1. What laws are used to regulate advertising on medicines in your jurisdiction?
Republic Act No. 3720, as amended by Republic Act 9711, or the Food and Drug Administration (“FDA“) Act (“FDA Act“), regulates the manufacture, importation, distribution, sale, marketing, promotion and advertisement of medicines or drugs, in the Philippines.
Aside from the FDA Act, the following laws and regulations also regulate the advertisement of medicines:
- Rules and Regulations Implementing the FDA Act (“FDA Act IRR”), which include a Section on Advertisements, Promotions, Sponsorship, and Other Marketing Activities;
- Administrative Order 65-1989 issued by the Department of Health (“DOH”), which provides for guidelines on the advertisement and promotions to implement the Generics Act of 1988;
- Republic Act No. 7394 or the Consumer Act of the Philippines (“Consumer Act”), which governs the advertisement of consumer goods (including drugs);
- Philippine Department of Trade and Industry (“DTI”) Administrative Order No. 2-93 or the Rules and Regulations Implementing the Consumer Act, as amended (“Consumer Act IRR”), which provide additional guidelines to implement the provisions of the Consumer Act;
- Administrative Order 2015-0053 issued by the DOH or the Implementing Guidelines on the Promotion and Marketing of Prescription Pharmaceutical Products and Medical Devices (“PPPMD Guidelines”), which provides for detailed rules and guidelines on the advertising and promotion of medicines and medical devices to the public and healthcare professionals;
- Philippine Intellectual Property Code (“IP Code”), which regulates the use or inclusion of a trademark in the advertisement of medicines; and
- Data Privacy Act of 2012 (“DPA”) and the Implementing Rules and Regulations of the DPA (“DPA IRR”), if the advertising is performed through direct marketing and the use of personal information;
2. Are there any self-regulatory or other codes of practice which apply to the advertising of medicines? a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)? b) What is the legal status of the self-regulatory codes?
a. If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)?
Yes. The following industry codes and guidelines apply to the advertising of medicines:
- Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector (“Mexico Principles“), which calls upon the entire biopharmaceutical sector and eco-system to embrace aligned standards for ethical interactions, including companies and industry associations, healthcare professionals (“HCP“) and organizations and government regulators and anti-corruption enforcement authorities.
- Code of Ethics of the Ad Standards Council (“ASC“);
The advertising industry in the Philippines is self-regulated. The ASC, which took over the functions of the Advertising Board of the Philippines, is the self-regulatory agency that screens and regulates the content of advertising materials. Its members consist of players from the advertising industry, and such membership in the ASC is voluntary. Members of the ASC agree to voluntarily adopt the rules of the ASC and subject themselves to the restrictions in the ASC rules.
- Pharmaceutical and Healthcare Association of the Philippines (“PHAP“) Code of Practice (“PHAP Code“);
PHAP is a non-stock, non-profit association with member companies including generic pharmaceutical companies, pharmaceutical distribution companies, medical device manufacturers, health research companies, over-the-counter pharmaceutical manufacturing companies, and pharmaceutical retailers. The PHAP Code governs the conduct of its members and provides for a set of rules on the interaction between members of PHAP and HCPs, and marketing and promotional activities.
- Code of Ethics of the Philippine Medical Association (“PMA”) (“PMA Code”) and its implementing guidelines.
The PMA Code applies to physicians, and regulates the ethical and professional standards of the practice of medicine.
b. What is the legal status of the self-regulatory codes?
The self-regulatory and industry codes do not have the force of law. However:
- The Consumer Act IRR provides that all advertising materials shall conform to the Code of Ethics of the Advertising Board of the Philippines, Inc., which is now the ASC;
- The ASC Code of Ethics impose sanctions on its members that violate its rules of conduct;
- The PMA Code considers violations thereof as unethical conduct and shall be a sufficient ground for reprimand, suspension or revocation of certificate of registration of the offending party member; and
- The PHAP imposes penalties on its members for violations of the PHAP Code.
