Produced annually by UK publishers Law Business Research Ltd., this 2015 edition of Getting the Deal Through: Life Sciences has been fully revised and updated to cover the key issues of current applicable regulation, including full analysis of important aspects of cross-border transactions and international law. With contributions from leading practitioners active in 26 jurisdictions worldwide, Lidings’ attorneys have authored exclusive coverage of Russian regulation of the life sciences sector, including those issues of most direct relevance to the firm’s major pharmaceutical clients.

1. Life
SciencesIn 25 jurisdictions worldwide
Contributing editor
Alexander Ehlers
2015

2. Life Sciences 2015
Contributing editor
Alexander Ehlers
Ehlers, Ehlers & Partner
Publisher
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gideon.roberton@lbresearch.com
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3. CONTENTS
2 Getting the Deal Through – Life Sciences 2015
Introduction5
Alexander Ehlers
Ehlers, Ehlers Partner
Argentina6
Andrea Robles
Moeller IP Advisors
Australia11
Kim O’Connell and James Ellsmore
King Wood Mallesons
Austria16
Rainer Herzig
Preslmayr Rechtsanwälte OG
Belgium21
An Vijverman
Dewallens partners
Colombia27
Carlos R Olarte, Andrés Rincón and Gina Arias
OlarteMoure
Denmark32
Poul Heidmann and Nicolaj Kleist
Bruun Hjejle
France36
Christophe Henin and Anne Servoir
Intuity
Germany40
Alexander Ehlers
Ehlers, Ehlers Partner
Hungary47
Sándor Németh and Ádám Simon
Szecskay Attorneys at Law
India52
Archana Shanker and Devinder Singh Rawat
Anand and Anand
Italy57
Laura Opilio and Maria Letizia Patania
CMS Adonnino Ascoli Cavasola Scamoni
Japan62
Junichi Kondo, Yoshikazu Iwase and Hiroko Kasama
Anderson Mo¯ ri Tomotsune
Mexico68
José Alejandro Luna Fandiño and Erwin Carlos Cruz Saldivar
Olivares
Peru74
Maritza Reátegui, Marta Fernández and Cecilia Alarcón
Muñiz, Ramirez, Perez-Taiman Olaya Abogados
Philippines79
Rose Marie M King-Dominguez, Carlos Roberto Z Lopez,
John Paul V de Leon and Mark Xavier D Oyales
SyCip Salazar Hernandez Gatmaitan
Portugal84
César Sá Esteves and Ana Menéres
SRS Advogados
Russia90
Andrey Zelenin and Sergey Patrakeev
Lidings
Singapore95
Benjamin Gaw and Tony Yeo
Drew Napier LLC
South Africa 105
Dario Tanziani, Alexis Apostolidis and Pieter Visagie
Adams Adams
Sweden111
Odd Swarting and Camilla Appelgren
Setterwalls Advokatbyrå AB
Switzerland117
Frank Scherrer
Wenger Vieli Ltd
Turkey122
Özge Atılgan Karakulak, Dicle Dog˘an and Tug˘çe Avcısert Geçgil
Gün + Partners
Ukraine128
Timur Bondaryev, Lana Sinichkina and Svitlana Malynovska
Arzinger
United Kingdom 134
Barney Sich and Antonina Nijran
Fasken Martineau LLP
Venezuela141
Luis E López-Durán and Rosa Virginia Superlano
Hoet Pelaez Castillo Duque

4. RUSSIA Lidings
90 Getting the Deal Through – Life Sciences 2015
Russia
Andrey Zelenin and Sergey Patrakeev
Lidings
Organisation and financing of health care
1 How is health care in your jurisdiction organised?
Health care in Russia is allocated by the Constitution within the joint com-
petence of the federal government and regional authorities (article 72,
Constitution). The federal government is in charge of securing a uniform
policy in the health-care sector (article 114, Constitution).
The regulatory framework for health-care matters in Russia is repre-
sented by two fundamental statutes:
• Federal Law No. 323-FZ on the Foundations of Healthcare for Russian
Citizens, dated 21 November 2011; and
• Federal Law No. 61-FZ on the Circulation of Drugs, dated 12 April
2010.
