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Establishing a baseline to monitor public health implications of new Intellectual

Property Rights regime on pharmaceuticals in Sri Lanka

All rights reserved.

Department of Community Medicine, Faculty of Medicine,

University of Colombo, Sri Lanka

and

Health Action International -Asia Pacific

ISBN : 978-955-52994-0-4

Department of Community Medicine,

Faculty of Medicine, University of Colombo.

25, Kynsey Road,

Colombo 08, Sri Lanka

TP number: +94(0) 11 2695300/ +94(0) 11 2677765

Fax number: +94(0) 11 2691581/ +94(0) 11 2677765

Suggested citation

Weerasinghe, M. C. (2010) Establishing a baseline to monitor public health implications of

new Intellectual Property Rights regime on pharmaceuticals in Sri Lanka, Department of

Community Medicine, Faculty of Medicine, University of Colombo, Sri Lanka, Health

Action International Asia Pacific.

Principal investigator (PI)

Dr. Manuj C. Weerasinghe MBBS, MSc, MD(Com Med), PG Dip(Applied Sociology)

Senior Lecturer, Department of Community Medicine,

Faculty of Medicine, University of Colombo.

Research Assistant

Dr. W.M. Hiruni Dangalla MBBS

Department of Community Medicine, Faculty of Medicine, University of Colombo.

Other Contributors to the Project

Dr. B.V.S.H. Benaragama MBBS, MSc (Med Adm)

Director, Medical Technology and Supplies Division, Ministry of Health, Sri Lanka.

Cover photographs by

Mr. Amal Ranawaka

This research was funded by the Health Action International - Asia Pacific.

i

FOREWORD

The provision of drugs to the people at an affordable price to improve access is a major

challenge faced by the health providers. Two major contentious issues come into play when

we discuss the access to medicinal drugs. First is the Cosmetic Devices and Drugs Act of 1980

of the Democratic Socialist Republic of Sri Lanka and the drug registration system. Another

aspect that has received little or no attention is the implications to the access to drugs with the

establishment of the World Trade Organization and the enforcement of the Trade Related

Intellectual Property Rights (TRIPS) agreement. The provisions of the TRIPS agreement has

been incorporated into the Sri Lanka Intellectual Property Rights Act enforced in 2003 with

the potential for exclusive IP rights up to several years from the filing date. There is no doubt

that any research linking these two major issues would be a major challenge.

Dr M.C Weerasinghe a Senior Lecturer of the Department of Community Medicine has to be

congratulated on many counts. The subject he has taken on truly needs a baseline to be

established. The lack of an accepted and tested methodological approach has been taken by

Dr. Weerasinghe as a challenge and he has overcome this quite successfully. The analysis has

brought out the in depth understanding that he has on these complex and inter connected

issues. The results are very illuminating and the implications for public health are many. They

have to be disseminated and the problems related to the issue have to be brought to the notice

of all concerned.

It is with pleasure that I congratulate him on for taking on the daunting task of establishing a

baseline and putting together a document of clarity and quality for the sake of the health and

wellbeing of the people of Sri Lanka.

Thank you, for honoring me by your invitation to write the Foreword for this ground breaking

report of you research. Professor Rohini de Alwis Seneviratne

Professor and Head, Department of Community Medicine

Faculty of Medicine, University of Colombo, Sri Lanka

21st November 2010

ii

ACKNOWLEDGEMENTS

This research was conducted as a pioneering effort to establish a baseline to monitor the

effects on access to medicinal drugs in the arena of new IPR regime. Health Action

International Asia Pacific came forward to support this study with great enthusiasm. If not for

the support provided by Dr K. Balasubramaniam, advisor and Ms Jinani Jayasekera, projects

officer HAI AP this work would not have been a reality.

Dr. D.M. Karunaratna, Director General, National Intellectual Property Office, Sri Lanka

provided all the support to obtain the IPR data. I would like to thank Mr. Nalinda Atapattu,

National Intellectual Property Office for his help. Dr B.V.S.H. Beneragama, Director, DRA

contributed towards the success of the project and the Mr. Chula Edirisinghe, of DRA helped

to obtain the necessary data. I appreciate the support given by Prof. S. D. Jayaratne,

Chairman, State Pharmaceutical Corporation to conduct the prescription survey in a selected

SPC retail outlet. Ms. Sujathi Jayaratna, Manager (Promotions), Mr. W.U. Samaranayake and

Ms. Amitha Gunawardana of SPC, I remember with gratitude. Ms. Chintha Abeywardana,

World Health Organization, Sri Lanka helped in numerous ways.

Advice and help extended by Dr. Shilpa Modi Pandav, Dr Gopal Dabade and Ms. Ramya

Sheshadri at difficult times was a great help. Dr Krisantha Weerasuriya, WHO Geneva, my

mentor for last 18 years, was a driving force through out this work. Professor R de A.

Seneviratne, head and all the staff members of the Department of Community Medicine for

their continued support to carryout my research. All the staff members of DRA, SPC and the

Drug Evaluation Sub Committee (DESC) for supporting to complete this study successfully.

The research assistant for this project Dr Hiruni Dangalla did her best to complete this study

on time. I hope efforts of all who contributed this project will be fruitful in providing

improved access to medicinal drugs for the poorest segments in the society.

MCW

iii

Executive summary

he main objective of this study

was to establish a baseline to

monitor the public health

implications of new Intellectual Property

Rights regime and access to drugs. The

study was conducted in three phases; a

secondary data analysis of existing data

bases in the state, private and international

establishments; a prescription survey; and a

cross sectional survey of knowledge and

perceptions of personnel involved in

pharmaceutical regulations on IPR.

New Chemical Entities were defined as the

medicinal drugs registered with the DRA

for the first time in Sri Lanka. During the 5-

year period from 2005 to 2009, 70 NCEs

were registered at the DRA by 19

pharmaceutical companies. The 70 NCEs

were under 36 therapeutic groups according

to ATC classification Level 3. Except for

four therapeutic groups all other groups had

alternative drugs of the same therapeutic

group in the Sri Lankan market. Of the

NCEs, 24 (34.28%) had competitor brands

registered for the initial NCE at the time of

this study. One hundred and eight

applicants claimed patent rights for 874

(16.47%) chemical compounds and

therapeutic claims, from the National

Intellectual Property office in Sri Lanka

from 2006 up to 2010 March. The patent

information of the NCEs was also inquired

from the importers of these

pharmaceuticals. Official and unofficial

information suggested that all the NCEs

registered during this period are not

patented in Sri Lanka.

A 10% sample of daily prescriptions was

selected randomly from a SPC retail outlet.

A sample of 1664 prescriptions was

included in the study. Total number of

prescriptions with NCEs was 151(9.07%).

Of the 70 NCEs 22 (31.54 %) appeared in

the prescriptions. Percentage cost per

prescription for NCEs exceeded 50% for 82

(54.3%) prescriptions with NCEs.

Knowledge and perceptions of personnel

related to drug regulation was assessed

through a self administered questionnaire. It

was found that most of the participants

were not knowledgeable about the IPR

issues on pharmaceuticals.

T

iv

Table of contents

Foreword ........................................................................................ i

Acknowledgements ........................................................................ ii

Executive Summary ....................................................................... iii

Table of Contents ........................................................................... iv

List of Tables .................................................................................. v

List of Figures ................................................................................ viii

Abbreviations ................................................................................. ix

Introduction .................................................................................... 1

Methodology .................................................................................. 4

Results ............................................................................................ 9

Discussion ...................................................................................... 51

References ...................................................................................... 54

v

List of tables

Table 3.1: The year of registration of the NCEs .............................................................9

Table 3.2 : The year of registration of the NCEs .............................................................10

Table 3. 3: The year of registration of the NCEs .............................................................11

Table 3.4 : The therapeutic group of NCEs by ATC classification

- Level 3 and availability of alternatives in Sri Lanka ...................................12







Table 3.8: NCEs according to inclusion in Sri Lankan or

WHO essential drug lists ...............................................................................16

Table 3.9: Compounds and claims that can be categorized as pharmaceuticals registered

at the National IP office of Sri Lanka 2006-2010 ..........................................17

Table 3.10: The distribution of leading four applicants by name who applied

patent rights for chemical compounds and claims that can be

categorized as pharmaceuticals in Sri Lanka .................................................18

Table 3.11: Patent status of the NCEs ...............................................................................19



Table 3.14: Patent status of 70 NCEs as reported in USA patent office

at the time of first registration in Sri Lanka ...................................................22





Table 3.17: Price comparison of NCEs with the existing alternative drugs

in the same therapeutic group (ATC Classification level 3) .........................27


in the same therapeutic group (ATC Classification level 3) ..........................28

vi


in the same therapeutic group (ATC Classification level 3) ..........................29


in the same therapeutic group (ATC Classification level 3) .........................30

Table 3.21: Some NCEs listed with the competitor brands registered later in SL ............31



Table 3.24: Price comparison of some NCEs with the competitor brands

registered later in Sri Lanka ...........................................................................34

Table 3.25: International reference price comparison .......................................................36

Table 3.26: Distribution of the total number of daily prescriptions

included in the study ....................................................................................37

Table 3.27: The distribution of total number of drugs per prescription ............................38

Table 3.28: The distribution of NCEs prescribed in the prescriptions ..............................38

Table 3.29: The distribution of individual NCEs in the prescriptions ..............................39

Table 3.30: The distribution of NCEs in the prescriptions according

to the therapeutic group .................................................................................40

Table 3.31: The relationship between the prescriber and the total number

of drugs per prescription ................................................................................41

Table 3.32: Distribution of NCEs per prescription according to the prescriber ...............41

Table 3.33: Basic characteristics of the participants .........................................................43

Table 3.34: Familiarity of the participants to the Intellectual Property Act

of Sri Lanka before/after 2003 .......................................................................44

Table 3.35: The knowledge of the participants on the Intellectual Property

Act relating to patent granting in Sri Lanka...................................................44

Table 3.36: The distribution of the opportunities in participating in a training session/

workshop dealing with Intellectual Property Rights ......................................46

Table 3.37: Awareness of the participants on the Trade Related

Intellectual Property Rights (TRIPs) Agreement ...........................................46

