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Intellectual Property and Public Health in the Developing World

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Monirul Azam

2. Case Study on Bangladesh’s Pharmaceutical Industry, Legislative and Institutional Framework and Pricing of Pharmaceuticals

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2.1 Introduction

  • 1 See generally, Vandana Shiva, Protect or Plunder (Zed Books, 2001) and Edwin Mansfield, ‘Patents an (...)

1This chapter discusses the legislative framework for patents and the pharmaceutical sector, including the role of regulatory bodies, and the nature and strength of the pharmaceutical industry in Bangladesh. Developing countries and LDCs are apprehensive1 about strong patent protection, considering that patent protection may be harmful to the nascent stage of their pharmaceutical industries and may have negative implications for access to medicines by their populations. However, Bangladesh and other LDCs could continue production of the generic versions of patented medicines until 1 January 2033. Based on the data gathered by way of case study, this chapter explores the situation in Bangladesh along with the challenges and opportunities for the pharmaceutical industry during the waiver period. This chapter suggests that in the case of Bangladesh, the main health bottleneck is neither patents nor drugs, but rather the lack of proper health care services, health infrastructure and efficient health care personnel. Again, most of the necessary drugs for the local market are off-patent, but patented drugs and the related issues of price, availability and affordability could become a concern for Bangladesh in situations of multi‑drug resistance and in relation to diseases like HIV-AIDS, cancer and cardio-vascular problems. This is why it is vital that Bangladesh should adopt intellectual property policies for pharmaceuticals that not only meet societal goals for accessibility and affordability, but also promote innovation and the capability of local industries.

2.2 Legislative Framework: Pharmaceutical Patents and Pharmaceutical Regulation

2Considering that Bangladesh may need to devise a proper plan of action during the transition period to initiate proper institutional and infrastructural capacity building, it is important to understand existing legal and institutional mechanisms for dealing with pharmaceutical patents, and to identify their limitations and weaknesses.

2.2.1 Patent Regime: Patent Law and the Patent Office

  • 2 Patent law in the Indian subcontinent, including Bangladesh, has its origin in the 19th century, wh (...)
  • 3 Mohammad Monirul Azam, ‘Journey Towards WTO Legal System and the Experience of Bangladesh: The Cont (...)
  • 4 This list identifies countries that deny what the US Trade Representatives consider adequate and ef (...)

3Bangladesh inherited its patent law from the British Government during its rule in India, which was subsequently divided into the three countries of India, Pakistan and Bangladesh.2 Bangladesh essentially retains the colonial law; only a few minor amendments have been made since the enactment of the legislation. Although Bangladesh’s IP laws are often considered outdated and their enforcement is viewed as weak,3 Bangladesh has never been on the US Trade Representatives’ Special 301 watch list. Either it is not considered a feasible threat for economic loss or there is an understanding with the trade bodies in Bangladesh for future compliance with the TRIPS Agreement.4

  • 5 See ‘Innovation and Competitive Capacity’.
  • 6 Ibid.; Sampath pointed out that current patent law in Bangladesh is similar to Indian patent law po (...)

4The present legislative regime relating to patents and the pharmaceutical industry comprises the Drugs Act, 1940, the Patent and Designs Act, 1911 (PDA) and the Patent and Design Rules, 1933. In 2003, amendments were made to the PDA to establish the Department of Patents, Designs and Trademarks (DPDT). The DPDT is controlled by the Ministry of Industries and has the jurisdiction to issue patents and designs.5 The current patent law in Bangladesh is largely the same as it was in India, prior to changes in 1970.6

  • 7 WTO, Intellectual Property and Bangladesh, p. 270.
  • 8 PDA (Bangladesh), section 15A.
  • 9 PDA (Bangladesh), section 14.

5In common with other countries, Bangladesh follows a process for granting patents and has certain criteria for “something” to be patented: novelty, an inventive step and industrial application.7 When an application is made by the first and true inventor or an assignee/ legal representative, an examination of the specification commences. An examination of the specification can trigger one of three outcomes: (i) the specification is correct and the invention is patent-worthy, (ii) the specification does not reflect any new invention and is therefore rejected, or (iii) the specification is accepted subject to modification or amendment. There are provisions for appeal to the registrar and further to the High Court Division of the Supreme Court. Any amendments or modifications may be made to the original patent under an application for patents of addition.8 If such an application is successful without objection, or if an objection is found to be unjustified, the DPDT will issue a certificate of patent registration. Once granted, a patent is valid for 16 years from the date of application.9

  • 10 Section 2(10) of the PDA provides that the term “manufacture” includes any art, process or manner o (...)
  • 11 Ulrike Pokorski da Cunha, Study on the Viability of High Quality Drugs Manufacturing in Bangladesh (...)
  • 12 Murshed (2006).
  • 13 Jashim Uddin Khan, ‘New Patent Rights of Drug Suspended’, The Daily Star (Dhaka), 14 March 2008, ht (...)

6There have been disputes among scholars in Bangladesh about the patentability of pharmaceutical products under the PDA.10 Some consider that the patenting of pharmaceutical processes, but not of pharmaceutical products, should be adopted in Bangladesh.11 Other scholars argue that in the absence of a clear legislative provision or any court ruling on the distinction between processes and products, both pharmaceutical products and processes are patentable under the PDA.12 To some extent this is a purely academic debate, as in 2008 the DPDT suspended the patenting of pharmaceuticals in Bangladesh until 1 January 2016 or until the end of the TRIPS waiver periods in accordance with the Doha Declaration.13 The DPDT’s notification stipulates that applications relating to patents for medicines and agricultural chemicals will be preserved in a “mailbox” to be considered after the expiration of the waiver periods for the pharmaceutical patent.

  • 14 Nazmul Hasan, ‘General Secretary, Bangladesh Association of Pharmaceuticals Industries General Secr (...)
  • 15 Ibid.
  • 16 Md Farhad Hossain Khan and Yoshitoshi Tanaka, ‘IP Administration and Enforcement System Towards Mod (...)
  • 17 See ‘New Patent Rights of Drug Suspended’; Mohammad Monirul Azam and Yacouba Sabere Mounkoro, ‘Inte (...)

7Prior to the suspension, the available information indicates that from 1998 to 2007, patent applications and patents granted in Bangladesh increased two times more than in previous periods and that 90% of those patents were owned by MNCs.14 In 2007, the DPDT registered 269 foreign patent applications, of which 50% related to multinational pharmaceutical formulas.15 Table 2.1 shows the numbers and types of patents granted in Bangladesh from 1995 to 2012, highlighting that patent applications in Bangladesh increased significantly from 1998. This trend continued until the 2008 suspension in granting pharmaceutical patents. Most of the applications filed belong to foreigners and multinational corporations (MNCs)16 It is suggested that nearly 50% of the patents during this period (until 2007) refer to pharmaceutical patents.17

  • 18 Interview with an official of the Department of Patents, Designs and Trademarks (DPDT), Dhaka, Bang (...)

8The number of granted patents decreased after 2007 because of the suspension of pharmaceutical and agrochemical patents by the DPDT, but overall patent applications increased between 2007 and 2012. It was confirmed by one official at the DPDT that most applications still relate to pharmaceutical and agrochemical products.18 Although the DPDT formally suspended pharmaceutical and agrochemical patents from 2008, available records at the DPDT show that since 2006, DPDT has transferred a good number of pharmaceutical and agrochemical products to the mailbox due to the lack of clear legal provisions for pharmaceutical products in Bangladesh. Table 2.2 includes a number of mailbox applications for pharmaceutical and agrochemical products between 2006 and June 2013.

Table 2.1: Patent applications and granted patents in Bangladesh (1995–2012)

Patent applied for

Patent granted

Year

Local

Foreign

Total

Local

Foreign

Total

1995

70

156

226

6

74

80

1996

22

131

153

18

52

70

1997

46

119

165

15

61

76

1998

32

184

216

14

126

140

1999

49

200

249

26

122

148

2000

70

248

318

4

138

142

2001

59

236

295

21

185

206

2002

43

246

289

24

233

257

2003

58

260

318

14

208

222

2004

48

268

316

28

202

230

2005

50

294

344

21

161

185

2006

22

288

310

16

146

162

2007

29

270

299

27

269

296

2008

60

278

338

01

36

37

2009

55

275

330

28

103

131

2010

55

287

342

20

71

91

2011

32

274

306

06

79

85

2012

65

289

354

14

139

153

Source: Department of Patents, Designs and Trademarks, Dhaka, Bangladesh, 2013.

  • 19 Email interview with a deputy registrar of the DPDT, Dhaka, Bangladesh, 19 July 2013.

9Of the mailbox applications (see Table 2.2), more than 90% related to pharmaceuticals. The great majority of applications were submitted by MNPCs.19

Table 2.2: Mailbox applications (pharmaceutical and agrochemical products)

Year

Number of applications

2006

111

2007

221

2008

183

2009

143

2010

123

2011

118

2012

94

2013 (June)

26

Source: Department of Patents, Designs and Trademarks, Dhaka, Bangladesh, 2013.

  • 20 Mohammad Monirul Azam and Kristy Richardson, ‘Pharmaceutical Patent Protection and TRIPS Challenges (...)
  • 21 Mohammad Monirul Azam, Status of Intellectual Property Teaching in Bangladesh (report submitted to (...)

10The reason for the smaller number of patent applications from local (i.e. Bangladeshi) researchers and research institutions is directly related to the low level of research conducted in Bangladesh; the lack of technical and financial resources to do innovative research; the low priority given to research and patenting by both research institutions and the government; and a low level of awareness about the benefits of patents among researchers, research institutions and industry.20 In terms of capacity to effect any change, the DPDT cannot yet accept online applications (relying on paper copies and the manual processing of applications), and its (single) office is located in the capital city of Bangladesh—Dhaka. Consequently, researchers or research institutions working outside of Dhaka have limited or no access to the DPDT.21 In addition to the role of the Patent Office and the PDA, the legislative and institutional framework with respect to pharmaceuticals also requires consideration.

2.2.2 Pharmaceutical Regulations: Relevant Laws and the Regulatory Body

11In Bangladesh, key legislation relating to pharmaceuticals includes (1) the Drugs Act, 1940 and its amendments (the Drug Rules, 1945 and the Drug Rules, 1946); and (2) the Drugs (Control) Ordinance, 1982 (DCO 1982) and its amendments [Drug (Control) (Amendment) Ordinance, 1984 and Drugs (Control) (Amendment) Act, 2006].

  • 22 See for details, Jude Nwokike and H.L. Choi, Assessment of the Regulatory Systems and Capacity of t (...)
  • 23 Although the Directorate of Drug Administration (DDA) was upgraded to the Directorate General of Dr (...)

12The DDA, the national regulatory authority (NRA) in Bangladesh, was established in 1976 under the Ministry of Health and Family Welfare. The DDA was empowered to regulate Bangladesh’s 838 manufacturers of allopathic, Unani, Ayurvedic, herbal and homeopathic, and biochemical products.22 It was upgraded in January 2010 and became the Directorate General of Drug Administration (DGDA).2323 The DGDA is responsible for dealing with the production, quality, registration, safety, efficacy, import, export and distribution of pharmaceuticals based on the power delegated to it by the different pharmaceutical regulations. Figure 2.1 lists the milestones that marked the gradual development of the pharmaceutical regulatory framework in Bangladesh.

13The Drugs Act, 1940 regulates the import, export, manufacture, distribution and sale of pharmaceuticals in Bangladesh. The Act was originally enacted by the Government of India in 1940, was adopted by the Government of Pakistan in 1957 and then subsequently adopted in Bangladesh in 1974.

Figure 2.1: Milestones in the gradual development of pharmaceutical regulation in Bangladesh

1940

Drugs Act (XXIII of 1940)

1945

Drug Rules, 1945 (under the Drugs Act, 1940)

1946

Bengal Drugs Rules, 1946

1966

Gazette of Pakistan: Office of the Chief Controller of Imports and Exports. Public Notice, 1966

1970

Dacca Gazette, Part I: Government of East Pakistan, Health Department Notification, 1970

1976

Directorate of Drug Administration (DDA), the national regulatory authority for drugs, is created

1982

Drugs (Control) Ordinance, 1982, Drugs (Control) (Amendment) Ordinance, 1982, and National Drug Policy, 1982

1984

Drugs (Control) (Amendment) Ordinance, 1984

1992

Institute of Public Health produces tetanus vaccines First edition of the National Formulary published

2001

WHO approves oral cholera vaccine tested at the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR-B)

2002

ICDDR-B studies establish that zinc treatment of diarrhoea reduces under-5 mortality by 50%

2003

Second edition of the National Formulary published

2005

National Drug Policy, 2005

2006

Drug (Control) Ordinance Amendment Act, 2006 Third edition of the National Formulary published

2009

South-East Asia Regional Office/Department of Family and Community Health/Immunization and Vaccine Development mission to discuss institutional development plan to build DDA capacity

2010

DDA upgraded to the Directorate General of Drug Administration (DGDA) WHO mission to assess pharmaceuticals in healthcare delivery in Bangladesh

2012

Revised New Drug Policy, 2012 drafted and submitted for approval

2016

DGDA has sent their recommendations for the proposed Drug Act 2016 and Drug Policy, 2016 to the Ministry of Health and Family Welfare.

