Market Information
Latin America and Caribbean

Market Brief :
The Biotechnology Market in Cuba

March 2003

© Department of Foreign Affairs and International Trade
Faxlink # 1100007

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

The Market Research Centre produces a wide range of market reports by region and sector for Canadian exporters. These reports are available from:

- DFAIT's InfoExport Internet site ( 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.

Quick Facts

Market Highlights

• Cuba has developed a large biotechnology sector and by the late 1980s it was producing more than three-quarters of its own pharmaceuticals.
• The economic crisis following the breakup of the Soviet Union forced Cuba to reorient the biotechnology sector towards commercial exploitation of scientific discoveries.
• The government is seeking foreign partners to provide technology and to commercialize biotechnology products.

Opportunities

• Cuba has developed a number of biotechnology products that are unique in the world and have enormous potential if they can be sold on world markets.
• Cuba's biotechnology institutions lack the knowledge, skills, and resources needed to drive the complex process of pharmaceutical commercialization in developed-country markets.
• There are opportunities for the commercialization of Cuban products in developing countries that do not recognize international patents.

Key Players

• All of Cuba's biotechnology institutes are government owned and most are located in the Western Havana Scientific District.
• Of the 43 institutes in the District, eight are cited in recent government promotional material as major players.

End-users

• There is a small potential market for pharmaceuticals and supplies imported for use within Cuba. The Ministry of Public Health controls all purchases for use by Cuban residents.

Export Checklist

• Cuba has a complex and restrictive import control system, but agreements for international joint ventures typically remove any impediments to imported material and equipment.
• Duties on imported pharmaceutical products are usually waived if they are for use by Cuban residents.

Market Overview

The government of Cuba has placed great emphasis on science and technology as a foundation for economic development ever since the 1959 Revolution. Fidel Castro expressed this philosophy in a frequently quoted speech in 1960: "The future of our country must necessarily be a future of men of science." Aggressive application of this policy to the health, agriculture, and food sectors for forty years has produced impressive results. According to the 2002 UN Human Development Report, Cuba has 530 physicians per 100 000 people compared with 279 in the United States, 229 in Canada, and 186 in Mexico. The country's infant mortality rate is almost as good as Canada's and is equal to that of the United States. A national immunization program reaches virtually all of the population and has nearly eliminated infectious disease as a cause of death. The country's scientific endeavours are supported by a strong education system, encompassing nearly 60 university centres. The number of scientists and engineers engaged in R&D per million people averaged 1611 during the 1990s.This places Cuba at the lower end of the range for developed countries and far ahead of any other developing nation.

Another outcome of the sustained promotion of science is a large biotechnology and pharmaceutical sector, including more than 100 research and production facilities that produce many unique Cuban-developed products. By the late 1980s Cuba was producing more than three-quarters of its own pharmaceutical consumption, an outstanding achievement for a developing nation. The country is an important producer of interferons and vaccines and has developed a number of advanced biotechnology processes for medical diagnosis and therapy.

After four decades of steady growth in the biotechnology industry, the situation deteriorated sharply with the breakup of the former Soviet Union in 1991. Cuba's real GDP fell by more than 40% between 1989 and 1993 when the former Soviet bloc countries terminated their special trade and financing arrangements. These concessions had previously paid Cuba higher-than-market prices for many of its exports, especially sugar.

Faced with the loss of billions of dollars annually in Soviet block subsidies, Cuba was forced to reorient its economy to attract foreign investment, most notably in tourism. It stopped producing some pharmaceutical products and implemented a ranking system that restricts prescriptions and gives priority to essential drugs while making many basic medicines unavailable.

In spite of these difficulties, the government reaffirmed its commitment to science and technology as a foundation for development. In August 1990 Cuba implemented the "Special Period in Peacetime," a plan for dealing with the economic crisis. This program designates three sectors as priorities for future economic development of the country: biotechnology, tourism, and sugar. Notwithstanding this renewed commitment, however, the country's ability to devote resources to this effort declined substantially during the 90s.

