CODE OF MARKETING PRACTICES   OF ASSOCIATION OF INTERNATIONAL PHARMACEUTICALS MANUFACTURERS  IN THE REPUBLIC OF KAZAKHSTAN

INTRODUCTION

• Code of marketing practices (hereafter referred to as “Code”) of Association of International Pharmaceuticals Manufacturers (further - AIPM) in the Republic of Kazakhstan is elaborated on the basis of international codes of marketing practices adopted by the scientific and research pharmaceutical industry and reflects ethical standards to be observed by all AIPM members at marketing their pharmaceutical products in the Republic of Kazakhstan.

• Provisions of the Code are to help pharmaceutical companies develop and apply norms of honest and responsible marketing practices taking into account interests of public health care in the Republic of Kazakhstan and also serve as a tool to resolve ethical issues among AIPM members should any dispute arise.

• The Code is a number of supplementary guidelines to be observed by AIPM members at marketing their medical means in the Republic of Kazakhstan, as the National legislation of the Republic of Kazakhstan shall always prevail in this domain.

• The Code stipulates AIPM members shall bear responsibility for and control compliance with high standards when promoting medicinal products in the Republic of Kazakhstan. All AIPM members shall take correct and honest decisions taking into consideration the patient’s interests first of all. Promoting medicinal products with failing to comply with the Code is prohibited.

• All AIPM members agree not to distribute any materials contradicting to provisions and requirements of this Code, as well as avoid taking any actions in the area of marketing medicinal products that are not covered herein.

• Respect for an individual, patient-orientation, transparency and observance of ethical norms are those values which shall form basis of everything • hatever AIPM members undertake.

• The Code consists of two main sections pertaining to marketing of medical means available on prescription and marketing medicinal products available without prescription.

I. BASIC TERMS USED IN THIS Code AND THEIR DEFINITIONS

• Distributor(wholesale company) – an entity with a licence granting wholesale realization of medicinal products, medical equipment and medical purpose items for their distribution according to the legislation of the Republic of Kazakhstan.

• Medicinal products – productsbeing or containing pharmacologically active substances designed for the purposes of prophylaxis, diagnostics and treatment, as well as changing the human organism’s condition and functions: medication, medicinal substance, crude drug of natural origin, medical bulk products, drug products and medical immunobiological drugs.

For the purposes of this Code medicinal products parapharmaceuticals, medical equipment and articles of medical purposes (contact lenses and vision correction lenses, items and materials, products, instruments, devices, gages and instrumentation) used for diagnostics, preventive and treatment purposes are viewed as equal to medicinal products;

• Marketing activity means any activity initiated, any material prepared by a representative of AIPM member or a third party acting on behalf of AIPM member (including health care specialists, distributors, sales personnel engaged under contract, partners by joint promotion of medicinal products and so on) for advertising purposes or stimulating prescription, supply, sales or distribution of medicinal products including immunobiological drugs.

• Public health specialist is a member of a medical, dental, pharmaceutical or nursing staff as well as pharmacists or any other person, who is authorized to prescribe, advise taking medicinal products or make decision on their procurement, supply and administration in the course of performing his/her professional duties.

• Medical representative - an employee of a company who has a completed medical, pharmaceutical education verified by the diploma, or a specially trained employee of the company which such qualification level so that to be able to competently explain the mechanism of action of medicinal products, their therapeutic effect and influence on pathogenic mechanisms of a disease. Medical representative’s duties include maintaining contacts with Public health specialists or other relevant officials with respect to promoting and marketing medicinal products. Activity of Medical representative is also regulated by Appendix No. 1 to this Code.

• Congress - a regular annual event intended for arranging an exchange of scientific and/or medical information, training of public health specialists in latest aspects of diagnostics, treatment of diseases including providing information concerning the company’s medicinal products.

• Symposium, conference, workshop – activities intended for arranging an exchange of scientific and/or medical information, training of public health specialists in modern aspects of diagnostics, treatment of diseases and providing information regarding the company’s medicinal products.

• Companies – are currently acting AIPM members.

• Ethic committee – Ethic committee at AIPM is full time collegiate authority governed by the legislation of the Republic of Kazakhstan, the Association‘s Charter, and resolutions of the General Meeting of AIPM members.

• Pharmaceutical warehouse – a business entity granted with a licence for storing medicinal products, medical equipment and articles of medical purposes qualified to requirements for the given type of rooms, sanitary, fire and other norms and requirements which in its turn shall be verified by issued opinion letters of sanitary, fire and pharmaceutical inspections. Pharmaceutical warehouse apart from storage may also be used for procuring and realizing medicinal products and drugs.

