appendix 1: convention membership and patent protection ...978-1-349-06599-8/1.pdf · appendix 1:...

Appendix 1: Convention Membership and Patent Protection for Pharmaceuticals

UK USA W. Germany Belgium Australia Spain Mexico Argentina New Zealand France Brazil Japan Philippines Italy Colombia Peru Venezuela Indonesia

SouRCES

Convention membership

c c c c c c c c c c c c c c

NC NC NC C*

Patents for Chemical Inventions, Sandoz Ltd, 1975.

Patent protection for pharmaceuticals

A NPP pp A A pp pp 0 A A 0 pp

NPP 0 0 0 p 0

UNCT AD Role of the Patent System in the Transfer of Technology to Developing Countries, TD/B/AC11/19, 1974.

NOTES

C =Member of the Convention for the Protection of Industrial Property. NC =Non-Member of the Convention. C* = Member of the Convention but no independent patentlaw. A = Patent protection for all pharmaceuticals. PP = Product by process protection. NPP = No product by process protection. P =Process protection only. 0 = No protection for pharmaceuticals, or effectively none.

218

Appendix II: Sample Drugs

Product Anatomical Product Anatomical name classification name classification

(a) (b) (a) (b)

Aldactone C3B Canes ten GIA Aldomet C2B Catapres C2B Alupent R3A Centyl K. C3A Amoxil JlC Ceporex JlD Anovlar 21 G3A Chymoclar JlA Anafranil N6A Clomid G3G Anugesic H.C. C5A Colofac A3A Apisate ASA Concordin N6A Asilone A2A Ativan N5A Daktarin DIA Atromid S. B4A Dalacin C JIF Aventyl N6A Dalmane N5B

Bactrim JIE Daonil AIOB Declinax C2B Baycaron C38 Dermovate D7A Bay olin M2A Deteclo JlA Beconase RIA Dimotane R6A Becotide R3A Dimotapp R5E Ben oral MIA

Beta Cardone CID Distalgesic W2B Dixarit N2C Betadine GIA Dorbanex A6A Betaloc C2B Duogastrone A2B Betnesol S3B

Betnovate D7A Duphaston G3D Duvadilan C4A Biogastrone A2B Dyazide C3A Bisolvon R5C Dytide C3A Blocadren CID

Bonjela AlA Bradilan C4A Epilim N3A Bricanyl R3A Eppy SID Brufen MIA Equagesic N2B Burinex C3B Esbatal C2B

Euglucon A lOB Calcitrar H4A Eugynon G3A

219

220 The International Diffusion of Pharmaceuticals

Product Anatomical Product Anatomical name classification name classification

(a) (b) (a) (b)

Fenopron MIA Macrodantin G4A Floxapen JlH Mandrax N5B Fluanxol N5A Maxolon A4A Fortral N2B Microgynon 30 G3A Fucidin D6A Minocin JlA Fungilin R2A Modi ten W5A

Moduretic C3A Gaviscon A2A Mogadon N5B Genticin D6A Motival N6C Gyno Daktarin GlA Mucaine A2A Gynovlor G3A Myambutol J4A

Haelan D7A Naprosyn MIA Halciderm D7A Negram G4A Harmogen G3C Nephril C3A Heminervi N5B Nobrium N5A Herpid D8A Nolvadex V3A Hydro met C2C Norgesic M3B Hypo vase C2B Norlestrin G3A

Nuelin R3A 1m odium A7C Nutrizym A94 lmperacin JlA Imuran V2C Opilon C4A lnderal CID Oraldene R2A Indocid MIA Orbenin JlH In tal R3A Orudis MIA

Ospolot N3A Keflex JlD Otrivine RIA Kelfizine J3A Ovulen 50 G3A Kenalog H2A

Parlodel G3C Larodopa N4A Penbritin JlC La six C3B Persantin CID Lasonil C5B Pexid CID Libraxin A3C Pimafucin GlA Limbitrol N6C Ponderax A8A Lincocin JlF Pons tan N2B Lioresal M3B P.R. Spray M2A Locoid D7A Praxilene C4A Lopresor C2B Prinalgin MIA Lomotil +Neomycin A7A Progynova G3C Lomotil A7A Propaderm D7A Ludiomil N6A Prothiaden N6A

Product name

(a)

Pro vera Pulmadil

Quest ran

Reacitvan Remiderm RetinA Rifadin Rimactane Robaxisal Rynacrom Rythmodan

Sandomigran Sectral Septrin Sere Serenace Serenid D Sinemet Sinequan Sofradex Sotacor Stromba Stugeron Surmontil Symmetrel Synacthen

NoTES

Appendix II: Sample Drugs

Anatomical classification

(b)

G3D R3A

B4A

N6B D7A DIOA J4A J4A M3B RIA CIB

N2C CID JIE A4A W5A N5A N4A N6A S3C CID Al4A A4A N6A N4A HIA

Product name (a)

Synadrin Synalar

Tagamet Tavegil Tegratol Tenormin Teronac Tetralysal Tetrex Tinaderm Tranxene Trasicor Trental Tryptizol Tixylix

Ultradil Plain Ultraproct

Valium Velosef Ventolin Vibramycin Vis ken Vivalan

Xyloproct

Zyloric

221

Anatomical classification

(b)

CID D7A

A2B R6A N3A C2B A8A JIA JIA DIA N5A C2B C4A N6A R5D

D7A C5A

N5A JID R3A JIA CID N6A

C5A

M4A

(a) From a subset of the Intercontinental Medical Statistics' (IMS) British Pharmaceutical Medical Index covering the 600 leading products in the UK in December 1976.