Source: Nwokike and Choi, p. 21 (2012).

  • 24 Drugs Act, 1940 (Bangladesh), Chapter III.
  • 25 Section 8(1) of the Drugs Act, 1940 provides that the expression “standard quality”, when applied t (...)
  • 26 Drugs Act, 1940 (Bangladesh), Chapter IV.
  • 27 Drugs Act, 1940 (Bangladesh), §§ 21–22.
  • 28 Section 35 of the Drugs Act, 1940 provides that “no patent or proprietary medicine or pharmaceutica (...)

14The Drugs Act, 1940 permits the import of certain classes of pharmaceuticals only under licenses or permits issued by the relevant authority appointed by government.24 All classes of pharmaceuticals imported into the country are required to comply with the prescribed standards and must be labelled and packed in the prescribed manner.25 Similarly, licenses are required for the manufacture, sale or distribution of pharmaceuticals.26 Further control over manufacturing and sales is exercised by periodic inspection of licensed premises.27 Surveillance of the standard of pharmaceuticals is maintained by taking samples from pharmaceuticals that are manufactured or offered for sale, for testing in the Central Drugs Laboratory.28 The Act also establishes a Drugs Technical Advisory Board and a Drugs Consultative Committee. The Drugs Technical Advisory Board advises the government on technical matters arising from the enforcement and administration of the Act, whereas the Drugs Consultative Committee was established to advise the government and the board to ensure the proper application and functioning of the Act throughout the country. Both the Drug Technical Advisory Board and Drug Consultative Committee work as complements to the DGDA, which is the only responsible regulatory body in Bangladesh for licensing the production of medicines, controlling ongoing production and, if necessary, withdrawing licenses. As the DGDA is responsible for the registration of pharmaceuticals, it needs to conduct inspections of pharmaceutical plants to ensure quality and efficacy of medicines licensed for distribution in the local market and also for exporting overseas. It also issues licenses for the import of raw materials for different pharmaceuticals and packed pharmaceuticals. The DGDA monitors quality control parameters of marketed pharmaceuticals through the Drug Testing Laboratory, which is located within the Institute of Public Health at Mohakhali, Dhaka, and is equipped with standard testing facilities.

15There are 33 district (regional) offices of the DGDA situated in different district headquarters (regions) in Bangladesh. All officers of the DGDA function as “drug inspectors” pursuant to drug legislation, and they assist the licensing authority in properly discharging their responsibilities.29 In addition, “a number of committees, such as the Drug Control Committee (DCC), a standing committee for procurement and import of raw materials and finished drugs, a pricing committee and a number of other relevant expert committees are there to advise the licensing authority and to advise on matters related to pharmaceuticals”.30

  • 31 Bangladesh Pharmaceutical Market, Q 2, 2010 (Espicom Business Intelligence, 2010).

16However, the DGDA needs qualified technical staff to monitor quality, safety and efficacy of pharmaceuticals produced by pharmaceutical companies in Bangladesh, as well as pharmaceuticals imported, registered and sold in pharmacies across Bangladesh. The DGDA itself has acknowledged that it does not have sufficient staff to monitor all domestic manufacturers.31 During the surveys for this study, most of the local pharmaceutical companies either strongly agree (50%) or agree (27%) that the DGDA maintains the quality of medicines produced in Bangladesh. However, one large and another medium- sized local pharmaceutical company and also three large multinational pharmaceutical company operating in Bangladesh disagree about the role of the DGDA in maintaining the quality of medicines. Table 2.3 reflects the position of different sized pharmaceutical companies regarding the role of the DGDA.

Table 2.3: Survey results relating to whether the DGDA adequately controls the quality of medicines produced in Bangladesh

Scale

Pharmaceutical industry (large, medium and small local industry) or multinational (n)

Total

%

Large

Medium

Small

Multinational

Strongly
agree

3

3

5

0

11

50

Agree

1

5

0

0

6

27

Unsure

0

0

0

0

0

0

Disagree

1

1

0

3

5

23

Strongly
disagree

0

0

0

0

0

0

  • 32 Interview with the Chief Executive Officer (CEO) of a leading pharmaceutical industry in Bangladesh
  • 33 Ibid.

17Although survey data indicate that the majority of participants agreed regarding the role of the DGDA for maintaining the quality of medicines in Bangladesh, the actual situation of quality control by the DGDA is not satisfactory. One top executive of a leading pharmaceutical company in Bangladesh said that most of the leading pharmaceutical companies and the Bangladesh Association of Pharmaceutical Industries (BAPI) rarely raise the issue of inadequacy of the quality control by the DGDA as there is an apprehension that this claim could have a negative effect on their pharmaceutical exports.32 However, he further added that most of the export-intensive pharmaceutical companies in Bangladesh maintain strict internal quality control with respect to the guidelines of the WHO and of the importing countries.33 The overall situation of the DGDA with respect to quality control is well reflected by the following remarks of an expert in another study:

  • 34 Quoted in Mohammad Monirul Azam, ‘The Impact of TRIPS on the Pharmaceutical Regulation and Pricing (...)

if we say that DDA is not maintaining and monitoring quality of medicine in Bangladesh that will have negative impact on our exports whereas if we say it is working properly that is also not the reflection of true scenario as they don’t have sufficient institutional and technical facilities to monitor huge number of pharmaceutical companies operating in Bangladesh therefore most of consumers in the local market rely on the reputation of the company to determine good quality or less quality of a particular medicine.34

  • 35 Interview with a staff member of the DDA, Dhaka, Bangladesh, 23 December 2009.
  • 36 Zafarullah Chowdhury, The Politics of Essential Drugs: The Makings of a Successful Health Strategy: (...)

18In 2009, the Government of Bangladesh reorganised the DGDA to provide it with more financial and technical resources and more administrative power so that it could work more efficiently. To some, these promised developments have yet to materialise.35 Apart from the weak role played by the DGDA, the Drugs Act, 1940 has been criticised as grossly inadequate for the control of prices of pharmaceutical raw materials and processed pharmaceuticals. It also largely failed to prevent the appearance of substandard and spurious pharmaceuticals on the market, unethical promotion, and the proliferation of harmful and useless pharmaceuticals.36 To address these weaknesses, the Government of Bangladesh introduced amendments to the Drugs Act, 1940 and the Drug Rules of 1945 and 1946 to provide further regulation relating to labelling and packing, biologicals, and other special products. Also in 1982, Bangladesh formulated its first National Drug Policy, 1982 (NDP 1982) and enacted the Drug Control Ordinance (DCO 1982), which broadened the power of the DDA beyond the operation of the Drugs Act, 1940.

  • 37 Ibid., p. 59.
  • 38 Ibid.

19The prime objective of the NDP 1982 was to ensure that procurement, local production, quality control, distribution and utilisation of all drugs came under unified legislative and administrative control.37 The NDP was intended to be the uniform policy for both the private and public sector, and for both the traditional and modern medical systems.38 It was framed to work as an integral part of national health policy to promote access to affordable medicine and healthcare for all. The major recommendations of the NDP 1982 were as follows:

  • There should be a basic list of 150 essential drugs and a supplementary list of 100 specialised drugs to be prescribed by specialists and consultants.

  • The 45 most essential drugs among the list of 150 drugs that are used by government healthcare centres at the rural level were to be manufactured and/or sold under their generic names only.

    • 39 Ibid., pp. 117–19.

    A National Formulary incorporating all formulations of essential and supplementary drugs was to be prepared and published not later than 1983. This was one of the most important initiatives to promote the use of generic drugs, because at that time most physicians relied on the drug promotion literature supplied by pharmaceutical companies to prescribe medicines; most of the time patients were prescribed costly branded medicines despite the availability of cheaper generic versions on the local market.39

  • Product patents in respect to pharmaceutical substances should not be allowed. Process patents could be allowed for a limited period, if only the basic substance was manufactured within the country. However, this was not formally adopted in national patent law in Bangladesh until 2008. In 2008, due to pressure from local pharmaceutical companies and public health non-governmental organisations (NGOs), a notification in the Official Gazette of the DPDT prohibited pharmaceutical patents until 1 January 2016, utilising the Doha waiver for pharmaceutical patents for LDCs.

  • To ensure good manufacturing practice (GMP), each manufacturing company should employ qualified pharmacists. No manufacturer should be allowed to produce drugs without adequate quality control practice. However, small national drug manufacturers might be allowed to do this on a collective basis.

  • A properly staffed and equipped National Drug Control Laboratory with proper facilities was to be set up as early as possible as and no later than 1985.

  • The government was to control the prices of finished drugs as well as raw materials, packaging materials and intermediates. The maximum retail price (MRP) of finished drugs was to be determined on the basis of cost of production and reasonable profit. The DDA was to be responsible for the control of pricing and its enforcement.

  • Multinational companies would not be allowed to manufacture simple products such as common analgesics, vitamins, antacids, etc. These were to be manufactured exclusively by local pharmaceutical firms.

  • The Drugs Act, 1940 was to be revised and replaced by new drug legislation with provision for a system of drug registration and control: control over prices of finished products and raw materials, and over the manufacture and sale of drugs.

  • 40 Interview with a policy analyst from a leading public health NGO, in Dhaka, Bangladesh, 12 February (...)
  • 41 DCO 1982 (Bangladesh), § 23.

20The DCO 1982 was enacted to meet the objectives of the NDP 1982. The DCO 1982 regulates the manufacture, import, distribution and sale of pharmaceuticals in Bangladesh; promotes the local pharmaceutical industry; and discourages imports of medicines.40 According to the DCO 1982, (i) no medicine of any kind can be manufactured for sale or be imported, distributed or sold unless it is registered with the licensing authority; (ii) no drug or pharmaceutical raw material can be imported into the country except with the prior approval of the licensing authority; (iii) the licensing authority cannot register a medicine unless such registration is recommended by the DCC; (iv) the licensing authority may cancel the registration of any medicine if such cancellation is recommended by the DCC on finding that such a medicine is not safe, efficacious or useful; (v) the licensing authority is also empowered to temporarily suspend the registration of any medicine if it is satisfied that such a medicine is substandard; (vi) the government may, by notification in the Official Gazette, fix the maximum price at which any medicine may be sold and at which any pharmaceutical raw material may be imported or sold; (vii) no person is allowed to manufacture any pharmaceuticals except under the personal supervision of a pharmacist listed in Register “A” of the Pharmacy Council of Bangladesh; (viii) no person, being a retailer, is allowed to sell any pharmaceutical without the personal supervision of a pharmacist listed in any register of the Pharmacy Council of Bangladesh; and (ix) the government may, by notification in the Official Gazette, establish drug courts as and when it considers necessary.41

21Further, the DCO 1982 introduced a rigorous enforcement framework for manufacturing, importing, distributing and selling unregistered products or counterfeit medicines, with penalties of imprisonment for up to 10 years and fines. It specifically introduced the following issues:

  • Dealing in substandard medicines is punished with imprisonment for up to five years and fines.

  • Importing raw materials without prior approval is punished with imprisonment for up to three years and fines.

  • Selling or importing medicines at prices higher than the maximum price fixed by the government is punished with imprisonment for up to two years with fines.

  • Illegal advertisement and claims are punished with fines.

  • Drug courts and related procedures were established for enforcing penalties.

22The Drug (Control) (Amendment) Ordinance, 1984 defines the process to appeal against an order or decision made by the regulatory authority.

  • 42 See for details, The Politics of Essential Drugs; and The World Bank, ‘Public and Private Sector Ap (...)
  • 43 Assessment of the Regulatory Systems, p. 11.
  • 44 The Politics of Essential Drugs, p. 50.

23The NDP 1982 and DCO 1982 resulted in substantial benefits for Bangladesh: in particular, they facilitated the increase in local production of essential drugs from 30% to 90%; furthermore, they helped local companies to gain a substantial market share of 97% of local needs, and as a result reduced the prices of medicines substantially in the local market.42 They also reduced the dependence on imports and, through prioritisation of useful products, helped Bangladesh to save approximately US$ 600 million.43 The DCO 1982 has also contributed markedly to the improvement in quality of medicines and resulted in the reduction of substandard drugs from 36% to 9%.44

  • 45 Ibid, p. 51.
  • 46 Ibid.
  • 47 The first four of these drugs are manufactured from locally produced raw materials. Local pharmaceu (...)

