1. Application Scope

Q2: What is IFPMA?

A2: The IFPMA is a non-profit, non-governmental organization comprising 26 leading international companies and 46 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 Web: www.ifpma.org

2. Medical Education

Q1: When is it appropriate and justified for a company to organize or sponsor an event for healthcare professionals outside of their home country?

A1: A company can only organize events involving travel if it is justified, i.e.:

(a) 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
(b) The relevant resource or expertise that is the object or subject matter of the event is located outside of the company’s home country.

Q2: Is there any restriction for accommodation, number of participants, or ceiling when sponsor a symposium, congress or other medical health care or educational program?

A2: According to IRPMA Code 7.1, the purpose and focus of all symposia, congresses and other promotional, scientific or professional meetings for healthcare professionals organized or sponsored by a company should be provide scientific or educational information. The venue and accommodation should be selected appropriately; member companies should avoid using renowned or extravagant venue.
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Q3: 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?

A3: 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.
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Q4: The COP prohibits stand-alone entertainment, leisure or social activities but allows entertainment of modest nature in conjunction with meals, etc., which is secondary to the main purpose of the event. How should companies interpret this in practice?

A4: When a company organizes an over one-day meeting and evening meals are provided, it would be permitted to provide some background music during the meal or to have an interlude when some local singers perform. However it would not be appropriate for a company to fund attendance at a concert by those same performers as this would be self standing and not incidental to the refreshments and the COP also prohibits the purchase of entertainment tickets. A self standing sightseeing tour would not be permitted but this would not prohibit a commentary about sights of interest en-route to a restaurant. The 'modest nature' of the entertainment may be interpreted as prohibiting high profile, inappropriate or expensive entertainers - even if their performance is secondary to a necessary meal. So an appearance by a well known TV or pop star would not be considered as modest whereas a folk dance display or performance by a local singer would be acceptable as entertainment for a meal interlude.
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Q5: Is there still a restriction that the duration of “social activities should not exceed 1/3 of the entire event?”

A5: According to the COP Article 7.5 and COP Benchmarks Article 6, entertainment in connection with an event is restricted to refreshments, meals and a commentary about sights of interest en-route to dinning venues. Member companies are not allowed to offer stand-alone social activities. Therefore, there is no need to stipulate that the duration of “social activities should not exceed 1/3 of the entire event.” However, member companies should strictly follow the principle that all entertainments should be secondary to the event.
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Q6: “Entertainments are restricted to the refreshment or meals connected with medical education event”. What is the definition of “medical education event”?

A6: A medical education event is as defined by the COP Article 7.1, Lunch and dinner meetings with healthcare professionals are allowed as health care 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.
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Q7: Are individual social activities with healthcare professionals such as golf, music concert etc. allowed?

A7: According to the IRPMA code 7.5.2 and 7.5.4, stand-alone social activities, such as golf, music concert etc., should not be paid by member companies. Entertainment in connection with an event is restricted to refreshments, meals and a commentary about sights of interest en-route to dinning venues.
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Q8: Is KTV an appropriate meeting venue?

A8: No. But if the dining venues provide such facilities, this can be used.
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Q9: According to IRPMA COP Article 7.5.4, self-standing entertainment or other leisure or social activities are not permitted, but this would not prohibit a commentary about sights of interest en route to a dinning or conference venue. Does this regulation apply to overseas academic conferences?

A9: IRPMA COP is applied to local and overseas conferences as well. Unnecessary stopovers should be avoided since they are considered as inappropriate entertainment for healthcare professionals.
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Q10: 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?

A10: Yes. The IRPMA COP Article 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.

3. Gifts and Items of Medical Utility

Q1: What kind of items are permissible as promotional aids?

A1: Promotional items should not be over NT$700, and should be related to the work of the recipient healthcare professional. Possible examples include pens, notepads and surgical gloves. Promotional items intended for the personal benefit of the healthcare professional, such as music CDs, paintings or food baskets would not be acceptable.
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Q2: What kind of items are envisaged as being items of medical utility?

A2: 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. A VCR or CD player however would not be permissible. Items should not be offered on more than an occasional basis, even if each individual item is appropriate.
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Q3: Whether cultural courtesy gifts could only be offered to healthcare professionals in festivals as defined by the COP?

A3: Yes. According to the IFPMA Code, no personal gifts could be offered to healthcare professionals. However, member associations could consider local customs and clearly define the festivals in which giving cultural courtesy gifts is appropriate. Considering the local custom, the COP Committee defines that giving gifts in Chinese New Year and Moon Festival is an acceptable practice. Yet, offering gifts in other festivals will be considered as not customary and is not allowed.
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Q4: Are lucky draws allowed?

A4: Yes. However, according to the COP Article 7.6.2, 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.
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Q5. Could we provide cash gifts or gifts for “Wedding”?

A5: IFPMA Code indeed prohibits payments in cash to healthcare professionals. Providing gifts for wedding is not a local custom in Taiwan; therefore, it’s not allowed as well.
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Q6. What should I do if I am invited to a wedding party?

A6: The wedding party is a personal event, and any expense incurred from this should not be at the cost of the company.
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Q7. Are sales representatives allowed to send or provide refreshments for healthcare professionals if the meetings are unplanned?

A7: 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.
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Q8. How to justify the promotional aids or reminder items in Article 7.6.3? Are electronic goods (such as a USB flash disk) included in the scope of personal gifts as stated in Article 7.6.2?

A8: (1) The justification of promotional aids or reminder items depends on whether the items are relevant to the practice of the healthcare professional or beneficial to the provision of medical services and for patient care. The COP could not provide an exhaustive list. It is suggested that companies should create an internal assessment mechanism to allow healthcare, regulatory and marketing directors to co-justify the appropriateness of promotional aids.
(2) Electronic goods (such as a USB flash disk) are included in the scope of personal gifts as stated in Article 7.6.2. However, those passing the review process as mentioned in COP Article 7.6.3 can be classified as gimmick.

4. Donation and Educational Grants

Q1: If the department requests sponsorship for a foreign speaker’s expenses (air fare, honorarium, etc.), what shall we do?

A1: 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 Studies)

Q1: The definition of PMS?

A1: 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.
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Q2: Following the approval by the IRB, JIRB, when should the PMS be posted on IRPMA website?

A2: The PMS should be registered on IRPMA website prior to the first patient screening. As the benchmark became effective on 1 Jan 2006, all new PMSs approved or conducted after 1 Jan 2006 and new sites initiated after 1 Jan 2006 for already approved PMS must be registered on the website.
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Q3: Are all items in the template for PMS Registry System necessary? (The Objective, No. of Sites, No. of Patients)

A3: Those items are essential for other companies and the public to examine if the study is valid and not for marketing purpose.