(b) Anatomical Classification -see Appendix IV.

Appendix III: Responses to Tightness Questionnaire

(a) Tightness ratings

Responding companies Mean Overall A B C D E F G rating rating

Argentina 4 4 3 3 3 4 3 3.4 3 Australia 2 2 I 2 I 2 I 1.6 2 Belgium 3 3 3 3 2 3 3 2.9 3 Brazil 4 5 4 3 4 4 3 3.9 4 Colombia 5 5 3 4 4 4 5 4.3 4 France 2 2 3 3 2 I 2 2.1 2 W. Germany 3 3 2 3 2 3 4 2.9 3 Indonesia 5 5 5 5 4 n.a. 5 4.8 5 Italy 2 2 2 3 2 I 3 2.I 2 Japan I I 1 2 I I I l.l I Mexico 4 5 3 5 4 4 5 4.3 4 New Zealand 3 3 3 3 2 2 2 2.6 3 Philippines 5 4 4 4 4 4 4 4.I 4 Peru 5 5 3 5 4 4 5 4.4 4 Spain 3 4 3 4 3 n.a. 5 3.7 4 UK 2 3 2 2 I 2 1 1.9 2 USA 1 1 1 1 I 1 1 l.O 1 Venezuela 3 2 2 4 2 3 2 2.6 3

NOTES

n.a. = not available

222

Appendix III: Responses to Tightness Questionnaire 223

(b) Tightness rankings

Responding companies Mean Overall A B c D E F G ranking ranking

Argentina 12= 11 11 6= 8= 11 8 9.9 11 Australia 4 4 3 2= 4= 6 3 3.9 3 Belgium 7 8 10 5 8= 8 10 8.1 7 Brazil 14 14 13 6= 11= 13= 11 12.0 12 Colombia 15= 15 15 13= 17= 16 17 15.6 16 France 5 3 9 10 4= 4 6 5.9 5 W. Germany 8 10 5 6= 6= 9 12 8.2 8 Indonesia 18 16 18 16= 15= 17·= 18 17.1 18 Italy 6 6 4 9 10 3 9 6.7 6 Japan 2 2 1 2= 1 2 2 1.9 2 Mexico 12= 17 14 16= 14 17= 14 15.1 15 New Zealand 11 9 8 11 6= 7 7 8.5 9 Philippines 17 12 17 13= 15= 12 13 14.3 14 Peru 15= 18 16 16= 17= 15 16 16.4 17 Spain 9= 13 12 12 11 = 13·= 15 12.4 13 UK 3 7 6 2= 3 5 4 4.4 4 USA 1 1 2 1 2 1 1 1.3 1 Venezuela 9= 5 7 15 11= 10 5 9.1 10

NOTES • = estimated

Appendix IV: Anatomical Classification* A

AI

AlA

A2

A 2A A 2Al A 2A2 A 2A3 A 2A4 A 2A5 A 2A6 A 2A7

A 2B

A 2C

A 3

A 3A A 3B A 3C A 3D A 3E

A4

A 4A

ALIMENTARY TRACT AND METABOLISM

STOMATOLOGICALS, MOUTH PREPARATIONS, MEDICINAL DENTIFRICES ETC.

Stomatologicals

ANTACIDS, ANTI-FLATULENTS AND ANTI-PEPTIC ULCERANTS Antacids, Anti-Flatulents Plain Antacids Plain Anti-Flatulents Antacids with Anti-Spasmodics Antacids with Anti-Flatulents Antacids with Anti-Flatulents and Anti-Spasmodics Antacids with Other Drugs Anti-Flatulents with Other Drugs

Anti-Peptic Ulcerants

Others

GASTROINTESTINAL ANTI-SPASMODICS AND ANTI-CHOLINERGICS

Synthetics Belladonnas and Derivatives Ataractic Combinations Analgesic Combinations Other Combinations

ANTI-EMETICS AND ANTI-NAUSEANTS

Anti-Emetics and Anti-Nauseants

224

Appendix IV: Anatomical Classification* 225

A 5 CHOLAGOGUES AND HEPATIC PROTECTORS

A 5A Bile Therapy, Cholagogues and Choleretics A 5B Hepatic Protectors, Lipotropics A 5C Cholagogue, Lipotropic Combinations

A6 LAXATIVES

A 6A Laxatives A 6Al Softeners and Emollients A 6A2 Irritants and Stimulants A 6A3 Bulk Producers A 6A4 Enemas A 6A5 Laxative Saline Preparations A 6A6 Others, including Combinations

A 7 ANTI-DIARRHOEALS AND INTESTINAL DISINFECT ANTS

A 7A Intestinal Anti-Infectives and Their Combinations A 7Al Plain A 7A2 Combinations

A 7B Intestinal Adsorbents

A 7C Others, including Lactic Ferments and Yeast

A 8 ANTI-OBESITY PREPARATIONS EXCLUDING DIETETICS

A 8A Anti-Obesity Preparations Excluding Dietetics A 8Al Amphetamine Plain A 8A2 Amphetamine Combinations A 8A3 Other Centrally Acting Anti-Obesity Products Plain A 8A4 Other Centrally Acting Anti-Obesity Combinations A 8A5 Other Anti-Obesity Preparations

