Improving Bangladesh's Pharmaceutical Sector Competitiveness (35 characters

POLICY NOTE IMPROVING THE COMPETITIVENESS OF THE PHARMACEUTICAL SECTOR IN BANGLADESH DRAFT
WORLD BANK
APRIL 2007
Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh
Table of Contents 1. 2. 3. 4. Executive Summary..................................................................................................................................4 Objective...................................................................................................................................................5 Methodology.............................................................................................................................................5 The Global Pharmaceutical Industry........................................................................................................5 R&D Based Pharmaceutical Firms.............................................................................................................5 Generic Pharmaceutical Firms....................................................................................................................6 Manufacturing Process...............................................................................................................................6 5. The Bangladesh Pharmaceutical Industry................................................................................................7 Overview.....................................................................................................................................................7 Bangladesh Pharmaceutical Marketplace ..................................................................................................8 Health Policy and Industrial Policy............................................................................................................9 6. Can TRIPS help Bangladesh export?.....................................................................................................10 The WTO and TRIPS...............................................................................................................................10 TRIPS Implications for Bangladesh.........................................................................................................11 Bangladesh Patent Law.............................................................................................................................13 7. Will the pharmaceutical sector be Bangladeshs next big export sector?...............................................13 Price 13 Quality 16 Drug Directorate Administration..........................................................................................................17 Drug Testing Laboratories....................................................................................................................18 International Certification.....................................................................................................................19 8. Increasing Competition to Improve the Industry ....................................................................................20 Competition in the Domestic Market.......................................................................................................20 Competition in the Export Market............................................................................................................21 9. Conclusions and Next Steps.....................................................................................................................23 APPENDIX ONE..........................................................................................................................................27 APPENDIX TWO: List of Interviewees.....................................................................................................30 APPENDIX THREE.....................................................................................................................................32
List of Acronyms Acronym API ASEAN BAPI BMA cGMP DCO DCC DDA DTL FDI GDP GMP GSK HIV/AIDS HVAC ICDDR,B ID LDC KWH MNC MSF MVA Nafdac NDP NGO NOC PP&E R&D RS SAARC SAFTA TGA TLC TRIPS UK UKMHRA UNDP UNICEF UNIDO USA USFDA WHO WIPO WTO Definition Active Pharmaceutical Ingredient Association of Southeast Asian Nations Bangladesh Association of Pharmaceutical Industries Bangladesh Medical Association Current Good Manufacturing Practice Drug Control Ordinance (Bangladesh) Drug Control Council (Zimbabwe) Drug Directorate Administration (Bangladesh) Drug Testing Laboratories Foreign Direct Investment Gross Domestic Product Good Manufacturing Practice Glaxo Smith Kline Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome Heating, Ventilation and Air-Conditioning International Center for Diarrhoeal Disease Research, Bangladesh Identification Least Developed Country Kilowatt Hours Multinational Corporation Medecins Sans Frontieres Manufacturing Value Added National Agency for Food, Drug Administration and Control (Nigeria) National Drug Policy Non Governmental Organization No Objection Certificate Plant Property & Equipment Research and Development Indian Rupee South Asian Association for Regional Cooperation South Asian Free Trade Association Therapeutic Goods Administration (Australia) Thin Layer Chromatography Agreement on Trade Related Aspects of Intellectual Property Rights United Kingdom United Kingdom Medicines and Healthcare Products Regulatory Agency United Nations Development Program United Nations Childrens Fund United Nations Industrial Development Organization United States of America United States Food and Drug Administration World Health Organization World Intellectual Property Organization World Trade Organization 3
1. Executive Summary Bangladeshs pharmaceutical sector is a dynamic growing sector. Firms in this sector are already expanding into international exports, API (Active Pharmaceutical Ingredient) production, and factory upgrades to improve quality. At the same time, the quality of drugs available domestically varies significantly. Some firms are producing world class quality drugs while others are producing drugs of a lower quality. The domestic regulatory institutions are not currently positioned to be able to effectively manage this situation, placing the public at risk. If Bangladeshs pharmaceutical firms can improve their cost competitiveness and their quality, they can potentially increase pharmaceutical exports. Furthermore, exporting provides Bangladesh firms the opportunity to participate in a fully competitive market and creates an incentive for firms to improve both quality and price competitiveness. Thus, the potential gains from investing in this sector include not only improving the quality of medicines available domestically, but also economic gains for the country that can positively impact poverty alleviation. This study explores ways to help the industry to become more globally competitive. It takes into account two external forces that are impacting Bangladesh. The first is WTOs TRIPS (Trade Related Aspects of Intellectual Property), which grants Bangladesh the right to domestically manufacture pharmaceuticals off-patent. It also provides limited export potential. Bangladesh should take advantage of this window of opportunity that TRIPS provides in order to create a sustainable and growing industry post-2016. In the long run, however, Bangladesh firms will have to excel based on the price and quality of their drugs. The second force is the rapidly changing international marketplace. Globalization means that the international marketplace is extremely competitive with firms looking for low cost manufacturing sources. Due to economies of scale and other factors, Bangladesh pharmaceutical firms may not currently be the low cost producer despite the many benefits the coutry offers. Furthermore, both India and China are evolving rapidly as their patent laws come into compliance with TRIPS and as they move upstream into more innovative research. The government and industry need to partner to build a long term sustainable and internationally competitive industry to meet these challenges and opportunities. The main focus should be on mechanisms to improve the cost and quality of pharmaceuticals manufactured in Bangladesh. Cost can be addressed via strategic investments in and support for the industry. Quality can be addressed through forging a partnership between industry and government to improve the financing, structure, and governance of regulatory functions. With the Caretaker governments focus on anti-corruption combined with the pharmaceutical industrys own interest in higher quality levels, there is potential for great gains in domestic quality control. In the meantime, international regulation for the export market can provide quality control as well. Specific recommendations include support for pharmaceutical firms that export, improved quality control, updating the patent law, and investigating API production, contract or toll manufacturing, and the feasibility of a bioequivalency laboratory.
2. Objective The objective of the study is to identify steps to assist the pharmaceutical sector in Bangladesh to improve its competitiveness in the global market, while at the same time making high quality drugs at a reasonable price available to the population of Bangladesh. The Terms of Reference for this study can be found in Appendix One. 3. Methodology This project was completed through in-depth interviews in Bangladesh with government, industry, NGOs, international organizations, and pharmacists along with a review of existing literature. This study focused more on the private sector than traditional World Bank studies as the private sector has an incentive to improve the quality and cost of its drugs. Thus, along with the government, they should be actors in tackling these issues. A list of interviewees can be found in Appendix Two. 4. The Global Pharmaceutical Industry Pharmaceutical manufacturing is a technically challenging but, if done well, financially rewarding industry. From 1993-1997, the average return on assets for the pharmaceutical industry globally was 10.96%.1 In 2006, the industry was estimated at $643 billion.2 Large research based Multinational Corporations (MNCs) dominate the industry in terms of revenue whereas generic firms are starting to dominate in terms of volume. R&D Based Pharmaceutical Firms The short-term product pipeline of global pharmaceutical MNCs is thin and niche. This absence of new blockbuster drugs in the near term is forcing MNCs to focus on the following: 1. Patent extensions. The National Institute for Health Care Management estimates that from 1989-2000 just 153 (15%) of all new US drug approvals were for medicines providing significant clinical improvements.3 The rest are for minor modifications of existing medicines. In general, the patent landscape for drugs is complex with drugs having multiple patents (some challengeable, some not) and variable patent coverage by country. In practice, it is often difficult to obtain a clear image of a drugs patent situation in a given country.4 2. Scale: MNCs are seeking to rationalize both R&D and manufacturing. The R&D facilities are increasingly based on centers of expertise where resources are assembled in one physical location around a single disease state. For example, Pfizer has moved from five global R&D sites to three. Manufacturing facilities must balance the economies of scale available at one large, low-cost facility in a logistically well-placed area with the need to be close to markets and comply with government regulations for local production. Whereas seven or eight years ago, Pfizer had approximately 120 manufacturing sites, today they have approximately 70.5 3. Cost cutting. MNCs are cutting costs by outsourcing parts of their manufacturing and finding new less expensive producers of APIs. MNCs are migrating from their small number of suppliers with whom they have traditionally worked to Indian and Chinese API manufacturers who can reliably supply lower cost bulk APIs.6 4. Mergers. Pharmaceutical firms are turning to strategic acquisitions to improve sales and profit.
Generic Pharmaceutical Firms Generic drug sales, including both branded and unbranded generics, were estimated at $87 billion in 2000, or 30% by value of total pharmaceutical world sales.7 They are predicted to grow between 14% and 17% a year over the next five years, well ahead of the single digit growth figures predicted for the overall pharmaceutical industry. The generic sector is expected to be highly competitive with many mergers and acquisitions as firms acquire scale. Generic firms core competencies lie in: 1. Reverse engineering. Typically, a manufacturer develops a generic drug by reverse engineering a patented drug invented by another firm to discover its chemical composition and then creating their own drug based on the same chemical composition. This process requires approximately 24 months to complete in the US as the firm needs to do the actual reverse engineering, design and implement manufacturing processes, complete the stability testing (if the product says that it has a shelf life of two years, the company must put it on the shelf for two years and then show it still has the same efficacy), and get USFDA approval.8 2. Consistently and reliably manufacturing high quality drugs at a low cost: Generic firms are also moving production to India and China to reduce costs. Large generic customers, such as US managed care organizations, also value reliability for if they do not receive their shipment of generic drugs, they must use the branded version instead, decreasing their profitability.9 3. Branding. In strictly regulated markets, all generic drugs are of the same quality. In countries with looser drug regulatory environments, there is a wider variation in generic quality. Thus, in these markets branding and marketing help differentiate products for the consumer. 4. Managing patent expirations. Generic firms are very good at challenging patents and managing the approval process. When a patent expires, there is usually a generic firm, ready with all the required approvals, on the market the next day. This is because generics make the most profit, sometimes up to 20%, when they are the only generic on the market.10 Over time, other firms enter and the drug prices drop towards marginal costs and the greatest profit potential is lost. The Waxman-Hatch Act in the United States increased this first-mover advantage by granting 180 days of exclusivity to the first firm who successfully challenges a patent upon its expiration. In order to be the first, Ivax, Reddy-Cheminor and Par started filing for US regulatory approval for Olanzapine approximately 10 years prior to the 2011 patent expiry.11 And generic firms do not just wait for a patent to expire, but aggressively challenge them. An article entitled In India a Little Lab Work and Lots of Lawyers, describes how Ranbaxy, an Indian firm, has been involved in 14 patent suits in the US from 2000-2003.12 Manufacturing Process There are generally two steps to pharmaceutical manufacturing. The first is Active Pharmaceutical Ingredients (API) manufacturing. API production is a highly sophisticated task based on technically demanding chemical and biochemical fermentation and synthesis processes. In 2004, the API market was $69 billion.13 There are two basic types of APIs: specialty APIs (tend to be hard to manufacture) and commodity APIs (tend to have many suppliers and price competition becomes more important). A significant portion of the manufacturing cost of a drug lies in APIs. For example, 40-50% of the cost of goods sold for generic oral solids, on average, comes from APIs.14 As commodity API manufacturing tends to be a high volume, low margin business based extensively on scale economies and large dedicated manufacturing lines, smaller manufacturers have limited opportunities to globally compete. Excluding specialty items, the average API margin is less than 10%. In fact, many large bulk API exporters from India consider 3% margin on export to be good enough.15
Unlike the chemical business of API production, the second step, final formulations, belongs to the manufacturing sector. In final formulations, firms mix APIs and excipients (other non-active ingredients), press them into pills, tablets, or solutions, and then package them for the consumer market. As firms can produce fifty or more products in a single plant with flexible equipment, scale economies matter less for formulations. Margins for final formulations average from 20-30%.16 There not only appears to be enough capacity to produce all needed APIs and bulk formulations but all production increases can be accomplished within the present capacity of the global industry. The industry is currently consolidating and shutting down excess capacity. However, this capacity glut is therapeutic area-specific and not all therapeutic categories (e.g. chronic diseases) have over-capacity.17 5. The Bangladesh Pharmaceutical Industry Overview The Bangladesh pharmaceutical sector is one of the fastest growing sectors in Bangladesh. In 2005, the market size was $500M and it is expected to grow at 10% per annum.18 Domestically, Bangladesh firms generate 82% of the market, locally-based MNCs account for 13% of the market and the final 5% is imported. Although there are 235 pharmaceutical companies registered in Bangladesh, only around 85 are actively producing drugs. The top 30-40 essentially capture almost the entire market, the top 10 capture 70% of the domestic market and the top two, Beximco and Square, capture over 25% of the market.19 The Essential Drug Company is the only government-owned drug company and it is rather successful. Twelve firms are listed in the stock exchanges in Dhaka and Chittagong.20 Exports, as shown in Table One, below, are growing rapidly. Table One Bangladesh Pharmaceutical Exports in USD millions21
Pharmaceutical Exports Total Exports Pharmaceutical exports as a % of total exports Pharmaceutical export growth rate FY1975 0.37 382.6 0.097% FY1980 0.15 749.3 0.020% -59% FY1985 0.04 934.4 0.004% -73% FY1990 0.12 1523.7 0.008% 200% FY1995 2.74 3427.5 0.080% 2183% FY2000 5.61 5752.2 0.098% 105% FY2002 6.60 5986.1 0.110% 18% FY2003 9.05 6548.4 0.138% 37% FY2004 12.69 7603.0 0.167% 40% FY2005 21.26 8651.5 0.246% 68% FY2006 27.54 10,514.0 0.262% 30%
Table Two, on the next page, shows that the majority of exports are from Novartis/Sandoz. Novartis/Sandoz has an EU certified plant in Bangladesh where APIs, excipients, and many of the packaging components are imported and then the final product is exported. It is unclear if Novartis exports are due to intercompany transfers or sales on the open market. Further research needs to be done to see what percentage of the growth in exports is due to Novartis/Sandoz and what percent is due to the rest of the industry.
