Pharmaceuticals and life sciences sector analysis
of PwC’s 2014 Global Economic Crime Survey
Pharmaceuticals and life
sciences’ fight against
bribery and corruption
60%
The majority of
pharmaceuticals and life
sciences executives see
bribery and corruption as
one of the highest risks
of operating globally.
40%
Two-fifths of
pharmaceuticals and
life sciences executives
say damage to corporate
reputation is the most
severe impact of bribery
or corruption.
60%
Three-fifths of the
sector’s most severe
economic crimes were
detected by corporate
controls.
www.pwc.com/crimesurvey
Contents
Key highlights 1
Economic crime in 2014
3
A ‘safe’ sector?
3
Bribery and corruption is the sector’s biggest threat
4
Operating in markets with high levels of corruption risk
7
Keeping an eye on intellectual property
8
Underestimating cyberthreats?
9
Controls top the list of fraud detection measures
10
Culture should be a priority from day one
11
Visibly cracking down on perpetrators could send a stronger message
12
Contacts13
About the survey
We define economic crime as the intentional use of deceit
to deprive another of money, property or a legal right.
The 2014 Global Economic Crime Survey was completed by 5,128
respondents (compared to 3,877 respondents in 2011) from 99 countries
(compared to 78 countries in 2011). Of the total number of respondents,
50% were senior executives of their respective organisations, 35%
represented listed companies and 54% represented organisations with
more than 1,000 employees. This report looks at responses from 259
pharmaceuticals and life sciences companies. For more information
about our methodology and definitions of terminology used, please see
our 2013 Global Economic Crime Survey report: ‘Economic crime: A
threat to business globally’.
Key highlights
Pharmaceuticals and life sciences sector
survey responses
No sector is truly safe…
The pharmaceuticals and life sciences
(PLS) sector reported one of the lowest
overall incidences of economic crime of
any sector. So can executives sit back?
In our view, the answer is an emphatic
no. More than one in four respondents
still say their companies have
experienced some form of fraud. And
the rate of fraud is slightly up from
2011, too.
Bribery and corruption are a
major threat… It’s the second most
commonly reported type of economic
crime for PLS companies. Sector
respondents are most concerned about
the damage it can do to their corporate
reputations.
Operating in markets with high
levels of corruption risk…
Expanding globally brings
opportunities, but operating in high
corruption risk markets can bring
additional challenges too. PLS
companies should increase their efforts
to cope with corruption risks – and be
willing to walk away if all else fails.
Cybercrime may be
underestimated… PLS respondents
report a lower incidence of cybercrime
than most other sectors. But awareness
is increasing. In our 17th Annual
Global CEO Survey, 43% of
pharmaceuticals and life sciences
respondents said they’re concerned
that cyber threats including data
security could threaten growth. Now is
the time to go from paying attention to
taking action.
And the crown jewels could
come under threat too …
Intellectual property (IP) is the sector’s
most important asset. The rate of IP
infringement is currently low, but
many PLS executives are concerned
about safeguarding intellectual
property.
Controls are effective… Corporate
controls are detecting a significant
number of serious economic crimes in
the PLS sector, and the internal audit
function is especially effective.
Yet fraud risk assessment is still
rare… The sector is lagging when it
comes to implementing annual fraud
risk assessments. In our view these can
be a valuable addition to your economic
crime fighting toolkit and a useful
means of focusing your efforts and
your expenditures.
PLS faces a threat from within…
Compared to the overall sample, a
greater percentage of serious economic
crimes are being committed by insiders
at PLS companies.
So culture may need a second
look. The large number of internal
perpetrators suggests the industry may
have more work to do when it comes to
culture. PLS respondents are less likely
to say their companies are contacting
law enforcement, and fewer are taking
several other types of action against
internal or external actors. Many PLS
companies may need to take another
look at their responses to economic
crime once it occurs.
PwC | Global Economic Crime Survey 2014 |
1
Figure 1: Economic crime percentage reported by industry
50%
49% Retail & Consumer
Banking, Capital Markets and 49%
Investment Management
Communication 48%
Financial Services 45%
45%
Hospitality and Leisure 41%
41% Government/State
40%
Global—37%
Manufacturing 36%
Insurance 35%
35%
Transportation/Logistics 34%
34% Other
Engineering/Construction 33%
31% Entertainment & Media
Energy, Utilities, & Mining 31%
30%
28% Automotive
Aerospace & Defense 28%
27% Chemicals
Pharma & Life Sciences 27%
27% Technology
25%
Professional Services
20%
20%
% of all respondents who experiences economic crime over the survey period
2
| Global Economic Crime Survey 2014 | PwC
Economic crime in 2014
A ‘safe’ sector?