Table 3.38: Knowledge of the participants on the Trade Related Intellectual

Property Rights (TRIPs) Agreement .............................................................47

vii

Table 3.39: Awareness of one or more medicinal drugs used under

patent in SL at present....................................................................................47

Table 3.40: Attitudes on the Intellectual Property Act relating to patent

granting in SL ................................................................................................48

viii

List of Figures

Figure 3.1.1: Relatively low cost NCEs ..............................................................................26

Figure 3.1.2: Relatively medium cost NCEs .......................................................................26

Figure 3.1.3: Relatively high cost NCEs .............................................................................26

Figure 3.1.4: Relatively very high cost NCEs .....................................................................26

Figure 3.2: Combination medications for glucosamine sulfate ........................................35

Figure 3.3: Combination medications for EPA & DHA ..................................................35

Figure 3.4: The distribution of the percentage price of NCEs in a prescription .............42

Figure 3.5: Possible public health implications of granting patents for

medicinal drugs ..............................................................................................45

Figure 3.6: Reasons not in favour of granting exclusive patent rights

to drugs...........................................................................................................48

Figure 3.7: Reasons in favour of granting exclusive patent rights to drugs .....................49

Figure 3.8: Suggestions to enhance respect for Intellectual Property

law while improving the access to medicinal drugs ......................................50

ix

Abbreviations ALA - alpha-linolenic acid

ATC - Anatomical Therapeutic Chemical

CaCO3 - Calcium Carbonate

Cap - capsule

CDDA - Cosmetic Devices and Drugs Act

DDD - Defined daily dose

DESC - Drug Evaluation Sub Committee

DRA - Drug Regulatory Authority

EDL - Essential drug list

EPA & DHA - Eicosapentanoic acid and decosahexanoic acid

FDA - Food and Drug Administration

GS - Glucosamine sulfate

INN - International Nonproprietary Names

IP - Intellectual Property

IPR - Intellectual Property Rights

IRP - International reference price

Mg - Magnesium

MgSO4 - Magnesium sulfate

MMR – Measles, Mumps and Rubella

MSM - Methyl sulphonyl methane

NA – Not available

NCE - New Chemical Entities

nmf - No match found

PTC code - Patent Cooperation Treaty code

P - Parental

LKR – Sri Lankan Rupees

SL - Sri Lanka

SPC - State Pharmaceutical Corporation

Tab - tablet

TRIPS - Trade Related Intellectual Property Rights

USD - United States dollar

Vit - Vitamin

WHO - World Health Organization

WIPO - World Intellectual Property Organization

WTO - World Trade Organization

1

Chapter 1

INTRODUCTION

he drug regulatory system in Sri

Lanka is governed by the

Cosmetic Devices and Drugs Act

of 1980 (CDDA) (Democratic Socialist

Republic of Sri Lanka 1980). The Drug

Regulatory Authority (DRA) of Sri Lanka

is responsible for the process of registration

under the authority of Director General of

Health Services. The Drug Evaluation Sub

Committee (DESC) advises the Director

General on the applications they receive for

drug registration. The DESC generally

relies on the information presented by the

applicant for this purpose. At present, the

need or the cost of the drug is not seriously

considered in registering pharmaceuticals in

Sri Lanka.

Cost of medicinal drugs and the

affordability to the ordinary consumer in

the developing countries has been a major

point of discussion. This is further

complicated by the pursuit of

pharmaceutical industry on extended patent

protection on essential medicines (Angell

2005). The debate on achieving public

health objectives and protection of

Intellectual Property Rights (IPR) is far

from over. In this atmosphere, IPR regime

in the world changed drastically with the

formation of the World Trade Organization

(WTO) and the enforcement of the Trade

Related Intellectual Property Rights

(TRIPS) agreement (World Trade

Organization 1990). Sri Lanka, a founder

member of the WTO, is a signatory to the

TRIPS agreement. As a developing country

new IPR regime is applicable in Sri Lanka

from the year 2005. However, for the

registration process of pharmaceuticals

under the CDDA, IPR status is not

recognized as a criterion for consideration

until now. The present Sri Lankan IPR Act

enforced in 2003 incorporated the

provisions of the TRIPS agreement, thus

providing exclusive IP rights up to a

minimum of 20 years from the filing date

(Democratic Socialist Republic of Sri

Lanka 2003).

Although 5 years have passed since the

beginning of the new IPR regime in Sri

Lanka, it is yet to examine the impact of

new IPR regime in respect of the prices and

availability of pharmaceuticals under the

patent.

T

2

It is crucial to establish a baseline to follow

and predict the implications of TRIPs

provisions to public health in the country at

this juncture as the real effects of new IPR

regime is to be expected within the next

decade in the pharmaceutical market.

There were no systematic research studies

undertaken in this area in Sri Lanka to date.

Establishing the baseline at this stage will

help to track and remedy the unforeseeable

effects that could occur in the future. It is

particularly important to provide evidence

for advocating consumer friendly

approaches in drug selection, registration

and maintaining affordable prices in the

pharmaceutical market.

With this background, the present study

was proposed to examine the patent status

of new drugs registered in Sri Lanka during

the period of five years of new IPR regime

(2005-2010), the price fluctuations and

perceptions of the pharmaceutical

regulators on the new IPR regime in respect

of public health implications.

3

Objectives

• To determine the patent status of the new chemical entities registered in Sri Lanka

during 2005-2010.

• To describe the price fluctuation in the market of new chemical entities/ patent drugs

registered during the period.

• To determine the proportion of the new chemical entities/ patented drugs of

therapeutic groups appearing in prescriptions dispensed at a selected state owned

pharmaceutical retail outlet.

• To determine the perception of personnel involved in pharmaceutical regulation on

public health implications of new IPR regime.

4

Chapter 2

METHODOLOGY

he intention of the study was to

establish a baseline for

monitoring the future trends in

IPR status and the access to medicinal

drugs in Sri Lanka. In the absence of a

system in place to obtain relevant

information on the issue, it was necessary

to device a methodology responsive to the

ground reality. Hence, the methodology

was developed to achieve the objectives of

the study with due consideration given to

the unavailability of routine data sources,

the logistic barriers, the administrative

difficulties and time constrains.

The study was carried out in three phases to

facilitate smooth functioning of the project.

Phase 1

This was a secondary data analysis using

available data in the state, private and

international establishments where access

to data was possible. Information was

obtained from the following sources.

1. Drug Regulatory Authority of Sri

Lanka

2. National Intellectual Property Office of

Sri Lanka

3. State Pharmaceutical Corporation of

Sri Lanka

4. Importers of pharmaceuticals

5. Online data base of Food and Drug

Administration-USA

(http://www.fda.gov/default.htm)

6. Online database of the United States

Patent and Trademark Office

(http://patft.uspto.gov/)

7. Online database of the European Patent

Office

(http://ep.espacenet.com/?locale=en_E

P)

8. Online database of World Intellectual

Property Organization

(http://www.wipo.int/pctdb/en/)

9. World Health Organization (WHO)

Health technology and pharmaceuticals

online data base on INN.

(http://mednet.who.int/public/default.a

spx?c=1f216b1a-c080-46a1-9a39-

c33717387926)

10. Online database of WHO collaborating

center for Drug statistics Methodology,

Norwegian Institute of Public Health

(http://www.whocc.no/news/)

T

5

11. Online database of International drug

price indicator guide

(http://erc.msh.org/mainpage.cfm?file=

1.0.htm&id=1&temptitle=Introduction

&module=DMP&language=English)

The information on the New Chemical

Entities (NCEs) registered from 2005-2009

in Sri Lanka was collected from the Drug

Regulatory Authority. NCEs were defined

as the medicinal drugs registered with the

DRA for the first time in Sri Lanka. It did

not mean newly discovered chemical

compounds. Hence, some of the medicinal

drugs that were considered as NECs in our

definition may not be considered in the

same manner internationally.

Although our objective was to search for

the patents obtained for NCEs in Sri Lanka

during period of 2006-2010, the patent

database at the National Intellectual

Property Office only had the descriptions of

the chemical compounds and claims but not

the international nonproprietary names of

the pharmaceuticals. Therefore, a list of

compounds and claims that could possibly

be categorized as pharmaceuticals

registered during the period of 2006 to

2010 March was obtained.

According to the information available in

the patent office, it is not possible to link

patent status of a compound to an actually

available medicinal drug in the country.

The only link that could be established

between the patented compound and an

outside data base, is the PTC (Patent

Cooperation Treaty) code given by the

WIPO. The WIPO database only states

what the chemical compounds are, but not

the exact medicinal drugs produced using

those compounds.

Therefore, the patent information of the

NCEs was sought from the importers of

these pharmaceuticals. Out of the 19

pharmaceutical companies that imported

the NCEs we could only contact 17

companies. First an authorized person of

each company was informed on the matter

over the phone. Then letters were sent to

these companies indicating information

required, and an envelope with a stamp and

return address. Reminders were sent to the

non respondents three times within a period

of 2 months over the phone to obtain

information. When there was no response

after three attempts the information was

considered as not available.

Phase 2

A prescription survey was carried out at a

SPC retail outlet to assess the appearance of

new chemical entities/patented drugs in the

6

prescriptions within a period of one month

from April to May 2010. The business

operations of the selected SPC retail outlet

are carried out over a 24-hour cycle from

8.00am to 8.00am the next day.

All the daily prescriptions dispensed at the

outlet were photocopied by the pharmacists.

During the period of data collection all the

photocopies of the previous day’s

prescriptions were collected and numbered.

10% of the daily prescriptions were

selected randomly from the total

prescriptions. Out of the sample of

prescriptions the ones with NCEs were

selected for sub analysis.

Price information of the new chemical

entities and the other drugs which appeared

in the prescriptions was obtained from the

State Pharmaceutical Corporation (SPC).

The missing price information was sought

from the importers of pharmaceuticals.

The percentage price of NCEs in a

prescription of the total price of the

prescription was assessed. In order to

calculate the total price of a prescription the

concept of Defined Daily Dose (DDD) was

used (World Health organization 2003).

The lowest price for the DDD of each drug

was calculated for the respective dosage

forms in the prescription.

