Crown Pharmaceutical Regulatory Affairs Post Graduate Certificate 2016 - Professor Peivand Pirouzi

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Pharmaceutical Regulatory Affairs in Russia

Professor: Peivand Pirouzi, Ph.D., MBA

2016Post-Graduate Certificate in Regulatory Affairs and Drug Submission

Crown Medical Research and Pharmaceutical Sciences

College of Canada



Table of Content

• Regulatory overview

• Pricing and state funding

• Manufacturing

• Clinical trials

• Marketing

• Advertising

• Packaging and labelling

• Traditional herbal medicines

• Patents

• Trade marks

• Product liability

• Reform



Russian Federation- Russia, also officially known as the

Russian Federation, is a country in

northern Eurasia.

- It has been reconstituted of Russian

Soviet Federative Socialist Republic of

Soviet Union after the dissolution of the

Soviet Union in 1991.

- It is a federal semi-presidential republic.

At 17,075,400 square kilometers, Russia

is the largest country in the world,

covering more than one-eighth of the

Earth's inhabited land area.

- Russia is also the world's ninth most

populous nation with nearly 144 million

people as of 2015.- Semi-presidentialism is a system of government, in which a

president exists along with a prime minister and the Cabinet,

with the latter two being responsible to the legislature of a state

(A state is an organized community living under one

government)

• Flag and coat of

arms



Ministry of Health of the Russian Federation

• The Ministry of Health of

the Russian Federation is

an agency of the

government of Russia.

• Formed in 2012

• Preceding Agency:

Ministry of Health and

Social Development

• Headquarters, in Moscow

• Website:

www.rosminzdrav.ru

• Coat of Arms

http://www.rosminzdrav.ru/



Duties of Ministry of Health Its main official responsibilities include:

• Developing and implementing state policy in healthcare;

• Developing and implementing federal health programs, including initiatives on

diabetes, tuberculosis, health promotion, health education, disease prevention etc.;

• Developing draft legislation and presenting it to the State Duma[which is the lower

house of the Federal Assembly of Russia (legislature), the upper house being the

Federation Council of Russia]

• Governance of federal medical facilities;

• Medical education and manpower development;

• Epidemiological and environmental health monitoring and health statistics;

• Control of infectious diseases;

• Development of health regulations;

• Development of federal standards and recommendations for quality assurance;

• Development and implementation of federal health programs

• Control and licensing of drugs.



Regulatory overviewLegislation of the Russian Federation

The Regulatory bodies governing the pharmaceutical markets are The Ministry of Healthcare and Social Development (the MOH),

the Ministry of Industry and Trade (the “MIT”) and the Federal Service for Surveillance in Healthcare and Social

Development (the Federal Service)

MOH is responsible for drawing up state policy and regulation in Healthcare and social development.

MOH submits to the government drafts of Federal Constitutional Law, Federal Law , Acts of President and government in the

Healthcare, including on the organization of medical assistance related to pharmaceutical activities, and the quality, efficacy

and safety of medicines.

- Fundamentals of the legislation of the Russian Federation on

Citizen’s Health Protection No. 5487-1, dated 22 July 1993

- Federal Law 86-FZ on Medicines, dated 22 June 1998

- Federal Law 184-FZ on Technical Regulation dated 27 December

- Federal Law 38-FZ on Advertising, dated 13 March 2006

- Federal Law 38-FZ on Licensing of Certain Types of Activities,

dated 8 August 2001



Pricing and state fundingstructure and funding of the national healthcare

system:

• It is state organized and state funded,

• Private healthcare sector is also developing

• Employers pay for their employees to the Federal Fund

of Mandatory Medical insurance (FFOMS),

• Certain employers obtain voluntary medical insurance to

supplement the minimum healthcare guaranteed by the

state.