Pharmaceuticals and life sciences (PLS) is one of the industries reporting the lowest
incidence of economic crime this year (see Figure 1). Still, more than one in four
respondents say their companies have experienced some form of fraud. And the rate of
fraud is slightly up from 2011 too. So while the risk may be lower than in some sectors,
PLS is far from ‘safe’ from economic crime.
Asset misappropriation is the most reported type of economic crime, at 60% (see Figure 2).
That’s less than across the overall sample, but it’s still enough to be a major issue. For the
PLS sector, a particularly damaging type of asset misappropriation is the ‘gray market’ in
medicines and the sale of counterfeit medicines. These can impact not just legitimate
sales revenues; if such products aren’t safe, they can also have a big impact on the brand.
With many of its products literally making a life or death difference for patients, the
sector needs to take a strong stand to fight such activities.
Bribery, corruption and procurement fraud are also common. And while other types of
frauds are less prevalent, PLS companies can’t afford to ignore them. Cyber-crime in
particular stands out as an area where the low incidence may be hiding a bigger problem.
Figure 2: Top types of economic crime experienced by the PLS sector during
the survey period
60
Asset misappropriation
31
Bribery and corruption
27
Procurement fraud
Accounting fraud
21
Cybercrime
10
Competition Law/Anti-trust Law
10
9
Human Resources fraud
7
IP Infringement
0
10
20
30
40
50
60
% of 70 pharmaceuticals and life sciences respondents who reported economic crime in the past
24 months
PwC | Global Economic Crime Survey 2014 |
3
Bribery and corruption is the sector’s
biggest threat
Bribery and corruption comes in number two in reported incidence. Of PLS
executives whose companies experienced economic crime, 31% say it included
bribery and corruption, slightly more than across the sample overall. With highprofile stories making the news, it’s currently top of mind. In recent years the sector
has faced criticism and concern over how it interacts with health care professionals.
New regulations now require greater transparency from the industry (see
Developing a smarter approach to increasing transparency requirements).
And over the past several years, there have been a number of high profile cases
where PLS companies have been accused of essentially paying doctors to prescribe
their medications, or of inappropriately promoting their products for conditions that
haven’t received regulatory approval. Some of these have resulted in massive fines;
the US government reported in February 2014 that the industry paid out $3.75
billion in fraud penalties in 2013.1
Developing a smarter approach to increasing transparency
requirements
Transfers of value between pharmaceutical and life sciences companies and the
healthcare professionals and organisations with which they do business are now
subject to a myriad of local, regional, and global regulations as well as self-imposed
industry codes. In 2013 alone, the United States and France implemented
transparency and disclosure requirements, and the European Federation of
Pharmaceutical Industries and Associations (EFPIA) – encompassing 33 European
countries– adopted a code of conduct requiring transparent interactions among
member organisations. Key Asia Pacific countries like Japan and Australia have also
enacted transparency requirements. To date, transparency and disclosure
requirements have generally been country-specific. However, the industry has begun
to develop initiatives to harmonise transparency and disclosure requirements across
geographic borders.
The transparency movement is not a fad; it is gaining steam, and as companies are
held to new regulations and standards each year, they should begin to manage their
transparency requirements on a global scale. Many of the regulations and
requirements imposed on pharmaceutical and life sciences companies have
commonalities that create opportunities for businesses to incorporate process
efficiencies and economies of scale when developing their transparency strategies.
We’ve outlined 5 key steps to developing an optimal global transparency programme
(See table Your path to an optimal global transparency programme). For more detailed
discussion, please see our report, EFPIA and Global Transparency Requirements:
Implementing an aggregate spend program in a global marketplace.
The Department of Health and Human Services and The Department of Justice, ‘Health Care Fraud and Abuse Control Program – Annual Report for Fiscal Year 2013’, (February 2014), http://oig.hhs.gov/publications/docs/hcfac/FY2013-hcfac.pdf
4
| Global Economic Crime Survey 2014 | PwC
1
Your
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11
22
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PwC | Global Economic Crime Survey 2014 |
5
So does that mean financial losses are the most severe impact of bribery and
corruption? For one in five the answer is yes, but twice as many – 40% – of sector
respondents say damage to corporate reputation is actually the greater impact (see
Figure 3). That echoes the results of our 17th Annual Global CEO Survey where
more than half of PLS CEOs told us they worry that lack of trust in business could
threaten growth. And one third of PLS CEOs believe that government and
regulator’s trust in the industry has deteriorated over the past five years.