When there were several DDDs for one

drug the DDD that is used under the most

common indication was considered in

calculating the price. When the DDD for a

drug was not available, the total daily dose

of the drug as given in the prescription was

considered for calculating the price. Even if

a NCE appeared in its generic name in the

prescription the price of the brand name

that is registered with the DRA was taken

into account. When a NCE appeared in

different brand names the price of that

particular brand was considered for the

calculation. In the event of topical

preparations that did not have a identified

DDD or when a specific dose was not

mentioned in the prescriptions, 5g was

considered as the total daily dose. For

vitamin K, the DDD of phytomenadion

(Vitamin K1) was considered as it was the

only form of vitamin K available in Sri

Lanka. Items in a prescription that were not

considered as medicinal drugs and not

considered for registration in the Drug

Regulatory Authority were excluded from

the study.

Phase 3

This was a cross sectional survey of

knowledge and perceptions of personnel

involved in pharmaceutical regulation in Sri

7

Lanka, on the implications of new IPR

regime on the public health.

Selection of participants

The participants for this component were

connected in some way to the activities of

pharmaceutical selection and regulation in

Sri Lanka. Members and employees of

Drug Regulatory Authority, Drug

Evaluation Sub Committee, and the State

Pharmaceutical Corporation, were included.

Data collection procedure A self administered questionnaire was used

to assess the knowledge and perceptions of

the personnel involved in drug regulation.

Both open and closed ended questions were

used.Identification data of participants were

not collected. Questionnaires together with

the information sheet and consent form

were directly distributed to some of the

participants to be completed and returned in

a sealed envelope provided to them. Mailed

questionnaire was the only option for some

of the participants. Questionnaire was sent

by post, providing an envelope with a

stamp and return address.

Data analysis

The data from phase 1, which included the

year of registration of the NCE at the Drug

Regulatory Authority, the therapeutic group

of NCEs by ATC classification - Level 3,

inclusion of NCEs in Sri Lankan or WHO

essential drug lists and the information

obtained from the National Intellectual

Property Office were presented in tabular

form. The information on patent status of

the NCEs obtained from the importers of

pharmaceuticals were tabulated. Patent

data obtained from FDA was presented

according to the year of expiry and the

existing patent period in USA at the time of

first registration in Sri Lanka.

The NCEs were divided into 4 categories

namely relatively low cost, medium cost,

high cost and very high cost drugs

according to the actual market prices. Price

fluctuations of the drugs during the period

were presented in graphical form.

The NCEs were divided into 4 categories

namely relatively low cost, medium cost,

high cost and very high cost drugs

according to the actual market prices. Price

fluctuations of the drugs during the period

were presented in graphical form.

One way analysis was done for the

prescription audit data obtained during the

phase 2 according to the respective

variables. Perceptions assessed through

8

questionnaire in phase 3 were also

presented in frequency distributions.

Ethical considerations

Ethical clearance for the study was obtained

from the ethics review committee of the

Faculty of Medicine, University of

Colombo. Permission from the Drug

Regulatory Authority, National Intellectual

Property Office and State Pharmaceutical

Corporation, were obtained prior to

secondary data collection.

9

Chapter 3

RESULTS

New Chemical Entities Registered in Sri Lanka

uring past 5 years 70 New

Chemical Entities (NCEs) were

registered at the Drug

Regulatory Authority by 19 pharmaceutical

companies as presented in Table 3.1 - 3.3.

Table 3.1: The year of registration of the NCEs

DGeneric Name Brand Name Year of

Registration

1. Alteplase Actilyse 2009

2. Daptomycin Cubicin 2009

3. Human Papillomavirus vaccine Cervarix 2009

4. Tenecteplase Metalyse 2009

5. Retapamulin Altargo 2009

6. Lanthanum carbonate Fosbait 2009

7. Sunitinib Sutent 2009

8. Zanamivir Relenza 2009

9. Levocetirizine Verizet 2009

10. Cadexomer Iodine Iodosorb 2009

11. Tigecycline Injection Tygacil 2009

12. Fondaparinux sodium Arixtra 2009

13. Pregabalin Pregab 2009

14. Fludarabine Fludara 2009

15. Nimotuzumab BIOMab EGFR 2008

16. Adefovir Adesera 2008

17. Ranibizumab Lucentis 2008

18. Valganciclovir Valcyte 2008

19. Levetiracetam Levitoz 2008

20. Lapatinib ditosylate Tykerb 2008

21. Calcium polystyrene sulfonate Kreduce 2008

10

Table 3.2 : The year of registration of the NCEs

Generic Name Brand Name Year of

Registration

22. Ciclesonide Osonide 2008

23. Escitalopram Nexito 2008

24. Tiotropium bromide Tiova 2008

25. Risedronate Oseorise 2008

26. Metolazone Metoz 2008

27. Telbivudine Sebivo 2008

28. Aceclofenac Aeronac 2008

29. Pegfilgrastim Neulastim 2007

30. Pemetrexed Almita 2007

31. Mycophenolate Sodium Myfortic 2007

32. EPA & DHA Maxepa 2007

33. Ursodeoxycholic acid Udihep 2007

34. Aripiprazole Arip MT 2007

35. Duloxetine Symbal 2007

36. Entecavir Baraclude 2007

37. Pimecrolimus Elidel 2007

38. Tirofiban Aggrastat 2007

39. Oxcarbazepine Oxetol 2007

40. Efavirenz Efavir 2007

41. Strontium ranelate Protos 2007

42. Dutasteride Avodart 2007

43. Ertapenem Invanz 2007

44. Etonogestrel Implanon 2006

45. Live attenuated Rota virus vaccine Rotarix 2006

46. Ornidazole Dazolic 2006

47. Insulin Detemir Levemir 2006

48. Infliximab Remicade 2006

49. Donepezil Aricept 2006

50. Cilostazol Pencil 2006

51. Ibandronic acid Bonviva 2006

11

Table 3.3: The year of registration of the NCEs

Generic Name Brand Name Year of

Registration

52. Insulin glargine Lantus Optiset 2006

53. Erlotinib Tarceva 2006

54. Bevacizumab Avastin 2006

55. Fludarabine Fludara 2006

56. Tizanidine Mulax 2006

57. Teriparatide Forteo 2006

58. Pravastatin Pravacol 2006

59. Tamsulosin Urimax 2006

60. Doxazosin Pencor 2006

61. Gefitinib Iressa 2006

62. Glucosamine sulfate Donna 2006

63. Reteplase Rapilysin 2005

64. Nebivolol Nodon 2005

65. Bisoprolol Concor 2005

66. Beractant Survanta 2005

67. Cabergoline Caberlin 2005

68. Gabapentin Gabalept 2005

69. Everolimus Certican 2005

70. Zaleplon Zalpilo 2005

As shown in table 3.4 - 3.7, the 70 NCEs

were under 36 therapeutic groups according

to ATC classification Level 3. ATC codes

were not available for 2 NCEs.

Except for 4 therapeutic groups namely

bile therapy (ursodeoxycholic acid), other

respiratory system products (beractant),

parathyroid hormones and analogues

(teriparatide) and low-ceiling diuretics,

excluding thiazides (metolazone), all other

therapeutic groups had alternatives in the

Sri Lankan market.

