3rd National Conference on medicines policy, Bratislava December 2006 Medicines Policy and equity in health How can generic drug producers contribute?

3rd National Conference on medicines policy, Bratislava December 20063rd National Conference on medicines policy, Bratislava December 2006

Medicines Policy and equity in healthHow can generic drug producers contribute?Medicines Policy and equity in healthHow can generic drug producers contribute?

Christian WieserChristian WieserGENASGENASSlovak Generic AssociationSlovak Generic Association


EEU legislationU legislationEEU legislationU legislation

„„Generic medicinal product shall mean a medicinal product Generic medicinal product shall mean a medicinal product which has the same qualitative and quantitative composition which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence the reference medicinal product, and whose bioequivalence with the reference medicinal product has beewith the reference medicinal product has beenn demonstrated demonstrated by appropriate bioavailability studies. by appropriate bioavailability studies. The different salts, The different salts, esters, ethers, isomers, mixtures of isomers, complexes esters, ethers, isomers, mixtures of isomers, complexes of derivatives of an active substance shaof derivatives of an active substance shalll be considered l be considered to be the same active substanceto be the same active substance, unless they differ , unless they differ significantly in properties with regard to safety and/or significantly in properties with regard to safety and/or efficacy.efficacy....“...“

Directive 2001/83/EC of the European Parliament (Medicinal Directive 2001/83/EC of the European Parliament (Medicinal products for human use) as amended by 2002/98/EC, products for human use) as amended by 2002/98/EC, 2004/24/EC, 2004/27/EC2004/24/EC, 2004/27/EC, P, Page 20, Art.10/2bage 20, Art.10/2b


Generic obsolescence

New innovative medicines

Innovative drugs and generics – Innovative drugs and generics – complementary from customer’s perspectivecomplementary from customer’s perspectiveInnovative drugs and generics – Innovative drugs and generics – complementary from customer’s perspectivecomplementary from customer’s perspective

High quality generics

Patent Patent expirationexpiration

Generics free Generics free up funds for up funds for innovative innovative medicinesmedicines

Innovation offers Innovation offers

– improved treatment improved treatment optionsoptions

– new therapeutic new therapeutic opportunitiesopportunities

and thereby leads to and thereby leads to replacement of replacement of olderolder//less effective less effective medicationmedication

Source: Novartis (adapted)Source: Novartis (adapted)


Strategic Customer ValuesStrategic Customer ValuesStrategic Customer ValuesStrategic Customer Values

High (Monopoly) Price

Low Therapeutic

Risk

High Affordability

Low price

High TherapeuticRisk

New TherapeuticValue

Generic Industry

Innovative Industry


GlobalGlobal Generics market Generics market

Pro-forma 2005 third party net salesPro-forma 2005 third party net sales11, in USD m, in USD m

• 11 Including acquisition for full year 2005 Including acquisition for full year 2005• Source: Company annual reports, quarterly reports and press releasesSource: Company annual reports, quarterly reports and press releases

Teva

Sandoz

Merck Gx

ratiopharm

Watson

Actavis

Stada

Mylan

Ranbaxy

Barr

Pliva

Krka

Cipla

7,511

5,751

2,232

1,989

1,632

1,562

1,270

1,249

1,159

1,088

976

689

624Gx salesNon-Gx sales


GENAS: Slovak Association of Generic producersGENAS: Slovak Association of Generic producers


The environment: AThe environment: AThe environment: AThe environment: A

Western Europe

CzechRepublic

SlovakRepublic

Male life expectancy at birth 75,4 72,1 69,5

Female life expectancy at birth 81,5 78,5 77,6

Source: Pharmaceutical Markets Fact Book 2004


The environment: BThe environment: BThe environment: BThe environment: B

C10A1 DDD/capita

0

10

20

30

40

50

60

CERIVASTATIN

LOVASTATIN

FLUVASTATIN

ROSUVASTATIN

PRAVASTATIN

SIMVASTATIN

ATORVASTATIN


The environment: CThe environment: CThe environment: CThe environment: C

Increasing life expectancyIncreasing life expectancy – – not least an outcome of not least an outcome of modern, modern, high high effective drugseffective drugs – – results in severe challenges for healthcare results in severe challenges for healthcare systemssystems. . The gThe generenerationation 65 65++ repre repressententss 14% 14% of the of the populpopulationation, , with with a drug consumption of approx.a drug consumption of approx. 30-40% 30-40%

• EU populEU populationation will decrease fromwill decrease from 376mio (2000) 376mio (2000) to to 364mio364mio (2050) (2050) • Share of working populationShare of working population (15-64) (15-64) will decrease by will decrease by 20% 20% • GenerGenerationation 65+ 65+ will increasewill increase fromfrom 61 Mio 61 Mio toto 103 Mio 103 Mio


Leading causes of death,Leading causes of death, SR 2002 SR 2002Leading causes of death,Leading causes of death, SR 2002 SR 2002

kardio53%

nádory22%

respiračné6%

externé6%

zažívacie6%

ostatné7%

kardio

nádory

respiračné

externé

zažívacie

ostatné

zdroj. MZ SR


Top 10 Top 10 molecules in terms of savingsmolecules in terms of savingsTop 10 Top 10 molecules in terms of savingsmolecules in terms of savings

poradie LiečivoJan - Sep

2005Jan - Sep

2006Pokles v *000 Sk

Pokles v %

1 SIMVASTATIN 180,416 132,614 -47,802 -26%

2 GABAPENTIN 64,251 32,777 -31,474 -49%

3 ALENDRONIC ACID 101,963 75,140 -26,824 -26%

4 RAMIPRIL 113,519 88,734 -24,785 -22%

5 VACCINE; INFLUENZA 24,870 390 -24,480 -98%

6 VITAMIN E 66,919 45,731 -21,188 -32%

7 BROMHEXINE 34,734 14,130 -20,604 -59%

8 FENOFIBRATE 112,817 92,301 -20,516 -18%

9 AMLODIPINE 188,673 171,984 -16,690 -9%

10 PIRACETAM 88,608 72,192 -16,416 -19%

Zdroj údajov: IMS, v cenách výrobcov, *000 SK


Impact of generic market entriesImpact of generic market entriesImpact of generic market entriesImpact of generic market entries