Part of the government's strategy for adapting to this new reality was to place much greater emphasis on commercial development of scientific discoveries as a means of displacing imports and expanding exports. This has created opportunities for Canadian firms. The government's policy is to maintain 100% ownership of its medical and biotechnology facilities, but there are numerous opportunities for joint ventures and licensing. In a typical joint venture the foreign partner provides inputs to support the manufacture of biotechnology products in Cuba in exchange for licences to market these items globally. Most biotechnology institutes now have commercialization companies or divisions attached to them. Joint ventures are not allowed in the provision of health care to the Cuban population.

While there are many opportunities, Canadian companies operating in this sector have learned that considerable investment and risk are involved in taking Cuban pharmaceutical products to international markets. Cuba's traditional customers for biotechnology products have been countries that do not recognize drug patents and many also lack rigorous standards for the import and sale of pharmaceuticals. Some products claimed to be Cuban inventions are actually covered by patents in other parts of the world. Even where patents are not an issue, it can take many years to comply with the stringent testing and registration procedures followed by developed countries. In some cases, product quality problems have hampered registration, causing large cost overruns.

Sector Profile

All of Cuba's scientific and technological innovation activities are centrally planned and coordinated by the government. Key policy decisions are made at the highest political levels, and there is a complex interrelated network of institutions and approval mechanisms. The broadest instrument for planning and coordination is a system known as sistema de la ciencia y la innovación tecnológica en Cuba, which comes under the authority of the Ministry of Science, Technology and Environment (Ministerio de Ciencia, Tecnología y Medio Ambiente-CITMA).

Under this system the country's scientific institutions are allocated to "poles" and are affiliated with one or more "thematic fronts." Using more familiar English terminology, physical clusters (poles) of institutions contribute to collaborative efforts organized around key science themes (fronts). Some of the institutions included in this system are owned by CITMA, but many of them belong to a variety of other ministries with a stake in science and innovation. The most important are the Ministry of Higher Education (Ministerio de Educación Superior-MES), the Ministry of Public Health (Ministerio de Salud Pública-MINSAP ) the Ministry of Agriculture (Ministerio de la Agricultura-MINAGRI), and the Ministry of Basic Industries (Ministerio de la Industria Básica-MINBAS).

The cluster commonly known in English as the Western Havana Scientific District (Polo Científico del Oeste de la Capital) includes more than 40 major research institutions mainly focused on technologies used for human health, pharmaceuticals, animal health, and agro-industry. Approximately 4000 scientists and engineers are employed at these institutions. In addition there is one scientific cluster established in each of the country's 14 provinces. Some institutions have operations located in multiple clusters.

Institutions that are primarily focused on biotechnology, mostly located in the Western Havana Scientific District, are affiliated with the Frente Biológico, the Frente Bioagrícola, or both. The former concentrates primarily on health and pharmaceuticals while the latter specializes in agricultural biotechnology. Members of these entities meet monthly to share information, coordinate efforts, and deal with common issues. Within this structure, individual research, development, and production efforts are organized into projects (proyectos) or programs (programas).

Major Developments

During 2002 accusations were levelled by American anti-Cuba activists and some US government spokespersons claiming that Cuba was developing biological weapons and providing technical assistance to rogue states. These charges were based partly on the sale to Iran of some "dual-use" biotechnology products and partly on stories by Cuban scientists who defected several years ago. This situation is difficult to assess from an unbiased perspective. U.S. policy towards Cuba is influenced by the Cuban community in the United States, which is highly receptive to anti-Castro rumours.

Former U.S. President Jimmy Carter has been quoted in the media as saying that U.S. officials have admitted to him that they have no evidence to back these accusations. For its part, the Cuban government offered to open all of its biotechnology centres to some 250 foreign scientists, 20 of them from the United States, during the Havana 2002 Biotechnology Congress in November 2002. Nonetheless, Canadian companies should consider the potential for negative publicity and shape their dealings with Cuba's biotechnology entities accordingly.

