Resource Toolkit
Resource Name | Format |
Communicating the Value of High-Standard Business Ethics: Within a Small and Medium Sized Enterprise (SME) | Microsoft PowerPoint | PDF |
Compliance Program Outcomes: A tool to build upon the 6 elements of a compliance program including ideas, examples, outcomes, measurements, and materials | Microsoft Word | PDF |
The Value from and Responsibility for ensuring Ethical Codes of Conduct: Industry and Association Responsibilities | Microsoft PowerPoint | PDF |
Data on Ethical Performance | Microsoft PowerPoint | PDF |
Mexico City Principles: A guide for the ethical conduct and interaction between the healthcare sector and the biopharmaceutical industry to ensure that medical decisions are made in the best interests of the patients. | Website |
Mexico City Principles
A guide for the ethical conduct and interaction between the healthcare sector and the biopharmaceutical industry to ensure that medical decisions are made in the best interests of the patients. This tool integrates applicable Mexico City Principles and also provides a guide for implementation within your Small and Medium Sized Enterprise (SME)
Applicable Mexico City Principles
10. Consultant and Speaker Arrangements
A. Consulting arrangements with healthcare professionals allow companies to obtain information or advice from medical experts on such topics as the marketplace, products, therapeutic areas and the needs of patients. Companies use this advice to inform their efforts to ensure that the medicines they develop, produce and/or market are meeting the needs of patients. In addition, healthcare professionals participate in Company-sponsored speaking programs in order to help educate and inform other healthcare professionals about the benefits, risks, and appropriate uses of medicines.
- Companies should continue to ensure that consultant and speaking arrangements are neither inducements nor rewards for prescribing or recommending a particular medicine or course of treatment.
- It is appropriate for consultants and speakers who provide 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 or speaking arrangement should be reasonable and based on fair market value.
- Consulting or advisory arrangements lacking a bona fide business purpose should not be used to justify compensating healthcare professionals for their time or their travel, lodging, and other out-of-pocket expenses.
B. The following factors support the existence of a bona fide consulting or speaking arrangement (not all factors may be relevant to any particular arrangement):
- a written contract specifies the nature of the services to be provided and the basis for payment of those services;
- a legitimate need for the services has been clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants;
- the criteria for selecting consultants and speakers are directly related to the identified purpose, and the persons responsible for selecting the consultants and speakers have the expertise necessary to evaluate whether the particular healthcare professionals meet those criteria;
- the number of healthcare 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;
- the venue and circumstances of any meeting with consultants or speakers are conducive with the primary focus of the meeting; specifically, resorts are not appropriate venues.
12. Conduct and Training of Company Representatives
A. Company representatives play an important role in delivering accurate, up-to-date information to healthcare professionals about the approved indications, benefits and risks of medicines. These representatives often serve as the primary point of contact between the Companies who research, develop, manufacture and market medicines and the healthcare professionals who prescribe them. As such, 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 healthcare professionals, receive training about the applicable laws, regulations and industry codes of ethics that govern the representatives’ interactions with healthcare 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 applicable laws and regulations.
- Companies should provide updated or additional training in all of the areas needed for their representatives who visit healthcare 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 with relevant Company policies that are consistent with these Principles and national and local industry codes of ethics.
14. Clinical Trials
A. All clinical trials (phases I to IV) and scientific research involving patients sponsored or supported by companies will be conducted with the intent to develop bona fide scientific knowledge that will benefit patients and advance science and medicine. Companies must ensure transparency and accountability in the presentation of research and publication of study results.
B. Clinical trials should not be used as inappropriate inducements for past or future sales.
C. Clinical trials should be undertaken in an ethical manner, without undue influence by competitors.
Your Guide to Implementation
10. Consultant and Speaker Arrangements
Fee-for-Services
- Establish guidance around: 1) HCP selection criteria for each type of service, 2) fair market value determination method (which includes limits on total yearly remuneration and/or on frequency of services), 3) and documentation (e.g., written contracting).
