Baker & McKenzie: Pharmaceuticals & Healthcare Asia Pacific Newsletter - 1st Quarter 2012

Facing legal sanctions and cultural gaffes is a reality when dealing with healthcare professionals in the Asia Pacific.

In this edition of the Asia Pacific Pharmaceutical Newsletter,
you will learn of the regulations and traditional practices governing interactions with healthcare professionals across the region. We discuss the following four points:

•    Can a pharmaceutical company provide gifts to a healthcare professional?
•    Can a pharmaceutical company offer give-aways or other gimmicks to a healthcare professional?
•    Can a pharmaceutical company sign a service contract with a healthcare professional?
•    Are healthcare professionals required by law to obtain a written pre-approval from their employer to be able to attend an event organized by a pharmaceutical company?

We hope you will find this Newsletter useful.

Australia

1. Can a pharmaceutical company provide gifts to a healthcare professional?
 

In Australia, there is no express legal prohibition on the provision of gifts to HCPs by pharmaceutical companies. However, the Medicines Australia Code of Conduct, a voluntary industry code, commands that no gifts, benefits in kind or pecuniary advantage should be offered or given to HCPs as an inducement to recommend, prescribe, dispense or administer a pharmaceutical company's product (e.g. gift vouchers, tickets to sporting events, cash or cash equivalents.)

There are limited exceptions for: (a) product brand name reminders; (b) company branded items of stationery; (c) educational material directed to HCPs or patients; (d) prize for a complying competition (e) sponsorship to attend an educational event; and (f) hospitality at an educational event.

2. Can a pharmaceutical company offer give-aways or other gimmicks to an HCP? Is there a specific threshold regulated by law?

●    The only types of give-aways which may be accepted are brand-name reminders which are educational and/or directly related to the practice of medicine.

●    Brand name reminders must not be items likely to be used outside of work, with a general utility that can be used in a home, car or social environment (e.g. pens, notepads, kitchen items, rechargers, power boards, USB hubs.)

●    Brand name reminders should have a company cost of less than AUD20.

●    If the item is for medical education, the value may be greater than AUD20, but can only be company branded.

       ●    Company branded pens, notepads and/or educational material may be given to delegates attending       educational events, or at trade displays.
 
3. Can a pharmaceutical company sign a service contract (such as for speaking and chairing at meetings, translating medical documents, writing medical articles and/or giving medical training) with an HCP?  

    Are HCPs required to get prior approval from their employer to sign such contract?
 
Yes, a pharmaceutical company may enter into a service contract with one or more HCPs to provide services, advice and/or guidance on a range of matters. A legitimate need must be clearly identified, while the purpose and objective of the interaction must be clearly articulated in a written contract. Any remuneration provided must be commensurate with the work involved.
 
In the private sector, whether or not prior approval from an employer is required will depend upon the contract of employment between the HCP and his/her employer.
 
If the HCP is a public sector employee, each Australian State will have differing laws, with consent likely to be required.
 
4. Are HCPs required by law to obtain a written pre-approval from their employer to be able to attend an event organized by a pharmaceutical company?
 
There is no such requirement.

1. Can a pharmaceutical company provide gifts to a healthcare professional?

●    PRC laws prohibit bribery offered by a pharmaceutical company to an HCP in exchange for improper benefits. Such "bribery" can be in the form of cash, gift, property, things of value, entertainment, hospitality and travel, among others.

The key factor to determine if a gift would be considered as bribery is whether or not the provision of the gift is intended to affect the HCP's impartial performance of his/her duties.

If the bribery value is over RMB100,000 (USD15,873), the pharmaceutical company and its responsible managing person may be held criminally liable. This threshold can be calculated accumulatively. For example, if the company provided briberies to various HCPs in different healthcare institutions over the past three years, and the total value of briberies is over RMB100,000, it can still be subject to criminal liability.

If the bribery is provided for the purpose of sales of products, such activities may also be investigated and covered by administrative penalties by the local Administration for Industry and Commerce, regardless of the gift value.
 

A bona fide courtesy gift and a gift given in acknowledgment of Chinese holidays may be allowed. However, it is generally recommend that the gift value be limited to under RMB200 (USD31.1). Although this is not a mandatory requirement, this threshold has been adopted by many MNCs, including pharmaceutical companies.
 