A9 DIGESTIVES, INCLUDING DIGESTIVE ENZYMES

A 9A Digestives, Including Enzymes

AlO ANTI-DIABETIC THERAPY

A lOA Insulins A lOB Oral Anti-Diabetics

226

All

AliA AllAl A11A2 A11A3 AllA4

AllB AliBI A11B2 AllB3 A11B4

AllC AllCl A11C2 A11C3

The International Diffusion of Pharmaceuticals

VITAMINS

Multivitamins with Minerals Prenatal Paediatric Geriatric Others

Multivitamins without Minerals Prenatal Paediatric Geriatric Others

Vitamin A and D, Including Simple Combinations Plain A Plain D Combinations

AllD Vitamin Bl, Plain and Combinations of Bl, B6, B12 AllDl Vitamin Bl, Plain or with B6 and B12 A11D2 Vitamin Bl, B6, B12 with Other Drugs AilE AllEl A11E2 A11E3

AllF

AllG AllGl A11G2

AllH AllHl A11H2 A11H3

AllJ

Al2

A12A A12B A12C

Vitamin B Complex B Complex Plain B Complex with Vitamin C Other Combinations

Vitamin B12 Plain

Vitamin C, Including Combinations with Minerals Plain Vitamin C Vitamin C with Combinations

Other Plain Vitamins Excluding K and P Nicotinic Acid Vitamin B6 Others

All Others

MINERAL SUPPLEMENTS

Calcium Potassium Other Mineral Supplements


Al3 TONICS A13A Tonics

Al4 ANABOLICS, SYSTEMIC Al4A Anabolic Hormones Al4Al Plain Anabolic Hormones Al4A2 Anabolic Hormones with Vitamins Only Al4A3 Other Anabolic Hormone Combinations

Al4B Other Anabolic Agents

Al5 APPETITE STIMULANTS

Al5A Appetite Stimulants

Al6 OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS

Al6A Other Alimentary Tract and Metabolism Products

B BLOOD AND BLOOD FORMING ORGANS

B 1 ANTI-COAGULANTS

B lAl Anti-Coagulants Oral B 1A2 Anti-coagulants Injectable

B 2 ANTI-HAEMMORRHAGICS

B 2A Anti-Fibrinolytics B 2B Vitamin K and Others

B 3 ANTI-ANAEMIC PREPARATIONS

B 3A Haematinics, Iron and All Combinations B 3Al Plain Iron B 3A2 Combinations

B 3B Liver Extracts and Combinations with Bl2

B 3C Others, Including Plain Folic Acid

B 4 CHOLESTEROL REDUCERS AND ANTI-ATHEROMA PREPARATIONS

B 4A Cholesterol Reducers and Anti-Atheroma Preparations

228

B 5

B 5A B 5A1 B 5A2

B 5A3

B 5B B 5B1 B 5B2 B 5B3 B 5B4

B 5C

B 50

B 5E

B 6

B 6A

B 6A1 B 6A2

c

c 1

C 1A C 1A1 C 1A2

C 1B

C 1C

C 1D C 101 c 102

c 103

C 1E


PLASMA SUBSTITUTES AND PERFUSION SOLUTIONS

Blood and Related Plasma Substitutes Including Dextran Whole Blood and Products of Whole Blood Including Plasma and Plasma Fractions

Others

I.V. Solutions over 50 c.c. Dextrose Electrolytes Normal Saline Others

Irrigating Solutions

Peritoneal Dialytics

LV. Solutions Under 50 c.c.

OTHER HAEMATOLOGICAL AGENTS, INCLUDING FIBRINOL YTICS AND HYALURONIDASE

Other Haematological Agents, Including Fibrinolytics and Hyaluronidase Systemic Topical

CARDIOVASCULAR SYSTEM

CARDIAC THERAPY

Cardiac Glycosides and Combinations Plain Cardiac Glycosides Cardiac Glycosides with Combinations

Anti-Arrythmics

Cardiac and Respiratory Stimulants

Myocardial Therapy excluding C 1A, C 1B, C 1C Coronary Vasodilators Beta Blocking Agents Excluding Products Classified in C 2B

Others

Other Cardiac Perparations

c 2

C 2A

C 2B

C 2C C 2CI C 2C2

C 2D

c 3

C 3A C 3B

C4 C 4A

c 5

C SA C 5Al C 5A2

C 5B

C 5C

c 6

C 6A

D

D I

DIA D IAI D IA2

D2

D 2A


HYPOTENSIVE$

Rauwolfia Alkaloids and Derivatives, Plain and in Combination, excluding Combinations with Diuretics

Synthetic Hypotensives, Plain and in Combination excluding Combinations with diuretics

Hypotensive Combinations with Diuretics Rauwolfia Diuretic Combinations Synthetic Hypotensive Diuretic Combinations

Other Hypotensives

DIURETICS

Thiazides and Combinations Other Diuretics

PERIPHERAL VASODILATORS

Peripheral Vasodilators

V ASOPROTECTIVES

Topical Anti-Haemorrhoidals With Corticosteroids Without Corticosteroids

Anti-Varicose Therapy, T apical

Systemic Vasoprotectives

OTHER CARDIOVASCULAR PRODUCTS

Other Cardiovascular Products

DERMATOLOGICAL$

ANTI-FUNGALS, DERMATOLOGICAL

Anti-Fungals, Dermatological Topical Systemic, Griseofulvin-Type Products

EMOLLIENTS AND PROTECTIVES

Emollients and Protectives

230

D 3

D 3A

D4

D 4A

D 5

D SA

D6

D 6A D 6B D 6C

D 7

D 7A

D 7B D 7Bl D 7B2 D 7B3 D 7B4

D 8

D 8A


CICATRIZANTS, EXCLUDING MEDICATED DRESSINGS

Cicatrizants, Excluding Medicated Dressings

ANTI-PRURITICS, INCLUDING TOPICAL ANTIHISTAMINES, ANAESTHETICS, ETC.