- Establish logistics-related limits for supporting the services (venue, transportation, meals, etc.) aligned with Section 4
12. Conduct and Training of Company Representatives
Training of Company Representatives
- Establish expectation that any interaction with external parties on behalf of the company could only occur after training on relevant policies/procedures have been completed.
- Establish process for tracking timely completion of such training by company representatives
14. Clinical Trials
Ethical Conduct of Clinical Trials
- Establish expectation that clinical trials are done only for the genuine generation of data for either new products or legitimate unanswered scientific questions.
- Establish expectation that all study results will be published transparently and timely.
- Establish clear rules for engagement of HCPs in the identification of clinical trial sites and any communications with HCPs related to the on-going clinical trials (e.g., only medical and not sales/marketing functions).
Applicable Mexico City Principles
2. Promotional Information and Activities
- A. No medicines shall be promoted for use in a specific economy until the requisite approval for marketing for such use has been given in that economy. Promotion should be consistent with locally approved product information.
- It is understood that national laws and regulations usually dictate the format and content of the product information communicated on labeling, packaging, leaflets, data sheets and in all promotional material.
- Companies commit that pertinent and appropriate information will be made available to all healthcare professionals in all economies, as permitted by applicable laws and regulations.
- Promotional information should be clear, legible, accurate, balanced, fair, objective and sufficiently complete to enable healthcare professionals to form his or her own opinion of the therapeutic value of the medicines concerned.
- Promotional information should be based on an up-to-date evaluation of all relevant evidence and reflect that evidence clearly. It should not mislead by distortion, exaggeration, undue emphasis, omission or in any other way.
- Promotional information should be capable of substantiation either by reference to the approved labeling or by scientific evidence. Such evidence should be made available on request to healthcare professionals. Companies should deal objectively with requests for information made in good faith and should provide data which are appropriate to the source of the inquiry.
- Companies are responsible for compliance with applicable laws and regulations, including intellectual property laws, and local, national, and regional industry codes of ethics.
- Clinical assessments, postmarketing surveillance and experience programmes and postauthorization studies must not be disguised promotion. Such assessments, programmes and studies must be conducted with a primarily scientific or educational purpose.
- Materials sponsored by a Company relating to medicines and their uses, whether promotional in nature or not, should clearly indicate by whom they have been sponsored.
3. Safety of Medicines
A. Medicines provided by Companies will conform to high standards of quality, safety and efficacy as determined by regulatory authorities in each economy in which they operate.
B. Companies will report adverse events or adverse drug reactions to regulatory authorities, subject to applicable laws and regulations.
4. Symposia and Congresses
A. The purpose and focus of all symposia, congresses and other promotional or non-promotional, scientific or professional meetings (an “Event”) for healthcare professionals organized or sponsored by a Company should be to inform healthcare professionals about products and/or to provide scientific or educational information.
B. Company relationships with healthcare professionals are regulated by multiple entities and intended to benefit patients and to enhance the practice of medicine. Interactions should be focused on informing healthcare professionals about products, providing scientific and educational information, and supporting medical education.
C. Any sponsorship provided to individual healthcare professionals must not be conditional upon an obligation to prescribe, recommend, or promote any medicine.
D. All Events should be held in an appropriate venue that is conducive to the scientific or educational objectives and the purpose of the Event or meeting. Companies should avoid using extravagant venues or resorts.
E. Hospitality should be limited to refreshments and/or meals incidental to the main purpose of the Event and should only be provided:
- to participants of the Event and not their guests; and
- is moderate and reasonable as judged by local standards.
F. Companies should not pay any costs associated with individuals accompanying invited healthcare professionals.
5. Informational Presentations by Company Representatives
A. In order to provide important scientific information and to respect healthcare professionals’ abilities to manage their schedules and provide patient care, Company representatives may take the opportunity to present information during healthcare professionals’ working day, including mealtimes, in accordance with applicable laws and regulations.
