Amended November 2016
Code of Ethics
MOPI AIMS & OBJECTIVES
The overall objective of the Malaysian Organisation of Pharmaceutical Industries (MOPI) is to ensure that all patients have access to affordable quality medicines. As a matter of basic principle the Malaysian Organisation of Pharmaceutical Industries shall:
- Support the development of international, regional and domestic policies which seek to ensure access to affordable medicinal care for all patients;
- Promote balanced and generic-friendly intellectual property rights in the pharmaceutical sector which ensure that timely access to markets is guaranteed for generic pharmaceutical products;
- Encourage the scientific development, professional awareness and general knowledge of medicines, biosimilars, health supplements and traditional medicines produced by domestic manufacturers
- Promote the global and regional harmonisation of regulations relating to pharmaceutical products, biosimilars, health supplement and traditional medicines produced by domestic manufacturers
- Provide guidance to international organisations and national governments in improving the regulatory and legal expertise relating to the registration and marketing of medicines, biosimilars, health supplement and traditional medicines produced by domestic manufacturers
- Promote uniform and effective GMP standards and quality controls for pharmaceuticals, biosimilars, health supplement and traditional medicines produced by domestic manufacturers and their active ingredients;
- Seek strict and effective controls to prevent the production and trade in counterfeit versions of medicines;
- Support open competition in the pharmaceutical industry which shall include supporting the rights of Governments to regulate their own substitution, prescribing and reimbursement policies.
- Assist the various Malaysian government ministries in the development of the domestic pharmaceutical manufacturing sector.
- Contribute towards better healthcare for all Malaysians by promoting accessibility to quality, efficacious and cost-effective pharmaceutical products.
- Liaise with and encourage the co-operation of all allied healthcare organisations and government institutions for the enhancement of health standards in Malaysia.
- Promote a positive view of the industry’s role, motives and performance through effective dialogues and communications with consumer organisations and the government sector.
- Encourage the provision of adequate competent manpower for the pharmaceutical industry and to upgrade the skills and knowledge of the industry’s workforce.
- Promote awareness among members to take due cognizance of their responsibility to protect the environment and take the necessary measures towards this end in their operations or manufacture of their products.
- Protect the consumer’s right of choice and promote the maintenance of a free and fair market for pharmaceutical products.
Notwithstanding any provision made under this Code, all marketing activities must conform to all existing and relevant government legislation governing the practice of the Pharmaceutical Industry.
MOPI Code of Pharmaceutical Marketing Practices
On Prescription (Ethical) Products
The Code owes its existence to the determination of the Organisation to voluntarily secure the acceptance and adoption of high standards of conduct in the marketing of pharmaceutical products which the industry makes available for prescription purposes to the public. For this reason, members of the Organisation have voluntarily concurred in the promulgation of this Code and submitted to its restraints. This Code essentially adopts The Mexico City Principles as developed by the APEC SME Working Group and endorsed by APEC Ministers (Foreign & Trade) at the APEC Ministerial Meeting in November 2011 in Honolulu, USA. The Mexico City Principles were further endorsed in the Statement of the 2012 Meeting of APEC Ministers Responsible for Trade held in Kazan, Russia in June 2012.
Adoption of this Code shall be voluntary by members of the Organisation and the Code will be periodically reviewed to reflect the highest standard of conduct within the Organisation.
The major sanction against any company that transgresses the Code is the sanction of adverse publicity.
The objective of the Code is to provide as clear as possible guidelines in disseminating accurate, fair, unbiased and objective information to the medical and allied profession so that rational prescribing decisions can be made. In so doing, members are obliged to adopt the high standard of conduct and professionalism in the marketing of pharmaceutical products.
There are obvious difficulties in drawing up exacting standards for the Code, especially where the success of application depends not only on strict adherence by members, but also the co-operation of non-members in the medical and allied professions. Self-discipline and restraints are an integral part of the Code, which must be applied not only in spirit but as well as to the letter.
The MOPI Code sets out standards for the Pharmaceutical Marketing Practices on Prescription (Ethical) Products to healthcare professionals to ensure that member companies’ interactions with healthcare professionals are appropriate and are perceived as such.
1.1 Scope: For the purposes of the MOPI Code:
- “Company” means any company that is a member of MOPI.
- “Healthcare professional/s” means any member of the medical, dental, pharmacy or nursing professions or any other person who in the course of his or her professional activities may prescribe, recommend, purchase, supply, or administer a pharmaceutical product.