Pricing and state fundingcircumstances for regulating prices of medicinal

products:

• Resolution 782, on State Control of the Prices of Medicines,

dated 9 Nov. 2001

• EDL is stablished by Government Ordinance 376-r dated 29

March 2007, and price of EDL is controlled by State through

registration of Max. prices and Max. mark-ups

• Government Decree 239 on Measures for Arranging the

State Regulation of Prices (Tarrifs), dated 7 March 1995,

other medicines prices & mark-ups are regulated on a

regional level.

Mark-up: A percentage or amount added to the cost of a commodity (medicine) to provide the seller with a profit and to

cover overheads, costs,etc.



Pricing and state fundingTiming and the procedure and pricing for state

funding or reimbursement:• State bodies purchase necessary medicines and distribute it freely to qualifying

citizens (patients)

• DLO (Provision of Supplemental Medicines) or ONLS (Essential Drug Program)

program: Certain categories of citizens(social security beneficiaries) receive certain

medicines free of charge. Purchase of medicines in ONLS are organized through

auctions at a regional level.

• MOH Order 655, dated 18 Sep 2006 approves the current list of medicines included

in ONLS program.

• Expensive medicines for treatment of certain diseases (formerly part of ONLS

program) is organized at the federal level and these medicines are purchased

through auctions which are conducted by MOH.

• Government Resolution 2053-r dated 31 Dec. 2008 stablishes the current list of

expensive medicines.

• Federal Law 94-FZ, dated 21 July 2005: Purchases of medicines in these programs

and other purchases of medicines for state or municipal needs under other programs

are carried out according to this Federal Law.

• The price of the medicines being purchased is determined at auction.



ManufacturingApplication:

• The manufacturing of medicines is subject to licensing.

• An application must be made to the Federal Services

conditions to obtain authorization :

• Government Resolution 415 dated 6 July 2006 states the regulation on the licensing the manufacturing of

Medicines and stablishes the following requirements:

1) The Licensee must either own premises and equipment or has the right to use qualifying premises and equipment

of other manufacturers

2) The licensee must comply with the rules for organizing manufacturing and quality control

3) The licensee must have legal ground for manufacturing patented and/or original medicines

4) The licensee must comply with prohibitions on selling disqualified medicines and requirements for destroying such

medicines.



Manufacturing5) The licensee should have specialized secondary education staff responsible for manufacturing, quality and labelling

of medicines, with at least 3 years experience.

6) The licensee’s staff must undergo professional training at least every five years.

Restrictions on foreign applicants

To manufacture medicines in Russia: Russian law does not directly prohibit foreign legal entities to apply for the

license of manufacturing the medicines. However, an application to apply for the license requires OGRN and certificate

on state registration which both can only be issued to a Russian legal entity.

To import medicines into Russia: Under Russian customs law, an importer must be either a Russian legal entity or a

registered entrepreneur in Russia with a direct contract with the foreign supplier and/or a Russian licensed customs

broker. Therefore, if a manufacturer intends to directly import medicines into Russia, a Russian subsidiary of a foreign

legal entity applies for a manufacturing and importing license.

OGRN – Major State Registration Number of the entry made in the Register about formation of a Russian company

(consists of 12 digits).A subsidiary established in Russia is a Russian company where a majority of capital or shares

with voting rights are owned by a foreign legal entity. The liability of the shareholders of this type of business is limited

by the contribution to the capital. The two forms of business that can be established in Russia are the private limited

liability companies or the public limited liability companies, open or closed.



ManufacturingKey stages and timing: Law of Licensing: when a complete application is submitted to

the Federal Service, within 45 days, the Federal service must decide whether to issue a

license and/or notify the applicant about the decision. Then the applicant produces a

document confirming payment of the license fee, and within three days the Federal

Service must issue the license.

Fee :The license filing fee is RUB300 (about US$10), and license issuance fee

isRUB1,000(about US$33)

Period of authorization and renewals: The license is issued for 5 year but it can be

extended for another five years, the licensee must file application within ten days to the

Federal Service.

