AFIDRO Code of Ethics 2019 - IFPMA

 
Association of
    Pharmaceutical Research
    and Development
    Laboratories

 AFIDRO
 Code
 of Ethics
 2019
Whereby the Good Practices of
the Pharmaceutical Industry
represented in the Association of
Pharmaceutical Research and
Development Laboratories,
AFIDRO are established

Bogotá D.C., Colombia
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    TABLE OF CONTENTS

    INTRODUCTION ......................................................................................................................... 4

    1.     DEFINITIONS ..................................................................................................................... 5

    2.     COMPANY PURPOSE AND RESPONSIBILITIES ..................................................... 7

    3.     SCOPE ................................................................................................................................. 8

    4.     GUIDING PRINCIPLES ON ETHICAL CONDUCT AND PROMOTIONS ............... 9

    5.     GENERAL GUIDELINES FOR INTERRELATIONS .............................................................. 10

    5.1.      ETHICAL CONDUCT................................................................................................ 10

    5.2.      TRANSPARENCY ..................................................................................................... 12

    5.3.      EVENTS ...................................................................................................................... 13

    5.4.      DONATIONS AND CONTRIBUTIONS ................................................................. 15

    5.5. DIGITAL ENVIRONMENT AND / OR INFORMATION TECHNOLOGY AND
    COMMUNICATION .............................................................................................................. 15

    6.     INTERACTION WITH HEALTH PROFESSIONALS .............................................. 16

    6.1. EDUCATIONAL AND ACADEMIC ACTIVITIES AND NON-PROMOTIONAL
    ACTIVITIES........................................................................................................................... 16

    6.2.      NON PROMOTIONAL MATERIALS ..................................................................... 16

    6.3.      DRUG PROMOTIONS.............................................................................................. 17

    6.4. MEDICAL VISITS OR PROMOTIONAL ACTIVITY CARRIED OUT IN FAVOR
    OF HEALTH SECTOR PLAYERS, MAY IN NO CASE BE CONDITIONED TO THE
    PAYMENT IN MONEY OR IN KIND AS DIRECT OR INDIRECT CONSIDERATION,
    OR AS COMPENSATION FOR THE TIME INVESTED IN SAID ACTIVITY. ............. 17

    6.5. PROMOTIONAL ITEMS, MEDICAL USE ITEMS, EDUCATIONAL ITEMS,
    GIFTS, MEDICAL SAMPLES .............................................................................................. 18
Código de Ética AFIDRO 2019                                                                                                                        3

           6.6.      PROFESSIONAL SERVICES ................................................................................... 19

           6.7.      CLINICAL RESEARCH ............................................................................................. 20

           6.8.      MARKET RESEARCH .............................................................................................. 20

           7.     INTERACTION WITH PATIENTS ............................................................................ 21

           7.1.      INTERACTION WITH PATIENT ORGANIZATIONS ........................................ 21

           7.2.      PATIENT SUPPORT PROGRAMS ........................................................................ 23

           7.3.      INTERACTION WITH PATIENTS AND CAREGIVERS..................................... 24

           7.4.      DIAGNOSTICS SUPPORT ...................................................................................... 25

           8.     INTERACTION WITH HEALTH SECTOR PLAYERS ............................................ 26

           8.1.      SCOPE OF APLICATION ......................................................................................... 26

           8.2. FUNDAMENTAL PRINCIPLES IN THE INTERRELATION WITH HEALTH
           SECTOR PLAYERS............................................................................................................... 26

           9.     COMPLIANCE CONTROL................................................................................................ 27

           9.1.      OVERVIEW................................................................................................................ 27

           9.2.      CONTROL ORGANISMS ......................................................................................... 28

           9.3.      CATEGORIES OF PENALTIES ............................................................................... 28

           9.4.      DISPUTE RESOLUTION PROCEDURE................................................................ 30

           9.5.      FEES AND EXPENSES ............................................................................................. 32
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    Introduction

    AFIDRO’S Code of Ethics constitutes the basis for the actions of the pharmaceutical companies which are members
    of the Association of Pharmaceutical Research and Development Laboratories – AFIDRO - in Colombia. The purpose
    of this Code is to promote an ethical culture, the commitment to transparency and the fight against corruption,
    preserving the integrity of users and protecting the general interest of society.

    This Code reflects the decision of AFIDRO’s member companies to self-regulate, agreeing to subject their actions and
    those of who act on their behalf to more strict ethical standards than those that comprise Colombia’s current legal
    system, as well as those established in the IPFMA’s Code of Good Practices, with the purpose of contributing to the
    development of a better health system in Colombia

    AFIDRO is very committed to promoting that the pharmaceutical industry’s promotional practices in Colombia,
    directed towards health professionals and payers, the distribution chain, patients in the case of over-the-counter
    medications, and to users in general, respond to the highest international ethical standards, promoting an industry
    that is responsible, comprehensive, transparent and attentive to any unfair practice.

    The ethical principles set forth in this Code are the reflection of an industry that is aware of its environment, of its
    country’s priorities and the challenges affecting the health system, and therefore acts accordingly.

    In order to fully comply with the above, we have reviewed and updated AFIDRO’s Code of Ethics, reflecting the
    commitment of the pharmaceutical research and development industry represented here, to the highest
    international standards.

    AFIDRO’s member companies, as well as the individuals or legal entities adhering to this Code voluntarily assume the
    obligation to adjust all their activities to the spirit of the following provisions:
Código de Ética AFIDRO 2019                                                                                                            5

           1.   Definitions
           Health Sector Player: Any person responsible for the prescription, recommendation, application, supply, purchase,
           sale or distribution of drugs, whether public or private, including, among others: Health Professionals, payers,
           distributors, logistics and purchasing operators, officials and / or contractors, pharmacists, chemists, druggist, health
           institutions, hospitals, clinics, foundations, universities, academic institutions, medical associations and scientific
           associations. For purposes of the provisions of this Code, the term also includes patients, caregivers and patient
           organizations.