24In a 1992 study by the DDA, based on the nominal retail prices of 30 important drugs in Bangladesh, 10 years after the introduction of the NDP and DCO in 1982, it was revealed that the retail prices of most drugs produced locally showed a downward trend from 1982 to 1992, or at worst were static.45 During that time, the minimum price decrease was 23.1% and the maximum decrease was 96.8%.46 However, among the 30 most important drugs reviewed in the DDA study, the prices of a small number of drugs including aspirin, paracetamol, ampicillin, amoxicillin, cloxacillin, antacids and chloroquine increased.47 Therefore, the NDP and DCO of 1982 were successful in partially meeting the objectives of reducing prices of medicines and promoting the local production of essential medicines and the local pharmaceutical industry.

  • 48 Quoted in Oxfam, Make Vital Medicine Available for People—Bangladesh (25 July 2010), http://policy- (...)

25While evaluating the role of the NDP and DCO of 1982, a foreign health expert who advised on Bangladeshi policy remarked that “it was pro-people and anti-poverty, an attempt to give people access to essential drugs. The policy had flaws but it was strong and it was enforced and mobilised throughout the country. The government took on the big drug companies and won”.48 It is also worth noting that the Association of Pharmaceutical Industries in Bangladesh initially opposed the adoption of the NDP and related ordinance in 1982, but later appreciated the policy, which is rightly reflected by Zafarullah Chowdhury, the prime mover and shaker behind the NDP in 1982:

  • 49 The Politics of Essential Drugs, pp. 18589.

the pharmaceutical association of Bangladesh which had fought tooth and nail against the NDP since 1982 suddenly printed a full page newspaper advertisement in several dailies declaring that ‘… the ordinance [the DCO 1982] represents a philosophy whose scope extends beyond the need of today into the realms of the future … it has been applied, tested and has to its credit today many examples of beneficial aspects’ … in the advertisement association showed by means of graphs the substantial drop in imports but dramatic growth in local production.49

  • 50 Ibid.
  • 51 Ibid.

26However, since the introduction of pharmaceutical patents under the TRIPS Agreement, and due to substantial progress in pharmaceutical production in the meantime, the NDP and DCO need to be updated to mediate between the country’s obligation to become TRIPS compliant and the local need to preserve the pharmaceutical industry and public health goals. Notably, combination pharmaceuticals are not considered therapeutically useful and are therefore not allowed in Bangladesh.50 This was a useful simplification when the DCO was drafted; however, nowadays it is obsolete and hampers the manufacturing of useful (often patented) combination therapies.51

27The Government of Bangladesh formulated the NDP 2005 to wipe out the limitations of the earlier regulations. The NDP 2005 was formulated to take advantage of the opportunities available to Bangladesh during the transition period leading to the implementation of TRIPS. The NDP was again revised and reformulated in 2012. In particular, and relevantly, the policy was formulated with the following objectives:

  1. to guide the drug sector of the country to perform better in the competitive world market;

  2. to make it more applicable, effective and adaptive to the remarkable technological advancements that have been made in the medicine world;

  3. to ensure that the common people have easy access to useful, effective, safe and good-quality essential and other drugs at affordable prices;

  4. to make the country a producer and exporter of good-quality drugs in the world;

  5. to strengthen the DGDA with more efficient manpower and infrastructure facilities, making it more effective as a drug regulatory authority (DRA);

  6. to provide, on a priority basis, required services and facilities to local drug manufacturing industries of all the recognised systems of drugs so that self-sufficiency is attained in the manufacture of both drugs and pharmaceutical raw materials;

  7. to update, from time to time, the criteria for registration of import of all systems of medicines in line with the quality guidelines followed in developed countries to ensure the safety, efficacy and usefulness of such medicines;

  8. to encourage all local and foreign companies to manufacture good- quality essential drugs in adequate quantities in the country;

  9. to continue the current system of controlling prices of the commonly used essential drugs as listed and updated from time to time by the government;

  10. to encourage foreign companies to invest, manufacture and sell drugs in Bangladesh with the corresponding assurance of the transfer of new technology and technical knowledge to the country;

  11. to ensure that no discrimination occurs between local and multinational companies with manufacturing plants in Bangladesh, while applying the principles of this policy;

  12. to encourage both local and multinational manufacturers to establish full-fledged R&D facilities in the country.52

28The implementation of the above policy measures in anticipation of future TRIPS-compliant patent law is crucial for Bangladesh, considering the present situation and future challenges for its pharmaceutical industry. Unfortunately, apart from policy revision, there is little policy action on the part of the government to encourage investment, public-private partnership, joint research, institutional support and modernisation in the pharmaceutical sector. These are very important components to ensure that the interests of Bangladesh’s pharmaceutical producers and investors are balanced, and that there is progression of local innovation against the need to ensure access to pharmaceuticals for the local population in a post-TRIPS-compliant regulatory environment.

2.2.3 Changes Required in Patent Law and Pharmaceutical Regulation in Bangladesh

29Existing patent law and pharmaceutical regulation in Bangladesh does not utilise exceptions and limitations available under the TRIPS Agreement to protect public health. Therefore, the laws need to be revised to ensure the right balance between pharmaceutical innovation and access to medicines after the introduction of pharmaceutical patents. In addition, some existing limitations need to be removed from domestic patent law and pharmaceutical regulations to maintain the principle of non-discrimination and compliance with the TRIPS Agreement.

  • 53 During interviews, officials at the DPDT and DGDA confirmed the prohibition of pharmaceutical paten (...)
  • 54 Section 8 of the DCO 1982 (Bangladesh) prohibits the manufacture, import, distribution and sale of (...)
  • 55 55 Import restrictions are laid down in section 8 for certain pharmaceuticals, mostly those manufac (...)
  • 56 Section 10 of the DCO 1982 (Bangladesh) stated that with the approval of the licensing authority (D (...)
  • 57 See sections 8, 9 and 10 of the DCO 1982 (Bangladesh).
  • 58 Only single ingredient products are allowed for production and distribution in Bangladesh.
  • 59 Without the prior approval of the DDA, it is not possible to publish any advertisements relating to (...)
  • 60 There is no test data protection in Bangladesh.

30In Bangladesh, existing pharmaceutical regulations and patent law impose certain limitations on pharmaceuticals. For instance, pharmaceutical patents (both product and process) are prohibited in Bangladesh until expiration of the pharmaceutical patent waivers under the TRIPS Agreement.53 There are also other limitations, such as restrictions on the manufacture of certain medicines;54 import of certain drugs manufactured in Bangladesh and of pharmaceutical raw materials;55 marketing approval and licensing;56 local production facilities;57 ingredients;58 advertising;59 and test data.60 These limitations either need to be removed or revised to meet the requirements of the TRIPS Agreement. Table 2.4 demonstrates that a number of changes need to be in place as part of moves towards TRIPS compliancy.

  • 61 Interview with an expert from an international public health NGO, Dhaka, Bangladesh, 15 January 201 (...)

31Bangladesh has made substantial progress in promoting local production of essential drugs by way of prohibiting pharmaceutical patents and putting restrictions on the import and production of drugs by MNCs that are produced locally. One participant who was interviewed appreciated the positive effects of these restrictions: “during (the) 1980s, 80% of local pharmaceutical market was controlled by MNCs, but now more than 80% of local market is controlled by the local generic producers”.61

  • 62 Interview with a deputy registrar from the DPDT, Dhaka, Bangladesh, 16 January 2012.

32Therefore, there is serious apprehension that Bangladesh’s withdrawal of these restrictions may have negative effects on the local market. One participant during an interview mentioned that “in principle if there is any patent on a particular product, it cannot be produced by the local generic producer without permission from the patent holder and without paying royalties, which will increase the price of pharmaceuticals”.62

33However, the “National Formulary”, which contains brief descriptions of all the pharmaceutical products produced in Bangladesh, shows that almost 90% of the pharmaceuticals produced in Bangladesh are off- patent; therefore, introduction of pharmaceutical patents may not create any problems for the generic production of these pharmaceuticals.

Table 2.4: Changes required for TRIPS-compliant pharmaceutical regulation in Bangladesh

Issues

Existing pharmaceutical
regulation in Bangladesh

Changes needed for TRIPS compliance

Product patent for pharmaceuticals

Currently, pharmaceutical patents are prohibited

Both process and product patents for pharmaceuticals need to be introduced

Duration of patent protection

Currently, patent law provides protection for only 16 years

Protection should be extended to 20 years

Local production facilities and local working

Certain pharmaceutical products are excluded from licensing unless made in local production facilities by MNCs

It is not mandatory to have a local production facility but there is debate regarding local working provisions as a grounds for issuing compulsory licenses

Import restrictions

Import restrictions on pharmaceuticals and pharmaceutical raw materials that are locally produced: if an item is not on the DDA’s essential drug list but is produced by at least three local companies, it may not be imported

No import restrictions whether locally produced or not as this would be discriminatory and hence a violation of WTO and TRIPS principles

Marketing approval restrictions

Marketing approval is not granted to MNCs if a particular pharmaceutical product is locally produced

No restrictions on the marketing based on products made locally or imported

Production restrictions

NCs are not allowed to produce some drugs, such as vitamins and antacids

M There must not be any restriction as this would be discriminatory

Single ingredient

Only single-ingredient products are allowed for production and distribution in the local market

Combination drugs need to be allowed

Advertising restrictions

No advertising is allowed on pharmaceutical products

Although unethical advertising may be restricted, advertising must be allowed

Test data protection

There is no test data protection for pharmaceuticals

There may be pressure from the MNCs and developed countries like the US and the EU for the introduction of test data protection

  • 63 Interview with the CEO of a medium-size local pharmaceutical company, in Dhaka, Bangladesh, 17 Janu (...)
  • 64 Ibid.

34Another participant mentioned that Bangladesh has tried to promote local pharmaceutical production by imposing restrictions under the pharmaceutical regulations rather than by prohibiting pharmaceutical patents expressly under the national patent law; therefore, the removal of these restrictions will have a severe effect on the pharmaceutical business in Bangladesh.63 He provided the example that in the absence of import restrictions, “if any importer can offer lower price for any particular product then the local producer will be under pressure to reduce price; otherwise they will have to lose the market, as being a low income country, price is the most important factor to choose a particular product”.64

  • 65 Interview with a marketing manager from a multinational pharmaceutical company (MNPC) operating in (...)

35From the perspective of consumers, the removal of restrictions may increase competition in the market and may even reduce the price of some pharmaceutical products. One participant during an interview also mentioned that a “TRIPS-compliant regime will lead to an increase in the flow of technology transfer and FDI [foreign direct investment] in Bangladesh and will result in the development of new drugs more suited to the needs of Bangladesh. It will also help Bangladesh to transform from ‘copycats’ to innovative companies”.65

  • 66 Interview with a policy analyst from a leading public health NGO in Bangladesh, 24 January 2012.

36However, one participant argued that “in Bangladesh people have distrust regarding MNCs as they charged very high prices for medicines prior to 1982 (before the introduction of DCO 1982), taking advantage of low-level technological and manufacturing capacities of local pharmaceutical companies”.66

37As Bangladesh needs to introduce pharmaceutical patents and the above-mentioned changes need to be made to existing pharmaceutical regulations and patent law, there is fear among stakeholders in Bangladesh that these changes will have a serious negative effect on the pricing of medicines in the country. Considering this great apprehension regarding the viability of the pharmaceutical industry and the negative consequences for drug prices, it is important to examine the status of the pharmaceutical industry in Bangladesh, and the likely effect of patenting pharmaceuticals on the pricing of drugs.

2.3 The Pharmaceutical Industry in Bangladesh

38The pharmaceutical industry of Bangladesh began in the 1950s when a few multinationals and local entrepreneurs set up manufacturing facilities in what was then East Pakistan. Now 265 companies are listed with the DGDA as producing medicines in Bangladesh.67 The pharmaceutical industry is currently the second largest taxpayer and meets 97% of local pharmaceutical requirements.68

2.3.1 The Nature and Size of Firms

  • 69 Study on the Viability of High Quality Drugs Manufacturing.