The powers of regulator: The Russian state facilities monitor compliance with the

license terms and conditions by visiting the facilities of the manufacturer, and if it does

not comply it can be subject to administrative fines and ultimately the license can be

annulled through a court decision. In certain cases it might lead to criminal liability for the

management of the company.



Clinical trialsClinical Trials are governed by the Fundamentals, MOH Order 266 dated 19 June 2003 which is about

the Law on Medicines, and the Rules of Clinical Practice in Russia, and also law on circulation of

medicines.

The relevant documents from ICH-GCP :

• Industry Standard OST 42-511-99 - Good Clinical Practice, adopted by the Russian Ministry of

Healthcare on 29 December 1998,

• National Standard of the Russian Federation GOST R 52379-2005 - Good Clinical Practice,

adopted by Order of the Federal Agency on Technical Regulation and Metrology No. 232-st, dated

27 September 2005.

Both documents are derived from the Good Clinical Practice guidelines (GCP) of the International

Conference on Harmonization (ICH), the latter document being a direct translation.

• fundamental law: (Law) the law determining the constitution of the government of a state



Clinical trials

Requirements:

• A permit from the Federal Service to perform clinical trials

• The consent of the Ethical Committee organized by the Federal Service

• Informed consent from all trial subjects before participation in the trial

• After the trial, a report of the trial must be prepared and filed with the

Federal Services

Conditions for each trial that should be met:

• Written agreement with duly accredited trial sites

• Insurance of the health of patients

• Civil liability of persons and entities performing trials



Marketing

Application

• Medicines are subject to obligatory state registration before their introduction into and

circulation in the Russian market.

• An application for state registration of a medicine must be made to the Federal

Service.

Conditions to obtain authorization

• For registration, each medicine must pass expert examination and clinical trials

providing its efficacy, safety and quality.

• The necessary documents must be filed with the application to the Federal Service.

• Marketing of medicine is subject to declaration of conformity and other state controls,

during which compliance of the medicine with the normative documentation approved

during its state registration is checked.



MarketingKey stages and timing

• The procedure for state registration of a medicine should generally

be completed within six months from the submission of a complete

application dossier.

Fee

• The fee for state registration of a medicine is RUB2,000 (about

US$67)(Tax Code).

• The expert examinations and clinical trials necessary for the process

of registration of a medicine are a separate, and much higher,

expense.



Marketing

• The registration of a medicine generally lasts for an

indefinite term.

• Foreign marketing authorizations is not recognized in

Russian jurisdiction.



Marketing- Abridged procedureWhich products can benefit from the abridged

procedure?

• Differences only in the composition of excipients and

manufacturing technology

• No effect on efficacy, quality and safety of the medicine

Duration of expedited registration procedure ?

• Within 3 months from submission of a complete application

dossier

• References to open literature and a bioequivalence study

report



Marketing

What powers does the regulator have to monitor

compliance with marketing authorization or impose

penalties for a breach of a marketing authorization?

• Release of a medicine in consumer packaging into the

Russian market is preceded by a declaration of its

conformity by checking the compliance of the medicine with

the normative documentation approved during its state

registration.



MarketingAdditional forms of state control :

• Preliminary state control 3 sample industrial batches of

medicines imported into or manufactured in Russia for the first

time , before any commercial circulation of the product

• Selective state control according to schedules drawn up by

the Federal Service relating to the safety of medicines on

the market

• Recurrent selective state control doubt in the quality of

medicines on application to the Federal Service



MarketingNon-compliance of medicines with their normative

documentation approved :

• During state registration the declaration of conformity is not

registered and medicine can not be released to market

• After being released to market recalling the relevant

batches from the market

• Medicine of poor quality treated as a violation of the

manufacturer’s license



Marketing

parallel imports of medicinal products into Russian jurisdiction :

• No restriction , however , importation of goods bearing trade marks

into Russia without authorization from rights holder is generally

prohibited under Russian trade mark law.

