medicines monitor · 6 7 medicines monitor 2017 2017 medicines monitor 6 a better life medicines...

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2017 MEDICINES MONITOR

2017 EDITION

MEDICINES MONITOR

Dutch association

InnovativeMedicines

MEDICINES MONITOR2017 EDITION

Life expectancy in the Netherlands is still on the rise. This is one of the main focuses of ‘A better life’. Currently Dutch men reach an average age of eighty years and women live a few years longer. Around the year 2040 they will even live to be ninety. Medicines make a key contribution to this development. However, alertness is still required. Though it is true that people live longer, they suffer from various chronic diseases increasingly. This calls for an adequate cooperation between health care providers, in order to encourage the correct use of medicines while maintaining manageable costs.

Finally it is interesting to look at the financial revenues of medicines. It is well known that they can prolong life and improve the quality of it. But they also save society hundreds of millions of euros every year. Think of extra labour participation and less sick leave. The infographics in this digital brochure show the relevant figures.

Those who would like to join in the public debate on the future of medicines, are very welcome to do so. Sooner or later, almost every Dutch person will need medicines, so this is a subject that concerns us all. As for every discussion, it is advisable to base opinions on facts as much as possible. This Medicines Monitor provides you with ample starting points.

Gerard SchouwDirector general Association Innovative Medicines

‘Sustainable health care’, ‘Medicines of tomorrow’ and ‘A better life’. These three are the central themes within our industry association for Dutch pharmaceutical companies. We have structured this brochure along those lines. In our annual Medicines Monitor, formerly called Pharma Facts, you will find the relevant recent key figures.Although the clear infographics are mainly self-explanatory, here follows a brief introduction.

Concerning the theme ‘Sustainable health care’, the increase of the number of medicines used in the Netherlands during the past ten years stands out, from a good six billion to over eight billion doses a year. Yet annual medicine turnover has remained at a reasonably constant level over the last decade: at around five billion euros. This means we achieve more with the same amount of money. Still it remains one of our most important challenges to monitor the cost of medicines sharply.

‘Medicines of tomorrow’ highlights a different topic. It shows that over twenty types of cancer are being treated with medicines that have been developed in the course of the last five years. More than seven thousand medicines are under development, of which over 1,800 for cancer. Many of these are new ‘personalised medicines’. It is interesting that also in the Netherlands, 600 applications for clinical research are submitted every year, approximately two thirds of those applications are filed by pharmaceutical companies. Innovation is clearly very much on the agenda, and this is good news for numerous patients and their families.

PREFACE

76

MEDICINES MONITOR 2017 2017 MEDICINES MONITOR

6

A BETTER LIFEMedicines are indispensable for the daily life of a huge number of people. The proper deployment of the right medicine enables them to live a longer and healthier life. It gives them back their freedom, allows them to return to work sooner and helps them to ease their pain. There is also a growing interest in preventive medicines, because of which diseases do not even have a chance to occur.

Innovative medicines for cancer have radically changed the lives of millions of people in Europe. Two in three patients diagnosed with cancer, stay alive for at least five years longer thanks to these medicines. The quality of life improves. Also because sometimes there is no more need for chemotherapy, a treatment that often causes serious side effects. The introduction of ‘perso-nalised medicines’ – tailor-made medicines – even offers us the perspective that instead of being the equivalent of a death sentence, cancer will become a chronic condition.

Because of their continuous search for new medicines, pharmaceutical companies have contributed considerably to the lengthening of life expectancy of the Dutch population.

83,182,780,680,179,276,575,372,6

79,778,875,573,872,570,871,470,3

20151950 1960 1970 1980 1990 2000 2010

MEDICINES PROLONG OUR LIVES

Absolute life expectancy, in the Netherlands in years

60

20

80

40

0

100

man woman

Source: Centraal Bureau voor de Statistiek (Statistics Netherlands), 2016

98


Major progress is being made in fighting cancer. It is expected that cancer will increasingly be considered a chronic disease, that can be controlled with medicines and treatment.

