Accessguide Template Document

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN BELGIUM

CBI MARKET SURVEY

THE PHARMACEUTICAL PRODUCTS MARKET IN BELGIUM

Publication date: February, 2010

Report summary This CBI market survey discusses the following highlights for the pharmaceutical products market in Belgium:  Belgium was the ninth largest pharmaceutical market in the EU in 2007, accounting for 2.8% of the EU pharmaceutical market. Between 2003 and 2007, Belgium’s consumption of pharmaceutical products increased by an annual average rate of 4.5%, amounting to € 3.9 billion in the latter year.  In 2007, Belgium was the thirteenth largest market for generic medicines in the EU, amounting to € 401 million, which accounted for 1.5% of the total EU market. Generic medicines in Belgium accounted for only 10% of the total pharmaceutical market in 2007.  In 2007, Belgium was the tenth largest producer of pharmaceutical products in the EU, accounting for 3.2% of total EU production. Belgium’s production increased by an annual average rate of 5.3% between 2003 and 2007, amounting to € 5.2 billion in 2007.  In 2008, Belgium was the largest importer of pharmaceutical products in the EU, accounting for 22% of total EU imports. Between 2004 and 2008, Belgium’s imports increased by an annual average rate of 2.2% in value and 10% in volume, amounting to € 24.7 billion or 192 thousand tonnes in 2008.  The role of developing countries in supplying pharmaceutical products to Belgium is minimal. In 2008, imports sourced in DCs accounted for only 0.4% of Belgium’s total imports. Nonetheless, imports from developing countries increased by a strong annual average rate of 51% between 2004 and 2008. India and Turkey were the main suppliers in 2008.

This survey provides exporters of pharmaceutical products with sector-specific market information related to gaining access to Belgium. By focusing on a specific country, this survey provides additional information, complementary to the more general information and data provided in the CBI market survey ‘The pharmaceutical products market in the EU’, which covers the EU market in general. That survey also contains an overview and explanation of the selected products dealt with, some general remarks on the statistics used, as well as information on other available documents for this sector. It can be downloaded from http://www.cbi.eu/marketinfo

1 Market description: consumption and production

Data concerning consumption and production of pharmaceutical products in Belgium are derived from the European Federation of Pharmaceutical Industries and Associations (EFPIA). The latest report from this organisation (The Pharmaceutical Industry in Figures, 2009 Update) provides data as of 2007. Data for previous years are derived from previous editions of this report. Please note that data for both consumption and production of pharmaceutical products are given at ex-factory prices.

Consumption Belgium was the ninth largest pharmaceutical market in the EU in 2007, accounting for approximately 2.8% of the EU pharmaceutical market (at ex-factory prices). Between 2003 and 2007, Belgium’s consumption of pharmaceutical products increased by an annual average rate of 4.5%, amounting to € 3.9 billion in 2007. Belgium’s pharmaceutical consumption increased at a lower rate than the EU’s pharmaceutical consumption, which increased by an annual average rate of 7.3% between 2003 and 2007.

Source: CBI Market Information Database • URL: www.cbi.eu • Contact: [email protected] • www.cbi.eu/disclaimer

of 10 CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN BELGIUM

Please, note that data on consumption of specific pharmaceutical products are fragmented and cannot be presented in a structured manner. Additional information can be found under the section ‘Trends in consumption’.

Generic medicines In 2007, Belgium was the thirteenth largest market for generic medicines in the EU, amounting to € 401 million, which accounted for 1.5% of the total EU market. Between 2005 and 2007, Belgium’s generic medicines market increased at a rate of 19%. Generic medicines in Belgium accounted for only 10% of the total pharmaceutical market in 2007. As a comparison, in Germany, the largest generic medicines market in the EU, the value share of generics was 30% in the same year.

In 2005, a regulatory framework introduced the possibility for doctors to prescribe pharmaceutical products by International Non-proprietary Name (INN) in Belgium (Simoens and De Coster, 2006). In this case, the pharmacist is obliged to deliver a ‘cheap’ pharmaceutical product, if one exists. A ‘cheap’ pharmaceutical can be a generic medicine or an original pharmaceutical product with a price equal to the reimbursement price. Doctors have to prescribe a minimum amount of ‘cheap’ pharmaceuticals, and they can face sanctions if they do not comply with this rule (Pharmaceutical Pricing and Reimbursement Information - PPRI, 2007).