- “Manufacture” means any act having the meaning assigned to it by the Control of Drugs and Cosmetics Regulations 1984. MOPI members shall observe and comply with cGMP in the manufacture of their pharmaceutical products. This will also include Distributors and Re-packers.
- “Pharmaceutical product/s” means any product having the meaning assigned to it by the Control of Drugs and Cosmetics Regulations 1984.
- “promotion” means any activity undertaken, organized or sponsored by a member company which is directed at healthcare professionals to promote the prescription, recommendation, supply, administration or consumption of its pharmaceutical product(s) through all media, including the internet.
- “Territory” This code is only intended to govern practices within Malaysia and therefore will comply with the laws of Malaysia.
1.2 Exclusions: This Code does not seek to regulate the following activities:
- Promotion of self-medication products that are provided “over the counter” with or without prescription.
- Pricing or other Trade Terms for the supply of Pharmaceutical Products
- The provision of non-promotional information by member companies
2. General Principles
Ethical interactions help ensure that medical decisions are made in the best interests of the patients. For relationships with Healthcare Professionals and other stakeholders to meet these standards, member companies should be guided by these six principles:
Healthcare and Patient Focus means everything member companies do is intended to benefit patients.
Integrity means dealing ethically, honestly and respectfully in everything member companies do.
Independence means to respect the need of autonomous decision-making of all parties, free from improper influence.
Legitimate Intent means everything member companies do is for the right reasons, is lawful, and aligns with the spirit and the values of these Principles.
Transparency means a general willingness to be open about member company actions while respecting legitimate commercial sensitivities and intellectual property rights.
Accountability means a willingness to be responsible for our actions and interactions.
3. Standards of Promotion
3.1 Promotional material for pharmaceutical products should be clear, legible, accurate, balanced, fair, objective and sufficiently complete and presented in such a way as to conform not only to legal requirements but also to high ethical standards and to be in good taste. Claims should not be stronger than scientific evidence warrants, and every effort should be made to avoid ambiguity.
3.1.1 Promotion should also be capable of substantiation either by reference to the approved labeling or by scientific evidence. Such evidence should be made available on request to healthcare professionals. Companies should deal objectively with requests for information made in good faith and should provide data which are appropriate to the source of the inquiry.
3.2 Nature and availability of information
3.2.1 Information provided to any Healthcare Professional on pharmaceutical products must accurately reflect updated data, current medical opinion or expert consensus based on latest references (preferably less than 5 years old). The approved Malaysian prescribing information remains the main guide for decisions.
$13.2.2 Information about pharmaceutical products should also be clear, legible, accurate, balanced, fair, objective and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the pharmaceutical product concerned.
3.2.3 Information to be capable of substantiation must be based on clinical and pharmacological evidence from properly conducted investigations. Such substantiation when requested by members of the medical and allied profession should be provided without delay. Theoretical projection of that evidence should be avoided. Extrapolation of data from animal studies is not allowed.
3.3 Claims and comparisons
3.3.1 Claims for a medical product must be based on an up to date evaluation of all relevant evidence and must reflect this evidence accurately and clearly including the reference of this substantiating evidence.
Up to date implies that if the information does not alter with time, the most recent available data is acceptable e.g. the resistance pattern for antibiotics.
3.3.2 Exaggerated or all-embracing claims must not be made and superlatives must not be used unless based on substantial scientific evidence and other responsible medical opinion. Claims should not imply that a pharmaceutical product or an active ingredient has some special merit, quality or property.
3.3.3 Any statement about side effects should be specific and based on data approved by the Malaysian Drug Control Authority (DCA) or on published data to which references are given. It must not be stated that a product has no side effects, toxic hazards or risks of addiction. The word “safe” must not be used.
3.3.4 The word “new” should not be used to describe any product or presentation which has been generally available, or any therapeutic indication for which the product / indication has been registered in Malaysia for more than 12 months.
3.3.5 Comparisons of products must be factual, fair, objective, unbiased and capable of substantiation. In presenting a comparison, care must be taken to ensure that it does not mislead by distortion, by undue emphasis, or in any other way, including omissions. “Hanging” comparatives, which merely claim that a product is “better or stronger” etc., must not be used.
3.3.6 Brand names of products of other companies must not be used unless prior written consent of the Brand Owner has been obtained.
$13.3.7 All claims must be based on DCA approved P.I.
3.4 Disparaging references
3.4.1 The products or services of other companies should not be disparaged either directly or by implication. Substantiated comparative claims inviting fair and objective comparisons with a group of products or with other products in the same field are permissible, provided that such claims are not presented in a way which is likely to mislead, whether by distortion, undue emphasis or otherwise.
