Transcript Slide 1

GENERIC MEDICINES IN EUROPE
An Overall Assessment
Conference on Generic Drugs
In Turkey and the EU
IEIS – Ankara 2 June 2005
GREG PERRY
EGA Director General
THE ROLE OF THE GENERIC MEDICINES
INDUSTRY IN EU PUBLIC HEALTH
1.Increasing the access to pharmaceutical
care through providing more affordable
medicines.
2.Increasing patient provision by
developing new formulations and
methods of delivery.
3.Stimulating medicinal innovation
through competition and increased
consumer choice.
THE ROLE OF THE GENERIC MEDICINES
INDUSTRY IN EU PUBLIC HEALTH
1. Providing budget head-room for
innovation.
2. To increase Europe’s share in the
growing global generic pharmaceutical
market
3. To create new sources of enterprise to
generate employment and investment
in Europe
ROLE OF GENERIC MEDICINES
“Pricing studies
have shown
unequivocally that
generic competition
is the most effective
way to ensure
lasting price
reductions”
WHO 55th Assembly
May 2002
“The promotion of
generics can have
important impact in
reducing costs and
creates headroom to
help pay for new
innovative products”
EU Council of Ministers
June 2000
G 10 RECOMMENDATION 4
To secure the development of a competitive
generic market
 Member States – facilitated by the Commissionshould explore ways of increasing generic
penetration in individual markets (including
generic prescribing and dispensing). Particular
attention should be given to improved market
mechanisms in full respect of public health
considerations
SOME KEY FACTS ON GENERICS
1. Generics sell at 20-80% of original price
2. Generating 13 Billion savings per year in EU 15
3. Highly competitive market with over 100,000
employees
4. Generic volume in EU 27% - USA >50%. But
major differences within the EU:
5-8 % B/IT/E (not growing)
8-15% PT/F (expanding)
40-50% UK (established)
+60% CEE (established and regional)
On the Horizon
Bio-Similar Products
Product
2001
Sales
($bill)
EPO
6.4
2005
insulin
G-CSF
HGH
4.0
2.1
2.0
2005
2006
2002
betainterferon
alphainterferon
1.9
2003
1.7
2002
global Patent
(EU)
expiry Indication
renal
anaemia
diabetes
neutropenia
growth
deficiency
multiple
sclerosis
hepatitis C
GENERIC MEDICINES AND THE EU
REGULATORY SYSTEM
1. Over 35% of major molecules are now patent
free and patent expiry will continue
2. Combination of EU expansion, patent expiry and
government policy results in the generic industry
fast becoming the main supplier of medicines in
the EU
3. The generic industry is the major user of MRP;
will be the major user of the DCP and a new
entrant into CP
THE GENERIC NECESSITY
GENERIC MEDICINES TREAT CRITICAL
ILLNESSES
1. Cancer / Oncology
2. Depression
3. Hypertension
4. Diabetes
5. Hyperlipidaemia (cholesterol)
6. Serious bacterial infections
7. Asthma
EUROPE’S AGEING POPULATION
250
225
Working age
200
175
Employment
150
125
Elderly
100
75
50
2000 2005 2010 2015 2020 2025 2030 2035 2040 2045 2050
EXPENDITURE ON HEALTH CARE IN
RELATION TO AGE
Source: Economic Policy Committee (2001) “Budgetary challenges posed by ageing populations
United Kingdom
France
Germany
um
lgi
Be
ia
str
Au
15
Finland
Spain
Sweden
Netherlands
Italy
United Kingdom
10
Denmark
Spain
5
France
a
tri
s
Au
Average expenditure per head expressed as a share of GDP per capita
(%)
20
0
0-4
5-9
10-14 15-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85-89 90-94
Age groups
95+
Economic impact
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%)
Pharmaceuticals and
Technology
Bulgaria
Czech Rep.
Hungary
Croatia
Poland
Estonia
Slovenia
Lithuania
Transitional countries
(15 - 30%)
Mali
Egypt
China
Indonesia
Thailand
Tunisia
Jordan
Argentina
South Africa
0
Developing countries
(24 - 66 %)
10
20
30
40
50
WHO - EDM
60
70
CEE HEALTH CARE GAP – THE
CHALLENGE OF AVAILABILITY
Average GDP per
capita in CEE is 5
times lower than
EU average
Real spending per
capita on health
in CEE is <400
Euros compared
to >1,600 Euros in
EU
CEE GENERICS %: 70% OF VOLUME FOR
30% OF COST
70
60
50
40
30
20
10
C
V
C
V
0
Originals
Generics
3 FOUNDATION STONES FOR
AFFORDABLE MEDICINES
Access to Affordable Medicines
EU Review
Prescribing
Efficient
Regulatory
System
Dispensing
Practices
National
Balanced
Patent
System
SPC/Patents
BETTER REGULATORY ENVIRONMENT
New Pharma Legislation introduces:
- A scientific definition of a generic medicinal product
- European Reference Product
- Restrictions on strategic withdrawal
- New Decentralised Procedure
- Option to use the Centralised Procedure
- A legal framework for biogenerics/biosimilars
- EU Bolar provision to encourage EU generic R&D
However...