II. PHARMACEUTICAL MARKET PARTICIPANTS

2.1. Role, training and obligations of medical representatives

• Medical representatives shall be adequately trained to be able to ensure provisioning the information of medicinal products manufactured by their company, in accurate, responsible and ethical manner.

• Basic obligations of the medical representative shall include:

1. Information interaction with public health specialists with respect to all medical aspects pertaining to application of medicinal products through individual visits and participation in public health specialists’ collective events.

2. Establishing professional relationships with public health specialists in accordance with ethical guidelines set out herein. Compliance with professional ethics with respect to patients, public health specialists, and the company represented by him/her, as well as representatives of competing companies, institutions and organizations.

• The following activities are beyond competence of a medical representative:

1. оrganizing and performing pharmacological and economic review;

2. issues of human resources;

3. carrying out clinical trials.

Note: upon instruction of the company’s management the medical representative may transfer documents in the course of the above mentioned activity types.

• The main objectives of pharmaceutical company’s medical representative in the Republic of Kazakhstan are as follows:

1. Collecting information and timely date communication regarding concurrent reactions associated with administration of medicinal products manufactured by the pharmaceutical company (indicated and non-indicated in Basic Prescribing Information); collecting and revealing data by falsified medicinal products, data on drug intentional damaging and theft cases; complaints for the product quality submitted to responsible persons of the company,

2. Providing public health specialists with authentic information of medicinal products and technologies developed by the company represented by him;

3. Training public health specialists how to apply promoted medicinal products, upon instruction of the company’s management through paying individual visits and arranging collective events for public health specialists;

• Professional ethics of the medical representative

• With respect to patients

If a medical representative is disclosed a professional secret, he shall not disclose whatever he has seen or heard in rooms of a medical institution during his/her visit of a public health specialist. He shall show his respect to the public health specialist and his patients.

• With respect to the public health specialist

The medical representative shall avoid using any material incentives in order to obtain the right to visit nor shall he offer any consideration or indemnities for this purpose.

The medical representative shall observe the regime and visiting hours specified by the public health specialist, request information of the visit duration desirable for the public health specialist, and shall not create a nuisance preventing normal operation of a medical institution.

• Data collection

Purpose of data collection:

1. Better understanding of the public health specialists’ professional expectations with respect to information on the medicinal product promoted;

2. Comparing the medicinal product’s properties with those of medicinal products of the relevant therapeutic group;

3. Providing the public health specialist with individualized information within the scope of officially approvedtherapeutic indications;

4. Rationalizing the work of the medical representative.

• With respecttorivals

The information provided by the medical representative of the medicinal products, activity or representatives of competing companies shall not contain any offensive remarks. Used statements shall be always thoughtful and scientifically based, extreme and emotional expressions shall be avoided. Comparative data shall be based only on published scientific data meeting requirements ofevidence based medicine (randomized multi-central researches, publications inpeer-reviewed journals and likewise). When using results of clinical trials performed on original preparation it’s required to mention that this trial pertains to the original preparation.

• With respect to his own company

The medical representative shall promptly (not later than 24 hours since the moment of receiving information on falsified preparations, data on intentional damaging and theft cases; complaints regarding the product quality) provide his company with all information obtained from primary sources (doctors, pharmacists, authorities fulfilling state regulation in the public health care area and others) which may be potentially related to concurrent reactions in connection with the promoted medicinal product.

Observance of confidentiality principles.

• Supervising medical representatives’ activities and contacts

The company shall through its representative office ensure supervision of:

- activity of medical representatives with respect to the quality of information provided during their visits and presentations, and ethicality of their conduct;

- professional level of the medical representatives by means of arrangement of individual training or consulting (courses, training etc.);

- visits to public health specialists (data shall be collected and recorded by the responsible employee of the company’s representative office).

• Responsibility of the company

General Manager shall guarantee that the company operates in compliance with requirements of this Code and also assume responsibility for proven facts of provisioning untimely, incorrect data or disinformation, or any facts of concealing thereof by any medical or other representative of the company.

• Each company shall set this Code and Appendix No. 1 equal to Internal regulation document and arrange familiarization briefing regarding provisions of the given Code and Appendix No. 1 for all employees involved in promoting medicinal products of the company.

2.2. Role, composition and obligations of Ethic committee

2.2.1. Purpose of creating Ethic committee.

Ethic committee is created with the view of ensuring coordination and providing control over activity of AIPM members aimed at compliance with ethical principles of marketing practices adopted in the scientific and research pharmaceutical industry.