- In practice, the FDA may consider the provisions in the PHAP Code to determine industry practice with respect to a particular issue, and how conduct that is complained of measures against industry practice.
3. Is there a statutory or generally accepted definition of “advertising”? a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example? b) Does the definition apply equally to all target audiences?
The Consumer Act defines “advertisement” as prepared and through any form of mass medium, subsequently applied, disseminated or circulated advertising matter. “Advertising” means the business of conceptualizing, presenting or making available to the public, through any form of mass media, fact, data or information about the attributes, features, quality or availability of consumer products, services or credit.
Under the PPPMD Guidelines, promotion is the practice of giving temporary additional value to a brand, product or service to achieve specific marketing objectives, and this is distinguished by the FDA from advertisement which it considers as any representation by any means whatsoever for the purpose of promoting, directly or indirectly, the sale or disposal of any pharmaceutical product.
b. Does the definition apply equally to all target audiences?
Yes. However, as will be discussed in the succeeding items, the materials and information that may be advertised will depend on the type of product that is subject of the advertisement and the target audience.
4. Are press releases regarding medicines allowed in your jurisdictions, and if so what are the restrictions on these (bearing in mind the target audience)?
Press releases may qualify as advertisements in the Philippines. They are subject to the following regulations:
- Press releases for prescription drugs may not be advertised or promoted in any form of mass media, except through medical journals, publications and/or literature solely intended for medical and allied professions.
- PPPMD companies cannot employ or contract any HCP or health worker to participate in a press release that promotes, advertises or endorses any pharmaceutical product or medical device in mass media, print, audio visual display or social media.
- Press releases that advertise over-the-counter (“OTC“) medicines to any target audience are generally allowed, subject to requirements and restrictions under the FDA Act and other applicable rules and industry codes on the content, truth and fairness of the information contained in the advertisement.
5. Are there any processes prescribed (whether by law or Codes of Practice) relating to the approval of advertising of medicines within companies?
The PPPMD Guidelines require PPPMD companies to establish an effective compliance program which shall include crafting of policies and procedures to promote compliance with the PPPMD Guidelines, and which must be approved and signed by the head of the company.
To ensure that a PPPMD company’s compliance program is effective, the company shall observe the 7 elements of effective compliance programs.
- Implementing written policies and procedures;
- Designating a compliance office and compliance committee;
- Conducting effective training and education;
- Developing effective lines of communication;
- Conducting internal monitoring and auditing;
- Enforcing standards through well-publicized disciplinary guidelines; and
- Responding promptly to detected problems and undertaking corrective action.
PPPMD companies are required to provide the FDA with copies of their pro-forma contracts that they use when dealing with HCPs.
6. Do companies have to have material approved by regulatory bodies prior to release?
Only medicines / drugs that are registered with or authorized by the FDA may be advertised, promoted, or subjected to any marketing activities in the Philippines. Furthermore, only claims (whether therapeutic or otherwise) that appear in the FDA-approved label or packaging of the health product may be included in the advertisement, promotion and sponsorship, and other marketing activities in relation to such health product.
Depending on the medium / material of advertisement, advertising materials may or may not require post or pre-screening by the ASC.
Under the rules and regulations of the ASC, advertisements include print, broadcast and cinemas, billboard and out-of-home (“OOH“) materials, merchandising and point of sale materials, internet and mobile ads. Under the ASC rules, advertisements must either be (i) pre-screened or (ii) post-screened by the ASC depending on the type/medium of advertisement, and the content of the advertisement.
As a general rule, printed materials are generally post-screened (without need of the advertising permit) by the ASC, subject to certain exceptions. By way of exception, print advertising materials pertaining to OTC drugs require prior screening by the ASC.
Broadcast materials (TV and radio ads), cinema ads and OOH ads require pre-screening by the ASC regardless of content.
On the other hand, print ads, merchandising materials and digital, internet, and mobile ads are post-screened, except when these pertain to OTC drugs and, with respect to other types of (non-drug) products, when they contain certain types of content that require pre-screening under the ACS Code.