Opportunities

Cuba develops, produces, and exports products based on biotechnology to more than 40 countries around the world, earning about $150 million1 annually from the sector. As part of "Special Period in Peacetime," the government has been forced to shift its emphasis away from basic science towards further commercial development and increased exports. While this reality is well recognized within Cuba's biotechnology sector, the institutions lack the knowledge, skills, and resources needed to drive the complex process of pharmaceutical commercialization. This creates opportunities forCanadian firms that possess the necessary expertise, provided that they are prepared for large investments and long-term commitment.

Cuba has developed a number of biotechnology products that are unique in the world. Some of them have enormous potential, especially since they tend to be much cheaper than alternative products now on the market. However, taking an unproven product through the rigorous process of testing required to obtain patents and licensing in developed countries can take many years.

A good example is the Cuban bacterial meningitis vaccine VA-MENGOC-BC. In 1999, after a two-year effort, the British firm SmithKline Beecham (now GlaxoSmithKline) obtained a licence from the US Treasury Department to market the vaccine in the United States. The licence was granted because this vaccine is acknowledged to be the only one of its kind in the world. It has been produced in Cuba and sold throughout Latin America since 1989, is patented in 19 countries, and has been certified by the WHO. GlaxoSmithKline holds the world rights to commercialize the vaccine outside Cuba. However, at the end of 2002 it is still not on the market because it is still undergoing clinical testing in Europe and New Zealand.

Over the short-to-medium term, developing countries provide greater opportunities for the commercialization of Cuban products. These countries have been Cuba's traditional export market because many of them do not recognize international patents and many also lack rigorous import controls on pharmaceuticals. The most important markets are in Latin America, but other growing markets include China and India, which do not acknowledge the patents of US and European drug companies. Even countries that abide by WTO rules, as China now does, can circumvent pharmaceutical patents where public health concerns receive priority. Cuban-developed drugs are usually much cheaper than those offered by the multinational pharmaceutical industry, and in many cases they are the only choice for developing countries.

A good example is erythropoietin (EPO), a recombinant version of a human protein that stimulates the production of red blood cells. It is used for kidney dialysis and chemotherapy among other applications. Cuba produces a generic EPO that sells for a small fraction of the price of Epogen, which is covered by patents held by Amgen and Johnston and Johnston. Cuba also sells a number of novel biotech products including hepatitis B and meningitis B vaccines, a skin-growth factor, interferons, thrombosis and heart-attack medicines, and AIDS treatments.

Infectious diseases kill close to 20 million people per year around the globe, half of them children under five. Cuba's experience with eradication of these diseases has enormous potential provided that the country receives assistance in developing manufacturing systems that are cost-effective and safe as well as in creating effective marketing vehicles.

Major Sectoral Trends

Although Cuba's biggest priority is the development of pharmaceuticals and human health products for export, there are also a few opportunities in the domestic market. Cuba managed to invest a reported $1.4 billion in the biotechnology sector during the 1990s, and it retained most of its related research programs. However, the loss of Soviet assistance required a number of major adjustments. One of them was the diversion of some biotechnology resources from human health to agriculture.

Biotechnology institutions are expected to contribute to the National Food Program. One of the goals of this policy is to increase food yields and nutritional value per hectare and to improve resistance to environmental stress as a means of increasing food production without reducing the amount of land allocated to sugar production. These efforts have included the genetic engineering of sugar cane, rice, tomatoes, fruits, and potatoes. Cuba also produces single-cell proteins for animal feed from molasses to reduce the need for imported feeds, and it makes biological pesticides to reduce imports of chemical pesticides. There are potential opportunities for cost-effective technologies that can contribute to this effort.

Another reaction to the economic crisis was the implementation of the National Medicines Program, which restricts prescriptions to those that are vital or at least essential. Non-essential products such as Ibuprofen, vitamin E and Erythromycin are not generally available except from the few pharmacies that operate in dollars. Still, according to one report, the Cuban health system spends half its budget on imported pharmaceuticals. In spite of some success in developing domestic products to displace imported drugs, many opportunities remain for technologies that can cost-effectively increase local production and develop low-cost alternatives to imported drugs.

