Transcript Generics and public health - WHO archives

Generics and public health
Dr Valerio Reggi
Department of Essential Drugs and Medicines Policy - EDM
World Health Organization
October 2003
Definitions
Generics are pharmaceutical products that
contain well-established drugs.
They are:
intended to be interchangeable with the
original product,
usually manufactured without a licence from
the original manufacturer,
marketed after the expiry of patent or
other exclusivity rights,
marketed either under a non-proprietary
name (INN or other approved name) or under
brand names ("branded generics").
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What are the potential benefits of generics?
Better access to needed medicines.
Well chosen generics make government or household
spend less without loss of quality or safety
1998 study by US Congressional Budget Office:
average generic medicine prescription price was less
than one third of average price of single-source
innovator brand drug
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Price differentials between generic and brand
products vary greatly among countries
Belgium
Italy
Spain
Germany
France
Canada
UK
US
20%
20% +
25%
25% - 30%
25% - 35%
40% - 50%
80% +
50% - 90%
Source: IMS, Pharma Strategy Group
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What are the potential benefits of generics?
Impact on the price of non-generics through
competition:
generics may be the only way to bring price
competition to a market that is based on product
differentiation, patent protection and heavy brand
promotion to both prescribers and patients access
to needed medicines.
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Why are generics less expensive?
Not because they are inherently different in
composition from patented drugs,
but mainly because of the structure of the generics
market: competitive, free from IPRs, often without
the R&D and particularly the marketing cost that
goes into branded proprietary drugs
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The worldwide role of generic pharmaceuticals
Public health need
National strategies
Social responsibility
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The worldwide role of generic pharmaceuticals
Public health need
National strategies
Social responsibility
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WHO - EDM
Public health need
In poor countries drugs are largest household
and second largest public expenditure for health
Pharmaceutical spending, as % of total health spending
Greece
Germany
Italy
France
Spain
Denmark
UK
United States
Netherlands
Norway
Developed countries
(7 - 20%)
Bulgaria
Czech Rep.
Hungary
Croatia
Poland
Estonia
Slovenia
Lithuania
Transitional countries
(15 - 30%)
Mali
Egypt
China
Indonesia
Thailand
Tunisia
Jordan
Argentina
South Africa
Developing countries
(24 - 66 %)
0
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10
20
30
40
50
60
WHO - EDM
70
Public health need
The cost of medicine is substantial - number
of working hours to pay full treatment course
600
500
Hours
500
400
460
And the burden falls heaviest on those least able to
pay:
Developed countries: 50-90 % publicly funded
Developing countries: 50-90 % paid out-of-pocket
Tuberculosis
300
Shigellosis
200
120
100
Gonorrhoea
100 100
20
0
Tanzania
Zimbabwe
20
20
6
Thailand
Based on average worldwide price and national
per capita income. Source: WHO/DAP
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1.4 1.4 0.4
Switzerland
WHO - EDM
Public health need
Despite the potential health impact and expenditure,
too many people still lack access to essential drugs

>1/3 of world’s
population lacks
regular access

320 million in Africa
have <50%

Problem worsens
with economic
pressures
Percentage of populations and number of countries with regular access to essential drugs:
1 = <50%
2 = 50-80%
3 = 80-95%
4 = >95%
5 = No data available
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(43)
(64)
(30)
(41)
(1)
WHO - EDM
Public health need
Millions of children and adults still die from
diseases readily treated with generic essential drugs
Developing Country Deaths (millions) 1990
INFECTIOUS & PARASITIC DISEASES
Respiratory infections
Age 5 & over
Under 5
Diarrhoeal disease
Tuberculosis
Measles
Malaria
Tetanus
Pertussis
HIV
Meningitis
NON-COMMUNICABLE DISEASES - A GROWING CHALLENGE
Heart attacks, strokes
Cancer
0
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1
2
3
4
5
WHO - EDM
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The worldwide role of generic pharmaceuticals
Public health need
National strategies
Social responsibility
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National strategies
As of the mid-1990’s, few countries had
achieved large generic coverage
D E V E LO P E D C O UN T R IE S
D e nm a rk
Unit e d S t a t e s
Unit e d Kingdo m
G e rm a ny
N e t he rla nds
Ire la nd
P o rt uga l
N e w Z e a la nd
J a pa n
F ra nc e
S pa in
D E V E LO P IN G C O UN T R IE S
Indo ne s ia
M o ro c c o
P hilippine s
0
10
20
30
40
50
60
% prescriptions generic
Source: DAP Global comparative pharmaceutical
expenditures and IGPA
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WHO - EDM
70
National strategies
Drug sales 1990 and 2000: originator and licensed
products grew from 50% to 64% of world market value
300
250
market
value in US
$ billion
102,3
200
Other
150
100
64,2
50
63,5
180,2
Originator
0
1990
2000
Source: IMS Health, customised study. Data from 52 countries/areas
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National strategies
Drug sales 1990 and 2000: market share of
originator and licensed products in high, middle
and low income country markets
70
60
50
% of market
by value
High (25)
Middle (23)
Low (4)
40
30
20
10
0
1990
2000
Source: IMS Health, customised study. Data from 52 countries/areas
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National strategies
Rapidly changing drugs markets
Czech Republic*, 1990 and 2000
100%
19,7
90%
80%
15,5
70%
8,5
44,6
60%
50%
48,6
40%
39,8
30%
20%
16,2
10%
0%
1990
Unbranded
7,1
2000
Other brands
Origin/licensed
status n/a
*2000 Population: 10.3 million
Source: IMS Health, customised study. Data from 52 countries/areas
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National strategies
Building a large generic market takes time
- and requires a combination of strategies
National strategies for generics:
50
45
40
35
30
25
20
15
10
5
0
5
8
19
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1.
2.
3.
4.
Supportive legislation & regulation
Reliable quality
Professional & public acceptance
Economic incentives
Percent of new prescriptions, U.S.
6
8
19
7
8
19
8
8
19
9
8
19
0
9
19
1
9
19
2
9
19
*
3
4
9
9
9
19
1
WHO - EDM
National strategies
1. Supportive legislation and regulation