 2.2.2. Competence scope of Ethic committee.

• Competence of AIPM Ethic committee (further – “Ethic committee”) shall include the following:

- considering applications and solving issues related to improper compliance with ethical standards and provisions of the given Code;

- electing the Chairman of Ethic committee (from among members of Ethic committee elected by General meeting of AIPM members) and termination of his powers.

2.3. Composition of Ethic committee.

• Ethic committee is created in the number five persons at least.

• Members of Ethic committee shall be elected by the General Meeting of AIPM members delegated with terms of office until the next annual General Meeting of Partnership members by a simple majority vote.

• Persons elected to Ethic committee may be reelected an unrestricted number of times.

• Ethic committee may not include the President or members of AIPM Executive Board.

2.4. Rights and obligations of members of Ethic committee.

• Members of Ethic committee are entitled to look through materials submitted by a claiming company related to collection of data regarding unethical promotion of medicinal products, articles for medical purposes and medical equipment which have caused the complaint, and also request from the claiming company materials confirming the company’s unethical conduct.

• Members of Ethic committee shall ensure confidence of information received and nondisclosure of any information become known to them in the course of fulfilling functions of Ethic committee.

• When exercising their rights and fulfilling their obligations, members of Ethic committee shall act for the benefit of following ethical standards of the Code, exercise their rights and fulfill their obligations with respect to AIPM members acting honestly and reasonably.

2.5. Chairman of Ethics Committee.

• Chairman of Ethics committee shall be elected by Ethics Committee members from among them by a majority of vote of the total number of the Ethics Committee members.

• Chairman of the Ethics committee shall only be a representative of an AIPM member.

• Chairman of the Ethics Committee shall organize its work, convene meetings of the Ethics Committee and chair thereon, organize record-keeping at meetings.

• Ethics Committee shall elect deputies Chairman of Ethic committee to execute functions in his absence and upon his instruction.

2.6. Meetings of Ethic committee.

• Meetings of the Ethics Committee shall be held when necessary.

• Meeting of the Ethics Committee shall be convoked by Chairman of Ethic committee at his sole discretion, or by the initiative of a member of Ethic committee or in case of receiving a claim filed by AIPM members.

2.7. Ethic committee’s office procedure.

• The office and decision-taking procedures of Ethic committee shall be established by Ethic committee itself.

• Members of Ethic committee shall take part in its operations on a non-repayable basis.

2.8. Approval and modifications of this Code.

• This Code, as well as any amendments and changes hereto shall be subject to approval by resolution of General Meeting of AIPM members.

• Any changes and amendments to this Code may be introduced by the initiative of Chairman of Ethic committee, a member of Ethic committee, the AIPM President, or an AIPM member.

III. MEDICINAL PRODUCTS DISPENSED ON A DOCTOR'S PRESCRIPTION

3.1. Promotion standards

• Information materials of medicinal products shall be accurate, clear and objective; they are to be presented in a form meeting legal and ethical standards. Information shall be based on recent assessments of all corresponding factual data and shall clearly reflect such factual data. Apart from this whenever new data on medicinal products are available which bring considerable changes to information on safety and / or effectiveness of medicinal products all informational materials regarding such medicinal products shall be reviewed and revised as required or withdrawn from circulation.

Statements about curative effect shall not exceed data containing indrug dosing administration instructions.

Additional information on a medicinal product not included in the text of approved dosing administration instructions shall be issued only upon the doctor’s individual request. Response to such request shall be provided by a competent person of the company and based on authentic information sources (name of scientific article, publication, edition name, number and year of publication, and page); response shall be transferred to the person requesting information or sent via mail service in sealed envelopes.

Any exaggerations, comprehensive statements or uncertainties at presenting any information should be avoided.

3.2. Scientific evidences and facts

• Informational materials shall be based on the latest assessment corresponding to the scientific data and shall not create an incorrect or misleading impression.

In all cases when particular statements regarding a medicinal product are made in advertising materials clear references to supporting information shall be given.

Drug administration instructions presented in the informational material shall correspond to information for medical specialists approved by the Health Care Ministry of the Republic of Kazakhstan.

Scientific data forming basis of informational materials and recommendations related to application of the medicinal product shall be available and provided upon request of public health care organizations.

• Compliance with requirements for product information on labels, packaging, package inserts, newsletters and advertisements, as described by the laws of the Republic of Kazakhstan and documents of the Ministry of Health, which have legal force in the Republic of Kazakhstan.

