Download the 7th PCP Breaking News (Primer on the Mexico City Principles “Implementing Guidelines on the Promotion and Marketing of Prescription Pharmaceutical Products and Medical Devices.”) here.

 

 The DOH-AO 2015-0053 is entitled “Implementing Guidelines on the Promotion and Marketing of Prescription Pharmaceutical Products and Medical Devices.” It was signed by Secretary Janette P. Loreto- Garin on December 21, 2015.

The Philippines, as a member of the Asia-Pacific Economic Cooperation (APEC) supports its thrust to promote the growth of small and medium enterprise (SME) which has been hampered by inappropriate business practices. These unethical business practices especially in the area of advertising and product promotion imposed a significant market access barrier and high costs for SMEs in the health products sector. To address these problems, APEC has endorsed certain principles for codes of business ethics for players in the medical devise and biopharmaceutical sectors. These principles are specifically contained in two documents to which the Philippine government is a signatory, namely: (a) The Kuala Lumpur Principles for the Medical Devices Sector and (b) The Mexico City Principles (MCP) for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector.

The DOH AO shall apply to all natural and juridical persons and entities engaged in the dissemination or publication of information, advertisements and other marketing instruments and promotion, sponsorship and other marketing activities of prescription pharmaceutical products and medical devices including their agents and/or their industry association.

The AO shall ensure that ethical interactions between industry and other stakeholders shall be guided by the principles embodied in the KL and Mexico City Principles, namely: Healthcare & Patient Focus, Integrity, Independence, Legitimate Intent, Transparency, Accountability, Appropriateness and Advancement.

Healthcare professionals (HCPs) referred to in this AO means any member of the medical, dental, pharmacy or nursing profession or any other person who, in the course of his/her professional activities, may prescribe, recommend, purchase, supply, administer or dispense a health product accordingly.

Healthcare Organization means either health care, medical or scientific associations or organizations such as a hospital, clinic, university or other institutions or learned society whose business address, place of incorporation or primary place of operation is in the Philippines or an organization through which one or more health professionals or other relevant decision-makers provide services.

Promotional materials or promotional aids means a non-monetary item given to HCPs or an organization for a promotional purpose with minimum value which must be relevant to the HCP’s work and not for personal benefit.

Salient points of the AO that concern the HCPs:

  1. Industry-HCP relationships shall be based on ethics and transparency to assure independence of HCP’s medical decisions and focus on protecting patients’ welfare.

  2. Information provided by Prescription Pharmaceutical Products and Medical Devices (PPPMD) companies shall be restricted to up-to-date evidence-based scientific data.

  3. No company shall 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.

  4. Grants, scholarships, subsidies, support, consulting contracts, educational or practice-related items can be provided or offered to HCPs but should not be in exchange for recommending and prescribing medicines and it must not interfere with the ethics and independence of the HCP’s practice.

  5. PPPMD companies may continue to sponsor symposia and congresses subject to the following restrictions:

    1. Only modest meals must be served

    2. No entertainment throughout the duration of the activity that would incur expenses. For example, sports and recreational activities including golf, bowling tournaments and fun runs; movie premieres; leisure, vacation or junket trips are not allowed.

    3. Venue must be conducive to the scientific or educational objectives of the event, no extravagant venues. Resort hotels (hotels with beachfront facilities) as well as hotels with and promoted as casinos are not allowed.

    4. Spouses, children or other family members or accompanying persons of a HCP cannot be sponsored by the company in any form, unless this person is also a HCP in the same field of specialization as the one being sponsored.

    5. A company may sponsor only 20 HCPs to each legitimate overseas (ASEAN or international) scientific educational event. A HCP may be sponsored as a mere participant or delegate to a congress or convention involving international travel only once in any calendar year.

 
  1. Excluded from letter (e) are company speakers, presenters, meeting officers (e.g. chairpersons, rapporteurs, organizers), clinical investigators/trialists, consultants or advisory board members. Also, in such cases, reasonable compensation or honoraria may be offered to the HCPs. However, a service agreement between the company and the HCP must be executed for such purpose.

  2. Sponsorship for travel of HCPs must be for Economy Class only (not Business, not Premium Economy, not First Class) unless otherwise justified by health reasons or special needs of the HCP.

  3. HCPs sponsored to overseas and local symposia, conventions or continuing professional development events have the obligation to transfer knowledge in the medical community (e.g. conduct echo lectures to HCPs who were unable to attend overseas conventions). An agreement to this effect should be made between the sponsoring company and the HCP.

  4. If the recipient of sponsorship by a PPPMD company is employed by the government, the HCP shall make a post-travel report to his respective agency including appropriate recommendations. Travel of government HCPs/employees shall be in accordance with pertinent rules and regulations regarding such.

6. Any item which does not have any DIRECT patient benefit or is not related to the work of the HCP is not allowed.

  1. Gifts or personal services and benefits unrelated to the work of the HCP shall not be provided by any company representative to a HCP or members of their family

  2. Companies may provide promotional aids to HCPs provided these are of modest value (not extravagant or expensive), and relevant to the practice of the HCP or education of the patients. Examples of these allowable promotional aids are organ system models, illustrations for patient education, BMI computation tables or similar instruments.

  3. Companies may occasionally provide items of medical utility to healthcare organizations (HCOs) and HCPs such as textbooks, subscriptions to medical journals or anatomical models that benefit patients or serve a genuine educational function for the HCO or HCP. These items of medical utility should be modest.

  4. Hospital and clinic equipment or appliances are not allowed (e.g. ECG machines, sphygmomanometers, laptops, projectors, refrigerators, airconditioners, etc.)

  1. Samples may still be provided to the HCPs subject to some restrictions (e.g. not to be given to the general public or distributed as gifts to any member of the HCPs’ family).

  2. Industry-funded research is allowed but shall comply with the policies and general guidelines stipulated in pertinent DOH, FDA and Philippine National Health Research System (PNHRS) issuances and other future revisions

  3. For clinical trials wherein the Philippines is one of the trial sites, the company may sponsor members of the research team to attend international meetings, presentation of trial results, and/or undergo training prior to the conduct of the trial. Under such conditions, the HCP may be provided with reasonable compensation/honoraria.

  4. HCPs must not participate in company-sponsored trials being used for marketing purposes only.

 

The DOH through the FDA shall be the lead agency responsible for the implementation and enforcement of this AO.

PPPMD companies including their agents and/or industry associations (Pharmaceutical and Healthcare Association of the Philippines or PHAP and the Philippine Chamber of Pharmaceutical Industry or PCPI) are ordered to strictly adhere to theses guidelines.

Complaints/reports of violation shall be filed in writing with the FDA using FDA Reporting Forms provided for such purpose. Reports should be submitted to the FDA through its Ethical Market Communications Unit in its Alabang Office.
Corresponding sanctions shall be recommended pursuant to RA 3720 as amended and RA 9502 and RA 7394 as applicable.

Only violations by the PPPMD companies are reported to the FDA. Violations by the HCPs are reported to the Professional Regulation Commission (PRC) or to their respective specialty societies and associations.

Page 4/4“Implementing Guidelines on the Promotion and Marketing of Prescription Pharmaceutical Products and Medical Devices.” 

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