2010 - Pharmaceutical Products - EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU
CBI MARKET SURVEY
THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

Publication date: February, 2010
CONTENTS REPORT SUMMARY ...................................................................................................... 2 INTRODUCTION .......................................................................................................... 4 1 2 3 4 5 6 7 CONSUMPTION ..................................................................................................... 5 PRODUCTION ...................................................................................................... 14 TRADE CHANNELS FOR MARKET ENTRY .............................................................. 20 TRADE: IMPORTS AND EXPORTS ......................................................................... 28 PRICE DEVELOPMENTS ....................................................................................... 34 MARKET ACCESS REQUIREMENTS ....................................................................... 35 OPPORTUNITY OR THREAT?................................................................................ 37 PRODUCT CHARACTERISTICS ........................................................... 39 INTRODUCTION TO THE EU MARKET ................................................ 43 LIST OF DEVELOPING COUNTRIES ................................................... 44 REFERENCES..................................................................................... 46
APPENDIX A APPENDIX B APPENDIX C APPENDIX D
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
Source: CBI Market Information Database URL: www.cbi.eu Contact: marketinfo@cbi.eu www.cbi.eu/disclaimer Page 1 of 46
Report summary
This CBI market survey covers the EU market for pharmaceutical products. The emphasis of the survey is on those products which are of importance to developing country suppliers. Statistical and background market information on consumption, production and trade, and information on trade structure, prices and market access is provided. Trends and forecasts, as well as opportunities for and threats to developing country suppliers, are highlighted and sources for more information are provided. Consumption The global pharmaceutical market was estimated at 484.1 billion at ex-factory prices in 2007. Europe (excluding Russia, Ukraine and Belarus) was the second largest regional market, accounting for approximately 31% of total sales of pharmaceutical products. The EU pharmaceutical market increased by an annual average rate of 7.3% between 2003 and 2007, amounting to approximately 141.3 billion at ex-factory prices in 2007. The highest growth rates were registered for the pharmaceutical markets in the Central and East European (CEE) and Baltic countries, mainly due to economic growth and increasing health expenditure taking place in these regions. The share of generic medicines in the total pharmaceutical markets in the EU varies widely from country to country. In Germany, the largest pharmaceutical products market in the EU, the value share of generics is 30%, whereas in France, the second largest pharmaceutical market, the share of generic medicines is only 10%. Moreover, in several countries in the CEE region, the share of genetic medicines in the pharmaceutical market in 2007 was higher than 30% (e.g. Poland 61% and Slovakia 45%). Different policies and regulations on generic medicines explain the wide variations in the market shares of generic medicines. The most important trends affecting consumption of pharmaceutical products in the EU are: EU demographics: The proportion of working age citizens contributing to social service funds is diminishing, while the elderly population, which is more susceptible to diseases and disorders, is increasing. Thus, government expenditure on health care is expected to increase in the EU. Self-medication: Consumers are increasingly avoiding expensive treatments by purchasing generally cheaper non-prescription drugs directly from pharmacies or other retail channels. Lifestyle pharmaceutical products: Pharmaceutical companies have been promoting lifestyle pharmaceutical products since the 1990s, which primarily boost the well-being and appearance of consumers. Generic medicines: Given the increase in healthcare expenditure in the EU, the use of generic medicines, which provide inexpensive medical treatment, is expected to rise enormously in the coming years. Production In 2007, pharmaceutical production in the EU amounted to approximately 162.5 billion (at ex-factory prices), representing an annual average increase of 3.5% since 2003. France was the leading producer of pharmaceuticals in the EU, accounting for a share of 21% in total EU production in 2007, followed by Germany (16%), the UK (14%) and Italy (14%). The most important trends affecting production of pharmaceutical products in the EU are: R&D and production in CEE countries: The EU has traditionally been a centre for pharmaceutical research and development. In the last few years, however, this leading role has been in decline. On the other hand, Central and East European countries in the EU are becoming increasingly important for pharmaceutical research and production, offering lowcost manufacturing and well-qualified medical specialists. Sourcing of Active Pharmaceutical Ingredients (APIs): Pharmaceutical manufacturers in the EU are increasingly sourcing APIs in the CEE region and in developing countries.
Outsourcing to low-cost countries: There is an increase in global outsourcing of pharmaceutical research and manufacturing activities from Western economies to low-cost countries, a development which is also applicable to EU companies. Biotechnology: Biotechnology is increasingly being applied to pharmaceutical products; this results in the creation of products based on the knowledge of human genomics. Generic medicines: The EU is moving towards a higher level of generic medicines production. As patents expire, pharmaceutical companies tend to focus on their generics department. Trade channels The main distribution channel for pharmaceutical products in the EU is the specialised pharmaceutical channel, which consists of pharmaceutical wholesalers, pharmacies, hospitals and self-dispensing doctors. In some cases, agents are also involved in the distribution chain or, as it happens in some markets, other retail channels are used outside the conventional pharmaceutical channel. It is important for exporters to note that the pharmaceutical channel imposes strict regulations for entering the EU market. Non-prescription pharmaceutical products, on the other hand, are subjected to fewer quality and safety checks between the producer and the final consumer in the EU. Therefore, other trade channels might apply, such as direct sales to large retailers. The trade structures of the EU markets are mostly similar, but deviate according to the different pharmaceutical and healthcare systems. Some variations for prescription products lie in the manner in which the product is dispensed to the end-consumer, but this does not affect a suppliers market approach. Wider variations, however, are found in the distribution trends and channels for non-prescription products in the different markets, since weaker regulations apply to these products, and major pharmacy chains and retailers often play a large role. Furthermore, there are no essential differences between the trade channels for packed and non-packed medicines. The different regulations for these two product groups do not affect the manner in which they enter the EU market. EU imports and the role of developing countries Total EU imports of pharmaceutical products increased by an annual average rate of 6.4% in value and decreased by 5.2% in volume between 2004 and 2008, amounting to 110 billion or 1.6 million tonnes in 2008. Due to its vital trading function for pharmaceutical products, Belgium was the leading EU importer of pharmaceutical products in 2008, accounting for 22% of the total EU imports in terms of value, followed by Germany (18%), France (11%), UK (7.8%) and Italy (7.2%). EU imports of pharmaceutical products are dominated by intra-EU imports, which accounted for more than 80% of total EU imports in 2008. Germany supplied 20% of total EU imports; Belgium was the second leading supplier, accounting for 15% of total imports. Imports from extra-EU countries (excluding DCs) accounted for approximately 17% of total EU imports. Imports from developing countries accounted for only 0.8% of total EU imports of pharmaceutical products in 2008. India, Turkey and Brazil were the largest suppliers. In spite of their low share, imports from developing countries increased by an annual average rate of 17% in value and 21% in volume between 2004 and 2008. Opportunities for exporters High costs of production and pressure to reduce healthcare costs compel large pharmaceutical companies to decrease the costs involved in manufacturing and drug development. As a result, these companies are increasingly outsourcing production of APIs and formulations to DCs or sourcing the needed ingredients in developing countries. This development provides an opportunity for DC suppliers to increase their competiveness and the scale of their production. However, producers in developing countries who aim at manufacturing APIs for EU pharmaceutical companies have to comply with EU legislation and to compete with other large DC and CEE exporters.
Introduction
This CBI market survey profiles the pharmaceutical products market in the EU. The emphasis of this survey lies on those products, which are of importance to developing country suppliers. The role of and opportunities for developing countries are highlighted. This market survey discusses the following product groups: Due to the limited availability of trade data on pharmaceutical products, which only make a distinction between packed and non-packed products (see Appendix A), a specific product selection cannot be made. Nonetheless, focus in this survey is given to pharmaceutical products which cover the most popular therapy classes worldwide, namely: Oncologics (Antineoplastics) Lipid regulators (Hypolipidemic agents or antihyperlipidemic agents) Respiratory Agents Antidiabetics Acid Pump Inhibitors Antipsychotics Angiotensin-II Antagonists Antidepressants Anti-epileptics Autoimmune agents For detailed information on the selected product groups please consult appendix A. More information about the EU can be found in appendix B. CBI market surveys covering the market in specific EU countries, specific product(group)s or documents on market access requirements can be downloaded from the CBI website. For information on how to make optimal use of the CBI market surveys and other CBI market information, please consult From survey to success - export guidelines. All information can be downloaded from http://www.cbi.eu/marketinfo Go to Search CBI database and select your market sector and the EU.
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1.1
Consumption
Market size
According to the European Federation of Pharmaceutical Industries Associations (EFPIA), the global pharmaceutical market was estimated at 484.1 billion at ex-factory prices in 2007. North America, the worlds leading market, accounted for a share of 46%. Europe (excluding Russia, Ukraine and Belarus) was the region with the second largest pharmaceutical market in the world in 2007, accounting for approximately 31% of total sales of pharmaceutical products. Despite its smaller size, the European market outpaced the North American market in terms of growth. Whereas the North American market increased at an estimated rate of approximately 4% in 2007, the European market increased at an estimated rate of around 7%. The Asian market was the fastest-growing market in the world, increasing at an estimated rate of over 13% in 2007 (EFPIA, 2008). The EFPIA also provides more detailed data on the EU market in particular. The organisation has reported the size of the pharmaceutical market in the individual EU countries as shown below. The most up-to-date data available are from 2007. According to the organisation, the EU pharmaceutical market increased by an annual average rate of 7.3% between 2003 and 2007, amounting to approximately 141.3 billion at ex-factory prices in 2007. Table 1.1 EU pharmaceutical market1 2003-2007, in million, at ex-factory prices
Annual change % EU 2006 2007 % 129,365 141,289 7.3% 18% 24,353 25,501 4.6% 18% 24,353 25,241 2.7% 12% 16,472 16,734 3.5% 10% 14,548 14,493 -3.5% 9.3% 12,154 13,209 7.5% 3.9% 4,244 5,503 16% 3.3% 4,230 4,616 7.3% 3.0% 4,009 4,237 13%3 2.8% 3,684 3,932 4.5% 2.5% 3,321 3,490 6.5% 2.2% 2,802 3,052 4.6% 1.9% 2,544 2,736 6.2% 1.4% 1,954 1,955 7.8%3 1.3% 1,706 1,902 14% 1.3% 1,685 1,860 8.3% 1.3% 1,740 1,848 4.1% 1.1% 1,352 1,601 22%4 1.1% 1,467 1,586 11%3 0.6% 671 846 20%3 0.4% 538 542 5.3%4 0.3% 468 487 5.6%3 0.3% 411 404 13%3 0.2% 213 257 21%3 0.1% 177 174 -1.7%5 0.1% 189 137 9.2%3 0.1% 80 77 -3.8%5 2004, 2005, 2006, 2007, 2008 and 2009
2003 2004 2005 Total EU2 106,455 116,160 125,502 France 21,320 22,760 23,838 Germany 22,670 21,551 24,846 Italy 14,606 15,195 15,749 United Kingdom 16,713 16,110 15,569 Spain 9,890 10,671 11,332 Greece 3,020 3,468 3,821 The Netherlands 3,477 3,579 3,795 Poland n.a. 2,939 3,546 Belgium 3,291 3,539 3,657 Portugal 2,715 2,879 3,105 Sweden 2,553 2,608 2,673 Austria 2,148 2,312 2,411 Hungary n.a. 1,556 1,844 Ireland 1,130 1,306 1,514 Denmark 1,351 1,410 1,536 Finland 1,571 1,689 1,740 Romania n.a. n.a. 1,083 Czech Republic n.a. 1,163 1,338 Slovakia n.a. 487 565 Bulgaria n.a. n.a. 489 Slovenia n.a. 413 442 Lithuania n.a. 276 322 Latvia n.a. 144 181 Cyprus n.a. n.a. n.a. Estonia n.a. 105 106 Malta n.a. n.a. n.a. Source: EFPIA, The Pharmaceutical Industry in Figures 1 Data are not available for Luxembourg 2 Please note that data are not always available for all EU countries in the different periods. For this reason, the total figure for each year does not include all 26 countries from 2002 to 2005. 3 Annual change is calculated on data available between 2004-2007
Annual change is calculated on data available between 2005-2007 Annual change is calculated on data available between 2006-2007
As seen in Table 1.1, France and Germany were the largest markets in the EU, each accounting for approximately 18% of the total pharmaceutical sales in 2007. Italy, the third largest market in the EU, accounted for 12% of the total pharmaceutical market and the UK, the fourth largest market, accounted for an 10% share. Spain, the fifth largest market, accounted for 9.3% of the total pharmaceutical market in the EU. Among the largest pharmaceutical markets in the EU, the UK is the only one which showed a negative development in the review period. The countrys pharmaceutical market decreased by an annual average rate of 3.5% between 2003 and 2007. Considering the ten largest markets in the EU, Greece represented the pharmaceutical market which increased at the highest annual average rate between 2003 and 2007, achieving 16%. The pharmaceutical markets in the CEE (Central and East European) and Baltic countries have registered the highest growth rates in the EU in the last few years. Although 2003 and 2004 data are not available for most of these countries, one can see that their markets achieved an impressive positive development as of 2004. Between 2004 and 2007, Polish consumption increased by 13% annually, affirming the countrys position as the largest CEE market. The Romanian market for pharmaceutical products, for instance, increased by an annual average rate of 22% between 2005 and 2007. Latvia and Lithuania have seen their pharmaceutical products market increase by an annual average increase of 22% and 13% respectively. Estonian demand for pharmaceutical products increased by 9.2% annually between 2004 and 2007. The rapid development of the pharmaceutical market in the CEE region and in the Baltic countries can be explained by the economic growth and increasing health expenditure taking place in these regions. National governments in these regions are committed to increasing patient access to medicine and improving the quality of health care (Pharmaceutical Pricing and Reimbursement in Central and Eastern Europe, 2008). Forecast: According to IMS Health, the global pharmaceutical market is expected to increase by approximately 4.5 to 5.5% in 2009, which is an almost similar annual increase in comparison to 2008. This would indicate that the pharmaceutical sector at large seems to be doing relatively well, since health concerns are only affected to a limited extent by the economic turndown. In addition, a 2007 report on the pharmaceutical industry by PricewaterhouseCoopers also forecasted that the global pharmaceutical market will more than double in value by 2020, reaching approximately 950 billion (US$ 1.3 trillion). Regarding the EU, it is forecasted that strong growth in the ten European markets which joined the European Union in 2004 helped to boost European sales over the past years. Nonetheless, no forecast on the growth of the EU pharmaceutical market is provided. This review above covers the pharmaceutical market as a whole (i.e. originator and generic medicines). The section below concentrates specifically on the generic medicines market. Generic medicines The EU market for generic medicines has gone through major changes in the past few years. By the end of 2004, EU patents expired for approximately 35% of the most frequently sold pharmaceutical products. This created a major opportunity over the ensuing years to increasing the share of generics, both in the pharmacy and hospital sectors (European Generic Medicines Association- EGA, 2007). In this manner, generic medicines producers are increasingly becoming the main suppliers of almost all pharmaceutical products dispensed to European patients. Generic medicines are used for a wide variety of common chronic conditions, such as cancer, diabetes, depression, asthma and Parkinsons disease (EGA, 2007). According to the EGA, generic medicines accounted for approximately 50% of the volume of pharmaceutical products in the EU in 2006, saving healthcare systems approximately 25 billion each year (EGA, 2007). In terms of value (at ex-factory prices), the EU market for
generic medicines was worth approximately 27.4 billion in 2007, accounting for around 21% of the total EU pharmaceutical market (Table 1.2). In 2007, KPMG estimated that the EU accounted for approximately 30% of worldwide sales of generic medicines (KPMG, 2007). Incidence of generics in the EU and EU countries The size of the market for generic medicines in the EU varies widely from country to country. In countries where generic medicines have been promoted for 10-15 years, the market is more mature than in countries where promotion is more recent, which explains the higher proportion of these products in the pharmaceutical market. Table 1.2 shows the size of the generic medicines market in the EU as a whole and in the individual EU countries. It provides information on the generic medicines market in two distinct but related ways: the absolute size of the generics market (in value) and the percentage of the pharmaceutical market as a whole accounted for by generic medicines. For each EU country, further information is provided on the share of their individual generics market in relation to the total EU generics market. As can be observed in Table 1.2, therefore, the market share of generic medicines is not directly related to the size of a countrys pharmaceutical market. Please note that the values in this table are given at ex-factory prices. In 2007, Germany was the largest pharmaceutical products market in the EU of which generic medicines accounted for 30% of the total pharmaceutical market. In contrast, the share of generic medicines with respect to the French pharmaceutical market was only 10%. In this manner, Germany is the leading market for generic medicines in the EU; it has the most generic medicines sold in absolute terms, accounting for 28% of the total EU generic medicines market. France, on the other hand, has only the fifth largest generic medicines market in absolute terms, accounting for 8.8% of the total EU generic medicines market. Regarding Central, East European and Baltic countries, the share of generic medicines in the pharmaceutical market in 2007 was higher than 30%. In Slovakia, for instance, the share of generic medicines was 45%. In spite of a significant market share of generic medicines, the pharmaceutical market in these countries is very small. Consequently, the market for generic medicines in these countries is also very small when considered in absolute - rather than in relative - terms. Table 1.2 EU generic market value in mln between 2005-2007, share of generics within the country in % value, share of generics with respect to EU total in % value, by EU country
Generics market (in million)2 % Share of generics with respect to its pharmaceutical market in 20072 21% 30% 29% 20% 61% 10% 7.2% 19% 13% 17% 19% 29% 15% 10% 21% 45% 20% 33% 8.0% % Annual change in generics market % Share of generics with respect to the EU total in 2007 28% 15% 12% 9.4% 8.8% 3.5% 3.2% 2.6% 2.2% 1.9% 1.7% 1.6% 1.5% 1.4% 1.4% 1.4% 0.6% 0.6%
Country
Total EU1 Germany United Kingdom Italy Poland3 France Spain The Netherlands Greece Portugal Austria Romania Sweden Belgium Denmark Slovakia Finland Slovenia Ireland
2005 2006 2007 20,426 21,532 27,409 7,230 7,428 7,648 4,095 3,462 4,217 2,063 2,257 3,397 2,128 2,405 2,585 1,883 2,119 2,423 669 778 951 668 778 886 409 594 715 394 485 607 323 435 512 337 416 456 353 392 443 311 368 401 198 356 381 n.a. 306 377 393 358 373 157 154 159 117 136 152
16%
2.8% 1.5% 28% 10% 13% 19% 15% 32% 24% 26% 16% 12% 14% 39% 23%4 -2.6% 0.4% 14%
Source: EFPIA (2009) 1 Data from EFPIA are not available for Bulgaria, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Luxembourg and Malta. 2 at ex-factory prices 3 The data for 2005 and 2006 on the Polish generics market are based on an estimate. As such they are not part of the aggregate for the EU market. Data for 2007 is based on EFPIA (2009) generics market figures. 4 Annual average change based on data between 2006-2007.
Please, refer to the individual country surveys for more information on generic medicines in the individual pharmaceutical markets. Forces which maximise or limit generic friendliness in the EU and EU countries Different policies and regulations on generic medicines explain the large variations in the shares of generic medicines in the pharmaceutical markets of different countries. Pricing and reimbursement systems are the most significant factors explaining these differences. Generic medicines have a market share which varies between 15% and 30% of the pharmaceutical market as a whole (in terms of value) in countries where relatively free pricing of pharmaceutical products is possible (e.g. Germany, The Netherlands, the United Kingdom). In countries with regulated prices (e.g. Austria, Belgium, France, Italy, Portugal, Spain), the market share of generic medicines amounts to less than 15%. When free pricing is in place, the prices of pharmaceutical products are usually higher, resulting in larger price differences between generic and originator pharmaceutical products, thereby facilitating the entry of generic medicines in the market. Pricing and reimbursement systems are further explained in Chapter 3 of this survey. Another factor influencing differences in the penetration of generic medicines in a countrys pharmaceutical market is its legislation concerning generic substitution. According to the Association of the British Pharmaceutical Industry, generic substitution is different to generic prescribing, and it happens when the pharmacist substitutes an originator pharmaceutical products prescribed by a physician with a generic medicine, without consulting either the patient or the doctor. Generic substitution is not permitted in certain EU countries, it is permitted and/or encouraged in some and it is permitted under certain conditions in others. In some countries (e.g. the UK), physicians are in fact allowed and encouraged to prescribe by a pharmaceutical products INN (International Non-proprietary Name), which is considered to be a force contributing to a higher incidence of generic medicines in the pharmaceutical market. In order to be sustained in a pharmaceutical market, generic medicines should be sold at competitive prices. In addition to regulations which establish pharmaceutical prices de facto, competitive prices for generic medicines can only be maintained when there is a high market volume. In order to achieve this volume, financial incentives for physicians, pharmacists and patients to prescribe/sell/consume generic medicines are essential. In order to create incentives for patients to accept generics, for instance, several governments and generic medicines associations in the EU have launched awareness-raising campaigns. Next to these incentives, the structure of reimbursement systems in different countries also impacts the penetration of generic medicines. In some reimbursement systems, a system called patient co-payment is in place, which consists of the amount which is not reimbursed by a third party, for example health insurance companies. In countries such as Portugal and Poland, this payment is not covered by the patients insurance; in some countries, however, patient co-payments are covered by private insurance (e.g. in France). In cases where patients directly participate in the payment of their pharmaceutical products, the choice for generic medicines is more natural, since the payment burden falls directly in the hands of the patients, and generics make this payment more economically viable. For a more elaborate discussion on reimbursement systems in the EU, refer to the section Price structure, in Chapter 3.
A patients choice for generic medicines might also be affected by a countrys cultural aspects. In Cyprus and Italy, for instance, patients have a reportedly general preference for originator pharmaceutical products over generic medicines, triggered by concerns about product safety and quality. Finally, it is relevant to mention that consumption of generic medicines may also be affected by a countrys economic situation. The dominance of generic medicines in Central, East European and Baltic countries reflects the relative poor economic situation in the region (Espicom, 2008); in some countries (e.g. Slovakia) generic medicines account for 45% of the pharmaceutical market in terms of value (see Table 1.2). Product groups In relation to the specific product groups considered in this survey, Table 1.3 shows the statistics on the worldwide sales of the ten leading pharmaceutical products in terms of value between 2006 and 2008. The information provided in this section covers the pharmaceutical market as a whole, and is not specific for generic medicines. Please also note that no information is available for the EU or for individual EU countries. Obviously, the pharmaceutical market consists of a much wider variety of product groups than the ten presented below. Pharmaceutical products cover a great diversity of diseases and disorders, which could not possibly be investigated thoroughly in this survey especially considering that the pharmaceutical market in the EU is very fragmented. In 2008, the ten leading product groups accounted for nearly 34% of the total pharmaceutical market and sales amounted to 181.8 billion, indicating a increase in sales of 1.3% between 2006 and 2008. The group of oncologics was the leading one in terms of sales in 2008, accounting for 6.7% of the global pharmaceutical market, followed by lipid regulators and respiratory agents, which accounted for respective market shares of 4.7% and 4.3%. Out of the ten leading product groups, only three experienced a decrease in worldwide sales between 2006 and 2008, namely lipid regulators, acid pump inhibitors and antidepressants. Between 2006 and 2008, the sales value of lipid regulators decreased by 9.3% annually, sales of antidepressants decreased by 8.0% and sales of acid pump inhibitors decreased by 2.9% per annum. Worldwide sales of oncologics and angiotensin-II antagonists experienced the highest increase between 2006 and 2008, at respective annual increase rates of 9.2% and 8.9%. Autoimmune agents increased by 12% between 2007 and 2008. Table 1.3 Leading pharmaceutical product groups between 2006-2008, sales in billion, share of global sales in %
2006 sales Share 2007 sales 2008 sales Annual (- in 2008 (- in change (- in Leading product groups billion)1 (%) billion)1 (%) billion)1 27.6 30.2 32.9 6.7% 9.2% Oncologics 28.1 24.6 23.1 4.7% -9.3% Lipid regulators 19.6 20.9 21.4 4.3% 4.5% Respiratory agents 16.9 17.6 18.7 3.8% 5.1% Antidiabetics 19.2 18.7 18.1 3.7% -2.9% Acid pump inhibitors 14.5 15.1 15.7 3.2% 3.9% Antipsychotics 13.2 14.2 15.7 3.2% 8.9% Angiotensin-II antagonists 16.4 14.4 13.9 2.8% -8.0% Antidepressants 11.1 11.5 10.4 2.3% 5.4% Anti-epileptics n.a. 9.7 10.9 2.2% 12%2 Autoimmune agents 11.1 n.a. n.a. n.a. n.a. Erythropoietin products 177 176.5 181.8 33.9% 1.3% Total Source: IMS MIDAS, MAT (2007, 2008 and 2009) 1 Sales cover purchases from pharmaceutical wholesalers and manufacturers worldwide. The figures above include prescription and certain over-the-counter data, and represent manufacturer prices. 2 Annual change based on data for 2007 and 2008.
1.2
Market segmentation
The 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. Dispensing method Pharmaceutical products can be divided into two categories: prescription and non-prescription products (see Table 1.4). Prescription products are those which are dispensed only when a prescription by a physician is presented, whereas non-prescription products can be distributed over-the-counter (these products are also referred to as over-the-counter products), without a prescription. Table 1.4 Market segmentation in the EU: prescription and non-prescription pharmaceutical products, in 2008, at consumer level prices1
Nonprescription 16% 11% 12% 27% 7% 22% 15% 7% 6% 9% 17%
NonCountry Prescription prescription Country Prescription Total EU2 86% 14% Ireland 84% Austria 92% 8% Italy 89% Belgium 85% 15% Netherlands 88% Bulgaria 72% 28% Poland 73% Czech Republic 73% 27% Portugal 93% Denmark 89% 11% Romania 78% Finland 89% 11% Slovakia 85% France 82% 18% Slovenia 93% Germany 85% 15% Spain 94% Greece 94% 6% Sweden 91% Hungary 85% 15% UK 83% Source: AESGP (2009) 1 Data excludes hospital sales. 2 Excluding Cyprus, Estonia, Latvia, Lithuania, Luxembourg and Malta
Dispensing channels Regarding dispensing channels, the EU market for pharmaceutical products can be divided into three segments: (general access) pharmacies, hospital pharmacies and other retail channels. In some countries in the EU, pharmaceutical products (prescription and non-prescription) can only be dispensed through pharmacies and hospital pharmacies, whereas other countries allow non-prescription products to be dispensed through other retail channels. Prescription products, however, can only be dispensed through pharmacies and hospital pharmacies. Pharmacies (general access): these pharmacies consist of a retail storefront, with a dispensary where pharmaceutical products are stored and dispensed. The dispensary is subject to the pharmaceutical legislation, which has specific requirements for storage conditions, handling equipment, warnings, etc. Hospital pharmacies: they usually handle more complex pharmaceutical products, with specific indications which require stricter safety regulations and patient compliance. Most of the products in these pharmacies are single-dose or unit dose. Hospital pharmacies are usually located in the premises of hospitals, with trained personnel, quality assurance and adequate facilities. In some cases, hospital pharmacies are only used for inpatient treatment, being restricted to internal use. In other cases, hospital pharmacies might also be allowed to dispense pharmaceutical products, which means that they also serve the outpatient sector. Other retail outlets: this segment consists of supermarkets, convenience outlets and mass merchandisers which sell non-prescription pharmaceutical products. For these outlets, regulations are less strict than in pharmaceutical outlets which sell prescription products. According to EFPIA, the vast majority of pharmaceutical products is sold through general access pharmacies and hospital pharmacies, in the form of prescription products. Nonprescription pharmaceutical products are accessible through (general access) pharmacies and hospital pharmacies as well, but they are additionally marketed through retail outlets in some