Table Two Recent Export of Some Bangladesh Pharmaceutical Firms22

Company Novartis Bangladesh / Sandoz Beximco Pharmaceuticals Square Pharmaceuticals Jams Pharmaceuticals Jayson Pharmaceuticals The Acme Laboratory Co Eskayef Bangladesh Aristopharma Renata Navana Pharmaceuticals Aventis ACI Essential Drug Co Globe Pharmaceuticals Opsonin Pharmaceuticals Export (USD) 12,820,162 1,400,000 1,200,000 633,721 626,546 600,000 331,876 305,648 281,788 240,175 223,999 156,392 124,687 68,410 34,109 Year of Export 2004-2005 2004 2004 2000-2004 2004 2004 2004 July 2004 June 2005 2004 Sept 2003 June 2005 2004 2004 2004 2005-2006 2004
Bangladesh Pharmaceutical Marketplace The Bangladesh pharmaceutical marketplace is predominantly a branded generic marketplace. Pharmaceutical firms in Bangladesh can either sell to the private sector pharmacies, to the government and its public health care facilities, or to international organizations operating in Bangladesh (e.g. UNICEF). Government sales are not as profitable as private sector sales as the government pays less and pays on consignment. Pharmaceutical firms still target the pubic facilities however as doctors working in public facilities get to know drugs and then prescribe them in their private practices. And, as drugs are not readily available at public facilities, patients receiving treatment at one still may go to a private pharmacy to procure the required drugs. Without these connections, many firms would move more of their attention to the private sector.23 A visit to four pharmacies in Dhaka and ten pharmacies in the bordering Gazipur, Narayanganj, Keranigonj and Manikgonj districts reveal that pharmacies sell from 200-22,000 types of medicines each. Each type of medicine has one to twenty five possible brands. Large pharmacies reported buying medicines according to sales trends e.g. what sells the most. Medium and small pharmacies reported being linked with a medical doctor and thus sales are usually skewed towards that medical professionals preferences. Most pharmacies are individual shops, though some chains are starting to develop, especially in urban areas. On average, each pharmacy visited has 1050 pharmaceutical firms that supply them medicines on a daily basis. For example, Beximco Pharmaceuticals has 1,200 people visiting pharmacies daily to take orders for drugs. Each pharmacy then recieves approximately 1215 Beximco shipments per month.24 None of the pharmacies visited will keep restocking any medicine that they consider a slow item. Small pharmacies report keeping a medicine for a maximum period of six months. Although there are approximately 300,000 private pharmacies in Bangladesh, the government has only 26,000 pharmacies officially listed. 25 The rest are illegal pharmacies as they have no license / licensed pharmacist on staff. Pharmacists have varying levels of education and many lack adequate training. For example, while the four large urban pharmacies visited each had one professional
pharmacist (with four years of coursework), two of the medium-sized pharmacies visited had one person trained for one year along untrained coworkers working as pharmacists. Rural pharmacists can have high school graduates with approximately two weeks training. The Bangladesh Pharmacist Society is currently implementing the first phase of a three-phased program to improve the skills of pharmacists. The three-phased program should be complete in seven to eight years.26 While about 95% of the consumers in big pharmacies visited purchase medicines with a prescription, as few as 50% of people in medium and small pharmacies visited have a prescription. If people dont have a prescription, they either come in and ask for a specific drug or come in and describe their ailment to the pharmacist who then makes a diagnosis and recommends a drug on the spot. Popular products include antibiotics of various levels, pain-killers, and gastric remedies. People purchase one to ten tablets or capsules at a time. The amount purchased depends more on the financial capacity of the consumer than on the required dose of medicine. There are several brands of each drug on the market with variable levels of quality. In the urban areas, the pharmacies visited tended to sell the higher quality brands whereas in more rural areas, the pharmacies visited tended to sell lower quality, lower cost brands. The political sway of the district also influenced the selection of brands as pharmacies tended to have brands associated with people who had power in that district. Medium and small pharmacies reported stocking cheaper drugs as the consumers cannot purchase expensive medicines. Pharmacies further away from the center of the city also had increasingly more ayurvedic and herbal medicines. Health Policy and Industrial Policy The pharmaceutical sector sits at the intersection of health policy and industrial policy and, as such, careful thought needs to be given as to how to balance potential tensions between these two sectors. For health policy, the government wants to ensure a predictable supply of high quality, low cost medicines. For industrial policy, the government wants to build up the domestic pharmaceutical industry. Historically, Bangladeshs drug policy has probably succeeded more clearly as industrial policy than health policy.27 The World Bank conducted a study on pharmaceutical production in the developing world and concluded that local production of medicines is often not feasible in the face of current realities of global trade, the international economics of the pharmaceutical industry, and an assumed real need of national governments to balance industrial policy and health policy. Many developing countries lack the business environment to have a successful domestic pharmaceutical industry. Furthermore, countries have not had the best success at improving access to medicines through building up a domestic industry. The study also correlated the strength of a local industry with independent variables to determine what factors enable a country to have a viable domestic industry. This work, however, was more of a research agenda than an evidence-based conclusion and the criteria represent more statistical trends than exclusive criteria.28 The identified criteria are: 1. Gross Domestic Product (GDP) greater than about $100 billion: Countries with greater than $5 billion dollars of pharmaceutical production (Sweden, Ireland, Korea, Russian
Federation, India, Brazil, Germany, and China) all have GDPs between than $100 billion a $1 trillion. South Africa, with a GDP of $570 billion, sits on the lower end of this scale and has a barely viable pharmaceutical industry, nationally or internationally. Again, these data are trends and not exclusive criteria and there are exceptions: Cuba and Jordan both manage to maintain a viable pharmaceutical industry without the hypothesized required size. 29 The current Bangladesh GDP is $69.02 billion.30 2. A population greater than about 100 million: As the pharmaceutical industry is technology-driven, not labor driven, large populations are only needed for the concentration effect i.e. the greater the sheer number, the greater the size of the high-quality labor pool and the greater the market to consume locally produced pharmaceuticals.31 However, many Eastern European countries with populations significantly less than 100 million have viable pharmaceutical industries. The current population of Bangladesh is 147 million.32 3. Sufficient numbers of the population enrolled in secondary and tertiary education: The pharmaceutical industry requires a base of highly skilled employees. Net secondary and tertiary enrollment in Bangladesh and some other countries is highlighted in Table Three, below. While Bangladesh almost matches India on secondary enrollment levels, Bangladesh falls behind in the realm of tertiary education. Also, while the percentages are close, India and China have much larger populations leading to a higher absolute number. Table Three Gross Enrollment Ratios in Selected Countries33
Country Secondary Tertiary Bangladesh 51.3% 6.5% India 53.5% 11.8% China 72.5% 19.1% Global Average 61.4% 18.6%
4. UNIDO competitiveness index greater than about 0.15: In 2003, UNIDO released a competitive industrial performance index based on MVA (Manufacturing Value Added) per capita, manufactured exports per capita, share of medium- and hi-tech activities in MVA, and share of medium- and hi-tech products in manufactured exports. Generally, as a country moves upwards on the competitiveness index scale, local production of pharmaceuticals increases. Bangladeshs 1998 score was 0.011, Indias was 0.054, and Chinas was 0.126.34 5. A net positive pharmaceutical balance of trade: Countries with a positive pharmaceutical trade balance are more likely to have sustainable local production above $1 billion. While, no one country is completely self-sufficient in pharmaceutical drug production, some countries such as India, China and Brazil are net exporters of medicines.35 Currently, even though domestic firms generate 95% of domestic pharmaceutical sales, Bangladesh is a net pharmaceutical importer as they import an estimated $189M of APIs36 and only export $30-$40M of finished product. However, this picture is changing as more and more firms export. 6. Can TRIPS help Bangladesh export? The WTO and TRIPS According to the WTOs TRIPS (Trade Related Aspects on Intellectual Property), all signatory parties are bound to implement 20 year product patent protection for pharmaceutical products into their domestic legislation. TRIPS is not a uniform law, but a framework that sets minimum standards for intellectual property protection. Countries must then design legislation to meet its requirements, but there is still significant flexibility.
