Download Impact of austerity on European pharmaceutical policy and pricing

Impact of austerity on European
pharmaceutical policy and pricing
Staying competitive in a challenging
environment
Contents
Foreword
1
Executive summary
2
Part 1. The environment today 3
Part 2. Mechanisms for reducing pharmaceutical spending
7
Part 3. The future pharmaceutical landscape 12
Part 4. Imperatives for the pharmaceutical industry
14
Notes
18
Contacts
21
The Deloitte Centre for Health Solutions
The Deloitte Centre for Health Solutions, part of Deloitte UK, generates insights and thought
leadership based on the key trends, challenges and opportunities within the healthcare and
lifesciences industry. Working closely with other centres in the Deloitte network, including the
US centre in Washington, our team of researchers develop ideas, innovations and insights that
encourage collaboration across the health value chain, connecting the public and private sectors,
health providers and purchasers, and consumers and suppliers.
Foreword
Welcome to the Deloitte UK Centre for Health Solutions report on the Impact of austerity on European pharmaceutical policy and pricing:
Staying competitive in a challenging environment. This report was generated using a combination of secondary desk research, analysis of
historical precedents and insight derived from project work and client conversations. It presents the Centre’s views on:
• current challenges faced by the pharmaceutical industry due to on-going austerity in Europe
• mechanisms being employed by governments to reduce overall spending on pharmaceuticals
• the likely future pharmaceutical landscape and the implications for pharmaceutical sales and profitability within Europe
• options available to the industry that will allow them to remain competitive in this challenging environment.
We hope that you find the research and insight informative and thought-provoking and welcome your feedback and comments.
Karen Taylor
Director, Centre for Health Solutions
Impact of austerity on European pharmaceutical policy and pricing Staying competitive in a challenging environment
1
Executive summary
Across Europe, a high percentage of healthcare
spending is publicly funded. The current financial
climate has placed significant pressure on public
spending and while the majority of governments
acknowledge healthcare provision to be strategically
important, their willingness and ability to pay is
subject to increasing pressures. As a high percentage
of healthcare costs are fixed and difficult to tackle in
the short term, governments are adopting a number
of aggressive pricing strategies to exert downward
pressure on drugs. These include the price they are
willing to pay for new drugs as well as the introduction
of policies to promote the use of cheaper, generic
equivalents. Indeed, evidence indicates that European
Union countries are now paying less for their
medicines. This, along with the high levels of debt
owed by struggling governments to pharmaceutical
manufacturers, is having a significant, negative impact
on the operations of pharmaceutical companies active
in Europe.
Countries within the European Union are experiencing
different levels of pressure to rein in their pharmaceutical
spending. Ten eurozone countries exhibit higher than
average pharmaceutical expenditure and these are the
countries currently implementing the most aggressive
cost-containment policies.
The future pharmaceutical landscape
will continue to prove challenging for
the industry, as financial crises exert
long-term effects on a country’s
pharmaceutical industry.
2
Revenues from branded drugs which have been
launched are of paramount importance for funding
future pharmaceutical innovation. As governments
seek to drive increased value from their healthcare
spending, the path to commercialisation is becoming
more challenging. New product launches are likely to
deliver less revenue which could lead to a decline in the
funding pool available for research and development.
The future pharmaceutical landscape will continue to
prove challenging for the industry, as financial crises
exert long-term effects on a country’s pharmaceutical
industry. Spending levels on drugs normally recover
quickly (in absolute terms) post-recession, but with
higher generic penetration.
The changing environment is hastening the
development of a two-tier market, in which
reimbursement prices of innovative and ‘me-too’
medicines are more widely differentiated. This has
implications for pharmaceutical sales and profitability
in Europe. Branded manufacturers need to be more
proactive in this period of austerity, so that they can
compete effectively. There are a number of strategies
that manufacturers could adopt including across
market and in-market actions.
Unfortunately for the pharmaceutical industry,
spending on pharmaceuticals will remain a relatively
easy target for rationalising healthcare costs.
With governments likely to continue to apply downward
pressure on pharmaceutical spending, the industry will
need to adopt proactive strategies both within and
across markets.
Part 1. The environment today
The financial crisis in Europe has ended the
tendency for pharmaceutical spending growth
to be above GDP growth
Prior to the onset of the financial crisis in 2008,
pharmaceutical companies shared in the growth of
healthcare expenditure experienced across Europe.
Analysis conducted by the Organisation for Economic
Co-operation and Development (OECD) shows that
across the OECD European Union (EU) member states,
healthcare spending as a proportion of gross domestic
product (GDP) increased significantly from 7.3 per cent
in 2000, to 9.2 per cent in 2009. However, by 2010
healthcare spending had marginally declined to 9.0
per cent of GDP.1 Over the same period, growth in
expenditure on pharmaceutical products, comprising
prescription-only medicines (PoMs) and over the
counter (OTC) products, had consistently been higher
than GDP growth until the emergence of the financial
crisis (see Figure 1).
… growth in expenditure
on pharmaceutical
products, had consistently
been higher than GDP
growth until the emergence
of the financial crisis.
Figure 1. Western European pharmaceutical spending growth vs. real GDP growth, 2000-10
20
15
Growth (%)
The recent global financial crisis has impacted on
governments and industries across the world.
This report focuses on the crisis in Europe, and its
impact on pharmaceutical companies who are active
in Europe, particularly Western Europe which has
borne the brunt of the crisis.
10
5
0
-5
2000
2001
2002
2003
Pharma spend growth
2004
2005
2006
2007
2008
2009
2010
GDP growth
Source: EIU, data accessed 15 May 2013
Western Europe defined as: Austria, Belgium, Denmark, Finland, France, Germany, Greece,
Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom
The financial crisis has created an age of austerity
across Europe with widespread cuts to public
spending
The current economic climate in the EU has placed
significant pressure on government public spending
with many governments implementing cost cutting
initiatives. OECD data indicates that on average, in 2010,
73 per cent of healthcare was publicly funded. While
the majority of governments have deemed healthcare
provision as strategically important, their willingness
and ability to pay for health services is under threat.
Despite this, governments in the major European
markets have maintained their absolute spending on
healthcare since the onset of the financial crisis in the
middle of 2008, due mainly to a high percentage of
spending on fixed costs and increasing demand from
their ageing populations.2
Impact of austerity on European pharmaceutical policy and pricing Staying competitive in a challenging environment
3
Unfortunately for the pharmaceutical industry,
spending on pharmaceuticals remains a relatively easy
target for rationalising healthcare costs. Indeed, data
from the Economist Intelligence Unit (EIU) indicates
that while healthcare expenditure in absolute terms
has been maintained during the crisis, this is not the
case for spending on pharmaceuticals (PoMs and OTC)
which has declined across major European markets
since 2009. In the ten years to 2009 spending on
pharmaceuticals across the EU increased, on average,
by 3.2 per cent annually, however in 2010 spending
stalled.3
EU countries are experiencing different levels of
pressure to rein in their pharmaceutical spending
According to Eurostat, in 2010 the proportion of GDP
consumed by total healthcare spending ranged from
approximately nine to 12 per cent across major Western
European economies. There was a much wider variation
between countries in terms of pharmaceutical spending
as a proportion of overall healthcare spending.