0

10 000 000

20 000 000

30 000 000

40 000 000

50 000 000

60 000 000

70 000 000

80 000 000

Q1/

2002

Q2/

2002

Q3/

2002

Q4/

2002

Q1/

2003

Q2/

2003

Q3/

2003

Q4/

2003

Q1/

2004

Q2/

2004

Q3/

2004

Q4/

2004

Q1/

2005

Q2/

2005

NORVASC

PLENDIL

ZOLOFT

RISPERDAL

SEROXAT

SKK

IMS


Generic blockbusters: # of treatments and costsGeneric blockbusters: # of treatments and costs

Source: IMS, Amlodipine at manufacturer prices

385 433

547 475

931 643

1 374 637

1 731 794

1 940 401

2 138 096

211 035

301 520

282 937

369 103

324 599

242 161

215 791

0 500 000 1 000 000 1 500 000 2 000 000 2 500 000

Year/00

Year/01

Year/02

Year/03

Year/04

Year/05

Year/06

Units (Absolute) Skk (Thousands)


Generic blockbusters: # of treatments and costsGeneric blockbusters: # of treatments and costs


Slovakia: Slovakia: Five of the top 20 are generic companiesFive of the top 20 are generic companiesSlovakia: Slovakia: Five of the top 20 are generic companiesFive of the top 20 are generic companies

Source: IMS HealthSource: IMS Health

EURO SalesYTD/10/06

EURO SalesYTD/10/06

%PPG Selected Market 553 178 18,8 ZENTIVA 52 624 7,8 SANOFI-AVENTIS 34 001 19,6 GLAXOSMITHKLINE 31 547 24,9 ROCHE 30 005 52,5 NOVARTIS PHARMA 24 911 15,0 PFIZER 23 727 13,0 SERVIER 20 857 10,7 ABBOTT 17 794 20,5 ASTRAZENECA 15 167 13,8 JANSSEN CILAG 14 711 24,4 ELI LILLY 14 571 30,7 GEDEON RICHTER 12 785 10,2 RATIOPHARM 12 693 7,4 SANDOZ 10 400 16,9 SCHERING AG 10 565 27,8 NOVO NORDISK 10 837 69,6 BOEHRINGER I 9 921 15,6 SCHERING PLOUGH 9 212 18,8 MENARINI 8 368 9,2 KRKA 8 383 16,6


Development of market shares Development of market shares (value)(value)Development of market shares Development of market shares (value)(value)

20

01

20

02

20

03

20

04

20

05

generiká originálne lieky

IMS, > 95% pharma market, Rx drugs only

31% 29% 30% 33% 32%


Status quo of Generics in SlovakiaStatus quo of Generics in SlovakiaStatus quo of Generics in SlovakiaStatus quo of Generics in Slovakia

The 2003-2006 Healthcare reforms effected a disproportional pressure onThe 2003-2006 Healthcare reforms effected a disproportional pressure onGeneric manufacturers:Generic manufacturers:

• Extreme price erosion on „exchangeable“ molecules, whereas less contested Extreme price erosion on „exchangeable“ molecules, whereas less contested (even less established,older) molecules occupied comfortable niches(even less established,older) molecules occupied comfortable niches

• Patient co-payments became main decisive factorPatient co-payments became main decisive factor

• Today Generic drugs in Slovakia are among the cheapest in all Europe Today Generic drugs in Slovakia are among the cheapest in all Europe

impact on potential further price cuts very questionableimpact on potential further price cuts very questionable


Status quo of Generics in SlovakiaStatus quo of Generics in SlovakiaStatus quo of Generics in SlovakiaStatus quo of Generics in Slovakia

The 2003-2006 Healthcare reforms effected a disproportional pressure onThe 2003-2006 Healthcare reforms effected a disproportional pressure onGeneric manufacturers:Generic manufacturers:

• Drug consumption in too many therapy groups below EU average Drug consumption in too many therapy groups below EU average Generics as a powerful tool to treat significantly more patients for similar Generics as a powerful tool to treat significantly more patients for similar costs costs

• Plans on generic substitution have to be considered counterproductivePlans on generic substitution have to be considered counterproductiveconsidering required Gx marketing activities considering required Gx marketing activities without adequate promotion by without adequate promotion by Generic producers, prescribers will switch to patent-protected, moreGeneric producers, prescribers will switch to patent-protected, moreexpensive drugs (incl. „me too“ molecules) expensive drugs (incl. „me too“ molecules)


Thank you very much

Ďakujeme za pozornosťĎakujeme za pozornosť


Christian WieserChristian Wieser

General Manager Sandoz SlovakiaGeneral Manager Sandoz Slovakia PrePrezidentzident asoc asociácie iácie GenasGenas

Ruzinovska 42Ruzinovska 4282103 Bratislava82103 Bratislava

Phone:Phone: +421.2.48200+421.2.48200..600 600 Email: [email protected]: [email protected]: Web: www.sandoz.skwww.sandoz.sk www.genas.skwww.genas.sk

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3rd National Conference on medicines policy, Bratislava December 2006 Medicines Policy and equity in health How can generic drug producers contribute?