Ref. Ares(2020)2433183 - 07/05/2020
Economic and
societal
footprint of the
pharmaceutical
industry in
Europe
June 2019
Foreword from EFPIA
I firmly believe that building a strong the gap is continuing to grow, all
European economy, a cohesive
in the context of increasing
European society and a healthy
competition from China and the
population are inextricably linked. It
Far East.
is one of the things that makes our
sector unique. As an industry we
What does this mean for Europe? As
invest a greater percentage of
a recent report1 from the European
revenue in research and
Political Strategy Centre stated:
development than any other sector,
“Particular attention needs to be
we are an integral part of Europe’s
paid to areas:
economic landscape and most
Nathalie Moll
a. where Europe possesses or is
importantly, our medicines transform
Director General, EFPIA
developing a competitive
the lives of patients and the way we
advantage,
manage our healthcare.
b. chooses to prioritise and invest
To help inform policy and shape
public resources, given their
industrial strategy, EFPIA
importance in addressing societal
commissioned PwC to conduct an
challenges,
analysis of the economic and
c. sees as vital to its strategic
societal impact of the
autonomy.”
pharmaceutical industry in Europe.
PwC’s analysis shows the impact on Given its dual role as a driver of
patients’ lives across a selection of
economic growth and significant
diseases. In addition, it indicates
positive impact on public health, the
that, in 2016, 2.5 mil ion jobs were
research-based pharmaceutical
supported by the pharmaceutical
industry is one of the industries of
sector, with the average Gross Value critical strategic importance that
Added per employee significantly
Europe can benefit from by fostering
higher than that of other key R&D
and supporting innovation, in
sectors at €156,000. The activities of particular by offering a predictable
pharmaceutical companies directly
regulatory environment and
contributed nearly €100 bil ion to EU incentives model.
economies, with an additional €106
bil ion provided through the supply
The report underlines the economic
chain and employee spending.
and societal contribution of the
innovative pharmaceutical industry
The race to attract life-science
to the European economy. From
research, development and
employment to investment, research
manufacturing and investment is a
to new treatments, as an industry,
global endeavour. The number of
we won’t rest in creating a healthier
new medicine approvals in the US is future for Europe.
outstripping approvals in the EU and
1 ‘EU Industrial Policy After Siemens-Alstom’, European Political Strategy Centre, European Commission, 18 March 2019.
Foreword from PwC
We are pleased to support EFPIA on there has been continued scrutiny
this important piece of work and we
on the affordability of medicines,
thank the companies and industry
and in particular, the need for
bodies who have contributed and
intel ectual property incentives to
helped make this work possible.
stimulate research and
commercialisation of new therapies.
The pharmaceutical industry has
delivered substantial value to the
This debate should consider the
health of European Union (EU)
benefits of innovative medicine as
citizens over decades and delivered
well as costs. We hope that our
Jo Pisani
significant economic value through
research is valuable in driving
Partner, PwC UK
the research, manufacturing and
productive dialogue and further
commercialisation activities that are
informs the debate by assessing the
conducted in Europe. Continued
overall contribution of the industry to
research and the application of new
economic prosperity and
technologies mean that treatments
employment, the health and societal
and cures for many more diseases
benefits of innovations in specific
are within grasp. However, with
areas of medicine, and by reviewing
many EU health economies having
the importance of incentive
to manage the increasing health
mechanisms in driving continued
costs of an ageing population and
R&D and commercialisation.
an increase in chronic diseases
Contents
Executive summary .........................................................2
Introduction .....................................................................4
Methodology ...................................................................5
Economic impact .............................................................6
Health and societal impact ............................................ 10
Role of IP incentives ...................................................... 14
Conclusion..................................................................... 16
References .................................................................... 18
Abbreviations
ART
Antiretroviral therapy
EFPIA
European Federation of Pharmaceutical Industries and Associations
EMA
European Medicines Agency
EU
European Union
GDP
Gross Domestic Product
GTAP
Global Trade Analysis Project
GVA
Gross Value Added
HAART
Highly Active Antiretroviral Therapy
HER2+
Human Epidermal growth factor Receptor 2-positive
HLY
Healthy Life Year
HR+
Hormone Receptor-positive
IP
Intel ectual Property
QALY
Quality Adjusted Life Year
R&D
Research & Development
SME
Small and Medium sized Enterprise
STEM
Science, Technology, Engineering and Mathematics
STR
Single Tablet Regimen
TA
Therapeutic Area
WHO
World Health Organization
Executive summary
We have shown that the whole of the pharmaceutical industry
Medicines benefit mil ions of people on a daily basis. In just a
across the EU in 2016 contributed to...
subset of medicines within HIV (HAART) and breast cancer
(HER2+, HR+) we saw that...
€206 billion
Over 650,000
in Gross Value Added and...
people in the EU were treated
with these medicines between
2007–2017, who are estimated
to have gained around...
2.5 million
2 million
healthy life years, leading to around...
jobs
46%
€27 billion
of people employed directly
by the industry are women
In productivity gains for
EU economies, and
approximately...