Under the PPPMD Guidelines, aall advertising, promotional or other marketing materials, whether written, audio or visual, for products within the scope of such order, may be subjected to a post-audit by the FDA and if any should be found to violate any FDA provisions, a cease and desist order and/or penalties and/or fines shall be issued by the FDA
7. Is comparative advertising for medicines allowed and if so, what restrictions apply?
The PPPMD Guidelines recognizes and allows comparative claims, in promotional materials subject to compliance with certain conditions, such as the following:
Under the PHAP Code, a claim of comparative efficacy or safety must not be based solely on a comparison of product information documents that do not reflect the general literature, as those documents are based on different databases and are not directly comparable. This applies to Philippine as well as overseas product information documents. Claims of comparative efficacy or safety should be based on data from adequate and well-controlled clinical trials, and if they are consistent with the body of other clinical data. Comparative data must be statistically significant and reliable (P < 0.05). Data must comply with the following conditions: lack of significance must be stated explicitly; and data must not be used to generalize or to indicate superiority or inferiority.
The PHAP Code also provides for the following requirements for comparative claims:
Under the ASC, “comparative claim” is claiming advantage over another brand or service, previous formulation/properties, a set of products, or versus non-use of product/service. This claim must always be properly qualified as to what it compares itself against. On the other hand, “direct comparison advertising” shall mean advertising which involves a comparison of the advertiser’s company, product, or service with an identified competitor, product, or service.
The ASC Code imposes certain conditions on comparative claims:
- no hanging comparisons; and
- they must be substantiated and must not contain unsupported comments about competitors’ products.
- Claims must be properly supported by scientific data and in accordance with local regulations;
- The use of adverse drug reaction data to compare two (2) drug products in promotional materials may be allowed to demonstrate a full, fair, and balanced comparison;
- Superiority claims must be supported by competent (measuring up to all requirements) and well-controlled clinical trials; and
- Claims related to difference in efficacy between drugs must be clinically relevant and statistically significant and reliable (p < 0.05).
- A comparison of competitive products or services must provide clear, substantiated, and verifiable bases for any comparative claim favorable to the advertiser.
- An unqualified, sweeping, exclusivity, or superiority claim may be permitted only if proven to be true on all material respects in relation to all products or services whether competitive or non-competitive.
- Indirect/ unbranded comparison advertising may be permitted provided it does not use features or elements that may be identified or directly associated with competitive brands such as, but are not limited to, symbols, slogans, titles, or statements.
- Competitive claims inviting comparison with a group of products or with other product categories, without identifying any specific brand, may be allowed provided these are adequately substantiated.
- Comparison must not be misleading, disparaging, or exaggerated.
- Comparison versus previous formulation should be supported by technical data from laboratory tests/ clinical studies or consumer use tests following accepted research protocol.
- Comparative claims, whether the comparison is with the marketer’s own previous process or product, or with those of a competitor, should be worded in such a way as to make it clear whether the advantage being claimed is absolute or relative.
The ASC Code does not permit direct comparisons for drug products.
8. Is it possible to provide information on unauthorised medicines or unauthorised indications? Is it possible to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals, or to send information to healthcare professionals?
Only medicines/drugs that are registered with or authorized by the FDA may be advertised, promoted, or subjected to any marketing activities in the Philippines.
Nonetheless, such provision is not intended to prevent the scientific community to be fully informed concerning scientific and medical progress. It is not intended to restrict a full and proper exchange of scientific communications media and at scientific conferences.
9. Please provide an overview of the rules that apply to advertising to the general public for prescription only medicines and over the counter medicines, an indication of the information that must or must not be included.
Pharmaceutical products classified by the FDA as a prescription or ethical drug may not be advertised or promoted in any form of mass media, except through medical journals, publications and/or literature solely intended for medical and allied professions.
Moreover, prescription pharmaceutical companies cannot employ or contract any HCP or health worker to promote, advertise or endorse any pharmaceutical product or medical device in mass media, print, audio visual display or social media. Such companies, including medical representatives, are not allowed to communicate directly to patients or their families in the promotion of their prescription pharmaceutical products.
