KRKA’S CODE · Promotional material refers to any material in a hard copy (brochure, leaflet,...

KRKA’S CODE O F P R O M O T I O N

CONTENT OF KRKA’S CODE OF PROMOTION1. Introduction2. Definitions3. General principles4. Standards of promotion 5. Transparency of promotion6. Products 7. Audience8. Promotional materials9. Informational or educational materials, items of

medical utility and inexpensive gifts 10. Samples11. Marketing staff12. Events and hospitality13. Educational support14. Service and consultancy15. Donations16. Patient organisations17. Disclosure of transfers of value to healthcare

professionals, healthcare organisations and patient organisations

18. Responsibility19. Enforcement

FINAL PROVISIONSReference documentsHistoryDistribution

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4 Krka's code of promotion

CONTENT OF KRKA’S CODE OF PROMOTION

1. Introduction This Code defines activities relating to promotional and non-promotional activities carried out by the Krka Group (KRKA, d. d., Novo mesto, its wholly owned subsidiaries and representative offices, (hereinafter: ‘the Company’ or ‘Krka’) in the marketing of its prescription-only medicinal products. In its marketing activities, Krka’s companies comply with the national laws and regulations, and with the current European, international and national codes on promotion and marketing of medicinal products. The provisions of Krka’s code of promotion (hereinafter: ‘Krka’s code of promotion’ or ‘the Code’) will be interpreted and implemented in accordance with all applicable rules.

The Code determines the requirements regarding Krka’s marketing activities and the promotion of prescription-only medicinal products as well as interactions with the healthcare community (including but not limited to healthcare professionals, healthcare organisations, patients and patient organisations). Krka may also adopt more specific and detailed internal rules relating to issues defined in the Code.

By adopting this Code, Krka demonstrates its commitment to the ethical standards in its marketing activities relating to prescription-only medicinal products and its commitment to the Company’s core values of integrity, transparency, mutual respect, collaboration and accountability.

The Code applies to and provides guidance to Krka employees when they promote products or give information about prescription-only medicinal products.

The principles set forth in the Code are mandatory and shall be implemented by all Krka subsidiaries and representative offices.

5Krka's code of promotion

2. Definitions

Frequently used terms refer to the following:

Krka refers to the KRKA, tovarna zdravil, d. d., Novo mesto, its representative offices and all its wholly owned subsidiaries;

The Code refers to Krka’s Code of promotion;

Product refers to prescription-only medicinal products;

Applicable rules refer to national laws and regulations, industry codes and guidelines relating to the promotion of medicinal products (e.g. Directive 2001/83/EC community code relating to medicinal products for human use, Code of Conduct of Medicines for Europe, etc.) and Krka’s internal rules (e.g. the Ethical code, Rules on fraud prevention, detection and investigation, etc.). If national laws impose more stringent requirements, Krka must comply with these national requirements.

Healthcare professional (HCP) refers to a natural person that is a doctor, a member of medical, dental, pharmacy, nursing professions or any other person who may prescribe, purchase, supply, recommend or administer a medicinal product. The definition of HCP includes: (i) an official or employee of a governmental agency or another organisation that may prescribe, dispense, purchase or administer medicinal products; (ii) an employee of a pharmaceutical company whose primary occupation is that of a practising HCP. The definition of a HCP is not: an employee of a pharmaceutical company, a wholesaler or a distributor of medicinal products.

Healthcare organisation (HCO) refers to an entity (i) that is a healthcare, medical or scientific organisation (irrespective of the legal and organisational form), such as a hospital, clinic, foundation, university or other teaching institution or learned society or (ii) through which one or more healthcare professionals provide healthcare services. The definition of a HCO is not: a wholesaler, distributor, and similar commercial intermediary.


Patient organisation refers to a not-for-profit organisation which is patient-focused and is mainly composed of patients and/or caregivers that represent and/or support the needs of patients and/or caregivers.

