The Geneva-based International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) represents research-based pharmaceutical companies and national associations around the world. IFPMA’s membership includes many multinational pharmaceutical companies and the national associations of both developed and developing countries. The IFPMA Code of Practice (IFPMA Code) states that national associations that are members of IFPMA, such as the Pharmaceutical Research and Manufacturers of America (PhRMA) in the United States, in turn adopt codes that not only meet local laws and regulations, but also are consistent with and at least as comprehensive as the IFPMA Code. The IFPMA also states that companies that are members of IFPMA agree to comply with the codes of their national member associations, but where a national member association does not exist, the IFPMA Code is intended by IFPMA to serve as a default code for those companies’ activities. The effective date of the revised IFPMA Code is September 1, 2012. By this date, national member associations are expected by IFPMA to address any gaps or inconsistencies between the IFPMA Code and their national codes of conduct, laws and regulations.
The IFPMA Code takes a stricter position on certain areas covered in the 2006 Code of Pharmaceutical Marketing Practices (2006 Code), especially toward items provided to health care professionals (HCPs). For example, the 2006 Code indicated companies could provide promotional aids or reminder items to HCPs and appropriate administrative staff, as long as the items were of minimal value and relevant to an HCP’s practice. In contrast, the revised IFPMA Code states that promotional aids may be provided to HCPs (but not to administrative staff), and that the items should be of minimal quantity (in addition to minimal value). In a similar vein, under the 2006 Code, companies could provide inexpensive cultural courtesy gifts to HCPs on an infrequent basis in acknowledgement of significant national, cultural or religious holidays, if allowed under local law and consistent with local practice. The IFPMA Code continues to allow for the provision of such cultural courtesy gifts, but only on an exceptional basis, and specifies that even under such circumstances, these gifts should not be provided if they could be perceived as interfering with the independence of an HCP’s medical decisions. Likewise, the 2006 Code stated that items of medical utility could be offered or provided to HCPs, if the items were of modest value and beneficial to patient care; whereas the IFPMA Code now specifies these items should not be provided on more than an occasional basis, and may be provided only if they “do not offset routine business practices.” The revised IFPMA Code also states that samples of a pharmaceutical product may be supplied to HCPs, in accordance with local laws and regulations, but that companies should mark the samples to ensure they cannot be resold or otherwise misused. This provision goes beyond the 2006 Code, which indicated only that the samples should not be resold or misused, without specifying how to help prevent such practices.
The IFPMA Code also expands upon the 2006 Code. Whereas the 2006 Code focused on pharmaceutical companies’ promotional interactions with HCPs, the key expansion of the IFPMA Code is that it addresses pharmaceutical companies’ interactions with medical institutions and patient organizations, as well as other types of interactions with HCPs.
Specifically, the IFPMA Code now includes a Section 11: Interactions with Patient Organizations. This section states that the pharmaceutical industry must interact ethically with patient organizations and respect their independence. For example, under the IFPMA Code, a company may not require that it be the sole funder of a patient organization or any of the organization’s programs, and a company must document the nature of its support (including the purpose and funding of any activity) in writing. A company may financially support a patient organization’s meeting, but only if the primary purpose of the meeting is professional, educational or scientific in nature, or otherwise supports the organization’s mission. The company must also ensure the meeting is held at an appropriate venue and location, and any meals or refreshments provided by the company are modest under local standards.
With regard to medical institutions, the IFPMA Code includes a new Section 9: Clinical Research and Transparency, which states that all human subject research must have a legitimate scientific purpose and must not constitute “disguised promotion.” Section 9 also states a commitment to transparency and disclosure of clinical trial information in clinical trial registries, databases and scientific publications, as set forth in 2009 and 2010 Joint Position statements issued by the IFPMA, the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Japan Pharmaceutical Manufacturers Association and PhRMA.
Another new section in the IFPMA Code is Section 10: Support for Continuing Medical Education. This section indicates a company’s financial support may be appropriate where the primary purpose of the continuing medical education (CME) program is the enhancement of medical knowledge. When a company provides content for CME programs, the IFPMA Code states that content must be fair, balanced and objective; designed to accommodate differences of opinion; and consist of information that can contribute to enhancing patient care.