Share of female employees
€13 billion in
healthcare cost savings due
to avoided complications
46%
24%
16%
Pharmaceuticals
Auto
Aerospace &
manufacturing
defence
2 |
Economic and societal footprint of the pharmaceutical industry in Europe
The value of the pharmaceutical industry
The advent of targeted breast cancer
community, which our analysis has not
to both patients and society is often lost
treatments designed to treat specific
quantified. We also have not accounted
in the public debate surrounding
genotypes have resulted in an estimated
for the effect of improved health on
medicine prices. This analysis seeks to
gain of over one mil ion healthy life years
increases in informal employment, such
highlight the broader value that the
in Europe for patients treated with
as domestic work, childcare, and family
research-based industry delivers to the
selected medicines between 2007 and
caretaking, the imputed value of such is
wider European community.
2017, and have delivered a wider impact
estimated at 20 to 40% of EU GDP2.
on both patients’ family members and
Moreover, the medicines have a ripple
The pharmaceutical industry is a major
the broader breast cancer population.
effect in that all of them have helped
contributor to the European economy.
pave the way for further innovations
We estimate that in total, it contributed
Prior to the advent of highly active
across different medical disciplines.
€206 bil ion in Gross Value Added (GVA)
antiretroviral therapy (HAART), an HIV
and 2.5 mil ion jobs in 2016, equivalent to diagnosis was almost a death sentence.
The current EU incentives model, which
1.4% of the EU’s combined GDP and
The development of HAART therapy has
includes Supplementary Protection
0.9% of the region’s employment1. The
turned HIV into a treatable disease, and
Certificates, Regulatory Data Protection,
largest contributions are made in
this is evidenced in the increases in
Orphan Market Exclusivity and Paediatric
Germany, the United Kingdom and
healthy life years and increases in
Rewards, is fundamental to ensuring a
France. As well as supporting a
productivity it has brought to the
strong pharmaceutical industry in Europe.
significant number of jobs, the industry
European HIV population. For patients
It has helped to generate investment in
has been making strides in areas of
treated between 2007 and 2017, the
areas with previously unmet needs and
representation and gender equality and
HAART therapies we looked at are
fostered a thriving industry that makes a
compares favourably with other key
estimated to lead to a gain of 800,000
significant contribution to the European
industries. In 2016, 46% of the
healthy life years and €22 bil ion of
economy and society. A survey of 18
pharmaceutical industry’s workforce
productivity. Outside of the quantifiable
EFPIA corporate members reinforces the
were women.
gains in healthy life years and
importance of these incentives.
productivity, these innovations have the
Respondents indicated that, within the
However, the benefits brought by
potential to reduce both health
current incentives environment, they have
pharmaceutical innovation are not just
inequalities and HIV transmission rates.
increased investment in the EU over the
economic. The industry improves the
past three years. Members indicated that
lives of mil ions of Europeans through its
It is worth noting that the benefits
intel ectual property (IP) incentives and
contributions to public healthcare and
quantified in our analysis represent only
faster market access are the leading
wider societal benefits. In order to
a fraction of the overall health and
factors influencing R&D investment
il ustrate some of these benefits, we
societal contribution of the
decisions, and that dismantling the
investigated two therapeutic areas –
pharmaceutical industry in Europe. Our
current incentive model would have a
breast cancer and HIV – as case studies, analysis focused only on specific
negative impact on their R&D and
measuring the impact of a selection of
medicines within two therapeutic areas.
Commercial operations in Europe.
medicines in each case study.
New, more effective drug therapies
Drastical y changing the incentives model
improve the psychosocial health of
therefore risks damaging the
patients, family members and the
pharmaceutical industry’s ability to deliver
value in Europe.
1 GVA captures the gross economic contribution that a sector makes to the economy, in terms of the value
that its activities add to overall economic output. GVA is broadly equivalent to GDP but it excludes some
indirect taxes. It is commonly used to measure the value of a company or sector of the economy for whom it
is difficult to attribute certain taxes.
2 Giannelli et al. (2012). GDP and the value of family caretaking: how much does Europe care?
Economic and societal footprint of the pharmaceutical industry in Europe | 3
Introduction
The value of the pharmaceutical These innovations have al owed us to
A better understanding of the
industry to both patients and
tackle complex diseases far more
broader value that the industry
effectively and with greater precision
delivers can contribute to more
society is often lost in the
than ever before. Yet these breakthroughs
holistic dialogue and
public debate surrounding
are expensive: accounting for the cost of
decision-making
failed drugs, the average cost of bringing
medicine prices
a new drug to market is now estimated
To better understand the direct and
to be over $2bn.3
indirect contribution of the
In the past 20 years, the pharmaceutical
pharmaceutical industry in Europe,
industry has pioneered research into a
Medicine prices are set through negotiation
EFPIA commissioned PwC to conduct a
vast range of life-saving medicines.
with governments based on the value
study focussed on three key areas:
Research into smal molecule medicines
they deliver to patients and health
• The economic impact of the industry;
and vaccines has paved the way for new
systems. Unlike other parts of the
• The health and societal impacts of
treatments in a number of key areas,
healthcare system, they are subject to
the industry; and
affecting mil ions of lives, including
rigorous value assessments before
• The enabling environment for
precision medicines, biologics, cell and
being reimbursed. Yet these value
continued investment in innovation.
gene therapies, siRNA and
assessments can overlook the direct and
digital therapeutics.
indirect benefits of pharmaceutical
innovation, both in the field of medicine
and to the wider patient population, their
careers, the community, and the economy.