Anti-Pruritics, Including Topical Antihistamines, Anaesthetics, etc.

COAL TAR, SULPHUR AND RESORCINOL PREPARATIONS, NOT OTHERWISE CLASSIFIED

Coal Tar, Sulphur and Resorcinol Preparations

TOPICAL ANTIBIOTICS AND SULPHONAMIDES EXCLUDING COMBINATIONS WITH STEROIDS

Topical Antibiotics Plain Topical Sulphonamides Plain Topical Antibiotics with Sulphonamides

TOPICAL CORTICOSTEROIDS

Topical Corticosteroids Plain

Topical Corticosteroid Combinations With Antiseptics With Anti-infectives With Antifungals Other Combinations

ANTISEPTICS AND DISINFECT ANTS, EXCLUDING MEDICATED DRESSINGS

Antiseptics and Disinfectants, Excluding Medicated Dressings

D 9 MEDICATED DRESSINGS

D 9A Medicated Dressings

DlO ANTI-ACNE PREPARATIONS

D 1 OA Anti-Acne Preparations

Dll

DllA

G

G

GlA G lAl G 1A2

G2

G 2A G 2B G 2C

G 3

G 3A

G 3B

G 3C

G 3D

G 3E G 3El G 3E2 G 3E3

G 3F

G 3G

G 3H

G4

G 4A

Appendix IV: Anatomical Classification*

OTHER DERMATOLOGICAL PREPARATIONS, INCLUDING MEDICATED SHAMPOOS

231

Other Dermatological Preparations, Including Medicated Shampoos

GENITO-URINARY SYSTEM AND SEX HORMONES

GYNAECOLOGICAL ANTI-INFECTIVES

Gynaecological Anti-Infectives Systemic Topical

OTHER GYNAECOLOGICALS

Oxytocics Topical Contraceptives Other Gynaecologicals

SEX HORMONES AND STIMULANTS GENITAL SYSTEMS

Hormonal Contraceptives, Non-Topical

Androgens and Combinations, Excluding G 3E, G 3F

Oestrogens and Combinations, Excluding G 3E, G 3F

Progestogens and Combinations, Excluding G 3F

Androgen and Female Hormone Combinations Androgen and Oestrogen Androgen and Progestogen Androgen and Oestrogen and Progestogen