EU countries, although their availability in this segment varies widely from country to country. As mentioned previously, dispensing pharmaceutical products through channels other than (general access) pharmacies or hospital pharmacies is prohibited in some EU countries. As shown in Table 1.4, the share of non-prescription pharmaceutical products in the pharmaceutical market is still limited. However, availability of non-prescription pharmaceutical products through retail outlets other than pharmacies is becoming more important in some EU countries, as sales of more products are gradually permitted through these channels. Further information on country-specific market segmentation is presented in the individual country surveys. Please also refer to Chapter 2 of this survey for more information on the trade channels concerning the EU market for pharmaceutical products. 1.3 Trends in consumption
General trends EU demographics: According to a report of The European Commission and Economic Policy Committee (2009), estimates that there will be four elderly persons for every ten working persons in the EU by 2020, increasing to 7 elderly persons to 10 working persons in 2060. This means that the proportion of working age citizens contributing to social service funds is rapidly diminishing, while the elderly population, which is more susceptible to diseases and disorders, is increasing. Thus, government expenditure on health care is expected to proportionally increase in the EU. Cost cuts on health care: Due to the economic recession, government spending is being squeezed in many EU countries. Health services across Europe will be under increasing pressure in the coming years. Governments are likely to pressure prices of pharmaceuticals and limit access to more expensive medicines, for instance by only reimbursing generic medicines or other cheap pharmaceutical products (Reuters, 2009). Self-medication: Consumers are increasingly willing to buy non-prescription drugs, due to convenience and cost-saving. In addition, governments of some EU countries (i.e. Ireland or Austria) have eased their regulations, providing more opportunities for consumers to buy medicines without prescription. The economic crisis is believed to have had a positive effect on this trend, as consumers can save money by buying non-prescription drugs from a pharmacist instead of other, more expensive, treatments. Generic medicines: Given the increase in healthcare expenditure in the EU, the use of generic medicines, which provide inexpensive medical treatment, is expected to rise enormously in the coming years (EGA, 2006). At the same time, however, some EU pharmaceutical companies which produce branded products have fought to slow the introduction of generic medicines into the market, often taking actions to extend their products patents (International Herald Tribune, 2008). Lately, the European Commission (EC) also acknowledged a delay in entry of generic pharmaceuticals on the EU market, which potentially leads to significant extra costs for EU consumers. Lifestyle pharmaceutical products: Pharmaceutical companies have been promoting the lucrative lifestyle pharmaceutical products since the 1990s. These products do not cure any diseases, but are primarily designed to boost the well-being and appearance of consumers (e.g. weight loss and rejuvenation). The market for these products has indeed grown in the last few years. Hair loss, sleep, weight loss and sexual dysfunction pharmaceutical products are currently the most popular sub-groups of lifestyle pharmaceutical products in the global and EU market (Businessweek, 2007). Although they are products which are not included in this surveys product selection, it is important to keep in mind that they are increasingly popular. Product-specific trends Oncologics: The rising consumption of oncologics can be attributed to the changing perceptions on cancer and to product innovations for the treatment of this disease. Cancer is no longer perceived as a life-ending disease, but as a chronic illness which can be treated with long-term therapies. Thus, the number of patients on chemotherapy in the EU, but also in Japan and North America, is increasing rapidly. IMS Health estimates that between
2007 and 2012, the global consumption of oncologics will grow by an annual average rate of 12 to 15%. This increase can also be attributed to the introduction of innovations to the oncologics market, which improve the patients quality of life, delay disease progression and help prolong the survival for patients suffering from different kinds of cancer (Reuters, 2008). Lipid regulators: the consumption of lipid regulators in the EU increases as the number of individuals who suffer from obesity and related chronic diseases (i.e. heart diseases, strokes, certain types of cancer) expands, a factor which is also related to the ageing of the EU population. Respiratory agents: This group is increasing in demand due to the expanding incidence of disorders in the respiratory system, such as asthma and chronic obstructive pulmonary disease. In the EU, this increase is also coupled to an ageing population, which is more susceptible to respiratory illnesses. About 80 million Europeans have some form of allergic disease and their prevalence is increasing. Around 30 million people in Europe have asthma, and as many as 6 million suffer from symptoms. Approximately 44 million Europeans have Chronic Obstructive Pulmonary Disease (COPD) (EFA, 2006). Acid pump inhibitors: The wide use of acid pump inhibitors may be attributed to factors such as stress and deficient diets. These factors increase the amounts of acid in the stomach, explaining the correlation between contemporary lifestyle, also experienced in the EU, and the increasing consumption of acid pump inhibitors. Antidiabetics: Due to an ageing population, and a lifestyle which contributes to the expansion of diabetes, the EU represents an increasingly important market for antidiabetics (International Diabetes Federation, 2008). The influx of more affordable and innovative product solutions drive up sales of antidiabetics in the EU, although reimbursement policies, which generally do not cover the more expensive forms of insulin, still restrict the expansion of novelties in the market. Nonetheless, the insulin market is at a growth stage in the EU, whereas the oral antidiabetics market has reached a mature phase (Frost & Sulivan in in-PharmaTechnologist, 2006). Antipsychotics: The use of antipsychotics in the EU is rising due to the introduction of atypical antipsychotics, which have milder side effects than typical ones. The use of atypical antipsychotics in the EU outstripped typical antipsychotics in 2006, providing room for further growth of these products in the future (Lundbeck, 2006). Antidepressants: Depression is among the health conditions showing the largest increase worldwide. It is estimated that about 23 million people in Europe are diagnosed as having depression at one point in their life. However, about 40% of patients with depression are not getting the treatment they deserve (European Alliance against Depression, 2007). The WHO (World Health Organization) estimates that depression will be the second-largest global health burden by 2020. The consumption of antidepressants worldwide and in the EU is, therefore, likely to increase further. Angiotension-II Antagonists: The increasing consumption of Angiotensin-II Antagonists can be explained by the growing number of hypertension cases. This growth is possibly related to lifestyle factors, such as stress and diet, but also to the ageing population, which is a demographic reality in the EU. Anti-epileptics: Although anti-epileptics are originally designed for the prevention of seizures, the growth in the application of these products for psychiatric disorders and movement disorders explains the rising demand for these products. Autoimmune agents: The recent increase in the consumption of autoimmune agents can be attributed to the expanding use of anti-TNF (TNF: tumor necrosis factor, which has an inflammatory action) and to the growth of approved indications for these products (Biological Drug Report, 2007). Moreover, the global market for autoimmune agents is expected to increase by an annual average rate of 3.7% between 2006 and 2012 (Business Insights, 2007). As the risk of developing autoimmune disorders develops with age, the increasing consumption of this product group can also be related to the ageing population in the EU.
1.4
Opportunities and threats
+ The consumption of pharmaceutical products in the EU is expected to keep rising in the coming years. As mentioned previously, the population in the EU is ageing and becoming more susceptible to diseases. In addition to this demographic factor, pharmaceutical innovations have allowed for a wider range of product application - more diversity in therapies is found and more diseases are treated. The growing pharmaceutical market in the EU is, therefore, a positive prospect for exporters of pharmaceutical products in developing countries. + Due to the increasing pressure on the price of medicines and the increasing awareness of the population towards healthcare expenditure, generic markets in the EU are expanding. Because EU production is expensive, cheaper production locations are sought. At the same time, an increasing number of EU countries is enacting policies stimulating the use of generic medicines. These factors are translated into opportunities for the promotion of generics from, and outsourcing of production in, developing countries. + Economic growth in the CEE and Baltic countries and increasing health expenditure provide good prospects for exporters in developing countries. The growing pharmaceutical market in these regions offer opportunities for developing countries to meet the large demand, especially concerning generic medicines, which are highly popular in these EU member states. +/- According to industry sources, the entry of developing countries into the EU pharmaceutical market is exclusive to the generic medicines, which limits DC opportunities to this sector. Development of a new prescription pharmaceutical product takes about 12 years, at a total cost of up to approximately 1.0 billion ($1.4 billion in year 2007 dollars). In this manner, only very large and developed pharmaceutical companies could go through the whole process of developing a new product, since this process is financed by the companys own resources. Therefore, generic medicines are a much better market for DCs, offering an opportunity but, at the same time, are a restricting factor. - Following the recent quality issues regarding various products made in China, there is a growing concern in relation to pharmaceutical products imported from China and other developing countries. One of these issues involved batches of Baxters generic heparin, a widely used injectable pharmaceutical product manufactured in China, which caused adverse patient reactions (PharmaManufacturing, 2008). Although this specific event took place in the USA, the so-called China Syndrome may spill over and lead to even stricter regulations for exporters in developing countries aiming to access markets in the EU. 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 this survey presents an example of an analysis of whether a trend/development is an opportunity or a threat. 1.5 Useful sources
The European Pharmaceutical Industry Association (EFPIA) http://www.efpia.org provides information, national codes of practice and links to national associations. IMS Health http://www.imshealth.com global source for pharmaceutical market intelligence. It provides critical information, analysis and services concerning this market. The European Self-Medication Industry http://www.aesgp.be - provides facts and figures on the European pharmaceutical, self-medication, and non-prescription market. European Generic Medicines Association http://www.egagenerics.com The World Health Organisation for Europe - http://www.euro.who.int
2
2.1
Production
Size of production
The global production of pharmaceutical products is dominated by the USA, which accounts for nearly 40% of the total pharmaceutical production worldwide (at ex-factory prices). Europe, the second largest producer, accounts for approximately 35% of total global production and Japan, the third largest producer, accounts for approximately 9% of production. Other regions of the world account for the remaining 16% of total global production of pharmaceutical products (EFPIA, 2008). The European Federation of Pharmaceutical Industries Association provides more detailed data on the pharmaceutical production in the EU, as shown in Table 2.1. According to the organisation, the EU had a pharmaceutical production of approximately 162.5 billion in 2007 (at ex-factory prices). Between 2003 and 2007, EU production increased at an annual average rate of 3.5%. Table 2.1 EU pharmaceutical production 2003-2007, in million, at ex-factory prices
Annual 2003 2004 2005 2006 2007 change %EU Total EU1 141,744 136,673 155,346 163,012 162,502 3.5% France 31,296 33,141 34,316 34,444 34,276 2.3% 21% Germany 21,262 20,893 22,653 23,699 26,219 5.4% 16% United Kingdom 21,685 22,555 22,935 24,849 22,857 1.3% 14% Italy 17,989 17,742 21,589 22,317 22,455 5.7% 14% Ireland 14,293 15,866 15,146 14,900 15,328 1.8% 9.4% Spain 9,374 9.656 11,114 12,459 14,004 11% 8.6% Sweden 5,758 5,565 5,720 7,196 6,688 3.8% 4.1% Netherlands 5,811 5,660 5,664 5,664 5,664 -0.6% 3.5% Denmark 5,985 4,593 4,877 5,278 5,537 -1.9% 3.4% Belgium 4,245 4,799 4,826 5,261 5,222 5.3% 3.2% Austria 1,325 1,597 1,799 1,874 2,249 14% 1.4% Poland n.a. 1,367 1,367 1,367 2,164 16%2 1.3% Portugal 1,560 1,590 1,745 1,829 2,003 6.4% 1.2% Finland 724 753 782 857 869 4.7% 0.5% Greece 437 449 525 666 704 13% 0.4% Romania n.a. n.a. 181 223 280 24%3 0.2% Cyprus n.a. n.a. n.a. n.a. 120 n.a. 0.1% Latvia n.a. 59 73 95 111 23%2 0.1% Malta n.a. 34 34 34 34 0.0%2 0.0% Source: EFPIA, The Pharmaceutical Industry in Figures 2005, 2006, 2007 and 2008, 2009 1 Data are not available for Bulgaria, Czech Republic, Estonia, Hungary, Lithuania, Luxembourg, Slovakia and Slovenia. 2 Annual change calculated between 2004 and 2007 3 Annual change calculated between 2005 and 2007
In 2007, France was the leading producer of pharmaceutical products in the EU, and accounted for a share of 21% in total EU production in 2007. Germany, the second largest producer in the EU in 2007, accounted for a share of 16% of the total EU production. The United Kingdom ranks third with a share of 14% of total EU production. Italy, the fourth producer, also accounted for 14% of the total EU production and Ireland, the fifth largest producer, accounted for a 9.4% production share. The development of the production in the individual countries in the EU shows a fairly positive scenario. Production of pharmaceutical products in Italy and Germany increased by an annual
average rate of 5.7% and 5.4% respectively, whereas production in France, Ireland and UK achieved a more modest growth of 2.3%, 1.8% and 1.3% respectively. Although data are not available for most of the Central, East European and Baltic countries, we can observe that production has generally increased in the countries for which data are available. Production in Romania, for instance, increased by 24% between 2005 and 2007. Production in Latvia increased by an annual average rate of 23% between 2004 and 2007. In the same period, production in Poland increased by 16%. Their share in the total EU production in 2006, however, remained very low. In 2007, Poland accounted for 1.3% of the total EU production, while Romania and Latvia accounted for only 0.2% and 0.1% respectively. According to EGA, the generic medicines industry is characterized by high diversity and competitiveness. Large generic companies are represented in most EU countries, as well as smaller players which are represented only in one or two countries. Generic companies in the EU employ around 100,000 people in the areas of development, production and sales. A substantial number of pharmaceutical patents is expiring in the EU market in the period 2008-2012. This is expected to lead to further market expansion of the generic medicines market. In 2011, approximately 11 drugs are expected to face generic competition. It is expected that the generic market will expand further due to the growth in importance of biogeneric / biosimilar drugs, which are the generic versions of biotechnology-derived drugs. In the EU, biological drugs enjoy increasing popularity due to the cost-saving opportunities they offer. Nonetheless, the patents of approximately 24 biological drugs will expire by 2010. This will provide possibilities for generic production (Lead Discovery, 2009). According to Lead Discovery, the top generic companies in the EU are Actavis from Finland http://www.actavis.com, Merk KGaA from Germany http://www.merck.de, Ratiopharm from Germany http://www.ratiopharm.com, Sandoz from Switzerland, which is Novartis AGs generics unit - http://www.sandoz.com and Stada from Germany http://www.stada.de. In October 2007, however, Merk KGaA sold its Generics division to Mylan Inc. (United States) (Lead Discovery, 2009). Please note that data regarding the production of generic medicines in the EU are not available. According to EFPIA, the pharmaceutical industry in the EU employed approximately 635,000 people in 2008, of which approximately 117,000 were involved in research and development. Additionally, R&D investment in the pharmaceutical industry amounted to 26 billion in 2007. The research-based pharmaceutical industry accounts for approximately 19% of the global business R&D expenditure (EFPIA, 2009). Forecast: In contrast to consumption, figures related to the forecast for pharmaceutical production in the EU are difficult to obtain. In general, production is expected to accompany the development of the pharmaceutical market. Even though the pharmaceutical sector has proved to be relatively immune to the economic crisis, as spending on health remains a basic necessity, there are certain areas in which the sector was affected. A number of R&D projects have been stopped due to lack of finance. Many pharmaceutical companies are losing banking facilities, such as provision of credit or funding to invest in raw material purchasing, packaging or overall product improvement. 2.2 Trends in production Mergers & Acquisitions: Since the beginning of 2006, there has been a number of merger and acquisition deals among originator companies. In the beginning of 2009, Pfeizer announced its acquisition of Wyeth. In 2008, Millennium was acquired by Takeda and ImClone by Eli Lilly. The acquisitions aim at expanding portfolios and increasing sales. A similar trend is also observable in the generic medicine domain. In 2007, Merck sold its
Generics division to Mylan Inc, the third largest generics company in the world. In 2007, Apotex, the largest Canadian generics company, acquired Lareq Pharma S.L. of Spain and Topgen of Belgium. This trend is likely to continue and lead to the consolidation of the industry. Sourcing of Active Pharmaceutical Ingredients (APIs): The CEE region: Czech Republic and Poland are the most attractive countries within the EU for the sourcing of APIs. The main advantage of these two countries, compared to strong competitors such as China and India is the low level of counterfeiting. As counterfeiting is increasingly regulated by EU legislation, it is more difficult for counterfeited APIs coming from China and India to make their way to the EU market. Developing Countries: High cost of production of APIs in Europe and extensive regulation of the industry has led many companies to start sourcing APIs in developing countries. In order to cut costs, many (generic) pharmaceutical companies orient themselves toward lower-cost manufacturing areas. EU legislation is also, partly, the cause of increased volumes of APIs manufactured in developing countries, mainly in Asia, entering the EU. The delay or gaps in regulation at the EU level in many cases has allowed low-quality exports from Asia to enter the EU market (PMR Publications, 2009). Outsourcing to low-cost countries: There is an increase in the global outsourcing of pharmaceutical research and manufacturing activities from Western economies to low-cost countries, a development which is also applicable to EU companies. Pharmaceutical contract manufacturing is steadily growing due to pressure on producers to lower costs, as well as to stringent regulatory requirements. Consequently, producers in outsourcing destinations have improved their manufacturing facilities to increase their competitiveness on a global scale. The global contract manufacturing market was worth approximately 18 billion in 2007. The market is expected to grow at a rate of 11.4% and reach approximately 27billion by 2011 (Business Insights, 2009). Research and Development (R&D) in the EU: The EU has traditionally been a centre for pharmaceutical research and development. In the last few years, however, this leading role has been in decline. Compared to the North American and Asian regions, the EU is a less attractive location for R&D investment, in terms of both market conditions and incentives for the creation of new biopharmaceutical companies (EFPIA, 2009). R&D and production in CEE countries: Although Western Europes production of pharmaceutical products will be negatively influenced in the future, as indicated above, Central and Eastern Europe are likely to continue increasing in importance, both for R&D and for production. Next to well-established West European pharmaceutical industries, Central and East European EU countries (mainly Poland and the Czech Republic) are expected to thrive. These countries offer low-cost manufacturing and well-qualified medical practitioners are available to conduct clinical research. Many Western pharmaceutical companies are moving part of their production to this region, or are setting up new production capacity, to cater for growing markets (PMR Publications, 2009). Counterfeit medicines: In developing countries, counterfeit medicines are already widespread. Recently, they are also increasingly being found on the EU market. Internet sales are the major source of counterfeit medicines. Lately, however, these products are also being found in the traditional supply chain. Some counterfeits contain toxic substances, others contain no active ingredient or, in some cases, the wrong amount of ingredients. This is damaging to the medical treatment, but can be extremely dangerous when patients take the medicine for treating serious diseases. EU associations representing pharmaceutical companies call for urgent measures against counterfeit medicines (EFPIA, 2009). EU sector inquiry on competition in the pharmaceutical sector: Given the decline in the competitiveness of the EUs pharmaceutical industry, i.e. decreased levels of innovation and delayed market entry of generic medicines, the European Commission announced, in 2005, a sector inquiry for the industry. In 2009, the European Commission issued the findings of the final report. The EC found out that, on average, generic medicines enter the market with a delay of seven months after expiration of patents of brand-name pharmaceuticals. Pharmaceutical innovators have become very creative in the strategies they employ to achieve additional protection for their products. Another way for
pharmaceutical innovators to retain their exclusivity on the market is to file for secondary patents or form patent clusters (there can be up to 1,300 patents for certain blockbuster medicines). Furthermore, the inquiry found that the pharmaceutical sector is highly regulated. There are shortcomings related to market entry due to the regulatory framework. Both generic and originator companies propose, as a possible remedy, the introduction of a single EU Community patent. Stakeholders also emphasized concerns related to market authorisation, reimbursement and pricing, which lead to delays in bringing pharmaceutical products to the market (European Commission, 2009). The sector inquiry contributed to the debate regarding pharmaceuticals, in particular generics, and the first antitrust investigations have already started (EC, DG Competition, 2009). Pharmaceutical legislation in CEE countries: Since their entry to the EU in May 2004, the Central and East European countries in question have harmonised much of their pharmaceutical legislation with that of the EU. Nonetheless, some EU directives in Poland, for instance, still have to be transposed into national law. As is true for the countries which joined the EU in 2004, Romania and Bulgaria also amended the applicable legislation and became full EU members in January 2007. The implementation of Good Manufacturing Practice (GMP) for pharmaceutical products is gaining ground across the region, which is expected to improve the quality of overall production and lead to a rise in market values (Espicom, 2009). Biotechnology: In 2006, the EU was the first region in the world to establish a regulatory framework for biosimilar/biogeneric drugs, thus opening the EU market for generic versions of biopharmaceuticals. This gives the EU a competitive advantage in the biosimilars industry. Biotechnology is being increasingly applied to pharmaceutical products, resulting in the creation of products based on the knowledge of human genomics (biopharmaceuticals). Biotechnology will allow health practitioners to predict a patients response to treatments and to create pharmaceutical products which are personalised according to the genetic variations of individuals. In 2007, biopharmaceuticals accounted for 9% of the total EU pharmaceutical market. Biopharmaceutical manufacturing is reported to have increased by 15% in 2008, driven by growth in sales of biologics (Business Insights, 2009). According to EFPIA, the biotechnology sector in Europe is growing rapidly, but still lags behind the USA. In 2006, Europes revenues resulting from biopharmaceuticals amounted to 9.1 billion, whereas they amounted to 44.1 billion in the USA. This is proportional to R&D expenditure in biopharmaceuticals; in Europe, expenditure amounted to 2.9 billion in 2006, while in the USA it amounted to 18.2 billion (EFPIA, 2008). Generic medicines: According to industry sources, the EU as a whole is moving toward a higher level of generic medicines production. As patents expire, pharmaceutical companies tend to focus on their generics department. Large pharmaceutical companies, such as Novartis, often have a whole subsidiary company which is responsible for the production of generic medicines (in the case of Novartis, this subsidiary company is Sandoz). Production of generic medicines in CEE countries: Generic medicines play a vital role in CEE countries, where high demand for these pharmaceutical products can be explained by their affordability. In spite of the recent introduction of EU pharmaceutical directives and improvement of patent protection in these countries, counterfeiting of Western pharmaceutical products is still prominent. The production of generic medicines has reportedly remained strong, even in countries where originator pharmaceutical products are manufactured (Episcom, 2009). Opportunities and threats
2.3
+ Whereas many complex pharmaceutical products (e.g. biopharmaceuticals) are produced in the EU or in other developed regions, pressures to achieve cost reduction imply that, at least at the lower end of the value chain (e.g. ingredients) or regarding simpler (and generic) products, more and more production is shifting to developing countries. + A promising opportunity for exporters in developing countries is the increase in the global outsourcing of pharmaceutical research and manufacturing activities from Western economies to low-cost countries, which is also applicable to EU companies. Another
opportunity is the sourcing of APIs in developing countries. Led by cost-cutting strategies, an increasing number of EU pharmaceutical companies start sourcing their ingredients in lower cost manufacturing environments, especially in Asia. + The growth in patent expiration for medicines in the EU provides an opportunity for exporters in developing countries, since it translates into more generic medicines available in the market. Exporters should keep an eye on patent expiration in the country/ for the product of their interest. + Certain EU countries have a higher share of generic medicines in their pharmaceutical market as a whole than others; these countries offer greater opportunities for exporters in developing countries. +/- There is a number of biopharmaceuticals for which the patent is expiring. After an EU-wide regulatory framework for biosimilars was established, an increasing number of biogeneric drugs is making its way to the generic market. If developing countries manage to comply with the strict regulations governing the biosimilar industry, this can potentially open a window of opportunity for them. On the other hand, the lions share of biotechnology products in the pharmaceutical industry is still under patent, which means that developing countries have a minimal chance of accessing this segment in the EU. In addition to the strict regulations related to biopharmaceutical products (which are even stricter than those in place for conventional pharmaceutical products), most developing countries do not have the capacity/expertise to produce them. - Exporters in developing countries might encounter increasing competition from developing European countries such as Ukraine, as well as Central and East European countries in the EU, where production of pharmaceutical products and generic medicines, specifically, is established and growing rapidly. - In addition to experiencing a significant growth in their pharmaceutical production, Central and East European countries in the EU are increasingly complying with the EUs safety and quality regulations, which gives them further advantage in relation to exporters in developing countries aiming at accessing the EU market. The EU is becoming more cautious about the quality of APIs originating in DCs and imported to the EU market. After numerous cases of counterfeiting, the pharmaceutical industry in the EU, regulatory agencies in EU member states and the European Union itself have started to impose more stringent requirements on the safety aspects of imported pharmaceutical ingredients. - Different policies and regulations on generic medicines explain large variations in the market shares of generics among different EU countries. Developing country exporters need to be knowledgeable about these regulations before they attempt to export, since countries which encourage/do not encourage generic substitution might contribute to/reduce the penetrability in these markets. Patient co-payment and/or incentives for doctors and/or pharmacists may also increase or decrease the use of generic medicines. - Pricing and reimbursement systems put caps on pharmaceutical prices in some countries, and DC exporters may have to adjust to commercialize their products profitably. For further information on pricing and reimbursement systems in the EU, refer to Chapter 4. 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 this survey presents an example of an analysis of whether a trend/development is an opportunity or a threat. 2.4 Useful sources
European Biopharmaceutical Enterprises (EBE) http://www.ebe-biopharma.org European Medicines Agency (EMEA) - http://www.emea.europa.eu Pharma and Healthcare Insight - http://www.pharmaceuticalsinsight.com CPHI, the worlds leading pharmaceutical ingredients and pharmaceuticals trade show, 5-7 Oct 2010, Paris: http://www.cphi.com Pharmagora, French pharmaceutical trade show, 27-29 March 2010, Paris: http://www.pharmagora.com
Expopharm, 28-31 October 2010, Munich: http://www.expopharm.de Infarma, trade fair focused on the Iberian Peninsula, Feb 2009 http://www.interalia.es/www.infarma.net/default.htm Piribo - http://www.piribo.com is a reliable source of information for the global biotechnology, healthcare and pharmaceutical industries. Espicom - http://www.espicom.com is an interesting and reliable source of information for the pharmaceutical and medical devices market.
3
3.1
Trade channels for market entry