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Countries were given the following transition periods: 1. January 2000: By this date, all developing countries who had patent protection had to bring their patent law into compliance with TRIPS standards (Article 65.2). Countries who did not have patent protection in place had to create a mailbox to receive patent applications. During the mailbox period, the country must grant exclusive marketing rights for those products for where patents have been filed in the mailbox, marketing approval had been obtained in the country, and the said product had previously been patented in another country (Article 70.8 and 70.9). Thirteen countries notified the WTO of their use of this transition period, but a number of these countries implemented full TRIPS patent protection before the 2005 deadline. As of 2003, 6 members were still using the transition period Cuba, Egypt, India, Pakistan, Qatar, and United Arab Emirates.37 2. January 2005: As of this date, all WTO countries, except the 49 Least Developed Countries (LDCs), had to ensure that their national laws fully conformed to the provisions of the TRIPS Agreement. If a pharmaceutical firm did not file a patent for a product before January 1995, it would remain in the public domain. If a pharmaceutical product was involved in the mailbox program, the country must grant exclusive marketing rights until the application is processed or five years has elapsed, whichever comes first. Although a substantial change happened when the developing countries started to process the mailbox patents in January 2005, in effect, patent protection will phase in over time as new drugs are developed and replace older drugs. Slowly the market composition will migrate towards more and more patented drugs and fewer and fewer generic drugs.38 3. January 2016: The 49 LDCs are not obliged to legislate product patent rights until 2016. Until then, LDCs can provide no patent protection at all, patent protection that is less than required by TRIPS or patent protection equal to or greater than TRIPS. Many LDC countries have implemented full TRIPS patent protection or expanded TRIPS-plus patent protection in advance of the 2016 deadline. Activists say this is due to pressure from multinational pharmaceutical companies or developed country governments while MNCs say that IP laws are individual to each country and may reflect other trade and policy priorities. TRIPS significantly changed the international pharmaceutical world as, before the start of the TRIPS negotiations, more than 50 countries did not grant pharmaceutical product patent protection at all and some excluded process patents as well.39 Implementation of product patent protection in India and China, two countries who had built their industries primarily based on loose patent laws and who are the worlds two largest manufacturers of generic drugs, provide probably the largest change. They are each profiled in Appendix Three. Many developing countries are challenged to implement TRIPS due to a lack of technical expertise to effectively implement TRIPS flexibilities; bilateral and other pressures not to use TRIPS and to adopt TRIPS-plus standards; difficulty in regulating anti-competitive practices; abuse of intellectual property rights; and difficulty in assessing pricing and patent status information. The US government spends approximately $1 billion to maintain its patent office,40 a sum few other countries can afford. Furthermore, much of the international assistance for TRIPS implementation has been focused on enforcing patent-holder rights instead of taking advantage of the flexibilities TRIPS offers.41 TRIPS Implications for Bangladesh TRIPS provides Bangladesh pharmaceutical firms with patent-free production rights domestically until 2016 and limited exporting advantage. Domestically, as long as Bangladesh has to import APIs however,
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they will have to buy these from firms which are compliant with TRIPS laws and hence will have to incorporate the higher royalty patent price for these. TRIPS also allows Bangladesh to export drugs patent free. The advantages that TRIPS does offer is somewhat offset by the pace and ferociousness of the Indian and Chinese generic market, where companies can produce drugs, even including the patent costs, at an enormously competitive rate. An analysis of the potential export market under TRIPS, shown below, reveals that the opportunities are also limited. Until 2016, Bangladesh may: 1. Export to any country if the drug is not under patent. For example, most drugs on WHOs Model List of Essential Drugs are not patented as affordability is one of the criteria used in designating medicines as essential.42 2. Export to another LDC or non-WTO country that has not implemented product patent protection. However, today, virtually all the LDC WTO members provide TRIPS patent protection. A 2001 IPR Commission study revealed that only 2 African LDCs had yet to provide for intellectual property protection, one of which is not yet a WTO member. In Asia, Myanmar currently engaged in the WTO accession process is perhaps the only country that has yet to put in place a patent protection regime.43 Article 65.5 of TRIPS says that any country availing itself of a transitional period flexibility shall not change their laws to result in a lesser degree of consistency with TRIPS. 3. Export to a country where the patent holder has not filed for patent protection for this drug. As companies do not file patents in all countries, there are gaps in patent coverage that can be exploited. Companies tend not to file patents in countries where sales and profit prospects are low or where there is no meaningful judicial patent protection. 4. Be the first one to market when a patented drug goes off patent. As previously discussed, there is great profit potential for the first generic firm to get approval for a product. The Bolar Exception of TRIPS allows any country in the world to start working on a drug before patent expiry. Thus, Bangladeshs patent-free LDC status does not offer any competitive advantages in this arena and Bangladesh will have to compete head to head in this very fierce and competitive market. 5. Export to a country that has issued a compulsory license for the drug and awarded the production contract to Bangladesh. Article 31 of TRIPS grants governments the right to issue a compulsory license for public health purposes. A compulsory license is where the government overrides a patent and grants another entity the right to produce the patented product. The 6 December 2005 Decision gives countries who do not have adequate manufacturing capacity (and all LDCs are given this status) the right to import the drug for which it issues a compulsory license. Thirty three developed countries have declared they will not use this TRIPS flexibility to import and eleven countries announced they would not use it unless it was a national emergency.44 Although Canada, Japan, the US, and the UK all have issued domestic compulsory licenses for pharmaceuticals, very few developing countries have. Potential reasons include legal battles with a developed country can be quite expensive and time-consuming; governments must balance fully exploiting TRIPS flexibilities with upsetting MNCs, who often do business with domestic firms for outsourcing or manufacturing; and the US can apply Section 301 of the Trade Act to threaten retaliation with trade sanctions if they consider a country to have non compliance with adequate standards of intellectual property.45 In a case being watched around the globe, Thailand issued a compulsory licenses for Mercks Efavirenz, an HIV/AIDS drug, in November 2006 and has since become a maelstrom of international pharmaceutical legal dispute.46
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Pre-2005, there were many countries which could fulfill a compulsory license exporting request as many countries were manufacturing patented drugs off-patent. As of 2005, Bangladesh will be one of the few places in the world where firms are legally producing patented drugs off-patent. As of 2005, India and China, the worlds largest suppliers of generic drugs, will no longer be able to engage in this process for any drug patented after 2005. Considering that firms require two to three years to reverse engineer and start producing a specific drug in a quality manner, this means that when a compulsory license is issued for any drug patented after 2005, Bangladesh will have an enormous head start. However, TRIPS has clearly stated that export for compulsory licensing is intended for health policy, not industrial policy. Therefore, TRIPS flexibilities offer some domestic advantages and limited export potential. In the long term, Bangladesh will have to rely on standard business practices of producing the highest quality product at the lowest price to compete on the international market. Bangladesh Patent Law Bangladeshs patent law is based on the Patent and Designs Act of 1911 and the Patents and Designs Rules of 1933. The law grants both process and product patent rights for pharmaceutical products. They have issued approximately 40 drug formula patents. The Patent office issues approximately 300 patents per year, 90% of which are held by MNCs.47 The patent law in Bangladesh is not consistent with the TRIPs in many ways. The most basic of these is that Bangladesh does not have to enact patent legislation of any kind until 2016. The Department of Patent, Designs and Trademarks within the Ministry of Industries is preparing a Draft Patent Act 2006. This draft law, prepared with the assistance of World Intellectual Property Organization (WIPO) excludes pharmaceutical patents, and includes the Bolar Provision48 and parallel importation.49 The current 1911 law already provided for compulsory licenses but the flexibility has never been used.50 A recent Dutch study of the patent law situation concluded that the current draft law still needs work. The study also concluded that the draft law is not likely to be passed by the current Caretaker government in the foreseeable future. Thus, the study recommends implementing a small piece of legislation that just declares TRIPS to be applicable in Bangladesh. 7. Will the pharmaceutical sector be Bangladeshs next big export sector? If the Bangladesh pharmaceutical industry wants to become Bangladeshs next big export sector, it needs to improve its price and quality in order to effectively compete on the international markets. Price It is unclear how well Bangladesh firms currently compete on the global market on the basis of price. Some firms report having a price advantage. Other firms claim that when they compete on the international market, they are toe-to-toe with other firms. UNICEF reports that when two Bangladesh pharmaceutical firms submitted a bid for a local tender, one was 40% higher and one was 80% higher than the winning bids for the same product in UNICEFs international competitive bids.51 Other firms report difficulties in competing with India as India has API facilities, good reverse engineering, good infrastructure support, and good backward linkages to raw supplies. The global price of a Bangladesh pharmaceutical product is determined by the following factors:
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1. Cost of raw materials: Square Pharmaceuticals, the largest Bangladesh pharmaceutical firm which generates 15% of the market, spent 3.093 billion Taka on raw materials (API and excipients) and packing materials in 2005-06. This represents 50.8% of sales52 and one of the largest drivers of their costs. Currently, Bangladesh firms do not manufacture many APIs. Rather, they focus primarily on generic final formulations based on imported APIs. Approximately fifteen to seventeen companies are involved in the manufacture of about twenty APIs, usually running the final chemical synthesis stage on API intermediaries instead of the complete chemical synthesis. The other 1000 required APIs are imported.53 API production in Bangladesh is hampered by Lack of production facilities. There is a project to develop an API Park which, when it is completed, should greatly address the infrastructure problem. Lack of scientific know-how. In the time required to develop required skills locally, firms can import these via consultants from e.g. India. Shipping and import costs for the raw solvent are currently too high. One competitive advantage that the Indian pharmaceutical industry has is they operate within a network where, depending on site location within India, there are all the support industries needed. Bangladesh needs to either consider how to facilitate cheaper importation of raw solvents or create backward linkages and develop this industry as well. Due to the nature of the API business with scale economies, it will be quite difficult for Bangladesh to effectively compete. However, Bangladesh pharmaceutical firms need to gain API skills if they are going to effectively compete in the global market for final formulations. If not, the entire generic drug industry in Bangladesh will be at risk as companies will have to pay increasingly more for imported APIs which are now, with the advent of TRIPS, coming under patent protection. 2. Labor costs: The Bangladesh Association of Pharmaceutical Industries (BAPI) estimates that Bangladesh firms can sell products for less due to lower personnel costs (approximately 20-30% lower than in India).54 In 2005-06, Square Pharmaceuticals spent 319 M Taka on salaries and allowances, or 4.5% of total revenue.55 Thus, Bangladesh can capitalize on their lower personnel costs to drive price competitiveness. 3. Fixed costs of machines and factories: In 2005-06, Square Pharmaceuticals had 2.27 billion Taka of PP&E (Plant, Property & Equipment) on its books and took a depreciation charge (an accounting term to represent the annualized PP&E expense) of 252 Table Four55 million taka or 4.1% of sales. All manufacturing industries Scale Economy Curves are dependent on scale to one degree or another. As mentioned before, API production is more scale dependent than final formulations. And some types of APIs are more subject to scale costs than others. Table Four, to the right, shows a generalized scale curve that needs to be created. If a Bangladesh firm builds capacity at a scale that is, for example, too far to the left, all the TRIPS patent exemptions may not be enough to counter their higher manufacturing costs.56 4. Power Costs: Some argue that Bangladeshs lower power costs (self generation power costs are approximately 2 Taka per KWH while government costs are 3.5 Taka per KWH in rural areas and 5.5
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Taka per KWH in cities57) give Bangladesh firms a competitive advantage. However, in 2005-2006, Square Pharmaceuticals spent 68.53M taka on electricity, gas and water. This is 1.13% of total sales,58 which, while a significant cost, is not a key driver of company success. 5. Tariff, taxes and other trade barriers: When a country imports a pharmaceutical product from Bangladesh, the country can apply a tariff and a tax to the product. While tariffs and taxes directly increase the price of the imported drugs, other trade barriers can indirectly impact the price by creating an artificial scarcity which can drive up prices. A WHO study of sixteen drugs in eighteen countries found an average tariff in the range of 4-10%.59 6. Supply Chain Cost: A significant portion of a drugs final cost is in the distribution of the drug which involves wholesalers, pharmacies, and other middlemen. This report assumes that when Bangladesh exports a drug to a country, its supply chain cost there is the same as the domestic manufacturers and hence this factor is neutral in determining international competitiveness. To understand the competitiveness of Bangladesh pharmaceutical firms, two studies which compare the prices of drugs found in Bangladesh versus other countries are shown below. The first comes from a comparison of two surveys: prices found at the 14 Bangladesh pharmacies visited in 2007 and prices from a survey conducted in 2002. The results are shown in Table Five. Table Five Price comparison of eight drugs60 Prices in Bangladesh taka per tab or capsule61
Name Bangladesh 2007 Anti-Infectives Ciprofloxacin HCL 500 mg tabs Norfloxcin 400 mg tabs Ofloxacin 200 mg tabs Cefodoxime Proxetil 200 mg tabs NSAIDS Diclofenac Sodium 50 mg tabs Anti-Ulcerant Rantidine 150 mg tabs Omeprazole 30 mg caps Lansoprazole 30 mg caps 2-4 4.0 4.0 0.8 2.7 4.6 8.7 68.0 80.6 21.0 34.2 26.6 101.6 240.9 224.7 29.0 102.5 83.3 0.6-0.9 0.4 10.0 7.0 79.4 7.2 10-14 14.0 15.0 25.0 5.5 2.4 4.7 13.4 49.9 19.9 29.3 42.0 46.2 15.4 24.0 31.1 276.7 216.9 232.2 185.5 139.5 35.9 96.3 91.0 India 2002 Pakistan 2002 Indonesia 2002 USA 2002 UK 2002
The second study, summarized in Table Six, comes from an 2004 IFC survey which compared drug prices for twenty products from Square Pharmaceuticals with equivalent drugs in India.
