Field-based medical programs are common adjuncts to development, headquarters medical, and commercial operations for most pharmaceutical companies in the United States. The shift in regulatory complexity, coupled with a waning acceptance and impact of the traditional “reach/frequency” business model observed by many pharmaceutical companies, has enhanced the strategic importance of field-based medical groups. Lack of standardized training and assessment of functional capabilities may threaten this enhanced role and raise the question of the need for a uniform certification process. To confirm or dispel our own bias about the need for certification, we explored this issue using an informal web-based survey tool. A simple majority (63%) of responders to our survey felt certification was not needed. It was interesting that the subset of managers was evenly split, while the majority (70%) of individual contributors was not supportive of a certification requirement. These results suggest that while certification is not an attractive option to the majority of responders, a meaningful minority of responders, including some managers of medical science liaison programs, believe certification is important. Our opinion is that while the move to certification is not imminent, this will continue to be an important topic for discussion and debate in the years to come.
CONTACT: Jane Chin, Ph.D. firstname.lastname@example.org
The original field-based medical information program was implemented in the 1967 by the UpJohn Company with the goal of providing medical information support to health care professionals beyond that available from a professional sales representative (1). Since that time, the number of field medical team (FMT) programs has expanded to include the majority of pharmaceutical companies in the United States who have an FDA-approved drug. In addition, other companies with compounds in latestage development are either creating or considering creating an FMT to help establish or support the medical rationale for a particular therapeutic agent. The role and activity, both current and proposed, of the medical science liaison (MSL) have been well described (2–4).
The complexity of managing and deploying an FMT has grown over the last decade due to increased regulatory oversight by the Pharmaceutical Manufacturers Association (PhRMA) and the Office of the Inspector General (OIG) as well as increased scrutiny by the Food and Drug Administration (FDA). Recent multibilliondollar fines (judgments) against several companies have raised the stakes regarding the nature of information that can be shared and the route (venue and person) through which the information can be appropriately delivered. In addition, the “share of voice” business model deployed by the pharmaceutical industry over the past few decades, which relied on reaching top prescribers with increasing frequency, has declined in both acceptance and impact. Meanwhile, consolidation of care into organizations that manage large populations of consumers has dramatically altered the type and scope of information required for decision making. Finally, health care complexity now demands that both (comparative) effectiveness and health economic evidence augment traditional safety and efficacy information in coverage and reimbursement decisions. All of these factors have combined to enhance the strategic importance of field-based medical professionals for both the health care community and the organizations that discover, develop, and commercialize pharmaceutical products.
It is our observation that the growth in FMTs has resulted in highly variable skills and training for the individual MSLs across the industry. This variability exists within individual companies and is magnified across organizations based on the author’s experience and anecdotal observation.
These factors raised our interest about a number of questions regarding whether the individual exchanging information with a health care provider should have special qualifications or capabilities. For example, would consistency of training and performance improve the perception of the MSL? Would certification or validation of the MSL role allay concern about uniform performance and increase acceptance of the MSL? If so, would this apply to both the health care provider’s acceptance of MSL and the companies that employ them? Would certification actually denote a minimum level of training and competence and, if so, by whose standard? What body should certify the MSL, private interests or government? If the latter, should it be administered by individual states or by a federal agency? Does certification truly add value, or is it a revenue-generating prospect for whoever controls the process? Finally, would it improve candidate talent or readiness for organizations, or would it rather create a new level of liability for the organization that chooses to hire a noncertified MSL candidate over one that is certified?
Currently, organizations rely on their own individual processes for hiring, training, and deploying MSLs based on organizational development and strategy. We are not aware of an organized effort to standardize the education, skills, and training required to join an FMT.
To validate our own opinions about certification, we contacted both MSLs and industry leaders responsible for FMT oversight. We did so by deploying a nonscientific, informal webbased survey to obtain feedback on a subset of questions regarding the need for, and support of, MSL certification. The survey was made available via the MSL Institute (MSLI) website and was open for response from May 12, 2010, to June 11, 2010. The survey link was sent proactively to all 2,005 members of the MSLI mailing list, which included, but was not limited to, professionals responsible for FMT program development and management. A reminder was sent at the midpoint of the period during which the survey was open and responses were limited to one per email address. Limitations of the survey methodology include the lack of validation of the survey instrument and the voluntary nature of data capture.