Promotion/Promotional refers to the marketing of prescription-only medicinal products that includes any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, recommendation, sale or consumption of medicinal-only products in particular: (1) advertising of medicinal products to HCPs, (2) visits by medical representatives to HCPs, (3) the supply of samples, (4) organisation of professional and promotional meetings attended by HCPs, (5) support and/or sponsorship of scientific congresses and other professional meetings attended by HCPs, (6) support of attendance of HCPs at scientific congresses and other professional meetings.

Promotional material refers to any material in a hard copy (brochure, leaflet, mailing etc.) or electronic form (presentation, video, e-brochure, e-mailing, etc.) intended for the promotion of a product(s). The promotional material may include information about the product, its therapeutic use, information about clinical experiences with a product, and comparisons with other treatment options. It may also include information about the price and reimbursement of the product.

3. General principles 3.1. The basis of interaction with healthcare

professionals In accordance with Krka’s mission of living a healthy life, Krka’s relationship with healthcare professionals is intended to benefit patients, to advance the practice of medicine and promote dissemination of the medical knowledge and experience. Interactions are focused on promoting to and informing healthcare professionals about therapeutic areas, products, features, indications providing scientific and educational information. Krka provides healthcare professionals with the latest up-to-date scientific medical and pharmaceutical knowledge and with up-to-date objective information on products and treatment options and


supports any such efforts and activities of healthcare society thus giving healthcare professionals an adequate basis for confident decisions about the best treatment options which are in favour and for the benefit of the patients.

Nothing may be offered or provided in a manner or on condition that would have an inappropriate influence on a healthcare professional’s independent decisions. No financial benefit or benefit-in-kind must be offered or provided (even if asked for) to a healthcare professional in exchange for prescribing, recommending, purchasing, supplying or administering products or for a commitment to continue to do so.

3.2. Appropriate usePromotion should encourage an appropriate use of products by presenting them objectively, without exaggerating their properties and in accordance with the approved national Summary of product characteristics (SmPC). In order to achieve this, Krka’s medical representatives only use approved up-to-date standardised promotional materials for the products and therapeutic areas they promote. Additionally, they can also present Summary of Products Characteristic (SmPC) for all products in promotion (obligatory in the case of HCP-demand).

4. Standards of promotion Krka maintains ethical standards in promotion at all times. Promotion is objective and balanced. Promotion is never such as to bring discredit upon, or reduce confidence in the Company and in the pharmaceutical industry in general. Promotion is always of a nature which recognises the special nature of the products and the professional standing of the recipient(s). Promotion is never led in a way that would be likely to cause offence.


5. Transparency of promotion The Company does not lead any form of disguised promotion.

The Company recognises the importance of transparency in relations and interactions between the Company and the healthcare community. Accordingly, Krka will disclose value transfers to healthcare professionals, healthcare organisations and patient organisations in accordance with the adopted standards.

6. Products

6.1. Promoted products Only products with granted marketing authorisation can be promoted. Products are promoted only within the scope of approved indications and other particulars listed in the approved Summary of product characteristics.

Rational use of products is promoted by presenting the products objectively and without exaggerating their properties.

7. Audience 7.1. Healthcare professionals Promotion of products is aimed at healthcare professionals only. Any data on healthcare professionals acquired during promotional activities are handled in accordance with applicable rules relating to personal data protection. Mailings, e-mails or other messages as part of promotional activities are sent only to those recipients who have given their prior consent or upon their request. Recipients can at any time cancel their consent and are immediately withdrawn from all the mailing lists of the Company.

Attendance of healthcare professionals at scientific congresses and other professional meetings organised by a third party is supported only upon a prior request of a healthcare professional for such support.