●    Despite the above, if the pharmaceutical company is a member of the China Association of Enterprises with Foreign Investment R&D-Based Pharmaceutical Association Committee ("RDPAC"), the company should also comply with the code of RDPAC, i.e. Code of Practice on the Promotion of Pharmaceutical Products (2010 Revision) ("RDPAC Code").

According to the RDPAC Code:

-     A pharmaceutical company is prohibited from providing cash or cash equivalents to HCPs;

-     Gifts for the personal benefit of HCPs are prohibited, except for permitted "cultural courtesy gifts";

-     Permitted "cultural courtesy gifts" are inexpensive gifts (with a value of no more than RMB200 [USD31.1]) not related to the practice of medicine and given on an infrequent basis in acknowledgment of the following official holidays in China: New Year, Spring Festival, Labor Day, National Day and the Mid Autumn Festival (items allowed to be provided as cultural courtesy gifts may include food, tea, flowers, plants, crafts, or locally produced products that relate specifically to one of the listed holidays);

-     Items of medical utility may be offered or given free of charge occasionally, on the condition that such items are of modest value and are beneficial to the provision of medical services and for patient care. Items may include an anatomical model for use in an examination room, or medical textbooks. The value shall be no more than RMB500 (USD79.4) per item, and a pre-paid coupon or a purchase card is not allowed; and

-     Promotional items may be provided to HCPs, but only if the gift is of minimal value (no more than RMB100 [USD15.9]) and is relevant to the practice of the healthcare professional. Possible examples of appropriate items include: pens, notepads and surgical gloves.

2. Can a pharmaceutical company offer give-aways or other gimmicks to an HCP? Is there a specific threshold regulated by law? 
 
Such give-aways may be considered as the above-discussed gifts.
 
A bona fide souvenir is allowed. However, the gift value should normally be no more than RMB200 (USD31.1.) It is also suggested that the company logo or event name be painted on the souvenir.

3. Can a pharmaceutical company sign a service contract (such as for speaking and chairing at meetings, translating medical documents, writing medical articles and/or giving medical training) with an HCP?  

    Are HCPs required to get prior approval from their employer to sign such contract?
 
Under PRC law, a pharmaceutical company may sign a service contract with an HCP under the following conditions:

●    The accumulated time of service to be provided by an HCP under the service contract shall be a maximum of one working day per week;

●    The HCP signing the service contract must obtain approval from the HCP's employer for signing the service contract; and

●    The services under the service contract cannot be provided when the HCP is on leave.
 
Moreover, according to the RDPAC Code, a pharmaceutical company may sign a service contract with an HCP, if the contract is not signed in exchange for prescribing, recommending, purchasing, supplying or administering products, or for a commitment to continue to do so. The service contract shall not be signed in a manner or on conditions that may have an inappropriate influence on the HCP's prescribing practice.

4. Are HCPs required by law to obtain a written pre-approval from their employer to be able to attend an event organized by a pharmaceutical company?

Under PRC law, the HCP is not required to obtain written pre-approval from his/her employer to be able to attend an event organized by a pharmaceutical company.
 
However, the HCP should report to the employer his/her attendance at any educational event held by other entities, including pharmaceutical companies. It is advisable that the pharmaceutical company should maintain a record of documents certifying that the HCP attending the pharmaceutical company's educational event has reported his/her attendance to the employer.

Hong Kong

1. Can a pharmaceutical company provide gifts to a healthcare professional?
 

The Prevention of Bribery Ordinance ("PBO") prohibits the unlawful offering, soliciting or acceptance of an "advantage" (which includes gifts under its legal definition) to or by (a) a government employee/official or public servant, or (b) to any person acting as an agent of another person (which would cover doctors in private hospitals). HCPs in both the public and private sectors are therefore covered by the PBO. Generally speaking, to conclude if the offering or acceptance of an advantage is lawful in Hong Kong depends on whether or not permission or lawful authority is provided.
 