Certain aspects are regulated in other statutes, for example Federal Law
No. 326 on Mandatory Insurance in the Russian Federation, dated 29
November 2010; and Federal Law No. 44-FZ on the Public Procurements
Contracting System, dated 5 April 2013 (in force from 1 January 2014).
Medical and pharmaceutical activities in Russia may be carried out
on the basis of a respective licence only. Such licences must be obtained
by medical or pharmaceutical companies, or by individual entrepreneurs
(doctors or pharmacists) who are carrying out medical or pharmaceutical
activities in their own name on an individual basis.
2 How is the health-care system financed in the outpatient and
in-patient sectors?
Russian health care (both outpatient and in-patient sectors) is financed
through:
• subventions from the federal budget;
• funds from municipal budgets;
• payments from the mandatory medical insurance fund that consists
of contributions from employers and budgetary allocations for the
unemployed; and
• income from medical institutions authorised under relevant laws and
regulations.
The law permits other miscellaneous funding sources, such as charitable
donations. Russian health care, in effect, provides universal coverage and
guarantees provision of certain services complying with minimum stand-
ards free of charge.
In recent years, the voluntary medical insurance system has become
an increasing source of health-care system financing. At the same time,
it should be noted that the reimbursement system is at the establishment
stage and is undergoing test periods in several ‘pilot’ regions in Russia.
There still remains much room for future developments.
Compliance – pharmaceutical manufacturers
3 Which legislation governs advertising of medicinal products
to the general public and health-care professionals?
Advertising of medicinal products in Russia is governed by the following
laws:
• Federal Law No. 38-FZ on Advertising, dated 13 March 2006 (Law on
Advertising);
• Federal Law No. 323-FZ on the Foundations of Healthcare for Russian
Citizens, dated 21 November 2011;
• Federal Law No. 61-FZ on the Circulation of Drugs, dated 12 April
2010; and
• Federal Law No. 135-FZ on the Protection of Competition, dated 26
July 2006.
The Law on Advertising contains special requirements and restrictions
relating to the advertisement of pharmaceutical products, medical equip-
ment and medical services, including methods of treatment and para-
pharmaceutical products (eg, nutrition supplements, which are often
confused with medicine by the Russian public).
4 What are the main rules and principles applying to
advertising aimed at health-care professionals?
Advertising of prescription medicines is allowed by Russian legislation
only if aimed at health-care professionals alone. Thus, it is not allowed to
place prescription medicines advertising in media accessible to the gen-
eral public. In cases where advertising is aimed at health-care profession-
als, certain conventional statutory restrictions may be inapplicable. The
following advertising to health-care professionals is allowed, assuming
the advertising is carried out exclusively at venues for medical or pharma-
ceutical exhibitions, fairs, seminars, conferences and other such events,
or appears in specialised publications for medical and pharmaceutical
professionals:
• advertising of medicines in dosages prescribed by doctors, treatment
methods, medical purpose items and medical equipment that require
special training for their use;
• advertising of medicines that contain restricted narcotic or psycho-
tropic substances that can be used for medical purposes; and
• advertising that would otherwise be prohibited because it may:
• contain references to specific examples of health improvements
linked to use of the advertised product;
• show individuals expressing gratitude for the advertised product;
or
• special warning formula concerning possible side effects associ-
ated with the use of the advertised product may be omitted in the
advertising aimed at health-care professionals.
It is also prohibited to combine advertising materials with administrations
and prescriptions that health-care professionals issue to their patients.
5 What are the main rules and principles applying to
advertising aimed at the general public?
Advertising aimed at the general public is eligible only for over-the-counter
medicines and para-pharmaceutical products. Such advertisements must
be accompanied by adequate warning language regarding side effects and
the need to read the instructions or consult a specialist doctor (alterna-
tively, regarding para-pharmaceutical products, the warning language must
emphasise that such product is not a medicine). The relevant warnings or
recommendations must satisfy certain minimum volume requirements (ie,
minimum duration for broadcasting adverts and minimum space in printed
adverts).
Advertising of an over-the-counter medicine should not contain infor-
mation deviating from the text of the relevant medicine’s instruction (part
of registration dossier).
