We have recently published two posts regarding the update made to the codes of PhRMA (Pharmaceutical Research and Manufacturers of America) and the IMC (Innovative Medicines Canada).
Now the time has come to talk about Interfarma (Brazilian Association of the Pharmaceutical Research Industry), which has just updated its Code of Conduct, the first edition of which was launched in 2007, with the main purpose of establishing principles of self-regulation, especially in regard to interactions with health professionals. Note that the document was approved in 2012 by the Brazilian Council of Medicine (CFM), by the Brazilian Medical Association (AMB), and by the Brazilian Society of Cardiology.
In 2016, the document underwent its first major review and update, including new sections and regulating the Ethics Council to settle disputes arising from possible reports of Code of Conduct violations.
However, a new review and update introduced some significant changes to the Code of Conduct, as summarized below:
| SECTION | CHANGE |
| General Principles | Inclusion of compliance with legislation related to Personal Data Protection. |
| Interaction with Public Agents and Politically Exposed Persons | The concept of “Politically Exposed Person” was added, broadening rules on interaction and enacting risk assessment. |
| Interactions and Relationships with Patient Associations | Interactions with other similar organizations was extended and the 15% cap on the total amount for project fees and organization was removed. |
| Hiring of Specialized Services | Hired professionals must enjoy absolute autonomy and freedom in formulating their opinions and analyses and must declare potential conflicts of interest. New rule for members of committees for the preparation of protocols or clinical guides. |
| Events Organized by the Company or Third Parties | New rules for events organized by third parties, including pipeline disclosure; stricter event rules if the organizer is not a medical association; banning commercial areas from defining sponsored health professionals for congresses and creating specific criteria for granting sponsorships; and removal of the first-class tickets for healthcare professionals. |
| Communication Actions | Press releases must not contain information of a promotional nature and information on social media must be conveyed via official channels or otherwise in a transparent manner, disclosing ownership of said information. |
| Promotional Materials | This section was entirely rewritten now considering some controversies already raised with the Association’s Ethics Council, such as adaptation of graphics, data from “in vitro” and animal studies, use of images of children, pregnant women, naked bodies, and people in sports activities, use of uniforms of sports team and/or professional athletes and promotional materials must note month and year. |
| Activities at Points of Sale Related to Medicines | Promotional actions with pharmacies/pharmacy chains/commercial partners prior to their accomplishment must be formalized. |
| Pre-launch Activities and Communication on Drugs Without Registration and Indications Not Approved by the Brazilian FDA, ANVISA (Off-Label) | Off label information may be reactively shared to health professionals and actively in scientific events, in the form of press releases and within the limits of administrative or judicial determinations; preceptorships cannot have the sole purpose of providing off-label information. |
| Offering Freebies to Healthcare Professionals | Offering freebies, items, and/or gifts to healthcare professionals is prohibited when: (i) for personal benefit, (ii) in exchange for any acquisition or recommendation of medications, (iii) in cash or equivalent, (iv) used in the office routine or in the maintenance and provision of healthcare services, (v) including medicine logo, (vi) promotional items (e.g. post-its, mouse pads, etc.); the offering of items with an institutional logo which are essential for education and safety of patients was allowed, and the ban on subscriptions to printed and digital specialized magazines for health professionals was revoked. |
| Distribution of Free Samples | The text was simplified, in which healthcare professionals are authorized to prescribe products to improve patient care. Companies must have adequate systems of control and accountability with respect to free samples, including how to take care of such free samples while in the possession of their representatives. All previous content provided for in Anvisa’s Rule RDC-60/2009 was removed, as the provision already establishes such rules. |
| Over-the-Counter Medicines | The text expressly allowing the distribution of freebies related to non-prescription medicines, to health professionals or those related to the field of health was removed, as it was conditioned to the current legal norms, which are enough to regulate the issue. |
| Direct Contact with the Patient | Company employees with a commercial role are prohibited from proactively contacting patients. |
| Medical Education | Support for scientific education is allowed through sponsorship of on-site or virtual courses, as long as such courses are not considered training or degree courses; support for the development of portals with scientific content and free access allowed; and companies may also carry out their own preceptorships or support Preceptorships by third parties. |
| Market Access Materials | Entirely new section emphasizing that companies must provide stakeholders with relevant scientific and economic information that is true, accurate, fair, balanced, and without distortions; materials must include a target audience statement and not have promotional purposes, materials that present Stated Assumptions, must be stored least during the next 12 months; materials must (i) be accurate, clear, robust, balanced, and complete, scientifically and/or statistically referenced, and not misleading, (ii) be fair and truthful, (iii) not present any designations, symbols, figures, images, drawings, figurative marks, slogans and any advertising arguments in relation to the medicines (iv) the brand name and logo of the product may be used, but for the sole purpose of increasing transparency and clarity in the discussion, in addition to ensuring that the information is clearly associated with the product’s packaging; market access professionals may have initial conversations with stakeholders prior to regulatory approval, only for payers’ budgeting and financial planning processes, providing them with technical data of the condition in question. |
| Supporting Programs | Another entirely new section in the Code, defining programs supporting patients or healthcare professionals (“diagnostic programs”); must not have the purpose of inducing the prescription, use, promotion, sale, recommendation, indication or endorsement; companies must define their own criteria; programs must not generate any type of compensation to the physician; individualized patient or healthcare professional data cannot be used for commercial purposes; must be transparent and not encourage judicialization; diagnostic programs cannot be run by commercial areas and information about the exam free of charge for the patient must be clear; only products duly legalized in Brazil and prescribed by the physician are allowed in patient support programs, and should not encourage off label use; the decision to enter or leave programs belongs to the patient; Patient Supporting Programs will have as objectives: (i) health promotion with increased quality of life; (ii) the support service and treatment adherence; (iii) the provision or clarification of public information for the benefit of the patient’s health and access, with the representation of the patient and/or physician with third-parties being prohibited; patient support programs may include services such as: (i) medicine discounts; (ii) free supply of medicines; (iii) home care; (iv) infusion and application; (iv) follow-up exams; (iv) monitoring of multidisciplinary professionals; (vii) provision of items exclusively related to a better adherence to the treatment. |
It is worth highlighting that the update was very well done, greatly improving the content of the Code of Conduct and mitigating conflicts of interest and risks associated with the interaction of the pharmaceutical industry with health professionals, patients, patient associations, and public agents.
Some aspects, however, may deserve more attention in upcoming reviews to the Code of Conduct, such as the Rare Disease Market, Donations and Subsidization, Transparency (disclosure of transfer of values from the pharmaceutical industry to health professionals), and Due Diligence and Interaction with Third Parties.
This new Code of Conduct is undoubtedly a remarkable instrument of self-regulation that greatly improves the moral standards of such a complex market.