Source: Centraal Bureau voor de Statistiek (Statistics Netherlands), 2016

Prostate cancer +24%64% 88%

All types of cancer

Percentages of increase in five-year survival rates of various types of cancer1989-1993 compared to 2008-2012

+15%47%

Colon cancer +8%62%54%

Non-small cell lung cancer +3%17%14%

Lung cancer +5%17%12%

Cervical cancer +3%66%63%

Period1989-1993

Period2008-2012

62%

Skin cancer/melanoma +8%81% 89%

Breast cancer +10%77% 87%

Small-cell lung cancer +3%7%4%

INCREASED CANCER SURVIVAL RATES

Source: Farminform, 2017

Doses prescribed (DOT), in billions

5 years or shorter on the market

longer than 5 years on the market

9

0

1

2

3

5

6

7

8

4

10

NEWEST MEDICINES PRESCRIBED RELATIVELY INFREQUENTLY

Dutch doctors take a very careful approach to the prescription of medicines that have recently been brought onto the market. As a result, Dutch patients will have to wait longer before being able to profit from the latest medical discoveries. In other EU-countries, doctors tend to opt for a new branded medicine more easily.

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

5,1%5,6% 6,7%

6,8% 6,9%6,7%

5,5%5,1%

5,8%5,2%

4,2%3,2% 1,9% 1,2%

0,7% 0,7% 0,8% 0,7% 0,7% 0,7% 0,6%

1110


The average period of time needed in the Netherlands for a medicine to become available for the patient, is 207 days, as from the moment of marketing authorisation. On average, this should take 90 days at most.

Average time in days between marketing authorisation and availability for the patient.

FROM MARKETING AUTHORISATIONTO AVAILABILITY FOR THE PATIENT

Source: EFPIA, Patient W.A.I.T. Indicator, 2016

1 in 6 Dutch is 65+

POLYPHARMACY IN ELDERLY PEOPLE

Nearly one million elderly people take more than 5 types of medicines every day. This increases the risk of side effects. Close cooperation between health care workers and involvement of the patient are essential in encouraging the correct use of medicine.

16.000Source: RIVM Polyfarmacie bij kwetsbare ouderen (Polypharmacy in vulnerable elderly people), 2013

elderly people end up in hospital as a result of erroneous use every year.

United Kingdom 138

Germany 110

Switzerland 76

Denmark 110

Austria 231

Netherlands 207

Finland 122

Norway 172

Italy 370

France 467

Slovenia 47631%

82%

62%

59%

74%

90%

49%

74%

90%

74%

74%

77%

Sweden 292

% of the 39 EMA-registered medicines available, in 2015

1312


88 90

In 2040 men are expected to reach an average age of 88 years while women will reach the age of 90 on average.Source: IFPMA

The number of patients diagnosed with prostate cancer remains more or less constant. However, the number of patients surviving after ten years has increased.

Ten-years prevalence The ten-years prevalence of cancer includes all patients who are still alive at a certain date and who have been diagnosed with a form of cancer in the past ten years.

Incidence The incidence of cancer con-cerns the rate of occurrence of new cases diagnosed in a cer-tain period (usually in 1 year)

numbers in thousands

Source: www.cijfersoverkanker.nl, 2017

Our life expectancy continues to increase

2010 2011 2015 2016*201420132012

50

60

70

80

0

10

20

30

40

* provisional figure

MEN LIVE LONGER WITH PROSTATE CANCERCOMPARED TO THE TOTAL NUMBER OF PATIENTS DIAGNOSED WITH PROSTATE CANCER IN THE PAST 10 YEARS

1514


The Netherlands leads the way as far as its reserve towards the use of antibiotics is concerned. Yet we clearly see regional differences in the Netherlands. The development of new antibiotics remains vitally important.