Financing Opportunities

One of Cuba's major motivations in seeking the participation of foreign firms in its biotechnology sector is the acquisition of foreign investment. There is virtually no local financing available, and Cuban contributions to joint ventures are normally limited to personnel, facilities, and proprietary information.

Cuban entities that import drugs and laboratory equipment frequently seek concessionary financing. Some Canadian companies have had difficulty obtaining payment from Cuban customers and there have been problems clearing Bills of Exchange through Cuban banks. Canadian companies might consider discounting invoices with Cuban financial institutions, but the costs can be high. The short-term insurance facilities of the Export Development Corporation (EDC) are not available to Canadian exporters due to longstanding debt problems with Cuba.

Canadian companies seeking capital for Cuban joint ventures have been forced to go to European and Asian markets. Under the US embargo, American companies and their foreign subsidiaries are prohibited from supporting these initiatives financially, even if the products are licensed for sale in the United States.

Funding for some joint projects has been obtained from international organizations, although these arrangements are not usually of a commercial nature. For example, Carleton University and the University of Havana received funding from the World Health Organization for their development of a new pneumonia/meningitis vaccine.

Short- and Long-term Prospects

Future prospects in the Cuban biotechnology market depend largely on the future of the American embargo. Possible changes in the US stance are difficult to predict because they depend on the complex political relationship between the Cuban expatriate community and the federal government. Business leaders in the United States are predominantly in favour of lifting the embargo. More than half of the certified U.S. claims against Cuba for expropriations in the early 1960s are held by 30 corporations, and many of them have already quietly made deals with third-country companies to use the disputed properties in Cuba until the embargo ends. Short-term political developments could lead to rapid changes in the biotechnology market with American firms moving in and financing suddenly becoming available. Canadian companies with an established position in the Cuban biotechnology market would generally benefit, notwithstanding the influx of competitors.

If the embargo continues, long-term prospects hinge on the continued steady recovery of the Cuban economy. The government's adaptation policies have been generally successful, and the economy has seen sustained growth since it bottomed out in 1993 after four years of rapid decline. Real GDP is expected to recover to 1989 levels in 2003. Real GDP growth in 2000 was 5.6% and government projections are for continued sustained growth in the range of 4% to 6% annually.

Key Players

The West Havana Bio-Cluster

Lists of the institutions engaged in Cuba's biotechnology sector differ widely because there are different interpretations of the degree of involvement that institutions have in that area. The entities described below are those listed as part of the "West Havana Bio-Cluster" in the Cuban government presentation to the Bio2002 International Biotechnology Convention & Exhibition held in Toronto in June 2002.

National Centre for Scientific Research - CNIC

The CNIC (Centro Nacional de Investigaciones Científicas) is the oldest of the institutions in the cluster, having developed within the university system. It has 976 personnel and research facilities of 35,000 m2 as well as five production plants. The Centre is focused on natural products and nanotechnology and produces the natural cholesterol-reducing drug PPG in addition to medical equipment and biocompatible materials. ( www.ceniai.inf.cu/POLO/centros/cnic.htm )

Centre for Genetic Engineering and Biotechnology - CIGB

The CIGB (Centro de Ingeniería Genética y Biotecnología) is the largest of Cuba's biotechnology research institutions with 1,245 personnel and facilities of 70,000 m2. It conducts research into vaccines, therapeutics, plant and animal biotechnology, bioinformatics, and proteomics. The CIGB produces recombinant hepatitis B vaccine and recombinant Streptokinase as well as recombinant interferons and epidermal growth factor. ( www.cigb.edu.cu )

