Approved on July 18, 2012
Effective from September 1, 2012
The benchmarks of IRRMA Code is set referring to the Code of Practice of European countries, United States, Japan, and other neighboring countries, current local market common rules, and the social expectation to the pharmaceutical industry. This Implementing Regulations should be periodically reviewed and revised by the COP Committee of IRPMA (once half a year). The revision will be adopted after being discussed and resolved by the Board of Directors and Supervisors.
1. The marketing of OTC drugs is excluded, but OTC drugs used under physician prescriptions or in hospitals are included.
2. Company representatives should at all times maintain a high standard of ethical conduct and professionalism and should follow hospital policies in their respective territory.
3. HCP Payment for Service: the honorarium of the Lecturer/ Moderator/ Chairperson/ Panelist/ Members of Focus Group or Advisory Board of symposia, congresses and alike may be paid up toNT$5,000/hr (might include the time spent for discussion. The time calculation can be round up as half hour if less than 30 minutes and one hour for time more than 30 minutes.)
Moderator / Chairperson: up to NT$10,000/specific venue.
Panelist / Members of Focus Group: up to NT$10,000/event.
Additional payment to a lecturer for concurrently serving as Moderator/ Chairperson/ Panelist/ Members of Focus Group or Advisory Board in the same event at the same venue should not exceed NT$10,000.
The number of moderator/chairperson cannot exceed the number of the lecturers. The number of moderator/chairperson, and lecturers needs to be properly balanced with the numnber of participants. In principle, the moderator/chairperson should at the minimum moderate questions and facilitate discussions, not just introduce the lecturers.
(International norms will be applied for international speakers/advisors).
*This article becomes effective from January 1, 2013. (Revised in February, 2016)
4. Appropriate venue: venues for the Event or meeting must not be lavish or deluxe. The selection of the location must be based on the following criteria:
- should be easy for the majority of participants to reach
- should avoid venues renowned for their leisure offerings or entertainment facilities or extravagant
- be limited to the venue that is under/equivalent to 5 star hotel
- blanket reservation and/or utilization of the entire place for entertainment or hospitality, e.g. shows, movies, etc. are prohibited
- The following venues are considered inappropriate and not permitted (not limited to):
- Sports Venues: e.g. golf courses, country clubs, stadiums, etc.
- Tourist Attractions: e.g. theme parks
- Entertainment Venues: e.g. nightclubs, theaters, karaoke, KTV
5. In the case of sponsoring domestic or international symposia, congresses or alike:
The travel reimbursement and registration fee should be exclusively limited to the attendees, not to family members or accompanied guests.
The flight tickets being sponsored should be up to business class only.
There must be at least 3-hour educational programs per half day to justify an overnight CME program.
Programs, daily sign-in sheet of participants, documents/invoices of expenses in relation to the event (such as hotel expenses, meeting expenses, speaker fee, and speaker contract/agreement) must be provided as evidences when there is a dispute.
6. Gifts and Other Items:
- Prohibition of Cash & Personal Gifts: Payments in cash or cash equivalent (such as gift certificate) must not be offered to healthcare professionals. Gift for the personal benefit of healthcare professionals (such as sporting or entertaining tickets, electronic items, etc.) must not be provided or offered.
- Prohibition of Promotional Aids: Promotional aids (such as gimmick) should not be provided to healthcare professionals. A promotional aid is a non-monetary item, printed with names of companies and/or products, given to healthcare professionals for a promotional purpose.
*This article becomes effective from May 16, 2018.
- Items of Medical Utility: Medical journal or textbooks for academic use can only be offered to individual hospital departments. Other items of medical utility with modest value may be offered to hospital or clinics if such items do not offset routine business practices and are beneficial to enhancing the provision of medical services and for patient care. Other items of medical utility must not be provided to individuals for their personal benefit.
- Cultural courtesy gifts are not allowed, including but not limited to, gifts offered to healthcare professionals on traditional festivals or flowers and funeral scrolls for funeral.
7. Donation and educational grants must be clearly separated from business. The intention of making a donation or providing an educational grant must not be associated with influencing purchasing, prescribing and pricing of medicines.
Donation and educational grants must not be given to personal accounts or the accounts of individual departments of hospitals.
Donation or educational grants must only be given to the government registered medical institutions, medical societies, associations and foundations.
IRPMA strongly recommends each member company establishes a proper review and approval process for Donation & Educational Grant.
8. The expenses of hospitality should be limited to refreshments and/or meals incidental to the main purpose of the Event and should not exceed NT$3,500 person/day. For overseas events, the principle is that the amount should not exceed NT$3,500 person/day. However, if the amount limits of the international/local regulations in the visiting countries exceed NT$3,500 person/day, the regulations of the visiting can be followed.
9. All PMS shall go through JIRB, IRB or Ethics Committee.
All human studies including PMS must be approved and managed by Medical Director or equivalent CR Manager of member companies.
All PMS must be registered on the website of IRPMA PMS registry system.