Trade channels
The main distribution channel for pharmaceutical products in the EU is the specialised pharmaceutical channel, which consists of pharmaceutical wholesalers, pharmacies, hospitals and self-dispensing doctors. In some cases, agents (which are normally integrated with wholesaling companies) are also involved in the distribution chain or, as it happens in some markets, other retail channels are used outside of the conventional pharmaceutical channel. It is important for exporters who are entering the pharmaceutical market in the EU to note that the pharmaceutical channel guarantees strict regulations, which are essential for the marketing of prescription pharmaceutical products in the EU. Non-prescription pharmaceutical products, on the other hand, are sold under weaker regulations, going through fewer quality and safety checks between the producer and the final consumer. Therefore, other trade channels might apply, such as direct sales to large retailers (e.g. pharmacy chains). National policies and regulations impact the distribution trends in the different EU countries. The trade structures of these markets are mostly similar, but also deviate according to the different pharmaceutical and healthcare systems. The major variations for prescription products lie at the end of the chain in the manner how the product is dispensed to the endconsumer - but this does not affect a suppliers market approach. Wider variations, however, are found in the distribution trends and channels for non-prescription products in the different markets, since weaker regulations apply to these products, and major drugstore chains and retailers often play a large role. Furthermore, there are no essential differences between the trade channels for packed and non-packed medicines. The different regulations which apply to these two product groups do not affect the manner in which they enter the EU market. The main trade channels for pharmaceutical products are given below: Figure 3.1 Trade channels for pharmaceutical products
Domestic Manufacturer Foreign Manufacturer
Wholesalers/ Importers
Internet & Mail Order
Large Retail Customers
Pharmacies
Hospitals
Selfdispensing doctors
End Consumer Source: Malaysia External Trade Development Corporation (MATRADE), 2005. Adapted by Profound Advisers In Development
Wholesalers/importers Several Europe-wide wholesalers operate in the EU. However, different health care systems, different pharmacy structures, different prescription patterns and, consequently, different product ranges in each country result in a fragmented wholesaling structure, which hampers the expansion of the wholesale business from the national to the EU level. Therefore, most players operate on a national level or only in a limited number of EU countries. Specialised pharmaceutical wholesalers are the most important intermediaries linking domestic and foreign manufacturers to pharmacists, hospitals and self-dispensing doctors. This trade channel applies to both prescription and non-prescription pharmaceutical products, but differs in levels of regulations and quality and safety controls for each of these product groups. Manufacturers in developing countries usually rely on their personal contact with importers/wholesalers in the EU for the marketing of their pharmaceutical products. The term wholesaler/importer is integrated in this survey, since wholesalers also act as importers. The role of importers/wholesalers is to ensure a continuous supply of pharmaceutical products from manufacturers to the channels dispensing these products. After buying pharmaceutical products from manufacturers, wholesalers are also responsible for their safe storage. Delivery quantities need to be small, and they work under just-in-time delivery conditions, answering to patient demand. Just-in-time delivery is more important for prescription pharmaceutical products than for non-prescription products, thus wholesalers/distributors give priority to the former group. Wholesalers provide pharmaceutical products to general access pharmacies, hospital pharmacies and other retail channels (in the case of non-prescription products). Pharmaceutical wholesalers can be divided into full-line wholesalers and short-line wholesalers. Full-line wholesalers carry the whole assortment of pharmaceutical products available in a country, in addition to providing various value-added services to manufacturers and retailers. In essence, they should fulfil requests for any product ordered by a pharmacist. One of the most important functions of wholesalers is the pooling of orders. In the case of pharmaceutical products, pharmacies/hospitals order all the products they need by one wholesaler, who pools the incoming orders before transferring them to the manufacturers. So the use of a wholesaler helps to reduce the number of contacts and, therefore, transaction costs between the manufacturer and end consumer. If pharmaceutical products were supplied directly instead, each pharmacy/hospital would have to get in contact with each manufacturer in order to obtain a complete assortment of products (IPF Institute for Pharmaeconomic Research, 2005). Fullline pharmaceutical wholesalers operate under two kinds of distribution systems: the onechannel (also known as single-channel) and the multi-channel system. Under the one-channel system, pharmaceutical companies make an agreement with an exclusive wholesaler for their whole product assortment, whereas under the multi-channel system wholesalers offer pharmaceutical products from different pharmaceutical companies. With the exception of Sweden and Finland, all EU member states have established a multi-channel distribution system. Short-line wholesalers only offer a limited product assortment, and do not provide the wide range of services that full-line wholesalers do. They are often sole traders who conduct the operation as a sideline to a core business, and many of them are actually pharmacists running the wholesaling business alongside that of a pharmacy. Both full and short-line wholesaling are present in a number of EU countries; nonetheless, in countries such as France, Italy, Belgium, Greece, Portugal, Spain and some East EU countries, pharmaceutical wholesalers are legally obliged to provide the complete product range to pharmacists thus, short-line wholesaling is prohibited (Institute for Pharmaeconomic Research, 2005). Both full and short-line pharmaceutical wholesalers are licensed and inspected equally. Although a large number of wholesalers is active in the EU, only a few EU-wide players have a very strong position on the EU market. Together with their associated companies, which play a strong role in helping the mother companies overcome national differences, the leading three wholesalers control approximately half of the EU intermediary pharmacy market. Celesio, from
Germany - http://www.celesio.com - controls around 18% of the market. It is the market leader in France, Austria, Portugal and has an important position in Germany. However, it is active across the EU as one of the largest players in most countries. It is among the largest pharmacy players in the UK. Phoenix - http://www.phoenix-group.eu.com - from Germany, together with Tamro, the leading Nordic group it acquired in 2004, holds 16% of the market. Phoenix is market leader in Germany, Italy, Hungary, the Czech Republic, Slovakia, Denmark, Finland, Sweden, Latvia, Lithuania, Bulgaria and Estonia. UK-based Alliance Boots http://www.allianceboots.com - holds 15% of the distribution market, but also has a very large retail section. It is the market leader in the UK and has a very important position in France, as well as further wholesale operations in the Czech Republic, Italy, The Netherlands, Norway, Russia, and Spain. Its retail operations lie in Ireland, Italy, The Netherlands, Norway and the UK, while its own brand of medicines is sold in a much wider range of countries. It is important to note additionally that wholesaling activities in the EU are regulated by Title VII of Directive 2001/83/EC as amended. These are the only EU provisions in the area of distribution of pharmaceutical products, since distribution laws are otherwise regulated at the national level (AESGP the Association of the European Self-Medication Industry, 2007). Please note that wholesalers may also act as agents. The agent takes an order from the customer and sends it to the pharmaceutical company. Please note also that the involvement of agents is restricted in the pharmaceutical sector, since a whole checking system and numerous regulations are in place along the distribution chain. This is also the reason why the agent/wholesaler role is integrated in this sector. Pharmacies In the case of large pharmacy chains, the need for pharmaceutical wholesalers is eliminated, since the chains are able to distribute pharmaceutical products to their retail stores from their own warehouses. Most countries in the EU have large pharmacy chains and, in some cases, pharmacy chains which have their own distribution logistics as well. In this case, pharmacy chains also take care of the products marketing, including authorisation and registration procedures. Since the involvement of wholesalers/importers is eliminated, this channel provides an opportunity for both exporters and pharmacies to internalise the profit which otherwise would be allocated to the distributors. The above-mentioned player, Alliance Boots, is an example of a large pharmacy chain - resulting from the merger between the main UK drugstore company and an Anglo-French wholesaler that often imports directly from developing country suppliers. The role of large pharmacy chains is case-specific and contact is directly established with the manufacturer. Although this is not a conventional channel for accessing the EU pharmaceutical market, it should be investigated by developing country exporters. Hospitals and self-dispensing doctors In the case of hospitals and self-dispensing doctors, direct access to manufacturers is very rare. These two segments are usually catered to via pharmaceutical wholesalers, which are able to provide the complete product assortment required. Direct contact between manufacturers and hospitals happens almost exclusively in the purchase of innovative pharmaceutical products, which often consist of biopharmaceuticals. Nonetheless, innovative pharmaceutical products offer very restricted opportunities to developing countries, and should not be a sector of relevance in this survey. Other retail channels Retail distribution of non-prescription pharmaceutical products through channels other than pharmacies is still restricted in most EU countries. Nonetheless, large retail customers are gaining an increasingly important role in the distribution of non-prescription products which are licensed for sale in non-pharmaceutical channels, such as drugstores, supermarkets and convenience outlets.
Alternative trade channels for the pharmaceutical sector in the EU include manufacturers selling pharmaceutical products directly to the consumer, whether it is via the Internet or through direct mail drugstores. This eliminates the intermediary role represented by wholesalers and pharmacies. Direct delivery to customers is an attractive option for manufacturers, since it allows them to internalise a larger part of the value addition, which would otherwise be distributed along the value chain. However, the size of the market for these newer distribution channels is minimal, thus this should not be a conventional channel for use by exporters. Alternative pharmaceutical trade channels are increasing, especially in the UK and Germany, although these channels are largely used by established players in the EU (and usually within the EU, thus not of major relevance to exporters in developing countries). It is important to mention that distance-selling of pharmaceutical products is illegal in several EU countries. For more information, please refer to the country surveys. Having analysed the main trade channels, it can be concluded that the most common and practical trade channel for developing countries which aim to access the EU market is through importers/wholesalers. This channel guarantees companies in developing countries that the marketing procedure allowing them to enter the market will be taken care of. Logistics-wise, therefore, the direct contact between exporters in developing countries and pharmacies, dispensing doctors and hospitals in the EU is costly and not practical. Custom-manufacturing Next to the channels described above, the opportunities for custom-manufacturing directly for EU pharmaceutical companies can also be investigated. Outsourcing/custom-manufacturing for EU companies is often an excellent opportunity for companies in developing countries, especially regarding generic medicines. They can manufacture products which their partner wants to market in the EU or, indeed, in areas outside the EU. An important benefit for the companies in developing countries which become involved in custom-manufacturing, is that they do not need to try and create brand awareness for their own products (brands) in the EU, which would normally be beyond their financial capabilities. Please, note that custommanufacturing must be done in GMP (Good Manufacturing Practice) plants. Parallel trade In addition to the conventional trade channels presented above, it is important to outline the role of parallel trade in the pharmaceutical market in the EU. According to The Observer, parallel trade of products in the EU pharmaceutical market started in The Netherlands in the 1970s and is now accounts for an estimated 2% to 3% of total European sales of pharmaceutical products. This type of trade is an arbitrage (i.e. takes advantage of the price differential) between patented pharmaceutical products amongst individual EU markets which are negotiated between each government and their respective pharmaceutical industry. In countries such as Greece, Spain and France prices of pharmaceutical products are lower than in countries such as the UK, Germany and The Netherlands. For this reason, traders in the latter countries buy products from the former countries and transport, re-pack and sell them at a higher price. Parallel trade in the EU is a controversial issue. On the one hand, the single EU market allows for free movement of pharmaceutical goods inside the EU, thus parallel trade does not consist of a conceptually illegal activity. Furthermore, parallel traders argue that increasing competition resulting from this type of trade helps reduce prices of patented products. On the other hand, parallel trade is often regarded as negative by the pharmaceutical industry, since shortages of pharmaceutical products have been reported in countries such as Greece due to its lower medicine costs compared to other EU countries. In addition, large international pharmaceutical companies have claimed that parallel trade compromises the quality and security of the supply of pharmaceutical products, thus putting the safety of patients at risk (The Observer, 2008).
Parallel trading in the pharmaceutical industry is limited, as it is - generally speaking - very difficult to market those products, because they are sold only on prescription. Please, note that prescription pharmaceutical products from parallel imports would in no way threaten the price level of generics/ the space of generic medicines in the market, thus exporters in developing countries should not see them as a threat to marketing their products, but as a point of awareness regarding the EU pharmaceutical industry. 3.2 Price structure
Pricing and reimbursement of pharmaceutical products in the EU are issues of national competence. In 1989, the pricing transparency measure (Council Directive 89/105/EEC) was introduced in the EU with the aim of reaching a degree of harmonisation in the manner that national authorities determine the price of pharmaceutical products which are reimbursed under individual national social security systems. Nonetheless, member states are not prevented from introducing their own price control on pharmaceutical products, as long as locally manufactured and imported products are not discriminated (AESGP, 2007). Therefore, the EU consists of 27 different pricing and reimbursement systems. It is thus suggested that these systems are researched on a per-country, per-product basis, in cooperation with EU market experts. Reimbursement systems and individual country price controls influence both the manufacture and distribution level prices. Reimbursement systems Reimbursement of professional services (i.e. pharmacists) and the pharmaceutical products provided is an integral part of the social and healthcare system in every EU Member State, and is part of their national responsibility. In this structure, social and healthcare systems provide financial compensation for (part of) a patients expenses linked to (certain) pharmaceutical products. This explains, in great part, the reason why these systems have a strong influence in the price-setting structure of pharmaceutical products. Reimbursement systems in the EU are usually considered to fall within the scope of national health systems which have a single player: the Ministry of Health, the Medicines Agency or Social Insurances. Nonetheless, most EU countries also have supplemental private insurance systems, which function differently from country to country, but which are an additional source for financing medical care. Pharmaceutical reimbursement systems vary greatly amongst different EU countries; each system has a different coverage, range of reimbursable products and size of reimbursement. Reimbursement is most commonly calculated as a percentage of the cost of the pharmaceutical products. Such percentage-based systems, and systems which include a combination of a fixed component and a percentage-based component, often have several different reimbursement categories. Reimbursement might be affected by severity of illness or effectiveness of the pharmaceutical product, for instance, or it may differ in relation to children or adults. According to the European Generic Medicines Association (EGA), EU Member States comprise eight different reimbursement models, which are used in a mixed form in each different country, involving a high number of competent authorities and decision-makers. In these reimbursement systems, there are positive lists (lists of reimbursable products) and negative lists (lists of non-reimbursable products) in use. Only Ireland and Sweden approve almost all pharmaceutical products on the market for reimbursement. The most common pharmaceuticals to be classed as non-reimbursable are products intended for short periods of self-care use (which usually consist of non-prescription products). In some countries, reimbursement decisions are made together with pricing decisions (i.e. reimbursement is directly related to price-setting procedures, having an impact on bringing prices up or down),
whereas reimbursement and pricing decisions are made independently in other countries. Please refer to the country surveys for specifications. One further characteristic of reimbursement systems in the EU consists of co-patient payment (i.e. regarding the price of a pharmaceutical, the amount which is not reimbursed by a thirdparty has to be paid by the patient). In addition to private out-of-pocket expenses on pharmaceutical products concerning the private market of non-reimbursable pharmaceuticals (which are often non-prescription products), out-of-pocket payments for reimbursable products are also implemented in most EU countries. In this manner, patients have to pay a nonreimbursable percentage of the pharmaceutical product price or a fixed co-payment fee for a prescription. Patient co-payment in the different EU countries functions according to one of the systems below: Fixed fee per prescription (per item, per prescription, or according to pack size); A percentage of cost of the medicines prescribed (partially reimbursed); The difference above the reference price (reference price is equal to the maximum reimbursed price); A combination of the above, usually comprised of a fixed fee and a percentage of the cost of medicines prescribed. One of the reasons why reimbursement systems are a topic of relevance in the EU is because they determine the outcome of the increasing financial burdens on premiums for social welfare programmes, as well as taxes. For this reason, it is important to note that the very nature of generic medicines, along with their subsequent lighter impact on social and healthcare systems if compared to originator products, is a point of attention with respect to cost-containment concerns related to healthcare expenditure. The increasing costs of pharmaceutical products have led governments to encourage the use of generic medicines in reimbursement systems. In Portugal, for instance, the prescription of cheaper generic medicines has been supported by paying a higher level of reimbursement for generic medicines. Price policies As mentioned previously, not all pharmaceutical products are reimbursed under social and health systems. If reimbursed, a pharmaceutical product might still be subject to price policies which are defined and revised annually in each individual EU Member State. However, this should be investigated in the country surveys, since variations exist among EU countries. Statutory price policies in the EU are generally applied at the manufacturing level and at the distributor level. Price controls at the manufacturing level: Price controls vary among different EU countries but, in the majority of the cases, statutory prices are set at the manufacturing level for reimbursable pharmaceutical products, and free pricing is in place for non-reimbursable ones. In 24 of the 27 EU countries, prices of outpatient pharmaceutical products (not hospital sales) are controlled, price control being largely limited to products with reimbursement eligibility. The manufacturer can freely set the price for nonreimbursable pharmaceutical products, which are mostly non-prescription. Statutory pricing is the most common price control policy in the EU. In this system, authorities set the price on a regulatory, unilateral basis. In most of the countries (22 EU countries) which use statutory pricing, a system of external price referencing (international price benchmarking) is in place. Another common system used is internal price referencing, whereby equivalent or similar pharmaceutical products within the same country are compared. In countries where statutory pricing is not used, however, prices of pharmaceutical products are negotiated between the manufacturer or wholesaler and the government authority (PPRI Pharmaceutical Pricing and Reimbursement Information, 2008).
Price controls at the manufacturing level specifically for generic medicines The price structure of generic medicines differs from the price structure which is in place for conventional originator pharmaceutical products. Thus, even though the stated systems apply to most pharmaceutical products, generic medicines have a different pricing system. Pricing systems of generic medicines in the EU are either: (1) a generic free-pricing system or (2) a generic price-regulated system. In countries where price-regulated systems prevail, prices of generic medicines are regulated and established according to: (a) an average of selected EU countries, (b) a percentage below the originator price, (c) a maximum price (price index), (d) a negotiable price (price / volume) or (e) some other measure. According to the European Generic Medicines Association (EGA), 22 countries in the EU have implemented price-regulated systems, which is done through reference-pricing systems. Among these countries, 8 have set price levels at a predetermined percentage below the originator price; 5 have price levels based on the average price of medicines in a selection of countries. Five EU countries work with maximum prices and 3 with negotiable prices. Most countries introduced such reference pricing mechanisms as a way to reduce health care expenditures, since reimbursement usually happens for products which have determined/controlled prices. In reference-pricing systems, generic medicines are divided into groups with identical or similar active ingredients or applications (i.e. the reference groups). Most national health authorities base the reference pricing on the active substance. Based on these criteria, the authorities determine a maximum reimbursement/reference price for each reference group (i.e. the portion to be reimbursed and the ceiling reference price). In doing this, health authorities also take into account the prices of existing medicines in the relevant reference group when determining the reference price. They either look at the lowest priced originator product (8 countries), the average price in the reference group (6 countries) or the lowest priced generic medicine (4 countries). The factors presented above make the price structure for generic medicines across the EU extremely complex. Therefore, it is suggested that price systems are researched on a per country, per product basis, in cooperation with EU market experts. More detailed information on national systems concerning generic medicine pricing can be found in the individual country surveys. Margin schemes at the distribution level: At the distribution level, 21 of the 27 EU countries have statutory wholesale margins, in the form of either a linear margin or a regressive scheme. The six remaining EU countries maintain no statutory wholesale mark-up. Pharmacy margins are regulated in all 27 EU countries. These margins usually take the form of a regressive scheme or a linear mark-up, but they may also be a fixed fee, such as the one applied in The Netherlands, or a fee-for-service remuneration, such as the margins in Slovenia and in the UK. In regressive schemes, higher margins are applied as the price of the pharmaceutical product decreases. Linear margins (or mark ups) consist of a flat percentage charged on the price of a product, whereas a fixed fee is an absolute value (rather than percentage) added to the price of the product. Statutory wholesale and pharmacy margins (at the distributor level) are applied to all pharmaceutical products in several EU countries, but non-prescription pharmaceutical products are excluded from these regulations in some countries (PPRI, 2008).
Taxes on pharmaceuticals: Most EU countries have a value-added tax rate for pharmaceuticals which is lower than the standard VAT rate. The exceptions are Austria, Bulgaria, Denmark and Germany, where the VAT rate for pharmaceutical products is the same as the standard VAT rate (EFPIA, 2008). A few countries have split VAT rates on pharmaceutical products, with a lower or even 0% rate for a specific group of pharmaceutical products. Additional taxes include pharmacy fees (e.g. Finland). On average, the retail price of a pharmaceutical product in the EU can be broken down in the following manner (EFPIA, 2008): Manufacturer: 65% Wholesaler: 6% Pharmacist: 20% State (including VAT and other taxes): 9% More detailed information on national price and reimbursement systems is given in the individual country surveys. In conclusion, pharmaceutical products can be generic or non-generic, prescription or nonprescription and reimbursable or non-reimbursable. The differing interplay of these categories results in different levels of volumes and price controls. Generic medicines can be either prescription or non-prescription, and either reimbursable or non-reimbursable. Reimbursable pharmaceutical products (with or without patient co-payment) are largely prescription products, and have higher levels of price controls. Exporters in developing countries aiming at accessing the EU market for pharmaceutical products should keep in mind that the specific pricing and reimbursement policies in their target countries will have an impact on their profit. This will happen because prices of imported pharmaceutical products are, by law, set in the same manner as prices of domestic pharmaceutical products. In markets where the distributor levels margins are high, there will be reduced income for manufacturers - resulting from lower selling prices. As it will be explained in the country surveys, margins at the distributors level are often fixed, but sometimes negotiable. Higher price caps will be translated into higher prices to consumers, which might have an impact on consumption and reduce marketing opportunities. Regarding products for which no direct price control mechanisms are in place, exporters might find more freedom in establishing prices, but will also be more susceptible to fluctuations in the international market and competition from other producers. 3.3 Useful sources
Pharmaceutical Pricing and Reimbursement Information (PPRI) - http://ppri.oebig.at The European Association of Pharmaceutical Full-Line Wholesalers (GRIP) - http://girp.eu European Association of Euro-Pharmaceutical Companies (EAEPC) - http://www.eaepc.org Please note that names and websites of other interesting players, as well as sources to find those players, are given in the individual country surveys.
4
4.1
Trade: imports and exports