39The pharmaceutical industry in Bangladesh is represented by all three sectors: private enterprises, the state-owned Essential Drug Company Limited and Ganashastha Kendra (as a civil society based public health research and policy center and also essential medicine producer).69 Among the 265 pharmaceutical entities registered for the production of various types of formulations under the DGDA of Bangladesh, some 154 are regular in operation according to the DGDA. On the other hand, BAPI (or Bangladesh Aushad Shilpa Samity in Bengali), established in 1972 with just 33 members, has also been playing a vital role in the development of this sector. Today, BAPI is a very strong organisation with as many as 144 companies as members. However, only 20–30 companies have large manufacturing units, including five MNCs that have their own manufacturing plants in Bangladesh. There are two joint venture companies: Roche Healthcare and Sun Pharma. Sun Pharma, an Indian company, began its operation in partnership with one local company. Although 265 companies have a valid license from the government, around 25 local companies dominate 86% of the total market. MNCs account for roughly 5% of the market.

Table 2.5: Allopathic pharmaceutical companies in Bangladesh

Nature/type of company

Number

Quality control practice

World class, large scale

5

Maintain international standards

Multinationals

5

Maintain international standards

Export oriented, medium scale

15

High standard in quality control

Local market oriented, medium scale

40

Satisfactory standard in quality

Small scale

80

Substandard quality

Licensed-oriented pharmaceutical company

120

Incomplete production unit

Source: Information collected from the Bangladesh Association of Pharmaceutical Companies, the Directorate General of Drug Administration, the Export Promotion Bureau of Bangladesh and the Board of Investment Bangladesh, 2012.

40In addition to the 265 allopathic companies mentioned in Table 2.5, 201 Ayurvedic, 268 Unani, 25 herbal and 79 homeopathic drug manufacturing companies operate in Bangladesh. The DGDA monitors and regulates the activities of all 838 companies.

2.3.2 Competitive Scenario

  • 70 IMS Health data, 2014.
  • 71 Ibid.

41It is notable that the pharmaceutical market in Bangladesh is now mostly dominated by local players. The top 10 selling companies are Bangladeshi, so competition mostly occurs among these companies. Table 2.6 provides a brief summary of the top 10 pharmaceutical companies in Bangladesh in 2014. Among the local companies, Square Pharmaceuticals is the largest firm in the market, followed closely by Incepta, Beximco, Opsonin, Renata and Eskayef.70 Other firms in the top 10 list include Aristopharma, ACI, ACME and Healthcare.71 The market is extremely concentrated: the top 10 firms cater to about 68.1

  • 72 IMS Health data, 2014 and statistics from DGDA, 2014.

42% of the market, and two companies, Square and Incepta, hold more than 28% of the entire market. The top 20 companies represent around 85%, and the next 11 firms 8.60%, of the total market.72

Table 2.6: The top 10 pharmaceutical companies in Bangladesh (2014)

Position

Company

Sales
(billion taka)

Market share (%)

Growth (%)

1st

Square

21.15

18.7

7.3

2nd

Incepta Pharma

11.78

10.4

15.6

3rd

Beximco

9.56

8.5

7.6

4th

Opsonin Pharma

6.35

5.6

19.8

5th

Renata

5.74

5.1

13.5

6th

Eskayef

5.09

4.5

12.0

7th

Aristopharma

5.07

4.5

15.7

8th

ACI

4.69

4.1

9.9

9th

ACME

4.51

4.0

14.1

10th

Healthcare

3.09

2.7

35.4

43Some of the world’s leading MNCs have also worked in Bangladesh for a long time, but due to the high value of products, limited product lines and strong local competition, they have not climbed to leading positions in Bangladesh. These include some of the world’s pharmaceutical giants, such as GlaxoSmithKline (GSK) (UK), Sanofi Aventis (Spain), Novartis (Switzerland), Novo Nordisk (Denmark) and Eli Lilly (US). Table 2.7 provides a comparison of the performance of these top five MNCs in Bangladesh.

Table 2.7: Top five Multinational pharmaceutical companies operating in Bangladesh (2014)

Company

Sales (billion taka)

Market share (%)

Growth (%)

Industry position (2014)

Sanofi Bangladesh

2.19

1.94

7.66

12

Novo Nordisk

2.04

1.81

–1.99

14

GlaxoSmithKline

1.79

1.59

5.93

17

Novartis

1.76

1.56

28.45

18

Sandoz

1.45

1.28

21.09

20

2.3.3 Local Sales, Export and Import

  • 73 See for details, K. Saad and Safwan, ‘An Overview of the Pharmaceutical Sector in Bangladesh’ (Brac (...)
  • 74 See Business Monitor International, Bangladesh Pharmaceuticals and Healthcare Report Q4, 2012.

44The pharmaceutical market in Bangladesh was worth US$ 1.5 billion in 2011 and it is still expanding.73 Pharmaceuticals are estimated to be the third largest industry in the country, and account for 1.3% of the country’s Gross Domestic Product (GDP) and 40.9% of its total healthcare expenditure. According to Business Monitor International, the pharmaceutical market size will reach US$ 2.27 billion by 2016.74

45The Bangladeshi pharmaceutical marketplace is predominantly a branded generic marketplace. Pharmaceutical companies in Bangladesh can sell to private sector pharmacies, the government and its public healthcare facilities, and to international organisations operating in Bangladesh (e.g. the United Nations Children’s Fund [UNICEF]). Government sales are less profitable than private sector sales, since the government pays less and only on consignment. However, pharmaceutical firms still target public facilities as those doctors then become familiar with the drugs and prescribe them in their private practices. As drugs are not readily available at public facilities, patients receiving treatment in any public or private hospital may need to go to the private pharmacy to procure the required drugs.

  • 75 Directorate of Drug Administration, Bangladesh, 10 June 2014, http://www.lightcastlebd.com/blog/201 (...)
  • 76 See, Azam and Richardson (2010a): 6.
  • 77 Ibid.
  • 78 Ibid.
  • 79 For example, the Gulf Central Committee for Drug Registration, the Therapeutic Goods Administration (...)

46In addition to meeting local needs, Bangladesh exports a wide range of pharmaceutical products (therapeutic class and dosage forms) to 92 countries75 in Asia, Africa and Europe. In 2006–07 total exports were US$ 28.12 million with a growth rate of around 47%.76 Bangladesh also exports specialised products like HFA (hydro‑fluoro-alkaline) inhalers, suppositories, hormones, steroids, oncology and immunosuppressant products, nasal sprays, injectable and IV (intra-venous) infusions.77 Many of the larger manufacturers in Bangladesh are now venturing into the production of anti-cancer drugs, anti-retroviral (ARV) drugs for the treatment of HIV/AIDS78 and anti-bird flu drugs. Some of the most stringent regulatory authorities in the world have approved Bangladeshi pharmaceutical products for export.79 Table 2.8 shows that pharmaceutical exports from Bangladesh rapidly increased between 1975 and 2006.

47Other statistics also reflect that pharmaceutical exports from Bangladesh are rapidly increasing every year. The statistics for drug exports from Bangladesh between 2006 and 2011 are as follows: 2006, 2663.39 million taka; 2007, 2477.41 million taka; 2008, 3277.19 million taka; 2009, 3471.69 million taka; 2010, 3813.50 million taka; and 2011, 4212.25 million taka.

Table 2.8: Pharmaceutical exports from Bangladesh (1975–2006) in US$ (millions)

Table 2.8: Pharmaceutical exports from Bangladesh (1975–2006) in US$ (millions)

Source: World Bank Study on the pharmaceutical industry in Bangladesh, 2008.

48Although the Government of Bangladesh declared the pharmaceutical industry to be a “thrust sector” and actively promotes pharmaceutical exports, the exporters of pharmaceuticals from Bangladesh need to cope with the following constraints and impediments:

    • 80 Bangladesh: World Pharmaceutical Market, Q2 2010, Espicom Business Intelligence Report 2010.

    reliability of drugs produced in Bangladesh and bad image of substandard drugs80

    • 81 Interview with a Bangladesh Association of Pharmaceutical Industries (BAPI) official, 15 March 2009

    absence of a “bio-equivalence test facility” in the country81

    • 82 Interview with a BAPI official, Dhaka, Bangladesh, 16 March 2009.

    delay in issuing a “Free Sale Certificate” by the NRA82

    • 83 United Nations Conference on Trade and Development (UNCTAD)/World Trade Organization (WTO), Banglad (...)

    export registration procedures for drugs in highly regulated importing markets like Europe and the US are very complex83

    • 84 Ibid.

    lack of information on registration and other regulatory formalities in importing countries84

    • 85 Interview with a BAPI official, Dhaka, Bangladesh, 16 March 2009.

    inordinate delays and bureaucratic hassles during Customs procedures for shipment of samples85

    • 86 Ibid.

    inadequate funds for overseas sales and market promotion86

    • 87 Ibid.

    absence of adequate export incentives87

    • 88 Ibid.

    lack of support and cooperation by the foreign missions and offices of the Government of Bangladesh88

    • 89 Bangladesh: Supply and Demand Survey.

    difficulty in finding reliable distributors/agents in importing countries89

49Although pharmaceutical companies in Bangladesh provide finished pharmaceutical products for the local market and for export to so many countries, local companies still rely mostly on imported raw materials. More than 750 basic raw materials, including packing materials, are imported into Bangladesh for use by local pharmaceutical companies.

50Two categories of raw materials imported into Bangladesh are active ingredients/basic materials and excipients.

51In Bangladesh, pharmaceutical products (including raw materials) are imported mostly from India, China, Italy, Germany, Switzerland and France. Other important sources of imports are Japan, Korea, Singapore, Austria, Belgium, Cyprus, Denmark, Greece, Hungary, Netherlands, Ireland, Spain, the UK and the US. It is argued that almost 85% of the required raw materials are imported, whereas the percentage of imported finished products is negligible—around 3% of total consumption in the local market.

52However, a number of packing materials used by local companies are now produced locally, and these include cartons, product literature, white bottles, empty syringe/injectable, strips, cork, plastic containers and droppers, among others. Imported packing materials include aluminium foil, coloured bottles, foil (blister and strip), alu alu, rubber stoppers, flip-off seals, tear-off seals, tubes, PVC, PVDC, and so on.

2.3.4 Production Capacity and Range

  • 90 Board of Investment, Bangladesh, Market Overview: Bangladesh is Poised for Major Growth in its Phar (...)

53Pharmaceutical companies in Bangladesh manufacture around 450 generic drugs for 5300 registered brands with 8300 different strengths and dosages. These include a wide range of products such as anti‑ ulcerants, fluoroquinolones, anti-rheumatic non-steroid drugs, non- narcotic analgesics, antihistamines and oral anti-diabetic drugs. Some larger firms are also starting to produce anti-cancer and ARV drugs.90

54Among the registered companies, 35–40 local companies— including five MNCs—are in regular operation and produce products as recommended by the national DCC and the DGDA. Among the MNCs, Aventis, GSK, Organon and Novartis have manufacturing plants in Bangladesh, while Sun Pharmaceutical and Roche Healthcare are operating as a joint venture in Bangladesh. 20 of these companies, including MNCs, are experiencing tough competition in the local market.

  • 91 Bangladesh: Supply and Demand Survey.
  • 92 Interview with a BAPI official, Dhaka, Bangladesh, 15 March 2009.

55Among the available 450 generic products, 117 are essential and controlled drugs, and 333 are decontrolled products.91 Although most of the active pharmaceutical ingredient (API) is imported, 21 local companies are now producing API at a “limited range and mostly intermediate in nature”.92 The main customers for this limited production are other local companies producing various types of formulations. Square, Beximco, Opsonin, Jayson, Remo Chemicals, Drug International, Gonoshastha, Globe, Pharmatek, Seftchem, Syripsn and Global Capsules are prominent suppliers of limited API in the local market.

56More than 40 different types of active ingredients are produced by local companies. These include oral rehydration solution, paracetamol BP, amoxicillin trihydrate/powder, ampicillin compacted/powder, cloxacillin sodium BP, cefalexin trihydrate compacted, EG shell, diclofenac sodium, empty hard gelatine, sodium chloride, potassium chloride, parasulphate and zinc sulphate, among others. Another 4–5 companies have begun new projects to produce active ingredients in groups such as cephalosporin, macrolide antibiotic, anti-ulcerative and anti-inflammatory. One company has set up a plant to produce anti- cancer and hormonal products.

  • 93 Government departments are not importing formulations other than basic materials. International hum (...)