Figure 3: Most severe impact of corruption and bribery
80%
70%
60%
40
36
Corporate reputation
50%
Financial loss
40%
30%
20
28
Distraction caused
by legal/regulatory
enforcement action
Loss of human
capital (recruiting,
morale, turnover)
20%
12
10%
8
7
0%
Pharmaceuticals and
life sciences
5
Total
The sector is aware of the risks, particularly as they relate to operating abroad; 60%
of PLS executives see bribery and corruption as one of the highest risks of operating
globally, compared to 53% across the sample. One in five acknowledge that they’ve
been asked to pay a bribe. And some executives worry that acting ethically is
costing their business; 26% say they’ve lost an opportunity to a competitor who they
suspect paid a bribe.
6
| Global Economic Crime Survey 2014 | PwC
Fighting TB could get harder
In 2013, a study showed that 1 in 10
of the antibiotics used to treat
tuberculosis – and 1 in 6 used in
Africa – was sub-standard. Some
were shoddily made, or damaged in
transit, while others were simply
counterfeits. That poses a clear risk
to individual patients, who may die
due to receiving inadequate
medicines. And there’s a menace to
public health lurking too. Pills that
contain too little of the active
ingredient to fight tuberculosis are
contributing to the development of
new, drug-resistant strains. That’s
creating a public health problem that
impacts countries around the globe,
not just emerging markets.
Operating in markets with high levels of
corruption risk
Around half of PLS companies have operations in markets with high levels of corruption
risk. That’s not surprising. Many are important to PLS companies’ growth plans, as
shown by the 42% of PLS respondents who say they’ve pursued an opportunity in one of
these markets in the past 24 months. But the challenges are changing how they operate;
43% of sector respondents pursuing growth opportunities in regions with high levels of
corruption risk say they’ve needed to adapt their business strategies.
Just what are they doing? And is it working? There’s no one answer. As is true across the
sample, additional due diligence is the most popular choice (see Figure 4). Compared to
respondents overall, more PLS executives say they’ll add contractual terms (51%) or will
provide additional training to staff (43%). Will this be enough? Not always. Nearly a
third of respondents – 30% – say they walked away from an opportunity in response to
corruption risk.
Corruption and bribery isn’t the only type of economic crime that can pose challenges.
In recent years India has seen allegations of manufacturing processes failing to meet
safety standards. And the prevalence of sub-standard or counterfeit drugs in Africa is
undoubtedly high (see Fighting TB could get harder)
Source: R. Bate, P. Jensen, K. Hess, L.
Mooney,§ J. Milligan, ‘Substandard and falsified
anti-tuberculosis drugs: a preliminary field
analysis’, (21 August 2014), http://www.aei.org
files/2013/02/05/-substandard-and-falsifiedantituberculosis-drugs-a-preliminary-fieldanalysis_142125219328.pdf
Figure 4: Changes to business strategy in response to high corruption risks
How did you alter your business plan or strategy?
Pharmaceuticals
and life sciences
Total
74
51
43
30
21
17
17
17
9
2
72
41
36
34
17
16
17
11
5
3
Perform
additional
due
diligence
Add
contractual
terms
Provide
additional
training
Walk away
from the
opportunity
Seek an
opinion
from the
Regulator
Change
the
valuation
Force
Carve out
adoption of certain
accounting assets
system
Don’t
know
Other
% of 47 pharmaceuticals and life sciences and 757 total respondents who report their company has altered business plans or
strategies in pursuit of an opportunity in a market with a high level of corruption risk
PwC | Global Economic Crime Survey 2014 |
7
Keeping an eye on intellectual property
64%
of pharmaceuticals and
life sciences CEOs said
they are concerned that
an inability to protect IP
could threaten growth.
Loss of IP is another major worry, and it’s more pronounced in emerging markets.
While just 2% of all PLS respondents have experienced IP infringement over the last
24 months, more than ten times as many (22%) believe it’s likely they will face an
incident in the next 24 months. And in our 17th Annual Global CEO Survey, 64% of
pharmaceuticals and life sciences CEOs said they are concerned that an inability to
protect IP could threaten growth.