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Table Six Price comparison of twenty drugs from Square Pharmaceuticals62

Price for drugs in pharmacies in Bangladesh (in Taka) 2.00 14.00 0.82 5.00 0.79 5.00 380.00 12.50 2.50 0.51 32.00 2.53 1.00 46.02 0.58 6.07 0.65 5.50 2.93 135.00 Sales price for end customer (assuming no taxes were applicable) 1.51 10.57 0.62 3.77 0.60 3.77 286.79 9.43 1.89 0.38 24.15 1.91 0.75 34.73 0.44 4.58 0.49 4.15 2.21 101.89 Price for equivalent drugs in pharmacies in India (in Taka) 0.84 9.86-17.28 1.23 3.71-4.93 0.61 5.12 370-493 12.33-18.50 3.70 0.61 37-43.21 1.03 1.24 8.02 0.99 3.70 2.47-3.07
Square Product Neotack (Ranitidine) 150 Tablet Ciprocin (Ciprofloxacin) 500 Tablet Ceevit (Ascorbic Acid) 250 Tablet Seclo (Omeprazole) 20 Capsule Entacyd Plus (Antacid + Simethicone) Tablet Vega (Rofecoxib) 25 Tablet Ceftron (Ceftriaxone) 1 gram IV Injection Lebac (Cephradine) 500 Capsule Alatrol (Ceterizine) Tablet Entacyd (Antacid) Tablet Tusca (Cough Syrup)100 ml Syrup Rex (Vitamin A, C & E) Tablet Multivit Plus (Multivitamin) Tablet Entacyd Plus (Antacid) Suspension B-50 Forte (Vitamin B Complex) Capsule Moxacil (Amoxycillin) 500 Capsule Ace (Paracetamol) Tablet Comprid (Gliclazide) Tablet Zif (Zinc, Iron, Folic Acid) Capsule Ceftron 250 mg IM Injection
Sales VAT and applicable taxes 0.49 3.43 0.20 1.23 0.19 1.23 93.21 3.07 0.61 0.13 7.85 0.62 0.25 11.29 0.14 1.49 0.16 1.35 0.72 33.11
Price realized by Square 1.46 10.25 0.60 3.66 0.58 3.66 278.19 9.15 1.83 0.37 23.43 1.85 0.73 33.69 0.42 4.44 0.48 4.03 2.14 98.83
Percent overpricing of drugs in Bangladesh 74% 42% to -19% -51% 35% to 1% -5% -29% 3% to -23% 1% to -32% -51% -39% -14% to -26% -29% -66% -45% -52% 9% 19% to -5%
A conclusive analysis of Bangladesh manufacturing cost competitiveness can not be drawn from just these studies as they do not neutralize for value chain costs (including both supply chain and distribution chain), differential packaging costs, VAT costs, tariffs and other trade barriers, potential quality differences, impacts of patent protection in different countries, nor other purchase price parity factors. Further research, based on factory gate costs is needed to accruately determine the cost competitiveness of pharmaceutical firms in Bangladesh. Quality In order to become a leading export sector, the pharmaceutical industry needs to make significant improvements in quality. Quality for pharmaceutical products is determined by: 1. quality of raw materials, 2. quality of manufacturing process and environment and 3. brand perception. While some products on the market are of world-class standards, others are less so. Some anecdotal reports of lower quality drugs are: The International Centre for Diarrhea Research, Bangladesh (ICCDR,B) tested 20 Zinc syrup formulations marketed in Bangladesh for zinc content. The samples were purchased from local pharmacies in Dhaka,. Only two of the products contained zinc concentrations within 5% of the stated zinc content. The rest had zinc, just not enough. The zinc degrades if exposed to light so it is placed in tinted glass bottles and normally packaged in a box.
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Therefore, the problem could come from either poor manufacturing or poor product handling in the distribution channel. UNICEF sent eleven drugs for testing to a laboratory in Australia and two came back as substandard. When they told the manufacturers, one company immediately stopped production until they found the problem, a very good response. The other company however, refused to address the problem, claiming that the test must be wrong. UNICEF sent the drug for a second testing to a lab in Denmark. This laboratory also said drug was substandard and the company still refused to address the issue.63 Medical professionals are very aware of the quality difference in brands. For example, one doctor interviewed knew that if she was prescribing Paracetamol, she would have to give twice as much of one brand as another brand to have the same effectiveness. Pharmacists also had very strong opinions on the quality of different brands. Firms that have invested in quality manufacturing facilities and quality processes are, in a sense penalized by the lack of quality control in the market. When firms who make minimal investments in quality can sell drugs right next to those of a firm that has invested substantially in quality and the consumer has no means to determine the quality difference, there is not a level playing field. There are three mechanisms in place to regulate quality of Bangladesh drugs: the Drug Directorate Administration (DDA), the Drug Testing Laboratory (DTL), and international certifications. Drug Directorate Administration The Drug Directorate Administration (DDA) has been charged with ensuring the safety, efficacy, and quality of drugs, as well as the relevance and accuracy of product information in Bangladesh.64 While extensive rules for regulating the market exist on paper, the market remains, in essence, a significantly under-regulated market due to corruption, the power of the pharmaceutical industry, and the weakness of the regulating authorities. The DDA is significantly under-resourced. The DDA has 44 inspectors, 16 located in Dhaka and then almost one per district (30 districts). The inspectors inspect manufacturing facilities on average once every 2 years for their license renewal,65 but some firms feel that this visit often seems nothing more than a courtesy visit. There is only one car for the DDA which the Director uses. Inspectors therefore need to take the bus or have the pharmaceutical firm they are inspecting provide them a ride. DDA staff are also potentially undertrained. Local inspectors shadow international inspectors who come to do site visits to learn from them. On the other hand, the WHO has held numerous training sessions. Currently, the DDA has a budget of 90M taka (approximately $1.3M). The DDA gets one third of this from the allocated government budget and the remainder from registration fees. The DDA currently has requested an upgrade from Directorate to Directorate General status which comes with an increased level of allocated resources. The government is considering this request. The current drug registration fee in Bangladesh is approximately $100 per drug. The DDA requested an increase in the drug regulation fee to 100,000 taka ($1,450) but the Ministry did not approve this request.66 The DDA is also reputed to have issues with corruption and low morale. A lack of accountability means there is no consequence for territory drug inspectors not taking action. Some hypothesize further resource allocation will achieve uncertain improvements in the quality of the DDAs services in the
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absence of significant restructuring. Others hypothesize that small increases in resources will not make a difference as incremental gains will just be absorbed into the system without changing it. Drug Testing Laboratories Drug testing is the most expensive tool in the drug regulatory process, but the only way to prove if a product is counterfeit or substandard. A global study of 325 drugs reported to the WHO shows that chemical analysis, including ID and TLC (Thin Layer Chromatography) testing could catch about 93% of substandard drugs in the sample.67 There are two chemical analysis drug testing laboratories in Bangladesh, each reporting to different parts of the government. One is in Dhaka and reports to the Director of Public Health in the Ministry of Health. The other is in Chittagong and reports the DDA. Although the Dhaka laboratory has Directorate General status, both laboratories are significantly under-resourced. Comparing the public laboratories to the private laboratories is a comparison of night and day. The public laboratories do not have an air control system, proper clothing and sanitation equipment for staff, proper personnel staffing and training, nor proper equipment, machines, or reagents. Perceptions of the laboratories vary from just being underresourced to being under-resourced and not doing well with the resources that they do have. In the case of the latter situation, questions arise over the laboratories ability to manage more resources effectively. There are no bioequivalency lab capabilities in Bangladesh. In order to get a generic final formulation approved for import into a regulated market, the drug needs to be tested for bioequivalency. Bioequivalency laboratories test the availability of the drug in the blood. They determine absorption rates, elimination rates, and other in vivo effects. Currently, Bangladesh pharmaceutical firms looking to export must use an international bioequivalence laboratory. As such, Bangladesh firms have to send products abroad to an internationally recognized bioequivalency laboratory at a cost of $30,000-$60,000 per drug.68 The Dhaka laboratory has no capability to go out and collect samples. They receive samples from DDA inspectors, police raids, and other groups.69 There is a suspicion that, due to corruption, they are not receiving random samples of drugs. Random sampling is extremely important to having overall testing quality. Table Seven, below, shows the number of drugs tested by the Dhaka laboratory. These numbers include samples collected from post market surveillance, from raids by different authorities and from new product submissions. Table Seven Number of Drugs Tested By Dhaka Public Laboratory70
Year Samples tested Samples passed 2001 3625 3594 2002 3159 3129 2003 3842 3809 2004 3918 3869 2005 3237 2845
If a drug fails their tests, they give a report to the DDA and have no further involvement in the matter. Therefore, the laboratory has no idea why, for example, so many drugs failed inspection in 2005.
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International Certification There are several different international manufacturing quality standards to which firms can adhere: 1. Good Manufacturing Practices (GMP) or Current Good Manufacturing Practices (cGMP): GMP and cGMP are promoted by the World Health Organization (WHO). They focus on the manufacturing process in order to minimize risk of a faulty final product. As testing each and every final product as it comes of the line could destroy or compromise the product, firms focus on ensuring quality manufacturing procedures and environment. GMP will certify a facility (not a drug or an organization) if it meets standards for starting materials, premises, equipment, processes, documentation, training and personal hygiene of staff. These standards are quite general and so how they are implemented really determines their stringency. There are two bodies in Bangladesh that can give GMP certification: The Government of Bangladesh through the DDA and International Organizations such as UNICEF which requires GMP certification to prequalify a firm for UNICEF purchases. Local DDA inspectors, hampered by lack of training and political pressures, are not as stringent as international inspectors. For example, while the DDA passes 95% of the firms they inspect,71 UNICEF globally has passed 63% in the past 4 years.72 Furthermore, local inspectors are even more lenient on inspections for domestic production than for international inspection. Currently, the DDA has certified 30 facilities for export.73 UNICEF has four companies fully GMP qualified and two companies partially certified (e.g. not all facilities/products) in Bangladesh.74 2. USFDA: The USFDA has to approve a drug before it can be imported into the United States. USFDA approval is also useful in other markets as an indicator of quality. There are several aspects to this approval. Both final generic drug producers and API producers give product samples to the FDA for chemical analysis and have a full scale plant, process, and production inspection (based on a USFDA-version of GMP standards that are different than the WHOs GMP standards). Generic drug producers must also have their product tested for bioequivalence. Successful applicants get two types of approval: product approval (based on data submitted) and market approval (based on patent clearance from the USFDA Orange Book). 75 This process can take several months and cost between $150,000 and $300,000. On average, the USFDA does 350-400 foreign inspections globally per year.76 3. UKMHRA: The UKs Medicines and Healthcare products Regulatory Agency (UKMHRA) has a similar process to the USFDA. They will certify facilities in order to permit access of products to the UK market. As there are agreements within Europe, this certification grants access to all European markets. UKMHRA is also useful in other markets as well as it is an indicator of quality. The UKMHRA charges firms for inspections. 4. TGA: The Therapeutic Goods Administration or TGA is the regulatory body for Australia TGA adopts the European standards unless there is a need for a unique Australian standard. The TGA approval also is useful globally as an indicator of quality. The TGA also charges firms for inspections. Bangladesh pharmaceutical firms require significant investments to meet these international standards. Many estimate that it is easier to build a facility from scratch than attempt to upgrade a facility to meet GMP or other international standards. Some examples of typical work that needs to be done in order to bring an existing Bangladesh pharmaceutical facility to international standards are: HVAC (heating, ventilation and air-conditioning) systems to ensure no cross-contamination. Bangladesh firms mostly use bag-filters (97% efficiency) whereas many international standards require hepa filters (98-99% efficiency). To install these, the facility needs to be shut down for approximately six months.
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Warehouse: International standards dictate that the warehouse must maintain the environmental standards that are stated on the product insert. If the product insert says store at less than 25 degrees Celcius, this must happen in the warehouse too. Bangladesh warehouses are not airconditioned and it can get up to 30 degrees Celcius in May, June, and July. Validation documentation: While the Bangladesh government does not require validation documentation, international certifications demand extensive documentation of procedures. The most important and challenging of these is the cleaning validation which documents all cleaning done when switching drugs on a production line to ensure that there is no cross-contamination.