57Any pharmaceutical product produced locally by at least three local pharmaceutical companies is not allowed to be imported. Private importers, agents and distributors directly import necessary goods, and market and distribute them through their own distribution channels. The end users are unable to import directly any product for their own use, as product registration is mandatory before import, except under certain conditions.93

58Any prospective manufacturer/importer has to apply in prescribed form for product registration and certifications, and must provide the following information:

  • name and address of the manufacturer

  • manufacturing license number

  • list of drugs

  • proposed MRP

  • estimated treatment cost (daily and full course)

  • product data sheet

  • technical data sheet

  • pharmaceutical data sheet

  • toxicological data sheet

  • clinical data sheet

  • report on environmental impact assessment/analysis

  • names of the existing manufacturers and market size

  • bio-data on the production, factory and quality control manager

59Another important issue for the pharmaceutical industry is the technology used for pharmaceutical research and production.

2.3.5 Use of Technology

  • 94 Bangladesh: Supply and Demand Survey.

60The leading pharmaceutical companies have been able to adopt advanced technology from developed countries. Pharmaceutical companies in Bangladesh have product development teams that continuously undertake R&D activities, mostly related to reverse engineering activities rather than basic research to make new inventions. Common R&D activities undertaken by the local pharmaceutical industry are:94

  • bibliographic searches aided by resource libraries

  • design and selection of process-maximising efficiency

  • environmental impact assessment reduction

  • accelerated and longer stability testing

  • product quality optimisation

  • translation of new scientific insights into products

61However, several companies have been conducting studies on vaccines for critical diseases, such as cancer and diabetes, in collaboration with foreign experts. Many studies are also being carried out to produce herbal medicines. Formulations development is ongoing in many companies irrespective of their size.

62There has been good progress in raw materials development in collaboration with Western countries. Test methods are developed and validation is done according to the British Pharmacopoeia and the United States Pharmacopeia. Stability studies and validation of processes are also undertaken for new formulations.

63As packing materials and packaging are very important for export marketing, companies with considerable exports take extra care to use modern and standard packaging systems with attractive printing materials and convenient storage and handling options. However, as per the existing price control system, no company can claim an extra cost for attractive packaging.

64So far, there are no research findings on the “new molecule” in Bangladesh, which may become a great drawback after the introduction of pharmaceutical patents. As pharmaceutical companies are not improving their innovative capacity, it will become difficult for them simply to rely on producing generic medicines in the long term.

2.3.6 Innovation Capacity and Research and Development

65During the survey, most pharmaceutical companies in Bangladesh agreed that local pharmaceutical companies do not invest enough in R&D to make new medicines. The findings of the survey on patenting and innovative capacity among pharmaceutical companies in Bangladesh are briefly described below.

  • 95 This was agreed by all the large, medium and small pharmaceutical companies that were surveyed in B (...)
  • 96 This was mentioned by two large local pharmaceutical companies during surveys.
  • 97 This was mentioned by four medium and two small local pharmaceutical companies during surveys.
  • 98 During interviews, representative from three MNCs discussed their innovation outside of Bangladesh (...)

66Large, medium and small pharmaceutical companies in Bangladesh all suggested that they do not have any new inventions or patents.95 Some large-scale companies mentioned that they had begun basic research, with a view to preparation for the post-TRIPS product patent regime.96 Some medium-sized and small companies mentioned that they are considering utilising traditional knowledge to make country‑specific traditional medicines as an alternative in a post-TRIPS regime.97 On the other hand, multinationals operating in Bangladesh stated that they have new inventions and patented pharmaceuticals elsewhere, some of which were also patented in Bangladesh prior to 2008. However, none of them were interested in disclosing details or discussing any possible effects of those patented pharmaceuticals in Bangladesh.98

67Table 2.9 reflects that 50% of the participants in the survey strongly agreed that Bangladesh has no capacity to produce new medicines; 36% also agreed with this statement, whereas 14% disagreed.

Table 2.9: Survey results regarding whether Bangladesh has the capacity to produce new medicines

Scale

Pharmaceutical industry (large, medium and small local industry) or multinational

Total

%

Large

Medium

Small

Multinational

Strongly agree

2

2

4

3

11

50

Agree

2

5

1

0

8

36

Unsure

0

0

0

0

0

0

Disagree

1

2

0

0

3

14

Strongly disagree

0

0

0

0

0

0

  • 99 Interview with an official from an MNPC operating in Dhaka, Bangladesh, 12 March 2009.

68During the interviews, an official from a multinational pharmaceutical company operating in Bangladesh stated that they have no innovative capacity in the local manufacturing unit, although they have many patents that are mostly based on their R&D in developed countries.99

  • 100 This was mentioned by two pharmaceutical researchers from the Department of Pharmacy, University of (...)
  • 101 Ibid.

69Although pharmaceutical researchers in Bangladesh consider it possible to improve innovative capacity in Bangladesh, most of the local pharmaceutical companies think only about quick cash profit rather than long-term investment for R&D.100 Therefore, researchers suggest that the government should provide the necessary funds for some basic research in the pharmaceutical sector.101

  • 102 As stated during the Bangladesh Pharmaceutical Expo, 22 January 2009.

70At present, applying for new pharmaceutical patents is also impossible in Bangladesh, as patent protection for pharmaceuticals is not allowed until 1 January 2016. This in itself creates a barrier for the local pharmaceutical industry in Bangladesh and will become a huge impediment in a post-TRIPS environment. Tension is evident between the current capacity of the industry (pre-TRIPS position) and its potential to develop and change. Samson H Choudhary, the then CEO of Square Pharmaceuticals, commented in 2009 that the NDP, while encouraging local industry, removed the incentive for technological advancements.102 Unfortunately, there appears to be no incentive to increase and encourage investment in R&D. No government initiatives are in place to support or promote R&D. The failure to support and promote R&D is potentially a major barrier to the post-TRIPS survival of the pharmaceutical industry in Bangladesh.

2.3.7 Government Incentives for Supply of Raw Materials and Exports

71The Government of Bangladesh introduced a flat rate of duty of 7.5% on the import of raw materials in 1997. Pharmaceutical products produced from imported raw materials for ultimate export enjoy “duty draw back facilities”. Locally procured raw materials enjoy the “value-added tax refund” benefit if the products are exported. To date, there is no special incentive for export production.

72There exists no provision for cash incentives for pharmaceutical export, such as tax reduction or low interest rates for investment loans from governmental financial institutions. However, this issue has been repeatedly discussed within the government and among stakeholders. Exporters are actively pursuing this cash incentive to remain competitive in the export market. For finished goods, the expected rate of cash incentive is 20%, and for raw materials to be used for export it is 30%. However, existing export policy in Bangladesh offers incentives that are applicable to all exporters, including pharmaceutical companies, such as exemptions from value-added tax (VAT) of 15% on products produced for export, tax exemptions for corporate export income, export credit guarantees for pre-shipment and post-shipment.

73To further develop the pharmaceutical export sector, skilled human resources will be a crucial element.

2.3.8 Human Resources

74In Bangladesh, there exists a pool of qualified professionals and experts engaged in the pharmaceutical industry sector. Leading local pharmaceutical companies have their own ongoing “product development research”, although this is mostly limited to reverse engineering rather than basic research for new innovation. Every company hires a number of pharmacists, sonologists and chemists who obtained their higher education from local universities and then undertook advanced degrees in developed countries. Technologies adopted in Bangladesh were introduced by multinationals and have been steadily replicated by local professionals. This sector now employs the highest number of science graduates in Bangladesh. There is also a strong pool of business graduates and management professionals working in the pharmaceutical industry who are expert in sales and marketing at both local and international levels.

75Moreover, the suppliers of pharmaceutical items regularly provide demonstrations of technology and technical know-how to local staff for their professional development. However, local universities in Bangladesh providing instruction in pharmacology, microbiology, chemistry, biochemistry and other related subjects lack adequate clinical laboratories and practical facilities to train their graduates with modern technologies and to provide them with the necessary tools to do innovative research. There is also no practical link or collaboration between the local pharmaceutical industry and the universities, the establishment of which should be considered seriously for the future supply of skilled and innovative manpower in local industry, and for future collaborative innovative research to enable the transition of local industry from copycat to innovative practices.

2.4 (Potential) Effects of Pharmaceutical Patents on the Pricing of Drugs in Bangladesh

  • 103 Interviews with the CEOs of a medium-sized local pharmaceutical company and another leading pharmac (...)

76In Bangladesh, prior to the introduction of DCO 1982, the prices of pharmaceuticals were very high. Due to a number of limitations introduced under the DCO 1982, the prices of pharmaceuticals were substantially reduced in Bangladesh. There is concern in Bangladesh that pharmaceutical prices will increase substantially after the introduction of pharmaceutical patents and the removal of the restrictions imposed under the DCO 1982. Some pharmaceutical companies even claim that prices have already increased in Bangladesh since the introduction of TRIPS-compliant patent law in India and China, as Bangladesh depends on them for the supply of raw materials.103

  • 104 Interview with a pharmaceutical researcher from a leading local pharmaceutical company, Dhaka, Bang (...)
  • 105 Ibid.
  • 106 Ibid.

77However, a researcher working in one of the leading pharmaceutical companies remarked that patent protection for pharmaceuticals in China and India will have no effect on the price of raw materials in Bangladesh.104 He further added that price may become a concern only if the local market becomes dependent on a particular drug patented in India, China or another country, or on a drug solely distributed by multinationals.105 He claimed that the increase in the price of raw materials is sometimes used as a pretext to increase the price of drugs.106

78However, during the survey (see Table 2.10), most participants— particularly local large, medium and small pharmaceutical companies in Bangladesh—either agreed (54%) or strongly agreed (23%) that TRIPS has influenced the rise of pharmaceutical prices. Representatives of some local pharmaceutical companies mentioned that they are still unsure about this, whereas all the multinationals either disagreed or strongly disagreed that TRIPS will have an effect on pharmaceutical prices. To date, there have been no empirical studies or field studies in Bangladesh investigating the possible effect of TRIPS on pharmaceutical prices. Survey participants here confirmed that they can provide no conclusive evidence regarding a price increase due to TRIPS and indicated that price increases were based on assumptions regarding the situation in other countries.

Table 2.10: Survey results on whether TRIPS has influenced the rise in pharmaceutical prices

Scale

Pharmaceutical Industry (large, medium and small local industry) and multinational

Total

%

Large

Medium

Small

Multinational

Strongly agree

1

3

1

0

5

23

Agree

3

5

4

0

12

54

Unsure

1

1

0

0

2

9

Disagree

0

0

0

2

2

9

Strongly disagree

0

0

0

1

1

5

  • 107 IMS Health data, 2014.

79To understand how the patenting of pharmaceuticals may have influenced prices, local drug demand and sales in Bangladesh, I identified 10 top-ranking drugs in terms of local sales along with the brand names of the drugs and the names of the supplying pharmaceutical companies in Bangladesh (see Table 2.11). Of the top 10 drugs in terms of local sales, none were supplied by multinationals (Table 2.11). Also, none of the drugs in the top 10 are patented in Bangladesh. Even after the introduction of pharmaceutical patents, therefore, there will be no increase in price for these top 10 drugs in Bangladesh. Again, among the top 20 drugs in terms of sales, only two were supplied by multinationals, and they are also not patented in Bangladesh.107

Table 2.11: Top 10 drugs in terms of sales in Bangladesh*

Rank

Brand

Company

Growth (%)

1

Seclo

Square

35.05

2

Losectil

Eskayef

–6.43

3

Maxpro

Renata

22.41

4

Pantonix

Incepta

13.11

5

Cef-3

Square

13.92

6

Napa

Beximco

4.34

7

Neotack

Square

3.58

8

Napa-Extra

Beximco

12.04

9

Sergel

Healthcare

28.73

10

Zimax

Square

–4.22

*Based on the information collected from the Directorate of Drug Administration, Association of Pharmaceutical Industries, 2013–14, the Pharmaceutical Market Review in Bangladesh and IMS Health data 2013–14.

80I also examined the retail prices of the 10 most important drugs in Bangladesh (in terms of responses about retail pharmaceutical sales from different pharmacies in two major cities in Bangladesh: Chittagong and Dhaka). Table 2.12 shows changes in the retail prices of these 10 important drugs in Bangladesh.

81After the introduction of pharmaceutical patents in India and China (the major supplier of pharmaceutical raw materials to Bangladesh), the prices of 5 of the 10 most important products increased, 4 decreased and 1 product’s price remained stable. As all 10 products are off-patent, there should be no substantial price increase after the introduction of pharmaceutical patents and the removal of restrictions in Bangladesh.