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5. Lidings RUSSIA
www.gettingthedealthrough.com 91
An advertisement of a pharmaceutical product (drug) aimed at the
general public must not:
• be addressed to minors (ie, persons under 18 years);
• refer to specific cases of curing the disease or improving health condi-
tions due to the use of the advertised product;
• include individuals expressing gratitude for the effect of the adver-
tised product;
• create a positive impression about the benefits of the advertised prod-
uct by referring to the results of the clinical and other trials performed
as a requirement for the registration of such product;
• assert or assume that the target audience of the advertisement may
suffer from certain diseases or health disorders;
• create an impression that a healthy person should use the advertised
product;
• imply that it is not necessary to consult a doctor in order to use the
advertised product;
• guarantee positive effects of the advertised product, its safety, effi-
ciency and the absence of side effects;
• present the advertised pharmaceutical product as a biologically active
supplement or food supplement, or any other non-pharmaceutical
product; or
• contain assertions that the natural origin of the advertised product
guarantees its safety or effectiveness.
Advertising promotions involving giveaways of pharmaceutical products
containing narcotic and psychotropic substances are prohibited.
Advertising of para-pharmaceutical products (dietary supplements
and nutritional supplements, infant foods) must not:
• create the impression that they are drugs or have medicinal properties;
• contain references to specific instances of healing people or improving
their condition as a result of these additives;
• contain an expression of gratitude to individuals in connection with
the use of such additives;
• encourage the abandonment of a healthy diet;
• create an impression about the benefits of such supplements by refer-
ring to research (which is mandatory for state registration of such addi-
tives), and use the results of other studies in the form of direct advice
regarding the use of such additives; and
• regarding the advertising of baby foods: such advertising should not
represent these foods as full substitutes for breast milk and should not
contain a statement about the benefits of artificial feeding of children.
Advertising of products intended for use as substitutes for human
milk, and the products included in the diet of children during their first
year of life, should contain information about the age restrictions of
such products, and should not create the impression that expert advice
is not necessary.
6 What are the most common infringements committed by
manufacturers with regard to the advertising rules?
One of the most common infringements concerns failure to provide warn-
ings in adverts: at times, the supervising authorities have found infringe-
ments when advertising has created the impression that it is not necessary
to consult a doctor in order to use the advertised product.
Another common infringement relates to para-pharmaceutical prod-
ucts that are advertised in bad faith, with the result that the public per-
ceives the advertised product as a medicine.
7 Under what circumstances is the provision of information
regarding off-label use to health-care professionals allowed?
Russian law does not regulate the procedures for providing information
on off-label use to health-care professionals. Therefore, such informa-
tion may be conveyed to them by any lawful means, including in scientific
monographs, professional research articles, professional guidebooks, con-
ferences or roundtable reports, as well as through meetings with health-
care professionals.
However, it should be noted that all information about properties and
characteristics of drugs and medical equipment must correspond to the
information contained in the product’s pre-approved instructions (leaf-
let) for use and application. This means that all advertising and market-
ing materials for a pharmaceutical product must reflect the information
contained in the product’s instructions. Any deviation in the information
circulated about the product and the instructions for its use shall be con-
sidered as contradiction, and the competent authorities may demand that
it is brought into full compliance with the pre-approved instructions for
use and application. According to the relevant procedures for prescrib-
ing the drugs approved by the Russian Ministry of Healthcare and Social
Development (MOH):
• off-label use of any drug for an outpatient is directly prohibited, and
the doctor is personally liable for the breach of this prohibition (such
liability may include compensation of damages as well as professional
debarment for a specified period of time); and
• off-label use of any drug for an in-patient must be preapproved by a
special commission to be created for this purpose within the respective
health institution.
8 Which legislation governs the collaboration of the
pharmaceutical industry with health-care professionals? Do
different rules apply regarding physicians in the outpatient
and in-patient sectors?