This ranged from approximately eight to 20 per cent.
Differences between countries are further highlighted
when the proportion of GDP spent on pharmaceuticals
is considered:
Reduced pharmaceutical spending across the region is
having a significant, negative impact on the operations
of pharmaceutical companies active in Europe.
Evidence indicates that EU countries are paying less for
pharmaceuticals. According to the European Federation
of Pharmaceutical Industries and Associations (EFPIA)
discounting and price cuts contributed to over
€7 billion in savings in five European countries alone
(Greece, Ireland, Italy, Portugal and Spain) in 2010 and
2011. The situation is exacerbated by other factors
such as difficulties, and in some instances, failure of
governments to pay their drug bills. At the end of 2011,
EFPIA estimated that the pharmaceutical industry was
owed over €12.5 billion by Greece, Italy, Portugal and
Spain, with the majority of debt owed by hospitals and
local governments.4
• the average spending on pharmaceuticals across all
OECD countries was 1.6 per cent of GDP
Governments are adopting aggressive pricing
strategies and changing policies
Continued austerity in Europe is driving governments to
seek greater value from their stretched healthcare budgets,
ideally measured on the basis of improved patient
outcomes. This has resulted in European governments
implementing a number of pricing strategies, prescribing
policies and other mechanisms aimed at reining in
or reducing spending on pharmaceuticals. These are
explored in more detail in Part 2.
4
• ten eurozone countries (highlighted in Figure 2) had
an expenditure in excess of this benchmark.
Of note is Greece, which of the eurozone countries
recorded the second highest expenditure on
pharmaceuticals as a percentage of GDP in 2010.
Since 2012 the package agreed with the Troika
(comprising the country’s three major creditors the
European Central Bank, European Commission and
International Monetary Fund) has focused on reducing
pharmaceutical expenditure. Its target is a reduction
in pharmaceutical expenditure to just one per cent of
GDP by 2014, well below the current OECD average.5
The OECD data highlights the differences in
pharmaceutical spending across member countries.
With several countries having similar population and
patient demographics, it appears that two of the key
drivers of these differences are pharmaceutical pricing
and reimbursement policies, and prescribing behaviour.
Interestingly, the EU countries experiencing higher
levels of pharmaceutical spending as a proportion
of GDP are those that are currently implementing
aggressive cost-containment policies (see Figure 2).
Figure 2. Expenditure by OECD countries on pharmaceuticals as a percentage of GDP, 2010
Hungary
2.6
Slovak Republic
2.4
United States
2.1
Greece
2.1
Japan
2.0
Portugal
2.0
France
1.9
1.9
Canada
Spain
1.8
Belgium
1.7
Mexico
1.7
Ireland
1.7
Germany
1.7
Slovenia
1.7
Poland
1.6
Italy
1.6
OECD AVERAGE
1.6
Iceland
1.5
Czech Republic
1.5
Korea
1.5
Estonia
1.4
Australia
1.3
Sweden
1.2
Finland
1.2
Switzerland
1.1
United Kingdom
1.1
Netherlands
1.1
Chile
0.9
New Zealand
0.9
Denmark
0.8
Norway
0.7
0.7
Luxembourg
0
0.5
1.0
1.5
2.0
2.5
3.0
Percentage of GDP
Eurozone countries with a higher than average proportion of GDP spending on healthcare
Source: OECD, Health at a Glance: Europe 2012
Note: Pharmaceuticals comprise PoM and OTC drugs. In some markets they also include other medical nondurables (approximately 5%). Pharmacist remuneration has
been added where it is separate from the price of medicines. Excludes medicines consumed in hospitals; includes wholesaler and retail margins, and value added tax.
… the EU countries experiencing higher levels of pharmaceutical
spending as a proportion of GDP are those that are currently
implementing aggressive cost-containment policies.
Impact of austerity on European pharmaceutical policy and pricing Staying competitive in a challenging environment
5
A price reduction in one country can exert
significant downward pressure on prices elsewhere
International reference pricing (IRP) is a tool used
by governments, to ensure that the price of a
pharmaceutical drug is moderated or benchmarked
in line with prices in other geographies. Typically,
IRP is used to cap the local reimbursement price of
a drug in a specific country. It is a tool that has been
implemented widely across Europe, for example:
Revenues from in-market drugs are important for
funding future pharmaceutical innovation
A key driver of healthcare improvements has been
the development of new and more effective drugs.
The development of new drugs requires investment
in research and development (R&D), which can be
supported by governments but more often than not
is funded by the industry itself. The reasons for
a declining return on investment in R&D include:
• 25 per cent of world pharmaceutical markets
benchmark the prices of drugs in the UK
• the cost of developing an asset has remained
relatively static over the last few years, while returns
from launched drugs are declining9
• 26 countries inside and outside of Europe reference
prices to Greece in some way.6
Therefore, any downward pressure on prices within
referenced markets presents a significant risk to the
revenues pharmaceutical companies can generate
globally. In 2011 it was estimated that a ten per cent
price cut in Greece cost the industry: €299 million in
Greece, €799 million in Europe and €2,154 million
worldwide.7 This illustrates that revisions to drug prices
in referenced markets such as Greece will have an
impact across Europe as well as other parts of
the world.
IRP is a widely used mechanism to control drug prices.
Financially-challenged countries are therefore altering
their reference price benchmarks to target those
countries that have lower drug prices. Of greater
concern to the pharmaceutical industry is a move to
take the lowest price among a group of reference
price countries, instead of the average price. The Irish
government has proposed such a mechanism, but only
for groups of interchangeable drugs for which a generic
alternative is available.8
In-market reference pricing mechanisms have existed
for several years. Germany has been a leader in
terms of introducing systems to benchmark prices
of generic drugs and branded originals and, more
recently, so called jumbo classes of compounds,
deemed similar enough to deliver equivalent clinical
benefits. Additionally, linking reimbursement levels to
the price of the lowest available drug within a class is
an effective way to reduce public drug spending. It is
therefore not surprising that similar systems are being
implemented in countries that are suffering most from
the economic downturn.
6
• losses due to terminations continue to take significant
value out of late stage pipeline10
• the industry is increasingly seeking to harness
external scientific and medical innovation through
collaborations with peers or via innovation hubs,
including academia and biotech11,12,13,14
• the introduction of stricter pricing and market access
hurdles has made the path to commercialisation more
challenging.
The need for governments to drive increased value from
their pharmaceutical spending has put renewed pressure
on industry to demonstrate more clearly the value and
cost effectiveness of new product launches. This has
resulted in the introduction of additional pricing and
market access hurdles, with premium pricing and, in an
increasing number of cases, access being reserved for
those drugs that can demonstrate true enhancements
over existing therapies.