Finlay Institute

This organization (Empresa de Producción de Biológicos "Carlos J. Finlay") has 920 personnel and 22,000 m2 of research and production facilities. It is best known for its meningitis BC vaccine, now produced under licence for markets outside Cuba by GlaxoSmithKline. The Institute also produces vaccines for leptospirosis, tetanus, DPT, and thyroid fever. It is conducting research into vaccines for meningococcic meningitis and cholera as well as combined vaccines. This organization should not be confused with another Finlay Institute in Florida named after the same scientist, who discovered the role of mosquitoes in the transmission of yellow fever in the late 18th Century. ( www.sld.cu/instituciones/finlay/index.htm

Centre for Molecular Immunology - CIM

The CIM (Centro de Inmunología Molecular) is the newest of the institutes in the bio-cluster. Opened in 1994, it has 275 personnel and 15,000 m2 of facilities. The CIM is focused on research into recombinant antibodies (mAbs) as well as radiodetection and radiotherapy for cancer. The Centre produces mAbs for transplantation and diagnosis, radiolabeled mAbs for cancer, and recombinant erythropoietin. ( www.cim.sld.cu )

National Centre for Bioreagents - BioCen

BioCen (Centro Nacional de Biopreparados) is a modern 70,000 m2 production facility with 720 personnel. It is mainly devoted to the manufacture of products developed by other institutes in the biotechnology cluster. The Centre produces recombinant hepatitis BC vaccine, microbiology culture media, allergens, and antianemics. ( www.biocen.cu )

Pedro Kourí Tropical Medicine Institute - IPK

The IPK (Instituto de Medicina Tropical "Pedro Kourí") is Cuba's leading centre for research and training in infectious diseases. It has 520 personnel and facilities of 30,000 m2. These facilities include a 200-bed hospital, the national microbiology laboratory, the national parasitology laboratory, and an epidemiological surveillance and research unit. The Institute is responsible for conducting clinical trials and for diagnosing and controlling emerging infectious diseases. The IPK hosts WHO/PAHO cooperating centres for virology, TB, vector control, and malacology. It provides training to the PhD level as part of the University of Havana. ( www.ipk.sld.cu )

National Centre for Laboratory Animals Production - CENPALAB

CENPALAB (Centro Nacional para la Producción de Animales de Laboratorio) is a large complex of facilities encompassing 74,000 m2 and employing 414 personnel. It is responsible for breeding laboratory-quality animals for use in Cuba's research programs. CENPALAB also develops new animal models for research use and provides toxicology services. ( www.ceniai.inf.cu/POLO/centros/cenpala.htm )

Centre for Immunoassays - CIE

The CIE (Centro de Inmunoensayo) specializes in the development and production of systems for diagnostic virology. With 244 personnel and 9,000 m2 of facilities, it is the smallest of the institutes in the bio-cluster. The CIE conducts research into new and innovative diagnostic tools. Its products include ultra-micro enzyme-linked immunoassay (ELISA) kits for a wide range of viruses (HIV, HCV, AFP, Dengue, HBV and Chagas, among others). In also develops ultra-miniature instruments for ELISA laboratory work based on a system known as SUMA (Sistema Ultramicroanalítico). ( www.ceniai.inf.cu/POLO/centros/inmuno.htm )

Other Institutes

There are several other institutes located in the West Havana Scientific District that appear on various lists of biotechnology centres. A complete list of institutes in the district, along with Internet links and a map of the district, is available online at www.ceniai.inf.cu/POLO/centros/centro/. This list is not necessarily current and it contains many broken links and is frequently inaccessible, but it is a useful starting point for companies seeking further information about this sector.

Major Competitors

According to Cuban officials quoted in the media, the country has biotech trade and production agreements with 9 countries and is negotiating technology-transfer agreements with 14 developing countries. An executive of a Cuban biotechnology organization said in an interview that the most important partners are Canada, England, China, and Brazil, with smaller participation from Spain and France.

The Cuban government does not announce the details of its agreements with foreign companies and there are no statistics that could demonstrate the relative value of competitors' participation in the market.

Although the US embargo against Cuba was lifted for medicine and medical supplies in 1992, American companies have not been able to take full advantage of related opportunities because licensed sales must be in cash or by third-country banks. According to media reports, the initial payments to Cuba for US sales of its hepatitis B vaccine will be made by GlaxoSmithKline in the form of food.