Table 2.12: Changes in retail price of 10 important drugs (in taka, the local currency)

Pharmaceutical product

Retail price 1981 (taka)

Retail price 199192 (taka)

Retail price 200910 (taka)

Remarks increase=I decrease=D stable=S

Amitriptyline 25-mg tablet

0.80

0.45

0.80

I

Aspirin
300-mg tablet

0.10

0.44

0.90*/0.50**

I

Atenolol
100-mg tablet

6.00

3.00

1.25

D

Cloxacilin
500-mg capsule

3.60

5.65

5.10*/5.70**

D

Cotrimoxazole tablet

2.00

0.65

1.70

I

Fursemide
40-mg tablet

0.60

0.50

0.50

S

Indomethacin 25-mg capsule

1.91

0.52

0.50*/0.90**

D

Metronidazole 200-mg tablet

0.70

0.63

0.80*/1.00**
(for 400-mg tablet)

I

Paracetamol 500-mg tablet

0.25

0.52

0.50

D

Rifampicin
150-mg capsule

5.18

3.50

5.90

I

*price of local generic drug; **price of similar product offered by multinational corporations (MNCs) in Bangladesh; unless indicated, prices were similar for local and MNC products.

Source: Directorate of Drug Administration, price of pharmaceuticals, 1981 and 1991–92 and retail price 2009–10, collected from retailers’ sales data records and invoices.

82In this respect, it may also be important to monitor disease and the major causes of death in Bangladesh, to enable the evaluation of possible effects of TRIPS on the availability and pricing of the pharmaceuticals necessary to deal with diseases that are prevalent in Bangladesh. The main causes of death in Bangladesh are identified in Table 2.13.

Table 2.13: Causes of death in Bangladesh

Cause of death

Prevalence (%)

1

Old age complications/senility

12

2

Asthma

6

3

Stroke/paralysis

6

4

Fever

5

5

Heart disease

5

6

Pneumonia

4

7

Diarrhoea

3

8

Hypertension

3

9

Gastritis/peptic ulcer

2

10

Diabetes

2

11

Drowning

2

12

Hepatitis B

2

13

Tuberculosis

2

14

Malnutrition

2

15

Typhoid

1

16

Tetanus after delivery

1

17

Accident/injury

1

18

Cancer

1

19

Tetanus

1

20

Anaemia

1

Source: National case studies on the institutional framework and procedures regulating access to pharmaceutical products needed to address public health problems, by Nazmul Hasan, CEO of Beximco; Health and Demographics, BBS 2000.

Table 2.14 provides statistical data about the prevalence of diseases and the proportion of mortality rates.

Table 2.14: Diseases prevalent in Bangladesh

Disease or symptom

Proportion of mortality (%)

Prevalence per 1000

1

Fever with cold or cough

24

44

2

Fever

14

26

3

Peptic ulcer

8

15

4

Diarrhoea

5

9

5

Blood dysentery

3

6

6

Asthma

3

5

7

Arthritis

3

5

8

Hypertension

3

5

9

Waste

2

5

10

Scabies

2

4

11

Influenza

2

3

12

Malaria

2

3

13

Diabetes

1

3

14

Toothache

1

3

15

Pneumonia

1

2

16

Dengue

1

2

17

Boil

1

2

18

Typhoid

1

2

19

Senility

1

2

20

Accident

1

2

Source: National case studies on the institutional framework and procedures regulating access to pharmaceutical products needed to address public health problems, by Nazmul Hasan, CEO of Beximco; Health and Demographics, BBS 2000.

  • 108 See Study on the Viability of High Quality Drugs Manufacturing.

83Tables 2.13 and 2.14 indicate a high percentage of imprecise diagnoses or undiagnosed illnesses, evidenced by the high prevalence of fever with no identified cause, or by ascribing deaths to “old age complications”.108

  • 109 Ibid.
  • 110 Ibid.
  • 111 Interview with a policy analyst from a public health NGO in Bangladesh, 27 January 2012.
  • 112 Ibid.

84Fever is identified as one of the prime causes of death in Bangladesh: it is an infectious disease that might be successfully treated by antibiotics, anti-malarial drugs or other medications. This suggests that in the case of Bangladesh, the main health bottleneck is not patents or drugs; rather it is a lack of proper healthcare services and/or efficient healthcare personnel.109 The high incidence of death due to tetanus after delivery also points to the need for better healthcare staff and better-equipped healthcare infrastructure. Malnutrition (which influences both the incidence and morbidity of other illnesses) and waste may also be cases of diagnosis failure, indicating that better infrastructure is required.110 Further, during interviews, one participant agreed that pharmaceuticals necessary for the treatment of tuberculosis (TB) and malaria are cheaper in Bangladesh compared to neighboring countries.111 Therefore, problems with treating malaria and TB are not related to the availability of drugs, but to the lack of proper healthcare infrastructure, particularly an inadequate number of physicians and/or testing facilities.112

  • 113 Interview with a patent examiner at the DPDT, Dhaka, Bangladesh, 19 January 2009.
  • 114 Interview with a marketing and business analyst from a leading MNPC in Bangladesh, 21 January 2009.
  • 115 See Study on the Viability of High Quality Drugs Manufacturing.

85In Bangladesh, most drugs used for prevalent diseases are off- patent; therefore, there is little possibility of a price increase for these products.113 During interviews, one participant argued that even if there is an increase, it would actually be due to a devaluation of the local currency against a strong US dollar, causing an increase in the costs of importing raw materials.114 There are two other contributing factors that increase pharmaceutical prices in the local market. The first is the lack of a proper energy supply, which is required to maintain high quality; thus a pharmaceutical manufacturing plant must have its own power generation. Second, investment in pharmaceutical manufacturing relies strongly on private equity because of the relatively high interest rates in Bangladesh and the legal limitations on banks with respect to the volume of lending sums.115

  • 116 Interview with a patent examiner, in Dhaka, Bangladesh, 18 January 2012.
  • 117 Ibid.
  • 118 During interviews, an expert on patent law in Bangladesh and a patent examiner at the DPDT, Dhaka, (...)
  • 119 Nwokike and Choi (2012).

86One participant argued that even if there is an increase in price, which may not affect off-patent drugs, the price may increase only for patented drugs imported from India, China and other countries.116 Typically, developed market therapeutical groups, such as those addressing diabetes, cardiovascular disease, allergies or psychological disorders, are among the most important in Bangladesh, whereas HIV/AIDS and anti-malarial drugs are not.117 This is because drugs substituted for those produced by local producers are not patented in Bangladesh, so there may not be an increase of price for these drugs. However, some interviewees argued that local producers would be prevented from producing new patented drugs to be used in the treatment of these diseases.118 As there are very few AIDS and malaria patients in Bangladesh, even if there was an increase in price for these drugs, there would be only a minimal effect on the overall access to medicines in Bangladesh. In a WHO Bangladesh report, it was reiterated that there is no significant drug availability problem in Bangladesh; most of the drugs for diseases prevalent in Bangladesh are produced by the local pharmaceutical industries.119

  • 120 An Overview of the Pharmaceutical Sector in Bangladesh’.
  • 121 Ibid.
  • 122 Ibid.
  • 123 Interview with an expert on Pharmaceutical Technology, University of Dhaka, Bangladesh, 29 January (...)

87In another study, it was reported that around 85% of the drugs sold in Bangladesh are generic and 15% are patented.120 Most of the patented drugs are in the category of new or second generation drugs addressing diabetes, cardiovascular disease, allergies or psychological disorders, sexual problems, cancer, HIV/AIDS and anti-malarial diseases.121 As some off-patent drugs are available for these diseases, patented drugs are used only in exceptional cases, such as drug resistance or extremely critical situations.122 However, it is argued by local experts that after the introduction of pharmaceutical patents, the prices of these patented drugs will increase and create access problems in the case of drug resistance.123

88Considering the above situation, Bangladesh may need to develop its patent laws and pharmaceutical regulations in a way that can promote innovation and access to medicines, and at the same time preserve the local pharmaceutical industry and encourage multinationals to participate in technology transfer and invest in the pharmaceutical sector of Bangladesh.

2.5 Waiver for the Least Developed Countries and the Pharmaceutical Industry in Bangladesh: Opportunities and Challenges

  • 124 Of those 49 countries, 34 are WTO members.
  • 125 WTO TRIPS Agreement: Current State of Pharmaceutical Industry’, pp. 21–23.
  • 126 Martin (2006).

89Of the 48 countries classified as LDCs,124 Bangladesh is the only one that has the pharmaceutical manufacturing capability to be (nearly) self‑ sufficient in pharmaceuticals.125 Considering the manufacturing capacity of local pharmaceutical companies and the waiver for pharmaceuticals until 2033, Bangladesh has the ability and opportunity to produce generic versions of patented medications to service the pharmaceutical needs of other poor countries that have no or low manufacturing capacity.126

  • 127 Having become TRIPS compliant, countries such as India and China are no longer allowed to produce g (...)

90Given the extension for TRIPS compliance granted to LDCs until January 2033, Bangladesh is free to continue to permit the production of generics for patented pharmaceuticals and to allow the sale and export of generic pharmaceuticals.127 Thus, there would seem to be no impetus to comply with TRIPS before the transition period begins. However, in saying that, generic products produced and manufactured in Bangladesh cannot be exported to other national markets where patent protection exists and the Bangladesh-based company does not have market approvals with respect to the pharmaceutical product. Consequently, during the transition period, export markets are limited to those in which patent protection is not available. Arguably, opportunities need to be developed and exploited during the remaining transition period, as they may be curtailed or unavailable in a TRIPS- compliant environment. Much depends on the policy direction taken by the government. In some areas, the government has taken action to support local participation in joint ventures with foreign companies and toll manufacturing for foreign companies.

91In the context of the joint venture as a possible opportunity for Bangladesh during the transition period, large foreign pharmaceutical companies from highly regulated markets are actively looking for joint venture projects in developing countries and LDCs. Several contracts have reportedly been signed between Bangladesh and certain Indian and Chinese pharmaceutical companies. Bangladesh has the ability to manufacture APIs for foreign companies for export. To that extent, the Government of Bangladesh has already taken the initiative via the NDP 2005 to set up an API park to facilitate the production of raw materials and finished products.

  • 128 What is Toll Manufacturing? (13 May 2010), http://fhsons.tripod.com/toll.htm
  • 129 See Nazmul Hasan in a presentation on ‘Future Prospects of Pharmaceutical Industry in Bangladesh’, (...)
  • 130 The global contract manufacturing market for pharmaceuticals was U$ 54.54 billion in 2013 and is ex (...)
  • 131 Some of the larger pharmaceutical companies in Bangladesh, such as Square and Beximco, have already (...)
  • 132 This was mentioned by the CEOs of two leading pharmaceutical companies in Bangladesh during intervi (...)
  • 133 A compulsory licensing regime and other required patent law reform options are explained in Chapter (...)
  • 134 These institutional and technical options are explained in Chapter 5 of this study.

92Similarly, toll manufacturing for foreign companies is an opportunity that should be exploited during the transition period. Toll manufacturing is a contract to manufacture a finished or semi- finished product for a client company. It is also referred to as toll processing, tolling, toll conversion, contract manufacturing or custom manufacturing, and can be defined as performing a service for a fee (toll). Toll manufacturing saves the client company capital investment, since the toll manufacturer already has the plant and equipment necessary to make the product.128 Toll manufacturing can take advantage of financial and tax incentives available in various markets.129 It presents an option130 for Bangladesh, which has a very strong manufacturing base in pharmaceutical products and manufacturing costs that are lower than in other countries.131 The further exploitation of the compulsory licensing regime is another alternative that should be pursued by the government for exporting pharmaceuticals to markets with little or no manufacturing capacity, as suggested by the chief executives of some leading pharmaceutical companies in Bangladesh.132 However, existing patent law in Bangladesh does not support compulsory licensing for exporting pharmaceuticals.133 In addition, there are challenges around the risk of producing substandard products, the complexities of export registration, the lack of existing testing labs, the lack of local investment in R&D and pricing anomalies.134 These challenges need to be overcome in the long term and require a governmental strategy to be put in place. However, at this stage, for Bangladesh, the lack of investment in R&D represents a challenge that will have a substantial effect on the local pharmaceutical industry in a TRIPS-compliant patent regime.

93During the surveys, most of the pharmaceutical companies in Bangladesh agreed that local pharmaceutical companies do not have enough investment in R&D to make new medicines. The findings of the survey on patenting and innovative capacity among pharmaceutical companies in Bangladesh are briefly summarised below.

  • 135 This was mentioned by representatives from two large local pharmaceutical companies during surveys.
  • 136 During surveys, none of the local companies provided any information on basic research or potential (...)
  • 137 Three MNCs responded to surveys but did not provide any information on medicines they had patented (...)

