| Topic | Details |
| Relevant statutory law(s) |
Therapeutic Goods Act 1989 (Cth), Therapeutic Goods Regulations 1990 (Cth), Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (Cth), and Health Practitioner Regulation National Law (as implemented by each Australian state and territory) |
| Industry code(s) of conduct |
Medicines Australia’s Code of Conduct (19th Edition, Version 2) (MA Code of Conduct), which provides a principles-based framework for appropriate and ethical decision making by pharmaceutical companies in Australia when promoting prescription medicines and interacting with, inter alia, HCPs. Medicines Australia is an independent body, and membership is voluntary. However, any advertisement or promotion of prescription medicines in Australia must comply with the MA Code of Conduct (this is included as a condition of marketing approval in a letter provided to the sponsor when a prescription medicine is included on the Australian Register of Therapeutic Goods (ARTG)). Otherwise, non-members need not comply with the MA Code of Conduct. |
| Other | Not applicable |
| Topic | Details |
| Relevant statutory law(s) |
Pharmaceutical Act (Arzneimittelgesetz) |
| Industry code(s) of conduct | PHARMIG Code of Conduct (amended version valid and applicable from 1 July 2020) |
| Other | Not applicable |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Legislative Decree No. 21 of 2015 concerning Private Health Facilities Resolution No. 48 of 2020 concerning Medical Devices and Products' Quality Control |
| Industry code(s) of conduct |
National Health Regulatory Authority ("NHRA") Code of Professional Conduct (2020) NHRA Continuing Professional Development Regulations Decision No. 10 of 2015 to issue NHRA disciplinary committees for health professionals |
| Other |
| Topic | Details |
| Relevant statutory law(s) |
Belgian Law of 25 March 1964 on medicinal products Belgian Act of 18 December 2016 on other provisions concerning health (so-called Sunshine Act) Belgian Royal Decree of 14 June 2017 implementing the Sunshine Act Belgian Royal Decree of 23 November 2006 Belgian Royal Decree of 10 June 2006 |
| Industry code(s) of conduct | |
| Other | Not applicable |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Brazilian Clean Company Act – BCCA (Law No. 12,846 of 01 August 2013) Brazilian Criminal Code (Decree Law No. 2,848 of 7 December 1940) Law No. 8,112 of 11 December 1990 Brazil's National Health Surveillance Agency – Anvisa |
| Industry code(s) of conduct |
Association of the Pharmaceutical Research Industry - INTERFARMA Code of Conduct Union of the Industry of Pharmaceutical Products - SINDUSFARMA Code of Ethics and Conduct Association of the Industry of Health Products for Selfcare - ACESSA Code of Conduct |
| Other | Not applicable |
| Topic | Details |
| Relevant statutory law(s) |
Not applicable |
| Industry code(s) of conduct |
Innovative Medicines Canada (IMC) Code of Ethical Practices (Annotated Version, 2022) and Note For Guidance On Virtual Interactions With Healthcare Professionals. Canadian Generic Pharmaceutical Association (CGPA) Code of Marketing Conduct Governing the Sale of Generic Pharmaceutical Products in Canada (effective April 1, 2019). Medtech Canada Code of Conduct and Guidance for Meals and Travel (January 2023). |
| Other | Not applicable |
| Topic | Details |
| Relevant statutory law(s) |
There is no current legislation with regards to hospitality offered by pharmaceutical companies engaging or interacting with HCPs. |
| Industry code(s) of conduct |
The Pharmaceutical Innovation Chamber (“CIF” by its Spanish acronym), which is a professional association of innovative pharmaceutical companies, holds a Code of Good Practices (the “Code”), in line with the Code of Good Practices of IFPMA. In addition, the Industrial Association of Pharmaceutical Laboratories (“ASILFA” by its Spanish acronym) has an Ethics and Good Practice Regulations. |
| Other | Not applicable |
| Topic | Details |
| Relevant statutory law(s) |
Criminal Law of the People's Republic of China Anti-unfair Competition Law of the People’s Republic of China Law of the People’s Republic of China on Healthcare Professionals |
| Industry code(s) of conduct |