Oestrogen and Progestogen Combinations

Gonadotrophins Including Other Ovulation Stimulants -e.g. Clomiphene Citrate

Other Sex Hormones

UROLOGICALS

Urinary Antiseptics and Anti-Infectives

232

G 4Al

G 4A2

G 4B

H

HI

HlA

H2

H 2A H 2Al H 2A2 H 2A3

H 2B H 2Bl H 2B2 H 2B3

H 3

H 3A H 3B H 3C

H4

H 4A

J

J 1

J IA

J IB


Specific Sulphonamides and Combinations with Antibiotics

Other Urinary Antiseptics

Other Urological Preparations Including Denito-Urinary Tract Anti-Spasmodics

SYSTEMIC HORMONAL PREPARATIONS EXCLUDING SEX HORMONES

ACTH

Acth

SYSTEMIC CORTICOSTEROIDS

Systemic Corticosteroids Plain Injectable Oral Others

Systemic corticosteroid Combinations Injectable Oral Others

THYROID THERAPY

Thyroid Preparations Anti-Thyroid Preparations Iodine Therapy

ALL OTHER HORMONES

All Other Hormones Including Glucagon

GENERAL ANTI-INFECTIVES SYSTEMIC

ANTIBIOTIC SYSTEMIC INCLUDING TRIMETHOPRIM

Tetracyclines and Combinations

Chloramphenicols and Combinations


J 1 C Ampicillin and Similar Types

J 1 D Cephalosporins

J IE Trimethoprim Combinations and Similar Types

J 1 F Macrolides and Similar Types

J 1 G Streptomycins and Combinations Between Themselves

J 1 H Other Penicillins

J lJ Penicillin Streptomycin Combinations

J lK All Other Antibiotics

J 2 AGENTS FOR SYSTEMIC FUNGAL INFECTIONS EXCLUDING GRISEOFULVIN

233

J 2A Agents for Systemic Fungal Infectious excluding Griseofulvin

J 3 SYSTEMIC ANTIBACTERIALS

J 3A Sulphonamides J 3B Sulphonamide Antibiotic Combinations, Excluding Tri

methoprim Combinations

J 3C Other Antibacterials

J 4 TUBERCULOSTATICS, EXCLUDING STREPTOMYCIN

J 4A Tuberculostatics, Excluding Streptomycin

J 5 ANTIVIRALS, EXCLUDING VACCINES

J SA Antivirals, Excluding Vaccines

J 6 SERA AND GAMMA GLOBULIN

J 6A Sera and Gamma Globulin

J 7 VACCINES

J 7 A Vaccines


J 8 OTHER ANTI-INFECTIVES, INCLUDING LEPROST A TICS

J 8A Other Anti-Infectives, Including Leprostatics

M MUSCULO-SKELETAL SYSTEM

M ANTI-INFLAMMATORY AND ANTI-RHEUMATIC PRODUCTS

M lA Anti-Rheumatic Non-Steroids M lAl Plain M 1A2 Combinations

M lB

M2

M 2A

M3

M 3A

M 3B M 3Bl M 3B2

M4

M 4A

M5

M SA

N

Nl NlA N lAl N 1A2

N lB

Anti-Rheumatic Corticosteroid Combinations

TOPICAL ANTI-RHEUMATICS RUBEFACIENTS

Topical Anti-Rheumatics Rubefacients

MUSCLE RELAXANTS

Muscle Relaxants, Injectable

Other Systemics Plain Combinations

ANTI-GOUT PREPARATIONS

Anti-Gout Preparations

OTHER DRUGS FOR DISORDERS OF MUSCULOSKELETAL SYSTEM

Other Drugs for Disorders of Musculo-Skeletal System

CENTRAL NERVOUS SYSTEM

Anaesthetics Anaesthetics General Inhalation Preparations Injectable

Anaesthetics Local, Except Dermatologicals

N2

N 2A N 2B N 2C

N 3

N 3A

N4

N 4A N 4Al N 4A2

N S

N SA N SAl N SA2

N SB N SBl N SB2 N SB3 N SB4

N6

N 6A N 6B

N 6C

N7

N 7A


ANALGESICS

Narcotics Non-Narcotics and Anti-Pyretics Anti-Migraine Preparations

ANTI-EPILEPTICS

Anti-Epileptics

ANTI-PARKINSON DRUGS

Anti-Parkinson Drugs Intravenous Others

PSYCHOLEPTICS

Ataractics Neuroleptics Tranquillizers

Hypnotics and Sedatives Non-Barbiturates, Plain Non-Barbiturate Combinations Barbiturates, Plain Barbiturate Combinations

PSYCHO-ANALEPTICS, EXCLUDING ANTIOBESITY PREPARATIONS -SEE A 8Al, A 8A2, A 8A3, A 8A4

Anti-Depressants, Thymo-Analeptics Psycho-Stimulants and Neurotonics excluding Amphetamines Psycholeptic, Psychoanaleptic Combinations

OTHER CNS DRUGS, INCLUDING PARASYMPATHETIC AGENTS

Other CNS Drugs, Including Para-Sympathetic Agents

23S

236

p

p 1

P 1A P 1B P 1C p 1D P 1E P 1F P 1G

R

R 1

R 1A R 1A1 R 1A2 R 1A3 R 1A4 R lAS

R 2

R 2A

R 3

R 3A R 3A1 R 3A2

R 3B

R4

R 4A

R S

R SA R SB


PARASITOLOGY

ANTI-PARASITIC PRODUCTS

Amoebicides Anthelmintics, Excluding Schistosomicides Schistosomicides Anti-Malarials Scabicides Ectoparasiticides, Excluding Scabicides Other Anti-Parasitic Agents

RESPIRATORY SYSTEM

NASAL DECONGEST ANTS AND ANTI-INFECTIVES

Nasal Decongestants and Anti-Infectives, Topical Plain Corticosteroids Plain Non-Corticosteroids Corticosteroids with Anti-Infectives Non-Corticosteroids with Anti-Infectives Others

PHARYNGEAL DECONGEST ANTS AND ANTIINFECTIVES

Pharyngeal Decongestants and Anti-Infectives

ANTI -ASTHMA TICS

Bronchodilators and Other Anti-Asthmatics Inhalants Others

Other Anti-Asthmatics- Respiratory Stimulants

CHEST RUBS AND OTHER INHALANTS

Chest Rubs and Other Inhalants

COUGH AND COLD PREPARATIONS

Cold Preparations Excluding Anti-Infectives Anti-Infective Cold Preparations


R5C Expectorants Including Balsamicos R 5Cl With Anti-Infectives R 5C2 Without Anti-Infectives

R 50 Cough Sedatives R 501 Antitussives Plain R 502 Others, Including Combinations

R 5E Nasal Decongestants and Anti-lnfectives Systemic

R SF Other Cough and Cold Preparations

R 6 ANTIHISTAMINES, SYSTEMIC

R 6A Antihistamines, Systemic

R 7 OTHER RESPIRATORY SYSTEM PRODUCTS

R 7A Other Respiratory System Products

s SENSORY ORGANS

s 1 Ophthalmologicals

S lA Anti-Infectives S lB Corticosteroids Plain S lC Corticosteroid Anti-Infective Combinations s 10 Others

s 2 OTOLOGICALS

S 2A Anti-Infectives S 2B Corticosteroids Plain S 2C Corticosteroid Anti-Infective Combinations s 20 Others

s 3 OPHTHALMOLOGICAL -OTOLOGICAL COMBINATIONS

S 3A Anti-Infectives S 3B Corticosteroids Plain S 3C Corticosteroid Anti-Infective Combinations S 3D Others