3 DiMasi et al. (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs. Tufts Center for the Study of Drug Development,
Tufts University, United States.
4 |
Economic and societal footprint of the pharmaceutical industry in Europe
Methodology
For the economic analysis, we estimated
Direct economic impact
the economic contribution of the
Consists of the economic value that
pharmaceutical industry, defined here as
the sector created directly and the
the pharmaceutical and life science
number of people that organisations
companies developing and distributing
within the sector employ.
medicines and vaccines4, in the EU.
The analysis examines how the industry
Indirect economic impact
Consists of the impact of the sector’s
contributes to the economy through
expenditure on suppliers (for example,
Gross Value Added (GVA) and
by purchasing raw materials) and
employment. GVA captures the gross
suppliers’ expenditure through
economic contribution that a sector
subsequent tiers of the supply chain.
makes to the economy, in terms of the
value that its activities add to overall
economic output.5 Employment captures
Induced economic impact
Consists of the impact of employees
the number of people who are directly
of both the pharmaceuticals sector
employed in a given sector, who have a
and its supply chain spending
contract of employment and receive
their wages.
compensation in the form of salaries.
In addition to the direct economic
For the health and societal impact case
brought to society. The case study
contribution of the industry, we used
studies, we investigated two therapeutic
approach covers only a fraction of the
input-output analysis to estimate the
areas: breast cancer and HIV. These
impacts of medicines, and is intended to
industry’s broader economic contribution
were chosen because they cover
provide il ustrative examples of health
through its supply chain and employee
different disease profiles, including
and societal benefits rather than be a
spending. The total contribution of the
non-communicable and communicable,
comprehensive analysis across the
industry is made up of direct, indirect
acute and chronic diseases, and affect
pharmaceutical industry.
and induced effects, which we define
people of different ages and
as fol ows:
socioeconomic backgrounds.
To understand the importance of the
current EU incentives model, which
For the two therapeutic areas, we
includes Supplementary Protection
focused on a subset of medicines that
Certificates, Regulatory Data Protection,
represent important innovations in their
Orphan Market Exclusivity and
field and address previously unmet
Paediatric Rewards, we surveyed EFPIA
patient needs. To assess their impact,
corporate members. The survey sought
we fol owed a bottom-up process to
to determine how the current incentives
estimate the aggregate health,
model affects their Europe based R&D,
productivity and cost impact of these
commercial and manufacturing
medicines for patients treated from 2007
operations and what dismantling this
to 2017. By estimating the incremental
incentives structure might mean for them.
gain in healthy life years6, working days
and the change in net health care costs
For more detail on the methodology,
compared with standards of care prior to please refer to the Technical Report.
the introduction of the medicines, we
were able to come up with a picture of
the benefits these medicines have
4 We have defined the pharmaceutical industry as using NACE code C21 (Manufacture of basic pharmaceutical products and pharmaceutical preparations). NACE codes
are a Europe-wide standard classification for businesses, which allow us to conduct analysis across countries consistently.
5 GVA is a similar measure to GDP, but GDP includes some additional indirect taxes which are difficult to attribute to individual sectors. The formula to calculate GVA is:
Direct GVA = Operating Profits + Depreciation + Amortisation + Direct employee costs.
6 In this report, the term ‘healthy life year’ is used as the plain English equivalent of the technical term: Quality-Adjusted Life Year (QALYs). One healthy life year is
therefore the same as one QALY and is equal to 1 year of life in perfect health. Or, for example, 2 years living with a severe illness which reduces quality of life by 0.5.
The QALY is a widely used health outcome measure which reflects both the length and quality of life lived. QALYs are measured in terms of the person’s ability to carry
out the activities of daily life, as well as freedom from pain and mental disturbance. (NICE).
Economic and societal footprint of the pharmaceutical industry in Europe | 5
Economic impact
The pharmaceutical industry is
Figure 1: GVA contribution of the pharmaceutical industry in the EU, 2016
a major contributor to the EU
250,000
economy. We estimate that in
total, it contributed €206 bil ion
200,000
in GVA and 2.5 mil ion jobs in
59,914
150,000
2016, equivalent to 1.4% of the
46,160
region’s combined GDP and
100,000
206,010
0.9% of employment.
