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 EthicsCouncil, 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.