It is also a general principle under the Code of Pharmaceutical Marketing Practices (the "Code", a local industry association code to which compliance by non-members is voluntary) that no financial benefit or benefit-in-kind may be provided or offered to an HCP in exchange for prescribing, recommending, purchasing, supplying or administering products or for a commitment to continue to do so.

Under the Code, inappropriate financial, material or personal benefits (including festive gifts), gratuitous payments in cash or cash equivalents should not be offered to HCPs to influence them in the prescription of products. Promotional items of nominal value, provided free of charge and on infrequent basis, are permissible as long as they are related to the HCP's work and/or entail a benefit to patients.

2. Can a pharmaceutical company offer give-aways or other gimmicks to an HCP? Is there a specific threshold regulated by law? 
 
Give-aways may fall under the wide definition of "advantages" under the PBO (see above discussion on gifts).

Under the Code, the following are generally allowed:
●    Promotional materials (containing mandatory information on products) and reminder promotion;

●    Entertainment of modest (HKD400, ~USD52) nature by reasonably local standards and which is secondary to refreshments and/or meals; and

●    Promotional items of nominal value (HKD150, or ~USD20 per item), provided free of charge and on infrequent basis if related to the HCP's work and/or entail a benefit to patients.
 
*  The Code is currently under revision and the above items/figures are likely to be amended.

3. Can a pharmaceutical company sign a service contract (such as for speaking and chairing at meetings, translating medical documents, writing medical articles and/or giving medical training) with an HCP?  

    Are HCPs required to get prior approval from their employer to sign such contract?

There is no specific prohibition against a pharmaceutical company signing a service contract with HCPs. However, the PBO should be observed, since a service contract may be considered an "advantage" under the PBO. Due authorization from the employer/principal should be acquired to minimize the risk of violating the PBO.
 
For HCPs in the public sector, such a contract will require prior approval by the public hospital. Also, a pharmaceutical company may not be able to enter into a contract with a specific HCP unless the HCP is contracted in his/her own capacity.
 
For HCPs in the private sector, it would be subject to the arrangement between the HCP and his/her employer.

4. Are HCPs required by law to obtain a written pre-approval from their employer to be able to attend an event organized by a pharmaceutical company? 
 
There are no specific requirements under applicable laws and regulations in Hong Kong. Whether or not authorization is required depends on the HCP's employer. For public hospitals, authorization is required under the Hospital Authority's internal guidelines. Also, designation of specific HCPs for event attendance is generally not recommended.

Indonesia

1. Can a pharmaceutical company provide gifts to a healthcare professional?

If the HCP is a civil servant, the gift will constitute a gratuity that is subject to clearance from the Anti-Corruption Commission (Indonesian acronym: "KPK").
 
Giving a gift in return for an opportunity to market breast milk substitutes is strictly prohibited.
 
2. Can a pharmaceutical company offer give-aways or other gimmicks to an HCP? Is there a specific threshold regulated by law?

The above comments on gifts apply to give-aways and gimmicks.
 
3. Can a pharmaceutical company sign a service contract (such as for speaking and chairing at meetings, translating medical documents, writing medical articles and/or giving medical training) with an HCP?  

    Are HCPs required to get prior approval from their employer to sign such contract?

In the case of a civil servant, the contract will be unlawful if given as quid pro quo for violating the HCP's duty as civil servants.

The above comments on gifts are also applicable to the fees payable to the HCP.

If the HCP is a civil servant, approval from his/her superior is probably required.
 
4. Are HCPs required by law to obtain a written pre-approval from their employer to be able to attend an event organized by a pharmaceutical company?

If the event is held during a work day, prior approval is probably required.

The above comments on gifts are also applicable to any benefits given to or enjoyed by the HCP.

Japan

1. Can a pharmaceutical company provide gifts to a healthcare professional?
 
Gifts to HCPs, including but not limited to cash, cash equivalents and other benefits, are strictly prohibited.

According to the Fair Competition Code for the pharmaceutical industry ("FCC"), pharmaceutical companies are not permitted to offer benefits to HCPs as a means of inducing unjustifiable transactions of the companies' drugs.
 
2. Can a pharmaceutical company offer give-aways or other gimmicks to an HCP? Is there a specific threshold regulated by law? 