50,000
99,935
GVA impact (€, millions)
0
Direct
Indirect
Induced
Total
Source: PwC analysis
Figure 2: Employment contribution of the pharmaceutical industry in the EU, 2016
3,000,000
2,500,000
2,000,000
1,072,000
1,500,000
2,494,000
1,000,000
780,000
Employment impact
500,000
642,000
0
Direct
Indirect
Induced
Total
Source: PwC analysis
The pharmaceutical industry directly
The benefits of the pharmaceutical
employs a large number of highly-skilled
industry’s productivity extend beyond
staff, who each make a significant
the industry itself: it helps to raise living
contribution to the economy.
standards, keep wages high and
increases tax revenues for government.
The pharmaceutical industry directly
contributes an average of €156,000 of
GVA for every employee. This figure is
significantly higher than the region’s
average of €59,000, and it is also higher
than other industries. For example, the
GVA per employee in the car
manufacturing industry is €85,000.
6 |
Economic and societal footprint of the pharmaceutical industry in Europe
Figure 3: Economic contribution of the pharmaceutical industry versus other key industries
Pharmaceuticals
Automotive
Aerospace
Computer
manufacturing
manufacturing
programming
€100bn
€211bn
€45bn
€261bn
Direct Gross Value
Direct Gross Value
Direct Gross Value
Direct Gross Value
Added (2016)
Added (2016)
Added (2016)
Added (2016)
642,000
2,480,000
410,000
3,180,000
Direct Employment
Direct Employment
Direct Employment
Direct Employment
(2016)
(2016)
(2016)
(2016)
€156,000
€85,000
€102,000
€82,000
Value added per
Value added per
Value added per
Value added per
employee
employee
employee
employee
Source: PwC analysis
Breaking down GVA by country shows
The pharmaceutical industry’s workforce is more gender balanced than
that the pharmaceutical industry offers
other key industries
the largest contribution to GVA in
Germany and the United Kingdom, with
The pharmaceutical industry has been making strides in areas of representation and
these countries accounting for 33% of
gender equality. In 2016, 46% of the pharmaceutical industry’s workforce across the
the total GVA created by the industry in
EU were women. This compares favourably against, for example, the gender
the entire region. The GVA contribution is distribution of the 18 mil ion scientists and engineers in the EU who are women (41%),
concentrated in these countries as they
and the distribution of scientists and engineers in high and medium-technology
are home to many large pharmaceutical
manufacturing who are women (just 17%).7
companies, who employ a large number
of staff in high productivity roles. Jobs
Figure 4: Percentage of female employees in the pharmaceutical industry
supported by the industry are also
versus other key industries
concentrated in these countries along
with France. Germany, France and the
Share of female employees
United Kingdom account for nearly half
(EU average)
(49%) the total jobs supported by the
industry in the region. For more detail
on country-specific results, see
Pharmaceuticals
46%
Technical Report.
Auto manufacturing
24%
Aerospace & Defence
16%
Computer programming
23%
Source: PwC analysis
7 Eurostat (2019). Women in science & technology
Economic and societal footprint of the pharmaceutical industry in Europe | 7
The Orphan Regulation has helped total of not more than €43 mil ion. Since
to address an unmet need in the
its adoption, the number of orphan
Ronny’s story
pharmaceutical industry, whilst
medicines in the EU has risen
also encouraging the growth of
significantly, from only 8 products prior
When Ronny was diagnosed
small and medium sized
to 2000, to 164 today9. The medicines
with neuroendocrine tumours,
enterprises (SMEs)
treat a wide variety of diseases, however,
he did what people do in
there has been a clear focus on orphan
Orphan diseases affect circa 30 mil ion
movies and asked how long
cancer medicines, which account for
people in the EU, with more than half of
he had to live. When the
more than 40% of orphan medicines
newly diagnosed cases occurring in
with market access, and medicines
oncologist said: ‘months,
children, a third of whom will die before
targeting il nesses with a particularly low
years…’, Ronny switched off.
they are five years old. Despite this, fewer
prevalence (below 3 in 10,000).
than 15% of orphan diseases benefit from
But he did remember the
what the European Medicines Authority
The number of medicines granted
oncologist adding: ‘But with
describes as ‘even minimal amounts of
orphan designation by the European
the right treatment you could
scientific knowledge’, and 95% of the
Commission has risen year on year,
live a lot longer.’ Fortunately,
7,000 known rare diseases have no
suggesting a greater number of higher
Ronny had access to the right
approved therapies.
quality applications. This goes hand in
treatment at the right time. He
hand with the rising number of scientific
The EU Orphan Regulation, adopted in
publications on rare diseases, which are
is now living a reasonable
December 1999, provides 10 years of
providing companies with the knowledge
quality of life, participating in
market exclusivity to medicines for
they need to develop effective orphan
orphan diseases
activities such as bicycle rides
8, alongside protocol
medicines.
assistance, reduced fees for regulatory
with his wife. He thinks he’ll
activities, and additional incentives for
SMEs contribute significantly to the
even be able to live to see
SMEs, defined by the EMA as enterprises
orphan medicines market, indeed, more
some of his grandchildren
with fewer than 250 employees and either than half the medicines that have so far
graduate from school.
an annual turnover of not more than
received orphan designation were
€50 mil ion or an annual balance-sheet
developed by SMEs.
