ospedali (AIFO)
Via Micheline 69
40127 Bologna, Italy
Tel.: (39-051) 503-318
Fax: (39-051) 505-282

Pharmaceutical Marketing Association  
(Associazione Italiano Marketing Farmaceutico)
via Euripide 9
20145 Milan, Italy
Tel.: (39-02) 480-1016-5
Fax: (39-02) 480-1012-5
E-mail: naviter.hw@galactica.it

Assosalute - Over-the-Counter Drug Manufacturers Association (Associazione Nazionale imprese dei farmaci per l'automedicazione)
Via Accademia 33
I-20131 Milan, Italy
Tel.: (39-02) 268-10248
Fax: (39-02) 268-10348
E-mail:assosalute@federchimica.it

Italian Association of Private Hospitals
Associazione Italiana Ospedalità Privata (AIOP)
Via Lucrezio Caro 67
00193 Rome, Italy
Tel.: (39-06) 321-5653
Fax: (39-06) 321-5703
Internet: http://www.aiop.it

Assobiomedica - Italian Association for Biomedical and Diagnostic Technology (Associazione nazionale per le tecnologie biomediche e diagnostiche)
via Olgettina 58
20132 Milan, Italy
Tel.: (39-02) 264 11 031
Fax: (39-02) 264 10 413
E-mail: assobiomedica@assobiomedica.it
Internet: http://www.assobiomedica.it

Assogenerici - Italian Association of Generic Drug Manufacturers
Via Toscana 10
00187 Rome, Italy
Tel.: (39-06) 428-153-29
Fax: (39-06) 427-468-64

Aschimfarma - Association of Italian Bulk Pharmaceutical Chemical Producers (Associazione Nazionale materie prime farmaceutiche)
Via Accademia 33
20131 Milan, Italy
Tel.: (39-02) 268-102-45
Fax: (39-02) 268-103-64
E-mail: info@aschimfarma.com
Internet: http://www.aschimfarma.com

Italian Research Institutes

International Centre for Genetic Engineering and Biotechnology (ICGEB)
Padriciano 99
34012 Trieste, Italy
Tel.: (39-40) 375-7333
Fax: (35-40) 375-7363
E-mail: icgeb@icgeb.trieste.it
Internet: http://www.icgeb.trieste.it

National Research Council (CNR)
(Consiglio Nazionale delle Ricerche)
Piazzale Aldo Moro
00185 Rome, Italy
Tel.: (39-06) 499-31
Fax: (39-06) 446-1954
Internet: http://www.cnr.it (Primarily Italian)

Institute for Pharmacological Research "Mario Negri" (Istituto di Richerche Farmacologiche "Mario Negri")
via Eritrea 62
20157 Milan, Italy
Tel.: (39-02) 390-141
Fax: (39-02) 354-62-77
Internet: http://www.irfmn.mnegri.it/default.asp
Private foundation for research and education in biomedical sciences

Italian Society of Biochemistry
(Instituto di Chimica Biologica)
Universita di Siena, Pian dei Mantellini 44
53100 Siena, Toscana, Italy
Tel.: (39-05) 772-980-26
Fax: (39-05) 552-980-57
E-mail: info@biochimica.it
Internet: http://www.biochimica.it (Italian)

Institute of Mutagenesis and Differentiation (CNR)
Via Svezia 2A/10
56124 Pisa, Italy
Tel.: (39-50) 574-161
Fax: (39-50) 576-661
Internet: http://www.area.pi.cnr.it/IMD

Advanced Biotechnology Centre
Biotechnology Department
Largo R. Benzi
10 I-16132 Genova, Italy
Tel.: (39-10) 573-72-82
Fax: (39-10) 573-72-95
E-mail: sbio@ist.unige.it
Internet:
http://www.biotech.ist.unige.it/bio/bioteng.html

Department of Biology and Genetics for Medical Sciences 
(Dipartimento di Biologia e Genetica per le Scienze Mediche)
Milan University
Via Viotti
3/5 - 20133 Milan, Italy
Tel.: (39-02) 236-931
Fax: (39-02) 706-024-72
E-mail: dibiogen@mailserver.unimi.it
Internet:
http://www.unimi.it/engl/
dipart/biogen.html

European Union Contacts

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 Federation of Pharmaceutical Industries Association (EFPIA)
250 Ave. Louise
Box 91
B 1050 Brussels, Belgium
Tel.: (32-2) 640-6815
Fax: (32-2) 647-6049
Internet: http://www.efpia.org

European Diagnostics Manufacturers Association (EDMA)
Place St. 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 Agency for the Evaluation of Medicinal Products (EMEA)
7 West Ferry Circus
Canary Wharf
London, UK E14 4HB
Tel.: (44-171) 418-8400
Fax: (44-171) 418-8416
Internet: http://www.eudra.org/emea.html

European Union Trademark Office
Av. Aguilera 20
03080 Alicante, Spain
Tel.: (346) 513-9100
Fax: (346) 513-9179

European Office of Patents
Office Europeen des Brevets
Erhardtstrasse 27
D80331 Munich, Germany
Tel.: (49-89) 239-90
Fax: (49-89) 239-94-465
Internet:
http://www.european-patent-office
.org/index.htm

Canadian Biotechnology Associations

Alberta Biotechnology Association
1150, 10180 - 101 St.
Edmonton, AB T5J 3S7
Tel.: (780) 425-3815
Fax: (780) 423-3893
Contact: Myka Osinchuk
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
c/o Seabright Corporation Ltd.
Memorial University of Newfoundland
Spencer Hall
220 Prince Philip Drive
St. John's, NF A1C 5S7
Tel.: (709) 737-4527
Fax: (709) 737-4029
Contact: David King, President
Internet: http://www.mun.ca/seabright/bioeast