USE OF ANTIBIOTICS IN THE NETHERLANDS IS LOW

Source: OESO Source: OESO

Less than 19%

19 to 21%

21 to 23%

23 to 25%

25% or more

Percentage of the population that was prescribed antibiotics, 2013. (adjusted for age)

15

20

25

30

10

5

0

Daily doses per 1,000 inhabitants

NLD EST SWE LV HUN SVN DEU NOR AUT DNK FIN LTU CZE GBR ISL PRT POL SVK IRL ESP LUX ITA BEL FRA GRC

35

REGIONAL DIFFERENCES IN THE NETHERLANDS

WITHIN EUROPE, FEWEST ANTIBIOTICS PRESCRIBED IN THE NETHERLANDS

1716


The number of new patients diagnosed with breast cancer has continued to grow until 2016. However, the number of patients that die of breast cancer remains almost unchanged. Chances of surviving the disease are improving. Earlier diagnostics, more effective treatments and innovative medicines all contribute to this.

CHANCES OF BREAST CANCER SURVIVAL ARE IMPROVING

Source: www.cijfersoverkanker.nl / www.stateline.nl, 2016

Number of new breast cancer patients in the Netherlands per year

Number of patients who die of breast cancer every year

2004 2008 20122006 2010 2014 2015*

* provisional figure

12.140

3.333

12.527

3.350

13.149

3.357

13.402

3.245

14.388

3.230

14.657

3.041 3.294

14.61415.000

13.000

12.000

10.000

11.000

14.000

9.000

8.000

7.000

6.000

3.000

2.000

1.000

5.000

4.000

0

1918


18

SUSTAINABLE HEALTH CARE

7% OF ALL EXPECTED PUBLIC HEALTH EXPENDITURE IS SPENT ON EXTRAMURAL MEDICINES

Source: Dutch National Budget VWS (Ministry of Health, Welfare and Sport) for 2017, Prinsjesdag (Dutch Budget day), 2016

7%

32%

27%

7%

27%Long-term care

Hospitals, medical specialists and other curative care

Other

Primary

We have been spending approximately the same amount of money on medicines for years in the Netherlands. Less than 10 percent of our total health care budget has been spent on medicines, around 5 billion euro every year. Due to the fact that our population is ageing budgets are under pressure. New technologies provide us with ever-growing opportunities. Beneficial as this may be for the patient, it will increase the cost of our health care. But it can also lead to savings, for example by means of e-health applications at home.

In the field of medicines, we see an increase in ‘personalised treatments’, through which patients receive real tailor-made care. This type of medicine is often far more effective than the traditional medicines. Furthermore, it can reduce side effects dramatically. The patient profits enormously. But there is a price tag. Particularly because the medicines involved are very complex and entail a complicated and vulnerable production process, mostly for a relatively small patient population.

We all want patients to have and continue to have access to the best medicine available. A medicine that also has been proven to be safe and effective. To achieve this a lot of money is needed. It easily takes 1 to 2 billion euro to develop a new medicine. At the same time, we want our health care to remain affordable. We have no use for new medicines if we don’t have the money to pay for them.

Cooperation between pharmaceutical manufacturers and other health care parties is indispensable in the effort to ensure better health care that is lasting and affordable. This is what we subscribe to.

In 2017, we expect to spend 73.5 billion euro on public health. Of this total, 4.8 billion euro (7%) is spent on medicines prescribed by general practitioners (extramural medicines).

2120


In 2015 costs of medicines in hospitals amounted to over 2 billion euro. The total hospital budget is more than 23 billion euro.

Source: CBS (Statistics Netherlands) 2016; Rijksbegroting (Dutch National Budget) 2016; Farminform 2017; IMS (Market prognosis 2015-2019, Netherlands)

MEDICINE COSTS IN HOSPITAL BUDGET ARE LIMITED

Sources: Life Cycle database – IMS Health, April 2015; IMS market segmentation database NL, April 2015; Farminform AIP turnover MAT December 2014. Based on calculations Association Innovative Medicines.

