MC Principles Flashcards
Adoption of the Mexico City Principle is mandated in
FDA Circular No. 2013-024
MC is adopted first before KL (t or f)
T
MC focuses more on which sector
Biopharmaceuticals
Aims to promote ethical interactions between biopharmaceutical companies and healthcare
professionals
Mexico City Principles
includes companies, regardless of ownership status, that develop, manufacture, market or distribute pharmaceutical and/or biologic products or medicines
Biopharmaceutical sector
means an event sponsored and organized by a society, college, university or other non-Company entity
for the purpose of providing medical and/or scientific information.
Congress
means an external, independent healthcare professional, scientist, patient association/patient
representative, public or private payer retained individually or through an entity (e.g. university, hospital
or research organization) to provide advice, information or other services
Consultant
means a provider of medical or health services and any other person or organization that
furnishes, bills, or is paid for health care in the normal course of business, including but not limited to
physicians, nurses, or pharmacists and their staff.
Healthcare Professional
means a person calling on healthcare professionals and/or their staff on behalf of a company
regarding the promotion or discussion of medicines
Representatives
PRINCIPLES
- Healthcare and Patient Focus
- Integrity
- Independence
- Legitimate Intent
- Transparency
- Accountability
Everything we do is intended to benefit the patients
Healthcare and patient focus
Dealing ethically, honestly and respectfully in everything we do
integrity
Respect the need of autonomous decision-making of all parties, free from improper influence
independence
Everything we do is for the right reasons, is lawful and aligns with the spirit and values of these Principles
legitimate intent
General willingness to be open about our actions while respecting legitimate commercial sensitivities and intellectual property rights
transparency
Willingness to be responsible for our actions and interactions
accountability
PRINCIPLES (2)
- INTERACTIONS WITH HEALTHCARE PROFESSIONAL
- PROMOTIONAL INFORMATION AND ACTIVITIES
- SAFETY OF MEDICINES
- SYMPOSIA AND CONGRESSES
5 . INFORMATIONAL PRESENTATIONS BY COMPANY REPRESENTATIVES - ENTERTAINMENT
- EDUCATIONAL ITEMS AND GIFTS
- SUPPORT FOR CONTINUING MEDICAL EDUCATION
- SAMPLES
- CONSULTANT AND SPEAKER ARRANGEMENTS
- COMPLIANCE PROCEDURES AND RESPONSIBILITIES
- CONDUCT AND TRAINING OF COMPANY REPRESENTATIVES
- PUBLIC SECTOR RELATIONSHIPS AND PROCUREMENT
- CLINICAL TRIALS
- COMPANY DONATIONS FOR CHARITABLE PURPOSES
- PATIENT ORGANIZATIONS
- ADHERENCE TO PRINCIPLES
provide valuable scientific, clinical, product, and policy information about medicines that may lead to improved patient care
(Interactions between Companies and healthcare professionals)
Interactions between Companies and healthcare professionals
Appropriate marketing helps to ensure that medicines are used correctly for maximum patient benefit; ______________ are critical to achieving these goals
(Interactions between Companies and healthcare professionals)
Company relationships with healthcare professionals
All interactions with healthcare professionals are to be conducted in a ________ and _________ manner
(Interactions between Companies and healthcare professionals)
professional and ethical manner
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
PROMOTIONAL INFORMATION AND ACTIVITIES
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 AND ACTIVITIES
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
SAFETY OF MEDICINES