           Educational Items: Items provided to Health Professionals for their education or the education of patients regarding
           diseases and their treatments, which may be offered by the Companies, provided that these items are mainly for
           educational purposes.

           Promotional Items: Non-monetary items provided to Health Professionals, including foods offered by the Companies
           within the framework of an event, which bear a corporate brand and / or product.

           Medical Use Items: Items that may be offered or provided by the Companies, if they are of modest value, contribute
           to the patient's education for the proper management of their treatment and do not correspond to those that Health
           Professional require for their routine medical practice.

           Company: Pharmaceutical laboratory associated with AFIDRO, which develops, produces and / or sells drugs in
           Colombian territory and / or any entity under its control such as a subsidiary, foundation, association, institute,
           agency, or third party service provider. The term also includes the moral or legal non-affiliated person that expressly
           and voluntarily adheres to this Code of Ethics. The terms "pharmaceutical company", "laboratory" or "company" in
           singular or plural have the same meaning as described herein.

           Caregiver: Person who provides assistance, usually in a home environment, to a sick or disabled person of any age.

           Gift or perks: Any benefit in cash or in kind delivered directly or indirectly, in a manner contrary to honest business
           practices, that has the ability to induce or encourage the recommendation, prescription, purchase, distribution,
           supply, dispensation or administration of drugs.

           Brief Statement: Document that contains a brief profile of the essential characteristics of the product, which must be
           shown in any promotional material addressed to Health Professionals.

           Donation: Act of generosity whereby a company (donor) gives a pecuniary amount free of charge or a good or service
           (donation in kind) in favor of a third party (beneficiary), who accepts it.

           Clinical studies: Any research conducted in humans to determine or confirm the clinical, pharmacological and / or
           other mechanistic effects, and / or to detect adverse reactions, and / or to study the pharmacokinetics, of one or
           several investigational drugs with in order to determine its safety, effectiveness and / or efficiency.
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    Event: any promotional, professional scientific meeting, congress, conference, symposium, work day, on-site or
    distance training course, or any other type of similar activity, including, but not limited to: experts meeting, visit to a
    manufacturing plant or research facility, training meeting for researchers related to the performance of clinical trials
    and post-authorization studies, organized or sponsored by a company.

    Scientific Exchange: Activities carried out by the Company’s medical area, in which objective, balanced, specific
    scientific information is provided, through the use of a balanced scientific language (benefits and risks / efficacy and
    adverse events), regarding the appropriate use of a product, management of a disease, the results of clinical studies,
    the appropriate use of diagnostic tests and / or health technologies, among others.

    Scientific exchanges regarding molecules, indications or dosage of products that are not approved by the health
    authority, can only be given in response to spontaneous requests originated by a health professional and must include
    an express statement regarding the non-approval of the molecule or the use of the medication, and may not carry
    the brand or logo of the product.

    In the event of scientific exchange regarding molecules, indications or dosage of products that are not approved by
    the health authority, it must include an express statement regarding the non-approval of the molecule or the use of
    the drug, and may not bear the brand or logo of the product.

    Interrelation: Any activity in which a company participates, carries out, organizes or sponsors, in which a Health
    System Player is involved and from whose interaction may directly or indirectly result in a collaboration, support or
    consideration of any kind in favor of any of the parts.

    Health Sector Institution: Any entity that has a responsibility or decision-making power over the purchase or use of
    drugs, such as: Institutions that Provide Health Services (IPS), Health Promoting Companies (EPS), Compensation
    Funds, Special Health Regime Entities or territorial entities, among others.

    Market research: Collection and interpretation of information about people or organizations through the use of
    statistical and / or analytical methods and applied science techniques, in order to obtain new insights or look for
    support elements in decision making.

    Drug: pharmaceutical preparation obtained from active ingredients, with or without auxiliary substances, presented
    in pharmaceutical form, which is used for the prevention, relief, diagnosis, treatment, cure or rehabilitation of a
    disease, including its container, label, tag and packing. The term "singular or plural" in the context of this Code applies
    to any substance or combination of substances regardless of their origin (chemical, biological, biotechnological,
    radiopharmaceutical or other synthesis) destined to be used by prescription, recommendation or under supervision
    of a Health Professional for the diagnosis, treatment or prevention of diseases in humans or to influence in the
    structure or any function of the human body, and includes medical devices, for purposes of the provisions contained
    herein.

    Logistics Operators: Natural and / or legal person that buys, sells, resells, distributes, stores, transports and / or
    delivers drugs and health technologies from the Pharmaceutical Companies or participates jointly in the sale or resale
Código de Ética AFIDRO 2019                                                                                                           7

           of Company products.

           Patient Organization: A non-profit, legally constituted, autonomous and independent organization, representing the
           interests and needs of patients, their families and caregivers, and whose objective is, among others, to provide direct
           support to the people affected by an illness, advocate for the rights of patients before Health Sector Players, to
           educate and create awareness regarding diseases, in terms of diagnosis, treatment, access to health services and
           social inclusion of patients, as well as the provision of information to patients in one or several therapeutic areas of
           interest.

           Patient Organizations can be comprised by volunteers, patients, caregivers, family members and even by Health
           Professionals or spokespersons.

           Patient: Person who receives health care, that is, who requires a service to promote, maintain, monitor or restore
           his/ her health.

           Payer: Natural or legal person who has the influence or power of decision to recommend or carry out the monetary
           acquisition of drugs and / or the disbursement of the corresponding resources, whether public or private. This term
           includes, but is not limited to, IPS, EPS, compensation funds, distributors, logistics / purchasing operators and
           druggists.

           Patient Support Program: Program implemented by a Pharmaceutical Company or by a third party on behalf of the
           Company, which involves direct or indirect interactions with a patient or caregiver, and whose main objective is the
           care and support of patients (awareness and education regarding the disease, guidance for access to medication,
           support in monitoring treatment, among others).