FUNDS AVAILABLE DUE TO PATENT EXPIRATION

With the patents that have expired in 2016 and those that will expire in 2017 and 2018, hundreds of millions of euros can be saved as a result of growing competition. This money can be used to pay for the development of new, innovative medicines.

2014 and 2015 Health care Insurance Act costs, provisional figures CBS (Statistics Netherlands) / 2016 Health care Insurance Act costs from the Rijksbegroting (Dutch National budget) 2017

5

10

15

20

25

0

2000 20092004 20152002 20122006 20112001 20102005 20162003 20142007 20132008

Health care costs in billions €

Health care Insurance Act: hospitals and medical specialists

Prescription medicines Available funds as a result of expired patents: Total Extramural Intramural

€ 0

€ -100.000.000

€ -50.000.000

€ -150.000.000

€ -250.000.000

€ -350.000.000

€ -200.000.000

€ -300.000.000

€ -400.000.000

2016 2017 2018

2322


The total turnover on medicines has remained practically constant during the last ten years, around five billion.

TOTAL TURNOVER ON MEDICINES REMAINS CONSTANT

5

Intramural turnover on

medicines in euros

Extramural turnover on

medicines in euros

Total turnover on medicines in billions of eurosAmounts are based on pharmacy purchase prices. The actual market price is the result of negotiations between health care stakeholders.


1996 20052000 2010 2015

3

2

1

4

0

2524


turnover total

VOLUME MEDICINES IN THE NETHERLANDS INCREASING

The total number of medicine doses is increasing, up to 9 billion in 2016. This increase is mainly caused by a growing prescription of generics in the Netherlands.

volume total

volume generic

volume branded medicines

Development in billions of standard daily doses Development in billions of euros


TURNOVER MEDICINES CONSTANT

We have been spending around 5 billion euro on medicines for years in the Netherlands. Turnover for generics has increased up to 0.8 billion. Branded medicines show an increase up to 4 billion.

Amounts are based on pharmacy purchase prices. The actual market price is the result of negotiations between health care stakeholders.


2015 20161996 2000 2005 20100

4

2

8

6

10

201620151996 2000 2005 20100

2

1

4

5

3

6

turnover generic

turnover branded medicines

2726


Compared to other sectors, such as education, transportation and housing, the price index of medicines has decreased considerably in the last 10 years.

Consumer price index compared to the price index for prescription medicines (1996 = 100)

Source: Stichting Farmaceutische Kerngetallen (Foundation for Pharmaceutical Statistics) 2015, Farminform 2016, CBS (Statistics Netherlands) 2016

Since 1996, various measures and agreements have contributed to the price decrease of medicines.

1. Housing, water and energy2. Transportation3. Total expenditure4. Education5. Food6. Prescription medicines

Total health care expenditure per country as % GDP

HEALTH CARE COSTS IN THE NETHERLANDSACCOUNT FOR 10,8% OF TOTAL EXPENDITURE

We spend a lot of money on good health care in the Netherlands. In 2015 the amount spent added up to about €5,000 per person. When we compare the costs of health care, we are in 7th position, behind countries like Japan, France, Germany and the US.

OECD 2016

PRT

8,9

8,4

302

USA

16,9

12,5

18.0

37

BEL

10,4

7,9

498

SWE

11,1

7,4

458

ESP

9,0

6,8

1.60

3

DEU

11,1

9,8

3.85

7

AUT

10,4

9,2

415

FRA

11,0

9,5

2.64

8

FIN

9,6

6,9

225

NLD

10,8

7,1

818

DNK

10,6

8,1

265

GBR

9,8

6,3

2.70

1

CH

11,5

9,3

506

ITA

9,0

7,6

2.19

1

JPN

11,2

7,4

4.73

8

IRL

9,4

5,9

302

2015 - 10,8%of $ 818 billion GDP

2000 - 7,1%of $ 502 billion GDP

percentage health care 2015 percentage health care 2000 in billion $ 2015 GDP

1

234

5

1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 20160

20

40

60

80

100

120

140

160

180

Introduction Medicines Pricing Act

(WGP)