With respect to permissible promotional activities of prescription pharmaceutical products, the following guidelines must be observed:
- Off-label promotion is not permitted.
- The following claims and/or comments shall be prohibited:
a. One-sided information and any decisive statement based on inadequate or truncated evidence;
b. Superlatives, exaggerations and lines with hanging comparatives, without supporting data. E.g., “This product is better (e.g., Safety, efficacy, quality, and price) because . . .”;
c. Unsupported comments about competitors and their products; and
d. Unspecified, unreferenced claims about side effects, safety and efficacy.
- Other prohibited words/phrases are:
a. Use of the word “new”, unless the product or indication has been available and generally promoted for less than twelve (12) months;
b. “Non-toxic”, and “no side effects”; and
c. Unspecified, unreferenced claims about safety, and efficacy without proper qualification.
OTC medicines may be advertised to the public and HCPs, subject to the requirements and restrictions under the FDA Act and other applicable rules and industry codes.
Under the ASC Code, some restrictions are, as follows:
Advertisements for non-prescription drugs, devices and treatments should not describe or dramatize distress (e.g., death or serious illness) in a morbid manner.
Advertisements should not offer false hopes in the form of a cure or relief for the mentally or physically handicapped either on a temporary or permanent basis.
Non-prescription drugs, devices treatments may not be directly or indirectly advertised as the answer to conditions of premature aging or loss of virility, unless officially so approved in writing by the FDA.
10. Are there any restrictions on interactions between patients or patient organisations and industry (e.g., consultation, sponsorship)? If so, please describe those briefly.
Yes. The PPPMD Guidelines recognize that prescription pharmaceutical product companies may give support to patient organizations, provided that the autonomy of such groups is upheld and support is not intended to influence them to favour any particular product. Patient organizations must also make a public disclosure of their funding sources.
Under the PHAP Code, when working with patient organizations, companies must ensure that the involvement of the company and the nature of the involvement are clear from the outset. No company may require that it be the sole funder of the patient organization or any of its programs. Companies that provide financial support or in-kind contribution must have in place, written documentation setting out the nature of support including the purpose of the activity and its funding. Companies may provide financial support for patient organization meetings provided that the primary purpose of the meeting is professional, educational, and scientific in nature, or otherwise supports the mission of the patient organization.
11. Which information must advertising directed at healthcare professionals contain, and which information is prohibited? For example can information about clinical trials, or copies of journal be sent?
Information contained in advertisements for HCPs must, among others:
- be consistent with the indications in the product registration and labelling materials approved by the FDA;
- have the written permission from the original author and shall be used verbatim and in the context intended by the author if direct quotes are used;
- represent the content of the substantiating sources accurately;
- properly cite the complete source; reflect fair and balanced information regarding risks and benefits of the product if using research data.
Under the PPPMD Guidelines, the following are prohibited in advertisements to HCPs:
- One-sided information and any decisive statement based on inadequate or truncated evidence;
- Superlatives, exaggerations and lines with hanging comparatives, without supporting data. E.g., “This product is better (e.g., Safety, efficacy, quality, and price) because . . .”;
- Unsupported comments about competitors and their products;
- Unspecified, unreferenced claims about side effects, safety and efficacy.
Other Prohibited Words and Phrases are:
- The word “new”, unless the product or indication has been available and generally promoted for less than twelve (12) months;
- “Non-toxic”, and “no side effects”; and
- Unspecified, unreferenced claims about safety, and efficacy without proper qualification.
12. May pharmaceutical companies offer gifts to healthcare professionals and are there any monetary limits?
No. Gifts or personal services and benefits unrelated to the work of the HCP shall not be provided by any PPPMD company representative to an HCP or members of their families. However, PPPMD companies may provide promotional aids or items of medical utility to HCPs, provided these (a) are of modest value; and (b) are relevant to the practice of the health care professions or education of the patients.
