MSL Accreditation Criteria
Accreditation Criteria
for Medical Science Liaison Certification Program
Perspective/ Evaluation Criteria
December 1, 2014
The Japanese Association of Pharmaceutical Medicine
Glossary
The definition of abbreviations and terminology used in this document in alphabetical order:
ABMAdvisory Board Meeting
CIOMSCouncil for International Medical Science
CONSORTConsolidated Standards of Reporting Trials
GCPGood Clinical Practice
GPSPGood Post-marketing Study Practice
GVPGood Vigilance Practice
Healthcare Professional
Any member of the medical, pharmacy or nursing professions
ICHInternational Conference on Harmonization
ICMJEInternational Committee of Medical Journal Editors
Industry sponsored study
A clinical trial, study, basic research sponsored by pharmaceutical or other companies from a planning phase
Investigator sponsored study
A clinical trial, study, basic research sponsored by investigators from a planning phase
KPIKey Performance Index
MRMedical Representative
MSLMedical Science Liaison※, who has high-level of medical/ scientific expertise, knowledge and degrees, internally/ externally helps to promote the proper use of medicines and the maximization of product value, from medical/ scientific perspectives. There is a clear distinction between their activities and the promotional sales activity. MSLs meet with key opinion leaders and medical researchers to communicate/ obtain medical information through medical/ scientific exchanges and conference activities.
※Also known as Medical Scientific Liaison
QCQuality Control
QAQuality Assurance
Table of contents
- Independence from promotional activities (Compliance structure)
- Internal positioning of MSL department
- MSL reporting line independent of Sales and Marketing departments
- Independence from MR role
- Independence from other departments that engage in promotional activities
- Branch-deployed MSL independent of a sales role in a branch
- Compliance structure
1.2.1.Archive of providing reprints (scientific document/journal)
1.2.2.Providing information on pre-marketed drugs/off-label use
1.2.3.Procedure for MSL interaction with HCPs
1.2.4.Scope of information MSL is allowed to provide to HCPs
1.2.5.Review structure of the materials MSL uses
1.2.6.Lecture meetings organized by MSL department
1.2.7.ABM organized by MSL department
1.2.8.Preliminary review of presentation of lecture meeting and manuscripts
1.2.9.Investigator sponsored study
1.2.10.Company sponsored study
1.2.11.Research grant
1.2.12.Ensuring company-wide compliance
1.2.13.Hotline and management structure
1.3.Assessment system
1.3.1.Performance assessment
1.3.2.KPIs independent of Sales and Marketing departments
1.3.3.Ensuring transparency in assessment
- Medical and scientific expertise
2.1.Scientific exchange with HCPs
2.1.1.Providing medically and scientifically fair information
2.1.2.Providing information on off-label use/pre-marketed drugs
2.2.Attendance at medical and scientific conferences
2.2.1.Reporting the latest medical/ scientific information
2.3.Support for research activities
2.3.1.Communication with HCPs on investigator sponsored studies
2.3.2.Internal review and research grant for investigator sponsored studies
2.3.3.Communication with HCP on company sponsored studies
2.4.Support for relevant departments
2.4.1.Medical/ scientific assessment of materials used by Sales and Marketing departments
2.4.2.Sharing new information obtained through MSL activity
2.4.3.Contribution to mid-to-long term directions for treatment in a disease area (life cycle management)
2.4.4.Providing off-label information in response to a request made by Sales and Marketing departments
2.5.Involvement in ABM
- Appropriate communication conforming to the objective of ABM
2.6.Involvement in publication
2.6.1.MSL as a scientist, author, or reviewer
2.6.2.HCP consultation on publication
2.7.Creating materials
2.7.1.Materials based on the latest medical/ scientific information
- Educational system
- Qualification requirements
3.1.1.Clarifying qualification requirements
3.2Educational program
3.2.1.Knowledge based training
3.2.2.Competency based training
3.3 Training content
3.3.1.Business basics
3.3.2.Organization management
3.3.3.Industry regulation and code of conduct
3.3.4.Research ethics
3.3.5.Medical studies
- Independence from promotional activities (Compliance structure)
1.1.Internal positioning of MSL department
1.1.1.MSL reporting line independent of Sales and Marketing departments
【Perspective】
◇MSL is independent of Sales and Marketing department, and their role is positioned as scientific activities that are not regarded as promotional in nature.