Relationsandinteractionsbetweenhealth-careprofessionalsandthephar-
maceutical industry are now covered under articles 74 and 75 of Federal
Law No. 323-FZ on the Foundations of Healthcare for Russian Citizens
(Law on Foundations of Healthcare). These provisions came into force on
1 January 2012. Article 74 of the Law on Foundations of Healthcare prohib-
its medical and pharmacy employees from the following:
• accepting gifts, cash, paid entertainment, holidays or travel expenses
from companies manufacturing or distributing medicines or medical
equipment;
• entering into written or oral agreements with companies manufac-
turing or distributing drugs or medical equipment concerning the
prescription or recommendation of certain drugs or equipment to
patients;
• receiving medicine or medical equipment samples from those compa-
nies to give away to patients;
• providing false or incomplete information on the number, type and
name of alternative medicines or medical equipment that may be used
in lieu of the prescribed medicine or piece of medical equipment; and
• one-on-one visits of medical representatives of those companies to
medical professionals or treating physicians.
The exceptions to the above prohibitions include medical profession-
als’ involvement in educational or scientific activities, clinical trials
and participation in informational events sanctioned by the enterprise
administration.
Article 75 of the Law on Foundations of Healthcare includes a defini-
tion of ‘conflict of interest’. In the event of a conflict of interest, the affected
medical professional must report the conflict to his or her superiors, who
in turn should refer the details to a special federal agency responsible for
resolving such situations.
It should be noted that violation of the above restrictions results in
the liability of health-care professionals and not of the pharmaceutical
industry. The bill introducing the ‘mirror’ liability for representatives of
the pharmaceutical industry has recently been amended to exclude any
specific penalties for them.
The ‘mirror’ requirements that apply to restrictions on the activities of
pharmaceutical industry representatives are reproduced in article 67.1 of
Federal Law No. 61-FZ on the Circulation of Drugs. These provisions came
into force on 25 November 2013.
9 What are the main rules and principles applying to the
collaboration of the pharmaceutical industry with health-care
professionals?
In addition to the rules and restrictions set out in articles 74 and 75 of the
Law on Foundations of Healthcare, principles stipulated in the Doctors’
Code of Ethics of the Russian Federation adopted by the medical commu-
nity in 1997 (Code) should also be mentioned. The Code is non-mandatory
and additional to the applicable laws and regulations. In particular, the
Code states that:
[…] a doctor shall not accept incentives from manufacturers or dis-
tributorsofpharmaceuticalproductsfortheprescriptionoftheirprod-
ucts. A doctor shall prescribe medicines strictly on the basis of medical
factors and solely in the interests of the patient.
Regardingcollaborationbetweenthemedicalcommunityandforeignphar-
maceutical companies, the Association of International Pharmaceutical
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6. RUSSIA Lidings
92 Getting the Deal Through – Life Sciences 2015
Manufacturers (AIPM) Marketing Code of Practice provides basic princi-
ples for such collaboration, providing in particular that such collaboration:
• should be aimed at informing health-care professionals about phar-
maceutical products, providing them with scientific and educational
information and supporting scientific research in medicine and medi-
cal education;
• should avoid causing conflicts of interest with regard to professional
obligations on the one hand and economic interests on the other;
• must not involve pharmaceutical companies offering, promising, pro-
viding or giving health-care professionals any kind of remuneration
for prescribing or recommending certain pharmaceutical products to
patients;
• must support professional training (including sponsoring participation
in conferences and other professional events, as well as issuing grants,
stipends and subsidies); and
• should not be made contingent on the amount of a pharmaceutical
product prescribed or sold.
It should also be noted that the MOH has recently enacted an instruction
that all medicine prescriptions be issued without specifying trade names
(ie, only mentioning the medicine’s international non-patented name
(INN)).
10 What are the most common infringements committed by
manufacturers with regard to collaboration with health-care
professionals?
As the provisions of the Law on Foundations of Healthcare have come into
force only recently, no representative administrative practice is currently
in place, and hence no statistics on infringements are available.
11 What are the main rules and principles applying to the
collaboration of the pharmaceutical industry with patient
organisations?
Patient organisations are relatively new in Russia, and to date there is no
legal or regulatory framework governing their relationship with the phar-
maceutical industry.
The rights of individual patients in relation to pharmaceutical compa-
nies are more developed. According to the Russian Declaration of Patients’
Rights, adopted in May 2010:
[…] every person has the right to direct access to information on sci-
entific research, the possibilities of pharmaceutical therapy, and tech-
nological innovation. This information may be provided by public or
private sources, provided it meets criteria for accuracy, reliability, and
transparency.