With new product launches expected to deliver less
revenue, the funding pool available for R&D is likely
to decline. Decisions being taken by policymakers and
fund holders over the last few years are beginning to
impact the industry’s ability to invest in R&D. A number
of big pharmaceutical companies have undergone
cost cutting measures to reduce their R&D footprints,
rationalise internal headcount and streamline R&D
operations.15,16,17 One likely positive outcome is that
companies are now taking earlier and more pragmatic
decisions about which compounds are likely to succeed
in the clinical environment and, importantly for payers
and patients, are focusing on compounds that will
deliver true enhancements over existing therapies.
However, a potential negative is that continued
downward pressure on pharmaceutical pricing
could challenge the industry’s ability to invest in the
innovative medicines of the future.
Part 2. Mechanisms for reducing
pharmaceutical spending
Different mechanisms are being used across the EU to rein in pharmaceutical spending
There are a range of mechanisms that governments are using to rein in pharmaceutical spending (summarised in
Figure 3). These are being implemented in various ways across the EU and their impact is being felt at different
levels. The mechanisms can be segmented into three broad categories:
• tried and tested strategies, such as reference pricing
• new technology-driven systems, such as electronic prescribing (e-prescribing)
• more aggressive approaches, such as clawback or rebate systems.
This section of the report highlights examples of each mechanism, including where and how they have been implemented.
Figure 3. The Mechanisms driver tree
£
Mechanisms
to reduce
drug spend
£
Prescribing behaviours
• Introduction of international non-proprietary name
prescribing
• Generic substitution, whereby a pharmacist must
dispense the lowest-priced ‘interchangeable’ drug
from a predetermined list
Headline price cuts
•T
ransparent reductions in headline price of drugs
•P
rice cuts tend to be mandatory and differentiated
dependent on patent status
Reference pricing
calculations
•C
hanges to in-market and international reference
pricing mechanisms, including:
–changing the countries that are referenced
–modifying the calculation method e.g. selecting
the average price of cheapest three countries
rather than the average of all countries
Reimbursement controls
•P
ositive drug lists – where only those drugs
included on the positive drug list are reimbursed
•T
ypically these are drugs that meet strict pricing
criteria
Distribution margins
•R
eduction in wholesaler and pharmacist margins
• L evel of margin differs depending on the patent
status of a drug
Rebates and clawbacks
•Introduction of rebates from the pharmaceutical
industry to the country’s health system –
minimising the in-market effect of price cuts on
international reference pricing
Patient co-payments
• Patient pays the excess above reimbursement price
for selecting a more expensive alternative
•T
he reimbursement level is set at the price of
cheapest available drug
Tendering
• Increased tendering for products at a regional
level within markets
Source: Deloitte LLP research
Impact of austerity on European pharmaceutical policy and pricing Staying competitive in a challenging environment
7
Adoption of mechanisms to reduce drug spending within the EU
Prescribing behaviours
Greece
Portugal
Italy
International non-propriety name prescribing and e-prescribing
INN prescribing mandates that prescribers should write prescriptions according to the active ingredient, not the
brand name.
Greece introduced INN prescribing in 2012 to reduce its drugs bill. The proposal included a series of exceptions and
exclusions that may mitigate the effect on patients continuing therapy or with particular conditions. It also allows
physicians a 15 per cent allowance by volume for branded prescriptions.18 The pharmaceutical industry in Greece strongly
opposed the measures as unnecessary and potentially damaging to patient access.19
One way to promote INN prescribing is to implement an e-prescribing system where the brand name on a prescription
automatically reverts to the generic name. Countries that have introduced or reinforced e-prescribing include Estonia,
Lithuania and Portugal.20
Since 2011 Portugal will only reimburse for drugs prescribed via an INN e-prescribing system.21
Generic substitution
Generic substitution is where dispensers are directed to dispense the cheapest identical product ignoring any brandspecific prescriptions. Of 29 countries across Europe, 23 are using generic substitution.22 This has been in place in
EU countries since 2003, however there have been adaptations to systems including a requirement for patients to
pay the difference should they opt for a more expensive brand, and the introduction of ‘reference groups’ to discern
interchangeable products.
Greece and Italy both mandate patient co-payments should a patient choose a branded drug.
£
France
Germany
Portugal
Spain
Ireland
Headline price cuts
Headline price cuts are where governments impose a transparent reduction to a medicine’s list price. These reductions can
cause significant price declines in other markets due to international reference pricing.
France: The new government pledged to keep drug reimbursements at 2012 levels while seeking efficiencies in the
healthcare system. These efficiencies include reductions in the cost of medicines and other healthcare products.
Price cuts on originator and generic products are targeted to save €530 million by the end of 2013.23
Germany: In 2010, parliament passed the Pharmaceuticals Market Reorganisation Act (ArzneimittelmarktNeuordnungsgesetz – AMNOG), which assesses the therapeutic benefit of a drug versus a comparator and includes a
mandate for retrospective assessment of additional benefit for medicines previously deemed to be innovative.24 Existing
novel drugs will undergo comparisons with the current market, with price cuts applied should the drug no longer be
deemed innovative.25
Portugal and Spain: In 2010, both these countries introduced a wave of mandatory price cuts which reduced the prices
of generic medicines by a much larger proportion than branded drugs. Portugal reduced generic prices by 30 per cent and
branded drug prices by six per cent,26 while Spain reduced generics by 25 per cent and branded drug prices by ten to 16
per cent.27
Ireland: In October 2012 the Irish Department of Health, Health Service Executive and Pharmaceutical Health Association
agreed mandatory price cuts for pharmaceuticals.28
8
Reference pricing calculations
Greece
Portugal
Ireland
Germany
International reference pricing
Greece: In September 2010, a new reference pricing paradigm was introduced whereby the price set was the average
price of the three cheapest EU markets. The new system resulted in average price reductions of 9.5 per cent.29 In 2011 an
EFPIA letter stated that a ten per cent price cut lost industry €299 million in the Greek market and €799 million across EU
countries that reference Greece directly or indirectly.30
Portugal: In 2011 it altered the EU states that it references to include the Eastern European state of Slovenia.31
In-market reference pricing
Ireland: On patent expiry, the price to the wholesaler of a medicine will be reduced to 70 per cent of the original price.
A year after this reduction the wholesaler price will be reduced to 50 per cent of the original price. For existing patent
expired medicines, the price to the wholesaler will be reduced to 60 per cent of the original price, and a further reduction
to 50 per cent of the original price will follow a year after.32
Germany: Existing product prices have been amended based on reference to the price of a class of similar or
interchangeable compounds (jumbo group) as soon as the first generic is launched.33
Reimbursement controls
Greece
Ireland
Reimbursement or positive lists have been in existence for several years. Introduction of such lists in periphery countries
will control volumes of premium priced medicines and, importantly for governments and payers, the amount of public
sector funding that is used to pay for them. Setting the reimbursement level at that of the lowest priced drug within a
group of interchangeable drugs will shift the cost burden of more expensive medicines firmly to patients. If they desire a
more expensive brand, then the patient will have to pay the difference. The existence of a positive or reimbursed list also
allows payers to choose which drugs and classes of drugs are eligible for reimbursement.
