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Russia 2012: The Pharmaceutical Market& New Legislation - Building for Growth ina Fast Changing Marketplace
August 2012
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The Russian healthcare market is attracting increasing globalinterest not least because its value is expected to triple
within the next decade. However, market access across this
vast region is complex and challenging and has become even
more so ollowing the introduction o the On Fundamentals
of Protection of Public Health in the Russian Federation,
on January 1st 2012.
In essence, the legislation introduces two undamental
changes:
Regionalisation o decision-making. The 82 regions
across the Russian Federation are now tasked with
creating treatment protocols and dening Essential Drug
Lists (EDL). These lists would also orm the basis o new
reimbursement plans that will be rolled out incrementally
across the regions over the next ve years.
Pharmaceutical interaction with healthcare proessionals.
Under this legislation, clinicians and pharmacists are
banned rom accepting gits rom pharmaceutical
representatives, or receiving visits unless linked to
clinical trials or educational events.
For the pharmaceutical industry, this new legislation demands
a signicant change to market access strategies. Excellent
insight into the pharma-economy o each region, as well as
competitive position, is essential to prioritise activity, since no
company has the Key Account Management (KAM) resources
to address every regional market simultaneously. New Key
Opinion Leaders (KOLs), who are inuential at the regionallevel, must be identied; and messaging must target to reect
not only the local drivers and objectives, but also progress in
the development o standards o treatment.
Interaction with these decision-makers must also change romtraditional product detailing towards a less product-centric
education-led model, whilst also incorporating new channels
to market such as direct marketing and, where possible
eMarketing.
This paper outlines the changes acing pharmaceutica
companies operating across Russia this year and provides
guidance on how to best adapt market access strategies to
maximise the opportunity in a country set to become one o
the largest global pharmaceutical markets.
Executive Summary
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The Russian pharmaceutical market is one o the astestgrowing in the world. Its value is predicted to rise rom $24
billion today to $75 billion by 2020, according to Cegedim
Relationship Managements aggregated opinion rom industry
experts, government employees and analysts. In the interim,
however, the system o public health provision and the
landscape or pharmaceutical development and market access
is set to change dramatically. New regulations are designed to
increase patient access to drugs, emphasise the importance
o local drug R&D and manuacture, whilst also imposing
stringent compliance requirements upon state healthcare
proessionals.
For the pharmaceutical industry the market opportunity is
compelling. But the challenges cannot be underestimated. The
most signicant change came into orce on January 1st 2012
namely the new ederal law on public health protection:
On Fundamentals of Protection of Public Health in the
Russian Federation.
At the heart o the new law is a move towards the modernisation
o the health service through decentralisation and the
empowerment o regions to make decisions regarding both
reimbursement and treatment protocols. As Dmitry Medvedev,
ormer President o the Russian Federation, explained, [The]
centralization system, meaning vertical power, does not ully
work today. Thereore, we need to switch on now some new
mechanisms so that the country would work more dynamic
[ally].
The law also imposes airly strict rules on the interaction
between the pharmaceutical industry and healthcare
proessionals in order to levy ar greater control over the
promotion and prescription o drugs, trying to minimise the
risk o corruption and ensure patients have access to the right
medicines. Prior to the introduction o this law, pharmaceutical
companies could not only entertain healthcare proessionals
and oer gits legally, but even pay to encourage prescribingNow, not only is such activity orbidden, but the government
tried to undamentally change the conditions under which
representatives and healthcare proessionals can interact.
Introduction
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On Fundamentals of Protection of Public Health in the
Russian Federation denes what constitutes the public
healthcare system, the municipal and private healthcare
services; the means by which a citizens public health protectionrights are guaranteed and how the right to medical treatment
is carried out. It sets out the terms and procedures under
which state-guaranteed ree medical care is provided, and also
the rules governing provision o paying healthcare services.
It also introduces new regulations or the medical and
pharmaceutical sectors, including the rights and obligations
o medical organisations and medical and pharmaceutical
personnel, including specic training requirements.
The ederal law delimits powers in the public healthcare
between the ederal executive authorities, the regional
authorities, and the local sel-government; and sets liability or
breaching citizens public healthcare rights and endangering
public health and citizens lives by reusal to provide medical
assistance.