Restrictions on marketing practices such as gifts or "incentive

schemes" for healthcare establishments or individual medical

practitioners:

• Any gifts made for marketing purposes are subject to general rules

of Russian law.

• Civil Code prohibits gifts between commercial legal entities.

• Undue gifts may cause administrative and criminal liability for

bribery or commercial bribery.



MarketingRestrictions on marketing medicinal products on the

internet, by e-mail and by mail order :

• These activities are regulated and restricted if they qualify as

advertising.

• Internet advertising subject to general rules on advertising

• Email advertising prior consent of the addressee required

additionally

• Mail advertising specific rules were abolished in Russia at

the end of 2008. Only subject to the general rules on

advertising



Advertising of MedicinesWhich legislation applies and which regulatory

authority enforces it?

• Governed by the law on advertising. The Federal

Antimonopoly Service is the regulatory authority.

What types of medicinal product can be advertised?

• Only registered medicines

• Prescription medicines and medicines that contain narcotic or

psychotropic substances approved for medical use only when

advertised in specialized printed publications intended for

medical and pharmaceutical professionals



Advertising What restrictions apply to advertising that is allowed?

• Advertising must be fair and true

• advertisement of medicines must be accompanied by a

warning about contraindications against their use and

application

• the necessity to read the instructions on their use or the

necessity to consult a specialist

The Law on Advertising contains an important

general prohibition against using images of medical

and pharmaceutical professionals in any adverts.



Packaging and labelling of

Medicines

Which legislation applies and which regulatory

authority enforces it?

• Governed by the Law on Medicines. The Federal Service

enforces the relevant regulations.

• The main requirements for labelling medicines are set out in

Article 16 of the Law on Medicines.

• All the information must be stated in Russian



Packaging and labelling

What information must the packaging and/or labelling

contain?

• Trade and international non-proprietary names of the medicine.

• Name of the manufacturer of the medicine.

• Batch number and manufacturing date.

• Method of administration.

• Dosage and quantity of doses in a package.

• Shelf life.

• Conditions of sale.

• Conditions of storage.

• Precautionary measures in administration of the medicine.



Traditional herbal medicines

The regulation of the manufacture and marketing of

traditional herbal medicinal products in Russian

jurisdiction is the same as the regulation for other

medicines.



Patents• An invention is a technical solution in any field that relates to a

product (including a device, substance, strain of microorganisms,

plant or animal cell culture) or a method (the process of carrying out

actions relating to a material object by material means).

• To obtain patent protection an invention must be novel, inventive

(non-obvious) and industrially applicable

Which legislation applies to obtain patent protection

for an invention in Russia?

• The national patent system (by applying to the Federal Service for

Intellectual Property, Patents and Trade marks) (Rospatent)

(Russian Patent Office).

• The regional Eurasian patent system (by applying to the Eurasian

Patent Office).



Patents

• Eurasian regional patent system is similar to the European patent

system.

• Under the Eurasian patent system, one application and one patent

covers nine jurisdictions in the CIS region (the contracting states).



PatentsWhat types of medicinal products and related substances and

processes can be protected by patents?

• Methods/processes for treatment, diagnosis and prevention of

diseases

What types cannot be patent protected?

• Human cloning techniques

• Techniques for modifying the genetic integrity of human embryo

cells.

• Use of human embryos for industrial and commercial purposes.

• Other solutions inconsistent with the public interest and humane and

moral principles.



PatentsTo which authority must the application be made?

• Applications for Russian patents must be filed with the

Russian Patent Office. Applications for Eurasian patents are

filed with the Eurasian Patent Office. Both offices are in

Moscow.



PatentsFees

• Russian Patent Office fees are:

• RUB5,400 (about US$190) for filing an application, plus RUB810 (about US$28) for

each claim exceeding 25 claims.

• RUB8,100 (about US$285) for filing a request for substantive examination of one

independent claim. This fee is reduced by 20% for applications with international

reports.

• RUB10,800 (about US$380) for issue and registration.