product development authorized during patent life
abbreviated marketing authorization
differential registration fees
generic labeling
generic prescribing and substitution
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National strategies
Product development during patent period
varies among countries

Examples of “early workings” for generics





access to innovator product safety and efficacy data
production tests on a patent-protected product
laboratory tests for marketing approval
– e.g. bioequivalence
production and stockpiling prior to patent expiry
Countries with some early workings provisions



Argentina
Australia
Canada
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Hungary
 Tunisia
 USA

WHO - EDM
National strategies
Stages in Generic Substitution - legislative support
for generic substitution may evolve over time
1. No substitution
2. Substitution permitted


brand dispensing assumed
generic may be requested
3. Substitution encouraged


generic dispensing assumed
brand may be requested
4. Substitution required
Increasing generic support
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National strategies
Generic substitution laws can give each party a
voice

Regulatory authority


Prescriber


write ‘no substitution’ by hand on the prescription
Pharmacist - must substitute a generic unless:




declare products as ‘substitutable’ or ‘non-substitutable’
prescriber or patient forbid substitution
retail price of generic is higher than the brand
product has been declared not substitutable
Patient

may forbid generic substitution
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National strategies
2. Reliable quality




substitution / non-substitution lists
national regulatory capacity
enforcement of good manufacturing
practices (GMP)
distribution system inspection and
enforcement
GMP
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National strategies
3. Professional and public acceptance






involvement of professional groups
phased implementation
all training by generic name
use of generic names in clinical manuals
brand-generic / generic-brand indexes
public promotional information and activities
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National strategies
Pocket manuals put generic names and brand-generic
lists at health professionals’ figure-tips
 100+ countries have treatment guidelines, formularies
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National strategies
Public education campaigns help professional and
public acceptance to reinforce each other



Posters and brochures
Radio and TV messages
Other media
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National strategies
4. Economic incentives




price information for professionals and the public
retail margins favorable to generics
use of generics for insurers / reimbursement
development of generic industry
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WHO - EDM
National strategies
Price information - enlightens health
professionals and empowers consumers




relative / absolute price
information in clinical manuals
drug pricing guide
publication of pricing surveys
Using ATC/DDD-based system
to compare prices (e.g. Italy,
Netherlands, Tunisia)
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National strategies
Different types of dispensing margins create
different incentives for rational dispensing

Cost + fixed percentage


Cost + declining percentage


e.g.: cost + 20% for cheaper drugs, declining to 5% for
expensive drugs
Cost + fixed professional fee


e.g.: cost to pharmacist + 20 %
e.g.: cost + $3 professional dispensing fee
Cost + differential professional fee

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e.g.: cost + $4 for generics, $2 for brand name drugs
WHO - EDM
National strategies
Insurance coverage is everywhere rising - generic
essential drugs are needed for cost control
Established Market6
Economies
Middle Eastern
Crescent
5
4
Transitional Economies
Latin Americas
& Caribbean
3
Asia & Islands
2
1
Sub-Saharan Africa
0
0
10
20
30
40
50
60
70
80
Percentage coverage
of population
Each diamond represents % of population
covered in one country
Source: WHO/DAP Global pharmaceutical expenditures
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90
100
National strategies
WHO supports generic drug use through a
variety of efforts - some examples

Normative support



Generically-oriented drug information




International Non-propriety Names (INN)
International Pharmacopoeia
model list of essential drugs
model prescribing information
model formulary of essential drugs
Regulatory support


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manual on marketing authorization
support to national regulatory authorities
WHO - EDM
The worldwide role of generic pharmaceuticals
Public health need
National Strategies
Social responsibility
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WHO - EDM
Social responsibility
Generic pharmaceutical manufacturers and
distributors also have a social responsibility



priority on essential generic drugs
adherence to WHO ethical criteria for drug promotion
help to assure supply of “abandoned” essential drugs



ether for anesthesia
oxaminiquine, metrifonate for schistosomiasis
suramin sodium, pentamidine isethionate for African
trypanosomiasis
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Conclusions
Generics can play an important role in public
health
This role can be optimized through:
-
supportive legislation and regulations
capable and credible regulatory authorities
favorable economic environment
information and advocacy initiatives
Professional and public acceptance
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