12

Table 3.4 : The therapeutic group of NCEs by ATC classification- Level 3 and

availability of alternatives in Sri Lanka

Therapeutic group NCEs Alternative drugs

1. All other therapeutic products Lanthanum carbonate Naloxone

Calcium polystyrene

sulfonate

Protamine

Flumazenil

2. Antiadrenergic agents, peripherally

acting

Doxazosin Prazosin

3. Antibiotics for topical use Retapamulin Tetracycline

Fusidic acid

Chloramphenicol

4. Anti-dementia drugs Donepezil Rivastigmine

5. Antidepressants Escitalopram Imipramine

Duloxetine Fluoxetine

Sertraline

6. Antiepileptics Pregabalin Phenobarbital

Gabapentin Phenytoin

Levetiracetam Carbamazepine

Oxcarbazepine

7. Antihistamines for systemic use Levocetirizine Chlorphenamine

Promethazine

Cetirizine

8. Antiinflammatory and antirheumatic

products, non-steroids

Aceclofenac

Glucosamine sulfate

Indometacin

Diclofenac

Ibuprofen

9. Antimetabolites Fludarabine Methotrexate

Pemetrexed Fluorouracil

Cytarabine

10. Antipsychotics Aripiprazole Chlorpromazine

Fluphenazine

Haloperidol

13




11. Hypnotics and sedatives Zaleplon Thiopental

Zolpidem

Paraldehyde

12. Immunostimulants Pegfilgrastim Interferon alfa-2a

Interferon beta-1a

Filgrastim

13. Immunosuppressants Everolimus Basiliximab

Infliximab Ciclosporin

Mycophenolate

Sodium

Tacrolimus

14. Insulins and analogues Insulin Detemir Human soluble

insulin

Insulin glargine Isophane biphasic

Human aspart-

biphasic

15. Lipid modifying agents, plain Pravastatin Simvastatin

EPA & DHA Atorvastatin

Clofibrate

16. Low-ceiling diuretics, excl. thiazides Metolazone Not available

17. Muscle relaxants, centrally acting

agents

Tizanidine Baclofen

18. Ocular vascular disorder agents Ranibizumab Verteporfin

19. Other antibacterials Daptomycin Vancomycin

Ornidazole Teicoplanin

Metronidazole

20. Other antineoplastic agents Sunitinib Cisplatin

Erlotinib Carboplatin

Bevacizumab Oxaliplatin

Gefitinib

14



Therapeutic group

NCEs Alternative drugs

21. Antithrombotic agents Alteplase Streptokinase

Tenecteplase Heparin

Tirofiban Enoxaparin

Reteplase

Fondaparinux sodium

22. Beta blocking agents Nebivolol Atenolol

Bisoprolol Propranolol

Metoprolol

23. Bile therapy Ursodeoxycholic acid Not available

24. Cicatrizants Cadexomer iodine Hyaluronic acid

25. Direct acting antivirals Zanamivir Aciclovir

Valganciclovir Lamivudine

Adefovir Ribavirin

Entecavir

Telbivudine

Efavirenz

26. Drugs affecting bone structure

and mineralization

Strontium ranelate

Ibandronic acid

Risedronic acid

Alendronic acid

Pamidronic acid

Zoledronic acid

27. Drugs used in benign prostatic

hypertrophy

Tamsulosin

Dutasteride

Finasteride

Terazosin

Carvedilol

28. Hormonal contraceptives for

systemic use

Etonogestrel Norethisterone

Levonorgestrel

Medroxyprogesterone

15




29. Other beta-lactam antibacterials Ertapenem Cefalexin

Cefradine

Cefuroxime

30. Other dermatological preparations Pimecrolimus Tacrolimus

Cromoglicic acid

Finasteride

31. Other drugs for obstructive airway

diseases, inhalants

Ciclesonide

Tiotropium bromide

Beclometasone

Budesonide

Ipratropium

bromide

32. Other gynecologicals Cabergoline Bromocriptine

Ritodrine

33. Other respiratory system products Beractant Not available

34. Parathyroid hormones and analogues Teriparatide Not available

35. Tetracyclines Tigecycline Tetracycline

Doxycycline

36. Viral vaccines Rota virus, live

attenuated

Measles, live

attenuated

Human Papillomavirus

vaccine

Hepatitis B

MMR

16

Table 3.8: NCEs according to inclusion in Sri Lankan or WHO essential drug lists

Therapeutic group NCE WHO

essential

drug list#

SL

essential

drug list*

Direct acting antivirals

Efavirenz √ √

Viral vaccines Rota virus,

live attenuated

√

Other antineoplastic agents

Sunitinib √

Immunosuppressants

Mycophenolate Sodium √

Antidepressants

Duloxetine √

Drugs affecting bone structure

and mineralization

Ibandronic acid √

Hormonal contraceptives for

systemic use

Etonogestrel √

Other respiratory system

products

Beractant √

# WHO EDL 2010 March

* SL EDL 2009

As presented in Table 3.8, out of the 70

NCEs, 7 drugs (10%) were included in Sri

Lankan essential drug list, while 2 drugs

(2.8%) were in the WHO essential drug list.

17

Information on Patent registration

Table 3.9: Compounds and claims that can be categorized as pharmaceuticals applied

for patents at the National IP office of Sri Lanka 2006 - 2010

Year

Total number of patent

applications

Number of applications of probable

compounds and claims of drugs

2006 423 241 (56.9%)

2007 430 205 (47.6%)

2008 450 258(57.3%)

2009 366 153 (41.8%)

2010 up to March 109 17 (15.5%)

Total 1778 874(49.1%)

As shown in Table 3.9, 874 entries in the

database of patent applications in the

National Intellectual Property Office from

2006 up to 2010 March were chemical

compounds and claims that were

compatible with medicinal drugs. Due to

the complexity and possible duplications of

the entries in the database, actual number of

applications may be slightly lower.

It should be noted that the patented

compounds are not necessarily available as

medicinal drugs in the Sri Lankan market.

It is known that many of those compounds

will never be developed to the medicinal

drugs or be available in the pharmaceutical

market.

According to the information available and

presented in the patent office, it was not

possible to link patents status of a

compound to an actually available

medicinal drug registered in the country.

The only link that could be established

between the patented compound and

outside databases is the international PTC

code given by the WIPO. The WIPO

database only states what the chemical

compounds are, but not the exact

medicinal drugs produced using those

compounds. Hence, it is also difficult to

establish the INN of those compounds

from the available information in the

National Intellectual Property Office at

present.

18

Table 3.10: The distribution of leading four applicants by name who applied patent

rights for chemical compounds and claims that can be categorized as pharmaceuticals in

Sri Lanka

As presented in table 3.10, 108 had applied

patent rights for 874 chemical compounds

and claims that can be categorized as

pharmaceuticals from the National

Intellectual Property office Sri Lanka

during the period of 2006-2010 March. Out

of them Janssen Pharmaceutica, Pfizer

products, Novartis AG and Eisai R& D

management were the leading four

applicants accounting nearly 50% of the

total patent applications under this

category.

Applicants Number Percentage

Janssen Pharmaceutica 193 22.2

Pfizer products 166 18.6

Novartis AG 55 6.2

Eisai R& D management 34 3.9

Others 426 49.1

Total 874 100

19

Table 3.11 - 3.14 present the patent status of the new chemical entities registered in Sri Lanka

during the study period.

Table 3.11: Patent status of the NCEs

Generic Name Brand Name Importer Patent status

Nimotuzumab BIOMab EGFR ABC Not patented

Insulin glargine Lantus Optiset Aventis Not available

Alteplase Actilyse Baurs Not available

Reteplase Rapilysin Baurs Not available

Tenecteplase Metalyse Baurs Not available

Pimecrolimus Elidel Baurs Not available

Valganciclovir Valcyte Baurs Not available

Telbivudine Sebivo Baurs Not available

Bevacizumab Avastin Baurs Not available

Erlotinib Tarceva Baurs Not available

Pegfilgrastim Neulastim Baurs Not available

Everolimus Certican Baurs Not available

Infliximab Remicade Baurs Not available

Ibandronic acid Bonviva Baurs Not available

Donepezil Aricept Baurs Not available

Ranibizumab Lucentis Baurs Not available

Mycophenolate Sodium Myfortic Baurs Not available

Tamsulosin Urimax Citihealth Not available

Efavirenz Efavir Citihealth Not available

Adefovir Adesera Cityhealth Not available

Tiotropium bromide Tiova Cityhealth Not available

Tigecycline Injection Tygacil Edna Not patented

Aripiprazole Arip MT Edna Not patented

Duloxetine Symbal Edna Not patented

Bisoprolol Concor Emerchemie Not available

EPA & DHA Maxepa Emerchemie Not available

20



Fondaparinux sodium Arixtra Glaxo Not available

Zanamivir Relenza Glaxo Not available

Lapatinib ditosylate Tykerb Glaxo Not available

Human Papillomavirus vaccine Cervarix Glaxo Not available

Dutasteride Avodart Glaxo Not available

Live attenuated Rota virus

vaccine

Rotarix Glaxo Not available

Retapamulin Altargo Glaxo Not available

Cabergoline Caberlin Harcourts Not available

Ornidazole Dazolic Harcourts Not available

Escitalopram Nexito Harcourts Not available

Levocetirizine Verizet Harcourts Not available

Oxcarbazepine Oxetol Harcourts Not available

Pravastatin Pravacol Hemas Not patented

Cadexomer Iodine Iodosorb Hemas Not available

Etonogestrel Implanon Hemas Not available

Teriparatide Forteo Hemas Not patented

Entecavir Baraclude Hemas Not patented

Pemetrexed Almita Hemas Not patented

Fludarabine Fludara Hemas Not patented

Fludarabine Fludara Hemas Not patented

Gefitinib Iressa Hemas Not available

Sunitinib Sutent Hemas Not patented

Strontium ranelate Protos Hemas Not patented

Ciclesonide Osonide Hemas Not patented

Residronate Oseorise Hemas Not patented

Calcium polystyrene sulfonate Kreduce LifeServe Not patented

Tirofiban Aggrastat Mansel Not patented

Ertapenem Invanz Mansel Not patented

21



Gabapentin Gabalept Mega Pharma Not available

Zaleplon Zalpilo Mega Pharma Not available

Pregabalin Pregab Pharma Associate Not patented

Ursodeoxycholic acid Udihep Robert Hall Not available

Tizanidine Mulax Robert Hall Not available

Lanthanum carbonate Fosbait Robert Hall Not available

Levetiracetam Levitoz Robert Hall Not available

Daptomycin Cubicin SJ Enterprises Not available

Insulin Detemir Levemir Swiss Biogenics Not patented

Doxazosin Pencor Swiss Biogenics Not patented

Nebivolol Nodon Swiss Biogenics Not patented

Aceclofenac Aeronac Swiss Biogenics Not patented

Beractant Survanta Swiss Biogenics Not patented

Cilostazol Pencil Swiss Biogenics Not patented

Metolazone Metoz George Stewart Not available

Glucosamine sulfate Donna Nawakrama Not patented

Out of the 19 pharmaceutical companies we

could only contact 17 companies and only 8

of them responded. They confirmed that 25

drugs (35.71%) they imported were not

patented in Sri Lanka. Other companies did

not respond to our request. However,

unofficial information from rest of the

pharmaceutical importers suggested that

none of the NCEs are patented in Sri Lanka

at present.

22

As shown in table 3.14 - 3.16, 41 drugs

(58.5%) were found to enjoy patent rights

at US Patent office at the time of first

registration in Sri Lanka. The remaining

period of patent in USA was calculated

considering the year of first registration in

SL.

Table 3.14 : Patent status of 70 NCEs as reported in USA patent office at the time of

first registration in Sri Lanka

Generic name Brand

Name in

SL

Innovator

brand

FDA

patent

Year

of

expiry

Year of

Registration

in SL

Remaining

patent

period in

USA

Daptomycin Cubicin Cubicin y 2019 2009 10

Donepezil Aricept Aricept y 2022 2006 16

Dutasteride Avodart Avodart y 2015 2007 8

Erlotinib Tarceva Tarceva y 2020 2006 14

Ertapenem Invanz Invanz y 2017 2007 10

Etonogestrel Implanon Implanon y 2009 2006 3

Gefitinib Iressa Iressa y 2017 2006 11

Ibandronic acid Bonviva Boniva y 2023 2006 17

Insulin Detemir Levemir Levemir y 2019 2006 13

Insulin glargine Lantus

Optiset

Lantus y 2024 2006 8

Lapatinib

ditosylate

Tykerb Tykerb y 2021 2008 13

Papillomavirus

vaccine

Cervarix Cervarix y 2026 2009 17

Pemetrexed Almita Alimta y 2016 2007 9

Pimecrolimus Elidel Elidel y 2018 2007 11

Pravastatin Pravacol Pravachol y 2014 2006 8

Rota virus, live

attenuated

Rotarix Rotarix y 2022 2006 16

Sunitinib Sutent Sutent y 2021 2009 12

23

Table 3.15: Patent status of 70 NCEs as reported in USA patent office at the time of first