3.4.2 The clinical and scientific opinions of members of the medical and allied professions should not be disparaged either directly or by implication.
4. Printed promotional material
4.1 All printed material (including journal advertising) which is issued for promotional purpose by the product license holder or with his authority, must include the name and address of the product license holder or the business name and address of the part of his business responsible for the sales of the product.
4.2 When promotional material relates to published studies, a clear reference to these should be given in the printed material. Quotations from medical literature must not change or distort the intended meaning of the author or clinical investigator or the significance of the underlying work or study.
4.3 Promotional material such as mailings and journal advertisements and loose inserts must not be designed to disguise its real nature.
4.4 Advertisements in journals should not be designed so as to resemble editorial material.
4.5 Promotional material should conform, both in text and illustration, to canons of good taste and should recognize the professional standing of the recipient.
4.6 All printed promotional material, including advertisements should include the name of the product (normally the brand name), generic name of the product and the date of production of the advertisement.
4.7 Doctors’ and healthcare professionals’ names or photographs must not be used in a prominent manner in promotional material or in any way that is contrary to the ethical code of the medical profession.
4.8 Promotional material should not imitate the devices, copy, slogans or general layout adopted by other companies in a way that is likely to mislead or confuse.
4.9 Material and articles from the lay press should not be used as promotional material.
4.10 Scientific and technical information shall fully disclose the properties of the pharmaceutical product as approved in Malaysia based on the minimum abbreviated prescribing information and approved P.I.
5. Electronic and Audiovisual Materials
5.1 The same requirements shall apply to electronic promotional materials as apply to printed materials. Specifically, in the case of pharmaceutical product related websites:
• The identity of the pharmaceutical company and of the intended audience should be readily apparent;
• The content should be appropriate for the intended audience;
• The presentation (content, links, etc.) should be appropriate and apparent to the intended audience; and
6. Dissemination of Information of product or Indication
6.1 Local Meetings inclusive of Continuing Medical/Professional Education (CME’s): To the extent allowed by local laws and regulations, dissemination of scientific information for a pharmaceutical product or indication, which has been approved for marketing by the Malaysian Drug Control Authority (DCA) provided:
- Organized under the auspices of a Professional body or hospital-based CME committee.
- Relevant permission from authorized bodies (if required).
7. Artwork, graphics, illustrations, etc in print and other media
7.1 Artwork and graphics must conform to the letter and the spirit of the Code. Graphs and tables should be presented in such a way so as to give a clear, fair, balanced view of the matters with which they deal, and should only be included if they are relevant to the claims or comparisons being made.
8. Reprints, abstracts and quotations in print or other media
8.1 Material from medical literature or from personal communications received from healthcare professionals must accurately reflect the meaning of the author and the significance of the study (which should not be distorted by the addition of printed highlighting or underlining to give prominence to selected portions of the material).
$18.2 Care must be taken to avoid ascribing claims or views relating to the medical products to authors when such claims or views no longer represent or may not represent the current view of the authors concerned.
9. Distribution of promotional material in print or other media
9.1 Promotional material should only be sent or distributed to those categories of persons whose need for or interest in the particular information can reasonably be assumed, but must not exceed the categories sanctioned by law.
9.2 Any information designed to encourage the use of pharmaceutical products in clinics, industrial concerns, clubs or schools must be addressed to the medical advisor or medical officer or to the medical auxiliary staff.
9.3 No promotional material shall be issued unless the final text and layout have been certified by a senior official of the company, preferably a Doctor, a Pharmacist or a Regulatory Officer.
10. Symposia, congresses and other means of verbal communication
10.1 Symposia, congresses and the like are indispensable for the dissemination of knowledge and experience. Scientific objectives should be the principal focus in arranging such meetings.
10.2 When a Member Company sponsors a symposium, congress or other medical/health care or educational program, a doctor or pharmacist under the employment of a member company is allowed, on a professional basis, to attend Scientific meetings under the umbrella of a professional Society or Organisation of which he is a member (e.g., MMA, MPS) even though it may be organized by a competitor company.
Sponsorship is limited to travel, meals, registration fee, accommodation and relevant expenses.
10.3 Appropriate Venue: All Events should be held in an appropriate venue that is conducive to the scientific or educational objective and the purpose of the Event or meeting. Companies should avoid using renowned, extravagant venues.