• Information contained in indications for use, contraindications, warnings, precautions, side effects and dosage must correspond to the approved instructions for medical use.

3.3. Safety information

• Information concerning safety of pharmaceutical products (contraindications, precautionary measures, concurrent reactions etc.) shall be consistently and properly presented and meet international medical practice requirements. The word “harmless”, “safety”, “nonhazardous” or “safer” shall not be used without detailed explanation of the term.These can only be used if supported by published clinical data.

• Substantiated information of serious adverse reactions associated with administration of medical preparations shall be passed to the concerned public health bodies as soon as practicable.

3.4. Camouflaged and misleading advertising

• Advertising of products shall be in accordance with the laws of RK.

• Advertising and information products (mailing, advertisements published in medical magazines, other periodicals and media) shall not conceal or obscure true information.Thus, an intentional hidden use of promotional information materials is not allowed.

Note: an example of the camouflaged advertising may be the information, advertisements published in magazines and other periodicals, which are a part of editorial texts provided and paid for by a company.This statement does not apply to scientific articles and reprints thereof, or to publications of press releases, information on conferences and workshops, and informational articles paid by the Company on the condition that they do not contain advertising claims about medicines.

• Clinical post-marketing studies (including surveillance studies) and surveillance studies should be conducted in accordance with the laws of the Republic of Kazakhstan with the scientific or educational purpose. This statement applies both to the studies initiated by companies and to research sponsored by companies at the initiative of a researcher. Information about ongoing studies should be provided by the Association members on a periodic basis and updated at least 1 time every half a year. List of studies shall be posted at the web-site of the Association, specifying the type of the study, its objectives, the test product and the reference to permission of the MoH of RK.

3.5. Pre-registration information

• A medicinal preparation may not be promoted until the registration certificate is obtained from the Ministry of Health of the Republic of Kazakhstan.

3.6. Public Information

• When representative offices of pharmaceutical companies render assistance to public health bodies and public organizations with the programs aimed to inform population (patients) of certain diseases, their symptoms/syndromes, possible consequences and modern treatment modes, such type of activity shall comply with reliable data.

3.7. Procedural regulations of companies

• Prior to its distribution, the advertising and information products shall be duly approved by the company’s administration or, in certain circumstances, approved by the responsible person having the corresponding scientific or medical qualification.

• When distributing the advertising and information products, companies are to comply with provisions hereof, take into consideration requirements of the international codes regulating this aspect of marketing practices, and meet requirements of the national legislation of the Republic of Kazakhstan regulating advertising activity and content of advertising materials.

• Companies shall conduct regular control for and monitoring of authenticity of the advertising and information products distributed by them within the Republic of Kazakhstan.

3.8. Symposiums, congresses and other oral communication means

3.8.1. Goals

The main goal and purpose of the organization of all symposia, congresses and other promotional, scientific or professional events for healthcare professionals organized or sponsored by AMIP member companies shall be to provide scientific or educational information and/or to inform health care professionals about medicines.

3.8.2. Sponsorship

• If a pharmaceutical company or the Association shall be sponsors of a symposium, congress or a similar event related to public health or an educational program, the following conditions must be met:

- the company or the Association’s sponsorship shall be clearly defined in advance;

- final materials of the event (printed, audio and visual materials, etc.) shall exactly reflect fulfillment of the goals set forth, content of speeches and discussions;

- no invitation to participate in professional events cannot be used to encourage health professionals to order, supply, prescribe, recommend or sell drugs;

- accommodation and food for speakers/rapporteurs shall be deemed a common practice;

- reimbursement of costs associated with participation of health professionals in an educational event for educational purposes at company’s expense (registration fee, travel expenses, visa support, health insurance, accommodation and food) shall be permitted;

- provision of health professionals with financial compensation for the time spent to participate in the event shall be unacceptable;

3.8.3. Location of Professional Event

Events should be conducted in a place appropriate for the primary purpose of the event. Companies are prohibited from organizing events in places that are considered to be (or advertised) entertaining, tourist destinations, or are known for their extravagance, as a rule. Activities should not be conducted, for example, in places such as a ski resorts, spas, isolated leisure areas, other popular tourist resorts, as well as places with similar characteristics.

Accommodation in 5-star hotel is only allowed in the absence of other hotels of a lower class. Decision about the economy or business class flight shall be regulated by internal policy of a company. The company must document a justification.