7.2. General public/patients In accordance with our mission of living a healthy life, Krka can support educational programmes conducted to satisfy increasing demands of the community for scientific information and increase public knowledge concerning healthcare, prevention of diseases, signs and symptoms of diseases, and available methods of treatment. Such activities and programmes are designed and performed in accordance with the highest standards and support of the role of the healthcare giver. The information presented to the general public is very general information about a certain disease, it is objective and not misleading, without any elements of product promotion. Within the scope of such communication, the Company may provide the general public/patients with general leaflets/brochures containing information on diseases, treatments and health. The information presented in these brochures is non-promotional and no names of products are given.

When individual members of the general public (patients) address requests for advice on personal medical matters to the Company, the enquirer is advised to consult a healthcare professional. The Company only offers information about its products and the proper use of its products.

8. Promotional materialsPromotional materials, including their content and graphics, are prepared in such a manner that they do not induce ambiguity about the product, the marketing authorisation holder or producer, and do not imitate elements used by other companies. On all products or other promotional materials, the Company title is presented as a clearly visible Company logo or a Company banner. In addition to the Company title, all promotional materials also contain a complete contact address of the Company subsidiary and/or a Company representative office, or a website address with other contact details.

Promotional materials relating to products and their uses and therapeutic areas are prepared in accordance with the current SmPC and are compliant with all applicable rules.


8.1. Declarations and substantiation of promotion Information, declarations and graphic representations must be accurate, balanced, fair, objective and sufficiently complete to enable the recipients to form their own opinion of the therapeutic value of the product concerned. They do not mislead by distortion, exaggeration, undue emphasis, omission or in any other way. They are based on an up-to-date evaluation of all relevant evidence from medical and scientific literature. Unsubstantiated superlatives, declarations like ‘product has no adverse reactions/toxic hazards’ or ‘risks of addiction/dependency’ are not used. The term ‘new’ is used for no longer than 12 months since the product was launched in a particular market.

Quotations from medical and scientific literature or from personal communications are faithfully reproduced (except where adaptation or modification is required in order to comply with any other applicable rules, in which case it must be clearly stated that the quotation has been adapted and/or modified) and the precise sources identified.

References to the literature used in the promotion are clearly stated. The Company will provide corresponding literature or unpublished data (‘Data on file’), if so permitted by national legislation, whenever required from healthcare professionals, promptly upon request, otherwise only data from SmPC are used.

8.2. Comparisons with other products If comparisons with other products are made in promotion, such comparisons are based on relevant data and in accordance with SmPC of all the products mentioned. When comparative data are used, they are factual, objective and justifiable with reference to their source. For the comparisons only relevant, substantial and verifiable aspects are used. Comparisons are presented without distortion of data and in such a manner that they are not misleading for the acceptor.

8.3. Approval of promotional materials Promotional materials are verified and approved on a country level by country management in accordance with internal company procedures, which are designed to assure that all promotional materials comply with


the applicable rules as well as with the current Summary of product characteristics. Individual medical representatives cannot prepare their own promotional material and all promotional materials are prepared by competent departments in accordance with internal company procedures.

9. Informational or educational materials, items of medical utility and inexpensive gifts

No informational or educational material, item of medical utility, inexpensive gift or benefit in-kind is supplied, offered or promised to a healthcare professional as an inducement to recommend, prescribe, purchase, supply, sell or administer a prescription-only medicinal product. Informational or educational materials, items of medical utility, pecuniary advantages or benefits in-kind may be offered and/or supplied to healthcare professionals to whom the products are promoted only if they are of symbolic value – ‘inexpensive’, relevant to the practice of medicine, and if this is in accordance with national laws.

It is possible that informational or educational materials, items of medical utility and inexpensive gifts only bear the name and logo of the Company and the name of the product and/or its international non-proprietary name or the brand name. The intent of this material is to remind about the products (so-called brand reminders).

In the countries where applicable national rules permit it, an inexpensive gift not related to the practice of medicine may be given on an infrequent basis to healthcare professionals.