• Eurasian Patent Office fees are:• RUB25,500 (about US$900) for filing an application, plus RUB2,200 (about US$77)

for each claim exceeding five claims. These fees are reduced by 25% for applications

with international reports.

• RUB25,500 (about US$900) for filing a request for substantive examination of one

independent claim, and RUB44,500 (about US$1,560) for two or more independent

claims.



PatentsWhat are the key stages and timing?

Russian Patent Office procedure granted in 1.5-3 years from

filing an application, if there are no complications. Two main

stages: formal examination and substantive examination.

Eurasian Patent Office procedures can be granted in 1 year

from the filing date if there are no complications, or up to 2 years

if any issue arises during the application's examination.

Foreign applications may be extended to Russia under the

Patent Cooperation Treaty. This takes 31 months.



PatentsHow long does patent protection last?

• Both Russian and Eurasian patents last for a term of 20 years

from the application filing date, subject to due payment of

annual fees.

If a patent covers an invention related to pharmaceuticals,

pesticides or agrochemicals requiring specific authorization, in

certain circumstances the patent term can be extended for up

to five years.

How is a patent renewed or patent protection

extended?• To keep a patent valid, it is necessary to pay annual

maintenance fees.



Patents

In what circumstances can a patent be revoked?

• Failure to meet patentability requirements.

• Granted claims contain features that were absent in the

application as filed.

The invalidation action must be filed with the

Chamber for Patent Disputes of the Russian Patent

Office.



PatentsWhen is a patent infringed?

• The scope of the legal protection conferred by a patent is determined

by the granted claims.

• A patented invention is deemed to be used in a product/method if the

product/method contains each feature of the invention covered by an

independent claim of the invention, or a feature equivalent to it and

having become known in this art before performance of actions that

are a use of the patented product/method.

• Any person or legal entity using a patented invention without the

consent of the patent owner is considered to be a patent infringer.

• A product obtained directly by a patented method/process also

infringes the exclusive rights of the patent owner.



Patents• By law, Russian courts must treat Russian patents and the

Russian part of Eurasian patents in the same manner.

• A patent owner has an exclusive right to use and allow the

use of the patented invention.

• Third parties are prohibited from using the invention without

the patent owner's permission, except for specific cases such

as for experimental and non-commercial purposes that, by

law, do not infringe the patent owner's exclusive right.



Patentswhat remedies are available for patent infringement?

The exclusive rights in a patented invention can be protected,

among others, in civil proceedings by means of:

• Recognition of the right.

• Cessation of the infringing actions or actions that create a

threat of infringement.

• Compensation for damage.

• Publication of a court decision on the committed infringement.

Apart from civil liability, a patent infringement can involve

administrative and criminal liability.



Trade marks

• A trade mark is a designation that individualizes the goods or services of legal entities

or individual entrepreneurs.

• A name/brand of a medicinal product can be registered as a trade mark, provided

that it complies with the trade mark registerability criteria.

• The scope of granted protection is limited to the registered designation only and does

not extend to the generic name

a trade mark must:

• Possess sufficient distinctive character.

• Not be contrary to the public interest or accepted principles of morality.

• Not be misleading with respect to the origin of the relevant goods and services.

• Not be similar to earlier trade marks, company names, commercial designations and

so on.



Trade marksThe authority

• Russian trade mark applications must be filed with the Russian

Patent Office

Fee

The Russian Patent Office fees are:

• RUB10,500 (about US$361) for filing an application for a trade mark

in one class, plus RUB1,500 (about US$51) for each additional

class.

• RUB12,000 (about US$412) for registration of a trade mark.



Trade marksProcess and timing:

• After a trade mark application is filed it undergoes formal examination , If

there are no complications , It usually takes about 14 to 16 months from the

filing date to obtain a trade mark registration certificate.

• Russian trade marks are registered for an initial ten-year period.

Registrations can be renewed for an unlimited number of subsequent ten-

year terms, subject to payment of a renewal fee.