registration in Sri Lanka

Generic name Brand

Name in

SL

Innovator

brand

FDA

patent

Year of

expiry

Year of

Registration

in SL

Remaining

patent

period in

USA

Teriparatide Forteo Forteo y 2019 2006 13

Tigecycline Tygacil Tygacil y 2016 2009 7

Tirofiban Aggrastat Aggrastat y 2019 2007 12

Valganciclovir Valcyte Valcyte y 2015 2008 7

Zanamivir Relenza Relenza y 2013 2009 4

Adefovir Adesera Hepsera y 2018 2008 10

Aripiprazole Arip MT Abilify y 2015 2007 8

Ciclesonide Osonide Alvesco y 2018 2008 10

Duloxetine Symbal Cymbalta y 2019 2007 12

Efavirenz Efavir Sustiva y 2018 2007 11

Escitalopram Nexito Lexapro y 2023 2008 15

Everolimus Certican Zortress y 2017 2005 8

Gabapentin Gabalept Neurontin y 2017 2005 12

Lanthanum

carbonate

Fosbait Fosrenol y 2024 2009 5

Levocetirizine Verizet Xyzal y 2013 2009 4

Nebivolol Nodon Bystolic y 2020 2005 15

Oxcarbazepine Oxetol Trileptal y 2018 2007 9

Pregabalin Pregab Lyrica y 2018 2009 9

Retapamulin Altargo Altabax y 2018 2009 9

Tamsulosin Urimax Flomax y 2010 2006 4

Telbivudine Sebivo Tyzeka y 2023 2008 15

Tiotropium bromide Tiova Spiriva y 2023 2008 15

Tizanidine Mulax Zanaflex y 2021 2006 5

Fludarabine Fludara Oforta y 2022 2009 13

24

Table 3.16: Patent status of 70 NCEs as reported in USA patent office at the time of first

registration in Sri Lanka

y- Yes, nmf- no match found, NA – Not available

Generic name Brand Name

in SL

Innovator

brand

FDA

patent

Year

of

expiry

Year of

registration

in SL

Remaining

patent period

in USA

Fondaparinux sodium Arixtra Arixtra expired NA 2009 NA

Beractant Survanta Survanta expired NA 2005 NA

Fludarabine Fludara Fludara expired NA 2006 NA

Bisoprolol Concor Zebeta expired NA 2005 NA

Cilostazol Pencil Pletal expired NA 2006 NA

Doxazosin Pencor Cardura expired NA 2006 NA

Levetiracetam Levitoz Keppra expired NA 2008 NA

Metolazone Metoz Zaroxolyn expired NA 2008 NA

Cabergoline Caberlin NA expired NA 2005 NA

Aceclofenac Aeronac NA nmf NA 2008 NA

Alteplase Actilyse NA nmf NA 2009 NA

Bevacizumab Avastin NA nmf NA 2006 NA

Cadexomer iodine Iodosorb NA nmf NA 2009 NA

Calcium polystyrene sulfonate Kreduce NA nmf NA 2008 NA

Entecavir Baraclude NA nmf NA 2007 NA

EPA & DHA Maxepa NA nmf NA 2007 NA

Glucosamine sulfate NA nmf NA 2006 NA

Infliximab Remicade NA nmf NA 2006 NA

Nimotuzumab BiomabEGFR NA nmf NA 2008 NA

Ornidazole Dazolic NA nmf NA 2006 NA

Pegfilgrastim Neulastim NA nmf NA 2007 NA

Ranibizumab Lucentis NA nmf NA 2008 NA

Residronate Oseorise NA nmf NA 2008 NA

Reteplase Rapilysin NA nmf NA 2005 NA

Strontium ranelate Protos NA nmf NA 2007 NA

Tenecteplase Metalyse NA nmf NA 2009 NA

Ursodeoxycholic acid Udihep NA nmf NA 2007 NA

Zaleplon Zalpilo NA nmf NA 2005 NA

25

For 9 drugs (12.8%) the patents had expired

at USA at the time of the study. However,

the year of expiry was not available for

those 9 drugs. Levetiracetam only has data

exclusivity rights at present. However

patent rights for this drug had expired. For

mycophenolate sodium patent rights were

in force for the injection and suspension

form but not for the tablet form .The expiry

dates for those two forms are in year 2013

and 2014 respectively.

25 drugs were registered in SL in its

innovator brand. There were 2 different

innovator brands for the two dosage forms

of fludarabine. USA patents exist only for

its tablet form but not for the injection

form.

No match was found for 19 drugs (27.14%)

in the orange book of US FDA.

Price fluctuations of the new chemical entities (2006 -2010)

Only the NCEs with price fluctuations from

the first registration date to mid 2010 were

considered for the comparison as shown in

Figure 3.1.1 - 3.1.4. One year was divided

into 4 quarters and price changes during

each quarter were taken into account. The

drugs were divided into 4 categories

(relatively low cost, medium cost, high cost

and very high cost) according to the actual

market prices, for the convenience in

comparison.

26

Figure 3.1.2 : Relatively medium cost NCEs

0102030405060708090

2006

(1)

2006

(3)

2007

(1)

2007

(3)

2008

(1)

2008

(3)

2009

(1)

2009

(3)

2010

(1)

2010

(3)

Uni

t pric

e (L

KR

)

Year

Aeronac(aceclofenac) 100mgMaxepa(EPA+DHA) 250mgUdihep(Ursodeoxy cholic acid) 300mg

Figure 3.1.1: Relatively low cost NCEs

0

500

1000

1500

2000

2500

3000

3500

2006

(1)

2006

(3)

2007

(1)

2007

(3)

2008

(1)

2008

(3)

2009

(1)

2009

(3)

2010

(1)

2010

(3)

Uni

t pric

e (L

KR

)Year

Certican( Everolimus) 0.25mgTiova (Tiotropium bromide) inhalerValcyte (valganciclovir) 450mgAricept (Donepazil) 5mgRota virus vaccine (Live attenuated)

0

1000

2000

3000

4000

5000

6000

2006

(1)

2006

(3)

2007

(1)

2007

(3)

2008

(1)

2008

(3)

2009

(1)

2009

(3)

2010

(1)

2010

(3)

Uni

t pric

e (L

KR

)

Year

Bonviva (Ibandronate) 150mgLevemir( Insulin detemir) pen

54000

56000

58000

60000

62000

64000

66000

68000

2006

(1)

2006

(3)

2007

(1)

2007

(3)

2008

(1)

2008

(3)

2009

(1)

2009

(3)

2010

(1)

2010

(3)

Uni

t pric

e (L

KR

)

Year

Avastin (bevacizumab) 100g/4ml

Figure 3.1.3 : Relatively high cost NCEs Figure 3.1.4: Relatively very high cost

27

As presented in Table 3.17 - 3.20, the

NCEs are subjected to price comparison

with the existing alternative drugs in the

same therapeutic group.

Table 3.17: Price comparison of NCEs with the existing alternative drugs in the same

therapeutic group (ATC Classification level 3)

Therapeutic

group

NCEs DDD Price of

DDD

(LKR)

Alternative

drugs

DDD Price of

DDD

(LKR)

Antithrombotic

agents

Reteplase

Fondaparinux

Alteplase #

Tenecteplase #

Tirofiban ¥

20U

2.5mg

0.1g

40mg

10mg

170452.8

7665

-

-

-

Streptokinase

Heparin

1.5 MU

10 TU

4410

156.4

Direct acting

antivirals

Valganciclovir

Adefovir #

Entecavir ¥

Telbivudine#

Efavirenz #

0.9g

10mg

0.5mg

0.6g

0.6g

5900

-

-

-

-

Aciclovir

Lamivudine

4 g

0.3 g

131

642

Other beta-

lactam

antibacterials

Ertapenem 1g

6593 Cefalexin

Cefradine

Cefuroxime

2 g

2 g

0.5 g

34.4

173

130

Antihistamines

for systemic use

Levocetirizine 5mg

10.6 Chlorphenamine

Promethazine

Cetirizine

12 mg

12 mg

10 mg

0.33

0.14

0.60

28



Therapeutic group NCEs DDD Price of

DDD

(LKR)

Alternative

drugs

DDD Price of

DDD

(LKR)

Other antineoplastic

agents

Sunitinib*

Bevacizumab*

Gefitinib*

Lapatinib

ditosylate*

Erlotinib*#

50mg

100mg/4ml

250mg

250mg

-

28858.5

66770

8088.9

1114.2

-

Cisplatin *

Carboplatin *

Oxaliplatin *

50mg

450mg

50mg

790

4400

6800

Antimetabolites Fludarabine*

Pemetrexed*¥

50mg.vial

500mgvial

2608

171,350

Methotrexate *

Fluorouracil *

Cytarabine *

2.5mg

25mg

100mg

2.55

115

316

Other drugs for

obstructive airway

diseases, inhalants

Tiotropium

bromide

Ciclesonide¥

18mcg

0.16mg

1990

-

Beclometasone

Ipratropium

bromide

0.8 mg

0.12 mg

13.1

19.95

Antiinflammatory and

antirheumatic


Aceclofenac

Glucosamine

sulfate

0.2g

1.5g

12.76

37

Indometacin

Diclofenac

Ibuprofen

0.1 g

0.1 g

1.2 g

3

1.2

2.28

Immunostimulants Pegfilgrastim 0.3mg 3780 Interferon α2a

Filgrastim

2 MU

0.35 mg

3509

5133

Immunosuppressants Everolimus

Infliximab

Mycophenolate

Sodium

1.5mg

3.75mg

2g

1773.62

3105

1058.13

Ciclosporin

Tacrolimus

0.25 g

5 mg

475

610

29



Therapeutic

group

NCEs DDD Price of

DDD

(LKR)

Alternative

drugs

DDD Price of DDD

(LKR)

Antiepileptics

Pregabalin

Gabapentin

Levetiracetam

Oxcarbazepine#

0.3g

1.8g

1.5g

1g

39.8

136.5

59.48

51

Phenobarbital

Phenytoin

Carbamazepine

0.1 g

0.3 g

1 g

0.86

6.6

9.5

Antipsychotics Aripiprazole 15mg 7.5 Chlorpromazine

Fluphenazine

Haloperidol

0.3 g

10 mg

8 mg

5.7

34

7.4

Antidepressants Escitalopram

Duloxetine#

10g

60mg

29.75

-

Imipramine

Fluoxetine

Sertraline

0.15 g

20 mg

50 mg

4.2

2.30

20.4

Anti-dementia

drugs

Donepezil 7.5mg 42 Rivastigmine 9 mg 68.85

Muscle relaxants,

centrally acting

agents

Tizanidine 12mg 195.5 Baclofen 50 mg 280.3

Drugs affecting

bone structure

and

mineralization

Ibandronic acid

Risedronate ¥

Strontium

ranelate¥

5mg

5mg

2g

168.33

-

-

Alendronate

Pamidronate (P)