- In connection with such presentations or discussions, it is appropriate for occasional meals to be offered as a business necessity to the healthcare professional as well as members of their staff attending presentations, so long as the presentations provide scientific or educational value and the meals (a) are reasonable 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.
- Inclusion of a healthcare 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 is not appropriate.
6. Entertainment
A. Company interactions 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 form of entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips, to any healthcare professional. Such entertainment or recreational benefits should not be offered, regardless of (1) the value of the items; (2) whether the Company engages the healthcare professional as a speaker or consultant, or (3) whether the entertainment or recreation is secondary to an educational purpose.
- No standalone entertainment or other leisure or social activities should be provided or paid for by Companies. At events, entertainment of modest nature, which is secondary to refreshments or meals, is allowed.
7. Educational Items and Gifts
A. Payments in cash or cash equivalents (such as gift certificates) or gifts for the personal benefit of healthcare professionals should not be provided or offered to healthcare professionals.
- It is appropriate for Companies, where permitted by law or local codes of ethics, to offer items designed primarily for the education of patients or healthcare professionals if the items are of modest value and do not have value to healthcare professionals outside of his or her professional responsibilities.
- These items should not subsidize normal routine operations of a medical practice.
8. Support for Continuing Medical Education
A. 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 the medical practice.
- Companies should develop objective criteria for making CME grant decisions to ensure that programs funded are bona fide and quality educational programs and that financial support is not an inducement to prescribe or recommend a particular medicine or course of treatment.
B. Grants, scholarships, subsidies, support, consulting contracts, educational or practice related items should not be provided or offered to a healthcare professional in exchange for recommending and prescribing medicines, or otherwise in a manner that would interfere with the ethics and the independence of a healthcare professional’s prescribing practices. Companies should have a reasonable expectation that the grant is for the purpose of supporting legitimate education, scientific, or medical research.
9. Samples
A. When used appropriately, samples can be an important tool for healthcare professionals and provide benefit to patient health outcomes.
B. In accordance with local laws and regulations, samples of medicines supplied at no charge may be provided to healthcare professionals in order to enhance patient care. Samples must not be resold or otherwise misused.
- Companies should have adequate systems of control and accountability for samples provided to healthcare professionals including how to look after such samples while they are in possession of medical representatives.
- Samples should not be used as payment for services, return for favorable treatment, or other inappropriate inducements.
10. Consultant and Speaker Arrangements
A. Consulting arrangements with healthcare professionals allow companies to obtain information or advice from medical experts on such topics as the marketplace, products, therapeutic areas and the needs of patients. Companies use this advice to inform their efforts to ensure that the medicines they develop, produce and/or market are meeting the needs of patients. In addition, healthcare professionals participate in Company-sponsored speaking programs in order to help educate and inform other healthcare professionals about the benefits, risks, and appropriate uses of medicines.
- Companies should continue to ensure that consultant and speaking arrangements are neither inducements nor rewards for prescribing or recommending a particular medicine or course of treatment.
- It is appropriate for consultants and speakers who provide 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 or speaking arrangement should be reasonable and based on fair market value.
- Consulting or advisory arrangements lacking a bona fide business purpose should not be used to justify compensating healthcare professionals for their time or their travel, lodging, and other out-of-pocket expenses.
B. The following factors support the existence of a bona fide consulting or speaking arrangement (not all factors may be relevant to any particular arrangement):
- a written contract specifies the nature of the services to be provided and the basis for payment of those services;
- a legitimate need for the services has been clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants;
- the criteria for selecting consultants and speakers are directly related to the identified purpose, and the persons responsible for selecting the consultants and speakers have the expertise necessary to evaluate whether the particular healthcare professionals meet those criteria;
- the number of healthcare 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;
- the venue and circumstances of any meeting with consultants or speakers are conducive with the primary focus of the meeting; specifically, resorts are not appropriate venues.