Market segmentation The Belgian pharmaceutical market can be segmented in two distinct – but interlinked – manners: the dispensing method and the channels through which pharmaceutical products are dispensed to patients.

Regarding the dispensing method, the Belgian market for pharmaceuticals consisted for 85% of prescription products, whereas 15% was non-prescription products in 2008. In Belgium, both prescription and non-prescription product groups are dispensed through two channels: general access pharmacies and hospital pharmacies. Other retail channels remain limited, as indicated below:  General access pharmacies: In the Belgian pharmaceutical market, only pharmacies are allowed to dispense pharmaceutical products directly to patients.  Hospital pharmacies: In Belgium, hospitals are only allowed to distribute pharmaceutical products to hospitalised patients (in-patient distribution); nonetheless, some hospitals are authorised to dispense pharmaceutical products to patients who live in retirement and care homes (PPRI, 2008).  Other retail channels: drugstores and supermarkets are not allowed to sell pharmaceutical products in Belgium. Internet pharmacies more permitted to do this as of 8 February 2009. However, online supply is only allowed by a registered pharmacist through a pharmacy open to the public. Therefore, the monopoly of pharmacists in Belgium in the supply of medicines remains (Association of European Self-Medication Industry - AESGP, 2009).

According to EFPIA (2008), the shares of each segment of Belgium’s pharmaceutical sales amounted to approximately:  Pharmacies (general access): 86%  Hospital pharmacies: 14%  Other retail channels: 0%

Trends in consumption  Top-selling active ingredients: In 2007, the active ingredient which led the sales of pharmaceutical products (in value) in Belgium was atorvastatin (member of the drug class known as statins, used for lowering cholesterol), followed by clopidogrel (a potent oral antiplatelet agent often used in the treatment of coronary artery disease, peripheral vascular disease, and cerebrovascular disease) and salmeterol (a beta2-adrenergic receptor agonist pharmaceutical product which is currently prescribed for the treatment of asthma and chronic obstructive pulmonary disease - COPD) in combination with

corticosteroid (a steroid hormone) (Institut national d'assurance maladie-invalidité - RIZIV/INAMI in PPRI, 2008).  Non-prescription products: The market for non-prescription products indicated a slowdown in 2008, whereas the two previous years showed large growth in value. Moreover, in 2008, volume sales remained stable. The stabilisation of the non-prescription pharmaceuticals market can partly be related to a lower number of viral outbreaks in the winter, which reduced sales in analgesics, cough, cold and allergy remedies and digestive remedies (Euromonitor, 2009).  Common non-prescription products: Euromonitor data also show that analgesics and digestive remedies benefit from the success of double-dose acetaminophen and gastroprocinetic products (included in antacids) and probiotic ingredients (in diarrhoeal remedies), being products which are consumed in large quantities in Belgium (Euromonitor, 2008).  Forecast of non-prescription products: In contrast to the previous years, Euromonitor (2009) forecasts a slowdown in growth of the non-prescription products market until 2013. The impact of the economic crisis on the economy and on consumer confidence will continue to have an adverse impact on the market. However, in comparison to, for instance, clothing or consumer foodservice, it is difficult to reduce expenditures on health, a fact which should contribute to a continuing increase in sales, albeit a small growth.

For more information on trends for pharmaceutical products, please refer to the CBI survey ‘The pharmaceutical products market in the EU’.

Production In 2007, Belgium was the tenth largest producer of pharmaceutical products in the EU, accounting for approximately 3.2% of total EU production. In comparison, the largest EU producer in 2007 was France, accounting for 21% of total production. Belgium’s production increased by an annual average rate of 5.3% between 2003 and 2007, amounting to € 5.2 billion in 2007. However, in comparison to 2006, production decreased slightly in 2007. The increase in Belgium’s production of pharmaceutical products was more positive than the development of total EU production, which increased at a lower annual average rate of 2.3% during the review period.

