PHRMA updates its code on interactions with health professionals

March 14, 2022

A very sensitive issue for the pharmaceutical industry, and for the medical and hospital products industry concerns the limits in their interaction with health professionals, especially physicians who prescribe drugs, and medical and hospital products.

It is indeed a singular enterprise, as medicines and medical/hospital products intended to treat patients are prescribed by physicians rather than the manufacturer thereof. The challenge then is establishing limits undertaken by companies in this segment especially in marketing and even in medical education, so that there is no undue interference in the relationship of physicians with their patients. Furthermore, these companies already face an unsympathetic public opinion, which focuses on costs instead of the benefits to patient's health and well-being. Were it not for the pharmaceutical industry, the risk of dying from an infections caused by mere cuts or from flu complications would be common. The most recent example of the pandemic caused bySARS-COV-2: the number of deaths would be greatly multiplied without an intensive vaccination program.

The Pharmaceutical Research and Manufacturers of America – PhRMA, founded in 1958 and based in Washington, DC, updated its Code on Interactions with Health Professionals, seeking to further clarify the limits of actions by their members, so as to mitigate potential conflicts of interest and avoid initiatives that can be considered as acts of corruption in the public or private sectors; although the US does not criminalize such acts of corruption when the beneficiary is someone from the private sector, as does Brazil.

While the main changes were introduced to Section 7 “Speaker Programs and Speaker Training Meetings”, the new version did introduce changes to the following sections:

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2. Informational Presentations by Pharmaceutical Company Representatives and Accompanying Meals

3. Prohibition on Entertainment and Recreation

4. Pharmaceutical Company Support For Continuing Medical Education (CME)

5. Pharmaceutical Company Support for Third-Party Educational or Professional Meetings

6. Consultants

7. Speaker Programs and Speaker Training Meetings

10. Prohibition of Non-Educational and Practice-Related Items

11. Educational Items

15. Adherence to Code

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The changes are highlighted in bold below, session by session, after the update in force as of 2022:

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2019 UPDATE 2022 UPDATE
1. Basis of Interactions Our relationships with health care professionals are regulated by multiple entities and are intended to benefit patients and to enhance the practice of medicine. Interactions should be focused on informing health care professionals about products, providing scientific and educational information and supporting medical education. Promotional materials provided to health care professionals by or on behalf of a company should: (a) be accurate and not misleading; (b) make claims about a product only when properly substantiated; (c) reflect the balance between risks and benefits; and (d) be consistent with all other Food and Drug Administration (FDA) requirements governing such communications. 1. Basis of Interactions Our relationships with health care professionals are regulated by multiple entities and are intended to benefit patients and to enhance the practice of medicine. Interactions should be focused on informing health care professionals about products, providing scientific and educational information and supporting medical education. Promotional materials provided to health care professionals by or on behalf of a company should: (a) be accurate and not misleading; (b) make claims about a product only when properly substantiated; (c) reflect the balance between risks and benefits; and (d) be consistent with all other Food and Drug Administration (FDA) requirements governing such communications.
2. Informational Presentations by Pharmaceutical Company Representatives and Accompanying Meals Informational presentations and discussions by industry representatives and others speaking on behalf of a company provide health care providers with valuable scientific and clinical information about medicines that may lead to improved patient care. In order to provide important scientific information and to respect health care professionals’ abilities to manage their schedules and provide patient care, company representatives may take the opportunity to present information during health care professionals’ working day, including mealtimes. In connection with such presentations or discussions, it is appropriate for occasional meals to be offered as a business courtesy to the health care professionals as well as members of their staff attending presentations, so long as the presentations provide scientific or educational value and the meals (a) are modest as judged by local standards; (b) are not part of an entertainment or recreational event; and (c) are provided in a manner conducive to informational communication. Any such meals offered in connection with informational presentations made by field sales representatives or their immediate managers should also be limited to in-office or in-hospital settings. Inclusion of a health care professional’s spouse or other guest in a meal accompanying an informational presentation made by or on behalf of a company is not appropriate. Offering “take-out” meals or meals to be eaten without a company representative being present (such as “dine & dash” programs) is not appropriate. 2. Informational Presentations by Pharmaceutical Company Representatives and Accompanying Meals Informational presentations and discussions by industry representatives and others speaking on behalf of a company provide health care providers with valuable scientific and clinical information about medicines that may lead to improved patient care. In order to provide important scientific information and to respect health care professionals’ abilities to manage their schedules and provide patient care, company representatives may take the opportunity to present information during health care professionals’ working day, including mealtimes. In connection with such presentations or discussions, it is appropriate for occasional, incidental meals to be offered as a business courtesy to the health care professionals, as well as members of their staff attending presentations, so long as the presentation provides scientific or educational value and the meal provided is: (a) modest as judged by local standards; (b) not part of an entertainment or recreational event; and (c) provided in a manner conducive to informational communication. Any such incidental meals offered in connection with informational presentations made by field sales representatives or their immediate managers should also be limited to in-office or in-hospital settings. Inclusion of an attendee’s significant other or guest in a meal accompanying an informational presentation made by or on behalf of a company is not appropriate. Incidental meals can be provided only where there is a reasonable expectation, and reasonable steps are taken to confirm, that each attendee has a substantive interaction or discussion with the company representative. This Section 2 does not address informational presentations that do not include a meal provided by a company representative.
3. Prohibition on Entertainment and Recreation Company interactions with health care professionals are professional in nature and are intended to facilitate the exchange of medical or scientific information that will benefit patient care. To ensure the appropriate focus on education and informational exchange and to avoid the appearance of impropriety, companies should not provide any entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips, to any healthcare professional who is not a salaried employee of the company. Such entertainment or recreational benefits should not be offered, regardless of (1) the value of the items; (2) whether the company engages the health care professional as a speaker or consultant, or (3) whether the entertainment or recreation is secondary to an educational purpose. Modest, occasional meals are permitted as long as they are offered in the appropriate circumstances and venues as described in relevant sections of this Code. 3. Prohibition on Entertainment and Recreation Company interactions with health care professionals are professional in nature and are intended to facilitate the exchange of medical or scientific information that will benefit patient care. To ensure the appropriate focus on education and informational exchange and to avoid the appearance of impropriety, companies should not provide any entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips, to any healthcare professional who is not a salaried employee of the company. Such entertainment or recreational benefits should not be offered, regardless of (1) the value of the items; (2) whether the company engages the health care professional as a speaker or consultant, or (3) whether the entertainment or recreation is secondary to an educational purpose. Occasional meals that are modest as judged by local standards are permitted as long as they are offered in the appropriate circumstances and venues as described in relevant sections of this Code.
4. Pharmaceutical Company Support for Continuing Medical Education (CME)
Continuing medical education (CME), also known as independent medical education (IME), helps physicians and other medical professionals to obtain information and insights that can contribute to the improvement of patient care, and therefore, financial support from companies is appropriate. Such financial support for CME is intended to support education on a full range of treatment options and not to promote a particular medicine. Accordingly, a company should separate its CME grant-making functions from its sales and marketing departments. In addition, a company should develop objective criteria for making CME grant decisions to ensure that the program funded by the company is a bona fide educational program and that the financial support is not an inducement to prescribe or recommend a particular medicine or course of treatment. Since the giving of any subsidy directly to a health care professional by a company may be viewed as an inappropriate cash gift, any financial support should be given to the CME provider, which, in turn, can use the money to reduce the overall CME registration fee for all participants. The company should respect the independent judgment of the CME provider and should follow standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) or other entity that may accredit the CME. When companies underwrite CME, responsibility for and control over the selection of content, faculty, educational methods, materials and venue belongs to the organizers of the conferences or meetings in accordance with their guidelines. The company should not provide any advice or guidance to the CME provider, even if asked by the provider, regarding the content or faculty for a particular CME program funded by the company. Financial support should not be offered for the costs of travel, lodging, or other personal expenses of non-faculty health care professionals attending CME, either directly to the individuals participating in the event or indirectly to the event’s sponsor (except as set out in Section 9 below). Similarly, funding should not be offered to compensate for the time spent by health care professionals participating in the CME event. A company should not provide meals directly at CME events. 		4. Pharmaceutical Company Support for Continuing Medical Education (CME)
Continuing medical education (CME), also known as independent medical education (IME), helps physicians and other medical professionals to obtain information and insights that can contribute to the improvement of patient care, and therefore, financial support from companies is appropriate. Such financial support for CME is intended to support education on a full range of treatment options and not to promote a particular medicine. Accordingly, a company should separate its CME grant-making functions from its sales and marketing departments. In addition, a company should develop objective criteria for making CME grant decisions to ensure that the program funded by the company is a bona fide educational program and that the financial support is not an inducement to prescribe or recommend a particular medicine or course of treatment. Since the giving of any subsidy directly to a health care professional by a company may be viewed as an inappropriate cash gift, any financial support should be given to the CME provider, which, in turn, can use the money to reduce the overall CME registration fee for all participants. The company should respect the independent judgment of the CME provider and should follow standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) or other entity that may accredit the CME. When companies underwrite CME, responsibility for and control over the selection of content, faculty, educational methods, materials, and venue or digital platform belongs to the organizers of the conferences or meetings in accordance with their guidelines. The company should not provide any advice or guidance to the CME provider, even if asked by the provider, regarding the content or faculty for a particular CME program funded by the company. Financial support should not be offered for the costs of travel, lodging, or other personal expenses of non-faculty health care professionals attending CME, either directly to the individuals participating in the event or indirectly to the event’s sponsor (except as set out in Section 9 below). Similarly, funding should not be offered to compensate for the time spent by health care professionals participating in the CME event. A company should not provide meals directly at CME events, except that a CME provider at its own discretion may apply the financial support provided by a company for a CME event to provide meals for all participants This Section 4 applies to in-person CME events and virtual CME events conducted via a digital platform (with audio and/or video conferencing capabilities) with or without an associated in-person event.
5. Pharmaceutical Company Support for Third-Party Educational or Professional Meetings
Third-party scientific and educational conferences or professional meetings can contribute to the improvement of patient care, and therefore, financial support from companies is appropriate. A conference or meeting is any activity, held at an appropriate location (typically limited to the health care professional’s country of practice unless there are security or logistical concerns, which would include international scientific congresses and symposia), where (a) the gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentation(s) should be the highlight of the gathering), and (b) the main incentive for bringing attendees together is to further their knowledge on the topic(s) being presented. Financial support should not be offered for the costs of travel, lodging, or other personal expenses of non-faculty health care professionals attending third-party scientific or educational conferences or professional meetings, either directly to the individuals attending the conference or indirectly to the conference’s sponsor. Similarly, funding should not be offered to compensate for the time spent by health care professionals attending the conference or meeting. 		5. Pharmaceutical Company Support for Third-Party Educational or Professional Meetings
Third-party scientific and educational conferences or professional meetings can contribute to the improvement of patient care, and therefore, financial support from companies is appropriate. A conference or meeting is any activity, held virtually or at an appropriate physical location (typically physical locations are limited to the health care professional’s country of practice unless there are security or logistical concerns, which would include international scientific congresses and symposia), where: (a) the event is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentation(s) should be the highlight of the event), and (b) the main incentive for bringing attendees together is to further their knowledge on the topic(s) being presented. Financial support should not be offered for the costs of travel, lodging, or other personal expenses of non-faculty health care professionals attending third-party scientific or educational conferences or professional meetings, either directly to the individuals attending the conference or indirectly to the conference's sponsor. Similarly, funding should not be offered to compensate for the time spent by health care professionals attending the conference or meeting. This Section 5 applies to in-person third-party scientific and educational conferences or professional meetings and virtual meetings conducted via a digital platform (with audio and/or video conferencing capabilities) with or without an associated in-person event.
6. Consultants