Total EU imports
Total EU imports of pharmaceutical products increased by an annual average rate of 6.4% in value and decreased by 5.2% in volume between 2004 and 2008, amounting to 110 billion or 1.6 million tonnes in 2008. Intra-EU imports accounted for more than 82% of total EU imports in 2008, increasing by an annual average rate of 7.0% in value between 2004 and 2008. Belgium was the leading EU importer of pharmaceutical products in 2008, accounting for 22% of the total EU imports in terms of value. Between 2004 and 2008, Belgian imports increased by an annual average rate of 2.2% in value. Belgium has a vital trading function for pharmaceutical products. Import data relate to products arriving at the Antwerp port, and eventually re-distributed by (Belgian) pharmaceutical companies. Germany, the second largest EU importer in 2008, accounted for around 18% of total imports. France was the third largest importer, and accounted for 11% of total EU imports. Imports of pharmaceutical products by both Germany and France increased by an annual average rate of about 9.0% between 2004 and 2008. The UK and Italy were the fourth and fifth largest importers, accounting for respective shares of 7.8% and 7.2% of total EU imports in 2008. British imports decreased by an annual average rate of 0.5%, whereas imports by Italy increased by an annual average rate of 7.0% in the review period. In relation to the leading suppliers of pharmaceutical products to the EU, Germany maintained the leading position. In 2008, Germany supplied 20% of the total EU imports of pharmaceutical products. In addition, imports from Germany increased by an annual average rate of 11% in terms of value between 2004 and 2008. These factors substantiate Germanys pivotal role in the intra-EU trade of pharmaceutical products, a role which Belgium also shares, as explained previously. Belgian supplies accounted for 15% of total EU imports of pharmaceutical products in 2008; in addition, EU imports sourced in Belgium increased by an annual average rate of 7.4% between 2004 and 2008. Ireland was the third largest supplier of pharmaceutical products to the EU in 2008, accounting for 9.0% of total EU imports. Nonetheless, imports from Ireland decreased by an annual average rate of 3.6% between 2004 and 2008. Imports sourced in extra-EU countries (excluding DCs) accounted for approximately 17% of total EU imports. Between 2004 and 2008, imports from extra-EU countries increased by an annual average rate of 3.8% in terms of value. Switzerland and the USA were the leading extra-EU suppliers of pharmaceutical products to the EU. Swiss supplies accounted for 8.0% of total imports in 2008 and increased by an annual average rate of 9.0% between 2004 and 2008, whereas imports from the USA accounted for 6.5% of total imports and decreased by an annual average rate of 3.2% in the review period. Imports from developing countries accounted for only 0.8% of total EU imports of pharmaceutical products in 2008. India, the largest supplier, accounted for a mere share of 0.4% of total imports. Turkey and Brazil, the second and third largest DC suppliers, each accounted for an even smaller share of 0.1% of total EU imports of pharmaceutical products. In spite of their low share, imports from developing countries increased by an annual average rate of 17% in value and 21% in volume between 2004 and 2008. Imports from DCs consist almost exclusively of imports of generic medicines. Unfortunately, no breakdown of generic and originator pharmaceutical products can be provided in this section.
Table 4.1
EU Imports of pharmaceutical products, 2004-2008, million / 1,000 tonnes