Although Belgium is a global leader in the production of vaccines, its production of pharmaceutical products is not proportionally large. Belgian companies are mostly small, and only a few large pharmaceutical multinationals have production sites in the country. Nonetheless, Belgium is one of the main distribution centres for pharmaceutical products in the world (Espicom, 2009).

Please note that data concerning the production of specific product groups in Belgium are not available.

In addition to its production, Belgium’s pharmaceutical industry Research and Development (R&D) in 2007 was estimated at € 1.8 billion, accounting for approximately 8.3% of total EU pharmaceutical industry R&D. Thus, Belgium had the fourth largest pharmaceutical industry R&D in the EU. In comparison, the UK, which had the leading pharmaceutical industry R&D, accounted for a share of 29% of total EU R&D in 2007.

Many multinationals use Belgium as an international distribution centre. Leading multinationals in Belgium are:  Sanofi-Aventis - http://www.sanofi-aventis.com  Janssen-Cilag - http://www.janssen-cilag.com.  Pharma Belgium - http://www.pharmabelgium.be - a subsidiary of Celesio pharmaceutical distribution.  Omega Pharma - http://www.omega-pharma.be - one of the most dynamic manufacturers in the country.

Trends in production  New pharmaceutical products: Belgium produces a significant share of the new pharmaceutical products available worldwide. Among these products, one can find new drugs against epilepsy, bipolar disorder, allergies, obesity, reproductive medicine and tuberculosis; new chemo-therapy against blood cancer and preventive molecule against AIDS (Embassy of Belgium - Washington DC).  Research and MDG: Belgium’s pharmaceutical R&D industry aims at contributing to the health objectives of the Millennium Development Goals (MDG). The country’s laboratories are increasingly orientating themselves to researching alternatives to fight resistance to diseases such as HIV, malaria and tuberculosis in developing countries (Pharma.be, 2009).  Paediatric research: Upon the introduction of the EU-wide ‘Regulation on Medicinal Products for Paediatric Use’ in January 2007, Belgium’s pharmaceutical industry has focused on the research and development of pharmaceutical products for paediatric use. The regulation’s overall objective is to create a favourable climate for the development of quality pharmaceutical products for children (Pharma.be, 2007).

For more information on trends for pharmaceutical products, please refer to the CBI survey ‘The pharmaceutical products market in the EU’.

Opportunities and threats +/-Belgium is not among the main consumers of pharmaceutical products in the EU. Nonetheless, its vital trading role provides good prospects for exporters of pharmaceutical products in developing countries to enter the EU market. +/-Generic medicines play a small role in the Belgian market. However, new legal provisions and the loss of patent protection for high volume products such as omeprazole and simvastatin contribute to the expansion of Belgium’s generic market. In this sense, opportunities for exporters in developing countries also expand. - Belgium has one of the largest pharmaceutical industry R&D sectors in the EU, which puts the country in a competitive position in relation to other exporters of pharmaceutical products. +/- Regarding non-prescription products, a slowdown of sales is expected, due to the current economic crisis. However, as there is a continuing need for pharmaceutical products, the sales of pharmaceuticals are expected to increase again in the long-term.

Exporters should take into account that the same trend can be an opportunity for one exporter and a threat to another. Please, review these opportunities and threats according to your own situation. Chapter 7 of the CBI market survey ‘The pharmaceutical products market in the EU’ presents an example of an analysis of whether a trend/development is an opportunity or a threat.

Useful sources  European Federation of Pharmaceutical Industries and Associations (EFPIA) - http://www.efpia.org  Pharmaceutical Pricing and Reimbursement Information: Belgium - http://ppri.oebig.at/Downloads/Results/Belgium_PPRI_2007.pdf  Federal Ministry of Health, Food chain safety and Environment – https://portal.health.fgov.be  The Business Monitor publication ‘The Belgian Republic Pharmaceuticals & Healthcare Report 2008’- http://www.businessmonitor.com/pharma/belgium.html - provides forecasts on the Belgian pharmaceutical and healthcare industry.  Espicom - http://www.espicom.com – the pharmaceutical and medical device knowledge center  Furthermore, Belgian trade associations mentioned in Chapter 6 of this survey can be useful sources of information.