【Evaluation criteria】
●In the organization chart, MSL is independent of Sales and Marketing department.
●The division of duties for MSL department is clearly defined.
●Records to be kept
➢Organization chart
➢Division of duties
1.1.2.Independence from MR role
【Perspective】
◇MSL activity is clearly differentiated from that of MR. The environment is set up or improved so as to avoid confusion with MR activity from a HCPs’ perspective.
【Evaluation criteria】
●The role and responsibility of MSL/ MR are clearly defined.
●The differences between MSL/ MR materials are clearly defined.
●Records to be kept
➢Division of duties
➢Documents that describe the code of conduct/ role and responsibilities, job description of MSL and MR
1.1.3.Independence from other departments that engage in promotional activities
【Perspective】
◇MSL is independent of other departments that engage in promotional activities. The environment is developed so as to allow activities that are not regarded as promotional in nature.
【Evaluation criteria】
●MSL department has strategy and activity plan developed by their department which is independent of Sales and Marketing departments.
●The SOP for internal review is developed so that the strategies and activity plans developed by MSL department are not regarded as promotional activities, and review records are kept.
●Records to be kept
➢Activity plan
➢Internal review records
1.1.4.Branch-deployed MSL independent of a sales role in a branch
【Perspective】
◇The environment is developed so that branch deployed MSL is independent of a sales role in a branch and is able to conduct activities that are not regarded as promotional in nature.
【Evaluation criteria】
●The MSL report line is independent of a branch organization.
●The SOP is defined for how a branch member makes a request to MSL.
●Records to be kept
➢Response to a request made by a branch member
1.2.Compliance structure
1.2.1.Archive of providing reprints(scientificdocument/journal)
【Perspective】
◇The SOP for providing reprints is developed and followed.
【Evaluation criteria】
●The SOP for providing reprints is put in place, and records of provided reprints are kept.
●The criteria for choosing providable articles are defined.
●Records to be kept
➢Provided article reprints
1.2.2.Providing information on pre-approval drugs/ an off-label use
【Perspective】
◇The SOP for providing information on pre-approval drug/ an off-label use is put in place and followed.
◇Information is provided in response to a request from HCP, and is explained in a way that does not induce use.
【Evaluation criteria】
●The SOP for providing information on pre-approval drug/ an off-label use※is put in place, and records of providing information are kept.
※The SOP is created for both MR and MSL, respectively, in case they receive a request.
●The list of unapproved drugs/ off-label information is updated on a regular basis.
●The selection criteria for providable articles are defined.
●Records to be kept
➢Records of providing information/ explanation (including the reasons why the provided information is chosen)
➢Reasons why the articles are chosen, and a list of provided reprints (if reprints are provided)
1.2.3.Procedure for MSL interaction with HCP
【Perspective】
◇The environment is developed so that MSL can conduct scientific activities that are not regarded as promotional in nature when they meet with HCP.
◇The objectives of interaction include collecting customers’ unmet medical needs.
【Evaluation criteria】
●Sales and Marketing colleagues are not allowed to be present during interactionsbetween MSL and HCP, except for a brief introduction of MSL by Sales and Marketing colleagues during the first meeting.
●The SOP for MSL activities is put in place, and interaction records are kept.
●Records to be kept
➢Interactions
1.2.4.Scope of information MSL is allowed to provide to HCPs
【Perspective】
◇The clear criteria are set up for the objectives of interactions between MSL and HCP to avoid being regarded as promotional in nature.
◇Information given by MSL to HCP is scientific and not biased.
【Evaluation criteria】
●MSL interaction with HCP is scientific, objective and not biased.
●Provided information is based on the grounds and well-balanced.
●Non-promotional.
●Provided information contains mainly generic names, not brand names.
●The SOP for internal review of MSL materials is put in place, and review records are kept.
●Only internally-reviewed-and-approved MSL materials are used.
●Records to be kept
➢Internal review
➢Approved MSL materials
1.2.5.Review structure of MSL materials
【Perspective】
◇The internal review structure is put in place to check whether information provided with the use of MSL materials is appropriate as non-promotional activities.