10. Samples Samples – not for sale – in limited quantities may be supplied in accordance with the national rules and regulations. Samples may be supplied to healthcare professionals who are qualified to prescribe the


product in order to familiarise them with the product on an exceptional basis and for a limited time period; but only in response to a prior written request which has been signed and dated by the recipient. The supply of samples is controlled in such a way that it assures the accountability for the distributed samples. Medical representatives are properly trained to handle the samples adequately as long as they are in their possession. Together with samples, healthcare professionals are provided with a Summary of product characteristics and other relevant scientific information about the product. Samples must not be given as an inducement to recommend, prescribe, purchase, supply, sell or administer a product.

11. Marketing staff 11.1. Education The Company medical representatives, including the representatives retained by way of a contract with a third party who call on healthcare professionals in connection with the promotion of the Company's products, are adequately trained and have sufficient scientific knowledge to be able to provide accurate and complete information about the products they promote. The above-mentioned is assured through a regular training system for all new and existing medical representatives about the applicable rules.

11.2. Individual visits Medical representatives must work in a professional, responsible and ethical manner. During each visit they must provide healthcare professionals with a Summary of product characteristics or they must at least have it available for each product that they present. Medical representatives should ensure that the frequency, timing and duration of visits to healthcare professionals, together with the manner in which they are made, do not cause any inconvenience. Medical representatives must not use any inducement or subterfuge to gain a call. On a visit, or when seeking an appointment for a visit, medical representatives must, from the outset, take reasonable steps to ensure that they do not mislead as to their identity or that of the company they represent.


11.3. Duty to accept reports about adverse reactions and opinion about the products

At each visit medical representatives must have the form for reporting adverse drug reactions (CIOMS or other form if locally required) available. Reports about adverse drug reactions must be forwarded to the person responsible for pharmacovigilance in the country.

11.4. Market research and epidemiological researchMedical representatives can occasionally assist in market research and epidemiological research programs, if this is permitted by the national law. Approvals for inclusion in market research and epidemiological research are acquired by the national management according to all applicable rules. Medical representatives may collect data in an electronic or paper version, and must submit them to the relevant local responsible person. Involvement of medical representatives in market research and epidemiological research must be strictly separated from their promotional activities and must be assured by a country management team.

12. Events and hospitality 12.1. Objectives The purpose and focus of all promotional, scientific or professional meetings, congresses, conferences, symposia, and other similar events (including, but not limited to, visits to research or manufacturing facilities and training (each, an ‘event’)) for healthcare professionals organised or supported by the Company is to inform healthcare professionals about products and/or to provide scientific or educational information.

12.2. Venue All the events organised or supported by or on behalf of the Company are held in an appropriate venue that is conducive to the main purpose of the event. The event takes place outside the participants’ home country only if it is organised for participants from different countries, or if the


relevant resource or expertise that is the object or subject of the event is only available in another country. The Company avoids using venues that are renowned for their entertainment facilities or may be considered extravagant.

12.3. Information Promotional information which appears on exhibition stands or is distributed to participants at international events refers to products which are registered in the market where the event takes place, or are registered in the markets of participants and may thus also refer to products (or uses) which are not authorised in the country where the event takes place so long as (a) any such promotional material is accompanied by a suitable statement indicating the countries in which the product is authorised and makes it clear that the product or use is not authorised in a particular country; (b) any such promotional material which refers to prescribing information (indications, warnings etc.) authorised in a country or countries where the product is authorised should be accompanied by an explanatory statement indicating that marketing authorisation conditions differ internationally.

12.4. Hospitality Hospitality may be offered to health care professionals in connection with local, national or international scientific and/or educational events organised by the Company or a third party. Such events may take place in the country or abroad. Hospitality may be offered also in connection with the Company site visits.