In line with the FCC, pharmaceutical companies may provide:

1)   Goods or services necessary for the use of the company's drugs in medical institutions or such for enhancing their efficacy or convenience;

2)   Medical or pharmaceutical information or other documents or explanatory materials on the drug;

3)   Drug samples in accordance with the standards;

4)   Payment of remuneration for and costs of post-marketing surveillance, clinical trial or other medical or pharmaceutical research and study that the pharmaceutical companies request to HCPs; and

5)   Goods or services neither lavish nor excessive in connection with a lecture meeting and the likes on the subject of the drugs, organized for medical institutions, etc., or the assumption of related attendance costs.
 
3. Can a pharmaceutical company sign a service contract (such as for speaking and chairing at meetings, translating medical documents, writing medical articles and/or giving medical training) with an HCP?  

    Are HCPs required to get prior approval from their employer to sign such contract?

The pharmaceutical companies may enter into a contract with an HCP as long as the service to be provided by the HCP and the amount of consideration for the service are reasonable and socially acceptable.
 
Under the Rules of Ethics for Government Officials or other similar rules which apply to HCPs who work in the public sector, HCPs must obtain pre-approval from their ethics officer or other supervisor.
 
4. Are HCPs required by law to obtain a written pre-approval from their employer to be able to attend an event organized by a pharmaceutical company?

When HCPs receive any remuneration by attending the event, pre-approval is required.
 
There is no specific requirement for the approval. HCPs are obliged to submit all documents which are requested by the employer for the approval process.

Malaysia

1. Can a pharmaceutical company provide gifts to a healthcare professional?

Malaysia law does not specifically govern interactions with healthcare professionals.

But, in certain circumstances, the Malaysian Anti-Corruption Commission Act 2009 ("MACC") may apply. Under the MACC, it is an offense for any person to corruptly give, promise or offer to any person any gratification as an inducement to or as a reward for, or otherwise on account of any person or officer of a public body, doing or forbearing to do anything related to any matter or transaction actual or proposed or likely to take place.

The MACC has been drafted broadly; hence, material gifts to HCPs may constitute an inducement or a reward. In addition, clause 21 of the MACC prohibits bribery of officers of public bodies. The term "public body" includes, without limitation, government, local and statutory authorities; government departments, services or undertakings, and; companies or a subsidiary over or in which any of the same has a controlling power of interest.
 
The pharmaceutical industry in Malaysia self-regulates its promotional activities. The Code of Pharmaceutical Marketing Practices for Prescription (Ethical) Products issued by the Pharmaceutical Association of Malaysia ("PHAMA Code") generally provides that inappropriate financial or material benefit should not be offered to HCPs to influence prescription of pharmaceutical products. Section 14.2.2 of the PHAMA Code specifically disallows providing gifts to HCPs for their personal benefit.

However, section 14.2.4 of the PHAMA Code exempts inexpensive gifts of cultural courtesy of no more than RM100 given in acknowledgement of a significant festive occasion. Compliance with the PHAMA Code is on a self-regulatory basis, and while breaches of which will attract a fine of up to RM25,000 for a one-off breach or RM50,000 for a repeated breach, there is no corresponding mechanism to enforce the fine.
 
For completeness, also to be considered is the Code of Conduct for Pharmacists and Bodies Corporate issued by the Pharmacy Board Malaysia ("PBM Code,") which regulates conduct from the perspective of pharmacists. Section 4 1.1.2(h) states that pharmacists are not to accept inducement form suppliers that could reasonably be perceived as affecting pharmacists' independent professional judgment. In addition, section 1.8.1 requires pharmacists to avoid situations, whereby they, by accepting any financial or material inducement, would compromise their professional judgment on the choice of drug for their patient or client.
 
2. Can a pharmaceutical company offer give-aways or other gimmicks to an HCP? Is there a specific threshold regulated by law? 

Please refer to above information on gifts. Although give-aways or gimmicks are not specifically referred to, general principles similar to the above would apply.

Moreover, section 14.3 of the PHAMA Code states that promotional aids whether related to a particular products or of general utility may be distributed provided it is of a value of no more than RM100, and is relevant to the practice of medicine or pharmacy or of benefit to patient care. The threshold value for medical educational materials is higher at RM1,000.
 