           Health Professional: Member of the medical profession in any of its fields and specialties or professional in any field
           of health sciences, who provides clinical treatment and care to patients, and who in the exercise of his/her profession
           could perform activities pertaining to the prescription, supply, dispensing or administration of drugs. The term covers
           all persons responsible for prescribing, recommending, applying, supplying, buying, selling or distributing drugs,
           whether public or private, including distributors, logistics and purchasing operators of the general social security
           system health, collective purchasing organizations, pharmacists, pharmacists, druggists and payers in general.

           Promotion: Any activity carried out, organized or sponsored by a pharmaceutical company intended to promote,
           directly or indirectly, the prescription, dispensation, recommendation, sale or consumption of drugs for human use.

           2.   Company purpose and responsibilities
                2.1. Responsible and participatory social action of the business sector plays a decisive role in the development
                        of society and there is a worldwide consensus on the need for private companies to move towards
                        increasingly stricter ethical environments. Those who welcome the provisions of this Code are committed
                        to promoting greater transparency of the business decisions driven by the leaders of the business
                        community and contributing to the development of an environment based on healthy competition.
                2.2. This Code of Ethics constitutes the set of rules by which, the pharmaceutical companies members of
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                 AFIDRO, making use of their self-regulatory power, have agreed to be governed both in the field of drug
                 promotion and in the interrelation with the different health system players, in order to ensure that the
                 activities carried out in the development of their corporate purpose are carried out respecting the highest
                 ethical principles of professionalism and responsibility.
         2.3. Compliance with the principles set forth in this Code ensure that the information provided in the
                 framework of the promotion of drugs is complete and truthful, in the interest of protecting and improving
                 public health and in line with the interests of health administration, as well as those of the pharmaceutical
                 industry itself. The activities or materials associated with the promotion, as well as the interrelationships
                 with the health system players, should contribute, by their content or nature, to boost confidence in the
                 pharmaceutical industry.
         2.4. This Code has been prepared in accordance with Colombian regulations in force and applies without
                 exception to all persons associated with AFIDRO and to the legal or moral persons who voluntarily adhere
                 to it.
         2.5. This Code regulates the ethical standards of AFIDRO’s member companies in their interrelations with the
                 different health system players, directly or through entities under their control.
         2.6. The guidelines contained in this Code do not seek to restrict the exchange of medical and scientific
                 information during a drug’s development phase or the interrelation between pharmaceutical companies
                 and health professionals and / or patient organizations, but rather to frame such interactions within ethical
                 standards and transparency criteria that the companies agree to comply with.
         2.7. The responsibility of the Companies in relation to the provisions of this Code extends to activities
                 pertaining to training, complying and monitoring personnel under their responsibility, regarding the
                 fulfillment of the stipulations established herein. The companies are responsible for ensuring that all
                 personnel involved in promotional and relationship activities of any kind, whether directly employed or
                 externally contracted personnel, are in a position to strictly comply with the provisions of this Code.
         2.8. Companies will be responsible for correcting any violations to this Code that result from the inappropriate
                 behavior of any of their representatives. This obligation will be extended to the sales forces of third parties
                 used for the promotion of drugs.
         2.9. Companies must comply with the spirit and letter of this Code, maintaining the same standards of behavior
                 in their interactions with the different stakeholders.
         2.10. This Code does not intend to replace or substitute the legal regulations in force or the internal Codes of
                 Conduct of AFIDRO’s member companies. In the event of conflict between the provisions of this Code and
                 the national law and / or the Code of Conduct of the company, the member company must apply the most
                 restrictive norm.

    3.   Scope
           3.1. This Code of Ethics covers all forms of interrelation of Companies with health system players in
                    educational or promotional activities related to prescription drugs, carried out by any means including
                    digitally, within the development of their corporate purpose.

           3.2. This Code of Ethics does not regulate:

             3.2.1. The business transactions carried out by the Companies with the corresponding health system
                          players.
Código de Ética AFIDRO 2019                                                                                                          9

           4.   Guiding principles on ethical conduct and promotions
                AFIDRO’s member companies carry out medical, pharmaceutical and biopharmaceutical research in order to
                benefit patients and provide high-quality medical care support; they promote, sell and distribute their drugs in
                an ethical manner and in accordance with the rules and regulations on medicines and healthcare in force.

                The guiding principles set out below establish the basic standards that comprise AFIDRO’s Code of Ethics and
                that apply to the behavior of AFIDRO’s member companies and its agents, helping to ensure the appropriateness
                of their interrelations with the different health system players.

                4.1. The main priority of AFIDRO’s member companies is health care and the welfare of patients. Their relations
                      with the health system players must always be for the benefit of the patient, for the support of healthy
                      medical practice and other sciences related to the health of Colombians, as well as for the promotion of
                      research, science and development.
                4.2. Companies will comply with the highest standards in all research, development and promotion activities
                      regarding their medicines.
                4.3. Companies must always act within a framework of legality, strictly respecting the regulations in force.
                4.4. Companies will comply with the highest standards of safety and efficacy determined by the regulatory
                      authorities and will guarantee the quality in the production of medicines, ensuring they are fully supported
                      by scientific evidence and have complied with all the required research phases, according to international
                      standards.
                4.5. Companies must have an internal pharmacovigilance program that allows for the control and monitoring
                      of those medicines whose programs must be in accordance with the international standards in the matter.
                      Likewise, it is their responsibility to immediately and clearly notify the competent national authority
                      regarding any changes to the safety information for the prescription of the drug, derived from
                      pharmacovigilance programs or from decisions made by regulatory authorities in other countries.
                4.6. Company interactions with their different interlocutors must be ethical, appropriate and professional at
                      all times and must respect autonomy and independence. No Company should offer or supply something
                      in a manner or condition that could result in inadequate influence.
                4.7. Companies are responsible for the technical and scientific information, or that related to clinical studies
                      that is communicated or presented to health professionals regarding their drugs; making sure to provide
                      valid, truthful, accurate, and balanced data supported by scientific evidence.
                4.8. Companies consider that the ethical promotion of prescription drugs to health professionals is a vital part
                      of health promotion and the prevention and treatment of diseases.
                4.9. Companies will strictly adhere to the prohibition of promoting prescription drugs to the general public.
                      Health education and prevention campaigns are not considered promotional activities.
                4.10. The promotion of medicines should be based on accurate and balanced information and should not be
                      misleading. Information contained in the promotional materials must support an appropriate evaluation
                      of the risks and benefits of the medication and its proper use.
                4.11. The promotion of medicines must be transparent. Promotional material associated with drugs and their
                      use should clearly indicate who sponsors it. Payments made in the development of promotional activities
                      must be duly documented and there must be adequate supervision to guarantee their use for the intended
                      purposes.
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          4.12. Companies must respect the privacy, confidentiality and security of third party personal data to which they
                have access. To this end, they undertake to comply with the applicable regulations on personal data
                protection, respecting the respective policies, internal mechanisms and authorizations that guarantee
                compliance with the provisions contained in Law 1581 of 2012 and Decree 1377 of 2013, or the rules that
                modify, complement or replace them. Companies will guarantee that all personal data will be treated in
                accordance with the purposes for which it is collected and will take special care in protecting personal data
                of patients.
          4.13. Companies are aware that the transgression of the ethical guidelines established in this Code negatively
                impacts the entire sector, and therefore they undertake to adopt all corresponding measures to ensure
                that they observe the provisions contained herein.