10 mg

60 mg

19

8970

Insulins and

analogues

Insulin Detemir

Insulin glargine

40U

40U

1038.4

381.33

Insulin-soluble

Insulin isophane

biphasic

Insulin aspart

biphasic

40 U

40 U

40 U

600

625.7

507.2

30



*No accepted DDD. The unit price was considered to compare the price

# Price could not be obtained following extensive search

¥ Product was not launched by the pharmaceutical company

Therapeutic

group

NCEs DDD Price of

DDD

(LKR)

Alternative

drugs

DDD Price of

DDD

(LKR)

Lipid

modifying

agents, plain

EPA & DHA*

Pravastin ¥

250mg

30mg

23

-

Simvastatin

Atorvastatin

30 mg

20 mg

6.99

5.50

Beta blocking

agents

Nebivolol

Bisoprolol

5mg

10mg

17.36

33.3

Atenolol

Propranolol

Metoprolol

75 mg

0.16 g

0.15 g

1.25

1.32

36.45

Drugs used in

benign

prostatic

hypertrophy

Tamsulosin

Dutasteride

0.4mg

0.5mg

30

101.3

Finasteride

Carvedilol

Terazosin

5 mg

37.5 mg

5mg

12.27

13.8

122.03

Other

gynecological

Cabergoline 0.5mg 192.5 Bromocriptine 5 mg 36

Viral vaccines Rota virus, live

attenuated*

Human

papillomavirus

vaccine*

1 vial

1 vial

2005

5950

Measles, live

attenuated*

Hepatitis b*

MMR*

1 vial

1 vial

1 vial

488.50

914

580

All other

therapeutic

products

Lanthanum

carbonate

Calcium

polystyrene

sulfonate*#

2.25g

-

139.5

-

Naloxone *

Protamine *

Flumazenil *

400mcg

50mg/5ml

0.5mg/5ml

575

200

4328.98

31

Topical preparations (antibiotics for topical

use (Retapamulin), other dermatological

preparations (Pimecrolimus) and

cicatrizants (cadexomer Iodine) were

excluded from the price comparison as no

accepted DDD was present.

The therapeutic groups where the price

could not be obtained after an extensive

search were also excluded from the price

comparison.

Because of the differences in the dosage

form and the strengths between the NCEs

and the alternative drugs a comprehensive

price comparison is difficult to achieve.

Table 3.21 - 3.23 present the 24 NCEs

(34.28%) which had competitor brands

registered for the initial NCE at the time of

this study. However, all competitor brands

are not actually available in the market.

Table 3.21: Some NCEs listed with the competitor brands registered later in Sri Lanka

Generic name NCE Competitor brands

Aceclofenac Aeronac Zerodol

Aclofen

Zifam

Clofen

Acefen

Acenac

Ceclofen

Adefovir Adesera Infovir

Aripiprazole Arip MT Arizol

Bisoprolol Concor Bis-od

Cilostasol Pencil

Citaz

Micilos

Pletaal

32

Table 3.22: Some NCEs listed with the competitor brands registered later in Sri Lanka

Generic Name NCE Competitor brands

Donepazil Aricept

Dozil

Elzer

Alzer

Dopasol

Doxazosin Pencor Magurol

Duloxetine Symbal Diliner

Dulojoy

Escitalopram

Nexito

Oxapro

Zavesca

Gabapentin

Gabalept

Gabanin

Gaba

Gabix

Alpentin

Neogab

Gabatin

Penral

Gabapen

Neupentin

Meogab

Gefitinib Iressa Gefam

Geftinat

Glucosamine Sulphate Donna Cartigen

Ibandronic acid Bonviva Bondronat

Insulin glargine Lantus Optiset

(solostar)

Actyrapid novolet

Levetiracetam Levitoz Torleva

Levocetirizine Verizet Rincit

LC-5

Lecope

33

Table 3.23 : Some NCEs listed with the competitor brands registered later in Sri Lanka

Generic Name NCE Competitor brands

Mycophenolate Sodium Myfortic Cellcept

Mycept

Myfilet

Nebivolol Nodon

Nebilol

Nebivas

Nebicard

Ornidazole# Dazolic Ornida

Giro

Oxcarbazepine Oxetol Carbox

Oleptal DT

Trileptal

Oxepin

Barzepin

Pregabalin Pregab Gabica

Gablin

Gabin

Regalin

Gabawin

Tamsulosin Urimax Maxrin

Ursodeoxycholic acid Udihep Ursodil

Zaleplon Zalpilo Zaplon

It is a known fact that many drugs are

registered in Sri Lanka solely for the

purpose of applying for tenders in the

Ministry of Health. There is no mechanism

to verify the actual number of drugs

available in the market at a given time.

34

Table 3.24: Price comparison of some NCEs with the competitor brands registered later

in Sri Lanka

Generic name DDD NCE Price

per

DDD

Competitor

brands

Price

per

DDD

Aceclofenac 0.2g Aeronac 11 Zerodol

Aclofen

9.83

17.00

Aripiprazole 15mg Arip MT 7.5 Arizol 17.35

Donepazil

7.5mg Aricept 596.25 Dozil

Elzer

57.95

42.00

Escitalopram 10g Nexito 15.85 Oxapro 29.75

Gabapentin

1.8g Gabalept

136.5

Gabanin

Gaba

Gabix

Alpentin

Neogab

Gabatin

Penral

262.80

147.60

279.90

378.00

263.88

127.2

246.42

Levocetirizine 5mg Verizet 10.6 Rincit 9.13

Mycophenolate

sodium

2g Myfortic 1058.13 Cellcept 1050.00

Nebivolol 5mg Nodon

17.36 Nebilol

Nebivas

28.20

22.80

Ornidazole 1 g Dazolic 42.30 Ornida 40.50

Oxcarbazepine# 1g Oxetol 51 Carbox

Oleptal DT

Trileptal

141.33

103.33

166.23

Pregabalin 0.3g Pregab 39.8 Gabica

Gablin

415.44

411.35

Ursodeoxycholic

acid

0.75g Udihep 202.4 Ursodil 106.20

35

Figure 3.2: Combination medications for glucosamine sulfate

Neoflex (GS + CaCO3 + MSM+ MgSO4 )

Cartiplus (GS+KCl)

Carticare (GS + MSM +Vit D3 )

Carti RD (GS+ MgSO4 + Vit D3)

Arthocare (GS+ chondroitin sulfate)

Cartifix (GS+ chondroitin sulfate + VitC +VitE +Mg)

Repare (GS+ KCl + MSM + MgSO4 +Vit E)

Nuflam (GS+ chondroitin sulfate)

Ezee (GS + MSM + VitE +Mg)

Figure 3.3: Combination medications for EPA & DHA

Pulse triomega high strength ( omega 3 fatty acids + Vit E)

Pulse omega 3( omega 3 fatty acids + Vit E)

Omega plus (EPA+ DHA+ GLA+ Vit E)

Tri omega (EPA+ DHA+ GLA+ ALA+ Sci-MX)

All the prices of the NCEs and competitor

brands could not be found after an

extensive search. Therefore, some of the

NCEs and the available competitor brands

in the market were used for price

comparison as shown in Table 3.24. It was

clear that the branded generics are not

always less expensive than the first

registered NCE.

After getting registered as a single chemical

compound, several combination

preparations of the same drug have

appeared in the market as presented in

figure 3.2 and 3.3. However, the

combination preparations with NCEs which

appeared in the prescriptions were excluded

from the sub analysis.

36

Table 3.25: International reference price comparison

1USD= 113.4 LKR

The comparison of available international

reference prices of the NCEs are given in

Table 3.25. Median price was considered as

international reference price for

fludarabine, efavirenz and gabapentin. Unit

price was taken as international reference

price for valganciclovir as median price

was not available. IRP was not available for

the other drugs.

Generic name Strength International

reference price

(USD)

International

reference price

(LKR)

Price in SL

(LKR)

Fludarabine

injection

50mg 201.6229/Vial 22864 /Vial 2608

Valganciclovir 450mg 34.4971/Tab-cap 3911.97/Tab-cap 2950

Efavirenz 600mg 0.4145/Tab-cap 47.00/Tab-cap -

Gabapentin 300mg 0.1312/Tab-cap 14.87/Tab-cap 22.74

37

Prescription Survey

Ten percent (10%) of the daily prescriptions

were selected randomly from the total

prescriptions dispensed at the SPC outlet

over a one month period. Total number of

prescriptions sampled during the period was

1664.

Table 3.26: Distribution of the total number of daily prescriptions included in the study

Day No of prescriptions

1 552 543 544 525 456 627 518 499 4310 5711 5612 3413 5514 5315 5616 5717 5718 5719 5720 5421 6022 4823 5424 5725 4226 5027 5328 5929 6530 6131 57

Total 1664

38

The average number of prescriptions per day was 53.

Table 3.27: The distribution of total number of drugs per prescription

As shown in Table 3.27, one fifth of

prescriptions (21.9%) had 1 drug per

prescription. The mean and median number

of drugs prescription were 3.43 and 3

respectively. The highest number of total

drugs per prescription was 19.

Table 3.28: The distribution of NCEs prescribed in the prescriptions

Total number of prescriptions with new chemical entities was 151(9.07%).

Total number of drugs per

prescription

Frequency

1 365(21.9%)

2 287(17.2%)

3 315(18.9%)

4 236(14.2%)

5 191(11.5%)

6 122(7.3%)

7 67(4.0%)

8 39(2.3%)

9 25(1.5%)

10 7(0.4%)

11 4(0.2%)

12 2(0.1%)

13 3(0.2%)

19 1(0.1%)

Total 1664(100%)

Number of NCEs per prescription Frequency

1 142 (8.5%)

2 9 (0.7%)

Absent 1513(90.9%)

Total 1664(100%)

39

Out of the 70 NCEs registered from 2005 to

2009, 22 (31.54 %) appeared in the

prescriptions. Gabapentin was the most

frequently occurring NCE (19.37%)

compared to other 22 NCEs. The findings

are presented in Table 3.29.