3. Can a pharmaceutical company sign a service contract (such as for speaking and chairing at meetings, translating medical documents, writing medical articles and/or giving medical training) with an HCP?  

    Are HCPs required to get prior approval from their employer to sign such contract?

Yes, the law and regulations in Malaysia do not restrict this arrangement.

No, Malaysian law does not require an HCP to get pre-approval from his/her employer to sign such contracts with a pharmaceutical company.
 
4. Are HCPs required by law to obtain a written pre-approval from their employer to be able to attend an event organized by a pharmaceutical company?
 
No, Malaysian law and regulations do not restrict this arrangement.

Philippines

1. Can a pharmaceutical company provide gifts to a healthcare professional?

Yes, but with exceptions.

1)   HCPs in the private sector.

There is presently no legislation in the Philippines that directly prohibits pharmaceutical companies from giving gifts to HCPs in the private sector. However, the Code of Ethics of the Philippine Medical Association provides that only gifts of reasonable value that primarily entail benefit to patient care or are related to physicians' work may be accepted by a physician from a health product company. Violation of the Code of Ethics may lead to administrative sanctions against the HCP.
 
2)   HCPs in the public sector.

Philippine Anti-Bribery and Anti-Corruption Law prohibits the giving of gifts, broadly defined as anything of value, to public officials. Certain laws provide, by way of exception, unsolicited gifts of nominal value which are not given by reason of the HCP's office/function.

Regulations of the Department of Health ("DOH") allow gifts to DOH officials, as long as they do not influence or give the appearance of influencing the official's performance of duties, not expressly prohibited by the DOH regulations, and as long as gifts of more than PhP10,000 are recorded in the DOH Registry.
 
2. Can a pharmaceutical company offer give-aways or other gimmicks to an HCP? Is there a specific threshold regulated by law?

Give-aways may fall under the definition of "gifts". See discussion above.
 
3. Can a pharmaceutical company sign a service contract (such as for speaking and chairing at meetings, translating medical documents, writing medical articles and/or giving medical training) with an HCP?  

    Are HCPs required to get prior approval from their employer to sign such contract?

There are no prohibitions with respect to HCPs in the private sector. The rule on pre-approval would depend on the HCP's employer.

As for HCPs in the public sector, whether or not the contract will be allowed or pre-approval required, generally depends on various factors (e.g. nature of the contract and the rules and regulations of the particular agency involved.)
 
4. Are HCPs required by law to obtain a written pre-approval from their employer to be able to attend an event organized by a pharmaceutical company?

For HCPs in the private sector, the rule on pre-approval would depend on the HCP's employer.

With respect to HCPs in the public sector, pre-approval is generally required.

Singapore

1. Can a pharmaceutical company provide gifts to a healthcare professional?
 
●    Under section 5 of the Prevention of Corruption Act (the "PCA"), gifts cannot be corruptly received, given or agreed to be received/given for the doing of or for preventing the doing of anything in relation to any actual or proposed transaction.

●    No gifts shall be offered or given to members of the medical profession for purposes of sales promotion (Singapore Association of Pharmaceutical Industries Code (the "SAPI Code") section 6.1.2).

●    Cash payments/cash equivalents (e.g. gift certificates) are not allowed (SAPI Code section 6.1.3).

●    Promotional items of insignificant value of no more than SGD20 (USD16) are permissible gifts as long as they are related to the doctor's work and/or entail a benefit to patients. Gifts as a token of appreciation for services rendered by the doctor should be limited to SGD50 (USD40) or less (SAPI Code section 6.1.4).

●    Food items and drinks that are inexpensive based on social/cultural norms may only be distributed to doctors in the course of day-to-day promotional activities and should be limited to no more than SGD20 (USD16) per doctor (SAPI Code section 6.1.5).

●    Congratulatory flowers for Promotions, Conferment of Awards or Clinic Opening should be limited to SGD150 (USD120) per occasion, while congratulatory messages in any form of media on behalf of  a doctor or of a healthcare establishment are strictly prohibited (SAPI Code section 6.1.6).

