generic medicines in europe an overall assessment
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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. - PowerPoint PPT PresentationTRANSCRIPT
GENERIC MEDICINES IN EUROPE
An Overall AssessmentConference on Generic Drugs
In Turkey and the EUIEIS – Ankara 2 June 2005
GREG PERRYEGA 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 Commission- should 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)
8,7%6,1%
55%33%
10%7%
41,1%22,7%
42,0%25,5%
4%2%
70%30%
84%58%
5%8,6%
55%26%
52,8%32,1%
7%5%
55,4%23,7%
0,0% 10,0% 20,0% 30,0% 40,0% 50,0% 60,0% 70,0% 80,0% 90,0%
Belgium
Czech Republic
France
Germany
Hungary
Italy
Latvia
Poland
Portugal
Slovak Republic
Slovenia*
Spain
UK**
Generic Market Shares 2004 in Selected EU Countries
% Share (Volume) % Share (Value) Source: EGA Members
* 2002 figures ** 2003 figures
Product 2001 global Sales ($bill)
Patent expiry (EU)
Indication
EPO 6.4 2005 renal anaemia
insulin 4.0 2005 diabetes G-CSF 2.1 2006 neutropenia HGH 2.0 2002 growth
deficiency beta-interferon
1.9 2003 multiple sclerosis
alpha-interferon
1.7 2002 hepatitis C
On the Horizon Bio-Similar Products
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
50
75
100
125
150
175
200
225
250
2000 2005 2010 2015 2020 2025 2030 2035 2040 2045 2050
Elderly
Working age
Employment
EXPENDITURE ON HEALTH CARE IN RELATION TO AGE
Source: Economic Policy Committee (2001) “Budgetary challenges posed by ageing populations
Denmark
Germany
Spain
Spain
France
France
Italy
Netherlands
Finland
United Kingdom
United Kingdom
0
5
10
15
20
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 95+
Age groups
Avera
ge
exp
end
itu
re p
er
hea
d e
xpre
ssed
as
a s
har
e o
f G
DP
per
cap
ita
(%)
Pharm
aceutical
s a
nd
Tech
nolo
gy
WHO - EDM
In poor countries drugs are largest household and second largest public expenditure for health
Economic impact
0 10 20 30 40 50 60 70
South AfricaArgentina
JordanTunisia
ThailandIndonesia
ChinaEgypt
Mali
LithuaniaSloveniaEstoniaPolandCroatia
HungaryCzech Rep.
Bulgaria
NorwayNetherlands
United StatesUK
DenmarkSpain
FranceItaly
GermanyGreece
Developed countries(7 -20%)
Transitional countries(15 -30%)
Developing countries(24 -66 %)
Pharmaceutical spending, as % of total health spending
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
0
10
20
30
40
50
60
70
Originals Generics
V CC V
3 FOUNDATION STONES FOR AFFORDABLE MEDICINES
EfficientRegulatory
System
Prescribing
Dispensing
Practices
Balanced PatentSystem
Access to Affordable Medicines
EU Review
NationalSPC/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
2 years Market Excl. (1 year ME)
Generic
Application
Assessment, MA granted, MRP, price, reimbursement; preparation of launch, production (if there is not patent)
Additional 1 year Market Excl. if new indication registered by originator during first 8 years
Launch of generics if no patent, no +1 year
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
0 5 10 15 20 25 30 35 40
DE
ML
GR
UK
P L
DK
NL
CY
IE
FR
CZ
LT
RO
P T
AU
ES
IT
SW
BU
CR
ET
LV
SV
BE
SK
MAX TIME (Weeks)
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
European Generic medicines Association
“Making medicines affordable and industry competitive”
Europeans have a right toaffordable 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.