Decisions regarding the selection or retention of health care professionals as consultants should be made based on defined criteria such as general medical expertise and reputation, or knowledge and experience regarding a particular therapeutic area. It is appropriate for consultants who provide advisory services to be offered reasonable compensation for those services and reimbursement for reasonable travel, lodging, and meal expenses incurred as part of providing those services. Any compensation or reimbursement made in conjunction with a consulting arrangement should be reasonable and based on fair market value. Token consulting or advisory arrangements should not be used to justify compensating health care professionals for their time or their travel, lodging, and other out-of-pocket expenses. The following factors support the existence of a bona fide consulting arrangement (not all factors may be relevant to any particular arrangement): • a written contract specifies the nature of the consulting services to be provided and the basis for payment of those services; • a legitimate need for the consulting services has been clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants; • the criteria for selecting consultants are directly related to the identified purpose and the persons responsible for selecting the consultants have the expertise necessary to evaluate whether the particular healthcare professionals meet those criteria; • the number of health care professionals retained is not greater than the number reasonably necessary to achieve the identified purpose; • the retaining company maintains records concerning and makes appropriate use of the services provided by consultants; • the venue and circumstances of any meeting with consultants are conducive to the consulting services and activities related to the services are the primary focus of the meeting; specifically, resorts are not appropriate venues. While modest meals or receptions may be appropriate during company sponsored meetings with health care professional commercial consultants, companies should not provide recreational or entertainment events in conjunction with these meetings. 		6. Consultants
Decisions regarding the selection or retention of health care professionals as consultants should be made based on defined criteria such as general medical expertise and reputation, or knowledge and experience regarding a particular therapeutic area. It is appropriate for consultants who provide advisory services to be offered reasonable compensation for those services and reimbursement for reasonable travel, lodging, and meal expenses incurred as part of providing those services. Any compensation or reimbursement made in conjunction with a consulting arrangement should be reasonable and based on fair market value and should not take into account the volume or value of past business that may have been or potential future business that could be generated for the company by the health care professional consultant. Token consulting or advisory arrangements should not be used to justify compensating health care professionals for their time or their travel, lodging, and other out-of-pocket expenses. The following factors support the existence of a bona fide consulting arrangement (not all factors may be relevant to any particular arrangement): • a written contract specifies the nature of the consulting services to be provided and the basis for payment of those services; • a legitimate need for the consulting services has been clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants; • the criteria for selecting consultants are directly related to the identified purpose and the persons responsible for selecting the consultants have the expertise necessary to evaluate whether the particular health care professionals meet those criteria; • the number of health care professionals retained is not greater than the number reasonably necessary to achieve the identified purpose; • the retaining company maintains records concerning and makes appropriate use of the services provided by consultants; • the venue and circumstances of any meeting with consultants are conducive to the consulting services, and activities related to the services are the primary focus of the meeting; luxury resorts, high-end restaurants, and entertainment, sporting, or other recreational venues or events are not appropriate. While receptions or meals that are modest as judged by local standards may be appropriate during company-sponsored meetings with health care professional commercial consultants, companies should not provide recreational or entertainment events in conjunction with these meetings.
7. Speaker Programs and Speaker Training Meetings Health care professionals participate in company-sponsored speaker programs in order to help educate and inform other health care professionals. Any health care professional engaged by a company to participate in such external promotional programs on behalf of the company will be deemed a speaker for purposes of this Code, and the requirements of Section 7 apply to company interactions with that health care professional in his or her capacity as a company speaker. Company decisions regarding the selection or retention of health care professionals as speakers should be made based on defined criteria such as general medical expertise and reputation, knowledge and experience regarding a particular therapeutic area, and communications skills. Companies should continue to ensure that speaking arrangements are neither inducements nor rewards for prescribing a particular medicine or course of treatment. Speaker training is an essential activity because the FDA holds companies accountable for the presentations of their speakers. It is appropriate for health care professionals who participate in programs intended to train speakers for company-sponsored speaker programs to be offered reasonable compensation for their time, considering the value of the type of services provided, and to be offered reimbursement for reasonable travel, lodging, and meal expenses. Such compensation and reimbursement should only be offered when (1) the participants receive extensive training on the company’s drug products or other specific topic to be presented and on compliance with FDA regulatory requirements for communications; (2) this training will result in the participants providing a valuable service to the company; and (3) the participants meet the general criteria for bona fide consulting arrangements (as discussed in Section 6 above). Speaker training sessions should be held in venues and locations (typically limited to the speaker’s country of practice unless there are security or logistical concerns) that are appropriate and conducive to informational communication and training about medical information; specifically, resorts are not appropriate venues. Any compensation or reimbursement made to a health care professional in conjunction with a speaking arrangement should be reasonable and based on fair market value. Each company should, individually and independently, cap the total amount of annual compensation it will pay to an individual health care professional in connection with all speaking arrangements. Each company also should develop policies addressing the appropriate use of speakers, including utilization of speakers after training and the appropriate number of engagements for any particular speaker over time. Speaker programs may include modest meals offered to attendees and should occur in a venue and manner conducive to informational communication. Speaker programs may include modest meals offered to attendees and should occur in a venue and manner conducive to informational communication. While speaker programs offer important educational opportunities to health care professionals, they are distinct from CME programs, and companies and speakers should be clear about this distinction. For example, speakers and their materials should clearly identify the company that is sponsoring the presentation, the fact that the speaker is presenting on behalf of the company, and that the speaker is presenting information that is consistent with FDA guidelines. Beyond providing all speakers with appropriate training, companies should periodically monitor speaker programs for compliance with FDA regulatory requirements for communications on behalf of the company about its medicines. 7. Speaker Programs and Speaker Training Meetings
Company-sponsored speaker programs provide substantive educational information about the benefits, risks, and appropriate uses of company medicines and related disease states. While speaker programs offer important educational opportunities to health care professionals, they are distinct from CME programs, and companies and speakers should be clear about this distinction. For example, speakers and their materials should clearly identify the company that is sponsoring the presentation, the fact that the speaker is presenting on behalf of the company, and that the speaker is presenting information that is consistent with FDA guidelines. Beyond providing all speakers with appropriate training, as discussed further below, companies should periodically monitor speaker programs for compliance with FDA regulatory requirements for communications on behalf of the company about its medicines. Incidental meals of modest value may be offered to attendees of company sponsored speaker programs, subject to the following principles: • The purpose of the speaker program should be to present substantive educational information designed to help address a bona fide educational need among attendees, taking into account recent substantive changes in relevant information (e.g., new medical or scientific information or a new FDA-approved indication for the product) or the importance of the availability of such educational programming. • Only those with a bona fide educational need for the information should be invited. • Incidental meals furnished to attendees must be modest as judged by local standards, as well as subordinate in focus to the educational presentation. • Companies should not pay for or provide alcohol in connection with the speaker program. • The speaker program should occur in a venue and manner conducive to informational communication, and a company representative should be physically present. For speaker programs at third-party venues, the third-party venue selected by the company should not be extravagant or the main attraction of the event or perceived as such. Luxury resorts, high-end restaurants, and entertainment, sporting, or other recreational venues or events are not appropriate. • Repeat attendance at a speaker program on the same or substantially the same topic is generally not appropriate unless the attendee has a bona fide educational need to receive the information presented. Attendance by speakers as participants at programs after speaking on the same or substantially the same topic is generally not appropriate. • Friends, significant others, family members, and other guests of a speaker or an invited attendee are not appropriate speaker program attendees unless such individuals have an independent, bona fide educational need to receive the information presented. The PhRMA Code does not address attendance at a speaker program that does not include an incidental meal to the attendee. In addition, the following principles apply to companies’ retention of health care professionals as speakers at company-sponsored speaker programs. First, health care professionals may be engaged by companies as speakers for company-sponsored speaker programs to help educate and inform other health care professionals who have an independent, bona fide educational need to receive information about the benefits, risks, and appropriate uses of company medicines and related disease states. Any health care professional engaged by a company to speak at such external promotional programs on behalf of the company will be deemed a speaker for purposes of this Code, and the requirements of Section 7 apply to company interactions with that health care professional in their capacity as a speaker. It is appropriate for companies to offer health care professionals speaking on behalf of a company compensation for their time and reimbursement of certain reasonable travel, lodging, and meal expenses incurred in connection with company-sponsored speaker programs. Second, company decisions regarding the selection or retention of health care professionals as speakers should be made based on defined criteria such as general medical expertise and reputation, knowledge and experience regarding a particular therapeutic area, and communications skills. Companies should continue to ensure that speaking arrangements are neither inducements nor rewards for prescribing a particular medicine or course of treatment. Companies should not select a health care professional to serve as a speaker based on past revenue that the speaker has generated or potential future revenue that the speaker could generate by prescribing or ordering a company’s products. Third, health care professionals engaged by the company as speakers also participate in company-sponsored speaker training programs. Speaker training is an essential activity because the FDA holds companies accountable for the presentations of their speakers. It is appropriate for health care professionals who participate in programs intended to train speakers for company-sponsored speaker programs to be offered reasonable compensation for their time and to be offered reimbursement for reasonable travel, lodging, and meal expenses. Such compensation and reimbursement should only be offered when (1) the participants receive extensive training on the company’s drug products or other specific topic to be presented and on compliance with FDA regulatory requirements for communications; (2) this training will result in the participants providing a valuable service to the company; and (3) the participants meet the general criteria for bona fide consulting arrangements (as discussed in Section 6 above). Speaker training programs should be held in venues and locations (typically limited to the speaker’s country of practice unless there are security or logistical concerns) that are appropriate and conducive to informational communication and training about medical information. Venues should not be renowned, extravagant, or the main attraction of the event or perceived as such. Luxury resorts, high-end restaurants, and entertainment, sporting, or other recreational venues or events are not appropriate. Finally, any compensation or reimbursement made to a health care professional in conjunction with a speaking arrangement (including company-sponsored speaker training) should be reasonable and based on fair market value and should not take into account the volume or value of past business that may have been or potential future business that could be generated for the company by the health care professional. Each company should, individually and independently, cap the total amount of annual compensation it will pay to an individual health care professional in connection with all speaking arrangements. Each company also should develop policies addressing the appropriate use of speakers, including utilization of speakers after training and the appropriate number of engagements for any particular speaker over time.
8. Health care Professionals Who are Members of Committees That Set Formularies or Develop Clinical Practice Guidelines
To avoid even the appearance of impropriety, companies should require any healthcare professional who is a member of a committee that sets formularies or develops clinical guidelines and also serves as a speaker or commercial consultant for the company to disclose to the committee the existence and nature of his or her relationship with the company. This disclosure requirement should extend for at least two years beyond the termination of any speaker or consultant arrangement. Upon disclosure, health care professionals who serve as speakers or consultants for companies should be required to follow the procedures set forth by the committee of which they are a member, which may include recusing themselves from decisions relating to the medicine for which they have provided speaking or consulting services. 		8. Health care Professionals Who are Members of Committees That Set Formularies or Develop Clinical Practice Guidelines
