Questions & Answers
1. Application Scope
Q1: Does the IRPMA Code regulate communications with the public?
A1: Yes. The IRPMA Code provides guiding principle for patient education materials. However, according to Article 69 of “Pharmaceutical Affairs Act”, direct promotion to the public is not allowed. Member companies should of course, comply with the local law.
Q2: What is IFPMA?
A2: The IFPMA is a non-profit, non-governmental organization comprising 27 leading international companies and 51 national and regional industry associations.
It is a requirement of IFPMA membership that member companies and member associations accept the conditions of the IFPMA Code and, subject to local laws and regulations, adopt codes that meet local requirements but are consistent with, and as comprehensive as, the IFPMA Code.
IFPMA Website: www.ifpma.org
Q3: Which interactions or activities of pharmaceutical companies are specifically outside the scope of the IRPMA Code?
A3: This Code specifically does not seek to regulate the following activities:
• Promotion of self-medication products that are provided “over-the-counter” (OTC) directly to consumers without prescription;
• Pricing or other trade terms for the supply of pharmaceutical products, including promotion and marketing of pharmaceutical products to commercial customers;
• Certain types of non-promotional information or activities; and
• Promotion of medical devices
2. Medical Education
Q4: Does the IRPMA Code allow for comparisons between different products to be included in promotional materials?
A4: Yes. Comparative statements must be used carefully. Any comparison made between different pharmaceutical products must be clear, accurate, balanced, fair, up-to-date and objective based on credible scientific data and be capable of substantiation. Comparative data and/or claims should mainly be based on well-established, head-to-head randomized controlled clinical trial (RCT) results or meta-analysis of RCTs or both, and these results should be consistent with each other. Alternative high quality evidences, i.e. systematic review of cohort studies that can be substantiated by peer-reviewed journals, should also be considered acceptable, but its conclusion should not overwhelm that from evidence, such as head-to-head RCT(s) or their meta-analysis, if they existed; the context of overall evidence of the topic should be considered for fair justification. Care must be taken to ensure that there is a sound statistical basis. Differences which do not reach statistical significance must not be presented in such a way as to mislead. Under no circumstances should comparative data and/or claims be misleading. It must be consistent with the local health authority-approved package insert. Any disparaging reference to other product or manufacturer must be avoided. The information of the comparison drug should be sufficiently mentioned in the promotional material in order for a fair and objective judgement. The use of comparison drug’s brand name requires written consent from that company.
Q5: Does the IRPMA Code allow for quotations to be included in promotional materials?
A5: Yes. Quotations from medical and scientific literature or from personal communications should be faithfully reproduced (except where adaptation or modification is required in order to comply with any applicable codes, in which case it must be clearly stated that the quotation has been adapted and/or modified) and the precise sources identified. Quotations should not change or distort the intended meaning of the author or the significance of the underlying work or study.
Q6: Are reprints considered as promotional material under the IRPMA Code?
A6: No. Reprints of scientific and medical articles, when used as stand-alone documents, are not developed by pharmaceutical companies and as such cannot be considered as promotional materials. If, however, they are proactively presented to a healthcare professional together, with other, company-originated documents, they then become promotional materials. In all cases, where promotion refers to, includes, or is presented together with scientific or medical articles or studies, clear references should be provided. Any reprint of artwork (including graphs, illustrations, photographs or tables) taken from articles or studies and included or presented with promotional materials should clearly indicate the source of the artwork and be faithfully reproduced.
Q7: What is the definition of “simple statement of indication”?
A7: Simple statement of indication should relate to the PI label and must not contain promotional claims.
Q8: Is there any restriction for accommodation, number of participants, or ceiling when sponsor a symposium, congress or other medical health care or educational program?
A8: According to IRPMA Code 7.1, the purpose and focus of all Events for healthcare professionals organized or sponsored by a company should be to provide scientific or educational information. The venue and accommodation should be selected appropriately; member companies should avoid using renowned or extravagant venue.
Q9: When is it appropriate and justified for a company to organize or sponsor an event for healthcare professionals outside of their home country?
A9: A company can only organize events involving travel if it is justified, i.e.:
• A significant proportion of the invited healthcare professionals are from outside of the company’s home country, and it makes greater logistical or security sense to hold the event in another country; or
• The relevant resource or expertise that is the object or subject matter of the event is located outside of the company’s home country.
Q10: In case of one-day program, if participants who have difficulties to return to their hometown on that day due to traffic problem, what shall we do?