2004 value volume 2006 value volume 2008 value volume Average annual % change in value 1,585 6.4% 1,440 108 37 7.0% 3.8% 17%
Total EU, 85,657 of which from Intra-EU 68,867 Extra-EU ex. DC* 16,289 DC* 500 Source: Eurostat (2009) *Developing countries
1,965 1,851 98 17
98,995 79,727 18,641 627
1,384 1,250 108 25
109,965 90,132 18,904 928
4.2
EU imports per product group
Eurostat data was 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 this survey. Non-packed pharmaceutical products Total EU imports of non-packed pharmaceutical products increased by an annual average rate of 5.8% in value and 3.8% in volume between 2004 and 2008, amounting to 9.7 billion or 65 thousand tonnes in 2008. The vast majority (92%) of imports was sourced in intra-EU countries. Belgium, the leading supplier, accounted for nearly 80% of total imports. Furthermore, imports from this country increased by an annual average rate of 7.5% in terms of value between 2004 and 2008. As mentioned previously, Belgium plays an essential role in the EU trade of pharmaceutical products. Supplies sourced in extra-EU countries (excluding DCs) accounted for another 7.0% of total EU imports of non-packed pharmaceutical products. The USA was the most important extra-EU supplier of non-packed pharmaceutical products to the EU in 2008, accounting for 3.8% of total imports. Nonetheless, imports from the USA decreased by an annual average rate of 0.9% between 2004 and 2008. Imports from Switzerland, the second most important extra-EU supplier, accounted for 1.7% of total imports in 2008, but decreased by an annual average rate of 2.2% between 2004 and 2008. Imports from developing countries accounted for only 0.7% of total EU imports of non-packed pharmaceutical products in 2008. Between 2004 and 2008, imports of non-packed pharmaceutical products from developing countries decreased by an annual average rate of 7.2% in value and increased by 8.4% in volume. India and China, the most important DC suppliers, accounted for respective shares of 0.5% and 0.2% of total EU imports. Imports from India increased by an annual average rate of 23% between 2004 and 2008, whereas imports from China had a substantial decrease of 27% in the review period. Other suppliers in developing countries account for very small market shares. Turkey, for instance, was the third largest developing country supplier of non-packed pharmaceutical products to the EU in 2008, but accounted for less than 0.1% of total EU imports. Table 4.2 EU imports and leading suppliers of non-packed pharmaceutical products 2004 - 2008, share in % of value
2004 2006 2008 Leading suppliers to EU in 2008 mln mln mln Share in % 7,727 8,910 9,681 6,800 8,201 8,945 Belgium (80%), Ireland (2.7%), Germany Share (%)
Total EU, of which from Intra-EU
92%
2004 2006 2008 mln mln mln Extra-EU ex. DC* DC* Source: Eurostat (2009) *Developing countries 837 90 634 75
Leading suppliers to EU in 2008 Share in % (2.1%), Denmark (1.9%), France (1.5%) 669 USA (3.8%), Switzerland (1.7%), Japan (0.9%) 67 India (0.5%), China (0.2%)
Share (%) 7.0% 0.7%
Packed pharmaceutical products Total EU imports of packed pharmaceutical products also increased by an annual average rate of 6.5% in value and decreased by 5.5% in volume between 2004 and 2008, amounting to 100 billion or 1.5 million tonnes in 2008. As was true for non-packed pharmaceutical products, intra-EU countries supplied the vast majority of EU imports. Intra-EU supplies accounted for 81% of total EU imports. Germany, the leading supplier of packed pharmaceutical products, accounted for 22% of total imports. Furthermore, imports sourced in Germany increased by a significant annual average rate of 11% between 2004 and 2008. Ireland, the second most important EU supplier of packed pharmaceutical products, accounted for 9.6% of total imports. Nonetheless, imports sourced in Ireland decreased by an annual average rate of 3.9% between 2004 and 2008. Other important intra-EU suppliers of packed pharmaceutical products in 2008 were Belgium and France, each accounting for around 9.0% of total imports. Imports sourced in Belgium increased by an annual average rate of 7.3%, whereas imports sourced in France increased by an annual average rate of 6.1% in terms of value between 2004 and 2008. Extra-EU suppliers (excluding DCs) accounted for an 18% share of total EU imports of packed pharmaceutical products. Between 2004 and 2008, imports from extra-EU countries increased by an annual average rate of 4.2%. Switzerland and the USA, the leading extra-EU suppliers, accounted for respective shares of 8.6% and 6.7% of total EU imports. Imports from Switzerland increased by an annual average rate of 9.3%, whereas imports from the USA decreased by an annual average rate of 3.3% between 2004 and 2008. Imports sourced in developing countries increased by a strong annual average rate of 20% in value and 24% in volume between 2004 and 2008. Nonetheless, DCs accounted for only 0.9% of total EU imports of packed pharmaceutical products in 2008. India, the main developing country supplier, accounted for 0.4% of total imports. Imports from this country increased by a strong annual average rate of 26% between 2004 and 2008. Imports from Turkey, the second main developing country supplier of packed pharmaceuticals in 2008, increased by an annual average rate of 19% between 2004 and 2008. Nonetheless, Turkey only accounted for approximately 0.2% of total EU imports. Table 4.2 EU imports and leading suppliers of packed pharmaceutical products 2004 - 2008, share in % of value
2004 2006 mln mln 77,929 90,085 2008 Leading suppliers to EU in 2008 mln Share in % 100,284 Germany (22%), Ireland (9.6%), Belgium 81,188 (9.3%), France (8.5%), UK (8.2%) 18,235 Switzerland (8.6%), USA (6.7%) 861 India (0.4%), Turkey (0.2%) Share (%)
Total EU, of which from Intra-EU
81% 18% 0.9%
62,067 Extra-EU ex. DC* 15,452 DC* 409 Source: Eurostat (2009) *Developing countries
71,525 18,007 552
Please refer to the country surveys for imports per product group by individual EU member states.
4.3
The role of developing countries
Developing countries play a very limited role in the EU imports of pharmaceutical products. As previously mentioned, EU imports of pharmaceutical products from developing countries only account for 0.8% of total imports. Between 2004 and 2008, imports from DCs increased by an annual average rate of 17% in value and 21% in volume, amounting to 928 million or 37 thousand tonnes in 2008. In 2008, Germany was the EU country with the highest levels of imports from developing countries in terms of value. In addition, German imports sourced in developing countries increased by an annual average rate of 20% between 2004 and 2008. The UK was the second largest importer from developing countries in the EU; British imports from DCs also increased substantially in the review period. Between 2004 and 2008, these imports increased by an annual average rate of 13% in terms of value. In the case of Belgium, the third largest EU importer of pharmaceutical products from DCs, imports sourced in developing countries increased by an even stronger annual average rate of 51%. Other EU countries also reported a significant increase of pharmaceutical product imports from developing countries between 2004 and 2008. Denmark, for instance, reported an annual average increase of 55% of imports sourced in developing countries. Portuguese imports from developing countries also had a strong annual average increase of 132%. In The Netherlands, this increase amounted to 29%. A few EU countries, such as Ireland, the Czech Republic and Finland showed a negative development in relation to imports sourced in developing countries in the review period. Nonetheless, it is important to note that imports from DCs in these countries already accounted for a very small share of total imports. Table 4.4 Imports of pharmaceutical products from developing countries 2004-2008, million / 1,000 tonnes
2004 value volume 2006 value volume 2008 value volume Average annual % change in value 17% 20% 13% 51% 33% 11% 0.4% 12% 54% 4.6% 29% 7.0% -4.5% 54% 132% 2.4% 55% 25% 59% -2.4% 9.6% 34% -0.4% -16% 81% -17% -42% 126%
Total EU Germany United Kingdom Belgium Hungary Romania France Poland Austria Slovenia The Netherlands Spain Ireland Greece Portugal Slovakia Denmark Sweden Italy Czech Republic Latvia Bulgaria Finland Lithuania Cyprus Malta Estonia Luxembourg
500 105 108 17 18 35 46 22 5.2 23 9.7 18 24 2.9 0.5 13 2.2 4.8 1.7 12 6.9 3.0 8.6 9.4 0.3 1.3 1.2 0.0
17 3.1 6.9 0.8 0.2 2.3 0.2 0.4 0.1 0.5 0.4 0.2 0.6 0.0 0.0 0.1 0.0 0.2 0.1 0.1 0.4 0.1 0.0 0.2 0.0 0.0 0.0 0.0
627 139 132 30 26 55 30 22 14 18 14 30 32 3.1 7.5 10 13 7.9 5.9 12 10 5.0 2.4 3.5 0.5 2.7 0.1 0.0
25 7.8 9.7 1.2 0.4 1.0 0.6 0.3 0.2 0.5 0.6 0.3 0.7 0.0 0.2 0.1 0.1 0.4 0.1 0.1 0.3 0.2 0.0 0.1 0.0 0.0 0.0 0.0
929 216 177 87 57 53 47 35 29 27 27 23 20 16 15 15 13 12 11 11 9.9 9.9 8.5 4.6 3.5 0.6 0.1 0.0
37 8.0 13 2.0 3.7 2.3 1.5 0.5 0.6 0.4 1.4 0.4 0.4 0.1 0.3 0.1 0.3 0.5 0.2 0.1 0.3 0.2 0.1 0.1 0.2 0.0 0.0 0.0
Source: Eurostat (2009)
Please refer to the country surveys for imports per product group by individual EU member states. 4.4 Exports
Total EU exports increased by an annual average rate of 7.1% in value and 6.8% in volume between 2004 and 2008, amounting to 133 billion or 2.0 million tonnes in 2008. The main exporters in the EU were Germany and Belgium, accounting for respective shares of 21% and 20% of total EU exports. German exports increased by an annual average rate of 12% in value between 2004 and 2008, whereas Belgian exports increased by an annual average rate of 6.6%. France and the UK were also important exporters, accounting for respective shares of 12% and 11% of the total exports in 2008. French exports increased by an annual average rate of 7.1% in the review period, while exports by the UK had a more modest annual average increase of 2.4%. Among the main exporters, Ireland, the fifth largest exporter in the EU, was the only country which saw a negative development in terms of value between 2004 and 2008; its exports decreased by an annual average rate of 2.8%. Exports to intra-EU countries accounted for 66% of total EU exports in 2008, of which the main destinations included Belgium (15%), Germany (13%) and France (6.4%). Exports to extra-EU countries accounted for 23% of total EU exports. Among extra-EU countries (excluding developing countries), the USA was the main destination for EU exports of pharmaceutical products. Approximately 9.2% of total EU exports was directed to the USA market in 2008. Switzerland, the second most important destination for EU exports of pharmaceutical products, received 3.8% of the total EU exports. Exports to developing countries accounted for 10% of total EU exports of pharmaceutical products in 2008, of which the main destination was Turkey, with approximately 1.3% of the total exports. China, the second main destination for EU exports of pharmaceutical products, accounted for only 0.9% of the total exports. Table 4.5 EU exports of pharmaceutical products 2004-2008, million / 1,000 tonnes
value 2004 volume 2006 value volume 2008 Average value volume annual % change in value 1,734 132,787 2,029 7.1% 1,298 215 221 88,234 31,110 13,444 1,497 259 273 6.6% 6.4% 13%
Total EU, 100,854 of which to Intra-EU 68,458 Extra-EU ex. DC* 24,288 DC* 8,108 Source: Eurostat (2009) *Developing countries
1,559 120,905 1,165 212 182 79,851 31,041 10,015
4.5 -
Opportunities and threats
Developing countries account for a very small share of the EU imports of pharmaceutical products, which indicates that the market for DC exporters is faced with various restrictions and obstacles. In 2008, imports from developing countries accounted for only 0.8% of total EU imports of pharmaceutical products. + Although imports of generics are not mentioned separately in this survey, there is little evidence that generics are not a sizeable percentage, of that 1% which is imported into the EU. It is safe to assume that generic medicines actually constitute a significant share of the total imports from DCs. Furthermore, most of it is packed (in terms of value), which points toward a clear market opportunity for DC exporters. + At the same time, data indicate that imports from developing countries have increased substantially in the review period. Total imports of pharmaceutical products from developing countries increased by an annual average rate of 17%. During the review
period, imports from countries with very small imports share, such as Mexico, Egypt and Morocco, experienced significant increases in terms of value. In spite of this increase, imports sourced in new EU member states have experienced even higher increase rates in the review period. EU imports sourced in Hungary, Poland and Slovakia, for instance, have had annual average increase rates of 24%, 50% and 24%, respectively. These countries are potential competitors to exporters in developing countries, which might restrict the role of DCs in the EU market. Developing countries aiming to export pharmaceutical products to the EU have to face strong competition from large producers, namely China and India especially for nonpacked pharmaceutical products. These two countries account for the largest share of imports from developing countries, and already have an established position in the EU pharmaceutical market. In order to export, developing country suppliers will be faced with a series of requirements related to quality, linked to the tight controls which are present in the EU pharmaceutical market. Additionally, exporters will be required to deal with price controls, regulation and reimbursement systems in the different EU countries. 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
4.6
http://epp.eurostat.ec.europa.eu/newxtweb/assets/User_guide_Easy_Comext_20090513.pdf
5
5.1
Price developments
Price developments
Prices for pharmaceutical products, especially prescription products, continue to diverge dramatically across the Member States of the European Union - with some market leaders products costing up to 50% more in the high-price Northern markets, as compared to the Southern European markets. The accession of the East European countries to the European Union has led to a wider divergence in prices. As explained previously, pricing systems vary in the individual EU countries, thus this is also the case for recent developments in prices of both originator and generic medicines. These developments depend on the interaction between originator and generic medicines which are on the market, and whether this market follows a free-pricing model or uses a reference-pricing system. When a pharmaceutical product is still patented (i.e. an originator product) the size of its market is generally proportional to the competition it faces. When its patent expires, generic medicines with the same active ingredient, but at lower prices, become available. The availability of generic medicines directly affects the prices of originator pharmaceutical products. In markets enjoying free-pricing models, such as Germany and The Netherlands, the price for the originator medicine declines once a generic medicine is available. This decline is, in turn, proportional to the size of an originator products market (which varies depending on the areas of treatment, for instance). In larger markets, many generic producers will step in to grab a share of that market, leading to larger decreases in prices. In small markets, few companies step in and the result is a smaller decrease in prices. What comes next is reference-pricing systems; price regulations applied by governments directly affect price developments for originator and generic medicines. In countries where a reference-pricing system is applied, the regulation of prices of pharmaceutical products obeys certain criteria, as described in Chapter 3, under Price Structure. In general, prices of pharmaceutical products in the EU are declining, due the increasing availability of generic medicines. In addition, insurance companies have tried to drive prices down, since expenditure on pharmaceutical products accounts for approximately 15-20% of the price of healthcare. For more detailed information on price developments in individual EU countries, please refer to the individual country surveys. In addition to the country surveys, exporters in developing countries are advised to consult their EU partner, who can provide further information for their country/countries of interest and for specific products, along with information on the authorities/bodies with which prices should be negotiated. 5.2 Useful sources
Pharmaceutical Pricing and Reimbursement Information (PPRI) - http://ppri.oebig.at European Generic Medicines Association - http://www.egagenerics.com
Market access requirements
As a manufacturer in a developing country preparing to access EU markets, you should be aware of the market access requirements of your trading partners and the EU governments. 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 your market sector and the EU in the category search, click on the search button and click on market access requirements. The European Union has comprehensive legislation regulating imports, production and marketing of pharmaceutical products for human use. The main provisions are specified in the following Directives: Directive 2001/83/EC of the European Parliament and of the Council of November 2001 on the Community code relating to medicinal products for human use. European Directive 2003/94/EC lays down the principles and guidelines of good manufacturing practice (GMP) for medicinal products for human use. Directive 2005/28/EC lays down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. More information at: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/index.htm Although the REACH legislation applies to chemicals in the EU, pharmaceutical products are, in the first instance, exempted from it. Nonetheless, it is the responsibility of all actors within the industry to control and evaluate chemicals which are used in its preparations: this is clearly applicable to companies which import chemicals into the EU. It is also important to note that pharmaceutical products have no exemption when it comes to substances of very high concern (SVHC). Please also note that supplementary equipment, such as syringes, test kits and sterile swabs are subject to the REACH legislation. For further information on REACH, please refer to: http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm Packaging Packaging requirements are provided by Directive 2001/83/EC of the European Parliament. The choice of a medicinal products pack size should be decided in accordance with the principles of rational use. Every pack size may be available in any Member State, since a Community marketing authorisation is valid throughout the EU countries. For this reason, the pack size is chosen according to the duration of the treatment and to the dosage, as described in the summary of product characteristics. Pack sizes should not be too close to one another. For example, pack sizes of both 28 dose units and 30 dose units and/or of 56 dose units and 60 dose units would not be considered acceptable. The logo, format, layout, style, colour scheme and, if possible, also the pack dimensions must be identical for all the versions of packs of that medicinal product throughout the EU. The European Medicines Agency provides the guidelines for plastic packaging materials intended to be in direct contact with the active substance or medicinal product. The materials may be part of the container, the closure or seal or of other parts of the container closure system(s). Elastomeres and natural and synthetic rubber are not included within the scope of the packaging guideline. The packaging criteria presented by the agency vary according to the physical state of the active substance, the pharmaceutical dosage form and the route of
application of the medicinal product. More information is available at: http://www.emea.europa.eu/pdfs/human/qwp/435903en.pdf Labelling Labelling requirements are provided by Title IV of the Directive 2001/83/EC of the European Parliament. The label text should be in accordance with the summary of products characteristics. Regarding products authorised by the EU, there is a single summary of product characteristics agreed at the EU level. The particulars on the label should be easily legible, clearly comprehensible and indelible. The labelling must be presented in the language or languages of the Member State(s) where the product is placed on the market. If more than one language is used, then all of the text must be in each language without affecting readability. The content of all language versions must be identical. It is recommended to group different text elements for each language, where appropriate. Member States may require the use of certain forms of labelling making it possible to indicate : o the price of the medicinal product, o the reimbursement conditions of social security organisations, o the legal status for supply to the patient, in accordance with Directive 2001/83/EC, o identification and authenticity. The information specific to a Member State should be placed on the label in a boxed area (the so-called blue box), to appear on one side of the pack. The marketing authorisation number consisting of "EU" followed by a nine-digit number (e.g. "EU/1/96/000/000") must appear on the package, whilst the (national) identification number, if any, can only appear (once) in the blue box. 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
Opportunity or threat?
Several of the previous chapters, covering consumption, production and trade, provided information on trends and developments shaping the EU market for pharmaceutical products. These developments were translated into opportunities and threats affecting the opportunities for developing country exporters to do business in the EU. However, it is important to keep in mind that the same development or trend can be an opportunity for one exporter and a threat to another. Exporters should therefore analyse if the developments and trends discussed in the previous chapters provide opportunities or threats. The outcome of this analysis depends on the specific situation of an exporter. Opportunities High cost of production and pressure to reduce healthcare costs compel large pharmaceutical companies to decrease the costs involved in manufacturing and drug development. As a result, these companies are increasingly outsourcing production of active pharmaceutical ingredients (APIs) and formulations to developing countries or sourcing the needed ingredients in developing countries. This provides an opportunity for companies in developing countries to increase the scale of their production and also to increase their competitiveness on a global scale, which can have a positive impact on their revenues. The trend of outsourcing is so well developed that it has become a leading strategic choice of EU pharmaceutical companies, thus representing an enormous opportunity for contract manufacturers in developing countries. This is especially true in the case of China and India and other low-cost Asian countries, which are countries containing a large number of manufacturing facilities approved by the European health authorities. Contract manufacturers from India and China are increasing their competitiveness. This can have considerable spillover effects in the region, since production in low-cost developing countries can also help develop adequate infrastructure for their pharmaceutical industry, such as information and communication technologies. Threats On the other side of the spectrum, however, the outsourcing trend involves some threats to developing countries. Producers in developing countries who aim at manufacturing APIs for EU pharmaceutical companies have to comply with Good Manufacturing Practice (GMP), a process which can be difficult, costly or simply not desirable for some DCs. For example, Chinese producers of APIs target mainly the domestic market and often do not comply with the GMP standards required in the EU. Following an escalation in cases of counterfeit APIs making their way to the EU market, the European Commission, health authorities from member states and the EU pharmaceutical industry have decided to impose more stringent regulation regarding APIs coming from developing countries. To that end, member state regulatory authorities conduct inspections of manufacturing sites in developing countries. Furthermore, in order to comply with GMP and safety regulation, developing countries will have to incur additional costs. Costs of compliance with internal quality systems and external regulations for a medium-size manufacturing facility account for approximately 25% of the total cost of operating the site (excluding costs of raw materials), which can amount to as much as 40 million per year. This can lead to significant reduction in the profit margins of companies in DCs. In order to attract production, DCs also have to compete with each other in order to offer the smallest possible costs for EU pharmaceutical companies, which can lead to a race to the lowest point, thus further decreasing profit margins. Moreover, over half of the outsourcing business is directed to India, China and other low-cost Asian countries which benefit from
economies of scale due to their large volumes of production. Thus, it is difficult for other developing countries to compete with the above-mentioned countries. Another threat to developing countries is that, if they want to produce APIs, they have to compete with CEE countries which have some significant competitive advantages on their side. Firstly, their regulatory framework regarding the pharmaceutical industry is harmonised with EU requirements, thus pharmaceutical companies which decide to source APIs in this region are more confident about the quality of the ingredients and the compliance with GMPs. Secondly, manufacturing APIs in the CEE region still offers cost-saving opportunities for EU companies, as labour costs are significantly lower compared to Western Europe. Thirdly, a number of countries, such as Poland and the Czech Republic, have a pool of experienced scientists and a reliable corporate climate.
Appendix A
Product characteristics
Pharmaceutical products are also commonly known as medicines or drugs. They are substances which are used both in the treatment of illnesses/diseases and in the maintenance of an individuals health. According to the EU Directive 2001/83/EEC, pharmaceutical products can be defined as any substance or combination of substances presented for treating or preventing diseases in human beings. Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings. In this survey, we focus only on pharmaceutical products of a synthetic character. For this reason, the choice of product categories considered in this survey is based upon the list of Leading Therapy Classes by Global Pharmaceutical Sales provided by the IMS Health (2007), which can be found in Table A.1. The ten products presented in Table A.1 accounted for 34% of the global pharmaceutical market in 2007, including prescription and non-prescription products (among which selfmedication products are included). Whereas non-prescription pharmaceutical products, also known as over-the-counter (OTC) products, include all medicines which are available without a prescription from a physician, self-medication specifically relates to products which are directly available on shelf space in pharmacies, drugstores and supermarkets. Other non-prescription medicines are usually available behind the counter and are acquired during direct contact with (qualified) personnel. Table A.1 also shows therapeutic uses of the pharmaceutical products which are presented and their respective sub-groups. Table A.1. Leading Therapy Classes by Global Medicine Sales in 2008 Name of the Therapeutic use(s) of the Product sub-groups product product
Oncologics (Antineoplastics) Used in the treatment of various solid tumors, lymphomas, and leukemias. Also used in some autoimmune disorders such as rheumatoid arthritis (cyclophosphamide, methotrexate). Often used in combinations to minimize individual toxicities and increase response. Used in the management/reduction of cholesterol and fats (triglycerides) for the prevention of strokes and heart attacks. Alkylating agents Antibiotics/antineoplastics Antimetabolites Hormones/antineoplastics Miscellaneous antineoplastics Mitotic inhibitors Antineoplastic monoclonal antibodies Antineoplastic interferons HMG-CoA reductase inhibitors Miscellaneous anti-hyperlipidemic agents Fibric acid derivatives Bile acid sequestrants Cholesterol absorption inhibitors Anti-hyperlipidemic combinations Anti-histamines Anti-tussives Bronchodilators Decongestants Expectorants Miscellaneous respiratory agents Respiratory inhalant products Anti-asthmatic combinations Upper respiratory combinations Leukotriene modifiers Lung surfactants Sulfonylureas Non-sulfonylureas Insulin Alpha-glucosidase inhibitors Thiazolidinediones Meglitinides
Lipid regulators (Hypolipidemic agents or antihyperlipidemic agents) Respiratory Agents
Used in the treatment of respiratory system disorders and lung diseases.
Anti-diabetics
Used to manage type 1 diabetes mellitus. It may also be used in type 2 diabetes mellitus when diet and/or oral medications fail to adequately control blood sugar.
Acid Pump Inhibitors
Anti-psychotics
Used to suppress acid production in the stomach. Commonly used for acid reflux disease (or GERD), as well as for other conditions (such as ulcers) which involve stomach acid. Used in the treatment of acute and chronic psychoses, particularly when accompanied by increased psychomotor activity. Selected agents are also used as anti-histamines or anti-emetics.
Omeprazole Lansoprazole Esomeprazole Pantoprazole Rabeprazole Typical o Phenothiazines o Thioxanthenes o Butyrophenones Atypical o Clozapine o Olanzapine o Risperidone o Quetiapine o Ziprasidone o Amisulpride o Paliperidone
Angiotensin-II Antagonists Antidepressants
Treatment of hypertension of many causes, most commonly essential hypertension. Used in the treatment of various forms of endogenous depression, often used in conjunction with psychotherapy.
Anti-epileptics
Used to prevent the occurrence of epileptic seizures. Also used in the treatment of psychiatric disorders, such as bipolar disorder, and movement disorders.
Selective serotonin re-uptake inhibitors (SSRIs) Serotonin-norepinephrine re-uptake inhibitors (SNRIs) Noradrenergic and specific serotonergic antidepressants (NASSAs) Norepinephrine (noradrenaline) reuptake inhibitors (NRIs) Norepinephrine-dopamine re-uptake inhibitors Tricyclic antidepressants (TCAs) Monoamine oxidase inhibitor (MAOIs) Hydantoins Succinimides Barbiturates Oxazolidinediones Benzodiazepines Dibenzazepines Miscellaneous anticonvulsants
Autoimmune agents
Used in the treatment of autoimmune disorders, a condition that occurs when the immune system mistakenly attacks and destroys healthy body tissue. Source: EGA- European Generic Medicines Association; Centers for Disease Control and Prevention; Drug Guide; WHO- World Health Organization
As indicated above, pharmaceutical products concern a very broad range of products. These products can be imported as pharmaceutical products not placed in doses or packings for final consumption, or in doses or packings. Most formulated pharmaceutical products are traded in doses or packings for final use. This generally concerns packaging in blisters, which separates one pill/dosage from another. The demand for pharmaceutical products not in doses or packings for final consumption is also very large. However, with the exception of India and China, developing countries do not play a role in the manufacture of bulk pharmaceutical products (non-formulated Active Pharmaceutical Ingredients). Due to the limited availability of trade data on pharmaceutical products, which only make a distinction between packed and non-packed products, a more specific product classification cannot be made in Chapter 4. This survey focuses on generic pharmaceutical products. Because market data usually refer to these products as generic medicines, this is the term used in the survey. A generic medicine is
a pharmaceutical product which has the same active substance as an originator product. An originator medicine is the first version of a pharmaceutical product, developed and patented by an originator pharmaceutical company, which receives exclusive rights to marketing the product in the European Union for 15 years. Generic medicines can be found within prescription, non-prescription and self-medication products, and are available in all pharmaceutical application areas. Even newer sectors, such as biotechnology-based products, will see increasing generic availability as their patents expire. Originator and generic medicines are interchangeable and provide the same quality, safety and efficacy regarding their therapeutic effects (EGA, 2004). When marketed, a generic medicine is identified by its internationally approved and unique non-proprietary name (INN) or by its own brand name (WHO, 2007). The fundamental difference between generic and originator products is the fact that generic medicines are manufactured without a licence from the originator company and they are marketed after the patents expiry date (or the expiration date of other exclusive rights) in compliance with international patent law (WHO, 2007). Because product development costs are much lower, generic medicines are usually 20% to 90% less expensive than the originator products. This results in their wide use in cost-effective treatment programmes in many EU countries, thus providing an effective alternative to higher-priced originator medicines (EGA, 2004). Due to their lower costs, generic medicines constitute the only real opportunities for exporters in developing countries to access the EU market. Thus, this survey offers, albeit very limited, information on opportunities for exporters dealing with originator pharmaceutical products. The above distinction reveals further data limitations in this survey. Firstly, market figures do not make a distinction between generic and originator medicines, which means that readers will only acquire information on the total pharmaceutical market in some of the sections. Moreover, only limited information is available on the product group level. As mentioned previously, Table A.1 is used as a reference for product-level information, but not specifically for generic medicines. In short, this study focuses primarily on the pharmaceutical market as whole; information on the generic medicines market and on product level is given where and when it is available. In conclusion, this survey provides information and opportunities for exporters in developing countries producing prescription and non-prescription, generic pharmaceutical products, placed in doses or packings, as well as these not placed in doses or packings. Whenever possible, light is shed on the generic medicines industry but, due to data limitations, this cannot be done in all sections of the survey. Statistical product classification Combined nomenclature (CN) In this survey, trade data based on the Combined Nomenclature are used. These data are provided by Eurostat, the statistical body of the EU. The abbreviation CN stands for Combined Nomenclature. This Combined Nomenclature contains the goods classification prescribed by the EU for international trade statistics. The CN is an 8-digit classification consisting of a further specification of the 6-digit Harmonised System (HS). HS was developed by the World Customs Organisation (WCO). The system covers about 5,000 commodity groups, each identified by a six-digit code. More than 179 countries and economies use the system. In this survey, CN data are used to indicate imports and exports. Attention should be drawn to the fact that the groupings presented below differ widely from those in Table A.1 (i.e. they are not comparable, due to the fact that Eurostat solely takes products content into account, and not their application). Thus, they should be examined/viewed independently. Table A.1 indicates the products which are considered in the consumption and production chapters in this survey, next to information on the overall pharmaceutical products and generic medicines market. The list below concerns the product
groups (and their HS codes) considered in Chapter 4, which is related to trade. Furthermore, no distinction is made between generic medicines and originator medicines which, once again, limits readers access to specific information on the trade of generic medicines. Also note that the product groups are distinguished in terms of pharmaceutical products not placed in doses or packings for final consumption and those which are put in doses or packings. This list excludes pharmaceutical products which are not synthetic (e.g. containing hormones).
HS code 3003* Product description Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale - Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives - Containing other antibiotics Containing alkaloids or derivatives thereof but not containing hormones, other products of heading 2937 or antibiotics - Other Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale - Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives Containing other antibiotics Containing alkaloids or derivatives thereof but not containing hormones, other products of heading 2937 or antibiotics - Other
3003 10 3003 20 3003 40 3003 90 3004**
3004 10 3004 20 3004 40 3004 90