238

v

v 1

VIA

v 2

V 2A V 2B V 2C

v 3

V 3A

V4

V 4A V 4B V 4C

v 5

V 5A

V6

V 6A V 6B V 6C v 6D

v 7

V 7A V 7B V 7C v 7D V 7E V 7F V 7G


VARIOUS

ALLERGENS

Allergens

CYTOSTATIC AND IMMUNO-SUPPRESSIVE DRUGS

Anti-Leukaemics Other Cytostatics Immuno-Suppressive Drugs

ALL OTHER THERAPEUTIC PRODUCTS

All Other Therapeutic Products

DIAGNOSTIC AGENTS

Radio Contrast Media Urine Tests Other Diagnostic Agents

SURGICAL ANTISEPTICS

Surgical Antiseptics

GENERAL NUTRIENTS

Slimming Preparations Protein Supplements Infant Formulas Other Nutrients

ALL OTHER NON-THERAPEUTIC PRODUCTS

All Other Non-Therapeutic Products Toothpastes Other Non-Therapeutic Stomatologicals Artificial Sugar /Salt Substitutes Nappy Care Products Toiletry Products Contact Lens Care

* As used by Intercontinental Medical Statistics (IMS)

Appendix V: Downward Bias in Arrival Time Lag Figures Post-1-71

Original introduction date

Pre-1-61 Post-1-61 and Pre-1-71 Post-1-71

Mean arrival time lag

(months)

76.5

40.8 22.8

The table above suggests that mean arrival time lag declines between the three time periods. Analysis of variance indicates that Fis significant at the 0.1 per cent level. But the mean arrival time lag for post-1-71 introductions may be prey to a strong downward bias. These drugs may not have had sufficient time to reach many countries. The low arrival time lag figure may therefore be spurious. The figures below appraise the likelihood of such an occurrence.


Pre-1-71 Post-1-71

Mean number of countries

of introduction

9.9 8.2

The figures in the table above suggest that there is a tendency for post-1-71 introductions to go to fewer countries but that this is unlikely to be strong.

When original introduction dates ( ± 1-61) are correlated with numbers of countries of introduction per drug, the correlation coefficient

239


(Pearson) is - 0.44, where N = 192. The sign of the coefficient is consistent with fewer countries of introduction per drug for more recently discovered pharmaceuticals. But the correlation is not significant statistically.

As a precaution a 'core' sample is also used. The 'core' is defined as those drugs that are introduced into 10 or more countries. This is a device to standardise for the numbers of countries reached by pharmaceuticals. In effect the arrival time lag figures calculated for the core drugs, side-steps the 'country coverage bias' problem. The 3 tables below set out the results.


Pre-1-71 Post-1-71


Pre-1-71 Post-1-71


Pre-1-71 Post-1-71

Number of drugs in

10+ countries

73 16

Mean number of countries

of introduction

13.7 12.9

Mean time taken to reach lOth

country (months)

57.5 52.9

Mean number of countries of introduction reached in:

Mean arrival time

lag (months)

73.0 50.8

12 months 24 months 48 months

3.8 5.0 7.0 3.5 5.3 7.6

When the correlation coefficient between the original introduction date ( ± 1-61) and numbers of countries of introduction for the core sample, is calculated r = - 0.04, when N = 89. The correlation is not statistically significant.

Appendix V: Downward Bias in Arrival Time Lag Figures 241

COMMENT

Use of the 1-71 comparison base does not seem to have generated a spurious result. It is unlikely that the lower mean arrival time lag post-1-71 is a product of fewer arrivals. This impression is confirmed when the sample is standardised for number of countries reached, by the 10 + 'core' procedure. The difference between the mean arrival time lag figures in the first of the last 3 tables is significant at the 0.1 per cent level using the t test.

Notes CHAPTER 1 SPATIAL DIFFUSION

1. See Sam Peltzman, Regulation of Pharmaceutical Innovation, American Enterprise Institute, 1974.

2. See for example: W. M. Wardell, 'The Drug Lag: an International Comparison', Proceedings of the Fifth International Pharmacological Congress (July 1972); Wardell, 'Introduction of New Therapeutic Drugs in the United States and Great Britain: An International Comparison', Clinical Pharmacology and Therapeutics, vol. 14, no. 5 (Sept.-Oct. 1973) pp. 773-90; Wardell, 'The Drug Lag Revisited: Comparison by Therapeutic Area of Patterns of Drugs marketed in the United States and Great Britain from 1972-1976', Clinical Pharmacology and Therapeutics, vol. 24, no. 5 (Nov. 1978) pp. 499-524.

3. At a late stage some application data became available. This is described in Chapter 7.

4. J. E. S. Parker, The Economics of Innovation, Longman, 1974 and 2nd edn, 1978.

5. J. E. S. Parker, ibid. 6. C. T. Taylor and Z. A. Silberston, The Economic Impact of the Patent System;

a study of the British experience, Cambridge University Press, 1973. 7. For a summary of the Convention and its operation see: Special Issue on

Patents World Development vol. 2, no. 9 (Sept. 1974).

CHAPTER 2 THE SAMPLE

1. At a late stage in the preparation of this book some information became available on application dates. This is presented in Chapter 7.

CHAPTER 3 DIFFUSION LAGS

I. See F. Gross, 'Directions and Implicatior.s of Drug Legislation and Regulation in Europe', Publication Series 8035 and 8036, June 1980, Center for Study of Drug Development Rochester, New York.