8 According to the Orphan Regulation requirements, an orphan disease cannot have a prevalence higher than 5 in 10,000
9
EMA (2018) Annual report on the use of the special contribution for orphan medicinal products. Available online here: https://www.ema.europa.eu/en/documents/
report/annual-report-use-special-contribution-orphan-medicinal-products-2018_en.pdf
Figure 5: Types of organisations with orphan designations in development
from 2002 to 2012
13%
SMEs
Academia and public bodies
16%
Large companies
51%
Other
17%
Intermediate-sized companies
3%
Source: Charles River Associates (2017)
8 |
Economic and societal footprint of the pharmaceutical industry in Europe
The number of orphan-focused SMEs has risen since the adoption of the Regulation: of the 276 SMEs focusing on orphan
medicines that currently exist, 90% were incorporated after 2000.
Figure 6: Number of SMEs focusing on orphan medicines
30
25
20
15
10
5
0
1973
1975
1977
1979
1981
1983
1985
1987
1989
1991
1993
1995
1997
1999
2001
2003
2005
2007
2009
2011
2013
2015
2017
Source: European Medicines Agency SME Register
Alongside benefits provided by the
Regulation exclusively to SMEs, SMEs
developing orphan medicines can
benefit from attracting early investment.
Venture capitalists investing in orphan
medicine start-ups typical y do so on
average one year before they would in a
non-orphan medicine equivalent.10
Benefits aside, the orphan medicines
market is suited to SMEs, as it offers a
wide breadth of niche areas that require
bespoke research, creating an
environment with less direct competition.
10 Charles River Associates (2017). An evaluation of
the economic and societal impact of the orphan
medicine regulation
Economic and societal footprint of the pharmaceutical industry in Europe | 9
Health and societal impact
The benefits brought by
Breast cancer
Pharmaceutical innovations since 2005
pharmaceutical innovation are
have led to an improved prognosis for
Before 2005, many patients with
these patients. The subset of medicines16
not just economic. It improves
aggressive or advanced breast cancer
we investigated for both the HER2+ and
had very low chances of survival11 and
the lives of mil ions of
HR+ forms of the disease represent a
were limited in their treatment options.
pipeline of treatment innovation, in that
Europeans through its
Drug resistance12 in these cancers meant they capture both the first treatment
contributions to healthcare and that patients were forced to undergo
forms and their subsequent evolutions.
gruel ing and in some cases ineffective
wider societal benefits. The
chemotherapy courses.13 For certain
We estimate that between 2007 and
following case studies illustrate metastatic breast cancer patients, for
2017, over 500,000 breast cancer
example, average life expectancy after
some of these benefits.
patients received these targeted
diagnosis was 20 months, with patients
treatments, resulting in a gain of nearly
responding to chemotherapy for an
1.2 mil ion healthy life years.
average of just six months.14
Innovation in medicines has helped to
address this previously unmet need. In
our case study, we consider patients
with early and advanced HER2+15 and
advanced HR+ breast cancer.
546,000 breast cancer
patients treated between
2007-2017 of which 406,000
8% of the
had early stage and
patient population*
140,000 had late stage
1,160,000 healthy life
Average of 2.12 healthy
years gained in Europe
life years per patient
2.45 healthy life
1.17 healthy life
years gained
years gained
per patient with
per patient with
early stage
advanced stage
* With only 4% of patients with advanced breast cancer eligible for HER2+ treatment, and 10% of patients with
early stage cancer eligible for HER2+ treatment, this is a significant proportion of the eligible population.
11 Slamon et al. (2001). Use of Chemotherapy plus a Monoclonal Antibody against HER2 for Metastatic Breast Cancer That Overexpresses HER2.
12 Moiseenko et al. (2017). Resistance mechanisms to drug therapy in breast cancer and other solid tumors: An opinion.
13 Sledge et al. (2014). Past, Present, and Future Challenges in Breast Cancer Treatment.
14 Slamon et al. (2001). Use of Chemotherapy plus a Monoclonal Antibody against HER2 for Metastatic Breast Cancer That Overexpresses HER2.
15 HER2+ breast cancer is a breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of
cancer cells. Approximately 20% of breast cancer cases are HER2+ breast cancer.