Greece: In September 2012 a drug price schedule (positive list) was reintroduced whereby only products meeting strict
pricing criteria will be eligible for reimbursement. The reintroduction of such a list provides an immediate instrument for
Greece to reduce drug spending as some drugs will no longer be eligible for reimbursement.34
Ireland: There are plans to introduce a reimbursement list in 2013.35
Impact of austerity on European pharmaceutical policy and pricing Staying competitive in a challenging environment
9
Distribution margins
Greece
Ireland
Italy
Germany
Distribution margins vary widely throughout the EU. However, the vast majority of countries enforce some form of margin
control, with only six countries not enforcing wholesaler margin regulation.36
Greece: In 2012, pharmacy margins for reimbursed medicines were reduced from 26 per cent to 16 per cent, and to €30
on products priced at €200 or more. Wholesaler margins were reduced from 6.5 per cent to
4.9 per cent.37
Ireland: In 2011, the government reduced wholesale mark-up on most drug items from ten per cent to eight per cent.
Further reductions in 2011 resulted in additional, on-going savings of more than €34 million.38
Italy: In July 2010 margins for reimbursed drugs were reduced by 1.82 per cent. Originally margins were due to be reduced
by 3.65 per cent; however this was reduced to 1.82 per cent with a requirement that manufacturers pay 1.83 per cent of
the price of their drugs to regional health authorities.39
Germany: The government has aimed to increase transparency of negotiated pharmaceutical prices throughout the supply
chain. To the dismay of the industry, prices are effectively in the public domain as they are disclosed by pharmacists.40
Rebates and clawbacks
Italy
France
Portugal
Greece
Italy: Since 2010, rebates must be paid retrospectively when the cap for reimbursed medicine spending has been
exceeded, for example drug spending higher than 11.5 per cent of total healthcare spending. The scheme is administered
at a regional level and requires repayment of 6.5 per cent of the drugs sold to Italy’s national health service. The industry
is responsible for paying 100 per cent of retail overspending and 50 per cent of hospital overspending, with over-budget
regional payers also accountable for hospital overspending and mandated to pay the other 50 per cent.41
Payments for the rebate scheme are calculated twice a year based on two, six-month periods.42 The payment required for
rebates is based on data collected by the Observatory on the use of Medicines. Companies are provided with an annual
budget based on health service purchases of a company’s medicines.43
France: Pricing and reimbursement are determined by price/volume agreements where the manufacturer provides
an estimate of the patient population and, therefore, the cost of the new drug to the healthcare system. If this cost is
exceeded, the manufacturer has to pay a clawback.44
Portugal: Introduction of a payback system, whereby the pharmaceutical industry will pay the amount of overspending,
if drug spend exceeds the 1.25 per cent of GDP target in 2012 or 2013 respectively.45
Greece: In 2012 the pharmaceutical industry offered to set a ceiling on the amount the Greek
government would pay for outpatient prescription drugs for the year. In return, the government would pledge that it
would pay the €1.7 billion the industry is owed by the healthcare system.46 The clawback brokered by EFPIA set a €2.88
billion ceiling on Greece’s pharmaceutical spending for 2012. Reports indicate that as the government is failing to reduce
the debt it owes industry, the system is still under negotiation.47
10
£
Ireland
Portugal
Italy
Patient co-payments
Ireland: The patient co-payment system is being redesigned as part of the July 2012 Health (Pricing and Supply of Medical
Goods) Bill. Patients will pay the excess if they choose to have a higher priced drug dispensed instead of a cheaper generic.
The bill does not change existing arrangements for the supply of items through community pharmacies. In addition, it
provides exceptions on clinical grounds allowing patients to continue to have access to prescribed medicines. Patients will
face no additional charge if a particular brand of medicine is required for clinical reasons.48
Portugal: A percentage rate co-payment is applied which is determined by the category of drug prescribed (A,B,C or D).
If a generic is dispensed the patient co-payment is 10% less than the co-payment for an equivalent brand.49 Revenues from
patient co-payments were expected to double between 2011 and 2012, amounting to an extra €80-90 million.50
Italy: A patient co-payment system was introduced as a flat rate but then changed to a fixed charge plus
a percentage of the drug price, to incentivise patients to choose a cheaper drug.51
Tendering
Netherlands
Tenders are issued and the lowest price bidder wins the right to supply the market. The terms of the tender can vary and
are decided by the body issuing the tender.
Tendering tends to occur more in the generics market, where 52 per cent of global spending is offered for tender,
compared with only 14 per cent of branded drug spending.52 A recent survey of 19 EU countries showed that tendering
was more popular in countries with a mature generic medicines market (54 per cent of countries) than in countries with
a developing generic medicines market (12.5 per cent).53 Tendering and contracting are more widespread in emerging
markets, but the growth of tendering is increasing in Western Europe.
The customers who are most likely to tender vary country to country but broadly include governments and hospitals.
Tendering programmes can achieve significant savings in the short term. However, programmes have to be well designed
to deliver intended savings in the long term.54
Netherlands: In 2008, tendering for 33 off-patent drugs decreased prices by as much as 95 per cent, with immediate price
savings achieved. However, Dutch authorities had to balance these savings against losses in the distribution chain because
of the retail system’s reliance on discounts.55
The implementation of these mechanisms has impacted the prices of pharmaceuticals in a number of EU countries.
Of note are three experiencing severe financial difficulties:
• in 2011 in Portugal, combined sales of branded and generic drugs declined by ten per cent or €312 million
compared with 201056
• over the last ten years, the prices of medicines have fallen by 28 per cent in Italy57
• after the introduction of reference pricing in Greece in 2010, average drug price reductions of 9.5 per cent
were realised. This was partly due to manufacturers reducing the prices of branded drugs to close to that of the
reimbursed price to ensure that their brands are dispensed in preference to a cheaper generic.58
Impact of austerity on European pharmaceutical policy and pricing Staying competitive in a challenging environment
11
Part 3. The future pharmaceutical
landscape
The recent financial crisis is not the first to have had
an impact on the pharmaceutical industry, nor is it
likely to be the last. This part of the report examines
some of the lessons from past crises and evaluates
the likely impact of the current crisis on the future
pharmaceutical landscape.
Lessons from history: How pharmaceutical
markets developed in Argentina, Japan and Turkey
following prolonged recessions
There are many examples where financial crises directly
impacted the local pharmaceutical industry. Evaluation
of historical precedents in Argentina, Japan and Turkey
identifies a common pattern of events leading up to,
during and after the financial crisis:
1. Currency devaluation
2. G
DP contraction resulting in a reduction in public
sector health expenditure
3. P olicies focus on reducing expenditure on
pharmaceuticals for example:
a. introduction of in-market and international
reference pricing (IRP) systems
b. an increase in competitive tendering
c. mandatory price cuts
d. promotion of INN prescribing and/or generic
substitution
4. Once economic growth returns, drug spending levels
return to pre-crisis levels, but generic medicines gain
a significant increase in market share.
The following case studies are illustrative of the
potential impact an economic crisis can exert on
a country’s pharmaceutical industry.