     5.   General guidelines for interrelations

          The ethical and transparent behavior of pharmaceutical companies in their interactions with the different health
          system players who have the power to influence or decide on the prescription, dispensation, recommendation,
          sale, consumption or use of medicines for human use, or that have decision-making or regulatory power over
          these matters, whether they are health professionals, payers, patients or patient organizations, health system
          officials or control and surveillance entities, must comply with the following basic guidelines:

          5.1. Ethical conduct

               5.1.1. Companies are forbidden from offering or delivering gifts or perks directly or indirectly to an Health
                       Sector Player, under the terms of this Code.

               5.1.2. The following are considered gifts or perks, among others:
                     5.1.2.1. Any type of promotional or marketing activity of drugs under the system of prizes in cash or
                                in kind such as raffles, accumulation or delivery of points or other similar methods that in
                                essence suppose that the option to participate in such activity or the delivery of such benefit
                                for the third party depends on the prescription, dispensation, recommendation, purchase,
                                sale, disposal, consumption or use of a medication.
                     5.1.2.2. The offer and / or the provision of inappropriate hospitality that exceeds the necessary,
                                reasonable and moderate logistical means in the terms stipulated in chapter 5.3 of this Code.

               5.1.3. To the extent that business practices are not compensated through them, the following do not
                       constitute gifts or perks, among others:
                     5.1.3.1. The delivery, to the same Health Professional, of publications or subscriptions to journals,
                                publications, scientific articles (nonrenewable subscriptions) and / or the delivery of medical-
                                scientific books, maximum once a year, in digital or printed media, whose commercial value
                                in the country, does not exceed one and a half of the Current Monthly Minimum Legal Wage
                                (SMLMV) and, serve an educational purpose in benefit of patient care.
                     5.1.3.2. The delivery of electronic devices for the storage of technical or scientific information specific
                                to the exercise of the Health Professional, of a modest value that does not exceed ten percent
Código de Ética AFIDRO 2019                                                                                                         11

                                  (10%) of the Current Monthly Minimum Legal Wage (SMMLV for its acronym in Spanish). The
                                  capacity of the electronic device must be adjusted and limited exclusively to technical or
                                  scientific information contained therein.
                         5.1.3.3. The outside of the electronic storage device may not have any feature or element that may
                                  induce the recognition of the product brand, such as color, shape, font or any other element
                                  that identifies it, and may only be marked with the Company’s name.
                         5.1.3.4. Items delivered by the Companies in the development of their Patient Support Programs,
                                  whose elements do not exceed a monthly value of ten percent (10%) of the Current Monthly
                                  Minimum Legal Wage and where the item delivered is related to the activities implemented
                                  in the Support Program. The elements delivered must comply with the specifications
                                  established in Chapter 7 of this Code.
                         5.1.3.5. The fees for services that comply with the conditions established in Section 6.5 of this Code.
                         5.1.3.6. Scientific research, pharmaco-economics, or non-intervention activities, directed to, or in
                                  which Health Professionals participate, and which are developed in accordance with research
                                  protocols, international and national standards and the approval of the corresponding ethics
                                  committees.
                         5.1.3.7. Sponsorship and development of the Companies’ own events or the support to third party
                                  events that comply with all the provisions of Chapter 5.3 of this Code.

                    5.1.4. Principles applicable to contractual processes:
                              Companies are obliged to observe ethical conducts that guarantee and preserve the guidelines
                              expressed in this Code in contractual processes in which they participate, in accordance with the
                              following rules:
                         5.1.4.1. They will not offer, make or promise to make or offer payments, favors, prerogatives,
                                  rewards, or gratuities and / or any other benefit or utility with the capacity and / or purpose
                                  to influence the decisions of Health System Players and / or providers, whether legal or
                                  natural persons, with the purpose of obtaining or maintaining some benefit and / or ensuring
                                  an unjustified benefit.
                         5.1.4.2. They will immediately report any offer or request that is contrary to the honest practices of
                                  payments, favors, gifts, prerogatives, rewards or gratuities, according to the compliance
                                  control procedure established in this Code.
                         5.1.4.3. They will not enter into agreements with other competitors regarding the terms of the hiring
                                  processes and / or public or private bids to which they will concur, or with other bidders
                                  regarding the terms that will be presented in a contracting and / or bidding process, unless
                                  they participate as a consortium or joint venture or the proponents are part of a corporate
                                  group.
                         5.1.4.4. They will refrain from carrying out operations with third parties whose resources originate
                                  from illegal activities. For this purpose, they will strictly comply with the applicable money
                                  laundering and terrorist financing control regulations, as well as applicable local and foreign
                                  regulations against bribery and corruption.