2. For example, International Drug Registration. IFPMA Symposium Geneva, 2-5 October 1979. International Federation of Pharmaceutical Manufacturers Association (IFPMA) 1979.

3. For Example William M. Wardell (ed.), Controlling the Use of Therapeutic Drugs; an International Comparison, American Enterprise Institute, 1978.

242

Notes 243

4. IFPMA, Legal and Practical Requirements for the Registration of Drugs (Medicinal Products) for Human Use, Zurich, Switzerland 1975 or 1980 edn.

5. At a late stage in the preparation of this book some information became available on application dates. This is presented in Chapter 7.

CHAPTER 4 REGULATORY TIGHTNESS

1. William M. Wardell 'The Drug Lag: an International Comparison', Proceedings of the Fifth International Pharmacological Congress (July 1972).

2. IFPMA Legal & Practical Requirements for the Registration of Drugs (Medicinal Products) for Human Use, Zurich, Switzerland 1975 or 1980 edn.

CHAPTER 5 THE THERAPEUTIC IMPORTANCE OF DRUGS

1. Sam Peltzman, 'The Diffusion of Pharmaceutical Innovation' in Robert B. Helsm (ed.) Drug Development & Marketing, American Enterprise Institute, 1975.

2. I am most grateful, in particular to Dr D. W. J. Clark of the Department of Pharmacology, Otago University.

3. Innovative Activity in the Pharmaceutical Industry, National Economic Development Office, London 1973.

4. William M. Wardell, 'The Drug Lag Revisited', Clinical Pharmacology and Therapeutics vol. 24, no. 5 (Nov. 1978).

CHAPTER 6 LESS DEVELOPED NATIONS

1. See J. E. S. Parker, The Economics of Innovation: the National and multinational Enterprise in Technological change, 2nd edn, Longman, 1978.

2. Henry G. Grabowski, 'Regulation and the International Diffusion of Pharmaceuticals' in Robert B. Holms (ed.), The International Supply of Medicine, American Enterprise Institute, 1980.

CHAPTER 7 REGULATION LAG

I. Certificates of free sale or Certificates of Authorisation may apply not only to the country of origin but also to the country of export. Most of the less developed countries in the sample used here, apply some sort of 'free sale' requirement.

2. Except where Certificate of free sale restrictions apply.

Index Arrival Time Lag or Diffusion Lag,

chs 3-7, 31-136, 161, 162, 186, 201-7

Defined, I, 25, 26, 31-3 Downward Bias, 47-9, Appendix

v Argentina, 17, 21, 29, 33, 36, 40, 41,

43, 61, 63, 73, 90, 93, 94, ll2, 114, ll7, 118, ll9, 128, 135, 152, 153, 156, 164, 167, 169, 191, 193, 194

Australia, 17, 21, 29, 33, 35, 36, 40, 41, 43, 44, 45, 57, 61, 63_, 73, 90, 93, 94, ll2, ll4, ll7, 118, 119, 128, 152, 153, 154, 156, 164, 167, 169, 191, 193, 194, 196

Belgium, 17, 21, 29, 33, 34, 36, 39, 40, 41, 43, 45, 61, 63, 73, 90, 93, 94, 112, ll4, ll7, 118, 119, 128, 152, 153, 154, 156, 164, 167, 169, 191, 193, 194

Brazil, 17, 21, 29, 33, 36, 40, 41, 43, 61, 63, 73, 90, 93, 94, 112, 114, 115, ll7, 118,119,128,135, 152, 153, 156, 164, 167, 169, 191, 193, 194

Classification Problems, 173-80 Certificate of Free Sale, 195, 243 Colombia, 17, 21, 29, 33, 36, 40, 41,

43, 61, 63, 73, 78, 90, 93, 94, 112, 114, 115, 117, 118, 119, 128, 135, 152, 153, 156, 164, 167, 169, 191, 193, 194

Committee on Safety of Medicine (CSM), 24

Diffusion Lag, see Arrival Time Lag

Drug Lag, I, 59, 76-81, 105, 154, 157

Food and Drug Administration (FDA), 24, 52, 59, 71, 105, 131, 132, 163

France, 17, 21, 29, 33, 36, 40, 41, 43, 45, 61, 63, 73, 90, 93, 94, 98, 112, 114, ll5, 117, 118, 119, 128, 152, 153, 156, 164, 167, 169, 191, 193, 194

Grabowski, Henry G., 131, 132 Gross, F., 31

Home Marketing Overseas Application Lag (HMOAL), 161, 162, 165-74, 177-80, 182-6, 199, 200, 208-9, 2ll-12, 215

244

Important Drugs, 79, 80, ch. 5, 87-lll, 113-16, ll8, 131, 133, 155

Defined, 87-8 Indonesia, 17, 21, 29, 33, 36, 40, 41,

43, 61, 63, 73, 90, 92, 93, 94, 112, 114, ll7, ll8, 119, 128, 135, 152, 153, 156, 164, 167, 169, 191, 193, 194

International Federation of Pharmaceutical Manufacturers Associations (IFPMA), 51, 60

Intercontinental Medical Statistics (IMS), 10, 16, 17, 18, 27, 29, 39, 66

Italy, 17, 21, 29, 33, 36, 40, 41, 43, 45, 61, 63, 73, 90, 93, 94, 98, ll2, ll4, ll5, ll7, ll8, ll9, 128, 152, 153, 154, 156, 164, 167, 169, 191, 193, 196