16 See Technical Report for list of medicines considered in the study.
10 |
Economic and societal footprint of the pharmaceutical industry in Europe
Through more effective treatment these
al owing increased access to a similar
medicines have also reduced days lost
standard of care. For example, in
to il ness thus creating additional
Europe, four trastuzumab biosimilars
economic benefits. We estimate that the
have recently come to market,20
new treatments create productivity gains indicating a drive from pharmaceutical
of €9,700 per patient, or €5.3bn in total,
companies to continue innovating and
which is equivalent to about 3.5% of the
delivering impact.
total economic cost for breast cancer
care in Europe.17
Final y, the medical benefits of these new
treatments are not limited to HER2+ and
Outside of the quantifiable gains in
HR+ breast cancer treatment: they paved
healthy life years and productivity, these
the way for antibody-targeted treatment
innovations deliver a wider impact on
across many different cancer types.
both patients’ family members and the
broader breast cancer population. The
health and societal impact presented
here will likely be much greater than
that captured by our analysis. This is
Suzanne’s story
owing to the disproportionate
When Suzanne Leempoels found
contribution of women, more specifical y
mothers, to the economy in terms of
out at the end of her early breast
unpaid work. Global y, women spend up
cancer treatment that she had
to ten times more time on unpaid work
metastasis in her lungs, the first
than men,18 and as breast cancer largely
thought that crossed her mind was
affects women, the impact of improved
breast cancer treatment on unpaid work
that she wanted to live to one day
is significant.
meet her grandchildren. Fortunately,
her oncologist opted for curative
Improved treatments have also helped to
treatment, and five years later, her
alleviate the burden placed on primary
caregivers and patients’ immediate
cancer is inactive.
family members. It has been reported
that among breast cancer caregivers,
Suzanne now campaigns for
30% suffered from depression and
awareness on behalf of other
almost 80% of employed caregivers
metastatic cancer patients. In
missed work.19
particular, she wants to highlight
Furthermore, the patent lifecycle of these
that cancer is more than just a
medicines opens the way for new
medical problem; it affects all areas
entrants, such as biosimilars or improved
of life, from work and financial
versions through life cycle management,
security, to patients’ emotional
resulting in a healthy competitive
ecosystem. These new entrants are
condition and sense of self-worth.
typical y offered at a lower price, thereby
17 Luengo-Fernandez et al. (2013). Economic burden of cancer across the European Union: a population-based
cost analysis.
18 Promundo (2019). State of the World’s Fathers: unlocking the power of men’s care.
19 Grunfeld, E. (2004). Family caregiver burden: results of a longitudinal study of breast cancer patients and their
principal caregivers.
20 Generics and Biosimilars Initiative (2018). Biosimilars of trastuzumab.
Economic and societal footprint of the pharmaceutical industry in Europe | 11
HIV
Prior to the advent of highly active
vomiting, anaemia, neutropenia,
The advent of HAART, which saw the
antiretroviral therapy (HAART), an HIV
myopathy, pancreatitis, and peripheral
introduction of protease inhibitors and
diagnosis was considered by many to be neuropathy,21 as well as a high chance of
the development of backbone NRTIs, in
a death sentence. In the early 1990s, HIV developing AIDS. The low tolerability of
the mid-1990s marked a breakthrough
patients were treated with dual NRTI
these side effects contributed to
for patients. These backbone therapies
therapy (AZT with zalcitabine or
poor adherence.
became more efficacious with fewer side
didanosine) which had limited success in
effects over time. Our analysis looks at
lowering viral load and was accompanied
the health and societal benefits that
by severe side effects, including nausea,
HAART has brought.
Timeline of HIV treatment development
2000s onwards: Backbone therapies made over this time period became
Early 1990s: Mainstream practice was
more efficacious with fewer side effects. Major drug developments have
dual therapy combining two NRTIs,
been the ability to combine triple therapy into a single tablet (STR), as well
AZT with zalcitabine (ddC) or
as CCR5 and integrase inhibitors.
didanosine (ddI).
Mid 1990s: Advent of triple therapy, later cal ed HAART, thanks to the
development of protease inhibitors, the first of which was saquinavir. Early
forms of HAART later saw great improvement through the creation of PI-
boosters and the development of the back-bone NRTIs.
The development of HAART has turned
have better tolerability and thus improve
treatment pre mid-1990s23, bringing life
HIV into a treatable, chronic disease.
the quality of life for people living with
expectancy for people with HIV on
These new drugs tackle the potency of
HIV. The development of STRs has also
anti-retroviral treatment and responding
the virus with no further risk to the
enabled greater medication adherence
to treatment in line with the general
patient. In doing so, they have overcome
within the HIV community, which has had population24, meaning patients can
the single biggest chal enge facing HIV
a significant positive impact on viral
expect to live full lives. In total, for
drug development.
suppression in HIV patients.
patients treated between 2007 and 2017,
we estimate a gain of 775,000 healthy life
There are now more than 30 HIV drugs
Looking at a subset of STRs introduced
years. This increase in health extends
available, of which there are 13 fixed
in the last decade22, we can see the
their ability to work and contribute to
dose combinations that are cal ed single
difference these treatments have made to society, resulting in an estimated
tablet regimens (STR). Continued
patients’ lives and to society at large.
€207,000 in productivity gains on average
investment in the research and
We estimate that HAART gives the
per patient over their lifetime.
development of new anti retrovirals,
average HIV patient an extension of
including within STRs, has resulted in the 9 years in life expectancy (approximately
development of new combinations that
7.4 healthy life years) compared to
21 Darbyshire et al. (2000). Zidovudine (AZT) versus AZT plus didanosine (ddI) versus AZT plus zalcitabine (ddC) in HIV infected adults.