94Although some large-scale companies indicated that they had begun basic research,135 none of the local pharmaceutical companies in Bangladesh have so far contributed to any new inventions, or applied for any product patents.136 On the other hand, multinationals operating in Bangladesh agreed that they had new inventions, but that they were patented elsewhere; some were also patented in Bangladesh prior to 2008 and some were transferred to the mailbox to be considered after the introduction of pharmaceutical patents in Bangladesh. However, during surveys and interviews, none of the respondents disclosed any details or answered queries on the possible effects of those patented pharmaceuticals in Bangladesh.137

  • 138 He considers that “pharmaceuticals’ manufacturing opportunities in Bangladesh are brighter than eve (...)

95Despite the impressive growth in sales in the local market and exports of pharmaceuticals from Bangladesh over the years, there is uncertainty and tension between stakeholders (pharmaceutical companies, government officials, public health experts, and IP and pharmaceutical technology academics) with respect to two issues.138 The first is the question of what options are available for Bangladesh to serve its local industry and meet societal demands for access to medicines, while the TRIPS pharmaceutical patent regime is being developed. The second relates to what kind of technical and institutional capacity building is necessary for Bangladesh to cope with the challenges of a post-TRIPS patent regime.

2.6 Which Way for Bangladesh?

96The introduction of the DCO 1982 helped Bangladesh become self- sufficient in pharmaceutical production locally and reduce prices substantially. However, unlike India and Brazil, Bangladesh failed to encourage R&D for pharmaceutical innovation as well as imitation. Therefore, it is crucial that the country now decide what will be its best mode of operation. There are at least two options for Bangladesh: to introduce pharmaceutical patenting with effective measures for the access to medicine, or to argue for continuation of the waiver for pharmaceutical patenting, thereby avoiding a patent regime until the country reaches the threshold of innovation and qualifies for graduation to a patent regime. In this respect, it may not be out of place to examine the advantages and disadvantages of both options.

97In the context of Bangladesh, without any pharmaceutical patent regime, the advantages are cheaper generics for essential medicines. Continuing to imitate pharmaceuticals patented in other countries (as patenting of pharmaceuticals is suspended in Bangladesh until 2016) may result in profits for the local pharmaceutical industry by way of exports to non-WTO members, LDCs and countries with no patents for particular medicines. This may include the creation of more employment and the generation of more foreign income through exports, and stiff competition among the locals and multinationals operating in Bangladesh—where the consumer will have better and/or cheaper options. Again, by restricting imports of drugs that are manufactured in Bangladesh, the country can prevent foreign exchange and impose prohibition on drug promotion by multinationals, restricting them from producing certain medicines like vitamins and antacids, which will remain an exclusive business opportunity for the local industry.

98However, a patent-free regime for pharmaceuticals will also have majord is advantages for Bangladesh because leading local pharmaceutical companies are more interested in export than in ensuring adequate supply in the local market. Sometimes this may create an artificial crisis, resulting in shortage of supply and charging of higher prices. Again, in the absence of a patent, there may not be any technology transfer and foreign direct investment (FDI) in the pharmaceutical sector. Further, in a situation such as multi-drug resistance, patients cannot afford costly new or patented medicines as these are not produced by the generic producers in Bangladesh. Another problem related to a prohibition on pharmaceutical patents is that local pharmaceutical companies prioritise short-term cash profit and do not invest in R&D. Thus there will be no incentive for innovative researchers and “brain drain” may increase.

99On the other hand, the introduction of pharmaceutical patenting will have some advantages, and it may not create obstacles for access to the essential medicines listed by the DGDA of Bangladesh. This is because essential medicines are mostly off-patent, and multinationals may be encouraged under corporate social responsibility to make drug donations by reducing the price of new patented drugs in the local market, but only if there is a pharmaceutical patent regime. It will also encourage technology transfer and FDI in the pharmaceutical sector, and create incentives for innovative research and options for commercialisation. Again, in a situation such as multi-drug resistance, patients will have access to drug donations and reduced price medicines under the National Health Service (which is currently dysfunctional).

100Further, local pharmaceutical companies will be compelled to invest in R&D or perish (with no option for quick cash) and there may be an opportunity for more joint ventures and public-private partnerships.

101Nonetheless, a pharmaceutical patent regime may also have some disadvantages. It may even endanger the existence of the local pharmaceutical industry. There is an apprehension regarding higher prices for patented drugs if efforts for drug donation and bargaining for reduced prices fail. Higher prices will create a situation in which multinationals have the lion’s share of the local market and the local industry is marginalised. There is also concern that there may not be any real technology transfer and FDI in the pharmaceutical sector even after the introduction of pharmaceutical patents, and that MNCs may simply become sales offices rather than manufacturing units. There will be no discrimination between imported and locally produced drugs, and local pharmaceutical companies will face serious competition. The DDA may not have the capacity to ensure the quality of all medicines, resulting in lower-quality medicines on the market. Further, the DPDT does not have enough expertise to deal with large volumes of pharmaceutical patents; therefore unnecessary patenting may restrict generic competition and encourage “ever-greening”—extending the life of a patent by making small changes.

102Considering the advantages and disadvantages of the introduction of pharmaceutical patenting, it is difficult to decide which course of action will most benefit Bangladesh. The next chapter will explore the extent to which the paths taken by India, China, Brazil and South Africa under the TRIPS Agreement and other options for government intervention may be used as potential policy blueprints for LDCs like Bangladesh.

103The challenges and opportunities highlighted here all require action on the part of the Bangladeshi government; government intervention lies at the centre of what may help Bangladesh to develop a TRIPS-compliant patent law that balances the (economic) interests of pharmaceutical producers with the (social) need to ensure access to pharmaceuticals for the local population.

Notes

1 See generally, Vandana Shiva, Protect or Plunder (Zed Books, 2001) and Edwin Mansfield, ‘Patents and Innovation: An Empirical Study’, Management Science 32.2 (1986): 173–81.

2 Patent law in the Indian subcontinent, including Bangladesh, has its origin in the 19th century, when it was under the rule of the British East India Company. The first legislation relating to patents was enacted in 1856 as Act VI of 1856 and was based on the British Patent Law of 1852. Subsequently the power to rule the Indian subcontinent was transferred from the East India Company to the British Crown via the Government of India Act, 1858. New legislation for granting “exclusive privileges” for invention was introduced in 1859 as Act XV of 1859. This legislation contained certain modifications of the earlier legislation, namely the grant of exclusive privileges solely to useful inventions and the extension of the priority period from 6 months to 12 months. However, this Act excluded importers from the definition of inventor, and was also substantially based on the British Patent Act of 1852 with certain departures, which included allowing assignees to make applications in India and also taking prior public use or publication in India or the UK for the purpose of ascertaining novelty. Later the British Government enacted the Patents and Designs Protection Act of 1872 and the Protection of Inventions Act of 1883. These two Acts were consolidated into the Inventions and Designs Act of 1888. Finally abolishing the earlier patent laws, the Indian Patents and Designs Act, 1911 (PDA) was enacted, consolidating all the patent and design issues, including the establishment of the Office of Controller of Patents and Designs. Bangladesh adopted the same law as established by the Patents and Designs Act of 1911, and Bangladesh’s law remains unchanged today. See Mohammad Monirul Azam, ‘Globalising Standard of Patent Protection in WTO and Policy Options for the LDCs’, Chicago-Kent Journal of Intellectual Property 13.2 (2014): 402–88. See also, Controller General of Patents, Designs and Trademarks (CGPDT), India, History of Indian Patent System, http://ipindia.nic.in/ipr/patent/patents.htm

3 Mohammad Monirul Azam, ‘Journey Towards WTO Legal System and the Experience of Bangladesh: The Context of Intellectual Property’ (Paper accepted for presentation at the Society of International Economic Law 2010 Conference, International Economic Law and Policy [IELPO], University of Barcelona, 2010).

4 This list identifies countries that deny what the US Trade Representatives consider adequate and effective protection for intellectual property rights. For details, see USTR, Special 301 Report, 2009, 10 July 2010, https://ustr.gov/about-us/policy-offices/press-office/reports-and-publications/2009/2009-special-301-report

5 See ‘Innovation and Competitive Capacity’.

6 Ibid.; Sampath pointed out that current patent law in Bangladesh is similar to Indian patent law post-1970, which was followed until the introduction of TRIPS- compliant patent law in 2005. In fact, India introduced process patenting and other restrictive measures and prohibited product patents in 1970. However, Bangladesh has never introduced these changes in its patent law; rather, it has tried to encourage local industry by way of separate pharmaceutical regulation under its Drugs Control Ordinance, 1982 (DCO).

7 WTO, Intellectual Property and Bangladesh, p. 270.

8 PDA (Bangladesh), section 15A.

9 PDA (Bangladesh), section 14.

10 Section 2(10) of the PDA provides that the term “manufacture” includes any art, process or manner of producing, preparing or making an article, and also any article prepared or produced by manufacture. See also Md Mahboob Murshed, ‘Trips Agreement and Patenting of Pharmaceutical Products’, The Daily Star (Dhaka), 3 August 2006, http://archive.thedailystar.net/law/2006/08/03/index.htm (accessed by searching the Internet Archive index).

11 Ulrike Pokorski da Cunha, Study on the Viability of High Quality Drugs Manufacturing in Bangladesh (commissioned by Deutsche Gesellschaft für Technische Zusammenarbeit [GTZ] GmbH, 2007), https://www.unido.org/fileadmin/user_media/Services/PSD/BEP/en-high-quality-drugs-bangladesh-2007.pdf

12 Murshed (2006).

13 Jashim Uddin Khan, ‘New Patent Rights of Drug Suspended’, The Daily Star (Dhaka), 14 March 2008, http://www.thedailystar.net/news-detail-27621

14 Nazmul Hasan, ‘General Secretary, Bangladesh Association of Pharmaceuticals Industries General Secretary’, The Daily Star (Dhaka), 14 March 2008, http://www.thedailystar.net/story.php?nid=27621

15 Ibid.

16 Md Farhad Hossain Khan and Yoshitoshi Tanaka, ‘IP Administration and Enforcement System Towards Modernization of IP Protection in Bangladesh and a Comparison of the IP Situation between Japan and Bangladesh’, IP Management Review 2 (2004): 1–11.

17 See ‘New Patent Rights of Drug Suspended’; Mohammad Monirul Azam and Yacouba Sabere Mounkoro, ‘Intellectual Property Protection for the Pharmaceuticals: An Economic and Legal Impacts Study with Special Reference to Bangladesh and Mali: A Course’ (a course Paper submitted as a partial requirement for the Legal and Economic Foundations of Capitalism, MS in Law, Economics and Finance, IUC, December 2008), http://legriotdudeveloppement.blogspot.se/2012/06/intellectual-property-protection-for.html

18 Interview with an official of the Department of Patents, Designs and Trademarks (DPDT), Dhaka, Bangladesh, 24 January 2013.

19 Email interview with a deputy registrar of the DPDT, Dhaka, Bangladesh, 19 July 2013.

20 Mohammad Monirul Azam and Kristy Richardson, ‘Pharmaceutical Patent Protection and TRIPS Challenges for Bangladesh: An Appraisal of Bangladesh’s Patent Office and Department of Drug Administration’, Bond Law Review 22.2 (2010a): 1–15.

21 Mohammad Monirul Azam, Status of Intellectual Property Teaching in Bangladesh (report submitted to WIPO) (2013).

22 See for details, Jude Nwokike and H.L. Choi, Assessment of the Regulatory Systems and Capacity of the Directorate General for Drug Administration in Bangladesh (submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services [SIAPS] Program) (Arlington, VA: Management Sciences for Health, 2012).

23 Although the Directorate of Drug Administration (DDA) was upgraded to the Directorate General of Drug Administration (DGDA) in 2010, most government documents are yet to be replaced with the new name; thus, DGDA and DDA are used interchangeably throughout the study, which does not signify any major differences between the activities of the former DDA and the current DGDA.

24 Drugs Act, 1940 (Bangladesh), Chapter III.

25 Section 8(1) of the Drugs Act, 1940 provides that the expression “standard quality”, when applied to a drug, means that the drug complies with the standard set out in the schedules of the Act. Section 10 of the Act prohibits the import of certain drugs, such as (a) any drug not of standard quality, (b) any misbranded drug, and (c) any drug, for the import of which a licence is prescribed, otherwise under, and in accordance with, such licence etc.

26 Drugs Act, 1940 (Bangladesh), Chapter IV.

27 Drugs Act, 1940 (Bangladesh), §§ 21–22.

28 Section 35 of the Drugs Act, 1940 provides that “no patent or proprietary medicine or pharmaceutical specialty or any other medicine, whether allopathic, Unani, and Ayurvedic (forms of traditional medicines), homoeopathic or biochemic, for the time being not recognised by the accepted pharmacopoeias shall be offered for sale to the public or advertised for such sale, unless two samples thereof shall have been sent to the Director Central Drug Laboratory, and the latter shall have determined that the medicine or specialty is suitable or proper for use by the public”.

