Detailed review of rules and regulations applicable to Pharmaceutical and Life Sciences Industries in Russia in an easy-to-comprehend Q&A form

1. ®
Life Sciences
in 24 jurisdictions worldwide
Contributing editor: Alexander Ehlers
2014
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2. contents
Life Sciences 2014
Introduction Alexander Ehlers Ehlers, Ehlers & Partner 3
Contributing editor
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Life Sciences 2014
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First published 2010
5th edition
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3. Lidings
Russia
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 competence 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
represented 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 a medical or pharmaceutical company or by an individual entrepreneur (doctor or pharmacist) who is 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 standards 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 still
at a rudimentary phase, leaving room for future developments.
• Federal Law No. 38-FZ on Advertising, dated 13 March 2006
(the 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 Competition).
The Law on Advertising contains special requirements and restrictions relating to the advertisement of pharmaceutical products, medical equipment and medical services, including methods of treatment
and parapharmaceutical 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 the Russian legislation only if aimed at health-care professionals. Thus, it is not
allowed to place prescription medicines advertising in media accessible to the general public. In cases where advertising is aimed at
health-care professionals, 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 pharmaceutical 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 psychotropic 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 improve ments linked to use of the advertised product;
• show individuals expressing gratitude for the advertised
product; or
• special warning formula concerning possible side effects
associated 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 which health-care professionals issue to
their patients.
Compliance – pharmaceutical manufacturers
3 Which legislation governs advertising of medicinal products to the
general public and health-care professionals?
Advertisement of medicinal products in Russia is governed by the
following laws:
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 in application
to over-the-counter medicines and para-pharmaceutical products.
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Such advertisements must be accompanied by adequate warning
language regarding side effects and the need to read the instructions or consult a specialist doctor (alternatively, in application to
para-pharmaceutical products, the warning language must emphasise that such product is not a medicine). The relevant warnings or
recommendations must amount to not less than three seconds for
radio advertisements, not less than five seconds and 7 per cent of
the screen space for television, cinema and video commercials, and
not less than 5 per cent of the area of any hard-copy advertisement
distributed in any other form.
Advertising of an over-the-counter medicine should not contain information deviating from the text of the relevant medicine’s
instruction (part of registration dossier).
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
conditions due to the use of the advertised product;
• include individuals expressing gratitude for the effect of the
advertised product;
• create a positive impression about the benefits of the advertised
product by referring to the results of the clinical and other trials
performed as 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,
efficiency and absence of side effects;
• present the advertised pharmaceutical product as a biologically active supplement or food supplement, or any other nonpharmaceutical 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.
a background mention of certain drugs. According to state regulators, this practice is often used to circumvent restrictions that apply
to drugs advertising.
One other common infringement relates to para-pharmaceutical
products which are advertised in bad faith, with the result that the
public perceives the advertised product as a medicine.
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
referring to research (which is mandatory for state registration
of such additives), and use the results of other studies in the form
of direct advice regarding the use of such additives; and
• advertising of baby foods should not represent them 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 the child during its first year
of life, should contain information about the age restrictions of
such products and avoid the need for expert advice.
8 Which legislation governs the collaboration of the pharmaceutical
industry with health-care professionals? Do different rules apply
regarding physicians in the in-patient and outpatient sector?
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 warnings about possible side effects, or about the need to read
instructions or consult a physician. At times, advertisers produce
‘combined’ commercials that focus on food supplements but contain
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
information may be conveyed to them by any lawful means, including in scientific monographs, professional research articles, professional guidebooks, conferences 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 (leaflet) for use and application. This means that all
advertising and marketing 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 considered 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 prescribing 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.
Relations and interaction between health-care professionals and the
pharmaceutical industry are now covered under articles 74 and 75
of Federal Law No. 323-FZ on the Foundations of Healthcare for
Russian Citizens (the Law on Foundations of Healthcare). These
provisions came into force on 1 January 2012. Article 74 of the
Law on Foundations of Healthcare prohibits medical and pharmacy
employees from:
• accepting gifts, cash, paid entertainment, holiday or travel from
companies manufacturing or distributing medicines or medical
equipment;
• entering into written or oral agreements with companies manufacturing 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
companies 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 professionals’ involvement in educational or scientific activities, clinical
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Russia
trials and participation in informational events sanctioned by the
enterprise administration.
Article 75 of the Law on Foundations of Healthcare includes a
definition 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 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.