【Evaluation criteria】
●The SOP for the internal review of MSL materials is put in place, and review records are kept.
●Records to be kept
➢Internal review records
➢Approved MSL materials
1.2.6.Lecture meeting organized by MSL department
【Perspective】
◇Symposia organized by MSL are held independently from Sales and Marketing departments.
【Evaluation criteria】
●Symposia are hosted by MSL department that is independent of Sales and Marketing departments.
●Symposia are scientifically fair and neutral, not biased, and well-balanced in content.
●The logo and colors associated with a certain brand are not used in a symposium venue.
●The logo and colors associated with a certain brand are not used in the slides to be used in symposia.
●Sales and Marketing employees are not allowed to attend MSL department-organized symposia for the purpose of promotion. (It is acceptable to support events outside the venue or to listen to presentations for a self-learning purpose.)
●The SOP is put in place for the internal review of symposium planning and presentation topics, and review records are kept.
●Records to be kept
➢Internal review records
➢Materials used at symposia, such as slides
➢Symposia proceedings
1.2.7.ABM organized by MSL department
【Perspective】
◇ABMs organized by MSL are held independently from Sales and Marketing departments.
【Evaluation criteria】
●ABMs are hosted by MSL department that is independent of Sales and Marketing departments.
●Sales and Marketing employees are not allowed to attend MSL department-organized ABMs. (It is acceptable for MSL to give medical/ scientific presentation as a medical expert at ABMs organized by Marketing. If the discussion point in ABM will be related safety or rightness of usage, minimal attendees from Marketing will be allowed.)
●The objective of ABM is to collect opinions, and the time used by MSL department to give input accounts for less than half.
●The logo and colors associated with a certain brand are not used in an ABM venue.
●The logo and colors associated with a certain brand are not used in the slides to be used in ABMs.
●ABM attendees are chosen based on clear criteria.
●The SOP is put in place for the internal review of ABM planning and its content, and review records are kept.
●Records to be kept
➢Internal review records
➢Materials used at ABMs, such as slide
➢ABM proceedings
1.2.8.Preliminary review of presentation summaries and manuscripts
【Perspective】
◇A preliminary review structure is put in place for presentation summaries and manuscripts.
【Evaluation criteria】
●The SOP is put in place for the internal review of presentation summaries and manuscripts, and review records are kept.
●Records to be kept
➢Internal review records
1.2.9.Investigator sponsored study
【Perspective】
◇A department independent of Sales and Marketing uses fair and objective judgment in communication for investigator sponsored studies.
◇Communication for investigator sponsored studies is not regarded as promotional in nature.
◇MSL smoothly handles a request, either directly from HCP or via Sales/ Marketing department, by using optimal internal communication/ reporting process.
◇MSL is capable of promptly and appropriately sorting out how to deal with each request, including the decision to accept or not, in accordance with internal/ industry rules.
【Evaluation criteria】
●The SOP is put in place for communication for investigator sponsored studies, and communication records are kept.
●It is ensured that communication for investigator sponsored studies is not regarded as promotional in nature.
●An internal review structure independent of Sales and Marketing departments is responsible for review processes.
●The SOP for the internal review of investigator sponsored study plans is put in place, and review records are kept.
●Communication is appropriate and within the scope of on-label information.
●A written consent is obtained from investigators regarding support for investigator sponsored studies.
●Progress is monitored on a regular basis.
●Records to be kept
➢Communication
➢Internal review records
➢The outcome of a study supported by MSL
➢Progress
1.2.10.Company sponsored study
【Perspective】
◇When planning company sponsored studies, MSL communicates with HCP in an appropriate way, and conforms to internal/ external rules when understanding medical needs or selecting centers.
【Evaluation criteria】
●The SOP is put in place for communication for company sponsored studies, and communication records are kept.
●It is ensured that communication for company sponsored studies is not regarded as promotional in nature.
●An internal review structure independent of Sales and Marketing departments is responsible for review processes.
●The SOP for the internal review of company sponsored study plans, and review records are kept.
●Progress is monitored on a regular basis.
●Records to be kept
➢Communication
➢Internal review records
➢The outcome of a study supported by MSL
➢GCP/GPSP training attendance
1.2.11.Research grant
【Perspective】
◇A department independent of Sales and Marketing uses fair and objective judgment in handling research grant.