Local Capabilities

Cuba's biotechnology institutions are all government owned, and it is difficult for foreign analysts to assess the quality of the information they provide. The promotional material prepared by the Cuban government and used in presentations at biotechnology conferences in Cuba and abroad provides an overview of the country's capabilities.

Cuba's success in exporting to developing countries and in establishing major partnerships with foreign firms provides credibility for many of these claims, especially in the areas of communicable disease control and, potentially, cancer treatments. Direct contact at a technical level with the relevant institutions by prospective joint venture partners is the only way to make a full assessment.

According to a summary prepared for delegates at the November 2002 biotechnology conference in Havana, Cuba's greatest successes are in the following areas:

• natural and recombinant alpha and gamma interferons
• recombinant interleukin-2
• the first effective natural vaccine for meningitis B
• a recombinant vaccine for hepatitis B produced in yeast cells
• monoclonal antibodies for cancer diagnostics and the treatment of organ transplant rejection
• diagnostic systems for infectious and chronic diseases, including hepatitis BC, Dengue, HIV, HTLV-I/II, and celiac disease.

According to this source, other immunology-related investigations under development involve "conjugated and nasal vaccines, and those for the prevention of infections by haemophilus influenzae type B, Leptospirae, and the Dengue virus." The summary listed additional fields of interest as "the treatment of cancer via recombinant antibodies and therapeutic vaccines, the study of allergy and allergens, therapeutic recombinant vaccines for AIDS and hepatitis C, and the study of the regulation of the immune response."

Canadian Position

Canada has a strong position in the Cuban biotechnology sector. A number of Canadian companies, health institutions and universities have developed relationships with Cuban counterparts, and several Canadian scientists gave presentations at the November 2002 biotechnology conference in Havana.

Toronto-based YM Biosciences was the first company to implement a joint-venture agreement for marketing Cuban-developed pharmaceutical products. It negotiated a deal in 1995 under which the company will handle regulatory affairs, intellectual property, clinical trials, and licensing for Cuban products around the world. Its first venture involved a drug for cancer therapy called TheraCIM which was developed by CIM. This drug is currently in clinical trials and could be ready for sale as early as 2003. YM Biosciences also has a number of other Cuban-developed anti-cancer drugs undergoing clinical trials.

In early 2000 scientists at Carleton University in Ottawa announced that they had been awarded a patent jointly with the University of Havana for a new pneumonia/meningitis vaccine which was the result of ten years' work. The basic science was developed in Cuba, and Canadian scientists designed cheaper production processes. As a result, the new drug is much less expensive than the alternatives, which are too costly for wide distribution in developing countries.

In 2001, the Institute of Biomedical Engineering at the University of New Brunswick and the Hospital for Sick Children in Toronto announced a partnership with three Cuban universities with funding from the CIDA University Partnerships in Cooperation and Development program. The project is aimed at transferring the skills of Canadian experts in the fields of Biomedical and Clinical Engineering, providing support for laboratory upgrading, and assisting a variety of educational activities.

End-users

Demand Preferences of Major Customers

Cuban government authorities are actively looking for partners, but they are cautious in their dealings with foreign firms and they carefully evaluate proposals for joint ventures.

The basic conditions set out by the government are:

• Cuban facilities are not for sale.
• Agreements are negotiated for specific markets.
• Negotiation is carried out on the basis of defined projects and products, not on the basis of a centre's portfolio.
• Ongoing research projects are negotiated.
• Cuba is not offering surplus scientific capacity.
• Partnerships are approved for a specific period.
• The government revises its project offerings and partnership conditions regularly.

Procurement Practices of Key End-users

The process of partnering with foreign entities is regulated by the Ministry of Foreign Investment and Economic Cooperation (MINVEC). Individual institutions negotiate the initial deals, as do some of their commercial entities. These include Heber Biotec S.A., CIMAB, DALMER, ERON S.A., and TECNOSUMA among others.