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 community in 1997 (the 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 distributors of pharmaceutical products for the prescription of their
products. A doctor shall prescribe medicines strictly on the basis of
medical factors and solely in the interests of the patient.
Regarding collaboration between the medical community and
foreign pharmaceutical companies, the AIPM Marketing Code of
Practice provides basic principles for such collaboration, providing
in particular that such collaboration:
• should be aimed at informing health-care professionals about
pharmaceutical products, providing them with scientific and
educational information and supporting scientific research in
medicine and medical 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, providing 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 where all medicine prescriptions be issued without specifying trade names (ie, only mentioning the medicine’s 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 pharmaceutical industry.
The rights of individual patients in relation to pharmaceutical companies 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
scientific research, the possibilities of pharmaceutical therapy, and
technological 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 mandatory and represent mere recommendations for the 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 medical 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 public 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 currently effective Federal Law No. 94-FZ on Placement of
Orders for the Supply of Goods, Performance of Works or Rendering
Services for State and Municipal Needs, as amended (the Law on
State Orders, which terminates on 31 December 2013 and is then
replaced by 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 a company) may only file a complaint 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 applicant will be not a party (or a beneficiary) to
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?
Applicable laws do not make any distinction between manufacturers
of medical devices and manufacturers of pharmaceuticals in terms of
collaboration with health-care professionals. Both are regulated to
an equal degree by articles 74 and 75 of the Law on Foundations of
Healthcare, as described in question 8.
Also, 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 to medical
devices as opposed to the medicines).
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Pharmaceuticals regulation
19 Which medicines may be marketed without authorisation?
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 marketing authorisation for medicines in Russia. Such 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 procedure for registering and issuing registration certificates for active pharmaceutical ingredients.
Besides this, special requirements apply to the maximum manufacturer’s price for medicines put on a special list (vital and essential
drugs), which are subject to registration with MOH before placing
on the market.
16 Which authorities may grant marketing authorisation in your
jurisdiction?
As of 1 September 2010, pharmaceutical products are registered in
Russia by the Department for Regulation of Medicinal Products 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
product 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
institutions 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 registration of a pharmaceutical product is completed within
210 days, excluding 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 medicine 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 confirmed under a separate expedited procedure,
described in detail in article 29 of the Law on Circulation of Drugs,
which involves, among others, proving the quality of the medicine.
If proved positive, the registration for such medicine is granted and
the registration certificate is issued for an indefinite period of time.
Following state registration, registered medicines are listed in a
special state register of medical products, in accordance with article
33 of the Federal Law on Circulation of Drugs.
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 currently being discussed with regard to massive amendments to the Law on Circulation of Drugs. Pursuant to this ‘sunset
clause’, marketing authorisation may be revoked when a registered
drug is not marketed within two years of its initial registration.
Pursuant to article 13 of the Law on Circulation of Drugs, state
registration is not required for:
• pharmaceutical products manufactured on-site by pharmacies,
veterinary pharmacies or by individual entrepreneurs licensed
as pharmacists, according to prescriptions and requirements of
medical or veterinary organisations;
• natural plants as medicinal substances;
• drugs acquired by individuals outside Russia and intended for
personal use;
• medicines intended for export; or
• radiological drugs manufactured by medical organisations in
accordance 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 socalled ‘named patient supply’ programmes. In particular, a stateowned 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 administrative practice demonstrates
that in similar cases the administration and purchase of the medicine not registered in Russia may become an obligation of the public
hospital.
The new Law on Public Procurements Contracting System also
provides 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 any vital or essential drug must be registered with
the MOH.
Each year, the Russian government approves the list of vital and
essential drugs (the EDL) for the upcoming calendar year, based
on their international non-patented name (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, far north regions).
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. 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 particular, the sale price charged by
the manufacturer in other countries for the same product.
Regarding the actual price the manufacturer or foreign supplier charges the distributor, public health-care providers do not
usually interact directly with manufacturers and foreign suppliers of
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pharmaceutical products. The public health-care providers submit
a request for relevant drugs to the respective health-care authority
(regional or federal), which then organises the tender for the supply
of the relevant drugs and subsequently purchases directly the drugs
from the supplier (normally, the Russian distributor).