29 See DGDA for details, http://www.dgda.gov.bd/index.php/downloads/background

30 Ibid.

31 Bangladesh Pharmaceutical Market, Q 2, 2010 (Espicom Business Intelligence, 2010).

32 Interview with the Chief Executive Officer (CEO) of a leading pharmaceutical industry in Bangladesh.

33 Ibid.

34 Quoted in Mohammad Monirul Azam, ‘The Impact of TRIPS on the Pharmaceutical Regulation and Pricing of Drugs in Bangladesh: A Case Study on the Globalising Standard of Patent Protection in WTO Law’ (unpublished PhD thesis, University of Bern, 2014), p. 182.

35 Interview with a staff member of the DDA, Dhaka, Bangladesh, 23 December 2009.

36 Zafarullah Chowdhury, The Politics of Essential Drugs: The Makings of a Successful Health Strategy: Lessons from Bangladesh (Zed Books Ltd., 1995), p. 49.

37 Ibid., p. 59.

38 Ibid.

39 Ibid., pp. 117–19.

40 Interview with a policy analyst from a leading public health NGO, in Dhaka, Bangladesh, 12 February 2009.

41 DCO 1982 (Bangladesh), § 23.

42 See for details, The Politics of Essential Drugs; and The World Bank, ‘Public and Private Sector Approaches to Improving Pharmaceutical Quality in Bangladesh’, 15 (March 2008), http://documents.worldbank.org/curated/en/425011468208779300/pdf/451900NWP0Box31uality0no2301PUBLIC1.pdf

43 Assessment of the Regulatory Systems, p. 11.

44 The Politics of Essential Drugs, p. 50.

45 Ibid, p. 51.

46 Ibid.

47 The first four of these drugs are manufactured from locally produced raw materials. Local pharmaceutical companies believe this was due to the introduction of a 15% value-added tax on locally produced raw and packaging materials.

48 Quoted in Oxfam, Make Vital Medicine Available for People—Bangladesh (25 July 2010), http://policy-practice.oxfam.org.uk/publications/make-vital-medicines-available- for-poor-people-bangladesh-112437

49 The Politics of Essential Drugs, pp. 18589.

50 Ibid.

51 Ibid.

52 National Drug Policy, 2005 (Bangladesh), 14 July 2010, http://apps.who.int/medicinedocs/documents/s17825en/s17825en.pdf

53 During interviews, officials at the DPDT and DGDA confirmed the prohibition of pharmaceutical patents in Bangladesh until the country graduates as an LDC or the TRIPS waiver period elapses, whichever is earlier.

54 Section 8 of the DCO 1982 (Bangladesh) prohibits the manufacture, import, distribution and sale of certain medicines as follows: “8. Prohibition of Manufacture, etc, of certain medicines.—(1) On the commencement of this Ordinance, the registration or licence in respect of all medicines mentioned in the Schedules shall stand cancelled, and no such medicine shall, subject to the provisions of sub-section (2), be manufactured, imported, distributed or sold after such commencement”.

55 55 Import restrictions are laid down in section 8 for certain pharmaceuticals, mostly those manufactured in Bangladesh. Section 9 of the DCO 1982 (Bangladesh) lays down import restrictions for pharmaceutical raw materials as follows: “9. Restriction on import of certain pharmaceutical raw material—(1) No pharmaceutical raw material necessary for the manufacture of any medicine specified in any of the Schedules shall be imported. (2) No drug or pharmaceutical raw material shall be imported except with the prior approval of the licencing authority. (3) the licencing authority may award an approval under sub-section (2) on such conditions as it deems fit to specify”.

56 Section 10 of the DCO 1982 (Bangladesh) stated that with the approval of the licensing authority (DGDA) a foreign manufacturer may be allowed to manufacturer any drug only under licensing agreement with any manufacturer in Bangladesh if the drug is its research product and is registered under the same brand name in any of the countries specified in the DCO.

57 See sections 8, 9 and 10 of the DCO 1982 (Bangladesh).

58 Only single ingredient products are allowed for production and distribution in Bangladesh.

59 Without the prior approval of the DDA, it is not possible to publish any advertisements relating to the use of any drug or any claim with respect to therapies or treatment. See section 14 of the DCO 1982 (Bangladesh).

60 There is no test data protection in Bangladesh.

61 Interview with an expert from an international public health NGO, Dhaka, Bangladesh, 15 January 2012.

62 Interview with a deputy registrar from the DPDT, Dhaka, Bangladesh, 16 January 2012.

63 Interview with the CEO of a medium-size local pharmaceutical company, in Dhaka, Bangladesh, 17 January 2012.

64 Ibid.

65 Interview with a marketing manager from a multinational pharmaceutical company (MNPC) operating in Dhaka, Bangladesh, 21 January 2012.

66 Interview with a policy analyst from a leading public health NGO in Bangladesh, 24 January 2012.

67 See DGDA, Bangladesh, 13 June 2013, http://www.dgda.gov.bd/index.php/2013-03-31-05-16-29/drug-manufacturers/allopathic

68 The remaining 3% consists of imported hi-tech products such as insulin, other hormonal products, anti-cancer products and blood components/derivatives infusions. See Sayedul Islam, Bangladesh Zooms in Pharma as Priority Sector (27 July 2006), http://saffron.pharmabiz.com/article/detnews.asp?articleid=34473&sectio nid=50

69 Study on the Viability of High Quality Drugs Manufacturing.

70 IMS Health data, 2014.

71 Ibid.

72 IMS Health data, 2014 and statistics from DGDA, 2014.

73 See for details, K. Saad and Safwan, ‘An Overview of the Pharmaceutical Sector in Bangladesh’ (Brac EPL Study, Dhaka, Bangladesh, May 2012).

74 See Business Monitor International, Bangladesh Pharmaceuticals and Healthcare Report Q4, 2012.

75 Directorate of Drug Administration, Bangladesh, 10 June 2014, http://www.lightcastlebd.com/blog/2015/12/market-insight-how-the-bangladesh-pharmaceutical-sector-is-performing-in-2015

76 See, Azam and Richardson (2010a): 6.

77 Ibid.

78 Ibid.

79 For example, the Gulf Central Committee for Drug Registration, the Therapeutic Goods Administration of Australia, the medicines and healthcare products regulatory agencies of the UK and United States (US) food and drug administrations. These bodies have already issued good manufacturing practice clearance to many local pharmaceutical companies in Bangladesh.

80 Bangladesh: World Pharmaceutical Market, Q2 2010, Espicom Business Intelligence Report 2010.

81 Interview with a Bangladesh Association of Pharmaceutical Industries (BAPI) official, 15 March 2009.

82 Interview with a BAPI official, Dhaka, Bangladesh, 16 March 2009.

83 United Nations Conference on Trade and Development (UNCTAD)/World Trade Organization (WTO), Bangladesh: Supply and Demand Survey on Pharmaceuticals and Natural Products, International Trade Centre (September 2005).

84 Ibid.

85 Interview with a BAPI official, Dhaka, Bangladesh, 16 March 2009.

86 Ibid.

87 Ibid.

88 Ibid.

89 Bangladesh: Supply and Demand Survey.

90 Board of Investment, Bangladesh, Market Overview: Bangladesh is Poised for Major Growth in its Pharmaceutical Industry, http://www.boi.gov.bd/site/page/7b31d826-368c-4ed9-8077-d16310433060/Life-Science

91 Bangladesh: Supply and Demand Survey.

92 Interview with a BAPI official, Dhaka, Bangladesh, 15 March 2009.

93 Government departments are not importing formulations other than basic materials. International humanitarian agencies and organisations are importing formulations occasionally for direct supply to end users. No NGO imports formulations, but they do import raw materials (Ganashastha Pharmaceuticals).

94 Bangladesh: Supply and Demand Survey.

95 This was agreed by all the large, medium and small pharmaceutical companies that were surveyed in Bangladesh.

96 This was mentioned by two large local pharmaceutical companies during surveys.

97 This was mentioned by four medium and two small local pharmaceutical companies during surveys.

98 During interviews, representative from three MNCs discussed their innovation outside of Bangladesh and some patent applications in Bangladesh. However, none of them disclosed any further information during surveys or interviews.

99 Interview with an official from an MNPC operating in Dhaka, Bangladesh, 12 March 2009.

100 This was mentioned by two pharmaceutical researchers from the Department of Pharmacy, University of Dhaka, interviewed 12 March 2009.

101 Ibid.

102 As stated during the Bangladesh Pharmaceutical Expo, 22 January 2009.

103 Interviews with the CEOs of a medium-sized local pharmaceutical company and another leading pharmaceutical company, Dhaka, Bangladesh, 22 December 2008.

104 Interview with a pharmaceutical researcher from a leading local pharmaceutical company, Dhaka, Bangladesh, 23 December 2008.

105 Ibid.

106 Ibid.

107 IMS Health data, 2014.

108 See Study on the Viability of High Quality Drugs Manufacturing.

109 Ibid.

110 Ibid.

111 Interview with a policy analyst from a public health NGO in Bangladesh, 27 January 2012.

112 Ibid.

113 Interview with a patent examiner at the DPDT, Dhaka, Bangladesh, 19 January 2009.

114 Interview with a marketing and business analyst from a leading MNPC in Bangladesh, 21 January 2009.

115 See Study on the Viability of High Quality Drugs Manufacturing.

116 Interview with a patent examiner, in Dhaka, Bangladesh, 18 January 2012.

117 Ibid.

118 During interviews, an expert on patent law in Bangladesh and a patent examiner at the DPDT, Dhaka, Bangladesh shared this concern.

119 Nwokike and Choi (2012).

120 An Overview of the Pharmaceutical Sector in Bangladesh’.

121 Ibid.

122 Ibid.

123 Interview with an expert on Pharmaceutical Technology, University of Dhaka, Bangladesh, 29 January 2012.

124 Of those 49 countries, 34 are WTO members.

125 WTO TRIPS Agreement: Current State of Pharmaceutical Industry’, pp. 21–23.

126 Martin (2006).

127 Having become TRIPS compliant, countries such as India and China are no longer allowed to produce generic forms of patented drugs.

128 What is Toll Manufacturing? (13 May 2010), http://fhsons.tripod.com/toll.htm

129 See Nazmul Hasan in a presentation on ‘Future Prospects of Pharmaceutical Industry in Bangladesh’, considering the opportunity for toll manufacture with the pharmaceutical companies in Bangladesh, 12 October 2009, http://documents.mx/ documents/future-prospects.html

130 The global contract manufacturing market for pharmaceuticals was U$ 54.54 billion in 2013 and is expected to reach U$ 79.24 billion in 2019, increasing at an average annual rate of 7.5%. For details see Strong Growth Ahead for Contract Manufacturing, http://www.pharmamanufacturing.com/articles/2016/strong-growth-ahead-for- contract-manufacturing

131 Some of the larger pharmaceutical companies in Bangladesh, such as Square and Beximco, have already begun toll manufacturing.

132 This was mentioned by the CEOs of two leading pharmaceutical companies in Bangladesh during interviews, Dhaka, Bangladesh, 10–11 March 2015.

133 A compulsory licensing regime and other required patent law reform options are explained in Chapter 4 of this study.

134 These institutional and technical options are explained in Chapter 5 of this study.

135 This was mentioned by representatives from two large local pharmaceutical companies during surveys.

136 During surveys, none of the local companies provided any information on basic research or potential pharmaceutical patent applications.

137 Three MNCs responded to surveys but did not provide any information on medicines they had patented in Bangladesh.

138 He considers that “pharmaceuticals’ manufacturing opportunities in Bangladesh are brighter than ever because of the country’s LDC status until 2016, this is a win-win situation for both Bangladesh and foreign pharmaceutical or investment companies because investors/companies will get high returns on their investment and this will create high paid jobs in Bangladesh”. He adds that “the cost of medicines has increased in China and India since they entered the WTO. Bangladesh has a unique opportunity to pare the costs of manufacturing medicines due to the low-cost high- qualified manpower and its LDC status”. See Hasan, Nazmul, ‘Post 2005: Great time ahead for exports’, Pharmabiz (27 January 2005), http://www.pharmabiz.com/article/detnews.asp?articleid=25953&sectionid=50&z=y

Table des illustrations

Titre Table 2.8: Pharmaceutical exports from Bangladesh (1975–2006) in US$ (millions)
Crédits Source: World Bank Study on the pharmaceutical industry in Bangladesh, 2008.
URL http://books.openedition.org/obp/docannexe/image/3103/img-1.jpg
Fichier image/jpeg, 48k

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