Table 3.29: The distribution of individual NCEs in the prescriptions (n=160)

NCE Frequency

1. Gabapentin 31 (19.37%)

2. Bisoprolol 25 (15.62%)

3. Tamsulosin 20 (12.50%)

4. Nebivolol 10 (6.25%)

5. Glucosamine sulphate 10 (6.25%)

6. Aceclofenac 9 (5.62%)

7. Pregabalin 8 (5.00%)

8. EPA & DHA 7 (4.37%)

9. Ursodeoxy cholic acid 6 (3.75%)

10. Aripiprazole 6 (3.75%)

11. Donepazil 5 (3.12%)

12. Escitalopram 4 (2.50%)

13. Tizanidine 3 (1.87%)

14. Cabergolin 3 (1.87%)

15. Metolazone 3 (1.87%)

16. Cilostazol 2 (1.25%)

17. Ornidazole 2 (1.25%)

18. Mycophenolate sodium 2 (1.25%)

19. Insulin detimir 1 (0.62%)

20. Everolimus 1 (0.62%)

21. Levocetrizine 1 (0.62%)

22. Lanthanum carbonate 1 (0.62%)

Total 160 (100%)

40

Table 3.30: The distribution of NCEs in the prescriptions according to the therapeutic

group

Therapeutic group

(ACT classification-Level 3)

NCEs Total

1. Antiepileptics Gabapentin

Pregabalin

39(24.37%)

2. Beta blocking agents Bisoprolol

Nebivolol

35(22.01%)

3. Drugs used in benign prostatic

hypertrophy

Tamsulosin 20(12.57%)

4. Antiinflammatory and antirheumatic


Glucosamine sulfate

Aceclofenac

19(11.94%)

5. Lipid modifying agents, plain EPA & DHA 7(4.40%)

6. Bile therapy Ursodeoxycholic acid 6(3.14%)

7. Antipsychotics Aripiprazole 6(3.77%)

8. Anti-dementia drugs Donepezil 5(3.77%)

9. Antidepressants Escitalopram 4(2.51%)

10. Low-ceiling diuretics, excl. Thiazides Metolazone 3(1.87%)

11. Immunosuppressants Everolimus

Mycophenolate

3(1.87%)

12. Muscle relaxants, centrally acting

agents

Tizanidine 3(1.87%)

13. Other gynecologicals Cabergoline 3(1.87%)

14. Other antibacterials Ornidazole 2(1.25%)

15. No group * Cilostazol 2(1.25%)

16. Antihistamines for systemic use Levocetirizine 1(0.62%)

17. Insulins and analogues Insulin detemir 1(0.62%)

18. All other therapeutic products Lanthanum carbonate 1(0.62%)

Total 160(100%)

*As cilostazol has no ACT code, it was not included to a therapeutic group.

41

Highest number of the prescriptions with

new chemical entities (gabapentin,

pregabalin) belonged to antiepileptic group

(24.37%) as shown in table 3.30.

Table 3.31: The relationship between the prescriber and the total number of drugs per

prescription

Table 3.31 presents the distribution of the

total number of drugs per prescription

according to the prescriber. The mode for

total number of drugs per prescriptions for

specialists and non specialists were 3 and 1

respectively. The weighted mean of total

drugs per prescription for specialist was

4.11 and 2.2 for non specialists.

Table 3.32: Distribution of NCEs per prescription according to the prescriber

Prescriber Total number of drugs per prescription Total

1 2 3 4 5 6 7 8 9 10 11 12 13 19

Specialist

118 131 206 187 170 108 60 37 21 7 4 2 3 1 1055

Non

specialist

244 152 105 47 19 12 6 2 3 0 0 0 0 0 590

Not

mentioned

3 4 4 2 2 2 1 0 1 0 0 0 0 0 19

Total 365 287 315 236 191 122 67 39 25 7 4 2 3 1 1664

Prescriber Number of NCEs per prescription Total

0 1 2

Specialist

Non specialist

Not mentioned

929(61.5%)

565(37.3%)

19 (1.2%)

117(82.3%)

25 (17.7%)

0(0)

9(100%)

0(0)

0(0)

1055(63.4%)

590(35.4%)

19(1.1%)

Total 1513(100%) 142 (100%) 9(100%) 1664(100%)

42

As presented in Table 3.32 out of the 151

prescriptions with NCEs 126 (83.4%) and

25 (16.5%) were prescribed by the

specialists and the non specialists

respectively.

The cost of NCEs

The percentage cost of NCEs appearing in

a prescription in respect to the total price

of the prescription was assessed. The

defined daily dose (DDD) was used to

calculate the total price of a prescription.

Figure 3.4: The distribution of the percentage price of NCEs in a prescription

As presented in figure 3.4 out of the 151

prescriptions, 49 (32.5%) had a percentage

cost over 90% of the total cost. This

included 20 prescriptions with only NCEs.

Eighty two (54.3%) prescriptions incurred

more than 50% cost for NCEs.

0

10

20

30

40

50

60

freq

uenc

y

Percentage price of NCEs

43

Knowledge and perceptions of drug regulators

Table 3.33: Basic characteristics of the participants

Characteristics of the Participants Frequency

Profession

Specialist medical officer

Pharmacist

Scientific service

Other

8 (25.0%)

13(40.6%)

4(12.5%)

7(21.9%)

Contribution in medicinal drug regulation

Administrative

Administrative+ other technical assistance

Administrative+ advisory+ other technical assistance

Advisory

Quality control

Quality control + other technical assistance + clerical/documentation

Other technical assistance

Other

4 (12.5%)

1 (3.1%)

2 (6.3%)

8(25.0%)

4(12.5%)

1 (3.1%)

9(28.1%)

3 (9.4%)

Duration of involvement in work related to medicinal drug regulation

< 1 yr

1-4 yrs

5-10 yrs

>10yrs

2 (6.3%)

10(31.3%)

4(12.5%)

16 (50%)

Total 32 (100%)

As presented in Table 3.33, 40.6% of

the study population comprised of

pharmacists while 50% were involved

in work related to medicinal drug

regulation for more than 10 years. Other

contribution in work related to

medicinal drug regulation included law

enforcement and implementation.

44

Table 3.34: Familiarity of the participants to the Intellectual Property Act of Sri Lanka

before/after 2003

Over 80% of the participants had never

read or studied the Intellectual Property Act

relating to patent granting of Sri Lanka

before /after 2003 as shown in Table 3.34.

Table 3.35: Knowledge of the participants on the Intellectual Property Act relating to

patent granting in Sri Lanka

Knowledge on the Intellectual

Property Act relating to patent

granting of SL

Frequency Total

Yes No Missing

Knowledge on the agency in SL that is

authorized to grant patents for

medicinal drugs

14 (43.8%) 18 (56.3%) 0 (0) 32 (100%)

Knowledge on the minimum period of

exclusive patent rights granted in SL at

present

8 (25%) 23(71.9%) 1(3.1%) 32 (100%)

Knowledge on the term “Ever

greening” in respect to patents

5 (15.6%) 27 (84.4%) 0(0) 32 (100%)

Awareness of possible public health

implications of granting patents for

medicinal drugs

11(34.4%) 19(59.4%) 2 (6.3%) 32 (100%)

Table 3.35 presents the knowledge of the

participants on the IP Act relating to patent

granting of Sri Lanka. Although 14 (43.8%)

indicated that they are aware of the agency

Had read/ studied The Intellectual Property

Act of SL before 2003

The Intellectual Property Act

of SL after 2003

Yes 6(18.8%) 5(15.6%)

No 26(81.3%) 26(81.3%)

Missing 0(0) 1(3.1%)

Total 32(100%) 32(100%)

46

in Sri Lanka that is authorized to grant

patents for medicinal drugs only 2 (6.3%)

had given the correct answer.

Out of the 8 (25%) participants who said

they are knowledgeable on the minimum

period of exclusive patent rights granted in

Sri Lanka at present, only 3(9.4%) provided

the correct answer. The term “Ever

greening” in respect to patents was

correctly described by only 3 (9.4%)

participants out of the 5 (15.6%) who

mentioned that they are aware of the term.

The possible public health implications of

granting patents for medicinal drugs

mentioned by the participants are given in

Figure 3.5.

Figure 3.5: Possible public health implications of granting patents for medicinal

drugs

• Increase the cost of importing of drugs.

• Difficulties may arise when importing therefore the drugs may not be available

in the country.

• Cost of therapy goes up.

• New drugs can not be manufactured by others until patent period is over.

• Cheaper generics of newly developed drugs would not be available for

procurement.

• Patentee neither not using it, nor granting any other to use it.

• High cost of patented drug restricting their availability.

• Lead to creating monopoly.

46

Table 3.36: The distribution of the opportunities in participating in a training session/

workshop dealing with Intellectual Property Rights

As shown in table 3.36, out of eight

participants who had received opportunities

to participate in training sessions on

Intellectual Property Rights, six had only

one opportunity each. One did not

specifically mention about it. Only one

participant had received three training

opportunities in the form of workshops

conducted one in Ministry of Commerce in

2003. The opportunities that others had

received were lectures, sessions at DRA,

WHO workshop held in Bangladesh and a

workshop held at Medical Technology &

Supplies Unit.

Table 3.37: Awareness of the participants on the Trade Related Intellectual Property

Rights (TRIPs) Agreement

Had read/ studied

the TRIPs

Agreement

Frequency

Yes 10 (31.3%)

No 22 (68.8%)

Total 32 (100%)

Majority (68.8%) had not read or studied the TRIPs agreement.

Had an opportunity to participate in

a training session

Frequency

Yes 8(25.0%)

No 23(71.9%)

Missing 1 (3.1%)

Total 32(100%)

47

Table 3.38: Knowledge of the participants on the Trade Related Intellectual Property

Rights (TRIPs) Agreement

Knowledge on the TRIPs

Agreement

Frequency Total

Yes

No Missing

Knowledge on flexibilities

provided to developing countries in

application of TRIPS agreement for

medicinal drugs

6(18.8%) 25 (78.1%) 1(3.1%) 32 (100%)

Knowledge on any instance SL

has exercised the TRIPS

flexibilities to improve access to

medicines

0(0) 17(53.1%) 15(46.9%) 32 (100%)

Out of the 6 participants who admitted that

they are aware of the flexibilities provided

to developing countries in application of

TRIPS agreement for medicinal drugs, only

2 (6.25%) had specified such flexibilities.