To avoid even the appearance of impropriety, companies should require any healthcare professional who is a member of a committee that sets formularies or develops clinical guidelines and also serves as a speaker or commercial consultant for the company to disclose to the committee the existence and nature of his or her relationship with the company. This disclosure requirement should extend for at least two years beyond the termination of any speaker or consultant arrangement. Upon disclosure, health care professionals who serve as speakers or consultants for companies should be required to follow the procedures set forth by the committee of which they are a member, which may include recusing themselves from decisions relating to the medicine for which they have provided speaking or consulting services.
9. Scholarships and Educational Funds
Financial assistance for scholarships or other educational funds to permit medical students, residents, fellows and other health care professionals in training to attend carefully selected educational conferences may be offered so long as the selection of individuals who will receive the funds is made by the academic or training institution. “Carefully selected educational conferences” are generally defined as the major educational, scientific or policymaking meetings of national, regional or specialty medical associations. 		9. Scholarships and Educational Funds
Financial assistance for scholarships or other educational funds to permit medical students, residents, fellows and other health care professionals in training to attend carefully selected educational conferences may be offered so long as the selection of individuals who will receive the funds is made by the academic or training institution. “Carefully selected educational conferences” are generally defined as the major educational, scientific or policymaking meetings of national, regional or specialty medical associations.
10. Prohibition of Non-Educational and Practice-Related Items
Providing items for health care professionals’ use that do not advance disease or treatment education — even if they are practice-related items of minimal value (such as pens, note pads, mugs and similar “reminder” items with company or product logos) — may foster misperceptions that company interactions with health care professionals are not based on informing them about medical and scientific issues. Such non-educational items should not be offered to health care professionals or members of their staff, even if they are accompanied by patient or physician educational materials. Items intended for the personal benefit of health care professionals (such as floral arrangements, artwork, music CDs or tickets to a sporting event) likewise should not be offered. Payments in cash or cash equivalents (such as gift certificates) should not be offered to health care professionals either directly or indirectly, except as compensation for bona fide services (as described in Sections 6 and 7). Cash or equivalent payments of any kind create a potential appearance of impropriety or conflict of interest. It is appropriate to provide product samples for patient use in accordance with the Prescription Drug Marketing Act. 		10. Prohibition of Non-Educational and Practice-Related Items
Providing items for health care professionals’ use that do not advance disease or treatment education — even if they are practice-related items of minimal value (such as pens, note pads, mugs and similar “reminder” items with company or product logos) — may foster misperceptions that company interactions with health care professionals are not based on informing them about medical and scientific issues. Such non-educational items should not be offered to health care professionals or members of their staff, even if they are accompanied by patient or physician educational materials. Items intended for the personal benefit of health care professionals (such as floral arrangements, artwork, or tickets to a sporting event) likewise should not be offered. Payments in cash or cash equivalents (such as gift certificates) should not be offered to health care professionals either directly or indirectly, except as compensation for bona fide services (as described in Sections 6 and 7). Cash or equivalent payments of any kind create a potential appearance of impropriety or conflict of interest. It is appropriate to provide product samples for patient use in accordance with the Prescription Drug Marketing Act.
11. Educational Items
It is appropriate for companies, where permitted by law, to offer items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to health care professionals outside of his or her professional responsibilities. For example, an anatomical model for use in an examination room is intended for the education of the patients and is therefore appropriate, whereas a DVD or CD player may have independent value to a health care professional outside of his or her professional responsibilities, even if it could also be used to provide education to patients, and therefore is not appropriate. Items designed primarily for the education of patients or health care professionals should not be offered on more than an occasional basis, even if each individual item is appropriate. 		11. Educational Items
It is appropriate for companies, where permitted by law, to offer items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to health care professionals outside of his or her professional responsibilities. For example, an anatomical model for use in an examination room is intended for the education of patients and is therefore appropriate, whereas a laptop may have independent value to a health care professional outside of their professional responsibilities, even if it could also be used to provide education to patients, and therefore is not appropriate.. Items designed primarily for the education of patients or health care professionals should not be offered on more than an occasional basis, even if each individual item is appropriate.
12. Prescriber Data
Companies use non-patient identified prescriber data to facilitate the efficient flow of information to health care professionals. Such prescriber data, which does not identify individual patients, may serve many purposes, including enabling companies to: (a) impart important safety and risk information to prescribers of a particular drug; (b) conduct research; (c) comply with FDA mandated risk management plans that require drug companies to identify and interact with physicians who prescribe certain drugs; (d) track adverse events of marketed prescriptions drugs; and (e) focus marketing activities on those health care professionals who would most likely benefit from information about a particular drug. Companies that choose to use non-patient identified prescriber data to facilitate communications with health care professionals should use this data responsibly. For example, companies should (a) respect the confidential nature of prescriber data; (b) develop policies regarding the use of the data; (c) educate employees and agents about those policies; (d) maintain an internal contact person to handle inquiries regarding the use of the data; and (e) identify appropriate disciplinary actions for misuse of this data. In addition, companies should respect and abide by the wishes of any health care professional who asks that his or her prescriber data not be made available to company sales representatives. Companies may demonstrate this respect by following the rules of voluntary programs that facilitate prescribers' ability to make this choice. 		12. Prescriber Data
Companies use non-patient identified prescriber data to facilitate the efficient flow of information to health care professionals. Such prescriber data, which does not identify individual patients, may serve many purposes, including enabling companies to: (a) impart important safety and risk information to prescribers of a particular drug; (b) conduct research; (c) comply with FDA mandated risk management plans that require drug companies to identify and interact with physicians who prescribe certain drugs; (d) track adverse events of marketed prescriptions drugs; and (e) focus marketing activities on those health care professionals who would most likely benefit from information about a particular drug. Companies that choose to use non-patient identified prescriber data to facilitate communications with health care professionals should use this data responsibly. For example, companies should (a) respect the confidential nature of prescriber data; (b) develop policies regarding the use of the data; (c) educate employees and agents about those policies; (d) maintain an internal contact person to handle inquiries regarding the use of the data; and (e) identify appropriate disciplinary actions for misuse of this data. In addition, companies should respect and abide by the wishes of any health care professional who asks that his or her prescriber data not be made available to company sales representatives. Companies may demonstrate this respect by following the rules of voluntary programs that facilitate prescribers' ability to make this choice.
13. Independence and Decision Making
No grants, scholarships, subsidies, support, consulting contracts or educational or practice related items should be provided or offered to a health care professional in exchange for prescribing products or for a commitment to continue prescribing products. Nothing should be offered or provided in a manner or on conditions that would interfere with the independence of a health care professional's prescribing practices. 		13. Independence and Decision Making
No grants, scholarships, subsidies, support, consulting contracts or educational or practice related items should be provided or offered to a health care professional in exchange for prescribing products or for a commitment to continue prescribing products. Nothing should be offered or provided in a manner or on conditions that would interfere with the independence of a health care professional's prescribing practices.
14. Training and Conduct of Company Representatives
Pharmaceutical company representatives play an important role in delivering accurate, up-to-date information to health care professionals about the approved indications, benefits and risks of pharmaceutical therapies. These representatives often serve as the primary point of contact between the companies who research, develop, manufacture and market life-saving and life-enhancing medicines and the health care professionals who prescribe them. As such, the company representatives must act with the highest degree of professionalism and integrity. Companies should ensure that all representatives who are employed by or acting on behalf of the companies and who visit health care professionals receive training about the applicable laws, regulations and industry codes of practice, including this Code, that govern the representatives’ interactions with health care professionals. In addition, companies should train their representatives to ensure that they have sufficient knowledge of general science and product-specific information to provide accurate, up-to-date information, consistent with FDA requirements. Companies should provide updated or additional training in all of these areas as needed for their representatives who visit health care professionals. Companies should also assess their representatives periodically to ensure that they comply with relevant company policies and standards of conduct. Companies should take appropriate action when representatives fail to comply. 		14. Training and Conduct of Company Representatives
Pharmaceutical company representatives play an important role in delivering accurate, up-to-date information to health care professionals about the approved indications, benefits and risks of pharmaceutical therapies. These representatives often serve as the primary point of contact between the companies who research, develop, manufacture and market life-saving and life-enhancing medicines and the health care professionals who prescribe them. As such, the company representatives must act with the highest degree of professionalism and integrity. Companies should ensure that all representatives who are employed by or acting on behalf of the companies and who visit health care professionals receive training about the applicable laws, regulations and industry codes of practice, including this Code, that govern the representatives’ interactions with health care professionals. In addition, companies should train their representatives to ensure that they have sufficient knowledge of general science and product-specific information to provide accurate, up-to-date information, consistent with FDA requirements. Companies should provide updated or additional training in all of these areas as needed for their representatives who visit health care professionals. Companies should also assess their representatives periodically to ensure that they comply with relevant company policies and standards of conduct. Companies should take appropriate action when representatives fail to comply.
15. Adherence to Code
All companies that interact with health care professionals about pharmaceuticals should adopt procedures to assure adherence to this Code. Companies that publicly announce their commitment to abide by the Code and who complete an annual certification that they have policies and procedures in place to foster compliance with the Code will be identified by PhRMA on a public web site. The certification must be signed by the company's Chief Executive Officer and Chief Compliance Officer. The web site will identify the companies who commit to abide by the Code; provide contact information for their Chief Compliance Officers; and, at the appropriate time, publish the status of each company’s annual certification. Any comments received by PhRMA relating to a company's observance of the Code or conduct that is addressed by the Code will be referred by PhRMA to the relevant company's Chief Compliance Officer. In addition, companies are encouraged to seek external verification periodically, meaning at least once every three years, that the company has policies and procedures in place to foster compliance with the Code. PhRMA will prepare general guidance for such external verification and will identify on its web site if a company has sought and obtained verification of its compliance policies and procedures from an external source. 		15. Adherence to Code
All companies that interact with health care professionals about pharmaceuticals should adopt procedures that foster compliance with this Code. Companies that publicly announce their commitment to abide by the Code and who complete an annual certification that they have policies and procedures in place to foster compliance with the Code will be identified by PhRMA on a public web site. The certification must be signed by the company's Chief Executive Officer and Chief Compliance Officer. The web site will identify the companies who commit to abide by the Code; provide contact information for their Chief Compliance Officers; and, at the appropriate time, publish the status of each company’s annual certification. Any comments received by PhRMA relating to a company's observance of the Code or conduct that is addressed by the Code will be referred by PhRMA to the relevant company's Chief Compliance Officer. In addition, companies are encouraged to seek external verification periodically, meaning at least once every three years, that the company has policies and procedures in place to foster compliance with the Code. PhRMA has prepared general guidance for such external verification and will identify on its web site if a company has sought and obtained verification of its compliance policies and procedures from an external source..

