- 创建时间: 2020年1月17日, 星期五
By the Engagement with Industry work stream1
15 January 2020
Support for advanced vaccinology courses by the vaccine industry should help ensure that health care professionals and decision-makers obtain the latest and most accurate information and insights in fields related to vaccines and immunization that are critical to advance public health, improve prevention and care for patients and communities, and enhance the overall healthcare system.
The quality and integrity of medical education are crucial to help healthcare professionals and decision-makers expand their knowledge, skills, competence, and professional performance with the goal of improving health and patient outcomes.
Advanced vaccinology courses can be funded by participant registration fees, unrestricted educational grants, and in-kind contributions from organizing and co-sponsoring agencies. Advanced vaccinology course management should recognize that all organizing and co-sponsoring agencies’ interests and conflicts of interests must be managed with the highest degree of integrity ensure that their participation does not confer undue advantage for their institutions or organizations.
Purpose: This document provides guidance to advanced vaccinology course leadership and management to help ensure that involvement of the vaccine industry meets high standards and fosters mutually beneficial engagement and fruitful dialogue for future work in the interest of public health, and without conflict of interest.
Scope of this document:
- Financial arrangements between vaccinology courses and vaccine industry.
- Participation of course faculty and facilitators from industry.
Vaccine industry includes manufacturers of vaccines and manufacturers of vaccination-related equipment.
Not included in the scope of this document are internal vaccine industry employee training and education programs.
Vision: Advanced vaccinology courses are widely perceived as providing high-quality, up-to-date, independent, fair, balanced and objective education. They are designed to allow the expression of scientific theories and recognized opinions on vaccines and immunization, while having the potential to benefit from the expertise and financial support of industry.
- Advanced vaccinology courses are neutral educational platforms that express no favoritism towards proprietary vaccines, diagnostics, or devices of any commercial enterprise.
- Financial support from industry should be reasonable and appropriate, disclosed according to transparency principles, and provided in unrestricted grants2 .
- Ideally, vaccinology courses should not be funded solely by industry.
- Advanced vaccinology course materials and faculty should make reasonable efforts to use non-proprietary names for vaccines, diagnostics, and devices mentioned in the course and refer to products in a generic and not specific manner unless a product is unique and/or has important specific characteristics. Data regarding products should be objectively selected and presented with a balanced view that is without commercial bias for or against such products and, to the extent possible, there is meaningful disclosure of limitations on data, e.g. ongoing research, interim analysis, preliminary data or unsupported opinion. Discussion of product(s) should be balanced, objective and based on scientific methods generally accepted in the medical community.
- Vaccine industry employees are permitted to be advanced vaccinology course faculty and course facilitators for lectures, provided that their lectures are not constituted to favor their product over another company’s product. Advanced vaccinology course faculty should be aware of the possibility that Continuing Medical Education (CME) credits may not be awarded by accreditation organizations for specific lectures given by industry staff.
- When providing financial support to an advanced vaccinology course, industry places no restrictions on the content of the course. Curriculum and course content are the responsibility of the advanced vaccinology course management.
- When providing financial support to an advanced vaccinology course, industry should place no restrictions on the selection of participants to receive fellowship grants. Course management is solely responsible for fellowship selection. At the discretion of the course management, a small number of fellows from a sponsoring enterprise may be selected for course participation.
- All relevant companies should be given an opportunity to provide unrestricted grants to support the training activity. It is desirable that at least two different companies provide unrestricted grants to avoid a one-company sponsorship.
- The course website and communication materials should acknowledge the financial support provided by industry.
- Participation of industry staff in lecturing/workshop facilitation (i.e. through travel expenses) should be directly supported by their company.
- Industry staff should not participate on scientific or steering groups determining the programme, activities and structure of courses.
- Use of industry funding must comply with ethical restrictions of both the course and the company providing funding support.
- Funding by industry shall fully comply with all applicable laws, governmental regulations, including but not limited to anticorruption laws and any industry codes and guidances.
- Advanced vaccinology courses should have written agreements with companies sponsoring the course so that allowable and non-allowable expenses, as well as other restrictions on the use of funding, are understood before agreeing to receive industry support.
Examples of wording in sponsorship contracts (“Institution” refers to the course; “Company” refers to industry):
- The Educational Grant shall be used by the Institution for educational and training purposes only, more specifically to support the following educational/training program(s) organized by the Institution: List here the educational/training program(s).
- The Company and the Institution acknowledge and agree that the Institution shall have sole and complete control over selecting beneficiaries for the Educational Grant.
- The Institution shall remit to the Company a detailed accounting of the manner in which the Educational Grant was disbursed to beneficiaries or otherwise expended.
- The Institution recognizes and understands that the Company, as a pharmaceutical company, is subject to certain laws and regulations in the countries where it operates, including but not limited to the laws regulating the promotion and marketing of drugs’ prescription. As such, the Institution’s activities to be performed under this agreement will be undertaken independently, but subject to the Company’s rights and ability to ensure that any and all of them conform to such laws and regulations. The parties agree that any educational efforts will be conducted in an independent manner which should not be interpreted or inferred as a pre-marketing promotional activity for any products.
- The Institution will ensure meaningful disclosure of the Company’s funding and any significant relationship between the Institution and the Company on the Institution’s website, its communication materials, and to participants of the course.
- Anti-bribery and code of ethics: the Institution hereby warrants, represents and undertakes that it complies with, at any time during the term of this agreement, the Company’s applicable anti-bribery policy and code of ethics.
- The funds will be used in accordance with the conditions of the sponsorship contract between the Company and the Institution, but otherwise to support the organization of the course without restriction. The funds will be applied to technical activities of the course, support of the travel/participation of lecturers, and/or in the form of a fellowship awarded to selected participants.
- The Institution agrees to:
a. Comply with the Standards of Commercial Support of CME.
b. Acknowledge educational support from the Company on the Institution’s website.
c. Upon request, make available to the Company a report on the expenditure of the funds provided.
d. Provide the Company with an evaluation report of the course.
1This document was developed by the Engagement with Industry work stream, which was established at the November 2018 Advanced Vaccinology Course workshop (Vaccine 2019:37;2871–2881) by advanced vaccinology course directors to encourage vaccinology course collaboration with industry in ways that maintain independence and avoid conflict of interest. The work stream was led by Lance Rodewald, Philippe Duclos, and Narendra Arora. The document benefited from input from the Developing Countries Vaccine Manufacturers Network, the International Federation of Pharmaceutical Manufacturers & Associations, the Bill and Melinda Gates China Office, and the advanced vaccinology course directors. It was approved by the participants of the global collaboration during its second six-monthly teleconference on 14 January 2020.
2Some restrictions in how the funds are used may have to be applied to fully comply with all applicable laws, governmental regulations, including but not limited to anticorruption laws and any industry codes and guidances. e.g. “the Organisation shall not use the Contribution for the provision of any hospitality, entertainment and/or leisure time programmes and/or subsistence to any healthcare professionals, appropriate administrative staff and/or members and appropriate staff of the Organisation unless and to the extent permitted by applicable laws, regulations, codes and guidelines (including, without limitation, the IFPMA and EFPIA codes and any corresponding, equivalent or similar applicable national codes)”