3.8.4. Restrictions

• Health care professionals should not be given undue financial or material rewards. This restriction applies to the payment of fees for speaking, preparation of training materials, the amount of which must correspond to the fair market value.

• Provision of drinks and/or food (coffee break, lunch, dinner, etc.) in connection with professional event must be secondary to the main purpose of the event and shall be:

- provided for the participants of the event only;

- reasonable and justified for local conditions.

• Only background music and/or local performances by a local performer shall be allowed, secondary to the provision of food, the food initially available at the event location, provided that the company does not pay for them separately.

• Companies cannot organize and pay for cultural and recreational activities, tours, even if they are secondary to educational event.

3.9. Quality of the information provided

• A Company shall develop materials to promote a medicine, which are made available to a medical representative. These materials shall include the requisite literature references: source, date of placement in the source, original source of the information; data on the medicine’s advantages; procedure for administration of the medicine (especially about side effects), precautions and contraindications.The materials must have a clearly marked date of publication or expiration date on them, and they should be revised routinely in accordance with the company's internal policy, but at least one time in 2 years and either be revisd/re-approved, or withdrawn from circulation.

• Promotion of medicines by medical representatives must be within the indications for use, registered in the instructions for medical use of the drug, approved by the MoH of RK. Promotion of medicines by medical representatives under off-label use.

• Responses to individual requests of professionals regarding drug information outside officially sanctioned medical instructions, including off-label use, can only be given by specially trained personnel with medical training, not directly related to sales of medicines. The response is sent to the person requesting the information or is passed to a MR in sealed envelopes. Responses should be based on the available evidence-based scientific information, and data from clinical studies.

3.10. Requirements for the information

The information on medical preparations promoted by the company shall meet the following criteria:

- shall not be false or be misleading by its nature and shall not lead to medication administration error;

- impartially compare one of several materials, continuously checked and established based on a wide selection of properties of medical preparations, one of which shall be, among others, evidenced pharmacoeconomical profitability.

Comparative presentation of medical preparations may not:

- unduly gain profit from a well-known trade mark, trade name or other distinguishing features of a competitor;

- use discrediting or diminution of any trade marks, commercial names, other distinguishing features or standing of a competitor;

- make comparison between trade marks, trade names or other distinguishing features of an advertising spender and a competitor;

- represent medicinal preparations by means of reproduction or repetition of a medicine owned by another company and thus gain profits from a patented trade mark or trade name.

3.11. Gifts

Gift - any item that is given to health professionals at no charge. Nominal value of items for one health care professional offered nonrecurrently must not exceed the amount of 2 MCIs established by the legislation of the Republic of Kazakhstan for the relevant year.

3.11.1 Prohibition on gifts in the form of cash and gifts for personal use

It is not allowed to offer or provide gifts to healthcare professionals in the form of cash or cash equivalent (gift certificates/vouchers/payments), and to pay personal costs of health care professionals. It is also prohibited to offer gifts for personal use (such as tickets to sports or entertainment events, electronic devices, etc.).

3.11.2 Promotional tools

It is allowed to provide low cost promotional resourcese in small quantities in the form of industrial products related to the practice of health professionals, with an imprint of a trade, and (or) international non-proprietary name of a medicine (pens, notepads, mouse pads, mugs, calendars, notebooks , cubuses, etc.).

Industrial products, intended for personal use by health care professionals (music CDs, paintings, food baskets, etc.) cannot be used as promotional tools. Educational materials do not belong to this category of gifts.

3.11.3 Medical Items

It will be allowed to supply medical (functional) items related to current practices of a health professional and used in the provision of health services and patient care for a patient.

3.11.4 Gifts of “respect” as a part of cultural tradition

Gifts of “respect” can be transferred free of charge on special occasions as a part of the Kazakh cultural traditions and generally applicable practices in the Republic of Kazakhstan.

Gifts of “respect” may be given or offered to healthcare professionals, provided that the gift is not related to medical practice and does not bear a company’s logo. Nominal value of such gifts per one health care provider given once only shall not exceed the amount of 2 MCIs established by the legislation of the Republic of Kazakhstan for the relevant year.

The form of a gift should not give reason to believe that it is used as an encouragement to prescribe medicines. Giving gifts should not be seen as a ‘quid pro quo’.

3.12. Educational materials

• Reference and information materials, as well as other educational materials (medical publications) may be supplied to public health professionals and organizations for free, provided that they really pursue educational goals or based on their request.

3.13. Printed matter

• Printed matter shall be presented in a definite and legible form. Scientific substantiation and information about a medical preparation shall meet requirements of this Code.