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Recently, Brazil's Association of the Pharmaceutical Research Industry (INTERFARMA) has also updated its code of conduct, which will be the subject a future post.

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PHRMA updates its code on interactions with health professionals

March 14, 2022
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A very sensitive issue for the pharmaceutical industry, and for the medical and hospital products industry concerns the limits in their interaction with health professionals, especially physicians who prescribe drugs, and medical and hospital products.

It is indeed a singular enterprise, as medicines and medical/hospital products intended to treat patients are prescribed by physicians rather than the manufacturer thereof. The challenge then is establishing limits undertaken by companies in this segment especially in marketing and even in medical education, so that there is no undue interference in the relationship of physicians with their patients. Furthermore, these companies already face an unsympathetic public opinion, which focuses on costs instead of the benefits to patient's health and well-being. Were it not for the pharmaceutical industry, the risk of dying from an infections caused by mere cuts or from flu complications would be common. The most recent example of the pandemic caused bySARS-COV-2: the number of deaths would be greatly multiplied without an intensive vaccination program.

The Pharmaceutical Research and Manufacturers of America – PhRMA, founded in 1958 and based in Washington, DC, updated its Code on Interactions with Health Professionals, seeking to further clarify the limits of actions by their members, so as to mitigate potential conflicts of interest and avoid initiatives that can be considered as acts of corruption in the public or private sectors; although the US does not criminalize such acts of corruption when the beneficiary is someone from the private sector, as does Brazil.

While the main changes were introduced to Section 7 “Speaker Programs and Speaker Training Meetings”, the new version did introduce changes to the following sections:

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2. Informational Presentations by Pharmaceutical Company Representatives and Accompanying Meals

3. Prohibition on Entertainment and Recreation

4. Pharmaceutical Company Support For Continuing Medical Education (CME)

5. Pharmaceutical Company Support for Third-Party Educational or Professional Meetings

6. Consultants

7. Speaker Programs and Speaker Training Meetings

10. Prohibition of Non-Educational and Practice-Related Items

11. Educational Items

15. Adherence to Code

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The changes are highlighted in bold below, session by session, after the update in force as of 2022:

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2019 UPDATE 2022 UPDATE
1. Basis of Interactions Our relationships with health care professionals are regulated by multiple entities and are intended to benefit patients and to enhance the practice of medicine. Interactions should be focused on informing health care professionals about products, providing scientific and educational information and supporting medical education. Promotional materials provided to health care professionals by or on behalf of a company should: (a) be accurate and not misleading; (b) make claims about a product only when properly substantiated; (c) reflect the balance between risks and benefits; and (d) be consistent with all other Food and Drug Administration (FDA) requirements governing such communications. 1. Basis of Interactions Our relationships with health care professionals are regulated by multiple entities and are intended to benefit patients and to enhance the practice of medicine. Interactions should be focused on informing health care professionals about products, providing scientific and educational information and supporting medical education. Promotional materials provided to health care professionals by or on behalf of a company should: (a) be accurate and not misleading; (b) make claims about a product only when properly substantiated; (c) reflect the balance between risks and benefits; and (d) be consistent with all other Food and Drug Administration (FDA) requirements governing such communications.
2. Informational Presentations by Pharmaceutical Company Representatives and Accompanying Meals Informational presentations and discussions by industry representatives and others speaking on behalf of a company provide health care providers with valuable scientific and clinical information about medicines that may lead to improved patient care. In order to provide important scientific information and to respect health care professionals’ abilities to manage their schedules and provide patient care, company representatives may take the opportunity to present information during health care professionals’ working day, including mealtimes. In connection with such presentations or discussions, it is appropriate for occasional meals to be offered as a business courtesy to the health care professionals as well as members of their staff attending presentations, so long as the presentations provide scientific or educational value and the meals (a) are modest as judged by local standards; (b) are not part of an entertainment or recreational event; and (c) are provided in a manner conducive to informational communication. Any such meals offered in connection with informational presentations made by field sales representatives or their immediate managers should also be limited to in-office or in-hospital settings. Inclusion of a health care professional’s spouse or other guest in a meal accompanying an informational presentation made by or on behalf of a company is not appropriate. Offering “take-out” meals or meals to be eaten without a company representative being present (such as “dine & dash” programs) is not appropriate. 2. Informational Presentations by Pharmaceutical Company Representatives and Accompanying Meals Informational presentations and discussions by industry representatives and others speaking on behalf of a company provide health care providers with valuable scientific and clinical information about medicines that may lead to improved patient care. In order to provide important scientific information and to respect health care professionals’ abilities to manage their schedules and provide patient care, company representatives may take the opportunity to present information during health care professionals’ working day, including mealtimes. In connection with such presentations or discussions, it is appropriate for occasional, incidental meals to be offered as a business courtesy to the health care professionals, as well as members of their staff attending presentations, so long as the presentation provides scientific or educational value and the meal provided is: (a) modest as judged by local standards; (b) not part of an entertainment or recreational event; and (c) provided in a manner conducive to informational communication. Any such incidental meals offered in connection with informational presentations made by field sales representatives or their immediate managers should also be limited to in-office or in-hospital settings. Inclusion of an attendee’s significant other or guest in a meal accompanying an informational presentation made by or on behalf of a company is not appropriate. Incidental meals can be provided only where there is a reasonable expectation, and reasonable steps are taken to confirm, that each attendee has a substantive interaction or discussion with the company representative. This Section 2 does not address informational presentations that do not include a meal provided by a company representative.
3. Prohibition on Entertainment and Recreation Company interactions with health care professionals are professional in nature and are intended to facilitate the exchange of medical or scientific information that will benefit patient care. To ensure the appropriate focus on education and informational exchange and to avoid the appearance of impropriety, companies should not provide any entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips, to any healthcare professional who is not a salaried employee of the company. Such entertainment or recreational benefits should not be offered, regardless of (1) the value of the items; (2) whether the company engages the health care professional as a speaker or consultant, or (3) whether the entertainment or recreation is secondary to an educational purpose. Modest, occasional meals are permitted as long as they are offered in the appropriate circumstances and venues as described in relevant sections of this Code. 3. Prohibition on Entertainment and Recreation Company interactions with health care professionals are professional in nature and are intended to facilitate the exchange of medical or scientific information that will benefit patient care. To ensure the appropriate focus on education and informational exchange and to avoid the appearance of impropriety, companies should not provide any entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips, to any healthcare professional who is not a salaried employee of the company. Such entertainment or recreational benefits should not be offered, regardless of (1) the value of the items; (2) whether the company engages the health care professional as a speaker or consultant, or (3) whether the entertainment or recreation is secondary to an educational purpose. Occasional meals that are modest as judged by local standards are permitted as long as they are offered in the appropriate circumstances and venues as described in relevant sections of this Code.
4. Pharmaceutical Company Support for Continuing Medical Education (CME)
Continuing medical education (CME), also known as independent medical education (IME), helps physicians and other medical professionals to obtain information and insights that can contribute to the improvement of patient care, and therefore, financial support from companies is appropriate. Such financial support for CME is intended to support education on a full range of treatment options and not to promote a particular medicine. Accordingly, a company should separate its CME grant-making functions from its sales and marketing departments. In addition, a company should develop objective criteria for making CME grant decisions to ensure that the program funded by the company is a bona fide educational program and that the financial support is not an inducement to prescribe or recommend a particular medicine or course of treatment. Since the giving of any subsidy directly to a health care professional by a company may be viewed as an inappropriate cash gift, any financial support should be given to the CME provider, which, in turn, can use the money to reduce the overall CME registration fee for all participants. The company should respect the independent judgment of the CME provider and should follow standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) or other entity that may accredit the CME. When companies underwrite CME, responsibility for and control over the selection of content, faculty, educational methods, materials and venue belongs to the organizers of the conferences or meetings in accordance with their guidelines. The company should not provide any advice or guidance to the CME provider, even if asked by the provider, regarding the content or faculty for a particular CME program funded by the company. Financial support should not be offered for the costs of travel, lodging, or other personal expenses of non-faculty health care professionals attending CME, either directly to the individuals participating in the event or indirectly to the event’s sponsor (except as set out in Section 9 below). Similarly, funding should not be offered to compensate for the time spent by health care professionals participating in the CME event. A company should not provide meals directly at CME events. 		4. Pharmaceutical Company Support for Continuing Medical Education (CME)
Continuing medical education (CME), also known as independent medical education (IME), helps physicians and other medical professionals to obtain information and insights that can contribute to the improvement of patient care, and therefore, financial support from companies is appropriate. Such financial support for CME is intended to support education on a full range of treatment options and not to promote a particular medicine. Accordingly, a company should separate its CME grant-making functions from its sales and marketing departments. In addition, a company should develop objective criteria for making CME grant decisions to ensure that the program funded by the company is a bona fide educational program and that the financial support is not an inducement to prescribe or recommend a particular medicine or course of treatment. Since the giving of any subsidy directly to a health care professional by a company may be viewed as an inappropriate cash gift, any financial support should be given to the CME provider, which, in turn, can use the money to reduce the overall CME registration fee for all participants. The company should respect the independent judgment of the CME provider and should follow standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) or other entity that may accredit the CME. When companies underwrite CME, responsibility for and control over the selection of content, faculty, educational methods, materials, and venue or digital platform belongs to the organizers of the conferences or meetings in accordance with their guidelines. The company should not provide any advice or guidance to the CME provider, even if asked by the provider, regarding the content or faculty for a particular CME program funded by the company. Financial support should not be offered for the costs of travel, lodging, or other personal expenses of non-faculty health care professionals attending CME, either directly to the individuals participating in the event or indirectly to the event’s sponsor (except as set out in Section 9 below). Similarly, funding should not be offered to compensate for the time spent by health care professionals participating in the CME event. A company should not provide meals directly at CME events, except that a CME provider at its own discretion may apply the financial support provided by a company for a CME event to provide meals for all participants This Section 4 applies to in-person CME events and virtual CME events conducted via a digital platform (with audio and/or video conferencing capabilities) with or without an associated in-person event.
5. Pharmaceutical Company Support for Third-Party Educational or Professional Meetings
Third-party scientific and educational conferences or professional meetings can contribute to the improvement of patient care, and therefore, financial support from companies is appropriate. A conference or meeting is any activity, held at an appropriate location (typically limited to the health care professional’s country of practice unless there are security or logistical concerns, which would include international scientific congresses and symposia), where (a) the gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentation(s) should be the highlight of the gathering), and (b) the main incentive for bringing attendees together is to further their knowledge on the topic(s) being presented. Financial support should not be offered for the costs of travel, lodging, or other personal expenses of non-faculty health care professionals attending third-party scientific or educational conferences or professional meetings, either directly to the individuals attending the conference or indirectly to the conference’s sponsor. Similarly, funding should not be offered to compensate for the time spent by health care professionals attending the conference or meeting. 		5. Pharmaceutical Company Support for Third-Party Educational or Professional Meetings
Third-party scientific and educational conferences or professional meetings can contribute to the improvement of patient care, and therefore, financial support from companies is appropriate. A conference or meeting is any activity, held virtually or at an appropriate physical location (typically physical locations are limited to the health care professional’s country of practice unless there are security or logistical concerns, which would include international scientific congresses and symposia), where: (a) the event is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentation(s) should be the highlight of the event), and (b) the main incentive for bringing attendees together is to further their knowledge on the topic(s) being presented. Financial support should not be offered for the costs of travel, lodging, or other personal expenses of non-faculty health care professionals attending third-party scientific or educational conferences or professional meetings, either directly to the individuals attending the conference or indirectly to the conference's sponsor. Similarly, funding should not be offered to compensate for the time spent by health care professionals attending the conference or meeting. This Section 5 applies to in-person third-party scientific and educational conferences or professional meetings and virtual meetings conducted via a digital platform (with audio and/or video conferencing capabilities) with or without an associated in-person event.
6. Consultants
Decisions regarding the selection or retention of health care professionals as consultants should be made based on defined criteria such as general medical expertise and reputation, or knowledge and experience regarding a particular therapeutic area. It is appropriate for consultants who provide advisory services to be offered reasonable compensation for those services and reimbursement for reasonable travel, lodging, and meal expenses incurred as part of providing those services. Any compensation or reimbursement made in conjunction with a consulting arrangement should be reasonable and based on fair market value. Token consulting or advisory arrangements should not be used to justify compensating health care professionals for their time or their travel, lodging, and other out-of-pocket expenses. The following factors support the existence of a bona fide consulting arrangement (not all factors may be relevant to any particular arrangement): • a written contract specifies the nature of the consulting services to be provided and the basis for payment of those services; • a legitimate need for the consulting services has been clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants; • the criteria for selecting consultants are directly related to the identified purpose and the persons responsible for selecting the consultants have the expertise necessary to evaluate whether the particular healthcare professionals meet those criteria; • the number of health care professionals retained is not greater than the number reasonably necessary to achieve the identified purpose; • the retaining company maintains records concerning and makes appropriate use of the services provided by consultants; • the venue and circumstances of any meeting with consultants are conducive to the consulting services and activities related to the services are the primary focus of the meeting; specifically, resorts are not appropriate venues. While modest meals or receptions may be appropriate during company sponsored meetings with health care professional commercial consultants, companies should not provide recreational or entertainment events in conjunction with these meetings. 		6. Consultants