Clawback Increase

Agreement (VWS-KNMP)

Temporary introduction

measure ‘De Geus’

Transition agreement

Introduction clawback

Start agreement period

(Individual ) Preference policy

Introduction free pricing

DECREASE OF AVERAGE MEDICINE PRICE

6

2928


In addition to the direct benefits such as saved costs, the indirect benefits such as extra labour participation and less sick leave, yield an important social benefit.

INNOVATIVE MEDICINES YIELD A LOT OF MONEY

STROKE Stroke-related health care costs decreased

thanks to anti-hypertension medication.

DIABETESSaved health care costs as

a result of less complications thanks to modern

diabetes medicines.

MIGRAINE Less absence thanks

to triptans.

DIABETES Extra labour participation and less sick leave thanks

to modern diabetes medicines.

MULTIPLE SCLEROSIS Lower health care costs, less informal health care and less sick leave as a result of fewer relapses.

RHEUMATISM Less absence thanks

to biologicals.

BREAST CANCER Extra labour supply as a

result of increased survival of breast cancer thanks to better

treatment options.

715 287

115 115

500 100

36

10 12

30

125 42

High variant

Low variant

0,6 - 1,6BILLION EURO BENEFITS

37

5

Source: Marc Pomp, Arbeidsbaten en uitgespaarde zorgkosten door innovatieve geneesmiddelen (Labour benefits and saved health care costs thanks to innovative medicines), 2015

With simple methods and by tearing down health care partitions we will be able to save over 1.5 billion euro on health care costs.

+ €1,5 BILLION

Source: SIRM, 2016

Changing the health care system by tearing down partitions will benefit patients and society

30

MEDICINES MONITOR 2017

It often takes a long time for new extramural medicines to be included in the basic care package. The reimbursement process sometimes takes up to 232 days, where 90 days is the standard.

INCLUSION NEW MEDICINES IN BASIC HEALTH INSURANCE PACKAGE

Source: Zorginstituut Nederland (National Health Care Institute), 2016

900

Standard according to Transparancy

Directive

1

50

153

232

1A-LIST

1B-LIST

The average duration was 64 days, with a varying length, ranging from a minimum of 1 to a maximum of 153 days.

The average duration was 141 dagen, with a varying length, ranging from a minimum of 50 to a maximum of 232 days.

64% 8%14FILES OF DRUGS THAT CAN BE CLUSTERED (1A-LIST), OF WHICH 64% COMPLETED WITHIN THE LEGAL TERM

12FILES OF DRUGS THAT

CANNOT BE CLUSTERED (1B-LIST), OF WHICH 8%

COMPLETED WITHIN THE LEGAL TERM MEDICINES

OF TOMORROWThe development of innovative medicines is accelerating at an unprecedented pace. More than 7,000 new medicines are being developed. Such as ‘personalised’medicines: very effective drugs, tailor-made for small patient populations. We use more and more biologicals, medicines based on natural or human substances. DNA-diagnostics are used more often. Only a few drops of blood suffice to predict future diseases or, preferably, to prevent them. For the most part, these innovations are developed in laboratories of pharmaceutical companies – breeding ground for the medicines of tomorrow. Not only because of spectacular inventions, but also through meticulous testing of promising drugs for safety and effectiveness. A costly process that requires perseverance. But we are beginning to reap the benefits. For this, cooperation between universities, pharmacists and other health care parties is paramount. The Netherlands has the potential to be among the best in the world in the discovery and development of innovative medicines. That is why we should continue to invest in a thriving research climate.