3.13.1 Advertisements

• All printed advertisements shall include:

- Trade name (usually trade mark);

- The list of active ingredients using approved names (if any);

- Name and address of the company or its representative office responsible for the product promotion.

3.13.2. Full-size advertisements

• Full-size advertisements are the advertisements, which include proposed clinical use of the medical preparation. In addition to requirements of Clause 3.14.1, full-size advertisements shall also include information on medical preparation application, including:

• Registered indication or indications together with dosage and mode of administration;

• Brief information on contraindications, warnings and concurrent reactions.

3.13.3. Reminder advertising

• In the absence of regulatory instructions of the Republic Kazakhstan, an abbreviated or "reminder" advertising is defined as a brief announcement that contains a simple statement that determines therapeutic category of products.

• As for reminder advertising, requirements of paragraph 3.14.2 shall apply and a reference to the fact that additional information is provided in the instructions for use of the medicine.

3.13.4. References

• When the reference and information material is based on published scientific researches as the source, the printed matter shall include a clear reference to this fact.

Quotations from medical literature or personal speeches shall not modify or distort the meaning implied by the author or clinical researcher of the work or studies.

3.13.5 Frequency and volume of mailing

• Frequency and volume of mailing of printed matters to public health specialists shall be reasonable.

• Doctors’ requests to exclude their names from promotion mailing lists shall be respected and unconditionally satisfied.

3.14. Electronic materials, including audiovisual facilities.

All the requirements for printed materials also apply to audiovisual and electronic materials for the promotion of a medicine (eg,, Web sites, interactive discs, videos, text messages, as well as e-mails).

Applied to websites for medicines:

- information identifying the company must be clearly visible;

- target audience must be clearly identified, and the information must be relevant for the intended audience;

- links to external web sites are allowed only with the permission of their owners;

Every company must regularly monitor their web sites for the presence of notifiable side effects.

IV. NONPRESCRIPTION DRUGS (self-treatment means)

4.1. Basic principles

• Section IV of this Code includes any kind of promotion of medical preparations in the Republic of Kazakhstan, intended for use by population and available for public sale without prescription.

• Promotion of nonprescription drugs includes all kinds and forms of promotions carried out by a pharmaceutical company with the view of ensuring procurement, sale, and consumption. This stipulates the following:

- advertising of medical preparations aimed at the general public;

- advertising of medical preparations aimed at specialists administering treatment or supplying such products;

- visits by medical representatives to public health specialists;

- sponsorship of publicity events attended by public health specialists;

- sponsorship of scientific congresses, workshops etc. attended by public health specialists (including payment for transportation and accommodation costs).

4.2. Advertising in the Mass Media

4.2.1 Requirements for medical preparations

• In accordance with the laws of the Republic of Kazakhstan, only those medical preparations may have the corresponding status and may be promoted for the general public through all mass media, which by their composition are intended for application without a doctor’s intervention (for the purpose of diagnostics, medication ordering, or overseeing treatment).

4.2.2 Restricted indications

Mass Media advertising shall not include any references to such therapeutic indications as:

- Tuberculosis;

- sexually transmitted diseases;

- other serious infectious diseases;

- cancer and other oncological diseases;

- inveterate agrypnia;

- diabetes and other metabolic maladies.

4.3. Determination of a medical preparation’s affiliation

• All kinds of advertising of a medical product available to the general public without a prescription shall:

• Be presented in such a form that it must be clear that the information is of an advertising nature and the preparation is specified as medical;

• Include at least the following information:

- name;

- proposed clinical use;

- major side effects and contraindications;

- specific request to carefully read instructions for use of the drug.

4.4. Requirements for the information

• Advertisement of a nonprescription drug available to the general public shall not include any material which could:

- convey the impression that consulting a doctor or surgical intervention are unnecessary, and especially propose diagnosing or treatment by mail;

- imply that the effect of the medical preparation application is guaranteed, or is not accompanied by any concurrent reactions, exceeds or equal to the effect of the well-known treatment mode or preparation;

- assume that a person’s health will improve after administration of the medical preparation;

- assume that a person’s health will deteriorate without administration of this medical preparation;

- be aimed solely or substantially at children (use of children, their images and voices in the advertising of medicinal products, medical devices, except for medicines and medical supplies for children);

- assume that a food product, cosmetic item or another type of consumer goods is the medical preparation;

- assume that safety or effectiveness of the medical preparation is predetermined by its natural origin;

- result in an erroneous self-diagnosis due to the description or detailed information of the history of a particular diseases;

- substantiate recovery through incorrect or misleading images;

- use incorrect, stimulating or misleading examples of any changes to the human body caused by diseases, injuries, effect of a particular medical preparation on the human body or parts thereof.