IRB approval code or approval date should be shown on study-related documents.
Mandatory Medical Components for Post-Marketing Studies:
- Protocol to address scientific objectives
- To have specific scientific interest
- Pre-determined sample size justification based on study description
- Should be based on clinical & statistical significant meaning
- Patient consent obtained
- IRB approval secured
- Follow GCP Guideline
- Minimum to comply with TW DOH GCP
- Registry on IRPMA website
- Payment must be appropriate and according to study design. It must not be set to influence prescribing behavior
- Must reflect time & efforts from investigators
Post-Marketing Surveillance Studies must be non-interventional, no interference on treatment decision:
- PMS studies must have scientific or medical merit and objectivity and not be designed for, or conducted as, a promotional exercise.
- PMS studies must be research which is intended to generate data on safety parameters of a product that has been approved for registration when used in accordance with the product information.
- PMS studies are part of clinical research and the only extent of involvement of medical representatives is in recommending or identifying healthcare professionals to participate in the study. The study must be managed through the company's medical department.
- PMS studies must have a formal protocol, a requirement for data collection and generation of a report.
- When a company is intending to carry out a PMS study it must be registered on the website of IRPMA PMS registry system.
- Only patients being treated for approved indications of the product are to be enrolled in the PMS study.
- Decisions by HCPs to prescribe the product should be based solely on their clinical judgment. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. Starter packs or free trade packs must not be distributed as part of the PMS study.
- Any payment to a healthcare professional must be reasonable and commensurate with the work involved and not based upon the number of prescriptions written.
- A prompt report on the outcome of the study should be provided to participating healthcare professionals without undue delay.
- IRB approval code or approval date should be shown on study-related documents.
- Follow GCP principle
- Patient consent obtained
Essential Components for Market Research:
- With scientific research methodology:
- Sampling techniques
- Data collection techniques
- Analysis techniques
- Samples size: usually relatively small, and representative
- Subjects (respondents) consent required
- Must not collect medical information (e.g. efficacy, effectiveness or safety data) which can be linked to identifiable individuals
- Individual data collection is prohibited
- If the subjects are patients, the research must be conducted by independent third party
- Must not be used as a tool for direct patient promotion
- Brand and/or compound name should not be mentioned
- Can only be used for research purposes; with one-way communication from subjects to the sponsors
- No communication from sponsor to individual subjects (patients/physicians)
- General report sharing allowed
- Must not be used to influence subjects' view or behaviors
- Payment must be appropriate and according to study design. It must not be set to influence prescribing behavior.
Definition of a Patient Support Program (PSP)
A PSP is defined as a service for direct patient or patient carer interaction/engagement designed to help management of medication and/or disease outcomes (e.g. adherence, awareness and education), or to provide HCPs with support for their patients.
PSPs may also include the Companies providing a service or arranging financial assistance for patients who cannot afford their medication (e.g. reimbursement or discount schemes).
PSPs should be designed and used to enhance patient care, benefit healthcare system and achieve healthcare outcome rather than to promote pharmaceutical products and/or to influence the prescribing decisions.
Basic Requirements for PSP
·Patients and physicians written informed consent required if PSPs involve the collection of personal data
·Patient privacy must be protected
·Recommended to be conducted by a third party, and that third party is capable of ensuring appropriate patient data privacy protection and identifying and reporting of AEs
·Initiation and management of PSPs requires the involvement of the personnel in charge of PV to ensure appropriate monitoring and reporting of AEs
- ·HCPs should not be paid or obtain anything of value for enrolling patients in PSPs
10. Educational activities towards the general public
It is the responsibility of pharmaceutical companies to adhere to highest ethical standards and applicable laws and regulations when educating the general public on general medical related aspects, e.g. by conducting disease awareness programs.
In according with the Pharmaceutical Affairs Act in Taiwan, the promotion of prescription drugs to the general public is prohibited. Direct-to-consumer materials that are not product specific, but are disease state or therapy area related, should not be used to promote a specific
product but must nonetheless still be accurate, truthful and fair balanced, by ensuring pros / cons of available treatment alternatives are fully referred to.
The principal responsibility of educational activities to the general public is to provide the most current, evidence- based and unbiased information available. Important information must not be omitted if relevant. Claims should not be stronger than scientific evidence can support, and every effort should be made to avoid ambiguity. Only information that is based on the most up-to-date evidence that is scientifically valid and endeavor to avoid incorrect or misleading impressions of scientific information can be included and must be well-documented by reference to scientifically valid, verifiable data. All educational materials must contain a recommendation to consult with a healthcare professional to seek for guidance on their health status or disease treatment.
When sponsoring materials and/or activities, member companies shall undertake every effort to clearly indicate the sponsor.
*This article becomes effective from January 1, 2013.
Format for PMS Registry System
Title of Study
Number of Sites
Period of Study
Expected ending date
Number of Patients
IRB Approval Date
Publication Plan/ Date
*All items must be specified.