10.4 Consultant and Speaker Arrangements:
10.4.1 Consulting arrangements with healthcare professionals allow member companies to obtain information or advice from medical experts on such topics as the marketplace, products, therapeutic areas and the need of patients. Member Companies use this advice to inform their efforts to ensure that the medicines they develop, produce and/or market are meeting the needs of patients. In addition, healthcare professionals participate in Member Company-sponsored speaking programs in order to help educate and inform other healthcare professionals about the benefits, risks, and appropriate uses of medicines.
10.4.1.1 Member Companies should continue to ensure that consultant and speaking arrangements are neither inducements nor rewards for prescribing or recommending a particular medicine or course of treatment.
10.4.1.2 It is appropriate for consultants and speakers who provide services to be offered reasonable compensation for those services and reimbursement for reasonable travel, if such travel is necessary to perform the services. Lodging and meal expenses incurred as part of providing those services. Any compensation or reimbursement made in conjunction with a consulting or speaking arrangement should be reasonable and based on fair market value
10.4.1.3 Consulting or advisory arrangements lacking a bona fide business purpose should not be used to justify compensating healthcare professionals for their time or their travel, lodging, and other out-of-pocket expenses
10.4.2 The following factors support the existence of a bona fide consulting or speaking arrangement (not all factors may be relevant to any particular arrangement):
10.4.2.1 A written contract specifies the nature of the services to be provided and the basis for payment of those services;
10.4.2.2 A legitimate need for the services has been clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants
10.4.2.3 The criteria for selecting consultants and speakers are directly related to the identified purpose, and the persons responsible for selecting the consultants and speakers have the expertise necessary to evaluate whether the particular healthcare professionals meet these criteria;
10.4.2.4 The number of healthcare professionals retained is not greater than the number reasonably necessary to achieve the identified purpose;
10.4.2.5 The retaining Member Company maintains records concerning, and makes appropriate use of, the services provided;
10.4.2.6 The venue and circumstances of any meeting with consultants or speakers are conducive with the primary focus of the meeting.
11 Medical Representatives
11.1 Medical representatives must be adequately trained and possess sufficient medical and technical knowledge to present information on the company’s products in an accurate and responsible manner.
11.2 Medical representatives should at all times maintain a high standard of ethical conduct in the discharge of their duties. They are required to be instructed in and possess a copy of the Code.
11.3 The requirements of the Code which aims at accuracy, fairness, balance and good taste apply to verbal representations as well as printed material.
11.4 Medical representatives must not employ any inducement or subterfuge to gain access to Healthcare Professionals. No payment of a fee should be made for the grant of access to Healthcare Professionals..
11.5 A company will assume responsibility, under the Code, for correcting breaches of the Code resulting from misconduct or misrepresentation of fact by any representative.
11.6 The system of remuneration of representatives should not be such as to adversely influence the proper prescription and usage of pharmaceutical products.
12.1 Except when provided for specific clinical trials, samples of products given out should be modest, both in size and face value and clearly labeled as samples.
12.2 Where samples of products restricted by law to supply on prescription are distributed by a representative, the sample must be handed direct to the Doctor or given to a person authorised to receive the sample on the Doctor’s behalf.
12.3 An adequate recording system should be established for all samples distributed.
12.4 Samples which are sent by post must conform to the Postal and Poisons Regulations governing it.
12.5 Samples must not be used as unofficial bonus and an inducement to purchase.
12.6 MemberCompanies should have adequate systems of control and accountability for samples provided to healthcare professionals including how to look after such samples whilst they are in the possession of medical representatives.
13 Gifts and Other Items
13.1 Inappropriate financial or material benefits, including inappropriate hospitality, should not be offered to healthcare professionals to influence them in the prescription of pharmaceutical products.
13.2 Subject to Section 13.3, no gifts or financial inducement shall be offered or given to healthcare professionals for purpose of sales promotion.
13.2.1 Cash: Payments in cash or cash equivalents (such as gift certificate) must not be offered to healthcare professionals unless the same is as payment for bona fide services rendered.
13.2.2 Personal Gifts: Gifts for the personal benefit of the healthcare professionals (including, but not limited to, music CDs, DVDs, sporting or entertainment tickets, electronic items) must not be provided or offered.
13.2.3 Items of Medical Utility: Items of medical utility may be offered or provided, provided that such items are of modest value, do not exceed RM500.00 and are beneficial to the provision of medical services and for patient care. For medical educational material, e.g. journals, textbook & models, the limit is up To RM1,000.00.
13.2.4 Cultural Courtesy: An inexpensive cultural courtesy of not more than RM 250.00 may be given on an infrequent basis to healthcare professional in acknowledgement of significant national, cultural or religious occasions.