All forms of hospitality offered to healthcare professionals are reasonable in level and strictly limited to the main purpose of the event. As a general rule, the hospitality provided does not exceed what healthcare professional recipients would normally be prepared to pay for them and does not exceed the main purpose or the scientific value of the event. Hospitality is limited to registration fees, accommodation, travel and meals. Hospitality is offered only to persons who qualify as participants in their own right. The duration of hospitality is linked to the duration of the event. Most time should be dedicated to the scientific/educational programme.


12.5. Exhibitions Exhibitions are intended for advancement of scientific and professional knowledge and experience among healthcare professionals. On the exhibition stand, the name of the Company is clearly visible and recognisable. Informational or educational materials, items of medical utility and inexpensive gifts may be offered at the stand.

13. Educational support The Company may support scientific, medical and pharmaceutical education, thus contributing to the advancement of scientific medical knowledge of healthcare professionals.

The Company may provide educational support to individual healthcare professionals or healthcare organisations.

The event at which the attendance of a healthcare professional is supported must be directly associated with the healthcare professional’s practising therapeutic area. Educational support may only include the remuneration of registration fee, travel and accommodation. It must not include daily allowance or any other costs associated with the attendance of the event and cannot be extended to family members or accompanying persons.

The aim of the educational support offered by the Company is to facilitate the spread of the latest scientific developments, knowledge and medical practical recommendations among healthcare professionals, thus contributing to their competencies. The Company aims at building its positive image in the healthcare community by means of contributions to acquiring new knowledge.


14. Service and consultancy14.1. Healthcare professionals The Company may engage healthcare professionals in groups or individually to provide services, such as speaking at and chairing meetings, involvement in medical/scientific studies and training services, serving as experts at advisory board meetings, participating in market research or epidemiological research where such participation involves remuneration and/or travel. The arrangements that cover these types of genuine consultancy or other services and are to an extent relevant to a particular arrangement, must meet the following criteria:

a) a legitimate need for the services has been clearly identified before the services are required and before entering arrangements with prospective consultants;

b) a written contract or agreement is entered, which specifies the nature of services to be provided and the subject to the clause (g) below, the basis for payment of these services;

c) the remuneration for the services is reasonable and reflects the fair market value of the services provided;

d) the remuneration is made only for work performed;

e) the criteria for selecting consultants are directly related to the identified need and the persons responsible for selecting the consultants have the expertise necessary to evaluate whether the particular healthcare professionals meet those criteria;

f) the number of healthcare professionals retained is not greater than the number reasonably necessary to achieve the identified need;

g) the Company maintains relevant records, and makes appropriate use of the services provided by consultants;

h) the hiring of a healthcare professional to provide relevant service is not an inducement to recommend, prescribe, purchase, supply, sell or administer a particular product.


Krka supports all efforts made in order to provide transparency in any transfers of value between pharmaceutical companies and healthcare professionals, and complies with all applicable rules, while applying special attention to compliance with applicable personal data protection rules.

14.2. Healthcare organisations

Contracts between the Company and institutions, organisations or associations of healthcare professionals under which such institutions, organisations or associations provide any type of services to the Company are only allowed if such services (or other funding): (a) are provided for the purpose of supporting healthcare or research and development; (b) do not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer specific prescription-only medicinal products; (c) any remuneration for services granted does not exceed the value of the service; (d) the remuneration is not dependent on prescribing or recommending products and no condition of this type may be expressed or indicated.

15. Donations Donations, grants and benefits in kind to institutions, organisations or associations that are comprised of healthcare professionals and/or that provide healthcare or conduct research are only allowed if: (a) they are made for the purpose of supporting healthcare or research; (b) they are documented and kept on record by the Company; and (c) they do not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer specific products and if they are in accordance with all applicable and national rules.

16. Patient organisations In accordance with Krka’s mission, the Company may provide financial support and/or non-financial support to patient organisations for the benefit of healthcare/society. The Company does not seek any influence


on patient organisations' activities and/or materials they support on account of the Company's commercial interests.