●    Exceptional gifts during various festive seasons should be symbolic and modest, with a value of up to SGD50 (USD40), such as cakes, cookies and mandarin oranges. Each doctor should only be offered a maximum of two such gifts per year (SAPI Code section 6.1.7).

●    A doctor shall not ask for gifts, hospitality or other inducements that may affect or be seen to affect his/her judgment in making decisions about patients' treatment. A doctor may receive small, insubstantial gifts which cannot be regarded as inducement (Singapore Medical Council's Ethical Code & Ethical Guidelines (the "SMC Ethical Code") section 4.6.3.2).
 
2. Can a pharmaceutical company offer give-aways or other gimmicks to an HCP? Is there a specific threshold regulated by law? 

●    Give-aways or gimmicks may count as gifts under Singapore law. Gifts cannot be corruptly received/given, or agreed to be received/given for the doing of or for preventing the doing of anything in relation to any actual or proposed transaction (PCA section 5).

●    No gifts shall be offered or given to members of the medical profession for purposes of sales promotion (SAPI Code section 6.1.2).

●    Items of medical utility may be offered or given free of charge provided such items are of modest value and are beneficial to the provision of medical services and for patient care, with the value of such items limited to no more than SGD200 (USD160) (SAPI Code section 6.2).

●    A doctor shall not ask for gifts, hospitality or other inducements that may affect or be seen to affect his/her judgment in making decisions about patients' treatment. A doctor may receive small, insubstantial gifts which cannot be regarded as inducement (SMC Ethical Code section 4.6.3.2).
 
3. Can a pharmaceutical company sign a service contract (such as for speaking and chairing at meetings, translating medical documents, writing medical articles and/or giving medical training) with an HCP?  

    Are HCPs required to get prior approval from their employer to sign such contract?

●    The subject matter of the service contract (e.g. training or conferences) cannot be corruptly received/given, or agreed to be received/given,  for the doing of or for preventing the doing of anything in relation to any actual or proposed transaction (PCA section 5).

●    The SAPI Code and SMC Ethical Code allow for pharmaceutical companies to enter into such relationships with HCPs, subject to certain limits on sponsorship, hospitality, etc.

●    There are no restrictions under the SAPI Code and the SMC Ethical Code. However, the employers of HCPs may have contractual restrictions on such activities or internal codes of conduct regulating such activities.

●    A doctor should ensure that his/her participation at sponsored conferences does not occur in such a way as to appear to endorse such products or to persuade the patients or the public to use the products. Apart from identification and establishment of credentials, no details of services provided by the doctor or service details shall appear in any way in relation to such participation. A doctor who is sponsored by a company to participate in an educational event must declare all such conflicts of interest to the audience (SMC Ethical Code section 4.6.3).
 
4. Are HCPs required by law to obtain a written pre-approval from their employer to be able to attend an event organized by a pharmaceutical company?
 
●    There are no restrictions under the SAPI Code and the SMC Ethical Code. However, the employers of HCPs may have contractual restrictions on such activities or internal codes of conduct regulating such activities.

●    A doctor should ensure that his/her participation at sponsored conferences does not occur in such a way as to appear to endorse such products or to persuade the patients or the public to use the products. Apart from identification and establishment of credentials, no details of services provided by the doctor or service details shall appear in any way in relation to such participation. A doctor who is sponsored by a company to participate in an educational event must declare all such conflicts of interest to the audience (SMC Ethical Code section 4.6.3).

Taiwan

1. Can a pharmaceutical company provide gifts to a healthcare professional?

The Code of Conduct for Government Officials (applicable if HCPs are deemed to be government officials) maintains the following:
 
Subject to legality of purposes in any event, giving a gift (in cash or in kind) to a government official for the official's marriage, newborn baby, promotion, inauguration, retirement, resignation, or death or injury of himself/herself or his/her parent, spouse or children is allowed if the gift value does not exceed NTD3,000 (about USD100) and if the gift value from the same provider does not exceed NTD10,000 (about USD330) per year. Other than these occasions, the amount of gifts received by an official may not exceed NTD500 (about USD16.7), and the total amount of gifts received by a government agency may not exceed NTD1,000 (about USD33).
 