Decisions regarding the selection or retention of health care professionals as consultants should be made based on defined criteria such as general medical expertise and reputation, or knowledge and experience regarding a particular therapeutic area. It is appropriate for consultants who provide advisory services to be offered reasonable compensation for those services and reimbursement for reasonable travel, lodging, and meal expenses incurred as part of providing those services. Any compensation or reimbursement made in conjunction with a consulting arrangement should be reasonable and based on fair market value and should not take into account the volume or value of past business that may have been or potential future business that could be generated for the company by the health care professional consultant. Token consulting or advisory arrangements should not be used to justify compensating health care professionals for their time or their travel, lodging, and other out-of-pocket expenses. The following factors support the existence of a bona fide consulting arrangement (not all factors may be relevant to any particular arrangement): • a written contract specifies the nature of the consulting services to be provided and the basis for payment of those services; • a legitimate need for the consulting services has been clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants; • the criteria for selecting consultants are directly related to the identified purpose and the persons responsible for selecting the consultants have the expertise necessary to evaluate whether the particular health care professionals meet those criteria; • the number of health care professionals retained is not greater than the number reasonably necessary to achieve the identified purpose; • the retaining company maintains records concerning and makes appropriate use of the services provided by consultants; • the venue and circumstances of any meeting with consultants are conducive to the consulting services, and activities related to the services are the primary focus of the meeting; luxury resorts, high-end restaurants, and entertainment, sporting, or other recreational venues or events are not appropriate. While receptions or meals that are modest as judged by local standards may be appropriate during company-sponsored meetings with health care professional commercial consultants, companies should not provide recreational or entertainment events in conjunction with these meetings.
7. Speaker Programs and Speaker Training Meetings Health care professionals participate in company-sponsored speaker programs in order to help educate and inform other health care professionals. Any health care professional engaged by a company to participate in such external promotional programs on behalf of the company will be deemed a speaker for purposes of this Code, and the requirements of Section 7 apply to company interactions with that health care professional in his or her capacity as a company speaker. Company decisions regarding the selection or retention of health care professionals as speakers should be made based on defined criteria such as general medical expertise and reputation, knowledge and experience regarding a particular therapeutic area, and communications skills. Companies should continue to ensure that speaking arrangements are neither inducements nor rewards for prescribing a particular medicine or course of treatment. Speaker training is an essential activity because the FDA holds companies accountable for the presentations of their speakers. It is appropriate for health care professionals who participate in programs intended to train speakers for company-sponsored speaker programs to be offered reasonable compensation for their time, considering the value of the type of services provided, and to be offered reimbursement for reasonable travel, lodging, and meal expenses. Such compensation and reimbursement should only be offered when (1) the participants receive extensive training on the company’s drug products or other specific topic to be presented and on compliance with FDA regulatory requirements for communications; (2) this training will result in the participants providing a valuable service to the company; and (3) the participants meet the general criteria for bona fide consulting arrangements (as discussed in Section 6 above). Speaker training sessions should be held in venues and locations (typically limited to the speaker’s country of practice unless there are security or logistical concerns) that are appropriate and conducive to informational communication and training about medical information; specifically, resorts are not appropriate venues. Any compensation or reimbursement made to a health care professional in conjunction with a speaking arrangement should be reasonable and based on fair market value. Each company should, individually and independently, cap the total amount of annual compensation it will pay to an individual health care professional in connection with all speaking arrangements. Each company also should develop policies addressing the appropriate use of speakers, including utilization of speakers after training and the appropriate number of engagements for any particular speaker over time. Speaker programs may include modest meals offered to attendees and should occur in a venue and manner conducive to informational communication. Speaker programs may include modest meals offered to attendees and should occur in a venue and manner conducive to informational communication. While speaker programs offer important educational opportunities to health care professionals, they are distinct from CME programs, and companies and speakers should be clear about this distinction. For example, speakers and their materials should clearly identify the company that is sponsoring the presentation, the fact that the speaker is presenting on behalf of the company, and that the speaker is presenting information that is consistent with FDA guidelines. Beyond providing all speakers with appropriate training, companies should periodically monitor speaker programs for compliance with FDA regulatory requirements for communications on behalf of the company about its medicines. 7. Speaker Programs and Speaker Training Meetings
Company-sponsored speaker programs provide substantive educational information about the benefits, risks, and appropriate uses of company medicines and related disease states. While speaker programs offer important educational opportunities to health care professionals, they are distinct from CME programs, and companies and speakers should be clear about this distinction. For example, speakers and their materials should clearly identify the company that is sponsoring the presentation, the fact that the speaker is presenting on behalf of the company, and that the speaker is presenting information that is consistent with FDA guidelines. Beyond providing all speakers with appropriate training, as discussed further below, companies should periodically monitor speaker programs for compliance with FDA regulatory requirements for communications on behalf of the company about its medicines. Incidental meals of modest value may be offered to attendees of company sponsored speaker programs, subject to the following principles: • The purpose of the speaker program should be to present substantive educational information designed to help address a bona fide educational need among attendees, taking into account recent substantive changes in relevant information (e.g., new medical or scientific information or a new FDA-approved indication for the product) or the importance of the availability of such educational programming. • Only those with a bona fide educational need for the information should be invited. • Incidental meals furnished to attendees must be modest as judged by local standards, as well as subordinate in focus to the educational presentation. • Companies should not pay for or provide alcohol in connection with the speaker program. • The speaker program should occur in a venue and manner conducive to informational communication, and a company representative should be physically present. For speaker programs at third-party venues, the third-party venue selected by the company should not be extravagant or the main attraction of the event or perceived as such. Luxury resorts, high-end restaurants, and entertainment, sporting, or other recreational venues or events are not appropriate. • Repeat attendance at a speaker program on the same or substantially the same topic is generally not appropriate unless the attendee has a bona fide educational need to receive the information presented. Attendance by speakers as participants at programs after speaking on the same or substantially the same topic is generally not appropriate. • Friends, significant others, family members, and other guests of a speaker or an invited attendee are not appropriate speaker program attendees unless such individuals have an independent, bona fide educational need to receive the information presented. The PhRMA Code does not address attendance at a speaker program that does not include an incidental meal to the attendee. In addition, the following principles apply to companies’ retention of health care professionals as speakers at company-sponsored speaker programs. First, health care professionals may be engaged by companies as speakers for company-sponsored speaker programs to help educate and inform other health care professionals who have an independent, bona fide educational need to receive information about the benefits, risks, and appropriate uses of company medicines and related disease states. Any health care professional engaged by a company to speak at such external promotional programs on behalf of the company will be deemed a speaker for purposes of this Code, and the requirements of Section 7 apply to company interactions with that health care professional in their capacity as a speaker. It is appropriate for companies to offer health care professionals speaking on behalf of a company compensation for their time and reimbursement of certain reasonable travel, lodging, and meal expenses incurred in connection with company-sponsored speaker programs. Second, company decisions regarding the selection or retention of health care professionals as speakers should be made based on defined criteria such as general medical expertise and reputation, knowledge and experience regarding a particular therapeutic area, and communications skills. Companies should continue to ensure that speaking arrangements are neither inducements nor rewards for prescribing a particular medicine or course of treatment. Companies should not select a health care professional to serve as a speaker based on past revenue that the speaker has generated or potential future revenue that the speaker could generate by prescribing or ordering a company’s products. Third, health care professionals engaged by the company as speakers also participate in company-sponsored speaker training programs. Speaker training is an essential activity because the FDA holds companies accountable for the presentations of their speakers. It is appropriate for health care professionals who participate in programs intended to train speakers for company-sponsored speaker programs to be offered reasonable compensation for their time and to be offered reimbursement for reasonable travel, lodging, and meal expenses. Such compensation and reimbursement should only be offered when (1) the participants receive extensive training on the company’s drug products or other specific topic to be presented and on compliance with FDA regulatory requirements for communications; (2) this training will result in the participants providing a valuable service to the company; and (3) the participants meet the general criteria for bona fide consulting arrangements (as discussed in Section 6 above). Speaker training programs should be held in venues and locations (typically limited to the speaker’s country of practice unless there are security or logistical concerns) that are appropriate and conducive to informational communication and training about medical information. Venues should not be renowned, extravagant, or the main attraction of the event or perceived as such. Luxury resorts, high-end restaurants, and entertainment, sporting, or other recreational venues or events are not appropriate. Finally, any compensation or reimbursement made to a health care professional in conjunction with a speaking arrangement (including company-sponsored speaker training) should be reasonable and based on fair market value and should not take into account the volume or value of past business that may have been or potential future business that could be generated for the company by the health care professional. Each company should, individually and independently, cap the total amount of annual compensation it will pay to an individual health care professional in connection with all speaking arrangements. Each company also should develop policies addressing the appropriate use of speakers, including utilization of speakers after training and the appropriate number of engagements for any particular speaker over time.
8. Health care Professionals Who are Members of Committees That Set Formularies or Develop Clinical Practice Guidelines
To avoid even the appearance of impropriety, companies should require any healthcare professional who is a member of a committee that sets formularies or develops clinical guidelines and also serves as a speaker or commercial consultant for the company to disclose to the committee the existence and nature of his or her relationship with the company. This disclosure requirement should extend for at least two years beyond the termination of any speaker or consultant arrangement. Upon disclosure, health care professionals who serve as speakers or consultants for companies should be required to follow the procedures set forth by the committee of which they are a member, which may include recusing themselves from decisions relating to the medicine for which they have provided speaking or consulting services. 		8. Health care Professionals Who are Members of Committees That Set Formularies or Develop Clinical Practice Guidelines
To avoid even the appearance of impropriety, companies should require any healthcare professional who is a member of a committee that sets formularies or develops clinical guidelines and also serves as a speaker or commercial consultant for the company to disclose to the committee the existence and nature of his or her relationship with the company. This disclosure requirement should extend for at least two years beyond the termination of any speaker or consultant arrangement. Upon disclosure, health care professionals who serve as speakers or consultants for companies should be required to follow the procedures set forth by the committee of which they are a member, which may include recusing themselves from decisions relating to the medicine for which they have provided speaking or consulting services.
9. Scholarships and Educational Funds
Financial assistance for scholarships or other educational funds to permit medical students, residents, fellows and other health care professionals in training to attend carefully selected educational conferences may be offered so long as the selection of individuals who will receive the funds is made by the academic or training institution. “Carefully selected educational conferences” are generally defined as the major educational, scientific or policymaking meetings of national, regional or specialty medical associations. 		9. Scholarships and Educational Funds