2 Trade channels for market entry

Trade channels The trade structure for pharmaceutical products across the EU is mostly similar, but reveals slight variations according to the diverse pharmaceutical and healthcare systems existent in each country. These variations hardly affect an exporter’s market approach, since they are related to the way pharmaceutical products are domestically dispensed to the end-consumer. Some of the specific characteristics of the Belgian pharmaceutical trade channels and trends therein are outlined below:  Belgium has 11 full-line pharmaceutical wholesalers and 30 warehouses, which are part of a multi-channel distribution system (The European Association of Pharmaceutical Full-Line Wholesalers, 2007). Wholesalers provide the major part of pharmaceutical products which are dispensed through pharmacies. Direct supply from manufacturers is allowed in Belgium, but it is mostly used for non-prescription pharmaceutical products. Pharmaceutical products which are supplied to hospitals are most commonly distributed directly from the manufacturer (PPRI, 2008). Wholesalers are united in the Association Nationale des Grossistes-Répartiteurs de Spécialités Pharmaceutiques (NVGV – ANGR) - http://www.fedis.be.  As mentioned previously, only pharmacies are allowed to dispense pharmaceutical products directly to patients. Self-service is not allowed for non-prescription pharmaceutical products (Association of the European Self-Medication Industry - AESGP, 2009).  Since 1 June 2007 dispensing of pharmaceutical products by doctors (other than medical samples) is no longer allowed (Pharmaceutical Pricing and Reimbursement Information - PPRI, 2008).

Please, refer to the CBI survey ‘The pharmaceutical products market in the EU’ for further information on EU pharmaceutical trade channels.

Players of interest to exporters in developing countries are:  Febelco – http://www.febelco.be – pharmaceutical wholesaler  Aprophar/Alpha - http://www.aprophar.be - pharmaceutical wholesaler  Pharma Belgium (subsidiary of Celesio) - http://www.pharmabelgium.be – pharmaceutical wholesaler  CERP Phardip (subsidiary of CERP Rouen) - pharmaceutical wholesaler  Laboratoria Flandria - http://www.labo-flandria.be – pharmaceutical wholesaler  Antwerps Distributie Centrum - http://www.adcweb.be – pharmaceutical wholesaler

For more possible interesting players, please refer to the website of Belgian wholesalers association: http://www.fedis.be.

Price structure Pricing and reimbursement of pharmaceutical products in the EU are issues of national competence. Therefore, the EU consists of 27 different pricing and reimbursement systems.

At the ex-factory level, maximum statutory prices are set for all pharmaceutical products, with negotiations between the market authorisation holder and the Minister of Economic Affairs. Belgium does not have a system of free pricing, thus the prices of pharmaceutical products at both wholesale and pharmacy levels consist of a fixed margin, which means that pricing decisions are made at the manufacturer level (PPRI, 2008). This pricing structure applies to all types of pharmaceutical products, since prices of non-prescription medicines have also been controlled in Belgium since April 1993 (AESGP, 2009).

When it comes to pharmaceutical products distributed to hospitals, prices are directly negotiated between the hospital and the manufacturer regarding rebates/discounts. These negotiations are private and are not monitored (PPRI, 2008).

Different prices apply throughout the various trade channels. The margins applied to pharmaceutical products in Belgium can be expressed in the following manner:  Wholesaler: 13.1% (maximum of € 2.18 per package)  Pharmacist: 31% of the wholesale price (maximum of € 7.44 per package for non-hospital pharmacies); 22% for hospital pharmacies delivering to non-hospitalised patients  State (Value Added Tax - VAT): a discounted VAT of 6.0% is applicable to pharmaceutical products (the standard VAT rate is 21%)

Generic medicines If a reference price system is in place, the price of a generic medicine is not allowed to be higher than the maximum price of the original pharmaceutical product. If a reference price system is not yet in place, the price of a generic must be at least 30% lower (at ex-factory level) than the original pharmaceutical product (PPRI, 2008).

For further information on price structure of pharmaceutical products in Belgium, please refer to: http://ppri.oebig.at/Downloads/Results/Belgium_PPRI_2008.pdf.