Index 245

Japan, 17, 21, 29, 33, 36, 40, 41, 43, 45, 61, 63, 73, 90, 92, 93, 94, 98, 109, 112, 114, 115, 117, 118, 119, 128, 152, 153, 156, 163, 164, 167, 168, 169, 191, 192, 193, 194, 196

Less Developed Nations, 5, 13, 15, 17, 23, 25, 68, 69, 101, 104, ch. 6, 112-36, 197, 199, 200-l, 208-9, 214, 215

Merck Index, 53 Mexico, 17, 21, 29, 33, 36, 40, 41,

43, 61, 63, 73, 90, 93, 94, 112, 114, 115, 117, 118, 119, 128, 135, 152, 153, 156, 164, 167, 169, 191, 193, 194

Multinational Companies, 2, 3, 4, 9, 14, 25, 49, 56, 57, 120-1, 130, 133, 135, 161, 190, 213, 215

Multiple Correlations, 127-33, 201-7

National Economic Development Office (NEDO), 87

New Drug Application (NDA), 131, 132, 140-2, 158

New Zealand, 17, 21, 29, 33, 36, 40, 41, 43, 45, 61, 63, 73, 90, 93, 94, 112, 114, 117, 118, 119, 128, 152, 153, 154, 156, 164, 167, 168, 169, 191, 193, 194

Non-Arrival, 23, 77-81

Overseas Application Lag (OAL), 161-5, 170-l, 174-7, 179-82, 186-7, 194-8, 201, 204-9, 211-13, 215-17

Parker, J. E. S., 4, 7, 120 Patents, 7-10, 14-15, 53-6, 58

International Convention, 7-9, 15, Appendix I

Pharma Information, 18, 19 Peltzmann, Sam, l, 87 Peru, 17, 19, 21, 29, 33, 36, 40, 41,

43, 61, 63, 73, 90, 92, 93, 94, 112, 114, 117, 118, 119, 128,

135, 152, 153, 156, 164, 167, 169, 191, 193, 194, 196

Philippines, 17, 21, 29, 33, 36, 40, 41, 43, 61, 63, 73, 90, 93, 94, 112, 114, 117, 118, 119, 128, 135, 152, 153, 156, 164, 167, 169, 191, 193, 194

Regulation, Application Strategies, 3, 25, 26,

30, 49, 50-3, 57, 58, 73, 122, 135, 161-85, 196-201, 208, 213, 214, 215

and the Definition of Arrival Time Lag, 24, 25, 26, 27, 29, 30

and Country Coverage, 94-8 Harmonisation, 50-3, 58 and Less Developed Nations,

121-6, 127-9, 133, 134, 135, 136, 196-201, 213, 214

and Market Size, 65-76, 81, 84-6, 215, 216

and Patenting, 8, 9, 53-6 Questionnaire, 43, 60-2, 65 Regulation Lag, ch. 7, 137-214 Tightness or Stringency, 2, 3, 4,

11, 13, 25, 27, 43, 49, 53, 57, ch. 4, 59-86, 94, 96, 97, 98, 100, 111, 121-6 and ch. 7, 137-214, 215, 216

Research and Development, 7, 14, 50, 160

Risk Aversion, 4, 12, 68, 69-70, 73, 76, 85, 130, 215-16

Rochester School of Medicine and Dentistry, 18, 19

Sample, l 0, ch. 2, 16-30 Core Sample, 41-6 Sub-Sample 137-8

Salk Vaccine, 4, 87 Silberston, Z. A., 7 Spain, 17, 21, 29, 33, 36, 40, 41, 43,

61, 63, 73, 90, 93, 94, 112, 114, 117, 118, 119, 128, 135, 152, 153, 156, 164, 167, 169, 191, 193, 194 .

Switzerland, 17, 18, 29, 137, 157, 210

246 Index

Taylor, C. T., 7 Therapeutic Step, 2, 4, 10, 12, 13

Defined, 87-8 Transmission Time (TT), 185-94,

198-201, 205-8, 212-13, 215

UK, 16, 17, 19, 21, 23, 24, 27, 29, 31, 32, 33, 36, 40, 41, 43, 45, 51, 52, 61, 63, 65, 69, 73, 77, 90, 92, 93, 94, 112, 114, ll7, 118, 119, 128, 144, 152, 153, 156, 164, 167, 169, 191, 193, 194

USA 17, 21, 24, 29, 31, 32, 33, 34, 35, 36, 40, 41, 43, 45, 51, 52, 57, 61, 62, 63, 65, 69, 70, 71, 73, 75, 76, 77, 90, 92, 93, 94, 98, 109, 112, 114, 115, 117, 118, 119, 128, 152, 153, 154, 156,

163, 164, 167, 168, 169, 190, 192, 193, 194, 196

Venezuela, 17, 21, 29, 33, 36, 40, 41, 43, 61, 63, 73, 90, 93, 94, 112, 114, 117, 118, 119, 128, 135, 152, 153, 154, 156, 164, 167, 169, 191, 193, 194.

Wardell, William, M., l, 18, 51, 59, 105

West Germany, 17, 21, 29, 33, 36, 40, 41, 43, 45, 51, 52, 61, 63, 65, 69, 73, 77, 90, 93, 94, 112, 114, 115, 117, 118, 119, 128, 152, 153, 156, 164, 167, 169, 191, 193, 194

World Health Organisation (WHO), 50

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