17. Disclosure of transfers of value to healthcare professionals, healthcare organisations and patient organisations

Transparent relations and interactions between the Company and healthcare professional/organisations and patient organisations assist informed decision-making and help prevent unethical and illegal behaviour. The Company will disclose transfers of value on the territories where such a disclosure and/or reporting is not defined by applicable rules. Transfers of value may include anything of value that is provided or transferred by the Company (directly or indirectly via third party acting at its direction) to a recipient, including monetary payments or in-kind benefits.

Disclosures will be published on the web sites for each market on a yearly basis by 30 June for the previous year. The first publication will be by 30 June 2018 for year 2017.

17.1. Healthcare professionalsOn an individual, named basis, the following transfers of value shall be disclosed:

Fees for services and consultancy: aggregated honoraria (excluding expenses, such as meals and drinks, travel and accommodation) paid by the Company to a healthcare professional in exchange for the provision of services, such as serving as an expert on an advisory board, speaking at a Company organised event, participating in a focus group, etc. Fees paid in connection with R&D activities or market research are excluded from the scope of the disclosure.


If a healthcare professional refuses to provide consent required under applicable personal data protection rules, the data will be disclosed on an anonymous basis. If multiple healthcare professionals refuse consent, then the transfer of value data must be aggregated indicating the number of healthcare professionals included in the aggregation.

Provided support to attend third party organised congresses, site visits and Company organised meetings must be disclosed in these sub-categories. The (total) amount of support provided, which may include registration fees, travel and/or hotel costs and the number of healthcare professionals supported must be disclosed.

17.2. Healthcare organisationsOn individual, named basis, the following transfers of value shall be disclosed:

• Fees for services and consultancy: aggregated honoraria (excluding expenses, such as meals and drinks, travel and accommodation) paid by the Company to a healthcare organisation in exchange for the provision of services, such as serving as an expert on an advisory board, speaking at a Company organised event, participating in a focus group, etc. Fees paid in connection with R&D activities or market research are excluded from the scope of the disclosure;

• Grants and donations: aggregated monetary amounts and brief description of the nature of the grant or donation (e.g. research grant, equipment donation, product donation, etc.).

17.3. Patient organisationsOn an individual, named basis, On an individual, named basis, the following transfers of value shall be disclosed:

• Support: financial and in-kind support;

• Fees for services: contracted services per patient organisation, including a brief description of the nature of the transfer of value and the amount provided.


18. Responsibility Medical representatives and all marketing staff are responsible for providing true, accurate and essential information consistent with the Summary of product characteristics.

Marketing managers in the markets are responsible for the compliance of all marketing activities with all applicable rules.

Directors of subsidiaries and representative offices are responsible for the compliance of all activities (including the disclosure of transfers) with all applicable rules.

Directors of subsidiaries and representative offices and marketing managers are responsible for regular training and education of marketing staff on all applicable rules.

19. Enforcement The provisions of the Code must be respected in the Krka Group, i.e. in all representative offices and subsidiaries. Any breach of the Code provisions shall be considered as a breach of employees’ employment duties under applicable rules.


FINAL PROVISIONS

Reference documentsKrka’s Ethical Code Code of Conduct – Medicines for Europe

Krka Rules on fraud prevention, discovery and investigation Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)

HistoryDate of preparation: February 2008 First revision: September 2009Second revision: November 2012 Third revision: July 2014 Fourth revision: September 2017

DistributionHQ Marketing, HQ Sales/Region Slovenia, Management of ROCA and all employees in marketing and sales network at Krka.

Marketing managers are responsible for the distribution and training of all employees in marketing and sales network.

Krka's Code of promotion is published on Krka's internal website (Krkanet) and on Krka's public website.

www.krka.biz

KRKA’S CODE · Promotional material refers to any material in a hard copy (brochure, leaflet,...

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Transcript of KRKA’S CODE · Promotional material refers to any material in a hard copy (brochure, leaflet,...