In essence, the new law has our key tenets:
It provides a new system o accountable ofcials anddenes the responsibility o healthcare budget holders
It denes the rules o interaction between the
pharmaceutical industry and physicians including new
restrictions on the provision o gits and visits rom
representatives
It legalises standards o providing medical and drug aid
It introduces a regional structure under which high cost
nosologies will be purchased and supervised by regions
The introduction o this law must also be understood in the
context o the existing pharma 2020 government strategy
which is designed to rebuild the local pharmaceutical industry
and encourage innovative drug development. This strategys
objective is to ensure 50% o sold drugs should be manuactured
in Russia by 2020 a policy that has encouraged many multi-
national organisations to locate manuacture in Russia.
In addition, there is a clear desire to improve access to
healthcare through the creation o reimbursement programmes
across the country. Today, just 30% o drugs are unded by the
state, the rest are paid or out o pocket by Russian citizens and
purchased at pharmacies the majority o which are privately
owned and thereore all outside regulatory enorcement
Thereore, the law as it stands today applies only to that 30%
o the pharmaceutical market that is state-unded, mainly via
the 99% o hospitals that are state run.
Over the next decade, this will change as reimbursement plans
are introduced on a region by region basis. Some elements o
this process are already underway including the development
o standards o treatment. Over the next two to three years
reimbursement programmes will be introduced in a numbe
o pilot regions; with an estimate that reimbursement will be
in place across the Russian Federation by 2015 at which
point the value o the pharmaceutical market is going to be
growing even aster, turning Russia into one o the biggest
pharmaceutical markets in the world.
Elections to RussianState Duma
Modernization program
- the stage of activedevelopment of the
budget
Presidential Election
Year of treatmentstandards
Regional modeling ofdrug compensation
programs
Preparing of patientregistries
Slow down ofconcentration processin distribution chain
First innovationproducts of RussianPharma companies
The beginning ofactivity of self-
regulatoryorganizations
Licensing ofhealthcare
professionals
Start the process ofconsolidation of
regional programsreimbursement
Launch ofreimbursement
program inregions
The massprivatization of
HCP
Bln$
25
Bln$75
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Figure 1: Index - pg.11
Long Term Development Scenario of Russia Pharmaceuticalindustry
Legislative Overview
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For the pharmaceutical industry, the most undamental changeunder this law is the introduction o the regional structure,
under which drug provision and systems o reimbursement will
be developed in the regions. Each region has undamentally
dierent demographic and economic conditions, creating
unique requirements. Under the new ederal model, it will
simply not be possible to successully run market access
campaigns centrally: companies will have to invest in gaining
regional insight to determine priority regions; justiy market
access plans according to the dynamics o the specic region;
and monitor regional perormance in a changing healthcare
landscape.
Once a new drug has been registered by ederal authorities,
each region will be charged with the creation or updating o
treatment protocols, a process that must be reected within
the market access strategy or each region. The objective or
the pharmaceutical companies will be to get the product on
the Essential Drug List (EDL) in each region, which will be used
as the oundation or the reimbursement systems as they arerolled out.
First year The treatment protocol is prepared by
medical proessional, non-commercial organisations.
For the pharmaceutical company, pre-launch activity
includes work with Key Opinion Leaders (KOLs) and
educational activities with healthcare managers and
decision-makers. Companies must also attain product
certication and extend the educational activities to
physicians and healthcare management.
Second year During the second year, the treatment
procedure will be developed by the regional Ministry
o Healthcare, and includes procedures and stages
o disease management and the structure and sta
o medical institutions. Market access activity must
evolve to encompass the inclusion o drugs in treatment
protocols, the preparation and implementation procedure
o treatment and accumulated experience in the use othe treatment protocol.
Third year The standard o treatment developed by
Ministry o Healthcare comes into orce. This includes
the requency and usage o dierent medical services
drugs and medical devices. At this point, the drug could
be included on the Essential Drug List.
With 82 regions to address, or pharmaceutical companies, the
rst challenge is to determine which regions to cover. While
the industry is expected to increase the number o its sales
representatives who are increasingly trained as Key Account
Managers (KAMs) (up by 10% in 2012) - no pharmaceutica
company in Russia has the resources to address each region.
Indeed, even the largest companies have no more than 70
KAMs to support the entire country. With more than 500,000
healthcare specialists, including physicians and pharmacists
the ratio o KAM to clinicians remains low compared to the
major markets. However, with some 40% o these specialistslocated in the countrys 13 largest cities, supporting less than
20% o the total population, healthcare provision is highly
ragmented, which also aects market access strategy.
In addition, organisations have to also understand the evolving
role distributors will play in each region. Today there are around
100 to 150 tenders per day nanced by the state budget or
hospitals across Russia; and it will be important to track the
role distributors play in this regional market model, especially
as reimbursement strategies are introduced, broadening the
products available.