*
**
of which the following are excluded: - containing hormones or other products of heading 2937 but not containing antibiotics (HS code: 3003 31) - containing insulin (HS code: 3003 31) -- containing iodine or iodine compounds (HS code: 3003 90 10) of which the following are excluded: - containing hormones or other products of heading 2937 but not containing antibiotics (HS code: 3004 31) -- containing insulin (HS code: 3004 31) -- containing corticosteroid hormones, their derivatives and structural analogues (HS code: 3004 32) - other medicaments containing vitamins or other products of heading 2936 (HS code: 3004 50) -- containing iodine or iodine compounds (HS code: 3004 90 11) -- containing iodine or iodine compounds (HS code: 3004 90 91)
Statistical data: limitations Trade figures quoted in CBI market surveys must be interpreted and used with extreme caution. In the case of intra-EU trade, statistical surveying is only compulsory for exporting and importing firms whose trade exceeds a certain annual value. The threshold varies considerably from country to country, but it is typically about 100,000. As a consequence, although figures for trade between the EU and the rest of the world are accurately represented, trade within the EU is generally underestimated. Furthermore, the information used in CBI market surveys is obtained from a variety of sources. Therefore, extreme care must be taken in the qualitative use and interpretation of quantitative data, because it puts limitations on in-depth interpretation of relations between consumption, production and trade figures within one country and between different countries. The HS classification given differs from the product groups and products mentioned in the paragraphs above. This puts limitations on in-depth interpretation and of the possible relations between import and export figures on the one hand, and consumption and production figures on the other hand.
Appendix B
Introduction to the EU market
The European Union (EU) is the current name for the former European Community. Since January 1995 the EU has consisted of 15 member states. Ten new countries joined the EU in May 2004. In January 2007 two more countries Bulgaria and Romania - joined the EU. Negotiations are in progress with a number of other candidate member states. In this survey, the EU is referred to as the EU27, unless otherwise stated. Cultural awareness is a critical skill in securing success as an exporter. The enlargement of the EU has increased the size of the EU, and also significantly increased its complexity. With more people from culturally diverse backgrounds, effective communication is necessary. Be aware of differences in respect of meeting and greeting people (use of names, body language etc.) and of building relationships. There are also differences in dealings with hierarchy, presentations, negotiating, decision making and handling conflicts. More information on cultural differences can be found in chapter 3 of CBIs export manual Exporting to the EU (2006). General information on the EU can also be found at the official EU website http://europa.eu/abc/governments/index_en.htm or the free encyclopaedia Wikipedia http://en.wikipedia.org/wiki/Portal:Europe. Monetary unit: Euro On 1 January 1999, the Euro became the legal currency within eleven EU member states: Austria, Belgium, Finland, France, Germany, Italy, Ireland, Luxembourg, The Netherlands, Spain, and Portugal. Greece became the 12th member state to adopt the Euro on January 1, 2001. Slovenia adopted the Euro in 2007. Cyprus and Malta adopted the euro in 2008. Since 2002, Euro coins and banknotes replaced national currency in these countries. Denmark, United Kingdom and Sweden have decided not to participate in the Euro. In CBI market surveys, the Euro () is the basic currency unit used to indicate value. Table 1
Country
Exchange rates of EU currencies in , average yearly interbank rate