22 See Technical Report for medicines included in analysis.
23 See Technical Report for details on methodology
24 NHS UK. What is the life expectancy for someone with HIV?
12 |
Economic and societal footprint of the pharmaceutical industry in Europe
105,000 HIV patients were
8% of the
Patrick’s story
treated between 2007-2017
patient population*
Patrick Reyntiens was
diagnosed as HIV-positive in
1985. At the time, the disease
775,000 HLYs gained
Average of 7.4
was close to a death
in Europe
HLYs per patient
sentence. The great
breakthrough came in 1996,
* The medicines we have analysed are single tablet therapies. Many people are treated with multi tablet
regimens with the same active ingredients.
with the introduction of ‘AIDS
Cocktails’ (early HAART).
By reducing patients’ risk of developing
failures in treatment make the possibility
Initial y, Patrick was on 20 –
AIDS and other HIV-related
of virologic rebound high among patients
30 pil s a day and he felt
complications, HAART has also
in these groups.27 Through better
sicker on the medication than
al eviated pressure on healthcare
adherence and improved viral
systems. We estimate that, compared to
suppression, access to STRs would
from the virus itself. These
treatment in the early 1990s, treating
disproportionately benefit less privileged
days, however, Patrick takes
someone with HIV using HAART could
socioeconomic groups.
only five pil s a day. Many
result in net savings to the healthcare
patients only need to take
system of €11,000 per patient over their
Moreover, HAART has had a major
lifetime
impact on HIV transmission rates. A
one. Patrick’s quality of life
25. This suggests that despite the
high cost of new HIV medicines, they
recent study found that due to the
has improved enormously and
deliver value for money in the long-term.
reduction in virologic load, patients on
he uses his time to raise
HAART treatment presented no
awareness of HIV. He’s
In addition to the quantifiable gains in
transmission risk to their partners28.
healthy life years and productivity, these
Reducing the transmission risk could
hopeful treatment will continue
innovations have the potential to reduce
further significantly lower the prevalence
to improve and that one day
both health inequalities and HIV
of HIV across Europe and in turn, reduce
there might even be a cure.
transmission rates. HIV is most prevalent the healthcare burden of HIV and HIV
among vulnerable groups and especial y
related il nesses. Furthermore, studies
among those of lower socioeconomic
are now evaluating the use of such
status. Treatment outcomes for these
medicines as pre-exposure prophylaxis
groups tend to be worse, due to a
(i.e. taken to prevent HIV infection by
combination of factors including failure
those who do not have HIV but are at
to diagnose HIV early enough, late
substantial risk of getting it), which have
initiation of antiretroviral therapy (ART)26
proven successful in lowering HIV
and poor adherence to ART. These
transmission in America.
25 This could range from net savings of €40,000 to net cost of €31,000 depending on assumptions applied. See Technical Report for further information.
26 Lodi, S. (2014). Delayed HIV diagnosis and initiation of antiretroviral therapy.
27 Burch et al. (2016). Socioeconomic status and treatment outcomes for individuals with HIV on antiretroviral treatment in the UK: cross-sectional and longitudinal analyses.
28 European Centre for Disease Prevention and Control. (2018). The benefits of HIV treatment: undetectable means you do not pass on the virus.
Economic and societal footprint of the pharmaceutical industry in Europe | 13
Role of IP incentives
For the industry to continue to
The IP incentives considered in the
Figure 7: Percentage of respondents
deliver such value to the
survey are the Supplementary Protection
reporting a change in European
Certificates (SPCs), Regulatory Data
footprint in the last three years
European community, it is
Protection, Orphan Market Exclusivity,
essential that the legal and
and Paediatric Rewards, among others.
Change in European footprint
Research and development of new
% or respondents reporting a change in
regulatory environment
medicines can be a long, complex, risky
the last 3 years
encourages innovation and
– and ultimately expensive – process.
fosters growth. This kind of
These incentives are designed to
encourage continued innovation by
14%
environment has been enabled
offering additional protection for
in the EU through the
medicines that make it to market.
35%
introduction of several initiatives, Within the current environment, over
including IP incentives, which
80% of respondents reported that they
have increased or maintained current
have encouraged the
levels of investment, which is consistent
51%
development of innovative
with reported figures29 from the
medicines. To help understand
pharmaceutical industry. Research and
Development (R&D) and Commercial are
the importance of the current
the segments of the value chain that
Increase
No change
Decrease
incentives model, and the
have benefited most from this trend as a
potential effects of dismantling
result of maturing pipelines, incremental
Source: Results of PwC survey of EFPIA
investments in existing facilities and
corporate members
it, we undertook a survey of
capabilities, new product launches and
18 EFPIA corporate members.
partnership-led R&D approaches.