Argentina
Argentina’s economic crisis started in 1998 and lasted
four years, during which the economy shrank by 28 per
cent. The government implemented INN prescribing
and increased competitive tendering, which decreased
the value of prescribed drugs by as much as 45 per
cent, and delivered estimated annual savings of
$145 million.59 While economic growth returned after
two years, it took seven years for pharmaceutical sales
to return to pre-crisis levels.
12
Japan
Between 1994 and 2011 Japan suffered a total of
six years of negative economic growth, with no year
posting growth of three per cent or more between
1992 and 2010.60 Japan traditionally spent heavily
on pharmaceuticals, as high as 21 per cent of total
healthcare spending in the 1990s. In recent years the
government has introduced several reforms to reduce
this level of spending including biennial pricing reviews,
often resulting in price reductions,61 and measures to
expand the use of generic drugs to 30 per cent of the
pharmaceutical market, in volume terms, by March
2013.62
Turkey
Turkey underwent a significant recession during 2001
fuelled by two separate, financial crises. GDP shrank
from $589 billion to $561 billion and inflation increased
by 68 per cent. In 2004, the Turkish Ministry of Health
introduced IRP, which is estimated to have saved the
Turkish government over $900 million annually.
The use of generic medicines was promoted through the
introduction of generic substitution laws and mandatory
price cuts on generic drugs.63 As a consequence
the level of generic penetration in Turkey increased
markedly and, by 2005, the generic market was
estimated to be worth €1.8 billion, accounting for
51 per cent of the overall drugs market in terms of
volume and 35 per cent by value.64
The impact of the crises on the countries’ healthcare
systems, and their pharmaceutical industries
specifically, has had greater longer-term effects than
the recessions themselves. Each country exhibited
an increase in total healthcare and pharmaceutical
spending, but with higher generic penetration.
However, it is unrealistic to use Argentina, Japan and
Turkey as exact proxies for the current situation in
Europe, as there are considerable differences between
these markets, notably monetary union. Members
of the eurozone are prohibited from devaluing their
currency (the euro) unilaterally. Hence the first event in
the pattern identified above does not hold. However,
we have seen events 2 and 3 emerging across many
countries in Europe since the start of the global
financial crisis.
Reimbursement prices between innovative and
me-too medicines are becoming more widely
differentiated
The changing pharmaceutical and policy environment
is hastening the development of a two-tier market
in which innovative and undifferentiated, or me-too
medicines are treated very differently in terms of the
rules governing their pricing and reimbursement.
As well as the mechanisms highlighted in Part 2, there
are three trends that are hastening this differentiation:
Companies that are used to operating in a more
competitive pricing environment, such as generics
manufacturers, will already have developed the
operational efficiency necessary to remain profitable
in this environment. However, there are several actions
that branded manufacturers should consider to adapt
to this changing market scenario.
Figure 4. Western European pharmaceutical sales, 2000-17
• the rise of value-based pricing (VBP) being introduced
in a number of countries across Europe and due to be
launched in the UK from January 2014
• an increase in in-market reference pricing for groups
of interchangeable drugs.
This differentiation will mean greater competition
for drugs within a class and, increasingly, premium
pricing only for those drugs with a distinct patient
or indication-based value offer. Demand for these
innovative products will be high in Europe, but if the
prices demanded by manufacturers are to be funded
by already pressurised payers, many of the cost savings
required to pay for them will likely come from savings
in other areas of the healthcare and drug budget.
Implications for pharmaceutical sales and
profitability in Europe
The EIU anticipates that by 2016 the developed
European pharmaceutical market will recover the
sales value lost since the beginning of the financial
crisis in 2008 (See Figure 4). However, sales will likely
not exceed pre-crisis levels until 2017. Sales growth is
forecast to be low, about 0.9 per cent compounded
annually between 2011-17, while over the same time
period Datamonitor estimates profitability growth
will reach 1.3 per cent for the six largest European
pharmaceutical companies.
260
266
253 260
249 243 252
238 241 245
214
200 207
200
150
239
8.6%
CAGR
0.9%
-1.1%
250
US$ billion
• a rise in tendering, not only for generics, but also for
drugs within the same class
300
178
134 139
152
100
50
0
00
01 02
03
04
05 06
07 08
09 10
11
12
13 14
15 16
17
Source: EIU Data tool, accessed 23 May 2013
Note: 2000-09 actual, 2010-12 estimates, 2013-17 forecasts
Exceptions: Austria, Denmark, Ireland, Spain, Sweden, Switzerland: 2000-08 actual; 2009-12
estimates; 2013-17 forecasts; Italy, Netherlands, Norway: 2000-09 actual; 2010-12 estimates;
2013 forecasts
The EIU anticipates that
by 2016 the developed
European pharmaceutical
market will recover the
sales value lost since the
beginning of the financial
crisis in 2008.
Impact of austerity on European pharmaceutical policy and pricing Staying competitive in a challenging environment
13
Part 4. Imperatives for the
pharmaceutical industry
The industry needs to become more proactive to
survive current austerity
With changing healthcare policies across Europe, it is
essential for pharmaceutical companies to build the
data sets and capabilities to support the operational
excellence needed to navigate reference pricing
systems and manage any increase in tendering
activities. In November 2012, the EIU in collaboration
with Deloitte undertook a global study to examine the
recent wave of global healthcare reforms.65 The study
included a survey to assess pharmaceutical company
executive perceptions of how their companies are
reacting to these reforms. Two-fifths of pharmaceutical
executives interviewed believed that their company is
too reactive to drug policy changes (see Figure 5).
A minority, 20 per cent of respondents, considered
their company response to be part of broader,
considered strategic change.
Given the hastening pace of change it is time for a more
proactive response both in and across markets. In this
section we highlight nine actions, both in-market and
across market, companies can take to be more proactive
and allow them to remain competitive (see Figure 6).
While some of these are already being implemented,
greater application at scale and pace is needed.