A total of 139 responses provided a complete or near-complete response sufficient for analysis. Table 1 illustrates the response to the primary question, “Do you think MSL certification is necessary?” The responses are organized according to organizational affiliation and leadership role. For this primary question, 88 responders (63%) indicated that certification was not needed for the MSL role. There were 40 responders who were found to be managers or professionals accountable for the management of an MSL program at their respective company. Interestingly, the number of those for and against certification in this group was essentially evenly split (21 against vs 19 in favor). For the 94 responders determined to be individual MSLs, 66 (70%) expressed an opinion that certification was not needed.
When asked what major component should be included in a certification, most responders offered their opinion regardless of whether they supported certification or not (Table 2). The majority of responders indicated that “MSL job skills or competencies” should be the main focus. For those who provided added context to their answer, the main focus was the need for “regulatory” or “compliance” training as a key component of MSL certification.
We also sought opinions on the most appropriate body to administer or oversee certification, should one be implemented. Of the 92 individuals who responded to this questions, most (42%) felt the employee’s individual company should oversee any certification process, followed by professional associations (29%) such as the Drug Information Association, the American College of Clinical Pharmacy, or other.
Regarding frequency of any certification process, responses were essentially equally divided between “none” (44%) and “every 2 years” (42%). We also asked who should fund a certification process—to no surprise, the overwhelming majority of responders suggested the employer or hiring company should pay for the certification.
Certification is not a novel concept. Use of certification has been proposed for other pharmaceutical field forces, most notably sales representatives (5). However, even with the logarithmically higher number of sales representatives and far greater years of existence in the pharmaceutical industry, certification has been a tenuous concept to implement. These implementation challenges for sales forces have some relevance in identifying comparable difficulties for field medical organizations. Effective implementation of sales force certification would require substantive support both from sales representatives who would take the test and from physicians who interact with sales representatives. While organizations aiming to provide certification to their pharmaceutical customers may be justified in assuming that the industry cannot self-certify, this does not address the core question in certifying sales representatives: will certification mean anything to stakeholder perceptions that matter—including physician and government perception of field sales forces (5)? We suspect that the answer to this question may underline why certification remains a debate for even the most applicable field force in the pharmaceutical industry.
Certification is generally considered as a means to level the playing field in terms of talent acquisition. However, various factors would suggest that certification is actually a symptom of our industry’s challenge in normalizing this novel role, and certification may, in fact, provide an additional distraction to the current list of challenges confronting executives who must lead these programs.
First, the uniqueness of an individual company’s program may overshadow the general skills that a certification would address. This would defeat the purpose of standardization intended by a certification process and introduce confounding factors in validating such certification in a meaningful way. Similarly, certification could not address the practical aspects of interactions that are the foundation of the MSL’s competence—one may objectively assess the MSL’s theoretical understanding of important variables such as building relationships with health care stakeholders but cannot determine their ability to competently execute these variables. Assessing knowledge may be accomplished without certification and, due to trade secrets and proprietary data that are unique to individual companies, should remain under the purview of company-specific training. The assessment of an MSL’s recall of basic facts or lists of rules, such as the details of the PhRMA code, may be conducive for certification, although the same thing can be accomplished via simple testing. On the other hand, interpretation and application of those guidelines in the individual workplace will again vary and is primarily driven by the individual organization and the philosophy (risk tolerance) of their compliance and legal teams. Unlike a profession where the ability to manufacture a specific item can be objectively measured and assessed, the ability to interact with another human being is not easily determined, particularly with the backdrop of advanced knowledge of pathophysiology and pharmacotherapy. Various critical metrics of MSL competence such as their ability to navigate the complexities of scientific exchange in a highly regulated environment, or capacity to grasp multivariate industry forces that potentially have an effect in their companies’ therapeutic strategy, are difficult to diagnose by standardized tests.