Their responses are as follows:

In the event of a disaster facing the

country, the head of the country can

give rights to the government institution

to import the patent drugs after giving

some loyalty to the innovator.

parallel imports, compulsory licensing

None of the participants were aware of any

instance Sri Lanka had exercised the

TRIPS flexibilities to improve access to

medicines.

Table 3.39: Awareness of one or more medicinal drugs used under patent in Sri Lanka at

present

Awareness of one or more

medicinal drugs

Frequency

Yes 5(15.6%)

No 20(62.5%)

Missing 7(21.9%)

Total 32(100%)

48

Although 5 (15.6%) has responded that

they are aware of medicinal drugs used

under patent in Sri Lanka at present, only

one came with a name. The drug

mentioned is not patented in Sri Lanka at

present.

Table 3.40: Attitudes on the Intellectual Property Act relating to patent granting in SL

Majority (56.3%) was not in favour of

granting exclusive patent rights to

medicinal drugs and the reasons that were

provided are given in figure 3.7.

Stand on granting patent rights to medicinal

drugs

Frequency

In favour of granting patents 14(43.8%)

Not in favour of granting patents 18(56.3%)

Total 32(100%)

Figure 3.6: Reasons provided for not being in favour of granting exclusive

patent rights to drugs

As it had affected the cost and availability of medicines in Sri Lanka.

Competition reduces the price.

Exclusive IPR will increase the price.

Due to high cost, affordability is less.

Excessive cost of patent drugs.

It creates monopoly.

It will lead to monopoly and prices can never be competitive.

Medicines must be available to benefit the members of the community.

Exclusive patent rights without limits will be contrary to this principle.

The price will be high as there is no competition.

49

The reasons given in favour of granting exclusive patent rights to medicinal drugs are

presented in the Figure 3.7.

Perception on the quality and efficacy of the medicinal drugs: innovator vs. generic

Out of the 32 participants 8 (25%) agreed

that the innovator brand has superior

quality always and better therapeutic

efficacy while 2 (6.3%) agreed that there is

no difference between the quality of the

innovator brand and the generics/ branded

generics. Sixteen (50%) had the perception

that there can be quality difference in

innovator brand and others, but there is no

difference in therapeutic efficacy. Three

(9.4%) participants had observed that none

of the above three responses are correct. Of

them two respondents had noted that there

could be differences in both quality and

efficacy. Three (9.4%) had marked more

than one response.

Eleven (34.3%) participants provided their

suggestions to respect IPR law while

improving the access to medicinal drugs as

shown in Figure 3.8.

Figure 3.7: Reasons for being in favour of granting exclusive patent rights to

drugs

I think medicinal drugs are the most important products which are granted patent

rights.

Innovator may need a certain period to recover the expenditure incurred for

development (but not a 20 year period).

Innovators must have patent rights, unless they are not interested in research and

development.

Prevent counterfeit drugs & post marketing problems.

Research product should have a period of patency in a country.

This is what the developed countries do. We have to safeguard the inventions.

What can not be patented is already provided for.

To ensure the quality of the drug.

50

Figure 3.8: Suggestions to enhance respect for intellectual property law while improving

the access to medicinal drugs

Please make us aware of IPR related to medicinal drugs.

Selection of brand names by technical personnel.

Period of patent rights tend to increase the price of medicines.

As most of the drugs are imported from India we have to depend on how they adopt to

intellectual property laws.

Please arrange awareness program about TRIPS.

Access to medicinal drugs should not be a problem. At the end of the day what is

important is the “quality”. The generics we get in Sri Lanka are not even used in the

country it is produced. Respect for intellectual property law needs education and

application of rules.

The current system of limited period of patent rights to the innovator is satisfactory.

An education programme on IPR law should be implemented for the relevant people.

Workshop should be conducted to educate the administrative sector.

Small royalty to be paid to innovator by the generic manufacturer.

Should always respect the patent. But there should be adequate flexibility for the users.

Government to government granting permission to manufacturer and import patented

drugs exclusively for the use of state sector as generic versions particularly during

epidemics (communicable or non communicable).

Patient education and freedom for the clinician to decide on his/her prescriptions.

51

CHAPTER 4

DISCUSSION

he purpose of this study was to

establish a baseline to monitor

the public health implications of

new Intellectual Property Rights regime

and access to drugs. In absence of any

previous attempt to study this field in Sri

Lanka and lack of readily useable data

sources, a flexible approach was used.

Many sources were used to collect existing

data. Empirical data were also collected to

achieve certain objectives of the study.

New Chemical Entities were defined as the

medicinal drugs registered with the DRA

for the first time in Sri Lanka. It did not

mean newly discovered chemical

compounds. Hence, some of the medicinal

drugs that were considered as NECs in our

definition may not be considered in the

same manner internationally. Certain drugs

were registered in Sri Lanka long after

other countries allowed them in their

markets and are considered as NCEs in Sri

Lanka.

During the 5 year period from 2005 to

2009, 70 new chemical entities were found

to be registered at the Drug Regulatory

Authority by 19 Pharmaceutical companies.

The 70 NCEs were under 36 therapeutic

groups according to ATC classification

Level 3. Two NCEs did not have ATC

codes. Except for 4 therapeutic groups all

other groups had alternative drugs of the

same therapeutic group in the Sri Lankan

market. In addition, 24 NCEs (34.28%) had

competitor brands registered for the initial

NCE at the time of this study. However, all

competitor brands are not actually available

in the market. Selected NCEs and the

available competitor brands in the market

were used for price comparison. The

branded generics registered later in Sri

Lanka were not always found to be less

expensive than the first registered NCE.

This should be interpreted cautiously as

many NCEs registered for the first time in

Sri Lanka, were themselves branded

generics and not the innovator brand.

There were 108 applicants claiming patent

rights for the chemical compounds and

claims that confirm to be pharmaceuticals

from the National Intellectual Property

office of Sri Lanka during 5-year study

period. Out of them leading four applicants

Janssen Pharmaceutica, Pfizer products,

Novartis AG and Eisai R & D management

accounted for almost 50% of the patents

under this category. Of all entries on patent

T

52

application list from 2006 up to 2010

March, 874 (16.47%) consisted of chemical

compounds and claims that are compatible

with medicinal drugs. According to the

information available and form of

presentation in the patent office, it was not

possible to link actual patent status of a

compound to an actually available

medicinal drug registered in the country.

This is seen as a drawback from IPR point

of view. On the other hand it supports to

keep the distance from linking drug

registration to IPR.

The patent information of the NCEs was

sought from the importers of these

pharmaceuticals. Only 8 companies out of

17 contacted confirmed that 25 drugs

(35.71%) they imported were not patented

in Sri Lanka. However, unofficial

information from the rest of the

pharmaceutical importers suggested that

none of those NCEs are patented in Sri

Lanka. This is a positive sign for access to

drugs. Further this finding can be used to

monitor future trends.

The prescription survey was carried out to

explore the extent of NCEs appearing in the

prescriptions and the cost implications. A

10% sample of daily prescriptions was

selected randomly from a SPC retail outlet.

Total number of prescriptions included in

the study during the period of 31 days was

1664. One fifth of prescriptions (21.9%)

had 1 drug per prescription. The mean and

median was 3.43 and 3 respectively. The

highest number of drugs prescribed per

prescription was 19. Total number of

prescriptions with new chemical entities

was 151(9.1%). Of these, 142 and 9

prescriptions had 1 and 2 NCEs per

prescription respectively. Out of the 70

NCEs registered from 2005 to 2009 period,

22 (31.54 %) appeared in the prescriptions.

Percentage cost per prescription for NCEs

exceeded over 50% for 82 (54.3%)

prescriptions with NCEs. Although NCEs

are not patented, the cost is still acting as a

barrier. This is an important finding

affecting access to medicinal drugs. It could

be predicted that with time more NCEs will

be prescribed and the cost of the

prescription will be prohibitive.

In the prescription survey 1055 (63.4%)

prescriptions were prescribed by specialists

and 590 (35.4%) by non specialists. Out of

the 151 prescriptions with NCEs, 126

(83.4%), and 25 (16.5%) were prescribed

by the specialists and the non specialists

respectively. In calculating the mode,

number of drugs per prescriptions for

specialists and non specialists were 3 and 1

respectively. The weighted mean was 4.11

53

total drugs per prescription for specialists

and 2.2 for non specialists.

Knowledge and perceptions of personnel

related to drug regulation was assessed

through a self administered questionnaire.

For this phase of the study 32 participants

were enrolled. Of the participants 50%

were involved in work related to medicinal

drug regulation for more than 10 years.

Over 80% of the participants had never

read or studied the IPR Act of Sri Lanka

relating to patent granting. Majority

(68.8%) had not read/ studied the TRIPs

agreement. Of the participants, 18 (56.3%)

were not in favour of granting exclusive

patent rights to medicinal drugs. Eight

(25%) respondents had opportunities to

participate in training sessions on

Intellectual Property Rights. However,

most of the participants were not

knowledgeable on IPR. It was clearly

evident from inaccurate responses they

provided regarding Intellectual Property

Rights on pharmaceuticals. Awareness of

public health implications of new IPR

regime will certainly help the regulators to

be cautious in selecting and registering the

drugs. Hence, such inputs seem essential to

manage the negative implications of new

IPR regime.

54

References

Angell, M., 2005, The truth about Drug Companies, New York, Random House.

Democratic Socialist Republic of Sri Lanka, 1980, Cosmetic Devices and Drugs Act No 27 of 1980, Colombo, Democratic Socialist Republic of Sri Lanka.

Democratic Socialist Republic of Sri Lanka, 2003, Intellectual Property Act, No 36 of 2003, Colombo, Democratic socialist Republic of Sri Lanka.

World Trade Organization, 1990, Legal text, The results of Uruguay Round of Multilateral Trade Negotiations, WTO Cambridge Press.

World Health organization, 2003, Introduction to Drug Utilization Research, Oslo, World Health organization.

ISBN : 978-955-52994-0-4

Department of Community Medicine,

Faculty of Medicine,

University of Colombo.

25, Kynsey Road,

Colombo 08,

Sri Lanka

Tel: +94(0) 11 2695300/ +94(0) 11 2677765

Fax: +94(0) 11 2691581/ +94(0) 11 2677765

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