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?
In 2007, the Austrian Pharmaceutical Industry Association (Pharmig) published its first code of conduct (Pharmig Code of Conduct), which is strongly oriented towards the AMG. All members who join Pharmig must comply with this code of conduct.
Non-members can voluntarily comply with the Pharmig Code of Conduct.
With regard to the Pharmig Code of Conduct, it is generally to be seen as a contractual self-regulation.
There are four main self-regulatory deontological codes, which contain specific provisions on pharmaceutical advertising. They are identified on the basis of the issuing professional bodies:
(i) Pharma.be, a professional association of innovative pharma/EFPIA companies based in Belgium
(ii) BACHI (the Belgian Association for the Consumer Healthcare Industry), focusing on over-the-counter medicines and healthcare products sold in pharmacies
(iii) Mdeon, a common platform between different professional associations and healthcare professionals/organisations
(iv) FeBelGen, a professional association of Belgium-based generic medicine companies
The four abovementioned self-regulatory deontological codes are only binding on the members of the respective professional associations.
It is a separate set of binding rules that can be enforced against the members by imposing various corrective, supervisory and financial sanctions in case of violation of the code.
Yes, two associations – the Innovative Pharmaceutical Industry Association (representing manufacturers of innovative medicines) and the Pharmaceutical Manufacturers Association (representing manufacturers of generic medicines) – have approved the Code of Ethics for Pharmaceutical Marketing (hereinafter referred to as the Code of Pharmaceutical Ethics).
The Code of Pharmaceutical Ethics applies to pharmaceutical companies that supply medicines to the Lithuanian market. This Code regulates the ethics of marketing of medicines (in more detail than regulated by law). The Code regulates the relationship between pharmaceutical companies and healthcare professionals, and medical institutions, companies and pharmacists, companies and patients, companies and governmental authorities, defines issues of pharmaceutical support, ethics of sales promotion actions, etc.
The Code of Pharmaceutical Ethics does not have a binding legal force as a law or an order of the Minister of Health. It is a self-regulatory document that is binding only on members of associations that have approved the Code of Pharmaceutical Ethics. Public authorities that control the advertising of medicinal products do not follow the provisions of this Code.
Yes, industry associations have issued several Codes of Practices applicable to the advertising of medicines:
- The Council of Ethics and Transparency of the Pharmaceutical Industry (“CETIFARMA”); i) The Code of Ethics and Transparency of the Pharmaceutical Industry; ii) The Code of Good Practices of Promotion (Code of GPP); and iii) The Code of Good Practices of Interaction of the Pharmaceutical Industry with Patient Organisations (“CGCPI”).
- The Nacional Advertisement Regulation Council (“CONAR”): i) Advertisement Ethics Codes (“AEC”); and ii) Sectorial Ethics Code (“SEC”).
- The Over the Counter Medicines Association (“AFAMELA”): AFAMELA Advertisement Ethics Code.
Such codes apply to the company’s member of the industry associations that issue each one of them, only the healthcare professionals working for members are subject to these codes.
The legal status of the self-regulatory codes is private agreement between the members of each association.
The independent and self-regulatory Advertising Standards Authority in Ireland (‘ASAI’) has published a Code of Standards for Advertising and Marketing Communications in Ireland (‘ASAI Code’) that applies to advertising across the industries. If the advertisements are on radio or television channels, the General Commercial Communications Code (‘BAI Code’) of the Broadcasting Authority of Ireland applies.
The Irish Pharmaceutical Healthcare Association (‘IPHA’) has published two codes of practice specifically relating to the advertising of medicines; Code of Practice for the Pharmaceutical Industry (‘Pharmaceutical Industry Code’) and Code of Standards of Advertising Practice for the Consumer Healthcare Industry (‘Consumer Healthcare Code’).
The Association of Pharmaceutical Manufacturers of Ireland (‘APMI’), is an industry body representing manufacturers of generics and it has published the APMI Code of Practice on Advertising of Medicinal Products which is a code similar to the IPHA codes and based on the 2007 Regulations and the EC Directive 2001/83/EC as amended. For the purpose of this article, the IPHA Codes will be considered rather than the AMPI Code to avoid repetition and because the IPHA Codes are more detailed and apply to a wider audience.
The Pharmaceutical Industry Code and Consumer Healthcare Code applies to those who are voluntarily members of the IPHA. It is usually companies who are members of the IPHA. Individuals, such as healthcare professionals, can make an application on behalf of an organisation (for example a company or a public sector organisation) to become members of the IPHA.
The ASAI Code must be adhered to by members of the ASAI. It is generally companies that become members of ASAI. The BAI Code applies to Irish broadcasting services operating under contract with the Broadcasting Authority of Ireland or established under Irish statute.