14
Figure 5. Two-fifths of pharmaceutical executives agree that
their company’s response to reform is reactive
Question: My company’s response to healthcare reforms tends
to be reactive rather than part of broader, considered strategic
change
20%
41%
39%
Agree
Neither agree nor disagree
Source: EIU survey, November 2012
Disagree
Figure 6. Across market and in-market actions
Overarching action
Link future pricing
models to realworld data and
patient outcomes
• Work in partnership with payers and providers to build infrastructure and ensure data is gathered around drug
utilisation and patient outcomes
• Allows the gathering of real-world evidence to support drug efficacy and impact statements
Across market actions
In-market actions
Effective
international
reference pricing
management
• Enhance pricing models so that price
trajectory across Europe can be
understood
• Allows company pricing expertise to be
directed to those countries which are
likely to have greatest impact on IRP
• Informs strategies in countries which
allow free-pricing
Improve regulatory
affairs and
pharmaceutical
reputation
•A
im to build relationships with regulators
to ensure that payers understand the
value of pharmaceutical products and the
industry to their local market
Low cost
commercial models
• Low cost models could assist companies
in a pricing constrained market
• Strategies include reducing sales forces or
employing a distribution-only strategy for
non-core products
Improve data
efficiency to
enhance business
intelligence
• Improve data efficiency to support
internal reference pricing and tendering
activities
•T
his includes improving data analytics,
competitive market intelligence and
understanding of customer profitability
Pharmaceutical
company delivered
patient services
• Manufacturers could extend the delivery
of therapeutically aligned services, pillplus service models that reduce financial
pressure on health systems
Improve cost
transparency
across portfolios
•R
eview portfolio profitability – enhance
cost allocation across the portfolio
•S
cale up divestment of less profitable
brands
Lobby
• Membership of industry organisations
such as EFPIA increases in value in times
where the industry needs to understand
its collective bargaining power
Review the role
of generics and
biosimilars
•E
xpand or introduce generic or biosimilar
products in countries with rapidly growing
generic share
•E
xtend partnerships with biosimilar or
generic manufacturers
Source: Deloitte LLP research
Impact of austerity on European pharmaceutical policy and pricing Staying competitive in a challenging environment
15
An overarching need to link future pricing models
to real-world data and patient outcomes
The next generation of innovative, targeted medicines,
for example in cancer care, will pose a significant
cost burden for payers. Targeting these therapies to
highly specific patient populations will help to ease
this burden and ensure that health outcomes are
maximised. However, their high cost may still limit
access for patients in western healthcare systems.
Payers will increasingly expect reimbursement of high
cost, innovative, next generation therapies to link to
real-world utilisation and outcomes.
Mechanisms that link price more closely with the realworld value of a therapy, in either specific indications
or through actual patient outcomes, will be needed
to ensure that patients continue to have access to
innovative medicines. Such value-based pricing models
should move beyond ‘risk-sharing’ to systems that
employ utilisation and outcomes data in a holistic
fashion. This will require a fundamental shift in how
all healthcare stakeholders work together, including
governments, providers, clinicians and pharmaceutical
companies.
In addition, the requirement for systems utilising often
complex outcomes data could provide significant
opportunities for new technology entrants who are
able to manage the data required. This is likely to cause
a fundamental shift in how information is governed,
controlled and shared across stakeholders active within
healthcare systems.
Across-market actions aim to decrease the impact
of international reference pricing
Effective IRP management
While the economic environment remains unstable,
prices across Europe will continue to decline. This trend
may worsen as those countries that are have relatively
strong economies, such as the UK and Germany,
recognise the trend across Europe and seek to capitalise
on it to reduce public spending on pharmaceuticals and
improve government finances.
16
To tackle this, pharmaceutical companies need
to develop the data sets and capabilities required
to manage the potential negative impacts of IRP
effectively. For example, companies may need to
improve their pricing models to understand price
trajectory across Europe. Currently many models only
look at pricing and monitor expected changes when
there is an announced price change in a country.
In a situation where the pricing environment is
deteriorating, it would be advantageous for business
planning to run forward-looking scenarios and
stress test the in-market pricing trajectory and the
implications of in-market changes on IRP. This will
enable a pharmaceutical company to redirect business
planning initiatives to the countries where resources
can be used to influence the direction of IRP.
Low cost commercial models
Moving to a lower cost commercial model, such as
reducing sales forces or employing a distribution-only
strategy for non-core products, can assist in mitigating
the profit implications of a market and economic
environment in which trading and pricing
are experiencing a significant downturn.
Assessing the cost effectiveness of different sales
channels helps companies to identify the right multichannel mix for their medicines and, importantly, how
to allocate spending to maximise returns. This type
of assessment typically requires upfront investment in
channel tracking along with pilot projects in periphery
markets. The end goal is to achieve an improvement in
the sales effectiveness of different channel spending,
measured by change in sales relative to promotional
spending. This will facilitate a move to a lower cost
sales model.
Patient services delivered by pharmaceutical
companies
Over time manufacturers could extend the pace and
scale of developing therapeutically aligned services,
pill-plus service models that reduce financial pressure
on healthcare systems. Examples could include
providing a diabetes education service for patients
starting insulin therapy. Real-world evidence from local
healthcare systems could be used to illustrate the cost
savings from pill-plus service models, increasing the
value offered to healthcare payers and their willingness
to pay for drugs which manufacturers are prepared to
support with such services.
Lobby and improve relationships with payers
Membership of industry groups such as EFPIA
increases in value in times when the industry
needs to understand its collective bargaining power.
EFPIA conducts research into the impact on industry of
the changing pricing environment in Europe and is able
to co-ordinate the industry’s response to understand
the options available when negotiating with central
government. EFPIA could help to negotiate with
governments who are referencing the prices of drugs
in markets undergoing financial crisis, to ensure that
countries with healthier economies do not benchmark
local prices against financially-stressed member states
for a set period.
In-market actions to manage the effects of internal
reference pricing and tendering
Improve regulatory affairs and pharmaceutical
reputation
The reputation of the pharmaceutical industry and
the relative importance of the industry to a country,
for example through R&D investment, will be
important as it negotiates price cuts with governments.
An increased emphasis on promoting a positive
public perception, improving or maintaining good
government relations and regulatory affairs will be
essential. Decisions dictated by short-term profitability
may harm a pharmaceutical company’s reputation and
business, therefore a longer-term view will need to be
considered.
Improve data efficiency
IRP and in-market reference pricing are key policy
mechanisms across Europe. Their importance is set
to increase and pharma’s ability to maximise sales
and profitability will depend on building data sets
and capabilities to manage and optimise pricing in
this constrained environment. Any rise in tendering
practices also requires a similar skill set.
Improve cost transparency across portfolios
Portfolio reviews that include cost allocation by
brand enable a complete understanding of the
costs associated with marketing a drug and the real
profitability of each product. When costs can be
matched with income levels, an unbiased decision can
be made about whether to continue commercialising
products that are delivering less profit versus other
drugs in the portfolio. Brands that are identified as
poor performers can either be divested completely,
withdrawn from specific markets or have their
marketing strategy altered.
Review the role of generics and biosimilars
Developing biosimilar products or establishing
partnerships with generic manufacturers can help
manufacturers of branded products maintain market
share. However, many branded manufacturers are
selective about the markets in which they have generic
portfolios, and a number have publically stated that
generic medicines are not part of their long-term
strategy. This lack of flexibility removes some of the
options available to branded manufacturers to offset
market share losses in the patented drug market with
gains that could potentially be obtained by becoming
active in the generics and/or biosimilars markets.
Conclusion
Clearly, governments will continue to apply downward
pressure on pharmaceutical spending. However, there is
not a one size fits all solution, cost-reduction strategies
will be implemented in varying ways in each country.
Branded manufacturers need to take this into account
when considering which of the above actions are most
appropriate for their organisation and geographic
footprint. Adopting proactive strategies both within
and across markets will be essential in helping the
industry to meet the on-going challenges posed by
continuing financial austerity.
Companies need to have a comprehensive and accurate
view of the basics, for example pricing analysis showing
where discounts are given and profit is lost starting
from list price. They should expand their capabilities in
obtaining competitive intelligence and developing an
understanding of profitability by customer segment.