Chinese Medical Doctor Association R&D-Based Pharmaceutical Association Committee Code of Practice (2022) (RDPAC Code)(for member companies only, which include around 46 international pharmaceutical companies that have operations in China) Code of Ethics on Interactions with Health Care Professionals in China (AdvaMed China Code)(for member companies only, which include around 30 international pharmaceutical and medical device companies that have operations in China) |
| Other |
Announcement of the National Medical Products Administration on Issuing the Administrative Measures for the Record-filing of Pharmaceutical Representatives (for Trial Implementation) |
| Topic | Details |
| Relevant statutory law(s) |
Article 17 from Law 1751 of 2015. Article 133 from Law 1474 of 2011. Both Law 1751 of 2015 and Law 1474 of 2011 expressly forbid the promotion or granting of any sort of benefits or gifts to health care professionals and workers that are part of the Health Social Security General System (Sistema General de Seguridad Social en Salud). This includes the HCP that provide services within (i) the mandatory health plan, (ii) insurances and (iii) prepaid medical plans. Both cash and kind payments are covered by this prohibition. Furthermore, this ban is specifically addressed to the pharmaceutical companies, manufacturers, distributors, and suppliers of drugs or medical devices, equipment, inputs or any equivalent. Resolution 2881 of 2018 issued by the Ministry of Health and Social Protection. Despite the abovementioned prohibitions, the Government has acknowledged that this kind of practices are common in the health-related industries, and as such they cannot be forbidden per se, but it is needed to have a law that specifically regulates the conduct. Therefore, the Ministry of Health issued Resolution 2881 of 2018, by means of which it created a registry that seeks to collect information related to payments made by pharmaceutical companies to participants of the health sector as transferences of value (Transferencias de Valor). This registry called Registry of Valuable Transfers in the Public Sector (Registro de Transferencias de Valor en el Sector Salud, hereinafter "RTVSS") has the purpose of improving transparency on the health industry and providing information to further stablish laws, regulation and policies to improve it. The amounts of transfers mandatory for registry will be shown below. The Colombian Criminal Code (Law 599 of 2000) includes some crimes related to corruption that might be applicable to a lesser degree:
If one of the individuals is a public servant, then other crimes might be applicable.
Chapter XIII of the Legal Basic Circular Issued by the Superintendency of Companies. The Superintendency of Companies issued on 9 August 2021 the External Circular No. 100-000011 that complements the Chapter XIII of the Legal Basic Circular and establishes administrative instructions and recommendations aimed at the preparation and implementation, as a good practice, of good corporate governance and of effective corporate transparency and business ethics programs (Programa de Transparencia y Ética Empresarial – PTEE) that will allow the entities subject to the supervision of the Superintendency, to prevent and mitigate the risk of transnational bribery and corruption. In particular, companies in the pharmaceutical sector whose economic activity is one of those mentioned in the Circular and which, as of 31 December of the immediately preceding year, had obtained Total Revenues equal to or greater than 3,000 SMMLV (approximately USD73,000) or Total Assets equal to or greater than 5,000 SMMLV (approximately USD122,000), are obliged to implement the PTEE. Obligated companies that fail to comply with the provisions of the aforementioned Chapter could be exposed to the imposition of administrative sanctions, without prejudice to the administrative liability that arises for legal entities that carry out any act of transnational bribery (Law 1778 of 2016, Article 2). |
| Industry code(s) of conduct |