Rules are also set out in the AIPM Marketing Code of Practice, which states
that ‘when a patient asks a pharmaceutical company for information, such
requests must be satisfied’. Again, the aforementioned rules are not man-
datory and represent mere recommendations for AIPM members.
12 Are manufacturers’ infringements of competition law
pursued by national authorities?
The Federal Antimonopoly Service (FAS) is in charge of enforcing Federal
Law No. 135-FZ on the Protection of Competition, dated 26 July 2006, and
has been active in prosecuting violations on the pharmaceutical and medi-
cal equipment markets. Most violations relate to selective distribution and
alleged attempts to restrict access to product markets for new participants.
A growing number of violations prosecuted by the FAS relate to pub-
lic procurements. Apart from violations connected with reasonability of
certain particular bid requirements, special attention is paid to distributor
cartels designed to drive prices either down or up if product sales occur via
state procurement procedures as envisaged in the Federal Law No. 44-FZ
on the Public Procurements Contracting System, dated 5 April 2013.
13 Is follow-on private antitrust litigation against manufacturers
possible?
Follow-on private antitrust litigation against manufacturers is not possible
in Russia. The FAS is in charge of enforcement of antitrust law provisions.
Accordingly, a private person (individual or company) may only file a com-
plaint with the FAS against a manufacturer allegedly breaching antitrust
law requirements. The FAS may, upon consideration of the complaint,
initiate the administrative prosecution. However, the complainant will be
not a party to (or a beneficiary of) the relevant administrative proceedings.
Compliance – medical device manufacturers
14 Is the advertising of medical devices and the collaboration
of manufacturers of medical devices with health-care
professionals and patient organisations regulated
as rigorously as advertising and collaboration in the
pharmaceuticals sector?
The applicable laws do not make any distinction between manufacturers
of medical devices and manufacturers of pharmaceuticals in terms of col-
laboration with health-care professionals. Both are regulated to an equal
degree by articles 74 and 75 of the Law on Foundations of Healthcare and
article 67.1 of the Law on Circulation of Drugs, as described in question 8.
In addition, from the standpoint of advertising restrictions, the same
requirements generally apply both to medicines and to medical devices
(with some minor exceptions, which are reasoned by common sense
rather than by any particular requirements peculiar to medical devices as
opposed to medicines).
Pharmaceuticals regulation
15 Which legislation sets out the regulatory framework for
granting marketing authorisations and placing medicines on
the market?
The Law on Circulation of Drugs sets out the procedure for obtaining mar-
keting authorisations for medicines in Russia. The marketing authorisation
is issued by the MOH, and represents an essential prerequisite for lawful
circulation of the relevant medicine in Russia. The Law also provides a pro-
cedure for registering and issuing registration certificates for active phar-
maceutical ingredients.
Besides this, special requirements apply to the maximum manufac-
turer’s prices for medicines put on a special list of vital and essential drugs
(EDL), which are subject to registration with the MOH before placing on
the market.
The current EDL, which is effective for 2014, was adopted by the gov-
ernment on 7 December 2011. A new list for 2015 shall be adopted by the
competent authorities before the end of 2014.
16 Which authorities may grant marketing authorisation in your
jurisdiction?
All pharmaceutical products are registered in Russia by the Department
for Regulation of Medicinal Products Circulation of the MOH.
17 What are the relevant procedures?
In accordance with the Law on Circulation of Drugs, the procedure for the
registration of a new drug consists of the following stages:
• pre-clinical trial of a drug;
• filing an application for state registration of the pharmaceutical prod-
uct along with the dossier documents;
• obtaining expert opinions prior to clinical trials (toxicology, ethics,
quality assessment, etc);
• clinical trials of the product carried out by one of the health-care insti-
tutions specifically accredited by the MOH for this purpose; and
• final assessment of the registration dossier and registration of the
medicine.
A decision on the pharmaceutical product’s state registration is made on
the basis of the results of the above assessments and trials.