Regionalising Health Provision
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Managing Scale
Given the extraordinary complexity and scale o this market,
companies have to be ocused and prioritise. Once a new drug
has been registered, pharmaceutical companies will initially
prioritise up to 15 regions and then look to build momentum by
expanding into new areas. To identiy the priority regions and
market potential, pharmaceutical companies will need accessto a range o research insight, rom population demographics
and incidence o disease, to the macro economy, social and
healthcare requirements, healthcare budgets in the region,
nosology budgets, and the number o doctors, hospitals and
pharmacies.
Having identied the diverse stakeholders in each region,
the market access strategy will demand dierent levels o
interaction and messaging with each depending not only on
the specic interests, needs and nancial drivers o each
stakeholder, but also the evolution o the treatment protocols
It is also important to understand the changing impact o
KOLs and thought leaders on the treatment patterns o
doctors and their prescriptions. This includes both the ormal
impact o KOLs on procurement and treatment standards and,
equally important, the inormal inuence. A ew prominent
thought leaders typically strongly inuence the choice o many
clinicians, and it will be essential to track the role o thesethought leaders within new regional decision making roles to
maximise the value o market access investment.
In addition, it is important to identiy doctors inormal
networks o inuence Communities o Practice (CoP).
These groups pool ideas and can be instrumental in creating
new proessional practices; while proessional non-prot
organisations, which must now be registered with the Ministry
o Health under Article 76 o the act, will comprise both
patient associations and groups o healthcare proessionals,
and will play an important role in the creation o treatment
protocols. These organisations may also participate in the
activities o authorised ederal executive bodies, mandatory
health insurance unds, as well as in the development o state
programmes providing ree medical care to citizens.
However, the process o interaction is also a key issue that
needs to be reconsidered ollowing the introduction o On
Fundamentals of Protection of Public Health in the
Russian Federation which places signicant constraints on
the way pharmaceutical companies and clinicians can now
interact.
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Pharmaceutical Access Reorm
Indeed the biggest concern that pharmaceutical companieshave raised under the new law is in response to restrictions
now placed on healthcare providers and managers o medical
institutions. In act, the enorced version o this law relaxed
aspects o the limits on pharmaceutical/clinician interaction
due to a strong pharmaceutical industry resistance.
However, changes are still signicant and need to be
understood to ensure both pharmaceutical companies and
clinicians comply with the new requirements. Under Article 74
o the law, clinicians are now prohibited rom accepting gits
and unds rom pharmaceutical and medical device companies.
This includes payment or entertainment and recreation. They
are also banned rom receiving visits rom sales representatives
without approval o Head o the Clinic. However, exceptions
can be made relating to clinical trials and educational/research
activities a relaxation o the initial drat o the law.
Healthcare proessionals are also prohibited rom providing
the patient alse, incomplete or misleading inormation aboutthe product used; and rom receiving samples o medicines
and medical products or delivery to the population. Under the
new legislation requirements, clinicians are obliged to ensure
patients are inormed about the availability o similar products,
especially those available at a lower price.
Article 77 o the law is also relevant, as it reers to the
continuing education o healthcare proessionals, related
to pharmaceutical education. This can be undertaken by
educational research organisations engaged in medical
or pharmaceutical activities, such as clinics; by medical
organisations at clinics; or by producers o medicines
and medical devices, pharma, orensic agencies and other
organisations working in the healthcare sector.
Pharmaceutical companies also need to ensure the conict ointerest requirements outlined in Article 75 are considered
Namely, should a situation arise in which a healthcare
proessional or pharmaceutical specialist has possibly
attained material or other benets personally, or through
a medical representative, which aects or could aect the
proper perormance o his/her proessional duties because o
a conict between personal interests and the interests o a
patient, the specialist must inorm in writing the head o the
medical organization. The head o the medical (pharmaceutical)
organization must then notiy in written orm the authorized
ederal executive body within seven days, and a specia
commission will then be ormed to resolve the conict.
Educating Clinicians
So what do these changes mean or pharmaceutical companies
in practice? The key issue is that any pharmaceutical / clinician
interaction should now be based more on educational and /
or clinical research activity. Companies may reely visit duringclinical trials, and in order to improve the proessional skills
o the practitioners, as well as to collect inormation on side
eects relating to treatments and medicines. Similarly the
new law retains scope or practitioners to attend seminars
conerences and scientic events, even where these are
nanced by a single company.