Name Code 2008
December 2009 Bulgaria Lev BGN 0.512 0.511 Czech Republic Crown CZK 0.040 0.038 Denmark Crown DKK 0.134 0.134 Estonia Crown EEK 0.064 0.064 Hungary Forint HUF 0.004 0.004 Latvia Lats LVL 1.438 1.419 Lithuania Litas LTL 0.292 0.290 Poland Zloty PLN 0.284 0.242 Romania New Lei RON 0.273 0.237 Sweden Crown SEK 0.104 0.096 United Kingdom Pound GBP 1.260 1.112 Source: Oanda http://www.oanda.com/ (January 2010)
Appendix C
List of developing countries
OECD DAC list - January 2006 When referring to developing countries in the CBI market surveys, reference is made to the group of countries on this OECD DAC list of January 2006. Afghanistan Albania Algeria Angola Anguilla Antigua and Barbuda Argentina Armenia Azerbaijan Bangladesh Barbados Belarus Belize Benin Bhutan Bolivia Bosnia & Herzegovina Botswana Brazil Burkina Faso Burundi Cambodia Cameroon Cape Verde Central African Rep. Chad Chile China Colombia Comoros Congo Democratic Rep. Congo Rep. Cook Islands Costa Rica Cote dIvoire Croatia Cuba Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Ethiopia Fiji Gabon Nepal Gambia Nicaragua Georgia Niger Ghana Nigeria Grenada Niue Guatemala Oman Guinea Pakistan Guinea-Bissau Palau Guyana Palestinian Admin. Areas Haiti Panama Honduras Papua New Guinea India Paraguay Indonesia Peru Iran Philippines Iraq Rwanda Jamaica Samoa Jordan Sao Tome & Principe Kazakhstan Saudi Arabia Kenya Senegal Kiribati Serbia Korea Rep. of Seychelles Kyrgyz Rep. Sierra Leone Laos Solomon Islands Lebanon Somalia Liberia South Africa Libya Sri Lanka Macedonia St. Helena Madagascar St. Kitts Nevis Malawi St. Lucia Malaysia St. Vincent & Grenadines Maldives Sudan Mali Suriname Marshall Islands Swaziland Mauritania Syria Mauritius Tajikistan Mayotte Tanzania Mexico Thailand Micronesia, Fed. States Timor-Leste Moldova Togo Mongolia Trinidad & Tobago Montenegro Tunisia Montserrat Turkey Morocco Turkmenistan Mozambique Turks & Caicos Islands Myanmar Tuvalu Namibia Uganda Nauru Ukraine Uruguay Uzbekistan Vanuatu Venezuela Vietnam Wallis & Futuna Yemen Zambia Zimbabwe
CBI countries January 2008: CBI supports exporters in the following Asian, African, Latin American and European (Balkan) countries: Afghanistan Albania Armenia Bangladesh Benin Bolivia Bosnia-Herzegovina Burkina Faso Colombia Ecuador Egypt El Salvador Ethiopia Georgia Ghana Guatemala Honduras India Indonesia Jordan Kenya Kosovo Macedonia Madagascar Mali Moldova Montenegro Morocco Mozambique Nepal Nicaragua Pakistan Peru Philippines Rwanda Senegal Serbia South Africa Sri Lanka Suriname Tanzania Thailand Tunisia Uganda Vietnam Zambia
Appendix D