A10: Basically companies should select an appropriate venue that is in city areas for convenient transportation. However, if the case above happens, we may provide accommodation for limited participants who cannot return on the same day. In this case, on the 2nd day, no other social program should be arranged for those participants.
Q11: One medical society schedules its annual scientific conference to be held at a hotel by Sun Moon Lake. In addition to HCPs based in Taiwan, HCPs from China have also been invited to join the event. Can member companies sponsor the event?
A11: The intent of sponsoring a scientific program at an independent meeting is to support continuous professional development of HCPs that will lead to improved patient care or healthcare delivery. However, a meeting organized in a tourist attraction, lavish/resort location/hotel can generate negative publicity for conference organizers and its sponsors.
As stated in the IRPMA Code of Practice Benchmark 4, “tourist attractions” as event or meeting venues are considered “inappropriate”. The selection should be followed even with participants invited from outside Taiwan. In terms of location, member companies SHOULD NOT sponsor events at any tourist attractions, including , but not limited to, Sun Moon Lake, Kenting, Taroko Gorge… etc. (added in February, 2016)
Q12: “Hospitality should be limited to refreshments and/or meals incidental to the main purpose of the Event”. What is the definition of “the Event”?
A12: An Event is as defined by the IRPMA Code 7.1.1. Lunch and dinner meetings with healthcare professionals are allowed as healthcare professionals have very limited time allocated for information. Provided the main purpose of the lunch or dinner meeting is educational, to provide scientific information, or to discuss a business issue, it is not considered an Event (Article 7). The particulars of a meeting over a meal should either be agreed in advance or recorded retrospectively. Refreshments and meals connected with these activities should not cost more than NT$3,500 person/ day.
Q13: The IRPMA Code prohibits companies from providing entertainment, leisure and social activities to healthcare professionals and other stakeholders. Are there exceptions to this rule?
A13: No. When a company organizes a meeting, refreshments and/or meals incidental to the main purpose of the event can be provided. It would not be appropriate for a company to fund attendance at a concert, purchase of entertainment tickets or pay for entertainment in any form. However, if there is background music or a local performance at the venue where the event is taking place, which is not paid for by a pharmaceutical company and not interfering the main purpose of the meeting or event, this may be permitted.
Q14: Are individual social activities with healthcare professionals such as golf, music concert, etc. allowed?
A14: According to the IRPMA Code 7.1.6, no entertainment or other leisure or social activities should be provided or paid for by member companies. Hospitality should be limited to refreshments and/or meals incidental to the main purpose of the Event.
Q15: Is there any consideration for sponsoring HCPs attending overseas event?
A15: Sponsorship of HCP to international events is limited to 2 meetings per year. This limitation does not include or apply to programs where a HCP’s attendance has been funded (paid for his/her services) because the individual is giving a presentation at the international event on behalf of member company. Clinical trial related meetings are out-of-scope.
*This article becomes effective from January 1, 2013.
Q16: In regard to flight tickets under sponsorship, in case that there is no business class but only economy and first class available, what shall company do?
A16: According to the COP Benchmark Article 5, the flight tickets being sponsored should be up to business class only. Therefore, in this case the traveler must take economy class only.
Q17: While attending an event, are the invitees allowed to bring guests?
A17: Member companies must discourage invitees from bringing guests to company-organized events. In case they do, or in case an uninvited guest shows up, the company must not make any payments or reimburse/subsidize any costs associated with an individual accompanying an invitee, and uninvited guests are not permitted for the company hosted dinner/meal events. For example, the uninvited guests are not allowed to be part of the sponsored dinner and/or the meeting where business discussions must occur.
Q18: Is it necessary to have a contract with the invited healthcare professional as speakers or presenters for the payment of honorarium and related travelling and boarding expenses?
A18: Yes. The IRPMA Code 7.4 states that there should be a written contract about the payments to speakers or presenters. The contract can also be used as a reference to decide who should pay the expenses.
Q19: For the honorarium for local speaker to lecture overseas or to lecture in international symposia in Taiwan, should the international norms or a limit of up to NT$5,000/hr be applied?
A19: For international congress held overseas, the international norms should be applied. For the symposia held in Taiwan, the international norms can only be applied when the international event is organized by an international society and it is not a satellite program within the international event. Otherwise, the honorarium for local speaker should be limited up to NT$5,000/hr.
Q20: How to calculate additional payment?
A20: Chairperson/ Moderator of the advisory board and concurrently serve as advisory board member: may be paid up to NT$20,000 (up to NT$10,000 per event as member, up to NT$10,000 as the Chairperson).