Most large industry players have long had clear policies and
procedures regulating ethical interaction between company
employees and medical practitioners or pharmaceutica
workers. These policies will need to be aligned with the new
law, with the prohibition on provision o drug samples to
medical practitioners or patients, likely to mean signicant
revision o existing policies.
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Spending by Channel
85%
11%
2%2%
Samples
Meetings
Advertising
Clinical Trials
Detailing
Mailing/Others
Note: Less than 1%
Clinical Trials, Mailing/Others
Figure 2: Index - pg.12
Pharmaceutical Spending by Channel in Russia for 2011
The implications or pharmaceutical representative roles
and uture interaction are clear. Companies must be looking
to reassign representatives rom previous clinician detailing
activity towards new educational roles; whilst there will
be a shit away rom product specic promotion towards
educational disease specic events that provide key messaging
to the clinician without direct link to product or company name.
In addition, there is growing investment in new channels o
communication, including direct mail and, to a lesser degree,
eDetailing. The lack o Internet penetration across Russia
and Internet usage by physicians today remains a limitation,especially or pharmaceutical companies increasingly exploring
the value o digital marketing across the globe. According to
the latest research, 38% o the population o Russia is using
the Internet on a daily basis. Indeed, just 21% o physicians
are using the Internet daily or any proessional purposes.
Thereore, eMarketing is more a nice to have tool, and can
be used or very narrow targets, but it is not a way to get
coverage. However, it is likely that pharmaceutical companies
will explore alternative ways o communication to physicians
besides medical representatives, and the only one which oers
coverage is Direct Mailing.
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Transorming Market Access
The Russian market is becoming increasingly compelling ormulti-national organisations, since the 30% state share o
the Russian pharmaceutical market is ocused on high-cost,
innovative drugs. Today, there is no one multi-national company
that is dominating in this market; although key disease areas
such as diabetes, HIV and oncology are not well supported
by local providers. As the market value continues to grow
and reimbursement schemes are introduced across regions, it
will be imperative or companies both local and global to
respond to these changes with a new market access model.
In addition to prioritising regional activity and identiying the
stakeholders, rom decision-makers to distributors to patients,
organisations need to track the perormance o competitors.
Spending by Corporation
SERVIER
NOVARTIS
SANOFI
MENARINI
KRKA
ABBOTT
GIDEON RICHTER
ASTRAZENECA
TAKEDA
BAYER
Corporations Spending ($K) % % Change14 366
13 386
11 292
10 133
8 845
8 209
7 779
6 581
6 301
5 453
7.0%
6.5%
5.5%
4.9%
4.3%
4.0%
3.8%
3.2%
3.1%
2.7%
-16.9%
+4.1%
+0.7%
+9.5%
-0.4%
-34.2%
-9.8%
+19.0%
+7.6%
+17.9%
Figure 3: Index - pg.13
Pharmaceutical Spending by Corporation in Russia for 2011(% Change from 2010)
However, one o the main problems or pharmaceutical
companies in Russia is the total lack o access to industry data
which has been a core component o the pharmaceutical sales
model in other countries or years. There is no prescription
data; and sales data is provided by three dierent companies
with limited granularity, making it hard to draw the required
insights. Furthermore, there is no in-depth inormation about
healthcare specialists. The gures available do not make
it clear how many GPs or consultants have more than one
position. Indeed, some 30% o GPs may work in two places,
but traditionally, pharmaceutical companies have had no way
o determining accurate clinician data. Given the scale o thehealth service in Russia, this lack o inormation has made it
difcult to eectively target activity.
With the huge number o specialists operating across this vast
territory, one o the main components o successul market
access in Russia must be access to inormation about the
target audience on a named level. The new ability to access
inormation about physicians and pharmacists is transorming
the way pharmaceutical companies address the market.
Companies now have greater insight into the local thought
leaders and communities o practice at the hospital and
regional level. They are building strong relationships with Key
Opinion Leaders (KOLs), authorities and patients societies to
build inuence within specic therapeutic areas.
This inormation can also be combined with prescribing trends,
enabling pharmaceutical companies to embark upon ar more
eective and targeted market access activity. For examplequantitative indicators allow companies to rank experts by
doctor coverage and size o communities o practice, the
strength o inuence on prescriptions and the potential or
prescribing to new patients.