DATA EXCLUSIVITY- MOMENT OF
GENERIC APPLICATION
1. 8 + 2 +(1) formula for all MA procedures
0-8 years Data Excl.
Marketing
Authorisation of
Reference
Product
Generic
Application
2 years Market Excl.
Assessment, MA
granted, MRP, price,
reimbursement;
preparation of launch,
production (if there is
not patent)
Launch
of
generics
if no
patent, no
+1 year
(1 year ME)
Additional 1
year Market
Excl. if new
indication
registered by
originator
during first 8
years
COUNTRIES REQUESTING TRANSITIONAL
PERIOD FOR DATA EXCLUSIVITY
1. Poland
2. Hungary
3. Slovenia
4. Slovakia
5. Malta
TIME (WEEKS) AFTER MA FOR PRICE
AND REIMBURSEMENT GRANT
MAX TIME (Weeks)
SK
BE
SV
LV
ET
CR
BU
SW
IT
ES
AU
PT
RO
LT
CZ
FR
IE
CY
NL
DK
PL
UK
GR
ML
DE
0
5
10
15
20
25
30
35
40
EU SINGLE MARKET FAILURE
1. Maximisation of price competition restricted in Europe by
lack of a single market
25 pricing systems and medicines agencies
Differing prescribing and substitution cultures
Must produce packs and leaflets in accordance to 18
different national requirements and languages
Work through national wholesalers
Registration fees for each MA and line extension
2. Creation of added costs which are significant in a
predominantly price competitive industry based on high
volume sales. Significant contrast to USA (Note no
registration fee for generics at FDA).
INCREASED EU IP PROTECTION
1992 SPC Regulation
1992-1994 introduction of Product Patents for
pharmaceuticals in CEE and Southern Europe
Mid 1990s Increasing use of secondary patents
1994 TRIPS
2004 extension of data exclusivity to up to
11years
2004 over 6000 Patent extensions granted through
SPC Regulation
2006 Paediatric extensions
NEW FOCUS FOR INNOVATION
1. Despite increased IP in EU the rate of “innovation
is declining in EU”
2. In EU emphasis should be focused on:
A EU rival to USA National Institutes of Health
Better links between Science and Business
Pricing structures for real innovation
Improving not increasing patent system Community Patent
It is these factors that make US better place for
R&D than Europe - not IP nor pricing issues
Truth on Pharma Innovation
1. Only 22% of “New” medicines are truly innovative (Public
Citizen July 2001)
2. Only 15% of R&D is by industry - the vast majority is
through public funding. “Public researchers often tackle
the riskiest and most costly research, which is basic
research, making easier for industry to profit” (NIH 2000)
3. R&D times are down 35% since 1996 (Scrip 2002)
4. Profit as % of Revenue is 18% or Big Pharma compared to
average of 2-3% of other Fortune 500 companies
These facts and others need to be taken into account when
making pharma policy.
G10: LISBON GENERICS WORKSHOP
2003 RECOMMENDATIONS
 Educating prescribing doctors to use Generics
 Assisting doctors in understanding the economic
implications of prescription decisions
 Increasing the use of electronic prescribing
 Creating substitution lists
 Increasing incentives for generic dispensing and
substitution (regarded as particularly important in
systems where doctors are not economically
sensitive)
G10: LISBON GENERICS WORKSHOP
2003 RECOMMENDATIONS
 Improving consumer awareness of generic quality
and availability
 Increasing pharmaco-economic evaluation of new
products in comparison with existing products
 Establishing generic-oriented reimbursement and
health insurance systems
 Adopting reference pricing and free pricing
systems instead of controlled price systems
 Reducing the time delay for authorisation for and
marketing of generic product
CONCLUSIONS
Generic medicines play critical role in ensuring
equitable access to medicinal care in the EU 25.
Role will increase as population ages and demands
increase on healthcare systems
Market environment for generic medicines needs
improvement to maximise potential
New focus on innovation - no longer based on
increases in IP protection but R&D environment
All sectors need to work together to ensure
equitable access to medications for all EU Citizens
– A European value worth striving for
Generic Medicines ...
… Affordable Healthcare
Europeans have a right to
affordable healthcare.
Generic medicines help make it a
reality!
Generic medicines are less expensive than brand-name equivalents.
They save EU patients Є13 billion each year, and create the budget
headroom needed to pay for the newer expensive products,
treatments and services.
European Generic medicines
Association
“Making medicines affordable and industry
competitive”