In addition, Philippine anti-bribery and corruption laws, such as the Revised Penal Code and Presidential Decree No. 46, generally prohibit the giving of gifts to an HCP in the public sector (“public HCPs“) simply by reason of the public HCP’s official position, regardless of the underlying purpose. A public HCP covers doctors, nurses and other healthcare professionals / workers employed by or working in government-owned hospitals. As an exception, certain laws which also apply to public sector HCPs, such as the Anti-Graft and Corrupt Practices Act and the Code of Conduct and Ethical Standards for Public Officers and Employees, allow the giving of unsolicited gifts of nominal value to public HCPs.
13. Are pharmaceutical companies allowed to provide samples to healthcare professionals?
Pharmaceutical companies may provide samples to HCPs provided that:
- These are duly acknowledged by the HCP;
- Manufacturers and distributors shall not to give directly or indirectly, samples of prescription pharmaceutical products to the general public or anyone other than licensed physicians and dentists; and
- In the case of substantial amounts provided for indigent patients, the recipient HCP must execute a written statement that the samples shall be used for its intended purpose and shall not be used for financial gain.
Under the PHAP Code, in accordance with FDA regulations, free samples of a pharmaceutical product may be supplied to HCPs, and only with their consent, in order to enhance patient care or to gain clinical experience. Samples should not be sold or otherwise misused by medical representatives and employees. The quantity of samples given should be appropriate for HCPs to initiate therapy, and/or gain clinical experience with the product.
14. Is sponsorship of scientific meetings or congresses and/or attendance by healthcare professionals to these events? If so, which restrictions apply? Do additional restrictions apply to events taking place abroad?
Companies may support seminars, scientific meetings and third party conferences provided:
- The meals provided are modest;
- No entertainment that would incur expenses is provided during the entire duration of the activity;
- Conference organizers shall make a written request to the PPPMD Company containing relevant information such as scientific content, attendees, duration and cost;
- The support provided is consistent with the PPPMD Guidelines;
- The venue is appropriate and conducive to the scientific/educational objectives of the event. No extravagant venues are allowed, unless there is no other suitable venue in the locality where the event is to be held;
- All forms of support and activities are well documented;
- Attendees to such conference are legitimate or authorized; and
- Speakers shall disclose any potential or actual conflict of interest prior to topic presentation during the event.
Under the PPPMD Guidelines, PPPMD companies must inform the FDA of any activities / events undertaken by the said company, whether or not the activities are in conjunction with any medical society / association, at least one month prior to holding of the said activity, if the activity involves more than 100 HCP participants.
A PPPMD company may sponsor an HCP as a mere participant or delegate to a medical congress or convention involving international travel only once in any calendar year.
Sponsorships for public HCPs, however, should be carefully scrutinized, if not avoided altogether. Being something of value, a sponsorship may be deemed a “gift” that is prohibited by Philippine anti-bribery and corruption laws, unless such “gift” can be established as “an unsolicited gift of nominal value” that is not given by reason of the public HCP’s office.
15. What are the restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies?
The PPPMD Guidelines provide that purpose of the event must be to provide scientific or educational information. Hence, organizing non-scientific events may not be allowed.
To ensure appropriate focus on education and informational exchange and to avoid the appearance of impropriety, PPPMD companies shall not provide any form of entertainment that would incur expenses for recreational items, such as tickets to the theatre or sporting events, sporting equipment, or leisure, or vacation trips, to any HCP.
Entertainment or recreational benefits shall not be offered, regardless of (1) the value of the items; (2) whether the company engages the health care professional as a speaker or consultant, or (3) whether the entertainment or recreation is secondary to an educational purpose.
No stand-alone entertainment or other leisure or social activities shall be provided or paid for by companies during scientific meetings.