Ensuring that the systems architecture, data and
capabilities are in place locally will provide a foundation
for operational efficiency in pricing.
Impact of austerity on European pharmaceutical policy and pricing Staying competitive in a challenging environment
17
Notes
1.
Health at a Glance: Europe 2012, Organisation for Economic Co-operation and Development Publishing, November 2012.
See also: http://dx.doi.org/10.1787/9789264183896-en
2.
Ibid.
3.
Ibid.
4.
Letter from EFPIA President, Sir Andrew Witty, to European Heads of States and Governments, European Federation of
Pharmaceutical Industries and Associations, June 2012. See also: http://www.efpia.eu/sites/www.efpia.eu/files/EFPIA%
20Summit%20Letter%20FINAL%20200612.pdf
5.
Greece Memorandum of Understanding on Specific Economic Policy Conditionality, Draft 9 February, 2012. See also:
http://www.scribd.com/doc/81233785/Greece%E2%80%94Memorandum-of-Understanding-on-Specific-Economic-PolicyConditionality-9-Feb-2012
6.
The Pharmaceutical Price Regulation Scheme: An OFT market study, Office of Fair Trading, February 2007. See also:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3153015/
7.
Letter from EFPIA President, Sir Andrew Witty, to European Heads of States and Governments, European Federation of
Pharmaceutical Industries and Associations, June 2012. See also: http://www.efpia.eu/sites/www.efpia.eu/files/EFPIA%
20Summit%20Letter%20FINAL%20200612.pdf
8.
Health (Pricing and Supply of Medical Goods) Bill 2012, Houses of the Oireachtas, July 2012. See also:
http://www.oireachtas.ie/documents/bills28/bills/2012/6312/b6312s.pdf
9.
Measuring the return from Pharmaceutical Innovation 2012: is R&D earning its investment? Deloitte LLP, December 2012.
See also: http://www.deloitte.com/view/en_XB/xb/news/b47f30374ca4b310VgnVCM2000003356f70aRCRD.htm
10. Ibid.
11. Johnson & Johnson Announces Plans to establish Innovation Centers, Johnson & Johnson website, 18 September 2012.
See also: http://www.jnj.com/connect/news/all/johnson-and-johnson-announces-plans-to-establish-innovation-centers
12. Innovation and Investment, GSK website, accessed 6 June 2013. See also: http://www.gsk.com/partnerships/
innovation-and-investment.html
13. AZ sets up virtual neuroscience unit in Cambridge, Business Weekly, 2 February 2012. See also: http://www.businessweekly.
co.uk/biomedtech-/13519-az-sets-up-virtual-neuroscience-unit-in-cambridge
14. Pfizer Global research and Development, Pfizer website, accessed 6 June 2013. See also: http://www.pfizer.com/lajolla/
15. AstraZeneca to invest £330 Million in new strategic R&D centre and global headquarters in Cambridge, AstraZeneca website,
March 2013. See also: http://www.astrazeneca.com/Media/Press-releases/Article/18032013--astrazeneca-to-invest-researchcentre-and-global-hq
16. Pfizer site in Sandwich set to retain 650 jobs, BBC, 4 November 2011. See also: http://www.bbc.co.uk/news/uk-englandkent-15584902
17. Roche to streamline research and development activities, Roche website, 26 June 2012. See also: http://www.roche.com/
investors/ir_update/inv-update-2012-06-26.htm
18. INN Prescribing in Greece–The New Generic Frontier?, HIS, 29 November 2012. See also: http://healthcare.blogs.ihs.
com/2012/11/29/inn-prescribing-in-greece-the-new-generic-frontier/
19. INN RX is not needed says Greek pharma, SCRIP,
December 2012. See also: http://www.scripintelligence.com/home/INN-Rx-is-not-needed-says-Greek-pharma-338537
20. Ibid.
21. The current state of the Pharmaceutical Industry in Portugal, European Industrial Pharmacists Group 2012 General Assembly,
5 May 2012. See also: http://www.eipg.eu/records/2012/Pharma%20in%20Portugal.pdf
22. Health (Pricing and Supply of Medical Goods) Bill 2012: Second Stage, House of Oireachtas, 19 July 2012. See also:
http://debates.oireachtas.ie/seanad/2012/07/19/00009.asp
23. France to tackle deficit with more price cuts, generic prescribing and promo cuts, SCRIP, October 2012. See also: http://
www.scripintelligence.com/home/France-to-tackle-deficit-with-more-price-cuts-generic-prescribing-and-promo-curbs-335758
24. AMNOG – evaluation of new pharmaceutical, GKV Spitzenverband, 2013. See also: http://www.gkv pitzenverband.de/english/
statutory_health_insurance/amnog___evaluation_of_new_pharmaceutical/amnog___evaluation_of_new_pharmaceutical_1.jsp
25. Price cuts loom on latest pre-AMNOG call up, SCRIP, April 2013. See also: http://www.scripintelligence.com/home/Price-cutsloom-on-latest-pre-AMNOG-call-up-342452
26. Portugal Pharmaceuticals and Healthcare Report Q1 2011, Research and Markets, November 2010. See also:
http://www.researchandmarkets.com/research/a948d5/portugal_pharmaceu
27. Spain pharma: Deep cuts, EIU, 17 June 2010. See also: http://viewswire.eiu.com/index.asp?layout=ib3Article&pubtypeid=11524
62500&article_id=707209455&fs=true
18
28. Policies to Enhance Prescribing Efficiency in Europe: Findings and Future Implication, Front Pharmacol. 2010:1: 141,
October 2010. See also: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3153015/
29. Ignore our drug prices’ Greece tells Europe, SCRIP, December, 2012. See also: http://www.scripintelligence.com/home/
Ignore-our-drug-prices-Greece-tells-Europe-338216
30. Letter from EFPIA President, Sir Andrew Witty, to European Heads of States and Governments, European Federation of
Pharmaceutical Industries and Associations, June 2012. See also: http://www.efpia.eu/sites/www.efpia.eu/files/EFPIA%
20Summit%20Letter%20FINAL%20200612.pdf
31. The current state of the Pharmaceutical Industry in Portugal, European Industrial Pharmacists Group 2012 General Assembly,
5 May 2012. See also: http://www.eipg.eu/records/2012/Pharma%20in%20Portugal.pdf
32. The State Medicines Bill, Irish Pharmaceutical Healthcare Association, October 2012. See also: http://www.ipha.ie/alist/
the-state-medicines-bill.aspx
33. Policies to Enhance Prescribing Efficiency in Europe: Findings and Future Implication, Front Pharmacol. 2010:1: 141,
October 2010. See also: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3153015/
34. Troika sets new conditions for pharmaceutical savings in Greece, HIS, October 2012. See also: http://www.ihs.com/products/
global-insight/industry-economic-report.aspx?id=1065972416
35. Health (Pricing and Supply of Medical Goods) Bill 2012: Second Stage, House of Oireachtas, 19 July 2012. See also:
http://debates.oireachtas.ie/seanad/2012/07/19/00009.asp
36. The Pharmaceutical Distribution Chain in the European Union: Structure and Impact on Pharmaceutical Prices, Panos Kanavos,
Willemien Schurer and Sabine Vogler, March 2011. See also: http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/
structimpact_pharmaprices_032011_en.pdf
37. Ministerial Decision Nr. 3/7789: Provisions on the pricing of medicinal products, The Alternate Minister of Health, Greece,
January 2013. See also: http://www.sfee.gr/files/story/NEW_Ministerial%20Decision_Pricing_DYG3_a_oik%2097018_2012.pdf
38. Health (Pricing and Supply of Medical Goods) Bill 2012: Second Stage, House of Oireachtas, 19 July 2012. See also:
http://debates.oireachtas.ie/seanad/2012/07/19/00009.asp
39. Biosimilar policies in Italy, Generics and Biosimilars Initiative, May 2012. See also: http://www.gabionline.net/layout/set/print/
Country-Focus/Italy/Policies-and-Legislation
40. Germany pricing and reimbursement, Datamonitor Healthcare, February 2013. See also: https://service.datamonitorhealthcare.