Critically, pharmaceutical companies will need to monitor
market access perormance in response to these signicant
legislative changes. Typically, perormance is measured by
comparing the investment in promoting specic drugs with
survey inormation on the number o medical representative
visits received by a doctor, the products promoted, the
messages received/remembered, and the inuence on the
prescription. This inormation is typically compared with
the competition to assess market position. Now, with ewer
product-oriented meetings and more general educationa
events, as well as direct marketing, it will be important to track
the eect on prescribing o the new model.
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The Russian market is vast, ast growing and clearlyoers massive opportunities or pharmaceutical
companies. However, this is a complex market, with
huge scale and very dierent pharma-economies. From
the introduction last year o new price registration or
Essential and Vital Drugs (EDL), to the move towards
greater standardisation in care pathways, changes
are occurring at every level o health provision as
the government attempts to reduce sel-prescribing,
and provide greater access and choice to healthcare
services or its citizens.
EDL pricing is now based on the lowest prices paid
in European reerence markets, eectively creating
a price reeze; and the EDL will be the basis o the
reimbursement schemes being rolled out across regions
over the next ew years.
With the introduction o On Fundamentals o Protection
o Public Health in the Russian Federation, the way
pharmaceutical companies access the market must
undamentally change. The market will continue to
decentralise, and with a growing numbers o drugs being
included in the reimbursement list, a lack o unding will
aect prescribing opportunities in some regions.
From gaining unprecedented insight into the needs,
structures and drivers o each o the 82 regions, to
creating new ways o interacting with healthcare
proessionals that reect the educational/clinical
trial requirements o the legislation, pharmaceutical
companies need to improve market access strategies
i they are to adapt to the challenges o this complex
market.
It is those pharmaceutical companies that adapt to thisast-changing model and leverage new access to an
unprecedented depth o health proessional inormation
that will be best placed to maximise the considerable
opportunities available across what is set to become
one o the largest global markets.
Estimate based on 2002 census inormation (updated in April 2011)
http://en.wikipedia.org/wiki/List_of_cities_and_towns_in_Russia_by_
population
Conclusion
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Chart Index
Elections to RussianState Duma
Modernization program- the stage of activedevelopment of the
budget
Presidential Election
Year of treatmentstandards
Regional modeling ofdrug compensation
programs
Preparing of patientregistries
Slow down ofconcentration processin distribution chain
First innovationproducts of RussianPharma companies
The beginning ofactivity of self-
regulatoryorganizations
Licensing ofhealthcare
professionals
Start the process ofconsolidation of
regional programsreimbursement
Launch ofreimbursement
program inregions
The massprivatization of
HCP
Bln$
25
Bln$75
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Figure 1:Long Term Development Scenario of Russia Pharmaceutical industry
Source: Cegedim aggregated opinion from industry experts:government employees, industry leaders, anlaysts
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7/30/2019 Cegedim - Russia Pharma Market - Aug 2012
12/16White Paper12
Chart Index
Reproduction and distribution o this report is allowed onlywith the written authorization o Cegedim.
Spending by Channel
85%
11%
2%2%
Samples
Meetings
Advertising
Clinical Trials
Detailing
Mailing/Others
Note: Less than 1%
Clinical Trials, Mailing/Others
Figure 2:Pharmaceutical Spending by Channel in Russia for 2011
Source: CSD Global Promotion Database, 38 countries, Year 2011
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Chart Index
Spending by Corporation
SERVIER
NOVARTIS
SANOFIMENARINI
KRKA
ABBOTT
GIDEON RICHTER
ASTRAZENECA
TAKEDA
BAYER
Corporations Spending ($K) % % Change14 366
13 386
11 292
10 133
8 845
8 209
7 779
6 581
6 301
5 453
7.0%
6.5%
5.5%
4.9%
4.3%
4.0%
3.8%
3.2%
3.1%
2.7%
-16.9%
+4.1%
+0.7%
+9.5%
-0.4%
-34.2%
-9.8%
+19.0%
+7.6%
+17.9%
Figure 3:Pharmaceutical Spending by Corporation in Russia for 2011 (% Change from 2010)
Source: CSD Global Promotion Database, 38 countries, Year 2011
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Cegedim Relationship Management is the leading global provider o Pharmaceutical Customer Relationship Management
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Author:
Lucia Railean
Regional Vice President - Russia, China and Commonwealth o Independent States (CIS)
Cegedim Relationship Management
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7/30/2019 Cegedim - Russia Pharma Market - Aug 2012
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Russia 2012:
The Pharmaceutical Market &New Legislation - Building for
Growth in a Fast
Changing Marketplace
August 2012