29 Informa UK (2017) Pharma R&D Annual Review 2017.
“We made multi-milion €
investments focused on
modernising existing
R&D facilities, ramping
up R&D activities, and
enhancing R&D
capabilities
Respondent to PwC survey
14 |
Economic and societal footprint of the pharmaceutical industry in Europe
EFPIA members indicated that IP incentives and quicker market access are the
According to EFPIA members,
leading factors influencing R&D investment decisions. IP incentives were
dismantling the current incentives model
consistently ranked by the respondents in the top three factors influencing
would have a negative impact on
investment decisions.
pharmaceutical companies’ EU
research-based investment activity.
Respondents indicated that phasing out
Figure 8: Market factors in order of importance in terms of deciding which
current incentives in Europe would have
countries to invest
a material negative effect on their
European operations, with over half
Overall
indicating that this scenario would lead
rank
to a reduction in their R&D and
Commercial footprints of more than
IP incentives
25%. Organisations choosing to reduce
1
their footprint in Europe would seek
opportunities to increase investment in
regions where their IP is better protected
Accelerated approval/early access schemes
and innovation more actively rewarded.
2
This finding is consistent with previous
studies30, 31 which show that weaker
intel ectual property regimes limit the
Skills and wage costs of labour
wil ingness of companies to invest
3
in R&D.
Size of economy and potential for growth
4
Macro-economic/political issues
(e.g. inflation, political uncertainty)
5
Attractiveness to conduct clinical trials
“Investments have been
increased by more than
6
10% per year over the
last 3 years to launch
Tax rates
7
new products, continue
increasing our
investments in our
Infrastructure and transport
8
existing portfolio,
support the creation of
Source: Results of PwC survey of EFPIA corporate members
new affiliates, and
reinforce our expertise
and global organisation,
particularly in terms
of R&D
Respondent to PwC survey
30 NERA Economic Consulting (2007). Key Factors in Attracting Internationally Mobile Investments by the Research Based Pharmaceutical Industry.
31 Porter, M. (2000). Location, Competition, and Economic Development: Local Clusters in a Global Economy.
Economic and societal footprint of the pharmaceutical industry in Europe | 15
Conclusion
Our research provides evidence of the
The results of our survey of pharmaceutical
significant economic contribution that the
companies indicate that the current
pharmaceutical industry makes to
incentives model is important to ensuring a
economic prosperity and employment in
strong industry in Europe. It has helped to
the EU. We estimate that in 2016, it
generate investment in areas with
generated over €206 bil ion in GVA
previously unmet needs and fostered a
(including indirect and induced effects) and
thriving industry that makes a significant
employed over 2.5 mil ion people across
contribution to the European economy and
the EU.
society. Drastical y changing the incentives
model risks damaging the pharmaceutical
This study also highlights the valuable
industry’s ability to deliver value in Europe.
health and societal benefits of
pharmaceutical innovations in specific
There is an ongoing debate about the
areas of medicine. We estimate that for
affordability of medicines and the need for
over 650,000 HIV and breast cancer
the current level of IP incentives –
patients treated between 2007 and 2017,
justifiably so given the numerous
the subset of medicines analysed resulted
competing objectives of government.
in gains of nearly 2 mil ion healthy life years
However this debate should consider
and €27 bil ion in terms of productivity. It is
benefits as well as costs, and the
worth noting this only quantifies a fraction
pharmaceutical industry has contributed to
of the overall health and societal
many significant advances over recent
contribution of the pharmaceutical
decades. For example, cancer death rates
industry. Aside from addressing only two
have fal en by 20% over the last 20 years33,
therapeutic areas, we have not touched on
and close to 30 diseases are preventable
the ways in which new, more effective drug
by vaccination, preventing between 2 to 3
therapies improve the psychosocial health
mil ion deaths global y per year34. By
of patients, family members and the
providing better understanding of the
community, and our productivity
direct and indirect contribution of the
calculations do not account for increases
pharmaceutical industry in Europe, we
in informal employment, such as domestic
hope that our research will prove valuable
work, childcare, and family caretaking. The
by further informing the debate and
imputed value of such unpaid work has
facilitating productive dialogue.
been estimated at 20 to 40% of the EU
GDP32. Even the impact of the medicines
analysed here are likely to be greater than
stated, given that all of them have helped
pave the way for further innovations across
different medical disciplines.
32 Giannelli et al. (2012). GDP and the value of family caretaking: how much does Europe care?
33 Jönsson et al. (2016). The cost and burden of cancer in the European Union 1995–2014.
34 World Health Organization. (2018). 10 facts on immunization.
16 |
Economic and societal footprint of the pharmaceutical industry in Europe
Economic and societal footprint of the pharmaceutical industry in Europe | 17
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Economic and societal footprint of the pharmaceutical industry in Europe | 19
Contacts
Jo Pisani
Partner
Pharmaceuticals & Life Sciences,
PwC Strategy&
E: xx.xxxxxx@xxx.xxx
Dr. Nick Meadows
Director
Pharmaceuticals & Life Sciences,
PwC Strategy&
E: xxxxxxxx.xxxxxxx@xxx.xxx
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