4.5. Advertising aimed at public health specialists

4.5.1. Requirements for the information

• Any advertising of a nonprescription drug aimed at public health specialists who have the right to prescribe the same or to supply products, shall include:

- Basic information meeting the approved application data sheet;

- Attribution of the medical preparation to the group of non-prescription drugs.

• The information about non-prescription drugs shall be accurate, updated and verified.

• Any documentation related to the medical preparation and presented as a part of advertising thereof shall be reproduced clearly, stating definitely its sources and with reference to the publications or official presentation of the sources.

4.5.2. Subliminal and deceptive advertising

• Advertising of products shall be in accordance with the laws of RK.

• Advertising and information materials (mailing, ads in medical journals, other publications and in the mass media) should not hide or mask true information. Thus, the intentional subliminal use of promotional materials is not allowed.

4.5.3. Gifts and hospitality

• Gifts and hospitality towards public health specialists and associated with promotion of nonprescription drugs shall be regulated by requirements of Section III hereof.

V. PROCEDURE OF CONSIDERATION OF CLAIMS REGARDING IMPROPER COMPLIANCE WITH THE CODE

5.1. In case of any claims related to improper compliance with ethical norms and provisions hereof by members of the Association, concerned parties shall make every effort to solve the issues in an amicable manner.

5.2. A written claim shall be sent to the Ethics Committee, including detailed description of circumstances being causes for the claim.

5.3. The Ethics Committee shall consider the claim at its extraordinary meeting where both the plaintiff company and the defendant company must be present, and, being governed by this Code, shall issue its conclusion on the fact of infringement of the medical preparation ethical promotion.

5.4. If the defendant company admits its infringement, it shall within a month inform (in writing) all market participants who have received the unethical information of the actual infringement, as well as all measures taken by the company with the view of remedying the infringements.

5.5. If the defendant company refuses to admit the actual infringement of this Code, the initial claim shall be forwarded to an authorized law agency.

5.6. When the actual infringement of the Code is finally verified, all proceeding costs, including compensation of the plaintiff company’s advance payment shall be borne by the infringing company.

The infringing company shall within a month inform in writing all market participants who have received unethical information, of the fact of the infringement and of measures taken by the company to remedy the infringements.

5.7. When the fact of non-infringement of this Code is verified, all proceeding, consideration and expertise costs shall be borne by the plaintiff company.

If there is more than one fact (event) of infringement hereof by the company being a member of the Association, the Association’s Secretariat shall, on the instructions of the Supervisory Board, notify the headquarters of the infringing company in writing.

The headquarters of the infringing company shall within a month provide the Association with the internal action plan aimed to remedy the infringements and to make the infringing company’s operations compliant with provisions of this Code.

1. Subject of Regulation here of

These Regulations regulate relations between medical, pharmaceutical organizations, medical, pharmaceutical and medical workers, and determines the rights and duties of medical representatives.

2. Main Terms used in these Regulations

For the purposes hereof the following definitions shall be used: medical organization – a legal entity, regardless of the legal form, conducting medical activities as the main (authorized) business based on a license granted in accordance with the legislation of the Republic of Kazakhstan. Individual entrepreneurs engaged in medical activities shall be treated as healthcare organizations;

Pharmaceutical organization - a legal entity, regardless of the legal form, which performs pharmaceutical activities (organization of wholesale of drugs, pharmacy organization). Individual entrepreneurs engaged in pharmaceutical activities shall be treated as pharmaceutical organizations;

Medical worker - an individual who has medical or other training, working in a medical organization and whose job (official) description includes carrying out medical activities, or an individual who is self-employed, directly engaged in medical activities;

Pharmacist - an individual who has a pharmaceutical training, working in a pharmaceutical organization and whose job description includes wholesale of drugs, storage, transportation thereof, and (or) retail trade of medicines for medical use (hereinafter - drugs), their manufacture, sale, storage and transportation;

3. Medical Representatives’ Functions.

The main task of medical representatives is to provide the most current, complete and accurate professional information about drugs promoted by them for the most appropriate use thereof by medical doctors under officially approved indications, and to provide information about the direction of therapy development, new registered drugs or new registered indications, the results of clinical research reported under approved indications, and to collect information on side effects of drugs and comprehensive monitoring of safety, which is also the duty of the manufacturing company.