Selecting a suitable trading partner Finding a trade partner in Belgium does not deviate from the general EU method as described in the EU export guidelines. Belgian importers look for new suppliers in developing countries by visiting the country of interest, through recommendations or through trade fairs. The most common ways for developing country exporters to approach Belgian customers are through direct (e)mail, personal visits as follow up, inviting potential Belgian customers to visit them, building a network and visiting international trade fairs.

After obtaining contacts, evaluating potential trade partners should be done according to criteria such as information quality, geographic coverage; the kind of trade relation the partner is interested in, the position of the partner and the financial status and credibility.

The following websites can be of use when finding a trading partner in Belgium:  Europe Bloombiz.com - http://europe.bloombiz.com  Click on ‘companies’ in the centre of the page, and then search for ‘pharmaceutical products’, and select Belgium in the country list.  Europages - http://www.europages.com - online business directory, with full EU coverage. Search for ‘pharmaceutical products’ and filter by country, selecting Belgium on the left- sided tab ‘Refine your search’.  PharmaBuyers.com - http://www.pharmabuyers.com - provides contact information of 580 European importers of pharmaceutical products at a cost of US$40 (updated in 2009).

3 Trade: imports and exports

Imports

Total imports In 2008, Belgium was the largest importer of pharmaceutical products in the EU, accounting for 22% of total EU imports. Between 2004 and 2008, Belgium’s imports increased by an annual average rate of 2.2% in value and 10% in volume, amounting to € 24.7 billion or 192 thousand tonnes in 2008. The majority of Belgium’s imports (92%, in terms of value) was sourced in EU countries. Intra-EU imports increased by an annual average rate of 2.7% in terms of value between 2004 and 2008. Germany, which accounted for a 49% imports share in 2008, was the leading supplier of pharmaceutical products to Belgium. Moreover, imports sourced in Germany increased by an annual average rate of 9.8% in the review period. Other important intra-EU suppliers of pharmaceutical products to Belgium in 2008 were Ireland (24%), France (7.7%) and Italy (6.6%).

Extra-EU countries (excluding DCs) accounted for 7.4% of total Belgian imports in 2008. Between 2004 and 2008, imports sourced in these countries decreased by an annual average

of 10 CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN BELGIUM rate of 3.1%. The USA, the leading extra-EU supplier in 2008, accounted for 4.5% of Belgium’s imports.

The role of developing countries in supplying pharmaceutical products to Belgium is minimal. In 2008, imports sourced in DCs accounted for only 0.4% of Belgium’s total imports. Nonetheless, imports from developing countries increased by a strong annual average rate of 51% between 2004 and 2008. India and Turkey were the main DC suppliers in 2008. Whereas imports from India increased by an annual average rate of 110% in the review period, imports from Turkey increased by 25%.

In 2008, Belgium’s imports of pharmaceutical products consisted of packed pharmaceutical products (99%) and non-packed pharmaceutical products (1%).

Please, note that Belgium’s significant import figures are mainly attributed to the trade function of the port of Antwerp, and are not necessarily related to Belgium’s consumption of pharmaceutical products.

Table 3.1 Imports by and leading suppliers to Belgium 2004 - 2008, share in % of value Product 2004 2006 2008 Leading suppliers in 2008 Share € mln € mln € mln Share in % (%) Total 20,475 21,607 22,801 Intra-EU: Germany (49%), 92% pharmaceutical Ireland (24%), France (7.7%), products Italy (6.6%), UK (1.8%) 2,179 1,973 1,825 Extra-EU ex. DC*: USA (4.5%), 7.5% Switzerland (1.7%) 17 30 87 DC*: India (0.2%), Turkey 0.4% (0.1%) Packed 20,454 21,592 22,787 Intra-EU: Germany (49%), 92% pharmaceutical Ireland (24%), France (7.7%), products Italy (6.6%), UK (1.8%) 2,165 1,957 1,822 Extra-EU ex. DC*: USA (4.5%), 7.4% Switzerland (1.7%) 16 30 87 DC*: India (0.2%), Turkey 0.4% (0.1%) Non-Packed 21 15 14 Intra-EU: Sweden (27%), 81% pharmaceutical Netherlands (16%), UK (15%), products France (6.6%), Germany (5.4%) 13 16 3.3 Extra-EU ex. DC*: USA (14%), 19% Switzerland (2.6%), Israel (2.1%) 0.7 0.1 0.1 DC*: China (0.1%) 0.1% Source: Eurostat (2009) *Developing Countries

Imports by product group Eurostat data were used for this trade paragraph. However, as Eurostat classifies data on pharmaceutical products by non-packed products and packed products, a specific product selection cannot be made. For more information on the classification of non-packed pharmaceutical products and packed pharmaceutical products, please refer to Appendix A of the survey covering the EU.