There are potential human resource-related implications of MSL certification as well. If certification is portrayed as proof of MSL candidate competence, then companies that have limited the candidate pool to doctorateprepared candidates may have to address questions from those without advanced degrees who pass certification and accordingly demonstrate their competence for the role. This may be one of the reasons why many MSL professionals who do not hold doctoral degrees welcome the idea of certification—for these professionals, certification may indeed level the playing field from a job competition perspective (personal observation via Jane Chin, MSL Institute).
Finally, a proposal for certification must have its basis in differentiation in the eyes of the stakeholders whose opinions most impact the perception of the MSL role: the MSL’s customers. Will certifying an individual MSL make that person more credible or valuable in the eyes of a thought leader or key decision maker? This question is clearly beyond the scope of this commentary but one that has to be addressed at some point for industry-wide certification to be viable for the MSL.
The results of our nonscientific survey suggest that MSL certification is neither required nor desired by those performing the role. The desire for certification is divided among the small group of respondents identified as managers (21 against vs 19 in favor of certification). However, the overall majority of responders, and the overwhelming majority of MSL responders, indicated that certification is not required or desired. As one responder stated, “After 30 years as a liaison, I can assure you that most top physicians will not be impressed by the word ‘certified’ on a business card. How you prepare yourself, how you present yourself and your deliverables make, build and maintain the professional relationship. If you’re worried about distinguishing yourself from the sales rep there is definitely something missing that ‘certified’ won’t fix.”
One aspect of the survey that was of particular interest was the question regarding who should oversee any certification (and at what cost). The responses, in terms of cost, suggest a modest investment. However, the entrepreneurial spirit was clearly evident as several respondents suggested a two-day certification course costing as much as $10,000 per attendee. This highlights the dynamics in play around the certification process and who may stand to gain the most—those who provide certification as a commercial model with a renewable revenue source. This poses an additional, quality-based challenge to the certification providers: should a certified individual carry that certification to another employer without requirement of a new certification by the new company? It would not be beyond reason to assume that state governments, such as the state pharmacy association or board of pharmacy, could also view this as a revenue source. Yet the same challenge of transferability of certification from company to company stands for government-originated certification.
Many verbatim responses were strongly against the prospect of certification. For example, one responder noted, “I do not support the idea of MSL certification. I think it would be an unnecessary distraction of time and energy from a limited supply of both. All of us have well established professional credentials which qualify us for our job duties.” Another responder centered on individual company expectations for the MSL, noting that “each company has different expectations for MSL performance. While there are threads of similarity, the MSL work at my company is not consistent with colleagues from several pharma companies. The role does not translate consistently. I think it would be a disservice to promote certification for the role of the MSL.” This theme was repeated by other respondents.
If we assume that certification becomes a reality for FMTs, there should be a uniform approach to the certification process and minimum standards to ensure consistency across the industry. For example, certification on the guidance from the OIG or FDA must be uniform enough to allow standardized training regardless of individual company interpretation of these guidelines. Our collective experience suggests this would be a challenge. However, one could approach steps to certification readiness from the perspective of absolute aspects of compliance-related guidance, laws, and codes. In the end, it is likely that companies will create their own certification based on their specific MSL definitions and role profiles. Possible solutions to this dilemma regarding ownership of certification may include a concept such as certificate of completion as opposed to certification of modular offerings. To obtain a certification of completion, the MSL might be required to complete assigned readings, submit an essay, conduct an approved and job-appropriate project and present the findings at a forum such as DIA, ACCP, or ASHP
The certificate of completion could be integrated into a company’s individual certification or training process, rather than serve as the single certification program for all MSLs in the life science industry. Part of the process would have to include an assessment and agreement on what aspects of the role are amenable to certification.
Despite our collective opinion about, and resistance to, MSL certification, the fact remains that a sizable minority supports certification. Some clearly see this as a revenue source or an opportunity to control the MSL candidate pool. Others may view this as a method to legitimize and standardize a role that remains novel and highly variable since its inception more than 40 years ago. For now, however, we see no immediate or imminent need to strive for certification of the MSL role.
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Disclosure: Kenneth L. Massey has disclosed that he is an employee of Mitsubishi Tanabe Pharma America. Jane Chin has disclosed that she is a stock shareholder of SGEN. Jimmy Black has disclosed that he is a stock shareholder in Amylin Pharma and Bio/tech Holdings.