Thus, the prices of pharmaceutical products supplied by private companies to public health-care providers are determined in the
course of state procurement procedures carried out by the respective
authorities. These procedures must comply with the Law on State
Orders and respective regulations. In particular, a reverse tender or
auction mechanism is normally used for determining the ultimate
purchase price where the registered maximum price for an EDL drug
is the starting point, and the bidder who offers the lowest price wins
the auction. As the EDL is rather broad, virtually all auctions organised by the competent authorities cover EDL drugs only and thus
the registered price for the respective EDL drug is the starting point
in such tenders.
A non-EDL drug can only be supplied to a public health-care
provider through auction or tender (this is a mandatory requirement
of the Law on State Orders). The bidder offering the lowest price
should win the tender or auction.
The FAS is clamping down on regional authorities to eliminate
the practice of rigging state tenders and auctions, with the result that
only one bidder can qualify. Similarly, the FAS has initiated a few
antitrust proceedings against certain Russian distributors, accusing
them of concerted actions in the context of state tenders, with the
result that only one distributor participated in the auction with the
highest price and therefore won it, to the detriment of the public
interest. These cases of concerted actions, in turn, resulted in the
opening of criminal proceedings against the top managers of some
of those distribution companies.
medicines included in 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.
23 In which circumstances will the national health insurance system
reimburse the cost of medicines?
The production, import and sale or distribution of counterfeit pharmaceutical 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 requirements that manufacturers, importers and retailers
must follow, such as:
• for manufacturers – the licensee’s compliance with rules on the
production of medicinal products; and
• for wholesalers and pharmacies – the licensee’s compliance with
requirements that prohibit the sale of medicines that have lost
effectiveness, medicines with expired shelf-life dates, etc.
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 registered in Russia – in theory, have it purchased by the
hospital in the manner described in question 20 above.
Outpatient care
The reimbursement of EDL medicines depends on the patient’s category and nature of illness. Specifically, some classes of patients (for
example, 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 (for example, nonworking class II disabled, 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?
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 policies are widely used as a form of sales stimulation, subject to restrictions under Russian competition law that
apply to pharma companies with dominant positions in respective
product markets.
Recent administrative practice demonstrates that pricing issue
(combined with the discount policy) may be regarded under circumstances as an instrument restricting competition. Accordingly, the
FAS may issue a warning with the requirement to review the relevant contractual provisions. In the first line, this may be applicable
to contracts between the international manufacturers and Russian
distributors participating in public procurements.
Medicine quality and access to information
26 What rules are in place to counter the counterfeiting and illegal
distribution of medicines?
Violation of the aforementioned 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 infringement of IP right with possible criminal sanctions, in addition to damages which may be awarded to an
aggrieved party through a court action, as well as 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 prescription 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, pharmaceutical and veterinary professionals. As mentioned previously, public advertising of such medicines is prohibited.
The Russian government approves the EDL on an annual basis.
A draft of the EDL is prepared by the MOH. Accordingly, the
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97
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8. Russia Lidings
Update and trends
Recent updates and trends include:
• the introduction of GMP standards on a mandatory basis, starting
from 1 January 2014;
• the introduction of a new public procurement system, starting
from 1 January 2014;
• amendments to the Law on Circulation of Drugs (No. 61-FZ), which
introduce normative definitions for biological drugs and
biosimilars, create specific requirements for the orphan
medicines, differentiate between ‘generics’ and ‘interchangeable
medicines’, introduce more complicated registration procedure
for generics, decrease the statutory time frames for the
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 participants 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
the information about adverse health effects may lead to administrative or criminal liability.
However, there is still no uniform pharmacovigilance policy in
place. Creation of a uniform reporting and evaluation mechanism is
currently on the agenda for further regulatory developments.
•
•
•
•
registration proceedings in the frame of application for marketing
authorisation, etc;
the abstraction from use of medicine’s trade name in physician’s
administration and public procurements;
the adoption of medical aid standards for the treatment of most
common diseases (approximately 1,000 standards within 2013);
the introduction of new limitations for advertising of para
pharmaceutical products (nutrition supplements); and
discussions on the uniform regulation of medicines circulation at
the level of the Customs Union.
Vaccination
29 Outline your jurisdiction’s vaccination regime for humans.
Regulations for the vaccination regime for humans are contained
in the 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, namely the schedule for vaccinations within the upcoming
year. Public health-care establishments are obliged to provide their
patients with vaccines pursuant to this Vaccination Calendar.
Andrey Zelenin
Sergey Patrakeev
azelenin@lidings.com
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
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LIFE SCIENCES 2014
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