The Law on Circulation of Drugs requires that the process of state reg-
istration of a pharmaceutical product is completed within 210 days, exclud-
ing the time required for carrying out clinical trials and the time necessary
to produce the relevant documentation.
The registration certificate for a medicine must describe the medi-
cine form and dosage. A medicine registered in Russia for the first time
is issued with a registration certificate for five years. Following the expiry
of the initial five-year term, the registration of the medicine must be con-
firmed under a separate expedited procedure, described in detail in article
29 of the Law on Circulation of Drugs, which involves, inter alia, proving
the quality of the medicine. If proved positive, the registration for such
medicine is granted and the registration certificate is issued for an indefi-
nite period of time.
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7. Lidings RUSSIA
www.gettingthedealthrough.com 93
Following state registration, registered medicines are listed in a spe-
cial state register of medical products in accordance with article 33 of the
Federal Law on Circulation of Drugs.
Certain particular requirements are applicable to the state registration
of medical devices pursuant to the Regulation of the Russian Government
No. 1416 dated 27 December 2012.
18 Will licences become invalid if medicinal products are not
marketed within a certain time? Are there any exceptions?
The Law on Circulation of Drugs does not condition the validity of the
state registration of a pharmaceutical product by the marketing or sale of
a product within a certain time frame. However, the ‘sunset clause’ is cur-
rently being discussed with regard to massive amendments to the Law on
Circulation of Drugs. Pursuant to such ‘sunset clause’, a marketing authori-
sation may be revoked when a registered drug is not marketed within two
years of its initial registration.
19 Which medicines may be marketed without authorisation?
Pursuant to article 13 of the Law on Circulation of Drugs, state registration
is not required for:
• pharmaceutical products manufactured on-site by pharmacies, vet-
erinary pharmacies or by individual entrepreneurs licensed as phar-
macists, according to prescriptions and requirements of medical or
veterinary organisations;
• natural plants as medicinal substances;
• drugs acquired by individuals outside Russia and intended for per-
sonal use;
• medicines intended for export; or
• radiological drugs manufactured by medical organisations in accord-
ance with applicable laws and regulations.
20 Are any kinds of named patient programmes in place? If so,
what are the requirements for pre-launch access?
The Federal Law on the Circulation of Medicines allows for ‘named patient
supply’ programmes. In particular, a state-owned federal hospital may
decide to administer a medicine that has not been registered in Russia.
Such medicine must be intended for a specific patient. Recent adminis-
trative practice demonstrates that in similar cases the administration and
purchase of a medicine not registered in Russia may become an obligation
of the public hospital.
The new Law on Public Procurements Contracting System also pro-
vides for a simplified procurement procedure in cases of ‘named patient
supply’.
Pricing and reimbursement of medicinal products
21 To what extent is the market price of a medicinal product
governed by law or regulation?
Pursuant to article 61 of the Law on Circulation of Drugs, the maximum
sale price for certain vital or essential drugs must be registered with the
MOH.
Each year, the government approves the EDL of vital and essential
drugs for the upcoming calendar year based on their INN. If a medicine is
included in the EDL, its maximum sale price that the foreign supplier (for
imported drugs) or domestic manufacturer (for locally produced drugs)
may charge to the first distributor is subject to mandatory registration with
the MOH, based on the economic case presented by the supplier. If the
drug is not on the EDL, the supplier may establish the sale price at its sole
discretion.
The wholesale and retail margins for drugs included on the EDL are
also regulated in that the maximum wholesale and retail margins for such
drugs are established by regional authorities for their respective region.
The typical maximum wholesale margin is 15 per cent and the typical retail
margin is 25 per cent, although higher thresholds may apply in regions
requiring additional market stimulus (eg, regions in the far north).
If the drug INN is not included on the EDL, none of the above pricing
restrictions will apply.
22 Must pharmaceutical manufacturers negotiate the prices of
their products with the public health-care providers?
No. Even in relation to the drugs put on the EDL, a manufacturer is not
required to negotiate the maximum sale price for an EDL drug with
public health-care providers in order to register such price with the MOH.
Registration is made on the basis of the economic case showing, in par-
ticular, the sale price charged by the manufacturer in other countries for
the same product.