                    5.1.5. The Companies undertake to make available to their employees effective reporting or reporting
12                                                                                                 Código de Ética AFIDRO 2019

              channels and to adopt strict measures to correct and / or punish employees who violate or do not
              report any conduct that violates the principles and provisions of this Code. Additionally, they must
              make explicit that no employee will be subject to retaliation for reporting a behavior that violates
              the provisions of this Code.

        5.1.6. Companies cannot promote, manage, perform or finance legal actions that seek to force access to
              medications, such as writs of protection (acción de tutela).
     5.2. Transparency

        5.2.1. All promotional and non-promotional material related to drugs and their use, sponsored by a
              Company, must clearly indicate who sponsors it and comply with the requirements set forth in
              Section 6.3. When a Company finances, carried out or otherwise orders the publication of
              promotional material in scientific journals, said promotional material cannot be presented as
              independent editorial content and must clearly indicate who is sponsoring it.
        5.2.2. When Companies organize or sponsor events, this fact will be stated in all the documents related to
              the invitation, as well as in any work, paper or document published in relation to the event.
        5.2.3. Companies must document, in accordance with their internal procedures and current legislation, any
              transfer of value directly or indirectly made to Health Sector Players. This includes, among others,
              fees paid for the provision of services, financing granted for the execution of scientific and
              professional events and / or educational activities, hospitality expenses offered for an event,
              including transport costs, registration, lodging and food, and the registration or delivery of medical-
              scientific publications. In the same manner, the documentation duty covers all donations or
              contributions that the Companies deliver, directly or indirectly, to Health Sector Players. This
              documentation will not be disseminated or transmitted to competitors and will be compiled and
              maintained in accordance with the Company's own accounting and filing policies.
        5.2.4. The documentation duty described in the previous paragraph does not apply to payments made to
              Health Professionals with whom the Company has an employment relationship for the development
              of its corporate purpose, medical samples delivered in compliance with the provisions of this Code
              or printed promotional information delivered to Health Professionals.
        5.2.5. Companies must annually make available to AFIDRO, on the date on which the Executive Presidency
              so provides for publication, the list of Patient Organizations to which it has directly or indirectly
              granted economic support in cash or in kind, including a description of the support granted and its
              amount, its purpose and the identification data of the beneficiary organization. The Companies may
              not subject to confidentiality the financial support in money or kind to Patient Organizations. AFIDRO
              must publish the reported information and may contract an external audit company to corroborate
              its veracity.
        5.2.6. Companies manifest their commitment regarding the transparency of Clinical Studies and other
              research initiatives developed or sponsored by them. It has been recognized that there are important
              public health benefits associated with publicly disclosing information on Clinical Studies to
              Healthcare Professionals, patients and interested third parties, guaranteeing the security of personal
              data and compliance with current regulations regarding data protection, industrial property,
              contractual rights and good clinical practices.
Código de Ética AFIDRO 2019                                                                                                         13

               5.3. Events

                    5.3.1. Companies may organize, sponsor or support events directed to the different Health Sector Players,
                           in order to improve their level of knowledge in matters related to health care, the improvement of
                           the quality of life of patients, the provision of health services or the sustainability of the system,
                           among others.
                    5.3.2. The purpose of the events aimed at Health Sector Players organized, sponsored or supported by the
                           companies must be to provide scientific or educational information and / or inform on the medicines
                           advocating for the improvement of health care and attention to patients.
                    5.3.3. The offer or delivery of any sponsorship regarding hospitality expenses that takes place
                           independently of a scientific, professional and / or relevant health sector event, or that exceeds its
                           temporal and geographic scope, goes against the ethical guidelines established in this Code.
                           Hospitality must always be ancillary to the main purpose of the event and must be limited to
                           providing the necessary and reasonable means required for attendance and participation in the
                           event.
                    5.3.4. The invitation to an event can in no way be conditioned to an obligation or commitment to prescribe,
                           recommend, acquire, provide, administer or promote a drug.
                    5.3.5. In no case may a Transfer of Value be offered to a guest to an event as compensation for the time
                           spent attending it, except in the case of persons under contract for professional services directly
                           related to the event in question.
                    5.3.6. Companies are not allowed to organize or sponsor their own events, nor to support or sponsor third
                           party events, which contain elements or activities associated with entertainment, parties, raffles,
                           prizes or other games of luck in their agenda.

                           Activities such as a welcome reception and the closing meal that are usually part of official
                           congresses, symposiums and similar programs, as well as the recognition of academic, research
                           papers and / or publications by Health Professionals, provided they are collectively reasonable and
                           moderate and do not contain elements of leisure, entertainment, or luck activities are not included
                          in the prohibition of this numeral. Companies will also refrain from participating in events that
                          contain the elements previously mentioned.
                    5.3.7. Companies may not organize or sponsor national scientific, professional, and / or relevant events for
                          the health sector that take place outside of Colombia, with the exception of when the resources or
                          expertise relevant to the main purpose of the event are located abroad.

                          Companies may not organize their own national events outside the territory, except when most of
                          the participants, the relevant resources or expertise for the main purpose of the event, are located
                          abroad.
                    5.3.8. Companies may not carry out or sponsor case events that take in place in locations specially designed
                           for recreation, exclusively for tourism or predominantly associated with recreational or sports
                          activities.
                    5.3.9. Events organized or sponsored by the Companies must meet the following requirements:
14                                                                                             Código de Ética AFIDRO 2019