The IRPMA Code of Marketing Practices (a voluntary industry code):
1)   Payments in cash or cash equivalents (such as gift certificates) must not be offered to healthcare professionals.

2)   Gifts for the personal benefit of healthcare professionals (including, but not limited to, music CDs, DVDs, sporting or entertainment tickets and electronic items) must not be provided or offered.

3)   Promotional aids or reminder items may only be provided or offered to healthcare professionals and appropriate administrative staff if the gift is of minimal value and is relevant to the practice of the healthcare professional.

4)   Items of medical utility may be offered or given free of charge provided that such items are of modest value and are beneficial to the provision of medical services and for patient care.

5)   If allowed under local law and in accordance with local practice, an inexpensive gift unrelated to the practice of medicine may be given on an infrequent basis to the healthcare professional in acknowledgment of significant national, cultural or religious holidays.
 
2. Can a pharmaceutical company offer give-aways or other gimmicks to an HCP? Is there a specific threshold regulated by law? 
 
The Code of Conduct for Government Officials
Provision of give-aways or gimmicks to HCPs, who are deemed to be government officials, may fall under the same requirements as outlined above in relation to the giving of gifts.

The IRPMA Code of Markerting Practices
Promotional aids or reminder items may only be provided or offered to healthcare professionals and appropriate administrative staff if the gift is of minimal value and is relevant to the practice of the healthcare professional. The value of the gift should not exceed NTD700 (about USD23). The names of companies and/or products must be printed on the gifts.

3. Can a pharmaceutical company sign a service contract (such as for speaking and chairing at meetings, translating medical documents, writing medical articles and/or giving medical training) with an HCP?  

    Are HCPs required to get prior approval from their employer to sign such contract?

Yes, the law, regulations and codes of conduct in Taiwan do not restrict this arrangement.

Whether or not prior approval from an employer is required will depend upon the employment contract between the HCP and his/her employer or upon the employer's internal rules.

4. Are HCPs required by law to obtain a written pre-approval from their employer to be able to attend an event organized by a pharmaceutical company?
 
 There is no specific requirement under Taiwan law.

Thailand

1. Can a pharmaceutical company provide gifts to a healthcare professional?

Thai Law
●    In the case of HCPs deemed to be government officials, they may be provided gifts on a traditional, customary or cultural occasion, or on an occasion in which the manners practiced in society require the giving of such gifts.

●    Regardless, no government official may receive any gifts with a value in excess of THB3,000 (approximately USD90) on a single occasion from a person not related to the government official.

●    For HCPs deemed to be government officials, it is required that there must be no corrupt intent behind the provision of gifts.

●    The above requirement does not apply to HCPs not deemed to be government officials.

●    However, any gifts provided to HCPs not deemed to be government officials should still be of a nominal value and should not be given in return for the pharmaceutical company retaining or obtaining business, or to gain an improper or unfair advantage.
 
PReMA Code

●    Pharmaceutical companies in Thailand may be members of the Pharmaceutical Research & Manufacturers Association ("PReMA").

●    PReMA has issued a Code of Sales & Marketing Practices ("PReMA Code") for its members to adopt on a voluntary basis.

●    The PReMA Code provides that payment in cash or cash equivalents, or gifts for the personal benefit of HCPs, must not be provided to HCPs.

●    Gifts given to HCPs on customary or traditional occasions must be infrequent. The value of such gifts must not exceed THB3,000 per HCP and per occasion.
 
2. Can a pharmaceutical company offer give-aways or other gimmicks to an HCP? Is there a specific threshold regulated by law?

Thai Law

●    Give-aways or gimmicks for HCPs deemed to be government officials may be subject to the same requirements outlined above on the provision of gifts.

●    Although give-aways or gimmicks may not be given on a traditional, customary or cultural occasion (e.g. provided at training events held by the pharmaceutical company), the provision of such give-aways or gimmicks may still be acceptable as a common industry practice, on the condition that the give-away or gimmick is not due to any corrupt intent.

●    Any give-aways or gimmicks provided to HCPs deemed to be government officials must be of a nominal value and in no event shall its value exceed THB3,000.

●    The above requirement does not apply to HCPs not deemed to be government officials.