Here, too, emerging markets are causing the most concern. India’s decision to grant
a compulsory license – essentially a 97% price cut – to one cancer medication in
2013 was met with strong protests by the company’s manufacturer, whose CEO
argued that the country was setting a precedent that could deter innovation.2 And a
decision in 2013 by the Indian Supreme Court not to grant patent protection to a
leukemia drug has led to strong protests by the US Chamber of Commerce.3 The
issue is a major concern in other emerging PLS markets too, like South Africa and
Brazil.
Ranjitha Balasubramanyam, ‘Battle over patents: Is India changing the rules of the game?, Intellectual Property Watch (18 February 2014),
http://www.ip-watch.org/2014/02/18/battles-over-patents-is-india-changing-the-rules-of-the-game/
3
Staff reporter, ‘India patent regime not about access to medicine: US body’, The Hindu (11 February 2014), http://www.thehindu.com/business/Industry/
india-patent-regime-not-about-access-to-medicine-us-body/article5674425.ece
2
8
| Global Economic Crime Survey 2014 | PwC
Underestimating cyberthreats?
Only around 10% of PLS companies that have experienced fraud say the incidents
included cybercrime; that’s well below the overall average of 24%. Our discussions
with leaders in combatting cybercrime suggest that companies with valuable R&D
can be targeted by cybercriminals and not be aware of it; as such, the PLS sector
may be under-reporting this type of economic crime.
There’s also other evidence to suggest that the industry is already a target for
hackers. In Cisco’s March 2014 Threat Metrics, pharmaceutical and chemical firms
were 11 times more likely to encounter Web malware than companies overall.4
Executives are taking note; 46% of respondents say that the awareness of this type
of economic crime in their organisation is increasing. And nearly one in five say it’s
likely that their company will experience an incident of cybercrime in the coming
24 months. Indeed, in our 17th Annual Global CEO Survey, 43% of PLS CEOs said
they’re concerned that cyber threats including lack of data security could threaten
growth, so the issue is starting to get the attention of the top executive
management.
What can you do?
1. Educate employees at all levels (from top to junior management) about cyber
threats – cybercrime is not just the domain of the IT/network security
function. There are different types of cybercrime, from hacktivism to data
theft, which affect different functions of the company in varying ways.
2. Understand the potential culprits and their motivations to engage in a cyber
attack on the organisation.
3. Ensure that fundamental safeguards for effective cyber security are in place
– including ongoing monitoring, up-to-date personal or sensitive data
inventory, a back-up policy and business continuity plans.
4. Remember that technology assets are rarely the weakest link in the chain
– people; commonly your own employees, are often the ones who enable a
cyber attack.
4
‘March 2014 Threat Metrics’, Cisco Blogs (10 April 2014), http://blogs.cisco.com/security/march2014-threat-metrics/
PwC | Global Economic Crime Survey 2014 |
9
Controls top the list of fraud detection
measures
When it comes to identifying fraud, the PLS sector’s investment in internal controls
is paying off. Internal audit, suspicious transaction reporting and data analytics are
the top ways that PLS companies identify serious economic crime (see Figure 5). The
internal audit function is showing particular improvement. In 2011, it detected just
8% of frauds. This year that number is up to 21%, a major jump.
Fraud risk management systems were less successful, though. They detected just 1%
of the sector’s most serious offences, down from 2011’s 3%, compared to 9% of
crimes across the total sample. Why such a big difference? One reason may be quite
simply that only a minority of PLS companies are performing fraud risk assessments
at least annually.
Figure 5: Economic crime detection methods in PLS organisations
16
17
Suspicious transaction
reporting
12
Internal audit (routine)
21
11
Fraud risk management
2
Data analytics
14
5
Corporate security
(both IT and physical security)
Rotation of personnel
7
2
0
11
10
Tip-off (internal)
Corporate
culture
7
Tip-off (external)
Whistle-blowing system
Corporate
controls
9
5
5
0
4
Don't know
3
Other detection methods
(please specify)
5
7
Beyond
the
influence of
management
7
By accident
7
3
By law enforcement
5
2
2
Investigative media
0
5
10
15
20
25
30
35
40
% of 58 pharmaceutical and life sciences and 1538 total respondents who
experienced economic crime over the survey period
Total
Pharmaceuticals and life sciences
10 | Global Economic Crime Survey 2014 | PwC
45
50
About a third of PLS companies conduct fraud risk assessments each year; another
11% conduct them more frequently (see Figure 6). But 26% of sector respondents say
their companies don’t perform assessments at all, and 16% don’t know whether their
companies do or not. For those which don’t perform fraud risk assessments, nearly
half say they either aren’t sure what a fraud risk assessment is, or don’t know why
their company has chosen not to perform one. Only 7% say cost is the primary issue.