16. Is it possible to pay for services provided by healthcare professionals and if so, which restrictions apply?
Yes, the PPPMD Guidelines allows speaker and consultant arrangements between PPPMD companies and HCPs. In particular, the engagement of HCPs in medical conferences or scientific studies may be allowed, provided there is a written contract which specifies the nature of services rendered and payment for such services, including the following:
- Criteria for consultant selection is based on identified need and expertise;
- Contracting company keeps a record of all transactions;
- Compensation for said services is reasonable and reflect the fair market value for said services;
- Disclosure of any potential or actual conflict of interest by the consultant or speaker must be made; and
- Information is to be made public, if and when requested for legitimate purposes.
If the consultant is a public HCP, the consultant should be duly authorized by the head of his / her agency to engage in the private practice of the profession.
All manufacturers of drugs, medical devices, biological and medical supplies registered by the FDA shall collect and track all financial relationships with health care professionals and health care providers and report these to the DOH, which shall then make this list publicly available in accordance with existing laws. There are currently no clear timelines or deadlines imposed on such report.
17. Are pharmaceutical companies permitted to provide grants or donations to healthcare professionals or healthcare institutions? Does it matter if the grant or donation is monetary or in kind?
Donations from manufacturers and distributors of pharmaceutical products to HCPs / healthcare institutions, which are intended for charitable, humanitarian or health purposes are not prohibited. Such donations shall not be made for promotional reasons, or be an incentive to prescribe, recommend or purchase any pharmaceutical product or medical device. There is no distinction between monetary or donations in kind.
However, donations to public HCPs / healthcare organizations (“HCO“) in the public sector may be considered as a “gift” that is prohibited by Philippine anti-bribery and corruption laws.
18. Are pharmaceutical companies required to disclose details of transfers of value to healthcare professionals or healthcare institutions? If so, please indicate whether this is a legal requirement or not, and describe briefly what the companies must report and how. Do these transparency requirements apply to foreign companies and/or companies that do not yet have products on the market?
Yes. Under Republic Act No. 11223, or the Universal Healthcare Act (“UHC Act“) all manufacturers of drugs, medical devices, biological and medical supplies registered by the FDA shall collect and track all financial relationships with health care professionals and health care providers and report these to the DOH, which shall then make this list publicly available in accordance with existing laws.
Under the implementing rules and regulations of the UHC Act (“UHC Act IRR“), “financial relationships” with HCPs cover donations, educational grants, research funding, sponsorship related to events, travel, accommodation, registration fees, honoraria, support for continuing professional development (“CPD“), royalties, current or prospective ownership or investment interest, consultancy/speakership fees, etc.
On the other hand, “financial relationship: with healthcare providers include sponsorship of events, research and educational grants, payment of services, space rentals or facility fees, and donations for patients whether in cash or kind.
The FDA / DOH has published a draft administrative order, which contains the guidelines for compliance with the above requirements for the UHC Act and UHC Act IRR, for comments from the public.
19. When if at all with a competent authority have to get involved in authorising advertising? Is advertising on the internet (including social media) for medicinal products regulated, and if so, how? Should companies include access restrictions on websites containing advertising or other information intended for healthcare professionals?
Our response in item 6 above discusses the approval requirements for advertisements for drug / OTC products.
As currently defined, advertising is broad enough to include the internet as a form of mass media. Formal opinions of government agencies have arrived at the conclusion that internet is a form of mass media. While there are currently no specific rules in the Philippines regarding online advertisement of medicines, the general rules on advertisements would apply to this form of advertisement.
Therefore, pharmaceutical companies must take caution that it does not engage in online advertising of unauthorized drug products to the Philippine public. Furthermore, it must monitor content of its websites to ensure that the same does not contain unauthorized materials or information with respect to its drug products, such as unauthorized claims, comparisons and misleading information,
As mentioned in item 6, digital ads, ads on the internet, and mobile ads on OTC drugs require pre-screening under the ACS Code.
20. Are there any anti-bribery rules apply to communications between pharmaceutical companies and healthcare professionals or healthcare organizations?