References
The European Generic Medicines Association (EGA) <http://www.egagenerics.com> The Association of the European Self-Medication Industry (AESGP) <http://www.aesgp.be> The European Federation of Pharmaceutical Industries and Associations (EFPIA) <http://www.efpia.org> Pharmaceutical Pricing and Reimbursement Information (PPRI) <http://ppri.oebig.at> The World Health Organisation (WHO) <http://www.who.int> Simoens and De Coster (2006). Sustaining Generic Medicines Markets in Europe. Katholieke Universiteit Leuven, Belgium- Research Centre for Pharmaceutical Care and Pharmaco-economics. April, 2006. Available Online <http://www.egagenerics.com/doc/simoens-report_2006-04.pdf> Perry, G. (2006) The European Generic Pharmaceutical Market in Review: 2006 and Beyond. Journal of Generic Medicines. Vol. 4, no. 1. pp. 4-14. Available Online <http://www.egagenerics.com/doc/jgm_generics2006-gp.pdf> Lundbeck: Annual Report (2006) <http://www.materials.lundbeck.com/lundbeck/87/36>

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CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY

THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

APPENDIX A APPENDIX B APPENDIX C APPENDIX D

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

Opportunities and threats

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

Trade channels for market entry

Internet & Mail Order

Large Retail Customers

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

Trade: imports and exports

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

EU Imports of pharmaceutical products, 2004-2008, million / 1,000 tonnes

98,995 79,727 18,641 627

1,384 1,250 108 25

109,965 90,132 18,904 928

EU imports per product group

Total EU, of which from Intra-EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

Share (%) 7.0% 0.7%

Total EU, of which from Intra-EU

81% 18% 0.9%

71,525 18,007 552

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

The role of developing countries

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

Source: Eurostat (2009)

1,559 120,905 1,165 212 182 79,851 31,041 10,015

Opportunities and threats

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

Market access requirements

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

CBI MARKET SURVEY: THE PHARMACEUTICAL PRODUCTS MARKET IN THE EU

Lipid regulators (Hypolipidemic agents or antihyperlipidemic agents) Respiratory Agents

Used in the treatment of respiratory system disorders and lung diseases.