Financial assistance for scholarships or other educational funds to permit medical students, residents, fellows and other health care professionals in training to attend carefully selected educational conferences may be offered so long as the selection of individuals who will receive the funds is made by the academic or training institution. “Carefully selected educational conferences” are generally defined as the major educational, scientific or policymaking meetings of national, regional or specialty medical associations.
10. Prohibition of Non-Educational and Practice-Related Items
Providing items for health care professionals’ use that do not advance disease or treatment education — even if they are practice-related items of minimal value (such as pens, note pads, mugs and similar “reminder” items with company or product logos) — may foster misperceptions that company interactions with health care professionals are not based on informing them about medical and scientific issues. Such non-educational items should not be offered to health care professionals or members of their staff, even if they are accompanied by patient or physician educational materials. Items intended for the personal benefit of health care professionals (such as floral arrangements, artwork, music CDs or tickets to a sporting event) likewise should not be offered. Payments in cash or cash equivalents (such as gift certificates) should not be offered to health care professionals either directly or indirectly, except as compensation for bona fide services (as described in Sections 6 and 7). Cash or equivalent payments of any kind create a potential appearance of impropriety or conflict of interest. It is appropriate to provide product samples for patient use in accordance with the Prescription Drug Marketing Act. 		10. Prohibition of Non-Educational and Practice-Related Items
Providing items for health care professionals’ use that do not advance disease or treatment education — even if they are practice-related items of minimal value (such as pens, note pads, mugs and similar “reminder” items with company or product logos) — may foster misperceptions that company interactions with health care professionals are not based on informing them about medical and scientific issues. Such non-educational items should not be offered to health care professionals or members of their staff, even if they are accompanied by patient or physician educational materials. Items intended for the personal benefit of health care professionals (such as floral arrangements, artwork, or tickets to a sporting event) likewise should not be offered. Payments in cash or cash equivalents (such as gift certificates) should not be offered to health care professionals either directly or indirectly, except as compensation for bona fide services (as described in Sections 6 and 7). Cash or equivalent payments of any kind create a potential appearance of impropriety or conflict of interest. It is appropriate to provide product samples for patient use in accordance with the Prescription Drug Marketing Act.
11. Educational Items
It is appropriate for companies, where permitted by law, to offer items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to health care professionals outside of his or her professional responsibilities. For example, an anatomical model for use in an examination room is intended for the education of the patients and is therefore appropriate, whereas a DVD or CD player may have independent value to a health care professional outside of his or her professional responsibilities, even if it could also be used to provide education to patients, and therefore is not appropriate. Items designed primarily for the education of patients or health care professionals should not be offered on more than an occasional basis, even if each individual item is appropriate. 		11. Educational Items
It is appropriate for companies, where permitted by law, to offer items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to health care professionals outside of his or her professional responsibilities. For example, an anatomical model for use in an examination room is intended for the education of patients and is therefore appropriate, whereas a laptop may have independent value to a health care professional outside of their professional responsibilities, even if it could also be used to provide education to patients, and therefore is not appropriate.. Items designed primarily for the education of patients or health care professionals should not be offered on more than an occasional basis, even if each individual item is appropriate.
12. Prescriber Data
Companies use non-patient identified prescriber data to facilitate the efficient flow of information to health care professionals. Such prescriber data, which does not identify individual patients, may serve many purposes, including enabling companies to: (a) impart important safety and risk information to prescribers of a particular drug; (b) conduct research; (c) comply with FDA mandated risk management plans that require drug companies to identify and interact with physicians who prescribe certain drugs; (d) track adverse events of marketed prescriptions drugs; and (e) focus marketing activities on those health care professionals who would most likely benefit from information about a particular drug. Companies that choose to use non-patient identified prescriber data to facilitate communications with health care professionals should use this data responsibly. For example, companies should (a) respect the confidential nature of prescriber data; (b) develop policies regarding the use of the data; (c) educate employees and agents about those policies; (d) maintain an internal contact person to handle inquiries regarding the use of the data; and (e) identify appropriate disciplinary actions for misuse of this data. In addition, companies should respect and abide by the wishes of any health care professional who asks that his or her prescriber data not be made available to company sales representatives. Companies may demonstrate this respect by following the rules of voluntary programs that facilitate prescribers' ability to make this choice. 		12. Prescriber Data
Companies use non-patient identified prescriber data to facilitate the efficient flow of information to health care professionals. Such prescriber data, which does not identify individual patients, may serve many purposes, including enabling companies to: (a) impart important safety and risk information to prescribers of a particular drug; (b) conduct research; (c) comply with FDA mandated risk management plans that require drug companies to identify and interact with physicians who prescribe certain drugs; (d) track adverse events of marketed prescriptions drugs; and (e) focus marketing activities on those health care professionals who would most likely benefit from information about a particular drug. Companies that choose to use non-patient identified prescriber data to facilitate communications with health care professionals should use this data responsibly. For example, companies should (a) respect the confidential nature of prescriber data; (b) develop policies regarding the use of the data; (c) educate employees and agents about those policies; (d) maintain an internal contact person to handle inquiries regarding the use of the data; and (e) identify appropriate disciplinary actions for misuse of this data. In addition, companies should respect and abide by the wishes of any health care professional who asks that his or her prescriber data not be made available to company sales representatives. Companies may demonstrate this respect by following the rules of voluntary programs that facilitate prescribers' ability to make this choice.
13. Independence and Decision Making
No grants, scholarships, subsidies, support, consulting contracts or educational or practice related items should be provided or offered to a health care professional in exchange for prescribing products or for a commitment to continue prescribing products. Nothing should be offered or provided in a manner or on conditions that would interfere with the independence of a health care professional's prescribing practices. 		13. Independence and Decision Making
No grants, scholarships, subsidies, support, consulting contracts or educational or practice related items should be provided or offered to a health care professional in exchange for prescribing products or for a commitment to continue prescribing products. Nothing should be offered or provided in a manner or on conditions that would interfere with the independence of a health care professional's prescribing practices.
14. Training and Conduct of Company Representatives
Pharmaceutical company representatives play an important role in delivering accurate, up-to-date information to health care professionals about the approved indications, benefits and risks of pharmaceutical therapies. These representatives often serve as the primary point of contact between the companies who research, develop, manufacture and market life-saving and life-enhancing medicines and the health care professionals who prescribe them. As such, the company representatives must act with the highest degree of professionalism and integrity. Companies should ensure that all representatives who are employed by or acting on behalf of the companies and who visit health care professionals receive training about the applicable laws, regulations and industry codes of practice, including this Code, that govern the representatives’ interactions with health care professionals. In addition, companies should train their representatives to ensure that they have sufficient knowledge of general science and product-specific information to provide accurate, up-to-date information, consistent with FDA requirements. Companies should provide updated or additional training in all of these areas as needed for their representatives who visit health care professionals. Companies should also assess their representatives periodically to ensure that they comply with relevant company policies and standards of conduct. Companies should take appropriate action when representatives fail to comply. 		14. Training and Conduct of Company Representatives
Pharmaceutical company representatives play an important role in delivering accurate, up-to-date information to health care professionals about the approved indications, benefits and risks of pharmaceutical therapies. These representatives often serve as the primary point of contact between the companies who research, develop, manufacture and market life-saving and life-enhancing medicines and the health care professionals who prescribe them. As such, the company representatives must act with the highest degree of professionalism and integrity. Companies should ensure that all representatives who are employed by or acting on behalf of the companies and who visit health care professionals receive training about the applicable laws, regulations and industry codes of practice, including this Code, that govern the representatives’ interactions with health care professionals. In addition, companies should train their representatives to ensure that they have sufficient knowledge of general science and product-specific information to provide accurate, up-to-date information, consistent with FDA requirements. Companies should provide updated or additional training in all of these areas as needed for their representatives who visit health care professionals. Companies should also assess their representatives periodically to ensure that they comply with relevant company policies and standards of conduct. Companies should take appropriate action when representatives fail to comply.
15. Adherence to Code
All companies that interact with health care professionals about pharmaceuticals should adopt procedures to assure adherence to this Code. Companies that publicly announce their commitment to abide by the Code and who complete an annual certification that they have policies and procedures in place to foster compliance with the Code will be identified by PhRMA on a public web site. The certification must be signed by the company's Chief Executive Officer and Chief Compliance Officer. The web site will identify the companies who commit to abide by the Code; provide contact information for their Chief Compliance Officers; and, at the appropriate time, publish the status of each company’s annual certification. Any comments received by PhRMA relating to a company's observance of the Code or conduct that is addressed by the Code will be referred by PhRMA to the relevant company's Chief Compliance Officer. In addition, companies are encouraged to seek external verification periodically, meaning at least once every three years, that the company has policies and procedures in place to foster compliance with the Code. PhRMA will prepare general guidance for such external verification and will identify on its web site if a company has sought and obtained verification of its compliance policies and procedures from an external source. 		15. Adherence to Code
All companies that interact with health care professionals about pharmaceuticals should adopt procedures that foster compliance with this Code. Companies that publicly announce their commitment to abide by the Code and who complete an annual certification that they have policies and procedures in place to foster compliance with the Code will be identified by PhRMA on a public web site. The certification must be signed by the company's Chief Executive Officer and Chief Compliance Officer. The web site will identify the companies who commit to abide by the Code; provide contact information for their Chief Compliance Officers; and, at the appropriate time, publish the status of each company’s annual certification. Any comments received by PhRMA relating to a company's observance of the Code or conduct that is addressed by the Code will be referred by PhRMA to the relevant company's Chief Compliance Officer. In addition, companies are encouraged to seek external verification periodically, meaning at least once every three years, that the company has policies and procedures in place to foster compliance with the Code. PhRMA has prepared general guidance for such external verification and will identify on its web site if a company has sought and obtained verification of its compliance policies and procedures from an external source..

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Recently, Brazil's Association of the Pharmaceutical Research Industry (INTERFARMA) has also updated its code of conduct, which will be the subject a future post.

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Licks’ Blog provides regular and insightful updates on Brazil’s political and economic landscape. The posts are authored by our Government Affairs & International Relations group, which is composed of experienced professionals from different backgrounds with multiple policy perspectives.

Licks Attorneys is a top tier Brazilian law firm, speciallized in Intellectual Property and recognized for its success handling large and strategic projects in the country.

ABOUT US

Licks Attorneys Compliance’s Blog provides regular and insightful updates about Ethic and Compliance. The posts are authored by Alexandre Dalmasso, our partner. Licks Attorneys is a top tier Brazilian law firm, specialized in Intellectual Property and recognized for its success handling large and strategic projects in the country.

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O blog Licks Attorneys Compliance fornece atualizações regulares e esclarecedoras sobre Ética e Compliance. As postagens são de autoria de Alexandre Dalmasso, sócio do escritório. O Licks Attorneys é um escritório de advocacia brasileiro renomado, especializado em Propriedade Intelectual e reconhecido por seu sucesso em lidar com grandes e estratégicos cases no país.

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