Packed pharmaceutical products In 2008, Belgium was the leading importer of packed pharmaceutical products in the EU, accounting for 25% of total EU imports. Between 2004 and 2008, Belgian imports increased by an annual average rate of 2.2% in value and 10% in volume, amounting to € 25.7 billion or 191 thousand tonnes in 2008.

Since imports of packed pharmaceutical products accounted for nearly the entirety of Belgium’s imports of pharmaceutical products in 2008, the developments for this product group were the same as the development for the overall group of pharmaceutical products.

Non-packed pharmaceutical products In 2008, Belgium was only the fifteenth largest EU importer of non-packed pharmaceutical products. Between 2004 and 2008, Belgian imports decreased by an annual average rate of 16% in value and increased by 2.1% in volume, amounting to € 18 million or 1.4 thousand tonnes in 2008.

The largest share of non-packed pharmaceutical product imports in 2008 was sourced in intra- EU countries (81%). The leading suppliers were Sweden, which accounted for 27% of total Belgian imports, followed by The Netherlands (16%) and the UK (15%). Imports sourced in intra-EU countries decreased by an annual average rate of 9.6% between 2004 and 2008.

Imports sourced in extra-EU countries, excluding DCs, accounted for 18% of total Belgian imports in 2008. The leading supplier was the USA, which accounted for 13% of total Belgian imports. Imports from extra-EU countries decreased by a strong annual average rate of 30% between 2004 and 2008.

Imports from developing countries accounted for only 0.1% of Belgium’s total imports in 2008, and decreased by a strong annual average rate of 58% between 2004 and 2008. Imports from DCs were almost exclusively sourced in China.

Exports In 2008, Belgium was the second largest exporter of pharmaceutical products in the EU, accounting for around 20% of total EU exports. The largest exporter, accounting for 21% of total EU exports, was Germany. Between 2004 and 2008, Belgium’s exports increased by an annual average rate of 6.6% in value and 7.3% in volume, amounting to € 26.4 billion or 202 thousand tonnes in 2008. Approximately 70% of Belgium’s exports were destined to intra- EU countries. Germany, the leading destination, accounted for 36% of Belgian exports. Exports to extra-EU countries (excluding DCs) accounted for another 24% of total Belgian exports in 2008. The USA (13% of exports) and Canada (3.3% of exports) were the main extra-EU destinations. Exports destined to DC countries accounted for 6.0% of total Belgian exports, of which Turkey was the leading destination, accounting for 0.9% of total exports.

In 2008, Belgium’s exports of pharmaceutical products consisted of packed pharmaceutical products (99%) and non-packed pharmaceutical products (1%).

Due to Belgium’s significant trading function within the EU, exports from this country mainly concern re-exports.

Opportunities and threats + Belgium is the largest importer of pharmaceutical products in the EU and its imports experienced an increase in the review period; this indicates its potential as an entry port for exporters in developing countries who aim at accessing the EU. - In spite of importing substantial amounts of pharmaceutical products, Belgium is a net exporter, due to its important trading role in the EU. In addition, the country does not import large proportions from developing countries. In 2008, Belgian imports from DCs accounted for only 0.4% of total imports of pharmaceutical products. + Although imports from DCs account for a small share of total Belgian imports, they experienced a substantial annual average increase of approximately 50% in the review period, which indicates that opportunities are being created for exporters in developing countries. +/-The increase in overall imports of pharmaceutical product is mainly related to a strong increase in the imports of packed pharmaceutical products. In contrast, non-packed pharmaceutical products decreased in terms of value in the review period.

- Although opportunities for exporters in developing countries exist, one can observe that India and Turkey are the main players. This indicates that smaller players would face strong competition from DCs which already have an established position in the Belgian and EU market.