To build a new facility requires at least $10M, two years and available land. For example, Square Pharmaceuticals spent $50 million on its new plant designed to meet UK Certification, which they should be receiving quite soon.77 Beximco invested $65 million in new plant targeted at passing GMP and US certification. Beximco expects to be tested by the USFDA by the end of 2007.78 8. Increasing Competition to Improve the Industry With an average gross profit margin of 18%,79 the overall industry is thriving in Bangladeshs protected and underegulated market. However, a recent World Bank study found that the Bangladesh pharmaceutical industry inefficiently allocates resources with less productive firms having a higher share of total industry output than expected. The study hypothesized that this inefficiency is due to two factors. This first is related to the lack of competition, especially import competition. As unproductive firms have been shielded from competition in Bangladesh, they remain in business when, for efficiency purposes, the industry would be better off selling those firms assets and reallocating their market share to more productive firms. The second involves Bangladeshs bankruptcy rules and the lack of markets for used capital that prevent the exit of less productive firms.80 Competition is important as it pushes firms to accomplish more and produce better quality drugs at a lower cost. Competition can be increased through opening the Bangladesh domestic market to international competition and/or through exporting more and competing on the global market. Competition in the Domestic Market Historically, competition has been limited in the domestic market. The Drugs Act of 1940 and the Drug Control Ordinance (DCO) of 1982 (updated in 2005), regulate the process of registration, manufacture, distribution, sale, import and export of drugs in Bangladesh. In 1982, the Government of Bangladesh released this radical and far-reaching DCO based on self-reliance. The policy included: 1. Import restrictions: These restrictions meant that local companies increased their share of production from 35% in 1970 to 67% by 1998. The domestic pharmaceutical industry grew at 14% per year from 1981-1986. These economic benefits created an important source of political support for the government. 2. Limited drugs: The policy banned approximately 1700 drugs that were deemed harmful or nonessential. 3. Price controls: These were implemented to stop transfer pricing and resulted in a price drop of up to 40x for some drugs. 81 A study of the Bangladeshs drug laws from 1982 until 1999 by the Harvard School of Public Health concluded that while governments can enact health-related laws which are unfavorable to multinational corporations and receive significant domestic support, if they try to enact health-related laws detrimental
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to powerful domestic interest groups, they will not only have a much more difficult time, but it may even contribute to the governments downfall. In 1990, the government of General HM Ershad announced a new health policy which contained many populist measures that were designed to make the system more effective. Upon its release, the Bangladesh Medical Association (BMA) declared an instantaneous strike as the policy blocked private practice for doctors, a major source of income. Subsequent unrest from both the medical sector over this policy and other sectors dissatisfied with Ershads regime led to its downfall in 1990.82 The new government released circular number 18/93/2364 on March 5, 1994. Item two on this circular states, The drugs and medicines that are locally manufactured in adequate numbers will not be imported. As this Circular is not an ordinance or a law, just an Executive Order of the Ministry of Health, it is unclear what the legal ramifications of this are and if drugs can be imported. It is apparently possible for a firm to import a drug if it receives a NOC (No Objection Certification) from the Ministry of Health.83 Three organizations, UNICEF, ICDDRB, and GSK tried to import drugs and did not succeed as they were told the drugs were already manufactured in the country in sufficient quantity. Other organizations did succeed. For example, MSF, which falls under the NGO Affairs Bureau under the Prime Minister and has an exemption for humanitarian action can import drugs.84 Abott apparantly also imports Klaricid even though Square and Beximco manufacture the same drug.85 On April 18th, 2005, the Government of Bangladesh updated the National Drug Policy (NDP). The new NDP states, Another main objective of the NDP is to ensure self-sufficiency in all types of drugs. Therefore, all necessary measures should be undertaken to ensure that the current trend of increased rate of local production of drugs is sustained and further improved. Although the NDP also states that there will be no discrimination between local companies and multinational companies which have manufacturing plants in Bangladesh,86 due to the small size of the Bangladesh market and the trend towards large centralized manufacturing facilities with excellent logistics, few MNCs want to invest in production in Bangladesh. Thus, the law reinforces and strengthens barriers. The new Caretaker government has two options regarding competition in the domestic market: 1. Maintain the current situation with a highly protected domestic market and focus on increasing competition in the export markets. Most domestic pharmaceutical and health interests would favor this option. 2. Open the market to competition either fully or partially. One potential avenue is to trade access to a certain percentage of the Bangladesh market in return for techology transfers and training assistance. While increased competition domestically would cause difficulties for some Bangladesh pharmaceutical manufacturers, especially those with lower quality / higher price, it could improve the overal cost and quality of drugs available in the domestic market. Competition in the Export Market Another avenue to increase competition is on the international markets. When Bangladesh firms export, they face the full force of competition and must excel based on price and quality. Bangladesh pharmaceutical firms export approximately $27.54M of product to 68 countries.87 (However, approximately $12M of that comes from Novartis/Sandoz). Most exports are to the less-regulated markets such as Bhutan, Pakistan, Sri Lanka, Nepal, Vietnam, and Myanmar.88 Bangladesh firms do not have the accreditation yet to export to the regulated markets, though the industry is trending towards gaining accreditation in these markets. One of the largest local exporting firms in Bangladesh is Beximco, profiled in the box on the next page. 899091
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It is challenging to export a pharmaceutical product. Each country has its own product regulations, registration requirements, language requirements, cultural preferences, localized packaging requirements, and industry protection mechanisms. Furthermore, initiating exports to a country requires a significant investment in money, time and paperwork to register the product. As generic products and branded in less regulated markets, pharmaceutical firms also need to make significant investments in sales and marketing to create demand for sales. All these investments are made with no guarantees of future sales. Most pharmaceutical firms are family owned and while many have the capacity to export, some just do not have the expertise in-house.92 As a result, only approximately sixteen firms export products. There are no majority exporters e.g. companies who sell more than 50% of their output in export markets.93 However, many companies only initiated the process of registering their products in different international markets in the last 2 to 3 years94 so this picture is evolving.
Case Study: Beximco Beximco is one of the largest pharmaceutical exporters in Bangladesh. They started exporting to Russia in 1992. It was quite challenging as there was a significant learning curve on how to register products in foreign markets. But it was worthwhile as they get a 37% higher profit on exported products than domestic products. After learning how to export to Russia, Beximco expanded to other markets. 89 They currently have registered to export to 23 countries: Botswana, Cambodia, Georgia, Ghana, Hong Kong, Kenya, Iran, Malaysia, Mozambique, Myamar, Nepal, Pakistan, The Phillipeans, Russia, Somalia, Singapore, South Korea, Sri Lanka, Taiwan, Ukraine, VietNam, and Yemen.90 In the early 2000s, they started to upgrade their facilities in order to get the certifications to export to more regulated markets. In 2005, Beximco generated $1.3M in export sales or 2.7% of total sales.91
A recent World Bank study showed that firms in Bangladesh which export are 9 to 10% more productive than non-exporting firm. Some potential reasons for this advantage may be: 1. Technological learning from foreign buyers 2. Exporters improving their own technological capabilities in order to exploit profitable opportunities in export markets. For example, exporters need to adopt stringent technical standards to satisfy more sophisticated consumers or are under more pressured to meet orders in a timely fashion and ensure product quality for export markets that are more competitive than the domestic market. 3. Self-selection of better firms entering into export markets rather than the effect of exporting on the firms.95
The pharmaceutical industry has been aggressively investing in infrastructure. An analysis of capital stock growth rates reveal that firms over-invested in the 1990s and so slowed investments from 1999 to 2002. During this time, increased capacity utilization rates imply that firms appeared to be making more intensive use of their existing machines instead of purchasing new machines.96 From 2002 onwards, firms invested approximately $250M, most likely to upgrade facilities so that they could get international certifications required for export. The top ten firms accounted for 70% of the investments.97 This new NDP gives the right to both domestic companies and foreign companies with manufacturing capacity in Bangladesh to contract manufacture with domestic firms. It also gives the right to manufacture drugs for export based on the importing countrys standards and not Bangladeshs standards. Contract manufacturing is not only a good business opportunity, but it can, if done well, enable technology transfers to domestic firms. Worldwide revenues for pharmaceutical industry contract manufacturing and research services totaled $100 billion in 2004 and is predicted to grow at an average annual rate of 10.8% to reach $168 billion by 2009.98 Some firms are taking advantage of this opportunity. For example, Beximco contract manufacturers for GSK.
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9. Conclusions and Next Steps The Bangladesh pharmaceutical industry has the potential to be the next big exporting sector in Bangladesh and to provide high quality drugs at an affordable price domestically. In order to accomplish this, drug quality needs to be improved and firms need to continually strive to improve their price competitiveness. The Government of Bangladesh needs to partner with industry to build a long-term viable industry. While TRIPS offers Bangladesh a short-term window of advantage, long-term international success will be based on price and quality. Traditionally, industries make improvements in price and quality when faced with competition. There are two potential avenues for The Government of Bangladesh to increase competition: opening the domestic market to international competition or increasing Bangladeshs exports on the international market. If the Government of Bangladesh choose to increase competition via the export market, care needs to be taken to ensure that this goal is not accomplished in such a manner whereby a two-tiered manufacturing strategy evolves and high quality drugs are manufactured for export and lower quality drugs are made for domestic consumption. Thus, any support given to the pharmaceutical sector should be contingent on firms making the same drugs from the same production lines available domestically as are for export. The following is a list of several potential next steps. This is a preliminary list which requires more investigation to cost out the interventions, prioritize them, and then fully target the selected interventions. Furthermore, one intervention alone will not solve all challenges. There needs to be a network of components to make a functioning system. One. Government support for pharmaceutical firms that export. The government and industry need to discuss ways to work together to increase exports (including successful registration in foreign markets and subsequent sales) and to create initiatives specifically targeted at the Bangladesh pharmaceutical sector to encourage and reward activities that lead to increased exports. The government can help firms get prepared for inspections, get through the inspection process, and successfully launch exports. The government can also facilitate technology transfers. Furthermore, the government can provide incentives, such as duty-free imports of production technology. One specific area that should be investigated is the foreign currency allowance. To protect Bangladeshs foreign currency accounts, no company is allowed to spend more than $2,500 per month in a foreign country. This excludes registration but includes marketing costs. Firms can also retain 25% of earnings made in a country. The ceiling may be raised to $100,000.99 When a firm markets a drug in a new country, it is quite expensive due to sales and marketing costs to build demand. Another area that should be investigated is support and training for the industry. Mid- and small-level firms need training and assistance on manufacturing, product choice, investment choice, and how to export. Government sector training can be slow and bureaucratic, plus the government often requires training itself. Therefore, possibilities for trainings involving international organizations, exchanges with China and India, and other mechanisms should be investigated. Specific knowledge areas firms identified are: Inspections and GMP certification: Areas such as what is required for the HVAC system, how the process works, and what needs to be done to pass. How to export products: Areas include how to get USFDA, UKMHRA, or TGA approval, the regulation requirements of other countries, and how to manage the process.
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How TRIPS can help them. Assistance in targeting export markets and therapeutic categories. Not all pharmaceutical production is the same. Some therapeutic areas are more niche whereas others depend more heavily on low cost bulk APIs. And not all markets are the same. Markets vary in levels of regulation, level of product sophistication, level of quality of drugs on the market, and size of market potential. Bangladesh pharmaceutical firms need to analyze where they can have the maximum competitive advantage based on their current capabilities and cost structures. Two. Improved Quality Control: As low-quality drugs in the Bangladesh marketplace hurts the health of the people of Bangladesh and the reputation of the pharmaceutical sector globally, the Government of Bangladesh should investigate the financing, structure, and governance of the institutions used to regulate drugs. Financing: The resources for the DDA and the DTL institutions need to be significantly increased so that they are scaled to match the job required of them. Just giving them small incremental increases will not solve the problem as these incremental resources will most likely fall through the cracks. Options for increased resources that should be investigated include: o Increased regular budget: The DDA requested to be upgraded from a Directorate to a Directorate General which would result in corresponding increases in resources. The government is considering this request. o Increased fee revenue: While self-financing of drug regulatory agencies through higher fees used to only exist in industrialized countries such as France, Sweden, the UK, and USA, many countries are now introducing it. For example, Zimbabwes autonomous Drug Control Council (DCC) has now become entirely self-sustaining. The DCC charges $300 for imported drugs and less for a drug either repacked or manufactured in Zimbabwe. As a result, while the Ministry of Health still appoints DCC staff, the DCC acts as an independent agency.100 o Donations: Donations from international organizations, international financing institutions, or bilaterals could fill the gap. For example, the WHO has given support and training to the regulatory institutions. o Collaboration with the pharmaceutical industry: The pharmaceutical industry, having a vested interest in better quality drugs, is very proactive, active, and willing to pay for improvements. However, the pharmaceutical industry is also reputed to have significant influence over the DDA. The government has been hesitant to give industry more control as the government would like to maintain control over the regulatory function. Structure: The current system is not delivering adequate services even for the amount of resources these institutions have. Staff morale, accountability, transparency, and quality of service delivered are all low. Corruption is rampant. Further investigation needs to be done into the regulatory processes and agencies to determine how to improve them. Some areas to consider are as follows: o Reviewing regulatory procedures and incentives. Institutional measures to increase transparency and provide incentives for inspectors to find, report, and fine low quality manufacturers should be investigated. For example, there are currently 235 registered pharmaceutical firms but only approximately 85 are active. Criteria for receving a license and monitoring for continuation of the license should be investigated. o Cracking down on corruption: The current Caretaker government is targeting corruption and drug safety is an issue that should not be ignored. Cleaning up the drug inspection process is a good project for the Caretaker government to take on. Until corruption can be reduced in
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these agencies, perhaps international inspectors could be brought in for a limited time period to both train staff and complete inspections. o Making strategic personnel choices: The Director of the DDA post ends this year. The current director is also under investigation for corruption and missappropriation of Taka.101 A search should be undertaken to ensure that a driven Case Study: Nigeria and knowledgeable leader replaces him as leadership Professor Akunyili became the director of for these crucial institutions is so important. For Nigeria's food and drugs administration example, Dr. Dora Akunyili in Nigeria (Nafdac) in 2001. At this time, it was 102 singlehandedly drove immense change (see box). estimated that up to 80% of drugs in the Increasing pharmaceutical sector involvement: country's hospitals and pharmacies were fake. She clamped down on corruption, conducted The pharmaceutical sector has a vested interest in nearly 800 raids on drug-distribution outlets, improving quality. They should be given a larger and conducted public awareness campaigns voice in the process. For example, BAPI could with impressive results: an 80% drop in the organize peer reviews to expose bad quality levels of fake drugs in Nigeria. It was not producers. However, if the private sector feeds drug without cost as her one-woman war to to rid Nigeria of fake drugs created enemies. quality information to the government, the However, she is now a hero both in her government needs to take action and e.g. raid a country and internationally for her work102 factory, close down a pharmacy, or give exemplary punishment to offenders. Increasing public involvement: In many countries, public awareness campaigns have been very successful in improving drug quality. Bangladesh could investigate the possibility of a campaign combined with a toll-free number for consumers to report bad drugs. If such an initiative were enacted in Bangladesh, the government would have to be committed to responding and taking action as well. Increasing drug information for the public: Knowledge is power and if consumers knew which drugs were better, they would migrate to quality. The Central Laboratory could sample, for example, all the producers of one drug each month and then release the results to the pubic. The 2005 Drug Law already sets up a provision for such a measure by stating, any information on substandard, spurious, and counterfeit drugs should be made freely available to all concerns by wide publicity in both print and electronic media.103 Governance: The current DDA and DTL are fully in the government domain. As a police function this needs to remain a government function. However, ways should be investigated to see how the governance of parts of these institutions could be improved through involving more parties who have a stake in the outcome of their work. For example, an independent private testing laboratory, approved by the Government of Bangladesh, could provide drug monitoring and quality services. The Board of this institution could include BAPI, international organizations, academics, NGOs, and the government. Initial investment could come from a donation but operation expenses could be covered through a charge per product. Three. Further investigation into API production: API costs are a large portion of the drugs that Bangladesh produces and their costs will only rise as patent protection phases in. Further analysis needs to be completed to determine which APIs Bangladesh could target for successfully producing on a scale relevant to the Bangladesh environment and still be price competitive. As API production is scale dependent, if Bangladesh can succeed in API production, it is likely that just a couple of companies will be able to reach such a scale. However, if Bangladesh does not succeed, the entire generic drug industry in Bangladesh will be at risk as companies will have to pay increasingly more for imported APIs. If Bangladesh does decide to pursue API production, the following areas should be fully supported.