The self-regulatory codes do not apply to everyone automatically. Only members of ASAI and/or IPHA are required to abide by the respective codes. Membership to ASAI and IPHA is voluntary. It is up to companies to ensure compliance with the codes, but the ASAI and IPHA can investigate advertisements which are suspected not to be in compliance and make directions. The Health Products Regulatory Authority (‘HPRA’) is a regulatory body which protects and enhances public and animal health by regulating medicines, medical devices and other health products. The HPRA regulates the advertising of human medicinal products in Ireland.
APIFARMA – Portuguese Pharmaceutical Industry Association approved the following codes, which are applicable to Pharmaceutical Companies that are associated members:
- Code of Ethics for Promotion Practices of the Pharmaceutical Industry and Interaction with Healthcare Professionals and Institutions, Organisations or Associations Comprising Healthcare Professionals
- Code of Conduct Governing the Relations Between Pharmaceutical Industry and Patients´ Organisations
- Code of Good Practice for Communication
Such codes are solely binding for the respective associated members.
The German Association of Researching Pharmaceutical Manufacturers ["Verband Forschender Arzneimittelhersteller e.V. – VFA"] has founded the Association of Voluntary Self-Regulation for the Pharmaceutical Industry ["Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V. – FSA"] which established the FSA codex also regulating the advertising on medicines.
The FSA codex only applies to member companies of the VFA and FSA.
The FSA Codex is binding only for member companies of the VFA and FSA. It is no law and does therefore not need to be observed by non-members. This has also been confirmed by the German Federal Court of Justice ("Bundesgerichtshof – BGH"). Still, in some instances, courts relied on the more detailed provisions of the FSA Codex in order to interpret the more general statutory requirements under the HWG, the UWG and the anti-bribery provisions in the German Criminal Code ("Strafgesetzbuch – StGB").
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.
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
- 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.
Yes. Rules on advertising of medicinal products are stated in a self-regulatory code issued by the Swedish industry trade association, the Swedish Association of the Pharmaceutical Industry (Sw. Läkemedelsindustriföreningen, ‘LIF’), called the Ethical rules for the pharmaceutical industry (‘LER’).
Further, other self-regulatory and codes of practice initiatives that are applicable to advertising in general also apply to the advertising of medicinal products, such as The International Chamber of Commerce's Advertising and Marketing Communications Code (‘ICC Rules’).
LER applies to LIF member companies and industry associations affiliated to LIF, i.e., the Association for Generic Pharmaceuticals and Biosimilars in Sweden (Sw. Föreningen för Generiska läkemedel och Biosimilarer, ‘FGL’), the Association of Smaller Life Science Companies (Sw. Innovativa Mindre Life Sciencebolag, ‘IML’), and the Association and forum for Clinical Research Organizations active in Sweden (Sw. Branschorganisationen för CRO-företag, ‘ASCRO’).
LIF member companies are by their membership bound on a contractual basis to comply with LER and decisions by LIF's two disciplinary bodies, the Information Examiner Committee (Sw. Informationsgranskningsnämnden, ‘IGN’) and the Information Practices Committee (Sw. Nämnden för bedömning av läkemedelsinformation, ‘NBL’). LIF member companies shall also ensure that their affiliate companies observe and comply with LER in the event of activities on the Swedish market or targeted at the Swedish market. They are further obliged to enjoin their business partners to comply with LER in licence agreements and the like. The same applies to the members of FGL, IML and ASCRO.
Further, LER is widely recognised by the pharmaceutical industry as a whole (i.e., also by non LIF members) and although not legally binding, LER is applied by courts as an expression of fair and ethical marketing.
The following self-regulatory instruments may apply in Switzerland:
- The Code of Conduct of the Pharmaceutical Industry in Switzerland of 4 December 2003, revised on 6 September 2013 (“Pharma Code”) and the Code of Conduct of the Pharmaceutical Industry in Switzerland on Cooperation with Healthcare Professional Circles and Patient Organizations (“Pharma Cooperation Code”), are applicable to advertising and benefits.
- The Collaboration between the Medical Profession and Industry Guidelines (2013 version) and the Code of Ethics of the Swiss Medical Association (“FMH”), which both contain provisions concerning the acceptance of benefits by healthcare professionals, are also applicable to the acceptance of benefits.
The Pharma Code applies to all its signatories, which means a large number of pharmaceutical companies in Switzerland (see list published on https://en.scienceindustries.ch/involvement/pharma-code/pharma-code-signatories).
The Code of Ethics of the FMH is applicable to doctors who are members of the association, that is to say a large number of doctors in Switzerland. The Collaboration between the Medical Profession and Industry Guidelines has been incorporated to the Code of Ethics of the Swiss Medical Association, which means that it applies to the same persons.