31

3332


Medicines have a major impact on many diseases. Thanks to medicines, a large number of HIV-infected patients for example enjoy a reasonably good quality of life, and cancer mortality is decreasing.

MEDICINES ARE AMONG THE MOST POWERFUL FORMS OF CARE IN THE TREATMENT AND CURING OF DISEASES

Source: Health Advances analysis

95%Of the 15 million of hepatitis C patients in Europe 95% can be healed with an 8- to 12-week treatment.

37%From 2000 to 2012 mortality rate for cardiovascular conditions has decreased with 37% in EU5.

94%Since 1991 mortality of HIV-infected patients living in France has decreased with 94% (mortality: age-standardised).

21%Since 1991 mortality rate for all cancer types has decreased with 21%.

MEDICINES WITH NEW ACTIVE INGREDIENT

A growing number of promising medicines with new molecules are being developed.

period 1963-1976 period 1977-1996 period 1997-2016

Number of medicines per year

Average number of medicines per year

per period

15,9

25,2

30,2

Source: DiMasi, Tufts Center for the Study of Drug Development, Tufts University

THAT ARE APPROVED BY THE FDA PER YEAR

FDA = Food and Drug Administration

1990198019701960 2000 2010 2016

1963 1977

1997

0

20

10

30

40

50

60

3534


Kidneys • Pancreas • Neutropenia • Castleman disease • Cervix • Myelofibrosis Polycythemia Vera (bone marrow) • Stomach • GIST (rare form of soft tissue sarcoma) • Neuroblastoma

Basal cell carcinoma

Sarcoma (soft tissue)

Bowel

Lungs

Lymph nodes

Leukaemia

Breast

Kahler’s disease

Ovaries

Thyroid

Skin

Prostate

• belinostat (PTCL)• bortezomib (MCL)• brentuximab vedotin (Hodgkin’s,

ALCL)• chidamide (PTCL)• ibrutinib (MCL, WM)• idelalisib (CLL, FL, SLL)• mogamulizumab (ATCL)• pixantrone (NHL)• rituximab (NHL)• romidepsin (PTCL, CTCL)

• ado-trastuzumab emtansine• palbociclib• pertuzumab

• sonidegib• vismodegib

• bevacizumab• olaparib

• regorafenib• tipiracil/trifluridine• ziv-aflibercept

• cobimetinib• dabrafenib• ipilimumab • nivolumab• pembrolizumab• trametinib• talimogene laherparepvec• vemurafenib

• carfilzomib• daratumumab• elotuzumab• lxazomib• panobinostat• pomalidomide

• abiraterone acetate • enzalutamide• ra 223 dichloride

• mifamurtide (osteosarcoma)• trabectedin (liposarcoma or

leiomyosarcoma)

• afatinib• alectinib• ceritinib• crizotinib• gefitinib• nivolumab• necitumumab• osimertinib• pembrolizumab• ramucirumab

• blinatumomab (ALL)• bosutinib (CML)• ibrutinib (CLL) • obinutuzumab (CLL) • ofatumumab (CLL)• omacetaxine mepesuccinate (CML)• ponatinib (CML, ALL)• radotinib (CML)

• cabozantinib• lenvatinib mesylate• vandetanib

MANY NEW DRUGS FOR THE TREATMENT OF CANCER

Source: IMS Health, MIDAS, Lifecycle, R&D Focus, IMS Institute for Healthcare Informatics, 2015

Many new drugs have been introduced the past 5 years. New drugs and technologies have completely changed the treatment and curing of cancer.

3736


At this moment 7,000 new drugs are being developed, of which 1,800 to treat cancer. Many of these medicines are ‘personalised’.

OVER 1.800 ONCOLOGICAL MEDICINES ARE BEING DEVELOPED

Source: IMS Institute for Healthcare Informatics, 2014

38%

1.026

41%

352

38%

102

44%

369

37%

16

62%

59%

62%

56%

63%

biologicals

non-biologicals

Preclinical research

PHASE 1 PHASE 3PHASE 2

Clinical research

Pre-registration & registration

3938


Every year approximately 600 applications for new clinical research are submitted, 349 of which by pharmaceutical companies. Most applications are submitted for phase 3 research.