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The API Park: This park has been promised for many years with little action. Every day that it does not happen, its value declines as 2016 comes that much closer. Prioritizing the API Park and starting construction is vital. API skills: Skills in reverse engineering and chemical synthesis should start to be locally developed via collaboration with local universities and other programs to encourage technology transfer. Backward integration: In order to develop the entire supply chain for pharmaceuticals, this area should be considered.
Four. Investigation into the feasibility of a bioequivalency laboratory: Currently, there are no bioequivalency laboratories in Bangladesh. Further analysis of laboratory construction and operational costs needs to be done before it can be determined if a domestic laboratory could offer financially comparable services. Furthermore, if the purpose of this laboratory is for international approval and recognition, analysis needs to be done as to whether or not the international community would accept results from a bioequivalence laboratory located in Bangladesh, a country that is tied for the third worst situation for corruption in the world.104 Five. Update the patent law: The current patent law was written in 1911 and needs to be updated to reflect flexibilities afforded Bangladesh under TRIPS. Changes need to be made regarding product and patent law legislation, parallel importation, and Bolar exceptions. Furthermore, the current compulsory license legislation is extremely cumbersome e.g. you need to get a verdict from the appellate court which is challenging. The 2001 Human Development Report recommends a streamlined and procedural approach to compulsory licenses. The government should immediately pass legislation in this area. There is also not enough institutional capacity to handle patent issues. The Patent Office needs capacity building and training. Six: Investigation into contract or toll manufacturing. As production of both patented and nonpatented drugs move to low cost manufacturing areas, Bangladesh should investigate possibilities for working with foreign firms to contract manufacture for them. The latest NDP does provide for this, yet very few firms have taken up the challenge on this. Why this is the case and what can be done to remedy this should be further investigated.
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APPENDIX ONE
TERMS OF REFERENCE BACKGROUND Bangladesh has a vibrant pharmaceutical sector. In 2004, the total size of the pharma market of Bangladesh was estimated to be about $450M with an annual growth rate of about 10%. The pharmaceutical industry in Bangladesh is paying the second largest revenue to the Governments exchequer (after the garment industry). The Bangladesh Association of Pharmaceutical Industries (BAPI) established in 1972 and member of International Federation of Pharmaceutical Manufacturers Association (IFPMA), Geneva, has 149 pharmaceutical companies (out of about 200) as its members. Local market. The finished formulation-manufacturing base of Bangladesh is very strong as most of the pharmaceutical companies have their own manufacturing facilities. Around 95 percent of the total demand of Bangladesh is being met by local manufacturing. The industry lacks the capacity only for some specialized pharmaceuticals, such as vaccines, drugs using recombinant DNA, anti-cancer drugs and anti-retro virals. Overseas Market. Since the late 80s, Bangladesh started exporting finished formulations to some of the neighboring less-regulated overseas markets like Myanmar, Sri Lanka and Nepal. In the early 90s few major companies took initiative to explore some of the more-regulated markets like Russia, Ukraine, Georgia and Singapore. Success in registering and marketing these products in these countries was a major breakthrough for Bangladesh pharmaceutical industries. Today, Bangladesh pharmaceutical industry has successfully started exporting its quality products to about 52 countries across four continents. The impact of Trade Related Intellectual Property Rights (TRIPS). TRIPS provides Bangladesh with great opportunities for increasing its pharmaceutical exports. As a signatory of WTO /TRIPS, countries like China and India have already had to implement Patent Laws in their countries and hence, these countries are no longer allowed to export generic versions of patented drugs. For Bangladesh, the situation is very different. As a LDC, Bangladesh has received exemption from abiding by the patent laws until Jan. 1, 2016. Although, all the 49 LDCs have got this exemption, Bangladesh is the only country that would really be able to capitalize on this opportunity by exporting pharmaceuticals to other LDCs. Bangladesh pharmaceutical industry could tap into a huge export market by value addition of raw materials. This is facilitated by marked difference in the cost of production in the local market and the export prices) Other opportunities for Bangladesh include toll manufacturing under which other countries could get their products manufactured in Bangladesh. A number of companies have already constructed facilities as per USFDA and UKMHRA standard and are going for certification in the regulated markets. Joint ventures also may offer opportunities, e.g. India and China have very good expertise in producing active pharmaceutical ingredients (API) and formulation research and development (R&D) and may like to manufacture generic API outside their countries as they cannot manufacture any patented APIs in their countries after 2004. Bangladesh also has enormous opportunities to go for joint ventures with these large global companies for manufacturing pharmaceutical finished products. The Directorate of Drug Administration has a limited capacity to check the quality standards of drugs manufactured in the country. It was established as a Drug Regulatory Authority under the Ministry of
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Health and Family Welfare, in 1976. There are two Drug Testing Laboratories (DTL) in Bangladesh, one in Dhaka and the other in Chittagong. These two DTLs are always engaged in testing numerous drugs being introduced by about 200 pharmaceutical companies operating in the domestic sector. The DTLs are not modern and sophisticated enough to carry out different types of tests as required for export which are becoming more stringent by day. The Bangladesh standard for good manufacturing practices (GMP) doesnt stand up to the WHO level of GMP inspection. As a result, only 30 companies have thus far received a GMP license which allows them to export drugs to other countries. PROBLEM STATEMENT Bangladesh does not have a modern and sophisticated DTL with the facility of Bio-equivalency testing available necessary for the manufacturing and export of pharmaceuticals responding to high international standards. At the same time the present DTL capacity is insufficient to fulfill all duties on the local drug market as well. The locally available drugs have often been labeled as being of dubious quality and therefore having serious health implications. However, in contradiction, there is a fledgling private pharmaceutical that is exporting quality drugs. The TRIPS agreement could have potential benefits for the country in terms of quality of drugs and revenue thus fuelling growth. OBJECTIVE The objective of the study is to review options to assist the pharmaceutical sector in Bangladesh in improving its competitiveness in the global market, while at the same time making high quality drugs at a reasonable price available to the population of Bangladesh, which is part of the Health, Nutrition and Population Sector Program objectives. It will also outline potential support from the World Bank for private sector support to the pharmaceutical industry. EXPECTED OUTPUTS The expected outcome of this AAA is a Policy Note which will provide "just-in-time" advice to a Government and the pharmaceutical sector on key issues pertaining to TRIPS and qualitry of drugs on the lovcal market in Bangladesh. The study would address the following areas: 1. Overview of the pharmaceutical sector in Bangladesh Types and capacity of pharmaceutical industries Quality of industrys standards Quality of drugs on the market 2. Public policies and regulation for the pharmaceutical sector Legislation Drug registration, Drug Regulatory Authority Drug retail laws and practice Inspection capacity
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Quality control Prescribing practices Drug pricing in private and public sector Drug patents, generic drugs Orphan drugs
3. The Pharmaceutical Sector and global trade relations Position of Bangladesh manufacturing industries versus Big Pharma Present import-export balance The impact of TRIPS on the sector Regional cooperation 4. Conclusions and Recommendations The study will not address the following areas: procurement and distribution of drugs in the public sector, access to drugs in public health facilities, essential drugs policies, and prescription behavior by health workers. The study will not address these not because there wouldnt be any problems in these areas; in fact the opposite is true. This study would try to address issues close to the manufacturing process and look at what impacts the production and availability of high quality and affordable drugs in Bangladesh, while simultaneously advising on the enhancement of growth prospects for the pharmaceutical industry in the global economy. The outcome of the Note is expected to guide PSD in the Pharmaceutical sector in Bangladesh, while the Note will provide guidance to the Health sector about alternative ways of making high quality drugs more accessible to the population. The study results will be disseminated amongst Health Policy Makers, Executives and Managers in the Pharmaceutical Industry (through BAPI), and Development Partners in the Sector.