Philippine anti-bribery and corruption laws apply only to communications between pharmaceutical companies and public HCPs / HCOs. The Anti-Graft and Corrupt Practices Act prohibit communications in which:
- The company offers any employment to a public HCP, if the company has pending official business with the public HCP or had official business with the public HCP within the past year; and
- The company urges the divulging or untimely release by the public HCP of confidential information.
In addition, the Philippine Government Procurement Reform Act provides that:
- Companies participating in a public tender are prohibited from communicating with any member of the relevant bids and awards committee (“BAC”), its staff and personnel, secretariat and technical working group regarding the evaluation of their bids until a Notice of Award is issued; and
- The officers of the company that exert undue influence or pressure on members of the BAC or any officer or employee to favour a particular bidder, or employ schemes to suppress competition, may be held criminally liable.
21. What are the rules (whether statutory or self-regulatory) which govern the offering of benefits or inducements to healthcare professionals?
Under the PPPMD Guidelines, any item which does not have any direct patient benefit or is not related to the work of the HCP shall not be permitted. Gifts or personal services and benefits unrelated to the work of the HCP shall not be provided by any PPPMD company representative to a health care professional or members of their families. PPPMD companies may provide promotional aids to HCPs, provided these (a) are of modest value; and (b) are relevant to the practice of the health care professions or education of the patients. PPPMD companies may occasionally provide items of medical utility to HCOs and HCPs such as textbooks, subscriptions to medical journals or anatomical models which benefit patients or serve a genuine educational function for the HCO or HCP. Items of medical utility should be modest.
Under the PHAP Code, financial benefit or benefit in-kind (including grants, scholarships, subsidies, support, consulting contracts, or educational practice-related items) may not be provided or offered to HCPs in exchange for prescribing, recommending, purchasing, supplying or administering products or for a commitment to continue to do so. Gifts of any kind for the personal benefit of HCP are also not allowed, irrespective of value, kind or occasion.
In addition, Philippine procurement, anti-bribery and corruption laws, such as the Revised Penal Code and the Anti-Graft and Corrupt Practices Act, apply to the offering of benefits or inducements to public HCPs. Among others, the following acts are prohibited:
- The giving of gifts to public sector HCPs and communications that may constitute inducements such as employment offers are generally prohibited, subject to limited exceptions (such as unsolicited gifts of nominal value that are not given by reason of the public HCP’s office);
- The exertion of undue influence or pressure on members of the BAC or any officer or employee of a procuring government entity to take a particular action that favours or tends to favour a particular bidder; and
- The employment of schemes, in connivance with a public HCP, that tend to restrain or stifle competition in the bidding.
22. Which bodies are responsible for enforcing the rules on advertising and the rules on inducement? Please include regulatory authorities, self-regulatory authorities and courts.
The governing bodies responsible for enforcing the rules on advertising of medicines and rules on inducement are:
- FDA under the DOH for the provisions of the FDA Act, FDA Act IRR, PPPMD Guidelines, and other regulations it has issued;
- ASC for advertising materials in general;
- PHAP for its members;
- The Office of the Ombudsman, the Department of Justice and the regular courts for inducements involving public HCPs.
23. On what basis and before which bodies or courts can companies initiate proceedings against competitors for advertising infringements?
Violations of the laws, rules and regulations, issuances and guidelines issued by the competent authority on advertising (e.g., the DOH or FDA) will serve as basis for the institution of a complaint. For instance, the advertising of prescription pharmaceutical products in mass media is prohibited by FDA and DOH regulations. This may be the basis of a complaint or proceeding against the pharmaceutical company before the FDA. The decision of the FDA on the complaint or proceeding may be appealed to the DOH and subsequently to the appellate courts (i.e., the Court of Appeals and the Supreme Court).
In addition, depending on the circumstances of the advertisement, a party sustaining injury or damages as a result of the advertisement may commence a civil action for damages before the regular courts.
Finally, complaints may be brought before the ASC for violations of the ASC Code of Ethics and/or its Manual of Procedures. Such violations may arise from advertisements containing product claims that are prohibited by the ASC Code of Ethics, such as disparagement and unsubstantiated comparisons.