PLS executives may want to take another look. In our view performing a fraud risk
assessment at least annually can be a valuable addition to your economic crime
fighting toolkit.
Figure 6: Only a minority of PLS respondents are conducting fraud
assessments at least annually
42% have not conducted a fraud risk
assessment in the past 24 months, or
don’t know if they have.
16% 16%
In the last 24 months, how often has
your organisation performed a fraud
risk assessment?
26% 26%
10% 10%
Don't know
Don't know
Not at all
Not at all
Once Once
14% 14%
34% 34%
Annually
Annually
Every
six months
Every six
months
more often
or moreoroften
Culture should be a priority from day one
The need to refocus efforts on corporate culture are underscored by our survey
results. Nearly two thirds of PLS respondents (64%) say that the main perpetrator of
the most serious economic crime against their organisation was an internal actor,
compared to just 56% of executives overall. More of those internal actors were
junior staff members (44% vs. 34% overall). Indeed, 20% of the internal
perpetrators had been with the company for less than 2 years.
While that’s good news on the one hand – crime by senior management has a more
wide-reaching impact on the organisation – it’s also a sign that the industry needs to
act now to make sure that its whole staff is on-board from Day 1 with efforts to
promote an ethical culture.
PwC | Global Economic Crime Survey 2014 | 11
Visibly cracking down on perpetrators
could send a stronger message
Once a perpetrator has been identified, what should companies do? To deter future
crime, it’s important to take action. While around 80% of internal perpetrators in
the PLS industry were dismissed, in line with the global average, only 36% had to
answer to law enforcement, compared to nearly half of internal perpetrators overall
(see Figure 7). Fewer PLS executives say their company took civil action or informed
regulatory authorities too.
The sector is also less likely to take these types of actions against external
perpetrators. Fewer PLS executives say their companies notified law enforcement or
took civil actions. And fewer ceased business relationships as well.
In our view, many PLS companies may need to take another look at their responses
to economic crime once it occurs.
Figure 7: The PLS sector is taking less legal action against perpetrators of
serious economic crimes
7a: Internal perpetrators (not all choices listed)
79
82
Dismissal
Law enforcement informed
49
36
Civil action was taken,
including recoveries
44
27
17
Warning/reprimand
9
Notified relevant regulatory
authorities
23
7
0
Total
20
40
60
80
100
Pharmaceuticals and life sciences
% of respondents who reported economic crime in the past 24 months
7b: External perpetrators (not all choices listed)
Law inforcement informed
52
Notified relevant regulatory
authorities
39
39
37
Cessation of the business
relationship
26
Civil action was taken,
including recoveries
42
22
0
Total
61
10
20
30
40
50
Pharmaceuticals and life sciences
% of respondents who reported economic crime in the past 24 months
12 | Global Economic Crime Survey 2014 | PwC
60
70
80
Contacts
For more information on the Global Economic Crime Survey and the survey methodology, please refer to Economic crime:
A threat to business globally at www.pwc.com/crimesurvey.
If you would like to find out more about the information contained within this report, or to discuss any issues around economic
crime and how our team can help you, please get in touch with your local PwC contact or the sector report team:
Editorial team
Brian Riewerts
Marina Bello Valcarce
Principal, Sector report lead partner, PwC USA
Sector report project manager, PwC United Kingdom
T: +1 410 659 3390
E: [email protected]
T: +44 20 7212 8642
E: [email protected]
Forensic Service Leaders
Andrew Gordon
Andrew Palmer
Partner, PwC United Kingdom, Global Leader
Partner, PwC United Kingdom, Central Cluster Leader
T: +44 20 7804 4187
E: [email protected]
T: +44 20 7212 8656
E: [email protected]
John Donker
Erik Skramstad
Partner, PwC Hong Kong, East Cluster Leader
Partner, PwC USA, West Cluster Leader
T: +1 852 2289 2411
E: [email protected]
T: +1 617 530 6156
M: [email protected]
Pharmaceuticals and life sciences forensic specialists
Patricia A. Etzold
Ryan D. Murphy
Partner, PwC USA
Partner, PwC USA
T: +1 646 471 3691
E: [email protected]
T: +1 312 298 3109
E: [email protected]
Editorial team acknowledgements
In preparing this report, assistance was gratefully received from PwC teams in the US and UK. We’d also like to thank Elizabeth
Montgomery (Pwc Germany) for writing and editorial assistance.
PwC | Global Economic Crime Survey 2014 | 13
www.pwc.com/crimesurvey
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