Self-regulatory codes are private rules that are binding for their signatories only. Therefore, in case of contradiction between self-regulatory codes and the law, the latter shall prevail.
However, in case of gaps in the law, principles provided by private rules may be used to help interpreting the law.
There is no specific self-regulatory code on the advertising of medicines that is applicable to the whole industry. However, there are codes of conduct adopted by two main trade associations that govern various promotional and marketing activities of their members. These associations are the Pharmaceutical Research and Manufacturers Association (the "PReMA") and the Thai Pharmaceutical Manufacturers Association (the "TPMA")
These codes do not have legal effect Violation of the codes of practice by members of the associations may lead to sanctions, such as suspension of membership and /or some fines.
A number of self-regulatory codes of industry bodies regulate the advertising of medicines. The Codes of Practice essentially repeat the law, however in several respects, they go beyond. The majority of pharmaceutical companies operating in the UK opt to comply with a self-regulatory code.
The Association of the British Pharmaceutical Industry Code of Practice (“ABPI Code”), administered by the Prescription Medicines Code of Practice Authority (“PMCPA”), governs the advertising of prescription only medicines (“POM”). The ABPI Code is updated regularly and the latest version came into operation on 1 January 2019.
The Proprietary Association of Great Britain (“PAGB”) Consumer Code governs the advertising of over-the-counter medicines (“OTCMs”) to the general public. All advertising aimed at consumers must be submitted to PAGB for screening and PAGB approval must have been given prior to its release into the public domain. The PAGB Professional Code governs the advertising of OTCMs to persons qualified to prescribe or supply. The PAGB Codes apply to advertising for all OTCMs regardless of their route to market approval or traditional herbal medicines registration.
The Advertising Standards Authority ("ASA") sets the general standards required of all advertising in the UK and administers the broadcast ("BCAP") and non-broadcast ("CAP") advertising codes. ASA is an independent body, responsible for ensuring that the system operates in the public interest. In addition to the general requirements, Section 12 of the CAP Code contains provisions specifically relating to medicines; the BCAP Code contains similar rules in Section 11. It should be noted that the CAP Code does not apply to health claims in materials aimed at health professionals.
The ASA proactively checks for adherence to the required standards and has dealt with a number of cases relating to the advertising of medicines, particularly Botox products and homeopathic medicines.
All companies which are ABPI members are required to comply with the ABPI Code and accept the jurisdiction of the PMPCA as a condition of membership. The PMCPA, which operates independently of the ABPI, administers the ABPI Code and provides advice, guidance and training.
In addition, most of the other companies operating in the UK which are not members of the ABPI give their formal agreement to abide by the ABPI Code in their promotional activities. The ABPI Code covers the medical industry’s activities only, but those interacting with industry such as public relations agencies have a responsibility to ensure that their interactions comply with relevant legal requirements, and are asked to follow the ABPI Code where relevant and not to make requests that would breach the ABPI Code.
It is a condition of PAGB membership that all members comply with the PAGB Codes both in letter and in spirit. The PAGB Consumer Code notes that materials written by a third party and which mention a company’s brands are regarded as advertisements, and it is the responsibility of the member company to ensure that such materials are “factually accurate, consistent with the relevant SPC(s) and fully compliant with the Code”.
Alleged breaches of the ABPI Code are referred to the PMCPA’s Code of Practice Panel, which has the power to impose fines and other sanctions if a breach of the Code is upheld. A decision of the PMCPA’s Code of Practice Panel may be appealed to the Code of Practice Appeal Board. Where a company is found in breach, it must give an undertaking (accompanied by details of the action taken) that the practice in question has ceased forthwith and that all possible steps have been taken to avoid a similar breach in future. Administrative charges are also payable. Case reports are published once cases are concluded.
Additional sanctions are imposed in serious cases, which can include the audit of a company’s compliance procedures, a requirement for the pre-vetting of future material, recovery of material from those to whom it has been given, the issue of a corrective statement or a public reprimand. A company may also be required to publish brief details of cases in the medical, pharmaceutical and nursing press if it was ruled that the company (i) breached clause 2 of the ABPI Code; (ii) had to issue a corrective statement or was the subject of a public reprimand; or (iii) is suspended or expelled from the ABPI.
The PAGB does not impose financial sanctions for a breach of the PAGB codes, but a company may be expelled from the PAGB for failure to comply. PAGB also runs a post-publication complaints system for advertising aimed at persons qualified to prescribe and supply. PAGB does not adjudicate on formal complaints about member companies’ consumer advertising, as it will have approved the advertising prior to publication, but these are handled as informal queries.