• A trade mark can be revoked if it is not continuously used for any 3 year

period after its registration

• A registered trade mark is deemed infringed if an unauthorized person uses

an identical or confusingly similar mark for identical or similar goods or

services, and such use may result in a possibility of confusion.



Patents and Trademarks

Russia is party to, among others, the following international

conventions on patent and trade mark protection:

• Paris Convention for the Protection of Industrial Property 1883 (Paris

Convention).

• Patent Cooperation Treaty 1970.

• Trademark Law Treaty 1994.

• Madrid Agreement Concerning the International Registration of Marks 1891

(Madrid Agreement).

• Protocol Relating to the Madrid Agreement 1989.

• Nice Agreement Concerning the International Classification of Goods and

Services for the Purposes of the Registration of Marks 1957.

• Nairobi Treaty on the Protection of the Olympic Symbol 1981.

• Singapore Treaty on the Law of Trademarks 2006 (entry into force for

Russia on 18 December 2009).



Product liabilityLegal provisions

Civil liability in Russia for damage to health or death of patients caused by

medicines is established by:

• The Civil Code.

• The Fundamentals.

• Federal Law 2300-1 On Consumer Rights Protection dated 7 February

1992, as amended (Consumer Protection Law).

• The Law on Medicines.

Substantive test

Under the Civil Code, the substantive test for product liability in the context of

medicines consists of three elements:

• Damage to health or death of a patient.

• Defective medicine.

• Causal link between the defect and the damage caused.



Liability

• Compensation for injury is only recoverable if the injury occurred

before the expiration date of the medicine (Article 1097, Civil Code).

However ,liability may still arise even after the expiration date.

• Article 208 of the Civil Code further provides that claims for

compensation for damage to health or for death caused to a person

are not limited by time.

• Article 1098 of the Civil Code shifts the burden of proof to the

manufacturer, which is released from liability if it proves that the

injury was caused by a force majeure circumstance, or a violation by

the consumer of the rules for storage and use of the medicine.



Liability• Courts can order the party responsible for injury to compensate the

injured party by providing appropriate goods (compensate in kind) or

pay for losses (Article 1082, Civil Code). Damage to health or death

can only be compensated through financial compensation

• losses include real damages and lost profits

• Russian law does not use the concept of class actions as applied to

product liability claims. A concept similar to class actions was

recently introduced into the Code of Arbitrazh Procedure, which

governs procedures in State Arbitrazh (Commercial) Courts.

However, product liability disputes with consumers fall under the

jurisdiction of the Courts of General Jurisdiction



Reform

• Russian regulation of the pharmaceuticals market is about to

undergo important changes.

• The principal change will be the new Federal Law on Circulation of

Medicines, which purports to replace the Law on Medicines.

• Russian pharmaceuticals market has developed significantly over

the last ten years. Therefore, serious revisions are necessary.



THE REGULATORY AUTHORITIESMINISTERY OF HEALTHCARE OF SOCIAL DELELOPMENT (MOH ):

• The MOH is responsible for drawing up state policy and regulation in

healthcare and social development. The MOH submits to the Government

drafts of federal laws, acts of the President and the Government in

healthcare, including on the organization of medical assistance related to

pharmaceutical activity, and the quality, efficacy and safety of medicines.FEDERAL SERVICE FOR SURVEILLANCE IN HEALTHCARE AND SOCIAL

DEVELOPMENT:

• The Federal Service, among other things:

• Grants licenses for manufacturing medicines and pharmaceutical activities

(retail sale, wholesale of medicines and preparation of medicines).

• Keeps a register of licenses granted.

• Exercises state control in the sphere of circulation of medicines.

• Registers medicines and conducts accreditation.



Reference• www.rosminzdrav.ru

http://www.rosminzdrav.ru/

Crown Pharmaceutical Regulatory Affairs Post Graduate Certificate 2016 - Professor Peivand Pirouzi

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