Public health-care providers can only carry out their purchases
through public procurement proceedings. The general rule governing pub-
lic procurements is that the bidder offering the lowest price wins the bid.
It should be noted that certain restrictions apply to the formation of
public procurement lots. In particular, procuring drugs under their trade
names is generally not allowed (rather, the INN should be subject to pub-
lic procurement). In addition, one lot should not include more than one
INN when the start (maximum) price of the lot is above 1 million roubles
(for Moscow and St. Petersburg, this threshold is higher: 5 million roubles).
For certain types of drugs, the start (maximum) price of the lot is fixed at a
much lower level: 1,000 roubles for unique drugs having no analogue, for
narcotic or psychotropic drugs, as well as for radiology drugs.
23 In which circumstances will the national health insurance
system reimburse the cost of medicines?
The Russian mandatory medical insurance system provides for a limited
reimbursement of the cost of medicines, as described below.
In-patient care
EDL medicines (see question 21) are provided free of charge regardless of
the duration of treatment. If a patient is prescribed non-EDL drugs, they
must either purchase such medicine or – if the medicine is not yet regis-
tered in Russia – in theory, have it purchased by the hospital in the manner
described in question 20.
Outpatient care
The reimbursement of EDL medicines depends on the patient’s category
and nature of illness. Specifically, some classes of patients (eg, World
War II veterans, Heroes of the Russian Federation and children up to
three years of age) are entitled to obtain prescription drugs at no charge.
Other categories (eg, non-working class II disabled people, and pensioners
receiving a minimum pension) have to pay 50 per cent of the retail price of
the prescription drugs. The list of persons qualifying for such benefits is
established by Federal Law No. 178-FZ, dated 17 July 1999, on State Social
Care, and Government Resolution No. 890, dated 30 July 1994, on State
Support for the Development of the Medical Industry and Improvement
in the Supply of Medicinal Products and Medical Devices to the Public and
Health-care Institutions.
In addition, a person is entitled to free EDL drugs if such person suffers
from certain specific diseases (established by law) such as HIV, cerebral
palsy, cancer and tuberculosis.
24 If applicable, what is the competent body for decisions
regarding the pricing and reimbursability of medicinal
products?
The government approves the EDL on an annual basis. A draft of the
EDL is prepared by the MOH. Accordingly, the medicines included in the
EDL are subject to the pricing restrictions and reimbursement principles
described above.
The MOH approves the methodology for pharmaceutical producers
to set maximum manufacturers’ prices for medicinal preparations on the
EDL.
The Federal Tariff Service approves the methodology for regional
executive authorities to set the maximum wholesale and resale markups
on actual sale prices set by manufacturers of EDL drugs.
25 Are manufacturers or distributors of medicinal products
statutorily obliged to give a discount?
Neither manufacturers nor distributors are obligated to provide any special
discount on medicinal products. However, discounts or bonuses may be
freely negotiated in the context of a specific contract – such discount poli-
cies are widely used as a form of sales stimulation, subject to restrictions
under Russian competition law that apply to pharmaceutical companies
with dominant positions in respective product markets.
Recent administrative practice demonstrates that pricing issue (com-
bined with the discount policy) may be regarded under circumstances as
an instrument restricting competition. Accordingly, the FAS may issue a
warningwiththerequirementtoreviewtherelevantcontractualprovisions.
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8. RUSSIA Lidings
94 Getting the Deal Through – Life Sciences 2015
In the first instance, this may be applicable to contracts between inter-
national manufacturers and Russian distributors participating in public
procurements.
Regarding public procurements for the delivery of goods originating
from foreign countries carried out through an auction, the price of the
contract with the winner of the auction shall be decreased by 15 per cent
of the suggested contract price according to the Decree of the Ministry
of Economic Development and Trade of the Russian Federation dated 25
March 2014 No. 155 On terms of access of goods from foreign countries for
the purposes of central and local government procurement of goods, works
and services.
Medicine quality and access to information
26 What rules are in place to counter the counterfeiting and
illegal distribution of medicines?