Functional responsibilities of medical representatives include:

- distribute informational materials among medical and pharmaceutical workers, including treatment regimens with the use of promoted drugs;

- participation in the organization of seminars, round tables and lectures for medical workers and pharmacists;

- participation in organizing conferences, meetings with the workers of general health organizations and pharmacies;

- advertising campaigns in pharmacies;

- collecting and obtaining information about the side effects of drugs

Note: on behalf of the management of the company a medical representative may transfer documents as a part of the above activities.

4. Basic rules and regulations of medical representatives’ activity

Activities of medical representatives of pharmaceutical companies must be of an informative nature.

Medical representatives of pharmaceutical companies must have an adequate training and have the necessary knowledge to provide medical and pharmaceutical workers with complete, objective, reliable and up to date information on medicines. Responsibility for the content and the form of the information transmitted by medical representatives shall be borne by a pharmaceutical company.

When visiting medical and pharmaceutical workers medical representative must provide upon request:

1) instructions for use of the presented drug;

2) information about conditions of purchase from pharmacies (classification as prescription or over the counter drug, sold to persons entitled to benefits, etc.) of the drug and its availability in pharmacies.

Medical representatives must bring to the attention of the head of the relevant department of their company information on the practical use of pharmaceutical products of the company, including side effects, etc., obtained when visiting health professionals.

5. Procedure for activity of medical representatives when visiting medical, pharmaceutical and pharmacy organizations

Only medical representatives of pharmaceutical companies or of official representatives of pharmaceutical companies accredited in the Republic of Kazakhstan may conduct business in medical, pharmaceutical and pharmacy organizations.

When visiting medical, pharmaceutical and pharmacy organizations medical representatives must have an official confirmation (business card of company’s employee) from pharmaceutical company or representative office of a pharmaceutical company that this employee is authorized to engage in this work, and has proper knowledge and skills.

Frequency of visits to medical, pharmaceutical and pharmacy organizations by medical representatives is regulated by pharmaceutical companies or by representative offices of pharmaceutical companies accredited in Kazakhstan.

6. Restrictions imposed on medical workers and pharmacists in performance of professional activities

Medical representatives and pharmaceutical companies may not:

1) Provide health care providers and pharmaceutical workers with:

- cash or cash equivalents, such as gift certificate/voucher;

- payment for entertainment, leisure, travel to a place of resort.

- gifts (except for scientific information material and events described in paragraph 3.12 of the Code of Marketing Practices)

2) Organize participation of medical and pharmaceutical workers in ceremonies, celebrations, not related to scientific and educational activities conducted at the expense of organizations involved in development, manufacture and/or sale of drugs, medical devices, and organizations with rights to use the brand name of a drug; pharmaceutical wholesale organizations, pharmacy organizations (their legal representatives, and other persons and entities that operate on behalf of these organizations) (hereinafter referred to as - the company, the representative of the company);

3) Conclude written or oral agreements with medical and pharmaceutical workers on prescription or recommendation of medicines and medical devices to patients for payment or other material remuneration (except for contracts on clinical drugs trials, clinical trials of medical products);

4) Provide medical and pharmaceutical workers with samples of prescription drugs and medical products to give to patients with promotional purposes. The exception is provision of samples of prescription/non-prescription drugs and medical products:

- related to conduct of clinical trials of drugs and clinical trials of medical products;

- in clinical programs for early patient access to new therapies for treatment of rare and/or serious illness, with the permission of the MoH RK.

- if a medical product is intended to administer medicines supplied under public procurement under a contract, which also does not provide for supply of such medical products);

5) Visit medical and pharmaceutical workers during working hours outside of schedule, coordinated with the management of a medical or pharmaceutical organization, except when medical staff meets with representatives of companies to exchange information on adverse events, adverse side affects, identify adulterate or pirated medicines, and to conduct academic and research and training activities;

6) To provide medical professionals with forms for prescription of drugs, medical products containing advertising information, and prescription forms with a pre-printed name of a drug or a medical product.

7) Provide medical and pharmaceutical workers with advice and scientific and informative material on the use of drugs for indications not registered in the Republic of Kazakhstan.

Used Literature

1. IFPMA Code of Ethics (International Federation of Pharmaceutical Manufacturers and Associations)

2. Code of Pharmaceutical Companies’ Representative Offices Association in Kazakhstan

3. Code "On People's Health and Healthcare System"

4. Medicines and medical products licensing requirements in Kazakhstan