13.3 Promotional aid (and/or Brand Reminders) whether related to a particular product or of general utility, may be distributed provided the promotional aids is of small value (not more than RM 250.00) and relevant to the practice of medicine or pharmacy or of benefit to patient care. For medical educational materials e.g. journals, text books & models, the limit is up to RM 1,000.00.
13.4 Entertainment: No stand-alone entertainment or other leisure or social activities should be provided or paid for by member companies. At Events, entertainment of modest nature which is secondary to refreshments and/or meals is allowed.
Invitations to such meetings should not be extended to spouses unless they themselves are practicing members of the medical or allied profession.
14. Marketing Research
14.1 Methods employed for marketing research must never be such as to bring discredit upon or to reduce confidence in the pharmaceutical industry. This provision applies whether the research is carried out directly by the company concerned or by organisation acting on the company’s behalf.
14.2 Questions intended to solicit disparaging references to competing products or companies must be avoided.
14.3 Any incentives offered to the informants should be kept to a minimum and be commensurate with the work involved.
14.4 The identity of an informant must be treated as confidential, unless he has specifically agreed otherwise.
Information provided as distinct from the overall results of the research must not be used as the basis upon which a subsequent approach is made to that informant for the purpose of sales promotion.
15. Relations with the general public and lay communication media
15.1 Request from individual members of the public for information or advice on personal medical matters must always be refused and the inquirer recommended consulting his or her own doctor.
15.2 Promotional material issued for distribution or display anywhere to which the public has access must not include any message likely to arouse a demand for any Scheduled Poisons.
15.3 Patient education leaflet related to disease conditions must be fair, unbiased and not contain any product name and restrict reference to the company providing the leaflet to its name & logo. Therapeutic class/option or chemical name of drug or generic class is allowed, as long as it is unbiased.
15.4 Leaflets for instruction in the use of a specific medicine containing reference to the name and illustration of the product must only be provided to the public by a medically qualified practitioner or health care professional.
16. Valid patent rights
All valid patent and intellectual property rights of products and processes must be respected by members.
17. Company Procedures and Responsibilities
Companies should establish and maintain appropriate procedures to ensure full compliance with relevant codes and applicable law and to review and monitor all of their promotional activities and materials. A designated company employee, with sufficient knowledge and appropriate scientific or healthcare qualifications should be responsible for approving all promotional communications. Also, a senior company employee could be made responsible, provided that scientific advice is taken.
18. Public Sector Relationships and Procurement
$118.1The decision-making process by Member Companies and the Government during and including the government procurement process, through bidding or any other procedure of government procurement must be professional and ethical. There should be no attempt by Member Companies to exert inappropriate influence.
$118.2Member Companies must provide accurate and balanced information in all dealings with the Government
$118.3Member Companies and Government officials should ensure that their relationship complies with this Code and also with Government ethics rules and procedures
19. Clinical Research and Transparency
Companies are committed to the transparency of clinical trials which they sponsor. It is recognized that there are important public health benefits associated with making clinical trial information more publicly available to healthcare practitioners, patients, and regulatory agencies. Such disclosure, however, must maintain protection for individual privacy, intellectual property and contract rights, as well as conform to legislation and current national practices in patent law.
19.2 Distinct from Promotion
All human subject research must have a legitimate scientific purpose. Human subject research, including clinical trials and observational studies, must not be disguised promotion.
20. Company Donations for Charitable Purposes
20.1As a demonstration of good corporate citizenship, Member Companies recognize their responsibility to support worthwhile activities both within and outside their communities:
20.1.1 Donations including donations in kind, may be provided to organisations and institutions involved in promoting activities such as artistic, charitable, cultural, community, educational, humanitarian, health, philanthropic, and sporting activities in accordance with applicable laws and regulations
20.1.2 Member Companies should ensure that such support is not undertaken solely for product promotional reasons, and is not directed solely for product promotion purposes.
20.1.3 Funding and donation in-kind should be directed to organisations and documented in a manner that outlines the nature of the donation provided.
20.1.4 Acknowledgement by the recipient organisation of such support should be restricted to appropriate recognition of support
20.1.5 Member Companies should ensure that there are no incentives to prescribe, recommend, purchase, supply or administer a product based on financial support and that nothing should be offered or provided which would interfere with the independence of a healthcare professional’s prescribing or dispensing practices
21. Interactions with Patient Organization and NGOs
21.1 Member Companies should respect the autonomy of patient organisations and their independence
21.2 Support from Member Companies must not be conditional on the promotion of a specific medicine