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
Responsibility of the FDA
SAFETY OF MEDICINES
Companies will report adverse events or adverse drug reactions to regulatory authorities, subject to applicable laws and regulations
SAFETY OF MEDICINES
The purpose and focus of all symposia, congresses and other promotional or nonpromotional, scientific or professional meetings (an “Event”) for healthcare professionals organized or sponsored by a Company should be _____________________
(SYMPOSIA AND CONGRESSES)
to inform healthcare professionals about products and/or to provide scientific or educational information
symposia should only be for _______________________
educational purposes
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.
SYMPOSIA AND CONGRESSES
Any sponsorship provided to individual healthcare professionals must not be ___________ upon an obligation to prescribe, recommend, or promote any medicine.
(SYMPOSIA AND CONGRESSES)
conditional
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
Hospitality should be limited to ___________ and/or ___________ incidental to the main purpose of the Event
refreshments and/or meals
Companies should not pay any costs associated with individuals accompanying invited healthcare professionals (t or f)
T
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
INFORMATIONAL PRESENTATIONS BY COMPANY REPRESENTATIVES
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 ________________________
(INFORMATIONAL PRESENTATIONS BY COMPANY REPRESENTATIVES)
(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 _______________. Offering “take-out” meals or meals to be
eaten without a Company representative being present is ________________
(INFORMATIONAL PRESENTATIONS BY COMPANY REPRESENTATIVES)
is not appropriate
Company interactions are professional in nature and are intended to facilitate the exchange of medical or scientific information that will benefit patient care
ENTERTAINMENT
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
(ENTERTAINMENT)
as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips, to any healthcare
professional
No standalone entertainment or other leisure or social activities should be provided or paid for by Companies.
At events, entertainment of _____________, which is secondary to refreshments or meals, is allowed.
(ENTERTAINMENT)
modest nature
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
EDUCATIONAL ITEMS AND GIFTS
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 _________________ value to healthcare professionals outside of his or her professional responsibilities.
(EDUCATIONAL ITEMS AND GIFTS)
modest value and do not have
These items should not ___________________________ of a medical practice.
(EDUCATIONAL ITEMS AND GIFTS)
subsidize normal routine operations
Continuing medical education (CME), also known as ___________
(SUPPORT FOR CONTINUING MEDICAL EDUCATION)
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
(SUPPORT FOR CONTINUING MEDICAL EDUCATION)
Continuing medical education (CME), independent medical education (IME)
Grants, scholarships, subsidies, support, consulting contracts, educational or practice related items ______________ 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
should not be
When used appropriately, _______________ can be an important tool for healthcare professionals and provide benefit to patient health outcomes
samples
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 _______ or otherwise misused
resold
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.
(CONSULTANT AND SPEAKER ARRANGEMENTS)
Consulting arrangements with healthcare professionals
support the existence of a bona fide consulting or speaking arrangement
- a written contract
- a legitimate need for the services has been clearly identified in advance
- the criteria for selecting consultants and speakers are directly related to the identified purpose
- number of healthcare professionals retained is not greater than the number reasonably necessary to
achieve the identified purpose - maintains records concerning, and makes appropriate use of, the services provided
- venue and circumstances are conducive with the primary focus of the meeting; specifically, resorts are not
appropriate venues.
________________ play an important role in delivering accurate, up-to-date information to healthcare professionals about the approved indications, benefits and risks of medicines. They 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. They must act with the highest degree of professionalism and integrity
Company representatives
It is the responsibility of Companies to ensure that _______________ exist that facilitate compliance with these Principles and the spirit they embody. These procedures should be documented and provided to employees to further enhance compliance.
internal compliance procedures
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
____________ must provide accurate and balanced information to the Government
(PUBLIC SECTOR RELATIONSHIPS AND PROCUREMENT)
Company
Donations including donations in kind, cannot 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 (t or f)
F; may be provided
__________________ 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.
All clinical trials (phases I to IV) and scientific research
Clinical trials should not be used as inappropriate _________ for past or future sales.
(CLINICAL TRIALS)
inducements
As a demonstration of ________________, Companies recognize their responsibility to support worthwhile activities both within and outside our communities.
good corporate citizenship
Companies should respect the ______________ of patient organizations and their independence.
(Patient organizations)
autonomy
Implementation
- COMPANIES AND INDUSTRY ASSOCIATIONS
- HEALTHCARE PROFESSIONAL ORGANIZATIONS
- APEC ECONOMIES
Support from Companies must not be __________ on the promotion of a specific medicine
(Patient organizations)
conditional