◇Research grant is provided in a way that is not regarded as promotional in nature.
◇Transparency is ensured around research grant by signing a contract.
【Evaluation criteria】
●The SOP is put in place for research grant, and records are kept.
●It is ensured that providing research grant is not regarded as promotional in nature.
●An internal review structure independent of Sales and Marketing departments is responsible for review processes.
●The SOP for research grant is put in place, and review records are kept.
●Investigators are obliged to report the outcome of a study.
●The consent to comply with transparency guidelines is obtained.
●Records to be kept
➢Communication
➢Internal review records
➢The outcome of a study for which research grant is provided
➢Contract
1.2.12.Ensuring company-wide compliance
【Perspective】
◇Company-wide compliance is ensured and maintained by using an appropriate checkup/ feedback system.
◇Information held by MSL department is managed to avoid the misuse for promotional activities.
【Evaluation criteria】
●The SOP is put in place for the regular/ irregular checkup structure of compliance related materials/ records, and checkup records are kept.
●A cycle is put in place to collect feedback from HCP to improve.
●Training plan for compliance is developed and implemented.
●Sales and Marketing employees are not allowed to access detailed information of investigator sponsored studies held by MSL department.
●Records to be kept
➢Checkup
➢Compliance training attendance
1.2.13.Hotline and management structure
【Perspective】
◇A hotline and its management structure are put in place to mutually oversee compliance.
【Evaluation criteria】
●A compliance hotline is put in place.
●Employees in relevant departments are aware of the hotline.
1.3.Assessment system
1.3.1.Performance assessment
【Perspective】
◇Evaluators of MSL activity and their department are clearly independent of Sales and Marketing departments.
【Evaluation criteria】
●MSLs are evaluated by a report line independent of Sales and Marketing departments.
●An objective evaluation system with multiple evaluators is put in place.
1.3.2.KPIs independent of Sales and Marketing departments
【Perspective】
◇MSL KPIs are independent of sales-related items, and are set up as non-promotional activities.
【Evaluation criteria】
●KPIs are not set for promotional activities.
●KPIs are not set for MSL activities that may be regarded as promotional in nature.
1.3.3.Ensuring transparency in assessment
【Perspective】
◇Transparency is ensured for MSL activity evaluation. The environment is created so that evaluated MSL can file complaints against evaluation results.
【Evaluation criteria】
●The SOP is put in place for the evaluation of MSL activity, and records are kept.
●Evaluation criteria are clearly shown.
●The process for filing complaints against evaluation results and HR hotline are put in place.
●Records to be kept
➢Evaluation results
- Medical and scientific expertise
2.1.Scientific communication with HCPs
2.1.1.Providing medically and scientifically fair information
【Perspective】
◇Information is provided based on appropriate materials/ articles.
➢MSL uses materials appropriately reviewed from medical perspectives.
➢MSL uses articles appropriately chosen (Articles are not chosen in a biased manner.)
◇MSL works to increase knowledge by collecting the latest scientific information comprehensively.
【Evaluation criteria】
●MSL materials are reviewed appropriately from medical perspectives.
●The standards for providing reprints are defined.
●MSL attends conferences/ scientific trainings, and collects the latest scientific information.
●Records to be kept
➢Review
➢Information provision (interaction with HCP)
➢Attendance reports of conferences/ scientific trainings
2.1.2.Providing information on an off-label use/ pre-marked drugs
【Perspective】
◇MSL provides fair information by using articles grounded on medical and scientific evidences in a way that is not regarded as promotion for an off-label use/ an unapproved drug.
【Evaluation criteria】
●MSL provides fair information by using articles grounded on medical evidences in a way that is not regarded as promotion for an off-label use/ an unapproved drug.
●Records to be kept
➢Provided information (Interaction with HCP)
➢An article list (if reprints are provided)
2.2.Attendance at medical and scientific conferences
2.2.1.Collecting the latest medical/ scientific information
【Perspective】
◇Information not only on company products but also on competing products in relevant disease areas, as well as the latest studies, diagnostics, and treatment, is shared appropriately among internal stakeholders.
【Evaluation criteria】
●The SOP is put in place for information handling, and information is managed.