The most palpable impact of the revisions in the IFPMA Code will be in developing markets, where national laws, regulations and codes are not yet as rigorous as the IFPMA Code. In these rapidly growing markets, the IFPMA Code has the potential to drive more consistent and overall higher standards of conduct among multinational, regional and local companies that operate there. But the pace and extent of the change that the IFPMA Code will effect on established business practices and norms in these markets will depend on the vigor with which IFPMA member companies align with the revised Code, engage in self-regulation and fulfill their training and compliance obligations, as well as the tenacity with which the IFPMA and its member associations enforce their codes of conduct.
For pharmaceutical companies operating in developed markets, such as the United States and many European countries, the direct impact of the IFPMA Code is likely to be less significant because national laws, and regulations and codes are generally more expansive and stringent than the IFPMA Code.
For example, the IFPMA Code prohibits pre-approval or off-label promotion, without restricting the “full and proper exchange of scientific information.” In the United States, the prohibition on pre-approval or off-label promotion in the Federal Food, Drug, and Cosmetic Act, together with the regulations and guidance of the U.S. Food and Drug Administration (FDA), articulate the same general position on this issue. However, through guidance and enforcement activities, FDA has taken a more aggressive position on pre-approval and off-label promotion by prescribing numerous activities, which FDA believes help ensure scientific exchange does not become promotional communication. This point is illustrated by FDA’s Good Reprint Practices Guidance, which recommends that manufacturers disseminate only certain types of off-label publications (e.g., peer-reviewed publications that are not edited or supported by the manufacturer) and that such publications should be disseminated in a very specific manner (e.g., distributed with the approved labeling for the drug and a representative publication that reaches a contrary conclusion, and not accompanied by any promotional material). Similarly, FDA’s draft guidance on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices specifies a company should provide off-label information only in response to a bona fide unsolicited request, and the off-label response should meet several criteria (e.g., narrowly tailored to the question that was asked, directed only to the individual who asked the question and accompanied by a prominent statement that discloses all important safety information for the product and the unapproved nature of the use discussed in the response). See FDA Issues Draft Guidance, Requests Public Comments on Communication of Off-Label Information for more information.
As these examples show, FDA’s requirements and recommendations are more specific, and therefore more limiting, than comparable aspects of the IFPMA Code. Likewise, PhRMA’s Code on Interactions with Healthcare Professionals (PhRMA Code) tends to be more restrictive than the IFPMA Code. For instance, the IFPMA Code permits a company to sponsor an HCP’s attendance at scientific or professional meetings, limited to the payment of travel, meals, accommodations and registration fees. In contrast, the PhRMA Code states that a company should not provide financial support for the costs of travel, lodging or other personal expenses for non-faculty HCPs attending scientific, educational or professional meetings. The PhRMA Code also prohibits outright the provision of promotional aids or reminder items to HCPs, in contrast to the IFPMA Code, which permits these items under certain circumstances. The PhRMA Code also includes many topics, such as conflict of interest disclosures and the responsible use of prescriber data, that the IFPMA Code does not cover.
On the other hand, the IFPMA Code now addresses interactions with patient groups, whereas PhRMA has not issued similar guidance or provisions in its Code. While many PhRMA members’ current policies and procedures toward patient organizations may already be consistent with Section 11 of the IFPMA Code, if PhRMA opts to take a more expansive position (e.g., to require disclosure of relationships with patient organizations, as the EFPIA does), any PhRMA guidance issued in response to the revised IFPMA Code may prompt PhRMA members to modify their current practices in this area.
The revised IFPMA Code reflects the global industry trend to self-regulate pharmaceutical industry sales and marketing practices in the absence of clear regulatory guidance. The evolution of such Codes of Conduct also reflects recognition of an increasingly aggressive regulatory enforcement environment in which many in the industry are not certain of regulatory expectations or the limits of commercial speech. The revised IFPMA Code is also timely in view of the recent focus in the United States and elsewhere on practices relating to interactions with health care professionals, as evidenced by government investigations and actions under the Foreign Corrupt Practices Act (United States), the Bribery Act (United Kingdom) and other countries.
In this regulatory environment, pharmaceutical companies should carefully review their scientific exchange and sales and promotional activity programs to ensure consistency with regulatory expectations, and with the IFPMA Code and other Codes of organizations in which they are participating members (e.g., PhRMA Code in the United States).