24. What are the penalties, sanctions or measures that regulators or courts can impose for violating medicines advertising rules and rules on inducements to prescribe in your jurisdiction?
Failure to comply with the FDA Act, FDA IRR, and regulations issued by the FDA may result in the following:
i. FDA issuing a cease and desist order against the responsible establishment to stop the further release, printing, broadcast or dissemination of the advertising or promotional material, and/or penalties and/or fines shall be issued by the FDA;
ii. Seizure and confiscation of products that are subject of violative promotional or advertising materials;
iii. Withdrawal by the FDA of accreditation of the establishment’s medical director;
iv. Suspension/revocation of the licenses and registrations of the establishment;
v. for the advertisement of any health product that is adulterated, unregistered or misbranded:
- Imprisonment ranging from one year but not more than 10 years;
- Fine of not less than PHP 50,000 or PHP 500,000 (approximately US$ 1,000 to US$ 10,000), depending on the violator;
- additional fine of one percent of the economic value/cost of the violative product or violation, or PHP 1,000, whichever is higher, for each day of continuing violation;
- Fine and/or imprisonment, at the discretion of the court
If the offense is committed by a juridical person (i.e., a partnership or a corporation), the penalty of imprisonment will be imposed on the chairman of the board of directors, the president, general manager, or the partners and/or the persons directly responsible in the erring entity. If the offense is committed by a foreign national, such violator shall, in addition to the penalties prescribed, be deported after service of sentence.
- Any violation of the provision of the ASC Code of Ethics is usually the subject of the complaint that is presented to the ASC for hearing. Decisions may provide for the issuance for a cease and desist order on errant ad materials. Compliance is assured through specific sanctions on violations. An extreme case may cause all media, print and broadcast, to refuse to print / broadcast advertising material found to have violated specific provisions of the Code.
- Members that violate the PHAP Code of Practice will be meted with the following:
i. First offense shall be meted a fine of PHP 200,000.00
ii. Succeeding offenses of the same nature (e.g., interfering with HCP independence) or within the same section of the Code within a twelve month period shall be meted a fine of PHP 750,000.00 per offense, and the company name will be published on the PHAP website.
iii. Clean slate if no violations of the same offense are committed within a 12-month period. Reckoning date for all violations is the date when a decision was issued by the PHAP Ethics Committee.
- Violations of Philippine procurement, anti-bribery and corruption laws, which would apply to gifts in favor or inducements of public HCPs, may result in imprisonment of up to 15 years (depending on the particular offense) and a fine of up to three times the value of the gift given.
25. What is the relationship between procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts/government competent authorities?
Procedures/measures taken by self-regulatory authorities (such as the PHAP and the ASC) are generally separate and independent from the procedures/measures taken by courts or government authorities. Thus, as a general rule, measures of self-regulatory authorities are not appealable to the courts.
Nevertheless, Philippine law does not prevent parties aggrieved by decisions of self-regulatory authorities from seeking appropriate remedies (e.g., injunctions urgently necessary to prevent irreparable harm) before the regular courts, provided that such parties are able to establish the basis for such remedies. Also, nothing prohibits relevant regulatory agencies (such as the FDA) from administratively penalizing parties sanctioned by self-regulatory authorities, as long as such penalties are justified under applicable laws, rules and regulations.
26. Are there any recent enforcement trends in relation to pharmaceutical advertising in your jurisdiction? Please report any significant (publicly known) enforcement actions in the past two years.
Recent cases show that the FDA adopts a broad interpretation of actions that constitute advertising and promotion of pharmaceutical products and strictly construes the prohibitions on such activities. It has imposed fines on the basis that a general reference to a particular pharmaceutical product is “advertising” or “promotion” even if the brand name is not mentioned if the company making such general reference is the only owner and distributor of the product in the market.
This article was originally published in The Legal 500: Pharmaceutical Advertising Country Comparative Guide. For a full list of jurisdictional Q&As visit: https://www.legal500.com/guides/guide/pharmaceutical-advertising/