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

BIOTECanada
130 Albert St., Suite 420
Ottawa, ON K1P 5G2
Tel.: (613) 563-8849
Fax: (613) 563-8850
E-mail: info@biotech.ca
Internet: http://www.biotech.ca

British Columbia Biotechnology Alliance
3250 East Mall, Suite 220
Vancouver, BC V6T 1W5
Tel.: (604) 221-3026
Fax: (604) 221-3027
Contact: Theresa McCurry, Executive Director
Internet: http://www.biotech.bc.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

Canadian Medical Association
1867 Alta Vista Dr.
Ottawa, ON K1G 3Y6
Tel.: (613) 731-9331
Internet: http://www.cma.ca

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

Canadian Wholesale Drug Association (CDWA)
5255 Yonge St., Suite 505
Toronto, ON M2N 6P4
Tel.: (416) 222-3922
Fax: (416) 222-8960
Internet: http://www.cwda.com

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

Quebec Bio-Industries Association
801, route 344
PO Box 3158
L'Assomption, QC J5W 4M9
Tel.: (450) 589-4628
Fax: (450) 589-4866
E-mail: info@aqb.qc.ca
Internet: http://www.aqb.qc.ca

Toronto Biotechnology Initiative
64 Old Burnhamthorpe Rd
Etobicoke, ON M9C 3J5
Tel.: (416) 626-1835
Fax: (416) 626-1423
Contact: David Harper
E-mail: davidh@yorkmedical.on.ca

BIBLIOGRAPHY

Assobiotec, "Biotechnology in Italy and Worldwide," September 1996.

Beland, Genevieve-Catherine, "Market Profile: Biotechnology Sector in Italy - In Vivo and In Vitro Diagnostics," Groupe d'analyse des marches internationaux, October 1998.

Chemical Business Newsbase. "Italian Biotech Catching Up with Rest of Europe," February 2000.

---. "Pharmaceutical Manufacturing Review," September 1999.

---. "Pharmaceuticals in Italy," August 1999.

---. "Trio to Target Italian Generic Pharma Market," January 1998.

Chemical Market Report. "Aschimfarma: A Major Player in Bulk Pharmaceuticals," October 1999.

---."Custom Manufacturing 2000," February 2000.

---."Italy's Bulk Pharmaceutical and Intermediate: A Market Review," October 1999.

---. "Italy Retains its Position in Fine Chemicals," June 1998.

Chemical Week. "Patheon Enters Italy," January 1999.

Dun and Bradstreet. "Italy," Exporter's Encyclopedia, 1999.

Espicom Business Intelligence. "World Pharmaceutical Markets - Italy," September 1999.

---. "Medistat Country Profiles - Italy," September 1999.

European Commission Directorate. "Biotechnology R&D in Europe," 1996.

Guadagni, Nicola S.A. "Survey of the Italian Pharmaceutical and Medical Devices Sectors," Canadian Consulate General, Milan, 1999.

Marketletter. "Italian Biotech Patents Move," July 1999.

---. "Italian Biotechnology sectors Generates Sales," July 1999.

---. "Italian Government/Drug Industry Agree New C-Product Code," March 1998.

---. "Italian OTC firms' price cut protest," June 2000.

---. "Prospects for Emerging Euro Generics Markets," December 1998.

Medical and Health Care Marketplace Guide. "OTC Pharmaceuticals in Europe," 1998.

---. "Ethical Pharmaceuticals: Italy," 1998.

Organization for Economic Co-operation and Development. "Competition in the Pharmaceutical Industry

- Italy," Working Party No.2 on Competition and Regulation. June 2000.

Pharmaceutical Manufacturing Review. "Drug Industry Appeals to Health Ministry," June 1999.

PJB Publications. "Scrip's 1999 Yearbook - Countries - Europe," January 1999.

PJB Publications. "Barriers to Italian Research and Development," August 1998.

PJB Publications. "Barriers to European Biotech," May 1999.

Specialty Chemicals. "Italy Moves to Fine Chemicals," December 1999.

United States Department of Commerce. "Italy: Health Care Services," September 1998.

---. "Italy: Pharmaceuticals," January 1997.

OTHER REFERENCE MATERIALS

Useful Internet Sites

Advanced Biotechnology Centre: http://www.biotech.ist.unige.it

Association of Italian Bulk Pharmaceutical Chemical Producers (Aschimfarma): http://www.aschimfarma.com

Association of Manufacturers of Fine and Specialty Chemicals (Acfis): http://www.acfis.com

BioResearch Online: http://www.bioresearchonline.com

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

Canadian Commercial Corporation: http://www.ccc.ca

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

European Agency for the Evaluation of Medicinal Products: http://www.eudra.org/emea.html

ExportSource: http://exportsource.gc.ca

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

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

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

Information Systems for Biotechnology: http://www.nbiap.vt.edu

Italian Biotechnology Association (Mainly in Italian): http://www.assobiomedica.it

Italian Ministry of Health (Italian only): http://www.sanita.it

Italian Institute of Health (mainly in Italian): http://www.iss.it

Italian Pharmaceutical Manufacturers Association: http://www.farmindustria.it

Pharmaceutical Information Network: http://www.pharminfo.com

Pharmaffairs: http://www.pharmaffairs.com (an Italian on-line meeting point for participants in the pharmaceutical, herbal products, cosmetic and dietetic food industries)

Pharmweb: http://www.pharmweb.net

World Health Organization Regional Office for Europe: http://www.who.dk

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, January-March 2000.

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