The main importer of pharmaceuticals and raw materials is MEDICUBA, the import/export entity of the Ministry of Public Health (MINSAP).

MINSAP is responsible for all hospitals, clinics, and health services, except for those offered to foreigners in hard currency through Turismo y Salud, which is a division of Cubanacán. This company operates more than thirty hard-currency pharmacies that are reasonably well stocked. These pharmacies are located in many tourist destinations, international airports and specialized health institutions.

Dealing with Cuban Government Entities

The first challenge confronting Canadian companies interested in this market is to identify the best person to approach, since the real decision-makers are often not obvious. Canadian companies interested in discussing opportunities can narrow down the list of relevant institutions fairly quickly, usually by reviewing the ongoing projects and capabilities listed on their Web sites. These sites often include announcements of upcoming events such as seminars and conferences.

If the entities of interest have commercialization subsidiaries, they are usually the best point of approach, especially if they have the S.A. designation. These "semi-autonomous" corporations are not private companies as the name might imply. Their shares are held by trusted members of the Cuban political elite who are accountable to the government. Nonetheless, the executives of these corporations tend to have preferential access to decision-making processes.

If a potential opportunity is identified and a Canadian company wishes to proceed with negotiations, it should seek advice from Canadian trade officials in Cuba or from one of the few independent advisors now practising in Cuba. The negotiation and approval process is complex and involves multiple layers that can undermine apparently solid deals. Nonetheless, the process is flexible to some extent and companies with offerings that are highly attractive to the government may receive expedited treatment.

Export Checklist

Import Regulations

Cuba has a complex import-control system that requires import permits and imposes tariffs and other controls, including regulations concerning animal- and plant-based products. Provisions for satisfying these requirements, including potentially waiving them entirely, are part of the negotiation process, and the conditions for imports are specified in joint-venture agreements.

Companies contemplating direct sales of goods to Cuban government entities should consult a customs broker. Import permits will be provided by the buyer, and duties are likely to be waived on medicines and medical supplies.

Marketing Regulations

Although market entry has gradually become easier, Canadian companies cannot set up offices in Cuba without meeting stringent requirements for registration. Canadians require a business visa to travel to Cuba and call on potential partners or customers. Business visitors must provide the names of the Cuban entities they will visit, the dates of the trip, and an address in Cuba. The visa issuing process has recently been streamlined and now takes 14 days or less.

Key Contacts

Canadian Government Contacts in Canada

Department of Foreign Affairs and International Trade
Lester B. Pearson Building
125 Sussex Drive
Ottawa, ON K1A 0G2
Internet: www.dfait-maeci.gc.ca

Market Support Division (TCM)
Tel.: (613) 992-0484
Fax: (613) 996-6142
Contact: Chris Duggan, Trade Commissioner
E-mail: chris.duggan@dfait-maeci.gc.ca

Caribbean and Central America Division (LCR)
Tel.: (613) 996-6129
Fax: (613) 944-0760
Contact: Chad Fleck, Trade Commissioner
E-mail: chad.fleck@dfait-maeci.gc.ca

Canada Customs & Revenue Agency (CCRA)
NAFTA Information Centre
555 Mackenzie Avenue, 1st Floor
Ottawa, ON KIA 0L5
Tel.: (800) 661 6121
Fax: (613) 952 0022
Internet: www.nafta-customs.org

Canadian International Development Agency
Industrial Cooperation Division
200 Promenade du Portage
Hull, PQ K1A 0G4
Tel.: (800) 230-6349 or (819) 997-5006
Fax: (819) 953-6088
Internet: www.acdi-cida.gc.ca/busine-e.htm

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

Export Development Canada (EDC)
151 O'Connor Street
Ottawa, ON K1A 1K3
Tel.: (800) 850-9626 or (613) 598 2500
Fax: (613) 237 2690
Internet: www.edc.ca