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APPENDIX TWO: List of Interviewees

Pharmaceutical Industry o BAPI Hudson: SM Shaiuzzaman, Managing Director Acme: Mizanur Rahman Sinha, Managing Director Incepta: Abdul Muktadir, Managing Director General: Dr. Momenul Haq, Managing Director Professor Abu Nasser Muhammad Abduz Zaher o Square Pharmaceuticals: Samson Chowdhurry, Chairman Parvez Hashim, Executive Director A.B. Imtiaz Ahmed Khilji, Assistant General Manager, Quality Operations o Beximco: Nazmul Hassan, General Secretary o Roche: Md. Asser Shahrear Zahedee, Advisor o Glaxo Smith Kline: M Azizul Huq, Managing Director o Watson Pharmaceuticals (USA): Patty Eisenhaur, Director, Investor Relations Drug purchasing organizations o ICDDR'B Dr. Charles Larson, Director, Health Systems and Infectious Diseases Division Mr. Michael T. Behan, General Counsel o UNICEF: Mr. Mariye Tafari, Chief Supply & Procurement Section Mr. Peter Svarrer Jakobsen, Quality Assurance Officer (Denmark) Government of Bangladesh o Drug Directorate Administration: Dr. Md. Habibur Rahman, Director Kazi Alimuzzaman, Deputy Director o Drug testing Laboratory o Ministry of Commerce, WTO Cell: Sharifa Khan, Deputy Director o Ministry of Industry: Ms. Rukhsana Nasreen o Ministry of Heath and Family Welfare: Dr. Shamim o Tarriff Commission: Mr. Mostafa Abid, Deputy Chief Government of the United States of America o USFDA: Dr. Khadar Academia / Think Tanks o University of Dhaka: Professor Selim Reza, Department of Pharmaceuticals o Independent University: M Omar Rahman, Pro-Vice Chancellor o Center for Policy Dialogue: Professor Mustafizue Rahman International Organizations o World Bank Mrs. Yolanda Tayler, Lead Procurement Specialist Mr. Andreas Seiter, Pharmaceutical Specialist Mr. Jeff Gilbert, Global Pharmaceutical Industry Fellow Mr. Zaidi Sattar, Economist. o IFC: Mr. Per Kjellerhaug Mr. Syed Akhtar Mahmood Mrs. Monique Mrazek, Investment Officer, IFC Mr. Sarvesh Suri, Investment Officer, IFC o ADB: Mr. Farook Chowdhurry o Embassy of the Netherlands: Annemieke DelosSantos, Economic Affairs o WHO: Dr. Khaled Hassan, Medical Officer o UNIDO: Mr. KM Mostafa, National Project Coordinator of BQSP
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NGO o o
MSF: Frido Herinckx, Head of Mission Gonoshasthaya Kendra: Dr. Zafrullah Chowdhury
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APPENDIX THREE
China and India China China has a substantial pharmaceutical industry. In 2004, chemical drug manufacturing sales were $24.27 billion in 2004 and profits were $1.9 billion.105 China entered the pharmaceutical market with excipient manufacturing and then moved into API formulations 5-7 years ago. By 2003, they were the second largest producer of APIs after the United States with an output of 800,000 tons, half of which was for export.106 Today they have moved upstream and are doing final formulations, APIs, and innovative research. Chinas pharmaceutical industry is still considerably fragmented, but consolidating. In 1996, there were 5,396 Chinese pharmaceutical firms. In 2002, after the government initiated several efforts to increase the industry concentration, there were approximately 3,681 firms. This is still considered fragmented. Chinas top ten firms generated 15.48% of the industrys revenue in 2003. As a comparison, the top ten Japanese firms generated approximately 45% of the industry revenue in 2006, the top ten UK firms generated approximately 53%, and the top ten German firms generated approximately 60%.107 China founded its patent office in 1980 and passed its first patent law in March 1984. This 1984 patent law did not cover pharmaceuticals, causing international criticism. In 1992 China revised its patent law to cover new pharmaceutical compounds, new uses for pharmaceutical compounds, and pharmaceutical compositions. In 2000 the patent law was further amended to meet TRIPs requirements. Currently, most of Chinas industry is focused on bulk production of me-too pharmaceuticals but China is adapting rapidly to the new patent situation by moving upstream into innovative research. Chinese pharmaceutical firms spend only between 0.5% and 3% of revenue on R&D, a number far less than the average level of the MNCs in developing countries. However, the government is supporting the industry to develop its innovative capacity. There is a strong public research and innovation system financed by the government. The partnerships between public research institutions and pharmaceutical companies is emerging with results:108 patent applications have been increasing in China. In 1998, Chinese firms were awarded 224 patents. In 2002, the number more than doubled to 484. Patent applications increased even more rapidly. In 1998, 275 were filed. In 2002, 999 were filed.109 Local Chinese companies now account for seven out of ten patent applications in China, including gene therapy, antibodies, and peptides. There are other ties between government and the pharmaceutical industry. For example, some plants are government-owned or subsidized, allowing final product costs to be extraordinarily cheap. As TRIPS mandates no subsidies, this practice may have to alter in the future. Many firms are now GMP certified in China. China had a slow start in the 1990s with GMP as many firms resisted certification due to the costs it would incur. As of July 1, 2004, the Chinese government required all firms to use GMP standards to manufacture pharmaceuticals. The Chinese were very serious about enforcement and would stop production or even close down non-compliant facilities. The Chinese drug regulatory industry set up a weekly monitoring system for those firms compulsorily shut down. This policy and its rigorous enforcement sped up GMP adoption. In 1998, there were only 70 GMP approved firms. By June 30, 2004, there were 3200. By the end of 2003, 52 pharmaceutical ingredients firms from China passed FDA authentication whilst the number of Indian firms is 60.110
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India India is another of the worlds main supplier of generic drugs. It has a robust pharmaceutical industry that covers both end product formulations and APIs. In 2003, Indian pharmaceutical annual sales were approximately RS 300 billion ($6.9 billion) with RS 141 billion ($3.2 billion) of exports to over 90 countries. The overall capital investment is estimated at RS 45 billion ($1 billion).111 250 of the largest companies control 70% of the Indian market. In terms of the global market, India currently holds a modest 1-2% share, but it has been growing at approximately 10% per year. 112 India has low development costs, complex synthesis capabilities, growing experience with GMP compliance, and a large local market in which to gain experience. Indias pharmaceutical industry does not, however, have strong linkages to research institutions and universities.113 India is also known for having a large number of strong chemists, many with PhDs from the US and Europe, providing rapid, and creative, process development.114 India gained its foothold on the global scene with its innovatively-engineered generic drugs and API, and it is now seeking to become a major player in outsourced clinical research as well as contract manufacturing and research. In 1999, 70% of the APIs and 80% of the formulations in India were domestically produced. And India supplies a big portion of the worlds appetite for generic drugs. MSF estimates that approximately 70% of all patients in MSF HIV/AIDS projects currently take generic ARV medicines made in India. Worldwide, an estimated 350,000 people on ARV treatment depend on Indian generic production thats half of all those on ARVs in developing countries.115 Indian companies also produce 50% of the essential drugs UNICEF provides to children worldwide The Indian government viewed pharmaceutical policy as industrial policy, not health policy. While there is considerable variation in access to medicine along with the quality and pricing of drugs throughout India, the Indian government used industrial policy to jumpstart the industry in the 1970s.116 It established an incentive scheme for domestic producers (price controls, local content laws, limitations on the importation of APIs), promoted research and development, and legislated an enabling patent protection regime that only included process patents for a short period of time. Foreign firms were also required to make minimum capital investments in R&D facilities in India, and to reinvest part of their turnover in local R&D facilities.117 In the mid-eighties, the Indian government started encouraging exports through incentives such as upgrading exporters facilities and undertaking R&D.118 Thanks to the 1970 Patent Act, multinationals represent only 35% of the market, down from 70% thirty years ago.119 In 1999 and in 2002, the Government of India amended the Patent Act of 1970 in order to fulfill the TRIPS obligations, including the establishment of the mailbox facility. India started to assess mailbox applications in 2005. Although no official figures are available, MSF estimates that there were over 9,000 mailbox applications in India.120 India so far has granted only one patent, to Hoffman La Roche for its hepatitis C therapy, peginterferon alfa-2A. If an application meets the TRIPS Agreement standards of patentability, as interpreted and implemented under the national law, a patent will be granted for the remainder of the patent term, calculated from the application filing date in India.121 Just as US Constitutional law is interpreted and given meaning through case law, the new Indian patent law will gain meaning through case trials as well. For example Indian patent law defines a pharmaceutical substance that is patentable as one that means any new entity involving one or more inventive steps. (Section 2h of the Patents Amendment Act 2005 inserting a new clause Section 2(ta) in
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the Patents Act 1970). What exactly does new mean in this? And what does an inventive step mean? Critics wanted more definition so the Minister of Commerce and Industry established a Technical Expert Group, led by Dr. RA Mashelkar, to consider whether it is TRIPS-compatible to limit the grant of patents for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps. 122 The Committee report to the Ministry of Commerce and Industry, delivered in February 2007, added fuel to the fire in the current patent argument raging in India when it was discovered that some of the report was plagiarized from a report made by an industry-backed NGO. Novartis was referencing the Masheklar report in its current patent trial case. In 2005, the Indian Patent Office rejected Novartis's application for a patent for the cancer drug Gleevec. The Patent Office said that Novartis had not demonstrated that the drug provides higher efficacy than a different form of the drug that was already on the market in India. This is a requirement in India's patent law. Instead of appealing the rejection however, Novartis is challenging the law itself. Many activists argue that if Novartis is successful, they would not also impact generic production across India but set a global precedent.123 The Patent Act does provide protection for existing generic manufacturers in the form of automatic compulsory licenses or prior use rights. Generic versions of now-patented medicine could continue, provided that: 1). the generic manufacturer had been producing and marketing the product prior to January 1, 2005, 2). the generic manufacturer has made significant investment for such production and marketing and 3). that a reasonable royalty has been paid. This provision will, in theory, ensure the continued production of currently available generic medicines. However, a number of issues will still require clarification, including the definitions of significant investment and reasonable royalty.124 Many Indian companies who used to manufacture patented drugs off-patent are now being stopped. For example, Eli Lilly challenged four Indian companies who used to manufacture generic version of Cialis in India and won the case. Any Indian company that now wants to manufacture Cialis must now do so under a licensing agreement with Eli Lilly and pay a royalty. A number of other patent suits are already under way in India.125 This change in the patent law is driving an intense consolidation of the Indian pharmaceutical industry. Of the existing 24,000 players, it is expected that only 200 to 300 players will survive.126 As of 2004, the top ten control 37% of the market.127 Large Indian pharmaceutical firms such as Ranbaxy Laboratories and Dr. Reddys Laboratories are expanding their exports and increasing their R&D spending.128 There are 74 U.S. FDA-approved manufacturing facilities in India, more than in any other country outside the U.S, and in 2005, almost 20% of all Abbreviated New Drug Applications (ANDA) to the FDA are expected to be filed by Indian companies.129
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ENDNOTES
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1 2
Pharmaceutical industry overview. http://web.csustan.edu/manage/harris/industry1.html. Accessed on March 22, 2007 IMS Data. 2006. 3 Guidelines for the examination of Pharmaceutical Patents: Developing a Public Health Perspective. Carlos Correa, University of Buenos Aires. WHO-ICTSD-UNCTAD Working Paper. January 2007. 4 Health and Intellectual Property Rights: Thoughts on Ensuring Access to Medicines in 2005 and Beyond. Karin Timmermans. World Health Organization. 5 Interview with Mr. Jeff Gilbert, Global Pharmaceutical Industry Fellow at the World Bank. March 2007. 6 Contract Pharma. API Manufacturing: How will changes in India and China affect the outsourcing of APIs? George Karris. September 2002. 7 The World Medicines Situation. World Health Organization. 2004. 8 Interview with Patty Eisenheur, Watson Pharmaceuticals, Director, Inverstor Relations. March 2007. 9 Interview with Patty Eisenheur, Watson Pharmaceuticals, Director, Inverstor Relations. March 2007. 10 As Drug Patents End, Costs for Generics Surge. Milt Freudenheim. New York Times. December 22, 2002. 11 Contract Pharma. API Manufacturing: How will changes in India and China affect the outsourcing of APIs? George Karris. September 2002. 12 In India a Little Lab Work and Lots of Lawyers. Business Week Online. July 14, 2003. http://www.businessweek.com/magazine/content/03_28/b3841144_mz033.htm Accessed in March 2007. 13 A Strategy For Establishing the API Park. Farook Chowdhury. June 2006. 14 Contract Pharma. API Manufacturing: How will changes in India and China affect the outsourcing of APIs? George Karris. September 2002. 15 Interview with Nazmul Hassan, Beximco Pharmaceuticals CEO. February 2007. 16 Interview with Nazmul Hassan, Beximco Pharmaceuticals CEO. February 2007. 17 Interview with Mr. Jeff Gilbert, Global Pharmaceutical Industry Fellow at the World Bank. March 2007. 18 Data given to the writers of the Strategy For Establishing the API Park report. The figures were given by the industry and the authors note that it is difficult to obtain latest industry and firm information. They made their estimates based on statements from the industry and data from a survey of 54 firms for 1999-2003. 19 A Strategy For Establishing the API Park. Farook Chowdhury. June 2006. 20 Interview with Farook Chowdhury, author of A Strategy For Establishing the API Park. February 2007. 21 Bangladesh Export Statistics, EPB. 22 Bangladesh Association of Pharmaceutical Industries quoted in Study on the Pharmaceuticals Sector of Bangladesh. Jetro. 2005. 23 Interview with Square Pharmaceuticals. February 2007. 24 Interview with Nazmul Hassan, Beximco Pharmaceuticals CEO. February 2007. 25 Interview with Nazmul Hassan, Beximco Pharmaceuticals CEO. February 2007. 26 Interview with Bangladesh Pharmaceutical Society. Feburary 2007. 27 Bangaldesh Pharmaceutical Policy and Politics. Health Policy and Planning. Michael R. Reich. Harvard School of Public Health. 1994. 28 Local Production: Industrial Policy and Access to Medicines: An Overview of Key Concepts, Issues and Opportunities for Future Research. Warren A Kaplan. Richard Laing. Health, Nutrition and Population Discussion Paper. The World Bank. June 2003. 29 Local Production: Industrial Policy and Access to Medicines: An Overview of Key Concepts, Issues and Opportunities for Future Research. Warren A Kaplan. Richard Laing. Health, Nutrition and Population Discussion Paper. The World Bank. June 2003. 30 CIA Factbook, https://www.cia.gov/cia/publications/factbook/geos/bg.html. Accessed on March 22, 2007 31 Local Production: Industrial Policy and Access to Medicines: An Overview of Key Concepts, Issues and Opportunities for Future Research. Warren A Kaplan. Richard Laing. Health, Nutrition and Population Discussion Paper. The World Bank. June 2003. 32 CIA Factbook, https://www.cia.gov/cia/publications/factbook/geos/bg.html. Accessed on March 22, 2007. 33 World Bank Group EdStats, 2004. Bangladesh numbers are from the nearest available year to 2004, within 2 years. 34 Industrial Development Report 2002/2003: Competiting Through Innovation and Learning. UNIDO. 2002. 35 Local Production: Industrial Policy and Access to Medicines: An Overview of Key Concepts, Issues and Opportunities for Future Research. Warren A Kaplan. Richard Laing. Health, Nutrition and Population Discussion Paper. The World Bank. June 2003. 36 The $189M number was calculated off of Square Pharmaceuticals import numbers. According to Squares annual report, they import $28.44M of APIs. As Square generates 15% of total Bangladesh pharmaceutical sales, it can be assumed that the industry imported at least $189M of APIs. This number may be low as Square is one of the few companies that can manufacture its own APIs so their numbers may be on the low side of an average Bangladesh pharmaceutical firm.
