Cegedim - Russia Pharma Market - Aug 2012

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Russia 2012: The Pharmaceutical Market& New Legislation - Building for Growth ina Fast Changing Marketplace

August 2012


2/16White Paper2 Reproduction and distribution o this report is allowed only

with the written authorization o Cegedim.

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


3/16White PaperReproduction and distribution o this report is allowed only


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




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




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




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.




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.




Spending by Channel

85%

11%

2%2%

Samples

Meetings

Advertising

Clinical Trials

Detailing

Mailing/Others

Note: Less than 1%

Clinical Trials, Mailing/Others


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.




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%


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.




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




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


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




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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2011 EU Market Access Survey White Paper - June 2011

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Cegedim Relationship Management is the leading global provider o Pharmaceutical Customer Relationship Management

(CRM) solutions. The company provides the most comprehensively packaged oering, enabling Lie Sciences companies

to achieve rewarding and lasting relationships with customers, and to meet present and uture business objectives

and requirements. Solutions include:

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Contact Cegedim Relationship Management today for more information.www.cegedim.com/rm

[email protected]

Author:

Lucia Railean

Regional Vice President - Russia, China and Commonwealth o Independent States (CIS)

Cegedim Relationship Management

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Russia 2012:

The Pharmaceutical Market &New Legislation - Building for

Growth in a Fast

Changing Marketplace

August 2012

Cegedim - Russia Pharma Market - Aug 2012

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