●    However, any give-aways or gimmicks provided to HCPs not deemed to be government officials should still be of a nominal value and should not be given in return for the pharmaceutical company retaining or obtaining business, or to gain an improper or unfair advantage.
 
PReMA Code

●    Give-away or gimmicks must contain the brand name of the product and/or the logo and/or the name of the pharmaceutical company, and must not contain any promotional claims.

●    The give-away or gimmick must be of a low monetary value of less than or equal to THB500.

●    The give-away or gimmick should be relevant to the HCP's practice.
 
3. Can a pharmaceutical company sign a service contract (such as for speaking and chairing at meetings, translating medical documents, writing medical articles and/or giving medical training) with an HCP?  

    Are HCPs required to get prior approval from their employer to sign such contract?
 
Thai Law

●    There are no laws or regulations that prohibit a pharmaceutical company from entering into a service contract with an HCP, as long as there is a legitimate reason to employ the services of the HCP.

●    There are no laws or regulations that require the HCP to obtain pre-approval from his/her employer prior to being able to sign a service contract with a pharmaceutical company.

●    However, for transparency, the pharmaceutical company may inform the HCP's employer of its intent to enter into the service contract with the HCP, specifically in the case of HCPs deemed to be government officials.
 
PReMA Code

●    There is no specific prohibition against, or conditions for, pharmaceutical companies entering into service contracts with HCPs or for the HCP to obtain the pre-approval of his/her employer before entering into the service contract with the pharmaceutical company.

●    There is a specific requirement in relation to HCPs engaged as speakers and/or presenters at symposiums or congresses. In this respect, payments of reasonable honoraria (at fair market value) are permitted.
 
4. Are HCPs required by law to obtain a written pre-approval from their employer to be able to attend an event organized by a pharmaceutical company?
 
Thai Law

●    There are no laws or regulations which would require the HCP to obtain a written approval from the HCP's employer prior to being able to attend an event organized by a pharmaceutical company.

●    However, in the event that an HCP deemed to be a government official will be sponsored by the pharmaceutical company to attend the event, then the pre-approval of the HCP's superior must be acquired.

●    Although the above requirement on sponsorship may not apply to HCPs not deemed to be government officials, the pre-approval of the HCP's employer should nevertheless be obtained for the sake of transparency.
 
PReMA Code

●    There are no specific requirements for the HCP to obtain a written pre-approval from the HCP's employer in order to attend an event organized by a pharmaceutical company.

Vietnam

1. Can a pharmaceutical company provide gifts to a healthcare professional?

●    Gifts to HCPs, including but not limited to cash, cash equivalents(such as gift vouchers), stocks, goods, valuable papers, entertainment, traveling tours, services, are strictly prohibited.

●    On certain local traditional occasions, such as the Vietnamese Tet and Mid-Autumn Festival, Doctors' Day, and in special personal events, such as funerals and weddings, gifts of less than VND500,000 can be offered to HCPs.

2. Can a pharmaceutical company offer give-aways or other gimmicks to an HCP? Is there a specific threshold regulated by law?

●    Give-aways is an industry term and is not regulated by law.

●    There is also no specific threshold regulated by law for give-aways. However, the value for gifts required by law is less than VND500,000. Therefore, the value of give-away items should only be nominal to not be considered as an "influence" to HCPs.

3. Can a pharmaceutical company sign a service contract (such as for speaking and chairing at meetings, translating medical documents, writing medical articles and/or giving medical training) with an HCP?

Are HCPs required to get prior approval from their employer to sign such contract?

●    It is permitted to use HCPs for such services.

●    Under the Public Employee Law, before signing a service contract with a pharmaceutical company, the HCP must obtain pre-approval from the hospital's Head.

4. Are HCPs required by law to obtain a written pre-approval from their employer to be able to attend an event organized by a pharmaceutical company?

●    There is no such requirement under the law.

●    However, in practice, the requirement that HCPs obtain a written pre-approval from his/her employer is a way to demonstrate that a pharmaceutical company is transparent in the invitation and that there is no bribery and corruption involved.

Such requirement would help a pharmaceutical company minimize or withstand scrutiny (from an anti-corruption and bribery perspective) from any future investigation.