If a complaint filed with the ASA is upheld, the ASA asks the advertiser to withdraw or amend the advertising. Broadcasters are obliged, by a condition of their Ofcom licences, to enforce ASA rulings and not to run advertisements which breach the codes. Ofcom is able to levy fines and revoke licences in particularly serious cases of non-compliance. If non-broadcast advertisers do not comply with adjudications, CAP can issue an ‘Ad Alert’ to request those responsible for accepting ads for publication to consult CAP’s Copy Advice team before accepting any ads from the named advertiser. If advertisers do not co-operate with the self-regulatory system, the ASA can refer them to Trading Standards Services, which acts as a legal backstop in cases of repeated non-compliance. Publication of the results of adjudications on the ASA website can generate adverse publicity for those in breach of the codes, and persistent breaches can lead to disqualification from trade associations.
Ultimately, the system of self-regulation is supported by the MHRA, which has a clear role and acts on behalf of Health Ministers to protect public health by promoting the safe use of medicines. Complaints about advertising can be received by the MHRA and/or a self-regulatory body, and the MHRA works closely with these bodies and other statutory regulators to ensure a consistent approach on advertising standards. The Medicines Advertising Liaison Group provides a forum for cooperation.
The MHRA would not normally investigate cases where these are already under investigation by another self-regulatory body. It could, however, take action if serious public health concerns are raised or if self-regulation fails, for example in cases of repeated non-compliance. A Memorandum of Understanding sets out the relationship between the PMCPA process and the supervisory and enforcement function of the MHRA. The MHRA usually passes inter-company complaints referred to it on to the PMCPA, and may refer other complaints to the PMCPA with the complainant’s consent.
The MHRA has the power to issue notices requiring a person not to publish, or to cease publishing, an advertisement; if that person then publishes the advertisement in breach of the notice, he or she commits a criminal offence. There are also rules under which the publication of a corrective statement may be required. Advertising cases tend to be resolved informally and prosecutions are not common.
There is a self-regulation body and an arbitration procedure, but it is only applicable to members of the National Advertisers Association (ANDA).
It´d apply only to those companies and their employees engaged into the business of pharmaceutical related products and services member of ANDA
Like an arbitration clause, mandatory only to those who have committed themselves to resolve all disputes through a self-regulatory code.
Voluntary professional organizations, including the American Medical Association (“AMA”), the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and the Biotechnology Innovation Organization (“BIO”), provide additional guidance for health care professionals, drug manufacturers and research companies. For example, the AMA Code of Medical Ethics (https://www.ama-assn.org/delivering-care/ethics/code-medical-ethics-overview), which articulates the values physicians commit themselves to as members of the medical profession, offers guidance on advertising practices. Further, in October 2018, PhRMA’s board of directors adopted measures to enhance its Guiding Principles on Direct to Consumer Advertisements about Prescription Medicines (https://www.phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/PhRMA_Guiding_Principles_2018.pdf). Although not laws, these self-regulatory codes can have important legal relevance.
On June 1, 2019, the Advertising Self-Regulatory Council merged into BBB National Programs, Inc., a non-profit organization that replaced the Council of Better Business Bureaus as administrator of national self-regulatory programs, including the National Advertising Division (“NAD”). The NAD is an industry self-regulatory body charged with hearing and rendering decisions in advertising disputes, often as a more efficient alternative to litigation, and seeks to ensure that claims made in national advertising are truthful, accurate and not misleading. Although its recommendations are not legally binding, the NAD may refer cases to the FTC, the FDA, or other authorities where appropriate.
Several self-regulatory codes of conduct cover aspects of medicines advertising in Australia. The Medicines Australia Code of Conduct (Medicines Australia Code) and the Australian Self-Medication Industry Code of Practice (ASMI Code) regulate the promotion of medicines by pharmaceutical companies and aspects of their interaction with the public more broadly. Additionally, the Australia Association of National Advertisers Code of Ethics (AANA Code) provides some general principles which apply to all types of advertising and promotion.
Medicines Australia is the Australian industry body representing producers of prescription medicines. Its membership includes the majority of research-driven pharmaceutical manufacturers in Australia. Although the Medicines Australia Code does not have legal force, all members are required to abide by its provisions. Medicines Australia may also refer conduct to the Therapeutic Goods Administration (TGA) or Australian Competition and Consumer Commission (ACCC) where appropriate.
The ASMI Code is administered by Consumer Healthcare Products Australia (CHPA), the industry body for manufacturers of all non-prescription healthcare products, including over the counter (OTC) medicines. Similar to the Medicines Australia Code, all members of CHPA must abide by the ASMI Code and various sanctions, including cessation of conduct, remedial action and fines may be imposed for breaches.