Industry Canada
Canada Business Service Centres
235 Queen Street
First Floor, East Tower
Ottawa, ON K1A 0H5
Export Enquiries (888) 811-1119
Fax: (613) 954-5463
Internet: cbsc.org

Canadian Government Contacts in Cuba

Canadian Embassy
Street Address:
Calle 30 No. 518 esq. a 7ma.
Miramar, La Habana, Cuba
Mailing Address:
P.O. Box 500
(Havan) Ottawa, Canada K1N 8T7
Tel.: (53-7) 24-2516
Fax: (53-7) 24-2044
E-mail: Havan-td@dfait-maeci.gc.ca
Internet: www.dfait-maeci.gc.ca/cuba

Canadian Industry Contacts

Alliance of Manufacturers and Exporters Canada - National Office
5995 Avebury Road, Suite 900
Mississauga, ON L5R 3P9
Tel.: (905) 568-8300
Fax: (905) 568-8330
Internet: www.the-alliance.com

Forum for International Trade Training
30 Metcalfe Street, 4th Floor
Ottawa, ON K1P 5L4
Tel.: (613) 230-3553 or 1-800-561-FITT
Fax: (613) 230-6808
Internet: www.fitt.ca

Foreign Government and Industry Contacts

Embassy of Cuba in Canada
388 Main Street
Ottawa, ON K1N 6M8
Tel.: (613) 563-0141
Fax: (613) 563-0068
E-mail: cuba@embacuba.ca
Internet: www.embacuba.ca

References

Internet addresses for Cuba's principal biotechnology institutes are provided in the body of this market brief. Other useful sites are listed below. Cuban Internet sites tend to be highly erratic, even by developing country standards. There are frequent interruptions of service and some pages are only intermittently accessible. If a link is persistently unavailable, a search through one of the portals listed in this section can often locate an alternate route to the information. Another technique is to access the root site in the URL and follow the links to the desired page, which may have been moved. Not all of the sites listed here were accessible at time of publication, but all were accessible within the previous few days.

Cuban Internet Sites

Ministry of Science, Technology and Environment (Ministerio de Ciencia, Tecnología y Medio Ambiente-CITMA): www.cuba.cu/ciencia/citma
Provides an overview of Cuba's science system.

The Cuban Government official site CubaWeb: www.cubaweb.cu
Contains links to a number of publications including Granma, the official newspaper, with a version in English. It also includes the full text of key laws and a calendar of upcoming trade events.

InfoMed: www.sld.cu/instituciones
A portal for Cuban health information, provides links to many of the country's biotechnology institutions.

Cuba on the Internet (Cuba en Internet): www.cuba.cu/cubainternet/cubainternetes.html
Provides a comprehensive directory of Cuban Internet sites. This is a valuable tool because Cuban Internet addresses change frequently and are rarely forwarded.

Chamber of Commerce of the Republic of Cuba (Cámara de Comercio de la República de Cuba): www.camaracuba.cubaweb.cu.
Provides both free and subscription-based information including on-line databases and current news.

El Economista de Cuba (the online edition): www.eleconomista.cubaweb.cu
Provides current economic and business news stories.

Cuba Daily: www.cubadaily.com
An English-language site providing Cuban news items of general interest.

Canadian Government Internet Sites

InfoExport: www.infoexport.gc.ca/eservices-e.asp
The Canadian Trade Commissioner Service Internet site, provides information about business opportunities in Cuba and business practices there.

Trade Data Online: strategis.ic.gc.ca/sc_mrkti/tdst/engdoc/tr_homep.html
Industry Canada's statistical database providing export data by HS code and country of origin.

U.S. Internet Sites

CubaTrade: www.cubatrade.org
A non-political business-oriented site published by the U.S.-Cuba Trade and Economic Council in New York. It includes many unique items, including a list of foreign companies that do business in Cuba as well as the names of the 30 American companies that hold 56% of all certified claims against Cuba.

1 All monetary amounts are expressed in Canadian dollars, unless otherwise indicated. The conversion rate to Canadian dollars is based on exchange rate data obtained from Tradeline.