          5.3.9.1. Have a program with relevant medical, scientific or professional content, so that the quality
                   of the scientific or professional program is the main point of interest.
          5.3.9.2. Guest selection must be the result of a careful evaluation of their abilities, training and
                   experience, proving they deserve to benefit from the training in the matters addressed in the
                   event.
          5.3.9.3. The invitation to the event must be clearly and expressly identified in terms of its purpose,
                   and must clearly state and express its sponsors and scope.
          5.3.9.4. Sponsorship of hospitality expenses may only include actual travel expenses, registration,
                   lodging and guest meals, which must be moderate and reasonable, and may only be offered
                   for the duration of the scientific or professional activity.
          5.3.9.5. Refreshments and meals offered during the event should be moderate, reasonable and
                   accessory to the event’s main objective.
          5.3.9.6. Background music in the location of the event is permitted, as long as it is not paid by the
                   Company.
          5.3.9.7. The invitation cannot be extended to persons other than the beneficiaries for whom the
                   medical-scientific or professional content of the meeting is relevant for the development of
                   their practice or profession. Companies will not defray any expenses regarding companions,
                   even when the spouse or partner of the Health Professional Guest is also a Health
                   Professional, but there are no legitimate reasons for the spouse or partner to be also invited
                   to the event in question.
          5.3.9.8. Companies will be directly responsible for the payment of hospitality expenses, and may use
                   intermediary agencies, who must in turn strictly comply with the guidelines established
                   herein.
          5.3.9.9. Events supported by the Companies, but organized by third parties must be organized by a
                   legally constituted institution and comply with requirements stipulated in the previous
                   section. Companies must establish procedures for the verification of guest attendance to the
                   event in question.
          5.3.9.10. Companies must have an internal process to document that the hospitality expense
                   sponsorships given comply with all the requirements established herein, including, among
                   others, the amount, purpose, date, beneficiary, agenda and all pertinent documentation
                   necessary to prove the legitimate sponsoring need and that the sponsorship objectives are
                   met.
     5.3.10.   Hospitality expense sponsorships for Patients and Patient Organizations will strictly observe the
               following special requirements:
          5.3.10.1. Hospitality to Patient Organizations can only be paid or financed through the Patient
                   Organization and never directly to the individual Patients.
          5.3.10.2. Sponsored events for Patients cannot be promotional in nature, no attendance incentive
                   should be generated and no Patient data can be collected.
          5.3.10.3. For health reason the invitation to Patients may be extended to a companion who assists in
                   the condition of Caregiver.
Código de Ética AFIDRO 2019                                                                                                         15

               5.4. Donations and contributions

                    5.4.1. Company donations or contributions made to health care institutions must meet the following
                          requirements:
                        5.4.1.1. They obey to charitable or humanitarian reasons or for social benefit;
                        5.4.1.2. That they are granted without any consideration in favor of the donor; directly or indirectly,
                                  in money or in kind;
                        5.4.1.3. That the donation is not done for the personal benefit of the beneficiary’s employees,
                                  shareholders or officials;
                        5.4.1.4. That the donation does not constitute an incentive for the recommendation, prescription,
                                  purchase, supply, sale or administration of medications;
                        5.4.1.5. That the donation be formally documented, with the Company retaining a copy of said
                                  documents.
                    5.4.2. Companies are not allowed to grant donations to Individual Health Sector Players, but to duly
                          incorporated legal entities. Invitations or sponsorship of events are not included in this prohibition,
                          in the circumstances of moderation and reasonableness described in section 5.3 of this Code.
                    5.4.3. Companies may make contributions in the form of scholarships or academic recognition provided
                          that:
                        5.4.3.1. The payment of the value is made directly to the educational institution or scientific
                                  association and not to the beneficiary.
                        5.4.3.2. The company has no control or influence over the election of the beneficiary.
                        5.4.3.3. The present or future use, recommendation or prescription of medications is not used as
                                  criteria for the selection of candidates.
                              5.4.3.3.1. Companies should not make contributions to political parties in order to obtain
                                         advantages in business transactions or with the State, either directly or indirectly.

               5.5. Digital environment and / or information technology and communication
                    5.5.1. The continuous development of technology and the use of new media, supports and communication
                          channels by the pharmaceutical companies for the promotion of their products and their interaction
                          with the different Health Sector Players will not be an obstacle for the development of ethical
                          business behaviors. The nature of the medium, support or communication channel used does not
                          exempt laboratories from their obligation to comply with the ethical guidelines established in this
                          Code. Companies must refrain from using means that, due to their characteristics, technical
                          limitations or conditions of use, hinder compliance with the guidelines established herein.
                    5.5.2. The use of digital communication technologies provides academic information to the general public
                          regarding pathologies, their health implications, how to care for them, and non-pharmacological
                          options for their care, such as multidisciplinary and palliative care, among others.
                    5.5.3. Each Company may use a digital environment mechanism to educate Health Professionals on the
                          pharmacological options of their own products. The use of digital environment media for the
                          promotion of prescription drugs will be directed exclusively to Health Professionals with
                          authorization to prescribe and dispense medicines, within an academic and technical-scientific
                          framework. These activities must include measures to ensure that this information is only
16                                                                                                         Código de Ética AFIDRO 2019

                     disseminated to these professional groups such as:
                   5.5.3.1. A clearly legible warning indicating that the information is directed exclusively to Health
                            Professionals with authorization to prescribe or dispense medications, therefore specialized
                            training is required for its correct interpretation or,
                   5.5.3.2. The condition whereby the persons who gain access the content declare their condition as
                            Health Professional, with authorization to prescribe or dispense medication.
              5.5.4. Companies must refrain from making promotional or prescription medical content directly or
                     indirectly available to the general public by means of links, comments, markers or any other practice
                     that involves their repetition or re-submission.
              5.5.5. Companies are responsible for the content disclosed through the media, supports and
                     communication channels that directly or indirectly control or finance it, as well as for the
                     implementation of usage guidelines that establish standards of conduct, as well as a standard
                     operating procedure for the control of digital environment contents to which they give access, host,
                     copy or link. This procedure must contemplate the obligation to promptly and diligently correct any
                     irregularity.
              5.5.6. Companies must have responsible action digital environment guidelines for their employees that
                     establish consequences for non-compliance, both when presenting information about or on behalf
                     of the Company and when using a medium, support or channel provided thereby.
              5.5.7. In the interaction with Health Sector Players, Companies must always observe the rules applicable
                     to personal data protection.