600 APPLICATIONS FOR CLINICAL RESEARCH IN THE NETHERLANDS EVERY YEAR

BULK OF RESEARCH FUNDS SPENT PER CLINICAL TESTING PHASE

Investments in phase 3 clinical research are highest.

Source: EFPIA, 2016


Clinical research Usage

Determining dose, safety and effectiveness in patients with the condition con-cerned

Monitoring side effects and longer-term ef-fects in users

Examining how the new medi-cine is tolerated in the body of a limited number of healthy volun-teers

Gaining deeper insight into the effectiveness, advantages and possible side ef-fects in hundreds to thousands of patients who have the condi-tion concerned

Other N/a

349Applications from pharmaceutical companies

233Other applications (public sector, academia)

Source: CCMO, 2016



Clinical research

Registration & reimbursement Usage

21,2%

8,9% 10,7%

28,7%

5,1%

16,6%

8,9%

Examining the effect of new, possibly active substances in the laboratory

Determining dose, safety and effectiveness in patients with the condition con-cerned

Marketing au-thorisation based on submitted research files

Examining how the new medi-cine is tolerated in the body of a limited number of healthy volun-teers

Gaining deeper more insight into the effectiveness, advantages and possible side ef-fects in hundreds to thousands of patients who have the condi-tion concerned

Monitoring side effects and longer-term ef-fects in users

Other

DISTRIBUTION OF INVESTMENTS OVER THE DIFFERENT PHASES OF MEDICINE RESEARCH

119 162 165

5473

9

4140


83 % of the research on new medicines is conducted by pharmaceutical companies.

WHERE DO WE FIND RESEARCH AND DEVELOPMENT (R&D) FOR INNOVATIVE MEDICATION?

MEDICINES OF TOMORROW UNDER DEVELOPMENT

A large number of medicines is under development. Most research is conducted in the field of new cancer medication. In addition, there are many products for metabolic disorders and diseases of the nervous system in the pipeline.

Source: OHE from IMS LifeCycle R&D Focus database, 2015Source: European Medicines Agency, 2014

R&D innovative medication by academical institutes, public and public-private partnerships

R&D innovative medication by large companies

R&D innovative medication by SMEs

17%

27%

56%

28% 5% 3%8% 5% 3%12% 5% 3%5% 3% 3% 3%

Cance

r

Nervo

us sy

stem (e

xclud

ing d

emen

tia)

Met

abolic

diso

rder

s

Skin

cond

itions

Cardiova

scula

r sys

tem

Vacc

ines

Other

Diabet

es

Urogen

ital s

yste

m and se

x horm

ones

Ophtha

lmology

Immun

other

apy

HIV, he

patitis

B/C

Blood dise

ases

3% 2%2% 2%

Bacte

rial in

fectio

ns

Mus

culosk

eletal

diso

rder

s

Demen

tia

Rheum

atoid ar

thrit

is

4%

Respira

tory

syste

m

PHASE 1-3 R&D PER DISEASE AREA

42

MEDICINES MONITOR 2017

Dutch Association Innovative Medicines

P.O.Box 116332502 AP The HagueThe Netherlands

+31 (0)70 - 313 22 22info@innovatievegeneesmiddelen.nlwww.vereniginginnovatievegeneesmiddelen.nl

THE DEVELOPMENT OF A DRUG TAKES 10 YEARS ON AVERAGE

Source: Association Innovative Medicines

200

4YEARS

6YEARS

2YEARS

8YEARS

5YEARS

Patent application


Clinical research

Registration & reimbursement

Remaining patent period

Supplementary Protection Certificate

(SPC)

Patent expiration

44

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