com/hkc/strategy/market-access/pricing-and-reimbursement/article95501.ece
41. No dolce vita as Italian pharma faces full monti cuts, SCRIP, July 2012. Available at; http://www.scripintelligence.com/home/
No-dolce-vita-as-Italian-pharma-faces-full-Monti-cuts-332594
42. Elenco Dei Provvedimenti di interesse del settore approvati da gennaio 2011 a maggion 2012 (List of approved measures of
interest field of approved January 2011 to May 2012), Farmaindustria, 2012. Available at: http://www.farmindustria.it/
pubblico/in201205.pdf
43. How do you hurt us? Let me count the ways, SCRIP, July 2012. See also: http://www.scripintelligence.com/therapysector/Howdo-you-hurt-us-Let-me-count-the-ways-Assobiotecs-Palmisanos-lament-333393
44. French Pharmaceutical System: Focus on pricing and reimbursement, Sophie Delcroix-Lopes, CNAMTS, September 2011.
See also: http://whocc.goeg.at/Downloads/Conference2011/PraesentationenPPRIKonferenz/Day2_morning_
Sitzungssaal_0945_Delcroix.pdf
45. The current state of the Pharmaceutical Industry in Portugal, European Industrial Pharmacists Group 2012 General Assembly,
5 May 2012. See also: http://www.eipg.eu/records/2012/Pharma%20in%20Portugal.pdf
46. Drugmakers tell Greece we’ll cap your medicines bill, PharmaTimes, November 2012. See also: http://www.pharmatimes.com/
Article/12-11-06/Drugmakers_tell_Greece_we_ll_cap_your_medicines_bill.aspx
47. Greece “drops pharma clawback plan” PharmaTimes, 19 October 2012. See also: http://www.pharmatimes.com/
Article/12-10-19/Greece_drops_pharma_clawback_plan.aspx
48. Health (Pricing and Supply of Medical Goods) Bill 2012, Houses of the Oireachtas, July 2012. See also: http://www.oireachtas.ie/
documents/bills28/bills/2012/6312/b6312s.pdf
49. Is It Time to Reconsider the Role of Co-Payments in Europe? Office of Health Economics, January 2012. See also: http://news.
ohe.org/2012/01/11/is-it-time-to-reconsider-the-role-of-co-payments-in-europe/
50. The Economic Adjustment Programme for Portugal, Sixth Review – Autumn 2012, European Commission, December 2012.
See also: http://ec.europa.eu/economy_finance/publications/occasional_paper/2012/pdf/ocp124_en.pdf
51. Italy Healthcare System and Drug Regulatory Analysis, Datamonitor Healthcare, December 2012. See also:
https://service.datamonitorhealthcare.com/hkc/strategy/market-access/regulation/article91206.ece
52. Tendering & Contracting for generic & branded medicines across Europe – a comparison and Benchmarking, Nico Bacharidis,
November 2011. See also: http://www.ghp.org.uk/ContentFiles/PDIG%20Nico%20Bacharidis%20Presentation%20-%20
Nov%202011.pdf
Impact of austerity on European pharmaceutical policy and pricing Staying competitive in a challenging environment
19
53. Tendering for outpatient prescription pharmaceuticals: what can be learned from current practices in Europe?, P Dylst,
A Vulto and S , Simoens, Health Policy 101(2):146-52, July 2011. See also: http://www.ncbi.nlm.nih.gov/pubmed/21511353
54. Ibid.
55. Differences in costs of and access to pharmaceutical products in the EU, European Parliament, March 2011. See also:
http://www2.lse.ac.uk/businessAndConsultancy/LSEConsulting/pdf/pharmaceuticals.pdf
56. The current state of the Pharmaceutical Industry in Portugal European Industrial Pharmacists Group 2012 General
Assembly, 5 May 2012. See also: http://www.eipg.eu/records/2012/Pharma%20in%20Portugal.pdf
57. Facts & Figures of Pharmaceutical Industry in Italy, Farmindustria, January 2013. See also: http://www.farmindustria.it/
pubblico/slide_Brochure_2012_INGLESE.pdf
58. Greece, Pharmaceuticals & Healthcare Report, Business Monitor International, Q3 2012
59. Health policy and planning, Improving access to pharmaceuticals in Brazil and Argentina, Núria Homedes and Antonio
Ugalde, March 2006. See also: http://heapol.oxfordjournals.org/content/21/2/123.fullhttp://heapol.oxfordjournals.org/
content/21/2/123.full
60. EIU, Data tool, 2013. See also: http://data.eiu.com/default.aspx?geography_id=0&pubtype_id=1383181323
61. Japan: Healthcare and Pharmaceuticals Report, EIU, 2013. See also: http://viewswire.eiu.com/index.
asp?layout=ib3Article&article_id=830542267&pubtypeid=1152462500&country_id=1580000158&category_id=775133077
62. Japan: Healthcare and Pharmaceuticals Report, EIU, 2013. See also: http://viewswire.eiu.com/index.
asp?layout=ib3Article&article_id=720202456&pubtypeid=1152462500&category_id=775133077&country_
id=1580000158&page_title=Forecast
63. Turkey: Health System Review, Health Systems in Transition, Vol. 13, No. 6, 2011. See also: http://www.euro.who.int/__
data/assets/pdf_file/0006/158883/e96441.pdf
64. Generic Drugs in Turkey, IEIS. See also: http://www.ieis.org.tr/YAYINLAR/gendruginTr.pdf
65. Health care reform and life sciences: Threat, opportunity or both? EIU, November 2012. See also: http://www.deloitte.com/
view/en_GX/global/industries/life-sciences-health-care/health-care/df94ab7450e0e310VgnVCM1000003256f70aRCRD.
htm?id=us_twitter_deloittehealth_LS_EIUHCReform_042813
20
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Impact of austerity on European pharmaceutical policy and pricing Staying competitive in a challenging environment
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