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The Use of Flexibilities in TRIPS By Developing Countries: Can They Promote Access To Medicines? Sisule Musungu, South Center. Cecilia Oh, World Health Organization. August 2005. 38 Implementing the Doha Mandate on TRIPS and Public Health. Carsten Fink. Trade Note. The World Bank. May 29, 2003. 39 WTO Agreements and Public Health: A joint study by the WHO and the WTO Secretariat. 2002. 40 Multi-stakeholder Dialogue on Trade, Intellectual Property and Biological Resources in Asia. International Centre For Trade and Sustainable Development and Centre for Policy Dialogue. Dr. K. Balasubramaniam. April 2002. 41 Utilizing TRIPS Flexibilities For Public Health Protection Through South-South Regional Frameworks. Sisule Musungu, Susan Villanueva, and Roxana Blasetti. South Centre. April 2004 42 Implementing the Doha Mandate on TRIPS and Public Health. Carsten Fink. Trade Note. The World Bank. May 29, 2003. 43 The Use of Flexibilities in TRIPS By Developing Countries: Can They Promote Access To Medicines? Sisule Musungu, South Center. Cecilia Oh, World Health Organization. August 2005. 44 Compulsory Licensing of Pharmaceuticals and TRIPS. World Trade Organization. October 2005. 45 The TRIPS Agreement and Pharmaceuticals. Report of an ASEAN Workshop on the TRIPS Agreement and its Impact on Pharmaceuticals. World Health Organization. Jakarta, 2-4 May 2000. 46 Interview: Thailand Fed Up With High Drug Prices. The Star Online. Darren Schuettler. Feb 19 2007. Accessed via cpTech website: http://www.cptech.org/ip/health/ 47 Multinationals Patenting Drugs Despite WTO Waiver (quoting a BAPI source). Jasim Uddin Khan. The Daily Star. February 10, 2006. 48 The Bolar Provision allows organizations to use patented medicines for experimental purposes before the patent expiration. This is crucial for reverse engineering of a drug. 49 Parallel importation is when an organization imports a drug from another country. The importer does not have to pay a royalty as the exporter has already paid this royalty. Article 6 of the TRIPS Agreement allows this. 50 TRIPS and the Pharmaceutical Industry in Bangladesh: Towards a National Strategy. Tony VanDuzer. Centre for Policy Dialogue. April 2003. 51 Interview with UNICEF Supply & Procurement Section. February 2007. 52 Square Pharmaceuticals. Annual Report 2005-2006. 53 Interview with Nazmul Hassan, Beximco Pharmaceuticals CEO. February 2007. 54 Interview with Bangladesh Association of Pharmaceutical Industries. February 2007. 55 Square Pharmaceuticals. Annual Report 2005-2006. 56 The Boston Consulting Group. 57 Interview with Square Pharmaceuticals. February 2007. 58 Square Pharmaceuticals. Annual Report 2005-2006. 59 Trade Barriers and Prices of Essential Health-Sector Inputs. David Woodward. World Health Organization. Commission on Macroeconomics and Health. June 2001. 60 Developing Innovative Capacity in India to meet Health Needs. Dr. HR Bhojwani. April 2005. Paper prepared for the WHOs Commission on Intellectual Property Rights, Innovation, and Public Health. For all non-Bangladesh country data, original data was in India Rupees. 61 This was converted at a rate of Indian Ruppee to Taka 1.1766, which is an average of several currency price points during 2002. Dollar to Taka data converted at 0.01443 62 Data from IFC 2004. Currencies were converted at a rate of $1 USD for 58 Taka and 47 Rupees. 63 Interview with UNICEF Supply & Procurement Section. February 2007. 64 Ratanawijitrasin & Wondemagegnehu. Effective Drug Regulation: A Multi-country Study. World Health Organziation 2002. referenced in Drug Regulation and Incentives of Innovation: The Case of ASEAN. Sauwakon Ratanawijitrasin. 65 Interview with DDA. February 2007. 66 Interview with DDA. February 2007. 67 Multi-tier Approach to Quality Assurance. Thomas Layloff. Management Sciences for Health. 68 Interview with Square Pharmaceuticals. February 2007. 69 Interview with Drug Testing Laboratory. February 2007. 70 Per a laboratory circular posted on the wall of the laboratory 71 Interview with the DDA. February 2007. 72 Interview with UNICEF GMP inspector. February 2007. 73 Interview with DDA. Feburary 2007. 74 Interview with UNICEF Drug Procurement Team. February 2007. 75 Paper by Bill Haddad, Chairman and CEO of Biogenerics. wbln0018.worldbank.org/.../ 2adc484a5d57888f85256d350054080f/$FILE/Paper%20Bill%20Haddad.doc. Accessed on March 27th 2007. 76 Interview with Dr. Khadar. USFDA. March 2007.
77 78
Interview with Square Pharmaceuticals. February 2007 Interview with Nazmul Hassan, Beximco Pharmaceuticals CEO. February 2007. 79 A Strategy For Establishing the API Park. Farook Chowdhury. June 2006. 80 Firm Productivity in Bangladesh Manufacturing Industries. Ana M. Fernandes. The World Bank. August 2006. 81 Bangaldesh Pharmaceutical Policy and Politics. Health Policy and Planning. Michael R. Reich. 1994. 82 Bangaldesh Pharmaceutical Policy and Politics. Health Policy and Planning. Michael R. Reich. 1994. 83 Interview with UNICEF Supply & Procurement Section. February 2007. 84 Interview with MSF Coutnry Director. February 2007. 85 Interview with Nazmul Hassan, Beximco Pharmaceuticals CEO. February 2007. 86 National Drug Policy 2005. Ministry of Health & Family Welfare. Government of the Peoples Republic of Bangladesh. 87 Interview with BAPI. February 2007. 88 A Strategy For Establishing the API Park. Farook Chowdhury. June 2006. 89 Interview with Nazmul Hassan, Beximco Pharmaceuticals CEO. February 2007. 90 Bangladeshs Beximco Pharma Begins Exporting to Botswana. Asia Pulse. March 2007. 91 Beximco Annual Report. 2005. Conversion of Taka to Dollars at 1 BDT = 0.0144509 USD 92 Interview with Farook Chowdhury, author of A Strategy For Establishing the API Park. February 2007. 93 Firm Productivity in Bangladesh Manufacturing Industries. Ana M. Fernandes. The World Bank. August 2006. 94 A Strategy For Establishing the API Park. Farook Chowdhury. June 2006. 95 Firm Productivity in Bangladesh Manufacturing Industries. Ana M. Fernandes. The World Bank. August 2006. 96 Firm Productivity in Bangladesh Manufacturing Industries. Ana M. Fernandes. The World Bank. August 2006. 97 A Strategy For Establishing the API Park. Farook Chowdhury. June 2006. 98 The Indian Pharmaceutical Industry: Collaboration for Growth. KPMG. 2006. 99 Interview with BAPI. February 2007. 100 Public-Private Roles in the Pharmaceutical Sector: Implications for equitable access and rational drug use. Sara Bennett, Jonathan Quick, and German Velasquez. World Health Organization. 1997. 101 Limitless corruption in drug administration and crores of takas looted. The intelligence agency is investigating allegation against the Director. WB-DRUG (April 12, 2007). Jugantor, March 13, 2007 102 The Independent. Dr Dora, the scourge of Nigeria's drug fakers, is honored. December 2005. http://news.independent.co.uk/world/africa/article331948.ece. Accessed on March 27. 2007. 103 National Drug Policy 2005. Ministry of Health & Family Welfare. Government of the Peoples Republic of Bangladesh. 104 Transparency International Corruption Perceptions Index 2006. Transparency International. 105 Review of Chinas Biopharmaceutical Industries in Recent Years. Asiabiotech. Vol 10, Number 16. 2006. 106 Developing Innovative Capacity in China to Meet Health Needs. Zezhong Li. 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April 2005. Paper prepared for the WHOs Commission on Intellectual Property Rights, Innovation, and Public Health. 112 Wikipedia. Pharmaceuticals in India. http://en.wikipedia.org/wiki/Pharmaceuticals_in_India. Accesed March 2007. 113 Economic Aspects of Access to Medicines After 2005: Product Patent Protection and Emerging Firm Strategies in the Indian Phamraceutical Firm. Padmashree Gehl Sampath. United Nations University Institute For New Technologies. 114 Local Production: Industrial Policy and Access to Medicines: An Overview of Key Concepts, Issues and Opportunities for Future Research. Warren A Kaplan. Richard Laing. Health, Nutrition and Population Discussion Paper. The World Bank. June 2003. 115 Prognosis: Short Term Relief, Long Term Pain. The Future of Generic Medicines Made In India. Medecins Sans Frontieres Campaign for Access to Essential Medicines. Briefing Note. 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Developing Innovative Capacity In China to Meet Health Needs. Zezhong Li. April 2005. MIHR (Center for the Management of Intellectual Property in Health Research and Development) paper prepared for the WHOs Commission on Intellectual Property Rights, Innovation, and Public Health. 119 Wikipedia. Pharmaceuticals in India. http://en.wikipedia.org/wiki/Pharmaceuticals_in_India. Accesed March 2007. 120 Will the lifeline of affordable medicines for poor countries be cut? Consequences of Medicines Patenting in India. Medecins Sans Frontieres. February 2005. 121 Taking TRIPS to India Novartis, Patent Law, and Access to Medicines. The New England Journal of Medicine. Janice Mueller. February 8, 2007. 122 The Use of Flexibilities in TRIPS By Developing Countries: Can They Promote Access To Medicines? Sisule Musungu, South Center. Cecilia Oh, World Health Organization. August 2005. 123 Letter from US Representative Henry Waxman to Novartis. February 13, 2007. Accessed via cpTech website: http://www.cptech.org/ip/health/ 124 The Use of Flexibilities in TRIPS By Developing Countries: Can They Promote Access To Medicines? Sisule Musungu, South Center. Cecilia Oh, World Health Organization. August 2005. 125 Interview with Nazmul Hassan, Beximco Pharmaceuticals CEO. February 2007. 126 Pharmaceutical Industrial Partnering Trends in India. Dr. Harvinder Popli, Ranbaxy Labs. Asia Biotech. Volume 10, Number 16. 2006. 127 Developing Innovative Capacity in India to meet Health Needs. Dr. HR Bhojwani. April 2005. Paper prepared for the WHOs Commission on Intellectual Property Rights, Innovation, and Public Health. 128 Local Production: Industrial Policy and Access to Medicines: An Overview of Key Concepts, Issues and Opportunities for Future Research. Warren A Kaplan. Richard Laing. Health, Nutrition and Population Discussion Paper. The World Bank. June 2003. 129 Wikipedia. Pharmaceuticals in India. http://en.wikipedia.org/wiki/Pharmaceuticals_in_India. Accesed March 2007

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POLICY NOTE IMPROVING THE COMPETITIVENESS OF THE PHARMACEUTICAL SECTOR IN BANGLADESH DRAFT

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Table Two Recent Export of Some Bangladesh Pharmaceutical Firms22

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Table Six Price comparison of twenty drugs from Square Pharmaceuticals62

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

APPENDIX TWO: List of Interviewees

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

Improving the Competitiveness of the Pharmaceutical Sector in Bangladesh

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