Chairperson/ Moderator and concurrently serve as a Lecturer: NT$5,000/hr as a Lecturer, up to NT$10,000 as the Chairman/ Moderator per event.
There is no additional payment for preparation time.
Q21: What types of topics are considered appropriate as part of a program agenda for IRPMA member company-supported events targeting healthcare professionals?
A21: Event topics should be related to professional capability building for the benefit of HCPs’ daily healthcare practice.
For events that involve non-product / disease-related topics, the recommended ratio for the time spent on “product/disease-related educational topics” versus time spent on “topics related to healthcare practice capability building” is 3:1 (added in October, 2013)
3. Gifts and Other Items
Q24: What kinds of items are envisaged as being items of medical utility?
A24: Items might include an anatomical model for use in an examination room, or medical textbooks, as they are of modest value and both primarily involve a patient benefit.
However, items would not be permissible if such items are
• Provided to offset routine business practice including but not limited to surgical gloves, tissues, stethoscopes and the like.
• Provided to individual HCP for personal benefit including but not limited to DVD or CD player, mugs, backpacks, stationary, diaries, calendars and the like.
Items should not be offered on more than an occasional basis, even if each individual item is appropriate.
Q25: Are lucky draws allowed?
A25: Yes. However, according to the IRPMA Code 7.5.1, companies should not give items for personal benefits. Therefore, the prizes for the lucky draw should be limited to items of medical utility, and no personal gifts allowed for lucky draw.
Q26: Could we provide cash gifts or gifts for “Wedding”?
A26: IRPMA Code indeed prohibits payments in cash to healthcare professionals. Providing gifts for wedding is not allowed.
Q27: What should I do if I am invited to a wedding party?
A27: The wedding party is a personal event, and any expense incurred from this should not be at the cost of the company.
Q28: Are sales representatives allowed to send or provide refreshments for healthcare professionals if the meetings are unplanned?
A28: The purpose of the IRPMA COP is to improve the professional image of medical representatives. Refreshments for HCPs are allowed only if the meeting is for educational purpose or to provide scientific information as HCPs have very limited time allocated to meetings.
4. Donation and Educational Grants
Q29: If the department requests sponsorship for a foreign speaker’s expenses (airfare, honorarium, etc.), what shall we do?
A29: Companies can provide actual expenses to hospitals or associations organizing the events, but not through the department nor to the speaker directly.
5. PMS (Post-Marketing Study)
Q30: The definition of PMS?
A30: In order to stop commercial exercise under the different name of clinical studies (observational study, retrospective study...etc.), any study involving human subjects should be reviewed and approved by IRB to protect patients’ right. PMS that has to be posted on the IRPMA website is as defined by the IRB.
Q31: What are the scopes of the post marketing studies that should be posted on IRPMA website?
A31: The following study formats are within the scope of IRPMA PMS registry requirement:
• Phase IV clinical studies
• Pharmacoeconomic / Healtheconomic related studies (excluding PE studies using existing computerized database only)
• Epidemiological studies
• Non-interventional post marketing surveillance
• Retrospective data collection and analysis
All above mentioned post marketing studies conducted in Taiwan, including Taiwan local study or multi-country; multi-center studies, should be posted.
Q32: Following the approval by the IRB, JIRB, when should the PMS be posted on IRPMA website?
A32: The PMS should be registered on IRPMA website prior to the first patient screening.
Q33: Are all items in the template for PMS registry system necessary? (The Objective, No. of Sites, No. of Patients)
A33: Those items are essential for other companies and the public to examine if the study is valid and not for marketing purpose.
6. Interactions with Patient Organizations
Q34: What happens if only one pharmaceutical company wishes to support a particular patient organization? Is this allowed?
A34: Yes. Many patient organizations are supported by a number of pharmaceutical companies. There may, however, be situations where only one pharmaceutical company wishes to support a particular patient organization or one of its activities. It would be acceptable under the IRPMA Code for that pharmaceutical company to be the only pharmaceutical company providing funding as long as that company did not make its support conditional on it being the sole funder.
Q35: The examples of PSP?
Common examples of PSPs include:
i. Compliance programs where consenting patients on a medication are contacted to see how they are managing with their medication.
ii. Call centers where patients or patient carers can contact the Companies to obtain further information on medication or a particular disease area.
iii.“Nurse Educator” programs where the Companies have hired third party nurses to interact directly with patients to help them properly administer medications and/or manage their disease.