     6.   Interaction with Health Professionals

          6.1. Educational and academic activities and non-promotional activities

              6.1.1. Pharmaceutical Companies support, sponsor or carry out educational and academic training activities in
                     order to supply or provide scientific or educational information to Health Sector Players, in order to
                     improve Patient care and the Health System in general.
              6.1.2. Educational activities and academic training must comply with the provisions stipulated in Section 5.3 of
                     this Code.

          6.2. Non promotional materials

              6.2.1. Elements that contain medical, scientific or technical information, and must not contain elements
                     that identify the brand or information on the products.
              6.2.2. When Companies provide content for medical education activities and medical education programs,
                     such material must be balanced, objective, accurate, truthful, and must not be misleading, that is, it
                     must be supported by relevant data. The citations used in these materials should not change or
                     distort the meaning pursued by the author or the meaning of the underlying work or study. All
                     assertions must represent the content of the sources on which they are held and these sources must
                     be cited. Direct citations must be in context and be literal, and if third party statements (not found
                     in a publication) are cited, written permission by said person must be obtained. The visual elements,
Código de Ética AFIDRO 2019                                                                                                              17

                          graphics and tables used in these materials should not be distorted, and be consistent with the
                          associated data source and text.

               6.3. Drug promotions

                    6.3.1. Drug promotion is considered to be any activity carried out, organized or sponsored by a Company
                          aimed at promoting the prescription, dispensation, recommendation, sale or consumption of
                          medicines for human use, directly or indirectly.
                    6.3.2. Companies may not carry out off-label use promotions.
                        6.3.2.1. Se entiende por promoción fuera de indicación o de registro sanitario vigente:
                        6.3.2.2. Off label use promotions are understood as:
                              6.3.2.2.1.   The provision of information on health technologies that do not have a health
                                           registration or its conditions are different from those authorized in the Health Registry.
                              6.3.2.2.2.   The distribution of material or verbal messages that directly (explicitly or implicitly) or
                                           indirectly, seek to stimulate off label use.

                                           Scientific exchange activities are not understood as off use promotions long as they
                                           comply with the conditions established in this Code.

                    6.3.3. Promotional information must be clear, legible, accurate, balanced, honest and complete so as to
                          allow the recipient to form his own opinion on the therapeutic value of the drug in question.
                          Promotional information should be based on an up-to-date assessment of all relevant evidence, and
                          must be clearly reflected. It should not be confusing due to distortion, exaggeration, undue
                          emphasis, omission or in any other way. Any ambiguity should be avoided. Absolute statements such
                          as "single" or "none" should only be used when they are adequately supported and have scientific
                          basis.
                    6.3.4. The information offered must be complete, based on scientific evidence, and must include what is
                          expressly contained in the Brief Statement, in accordance with the legal provisions in force.
                    6.3.5. Companies may not suggest or promote the substitution of medical formula, nor adopt any measure
                          that violates the autonomy of the Health Professionals.
                    6.3.6. Companies must ensure that the representatives responsible for the promotion of their drugs are
                          adequately trained and have sufficient medical and technical knowledge, in order to transmit true
                          information of the drugs they represent. Company Sales Representatives must:
                        6.3.6.1. Maintain a professional relationship with the interlocutors they visit.
                        6.3.6.2. Report on the Health Professional's observations resulting from the visits, including adverse
                                   events, which must be reported to the Companies and to the health authorities in accordance
                                   with the applicable legislation.
               6.4. Medical visits or promotional activity carried out in favor of Health Sector Players, may in
                     no case be conditioned to the payment in money or in kind as direct or indirect
                     consideration, or as compensation for the time invested in said activity.
                    6.4.1. The promotion of drugs must be based exclusively on arguments, facts and scientific data.
                    6.4.2. When designing their promotions Companies must bear in mind, that the safety and life of the
18                                                                                                  Código de Ética AFIDRO 2019

                patients is their top priority, thus maintaining in their promotional campaigns a balance between the
                therapeutic and beneficial characteristics of the drug and information on precautions,
                contraindications , warnings, interactions and side effects.
         6.4.3. Companies must ensure that any material or activity that is developed and carried out for the
                promotion and prescription of medicines by health professionals, complies with the provisions of
                this Code, with the internal requirements of the Company, with universally accepted standards and
                current legal standards. The above requirements should apply to all electronic materials, including
                audiovisual materials.
         6.4.4. Companies must have clear and written policies for their review and approval of materials processes
                and / or promotional activities, and a suitable medical department to endorse, support and approve
                them. Each Company will be responsible for:
              6.4.4.1. The scientific endorsement of the content, for both materials and promotional activities
                       related to their drugs.
              6.4.4.2. Procedures for obtaining, printing, dissemination and appropriate use of scientific references.
              6.4.4.3. Monitoring, control and harmony of the promotional message with the prescription
                       information, in force and approved by the competent authority in Colombia.
         6.4.5. Companies are responsible for including the different supporting elements, required by law and
                other regulations in force in Colombia, in materials addressed to Health Professionals.
         6.4.6. Promotions should be based on scientific studies and the attributes of the drug and not on the
                weaknesses of the competitors. Comparisons will be acceptable provided they are objective, truthful
                and do not contain affirmations that affect the good name of third parties. Comparisons should be
                made on analogous or comparable matters supported by a scientific publication.
     6.5. Promotional Items, Medical Use Items, Educational Items, Gifts, Medical Samples
         6.5.1. The distribution and supply of Promotional Items are expressly prohibited.
                These may only be provided to Health Professionals, within the framework of an event and only in
                the amount necessary for the purpose of the event, pens and note pads, of a minimum value, which
                may be marked with the Company's logo.
         6.5.2. Medical use Items may be provided occasionally; their amount must not exceed fifty percent (50%)
                of a Current Monthly Minimum Legal Wage (SMLMV) during the entire year. They may include the
                Company logo, but not the product brand, except when the name of the product is essential for the
                correct use of the item by the patient.
         6.5.3. Informative or Educational Articles, including medical and scientific books or subscriptions to
                magazines, publications, and scientific articles that are provided by the Companies to Health
                Professionals, and electronic storage devices, may only include the Company logo and the
                therapeutic line, but not the product brand, except when this is essential for the correct use of the
                item by the patient.
                Books and subscriptions may only be delivered once a year, in digital or printed media, to the same
                Health Professional and their commercial value in the country, may not exceed, in total one and a
                half Current Monthly Minimum Legal Wage (SMLMV) for the same year.
                Electronic storage devices downloaded with technical-scientific medical information must be of
                moderate value, not to exceed 10% of a Current Monthly Minimum Legal Wage (SMLMV) and with
                a capacity adjusted and limited to technical or scientific information contained therein.
Código de Ética AFIDRO 2019                                                                                                          19