12. Conduct and Training of Company Representatives
A. Company representatives play an important role in delivering accurate, up-to-date information to healthcare professionals about the approved indications, benefits and risks of medicines. These representatives often serve as the primary point of contact between the Companies who research, develop, manufacture and market medicines and the healthcare professionals who prescribe them. As such, 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 healthcare professionals, receive training about the applicable laws, regulations and industry codes of ethics that govern the representatives’ interactions with healthcare 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 applicable laws and regulations.
- Companies should provide updated or additional training in all of the areas needed for their representatives who visit healthcare 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 with relevant Company policies that are consistent with these Principles and national and local industry codes of ethics.
13. Public Sector Relationships and Procurement
A. The decision-making process by Companies and Governments during and including the government procurement process, through bidding or any other procedure of government procurement, must be professional and ethical. There should be no attempt to exert inappropriate influence.
B. Companies must provide accurate and balanced information to the Government.
C. Companies and government officials should ensure that their relationships and fee-for-service arrangements comply with government ethics rules or procedures.
15. Company Donations for Charitable Purposes
A. As a demonstration of good corporate citizenship, Companies recognize their responsibility to support worthwhile activities both within and outside our communities.
- Donations including donations in kind, may be provided to organizations and institutions involved in promoting activities such as artistic, charitable, cultural, community, educational, humanitarian, health, philanthropic, and sporting activities in accordance with applicable laws and regulations.
- Companies should ensure that such support is not undertaken solely for product promotional reasons, and is not directed solely for product promotion purposes.
- Funding and donations in-kind should be directed to organizations and documented in a manner that outlines the nature of the donation provided.
- Acknowledgement by the recipient organization of such support should be restricted to appropriate recognition of support.
- Companies should ensure that there are no incentives to prescribe, recommend, purchase, supply or administer a product based on financial support and that nothing should be offered or provided which would interfere with the independence of a healthcare professional’s prescribing or dispensing practices.
16. Patient Organizations
A. Companies should respect the autonomy of patient organizations and their independence.
B. Support from Companies must not be conditional on the promotion of a specific medicine.
Your Guide to Implementation
2. Promotional Information and Activities
Copy Review
- Designate function/group responsible for managing copy review process (e.g., medical function).
- Establish copy review process (e.g., which functions/groups need to review and approve).
Ethical promotion of drugs
- Establish internal expectations (code and/or procedures) for promotion of products 1) according to regulator-approved label, 2) only to HCPs (for prescription only medications), and 3) in a manner that respects the independent relationship between HCP and patient.
3. Safety of Medicines
Adverse event reporting/escalation process
- Establish reporting process, which must genuinely reflect the company’s obligation in both collecting and reporting (e.g., timeline by which to report) of either product related adverse events (AEs) or product complaints (PCs).
Medical education, medical information review & management process
- Establish responsible function/group for overseeing, managing medical education and medical information (must be separate from sales & marketing).
- Set up medical information query intake and handling process.
4. Symposia and Congresses
Sponsorship of HCPs attendance to third-party conferences/events
- Establish selection criteria of HCPs attending conferences/events.
- Establish process for reviewing/approving business justification for supporting conferences/events and whether amount provided to HCPs is fair market value.
Company-organized events
- Establish process for reviewing/approving conference/event based on the appropriateness of conference venue.
Hospitality provided to HCPs
- Establish monetary threshold for meals with HCPs (must be incidental to the main business purposes and be only for HCPs, not guests of HCPs).
- Define permissible list of items, which could be given to only HCPs free of charge and of obligation for reciprocity. The scope of these items should include gifts to HCPs (including a ban on lavish items, cash equivalents, non-healthcare related services to HCPs), brand reminder items, items of medical utility (e.g., medical books), and items that HCPs use to enhance patient care (e.g., educational materials that ultimately reach the patient via the HCP).
- Establish process for vetting travel arrangements (e.g., specifically tied to legitimate documented business event, no side trips, no guests, etc.).