The production, import and sale or distribution of counterfeit pharma-
ceutical products and low-quality medicinal substances is prohibited in
Russia. To ensure medicines imported and sold in the country are of high
quality, Russian laws and regulations set out stringent licensing require-
ments that manufacturers, importers and retailers must follow, such as:
• for manufacturers – the licensee’s compliance with rules on the pro-
duction of medicinal products; and
• for wholesalers and pharmacies – the licensee’s compliance with
requirements that prohibit the sale of medicines that have lost effec-
tiveness, medicines with expired shelf-life dates, etc.
Violation of the above-mentioned obligations may lead to the suspension
or cancellation of a pharmaceutical licence (be it for manufacturing, or
wholesale or retail sale).
Importing and distributing fake and counterfeit medicinal products
may also qualify as infringements of intellectual property rights subject to
possible criminal sanctions, in addition to damages that may be awarded
to an aggrieved party through a court action and administrative penalties
(usually in the form of fines).
27 What recent measures have been taken to facilitate the
general public’s access to information about prescription-
only medicines?
Unlike in EU countries, there has not been any tangible effort aimed at
facilitating the general public’s access to information about prescrip-
tion medicines. In accordance with article 67 of the Federal Law on the
Circulation of Medicines, information on prescription medicines should
appear only in specialised publications intended for medical, pharmaceu-
tical and veterinary professionals. As mentioned previously, advertising of
such medicines to the public is prohibited.
28 Outline major developments to the regime relating to safety
monitoring of medicines.
Pursuant to article 64 of the Law on Circulation of Drugs, all market par-
ticipants involved in the sale and distribution of drugs must disclose and
report to the MOH any and all information about possible adverse effect
of the drugs sold or distributed by them if and when such information
becomes known to them. Failure to disclose information about adverse
health effects may lead to administrative or criminal liability.
However, the uniform pharmacovigilance policy is still in the process
of being formed. Creation of a uniform reporting and evaluation mecha-
nism is currently on the agenda for further regulatory developments.
Vaccination
29 Outline your jurisdiction’s vaccination regime for humans.
Regulations for the vaccination regime for humans are contained in
Federal Law No. 157-FZ on Immunological Prophylaxis of Infectious
Diseases, dated 17 September 1998. Pursuant to this statutory act, the
MOH annually approves the National Vaccination Calendar, which is the
schedule for vaccinations for the upcoming year. Public health-care estab-
lishments are obliged to provide their patients with vaccines pursuant to
this Vaccination Calendar.
Update and trends
Extensive amendments to the Law On Circulation of Drugs, which
have been the subject of heated discussion during the past two years,
have been formalised as a bill, and the path of this bill through the
State Duma appears to be quite smooth: it has successfully passed
the first reading, and there is a good chance it will become law
even before the end of 2014. The relevant amendments, inter alia,
introduce legal definitions of biosimilar and interchangeable drugs,
reframe the procedure for generic drugs registration, and abandon
the concept of ‘original drug’ (instead, a concept of ‘innovative drug’
is proposed).
Another bill extending the scope of liability for violations in
pharmacovigilance reporting has also successfully passed the first
reading in the State Duma.
In light of recent sanctions exercised against Russia by several
western countries, Russia’s access to foreign drugs through public
procurement processes has became more complicated. Currently,
the ‘third must out’ regulation is being discussed, under which a
foreign drug is not eligible for participation in public procurement
processes if a similar (interchangeable) drug is offered by at least two
manufacturers registered in the European Union.
One further aspect in this context is the bias of certain law
enforcement authorities to interpret restrictively the six-year data
exclusivity provision (which provides foreign manufacturers with
less comfort on the Russian market after state registration of a new
drug): similarly to the Bolar provision, this six-year period should
cover only the commercial use of exclusive data, because the use of
such data for the purpose of state registration of other drugs is not
regarded as a commercial use.
Finally, in terms of the transition to a reimbursement system,
certain pilot projects have been initiated in 2014 in several Russian
regions. The first results from these tests are currently being
evaluated.
Andrey Zelenin azelenin@lidings.com
Sergey Patrakeev spatrakeev@lidings.com
Naberezhnaya Tower Block C
Presnenskaya nab 10
Moscow 123317
Russia
Tel: +7 495 989 4410
Fax: +7 495 989 4420
www.lidings.com
© Law Business Research Ltd 2014

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