Exporters should take into account that the same trend can be an opportunity for one exporter and a threat to another. Please, review these opportunities and threats according to your own situation. Chapter 7 of the CBI market survey ‘The pharmaceutical products market in the EU’ presents an example of an analysis of whether a trend/development is an opportunity or a threat.

Useful sources  EU Expanding Exports Helpdesk  http://exporthelp.europa.eu  go to: trade statistics  Eurostat – official statistical office of the EU  http://epp.eurostat.ec.europa.eu  go to ‘themes’ on the left side of the home page  go to ‘external trade’  go to ‘data – full view’  go to ‘external trade - detailed data’  Understanding Eurostat: quick guide to easy Comext  http://epp.eurostat.ec.europa.eu/newxtweb/assets/User_guide_Easy_Comext_20090513.pdf

4 Price developments

Pricing systems vary across the EU, which is also the case for price developments. The main price development observed in Belgium in the last few years is the following:

 Price freezing is no longer applied in Belgium by the Minister of Economic Affairs. Regulated price cuts for ‘old pharmaceutical products’, however, are applied (PPRI, 2008).

Useful sources  ITC market news service (MNS) - http://www.intracen.org  PPRI – Pharmaceutical Pricing and reimbursement Information - http://ppri.oebig.at

5 Market access requirements

As a manufacturer in a developing country preparing to access Belgium, you should be aware of the market access requirements of your trading partners and the Belgian government. Requirements are demanded through legislation and through labels, codes and management systems. These requirements are based on environmental, consumer health and safety and social concerns. You need to comply with EU legislation and have to be aware of the additional non-legislative requirements that your trading partners in the EU might request.

For information on legislative and non-legislative requirements, go to ‘Search CBI database’ at http://www.cbi.eu/marketinfo, select ‘Pharmaceutical product’ and ‘Belgium’ in the category search, click on the search button and click on market access requirements.

Please refer to the CBI market survey ‘The pharmaceutical products market in the EU’ for information on the EU-wide legislation regulating imports, production and marketing of pharmaceutical products for human use, as well as information on packaging and labelling requirements.

Additional information on packaging can be found at the website of ITC on export packaging: http://www.intracen.org/ep/packit.htm

Information on tariffs and quota can be found at http://exporthelp.europa.eu

6 Doing business

General information on doing business like approaching potential business partners, building up a relationship, drawing up an offer, handling the contract (methods of payment, and terms of delivery) can be found in CBI’s export manuals ‘Export Planner’ and ‘Your image builder’. Furthermore cultural awareness is a critical skill in securing success as an exporter. Information on cultural differences in the EU can be found in chapter 3 of CBI’s export manual ‘Exporting to the EU’. These manuals can be downloaded from http://www.cbi.eu/marketinfo - go to search publications.

In Chapter 2, the importance of networks, trade fairs and company visits was expressed in terms of promoting your company and finding trade partners. Trade fairs also offer useful information on trends, potential competitors and the products and services they offer. Trade press should not be underestimated, both as a source of information (i.e. trends, companies) and as a means of promoting your company and your products.

Trade associations  L'Association Générale de l'Industrie du Médicament (AGIM)/ Belgian Pharmaceutical Industry Association – http://www.pharma.be (website in French and Dutch only).  FeBelGen - http://www.febelgen.be – Belgian Association of the Generics Industry  Algemene Pharmaceutische Bond/ L’Association Pharmaceutique Belge/ Belgian Pharmaceutical Association (APB) - http://www.apb.be (website in French and Dutch only)  Organisation des Pharmacies Cooperatives/ Organisation of Cooperative Pharmacies (OPHACO) - http://www. ophaco .org (website in French and Dutch only)

Trade press  Medinews.be - http://www.medinews.be (website in Dutch only)  Algemene Pharmaceutische Bond (APB) - http://www.apb.be (website in French and Dutch)

Trade fairs  Farma 2010, next event is expected to be held 22 – 24 October 2010 in Brussels – http://www.farmabeurs.be

This survey was compiled for CBI by ProFound – Advisers In Development in collaboration with Jan Ramakers Fine Chemical Consulting Group

Disclaimer CBI market information tools: http://www.cbi.eu/disclaimer