                             The outside of the electronic storage device may not have any feature or element that may induce
                             the recognition of the product brand, such as color, shape, font or any other element that identifies
                             it, and may only be marked with the Company’s name.
                    6.5.4. The delivery of gifts to Health Sector Players is expressly prohibited.

           Medical samples

                    6.5.5. Medical samples may be delivered to Healthcare Professionals who are authorized to prescribe
                             drugs, in accordance with the provisions of the laws in force, in compliance with the following
                             requirements:
                         6.5.5.1. The samples must delivered with the sole purpose of improving patient care;
                         6.5.5.2. They must be duly marked as medical samples, in accordance with current regulations, to
                                   ensure they are not sold or used in an improper manner.
                         6.5.5.3. They must be delivered to Health Professionals, in a modest and reasonable amount
                                   according to their purpose.
                         6.5.5.4. They must be subject to adequate control and monitoring systems, including the authorized
                                   monitoring of samples by Sales Representatives.
                         6.5.5.5. They cannot be offered or given as an incentive or reward for the prescription, administration,
                                    recommendation, payment or supply of any drug or service by the Company, to obtain any
                                    improper advantage, or for the personal use of the Professional who receives it.

               6.6. Professional services
                    6.6.1. Hiring Professional services as consultants and advisors for promotional or scientific activities is
                             allowed.
                    6.6.2. The hiring of Health Professionals must meet the following requirements:

                         6.6.2.1. There must be a legitimate need for contracting the services.
                         6.6.2.2. The Company must subscribe, in advance, a contract that identifies the services, the amount
                                    of the fees, the deliverables for which the Professional is responsible, the verification
                                    mechanism for their delivery and the term of the contract. Additionally, the contract must
                                    include a clause in virtue of which the Health Professional agrees to declare, expressly and
                                    clearly, that it provides services to the Company, whenever it is publicly stated.
                         6.6.2.3. The choice of Health Professional must be in accordance with the identified need and the
                                    number of Professionals hired must not exceed the amount reasonably needed to achieve the
                                    intended objective.
                         6.6.2.4. The agreed fees must obey market criteria, be consistent with the time invested, the services
                                    provided and the responsibilities assumed. The fees must be in money and not in kind, and
                                    cash payments are not allowed. The total annual fees that a Health Professional receives for
                                    services rendered to a Company must be reasonable.
                         6.6.2.5. The hiring of a Health Professional to provide the relevant service should not be an incentive
                                    to prescribe, recommend, acquire, provide and / or administer a drug.
20                                                                                                  Código de Ética AFIDRO 2019

             6.6.2.6. The payment of travel expenses, lodging and food costs related to the contracted services,
                      which are reasonable and duly supported and that comply with the requirements and
                      conditions set forth in Chapter 5 of this Code, may be agreed upon.
             6.6.2.7. The contracting company must keep the supporting documents for the services provided.
             6.6.2.8. The location of any meeting held with the contracted professionals should not be used to try
                      to promote prescription.
             6.6.2.9. All meetings organized by the Companies with Health Professionals must comply with the
                      terms and conditions set forth in Chapter 5 of this Code.
     6.7. Clinical research
         6.7.1. Any type of clinical study, sponsored by a Company, in any of its phases, must be conducted in such
               a way as to preserve its scientific support, in such a way that it is not used to exert undue influence
               on prescription by Health Professionals, or to expand the habit of prescribing medications. These
               studies should be developed in accordance with research protocols, international and national
               standards, and the approval of the corresponding Ethics Committees.

               All clinical studies sponsored by the Companies, who adopt the provisions of the Code, will be
               developed in accordance with the Good Clinical Practice Guidelines, the Declaration of Helsinki, the
               Nuremberg Code, the Universal Declaration on Bioethics and Human Rights of UNESCO, and other
               Colombian and international regulations, established for that purpose.
         6.7.2. Phase IV clinical studies should not exercise undue influence on formulation by health professionals.
         6.7.3. So-called "seeding studies", "clinical experiences" or similar, whose objective is to promote new

               medicines in order to influence the prescription habit of Health Professionals, are prohibited.

     6.8. Market research
         6.8.1. The Companies may conduct market research activites in order to obtain new insights or look for
               elements that support the decision making process for their business, however, this must be done
               according to the following conditions:

             6.8.1.1. The legitimate need for the investigation must be clearly established prior to initiating the
                      process;
             6.8.1.2. The anonymity and respect for the confidentiality of the participants must be guaranteed in
                      the corresponding report;
             6.8.1.3. The market research activities should not be carried out directly by the Company’s marketing
                      or sales personnel;
             6.8.1.4. Participants may receive moderate and reasonable compensation for their participation;
                      representing fair market value consistent with the time invested, the work done and the
                      responsibilities assumed. The payment must be made in cash or its equivalent (not in kind),
                      and be properly documented.
             6.8.1.5. Hiring Health Professionals and / or the entities to carry out the research, must be formalized
                      through a written agreement established with the Company sponsoring the study. Said
                      agreements must be approved prior to their implementation, specifying the nature of the
                      services provided, objectives, conditions for participation, remuneration for the Professionals,
                      target population, and collection methods.
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