- If applicable, establish different standards if an HCP is considered government official under local law, regulation, industry code or applicable global standards (e.g., US FCPA, UK Bribery Act)
5. Informational Presentations by Company Representatives
Information provided to HCPs
- See above re Section 2
- See above re Section 4
6. Entertainment
Entertainment provided to HCPs
- See above re Section 4
- Establish requirement that no standalone entertainment may be provided to HCPs.
7. Educational Items and Gifts
Items provided to HCPs
- See above re Section 4
- Establish expectation that items given cannot subsidize items that a professional HCP’s practice should cover on its own (e.g., capital goods, ordinary overhead cost).
8. Support for Continuing Medical Education
Policy on CME and Educational Grants
- Define roles & responsibilities of medical function.
- Establish process/controls for medical or other non-sales & marketing functions to review, approve and manage both CMEs and educational grants.
9. Samples
Samples
- Establish process for reviewing, tracking and tracing samples given out to HCPs (e.g., must be able to account for (reconcilable) the sample from beginning to end of supply chain.
- Establish expectation that sampling should be given in limited quantities/frequency, which is founded on notion that samples are meant only for 2 purposes: 1) to give HCPs experience with a new product, and 2) to assess if patients would have an allergic reaction (adverse event) after consuming the product.
- Ensure that any applicable local law, regulation and/or industry code requirements are taken into consideration (e.g., if your economy’s industry code or the prevailing industry best practice does not permit giving away samples, then no samples should be provided)
10. Consultant and Speaker Arrangements
Fee-for-Services
- Establish guidance around: 1) HCP selection criteria for each type of service, 2) fair market value determination method (which includes limits on total yearly remuneration and/or on frequency of services), 3) and documentation (e.g., written contracting).
- Establish logistics-related limits for supporting the services (venue, transportation, meals, etc.) aligned with Section 4
12. Conduct and Training of Company Representatives
Training of Company Representatives
- Establish expectation that any interaction with external parties on behalf of the company could only occur after training on relevant policies/procedures have been completed.
- Establish process for tracking timely completion of such training by company representatives
13. Public Sector Relationships and Procurement
Bids & Tenders
- Establish process to identify government officials
Interaction with Government Officials
- Establish expectation that any payments made to government are: 1) to institution, not individual, 2) traceable (e.g., wire transfer) and 3) according to only published fee schedules.
15. Company Donations for Charitable Purposes
Donations and Other Charitable Contributions
- Establish definition for what is in scope for donations/charitable contributions (e.g., no connection to any drug promotion or other commercial intent).
- Establish process to review and approve donations/charitable contributions (e.g., cross-functional committee reviewing donations; non-sales/marketing roles; what constitutes appropriate donations, etc.).
16. Patient Organizations
Interactions with Patient Organizations
- Establish expectation that the financial or in-kind support provided by the company is not the sole source of funding/support that the patient organization receives.
- Establish expectation that the financial or in-kind support provided by the company is conditioned on or in support of any specific medicine.
Applicable Mexico City Principles
10. Consultant and Speaker Arrangements
A. Consulting arrangements with healthcare professionals allow companies to obtain information or advice from medical experts on such topics as the marketplace, products, therapeutic areas and the needs of patients. Companies use this advice to inform their efforts to ensure that the medicines they develop, produce and/or market are meeting the needs of patients. In addition, healthcare professionals participate in Company-sponsored speaking programs in order to help educate and inform other healthcare professionals about the benefits, risks, and appropriate uses of medicines.
- Companies should continue to ensure that consultant and speaking arrangements are neither inducements nor rewards for prescribing or recommending a particular medicine or course of treatment.
- It is appropriate for consultants and speakers who provide 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 or speaking arrangement should be reasonable and based on fair market value.
- Consulting or advisory arrangements lacking a bona fide business purpose should not be used to justify compensating healthcare professionals for their time or their travel, lodging, and other out-of-pocket expenses.
B. The following factors support the existence of a bona fide consulting or speaking arrangement (not all factors may be relevant to any particular arrangement):
- a written contract specifies the nature of the services to be provided and the basis for payment of those services;
- a legitimate need for the services has been clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants;
- the criteria for selecting consultants and speakers are directly related to the identified purpose, and the persons responsible for selecting the consultants and speakers have the expertise necessary to evaluate whether the particular healthcare professionals meet those criteria;
- the number of healthcare 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;
- the venue and circumstances of any meeting with consultants or speakers are conducive with the primary focus of the meeting; specifically, resorts are not appropriate venues.
12. Conduct and Training of Company Representatives
A. Company representatives play an important role in delivering accurate, up-to-date information to healthcare professionals about the approved indications, benefits and risks of medicines. These representatives often serve as the primary point of contact between the Companies who research, develop, manufacture and market medicines and the healthcare professionals who prescribe them. As such, 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 healthcare professionals, receive training about the applicable laws, regulations and industry codes of ethics that govern the representatives’ interactions with healthcare 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 applicable laws and regulations.
- Companies should provide updated or additional training in all of the areas needed for their representatives who visit healthcare 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 with relevant Company policies that are consistent with these Principles and national and local industry codes of ethics.
14. Clinical Trials
A. All clinical trials (phases I to IV) and scientific research involving patients sponsored or supported by companies will be conducted with the intent to develop bona fide scientific knowledge that will benefit patients and advance science and medicine. Companies must ensure transparency and accountability in the presentation of research and publication of study results.
B. Clinical trials should not be used as inappropriate inducements for past or future sales.
C. Clinical trials should be undertaken in an ethical manner, without undue influence by competitors.
15. Company Donations for Charitable Purposes
A. As a demonstration of good corporate citizenship, Companies recognize their responsibility to support worthwhile activities both within and outside our communities.
- Donations including donations in kind, may be provided to organizations and institutions involved in promoting activities such as artistic, charitable, cultural, community, educational, humanitarian, health, philanthropic, and sporting activities in accordance with applicable laws and regulations.
- Companies should ensure that such support is not undertaken solely for product promotional reasons, and is not directed solely for product promotion purposes.
- Funding and donations in-kind should be directed to organizations and documented in a manner that outlines the nature of the donation provided.
- Acknowledgement by the recipient organization of such support should be restricted to appropriate recognition of support.
- Companies should ensure that there are no incentives to prescribe, recommend, purchase, supply or administer a product based on financial support and that nothing should be offered or provided which would interfere with the independence of a healthcare professional’s prescribing or dispensing practices.
Your Guide to Implementation
10. Consultant and Speaker Arrangements
Fee-for-Services
- Establish guidance around: 1) HCP selection criteria for each type of service, 2) fair market value determination method (which includes limits on total yearly remuneration and/or on frequency of services), 3) and documentation (e.g., written contracting).
- Establish logistics-related limits for supporting the services (venue, transportation, meals, etc.) aligned with Section 4
12. Conduct and Training of Company Representatives
Training of Company Representatives
- Establish expectation that any interaction with external parties on behalf of the company could only occur after training on relevant policies/procedures have been completed.
- Establish process for tracking timely completion of such training by company representatives
14. Clinical Trials
Ethical Conduct of Clinical Trials
- Establish expectation that clinical trials are done only for the genuine generation of data for either new products or legitimate unanswered scientific questions.
- Establish expectation that all study results will be published transparently and timely.
- Establish clear rules for engagement of HCPs in the identification of clinical trial sites and any communications with HCPs related to the on-going clinical trials (e.g., only medical and not sales/marketing functions).
15. Company Donations for Charitable Purposes
Ethical Conduct of Clinical Trials
- Establish definition for what is in scope for donations/charitable contributions (e.g., no connection to any drug promotion or other commercial intent).
- Establish process to review and approve donations/charitable contributions (e.g., cross-functional committee reviewing donations; non-sales/marketing roles; what constitutes appropriate donations, etc.).