AFIDRO’S Code of Ethics of 2022 (Asociación de Laboratorios Farmacéuticos de Investigación y Desarrollo) (Hereinafter "AFIDRO"). ANDI’s (Businessmen National Association) (Hereinafter "ANDI") Chamber of Pharmaceutical Industry Code of Ethics and Transparency of 2016. ANDI's Chamber of Medical Devices and Health Supplies Code of Ethics of 2020. |
| Other |
Pact for the Transparency and Integrity of the Pharmaceutical Sector in Colombia. This is an anti-corruption pact signed by members of ANDI and AFIDRO, as well as the Association of Pharmaceutical Industries in Colombia-ASINFAR (Asociación de Industrias Farmacéuticas en Colombia). It was signed with the purpose of fighting corruption in the pharmaceutical industry. This pact intends to create or straighten their current codes of ethics and protocols. |
| Topic | Details |
| Relevant statutory law(s) |
Main legal source of medicine law area in the Republic of the Croatia is the Croatian Medicinal Products Act (Cro. Zakon o lijekovima, Official Gazette of the Republic of Croatia No. 76/2013., 90/2014., 100/2018. – "Act"). With regard to advertisements of medical products, Articles 182 et seq. empower the Croatian Health Minister to enact an ordinance which will regulate the scope in question in detail. The key legal source of the subject matter at hand is therefore the Croatian Ordinance on the manner of advertising medicines (Cro. Pravilnik o načinu oglašavanja o lijekovima, Official Gazette of the Republic of Croatia No. 43/2015. – "Ordinance"). The English version of the Act is available online (whereby we note that the available version may not up to date). There is no (reliable) English version of the Ordinance available. |
| Industry code(s) of conduct |
Code Of Conduct Of Innovative Pharmaceutical Companies in interactions with healthcare professionals, healthcare organizations and patient organizations (Code) adopted by the General Assembly of the Innovative Pharmaceutical Initiative (Cro. Inovativna farmaceutska inicijativa). The English version of the Code is available online. |
| Other | Not applicable |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Act No. 40/1995 Coll., on the regulation of advertising, as amended (40/1995 Coll.) |
| Industry code(s) of conduct |
Codes of conduct binding only on the members of the respective pharmaceutical industry associations, e.g.: |
| Other | Guidance (i.e. non-binding recommendation) UST-16 (version No. 2) issued by the State Institute for Drug Control (UST-16) |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Danish Medicines Act Executive order 849/2021 On Advertising for Medicinal Products |
| Industry code(s) of conduct | The Pharmaceutical Industry’s Code of Practice on Promotion etc., of Medicinal Products aimed at Healthcare Professionals (The Promotion Code) |
| Other |
The Pharmaceutical Industry’s Code of Practice on Promotion etc., of Medicinal Products aimed at Healthcare Professionals (The Promotion Code) Guide 2022-04-20 No. 9400 on Advertising on Medicinal Products |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (hereinafter: "Directive") |
| Industry code(s) of conduct | |
| Other | Not applicable |
| Topic | Details |
| Relevant statutory law(s) |
The Finnish Medicines Act (395/1987) and Medicines Degree (693/1987), available in Finnish and Swedish at www.finlex.fi |
| Industry code(s) of conduct | |
| Other | Not applicable |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
|
| Industry code(s) of conduct |
|
| Other |
|
Please also see European Union.
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Legislative Decree 96/1973 Circular 27810/2018 of the National Organization for Medicines Ministerial Decision ∆ΥΓ3α/Γ.Π 32221/2013 Circular Nr. 16251/2019 issued by EOF. Circular Nr. 37201/2020 concerning scientific events issued by EOF. |
| Industry code(s) of conduct |
According to EU practices along with law 4316/2014 article 66 paragraph 7a of the Hellenic Association of Pharmaceutical Companies (SFEE) Code of Ethics and the practices of the European Federation of Pharmaceutical Industries and Associations (EFPIA). |
| Other |
EOF Notice published in 2021 regarding advertising/informational material, accompanied by a relevant Q&A memo. Law 4715/2020 set up and allowed Paperless ePrescription, allowing the refilling of remote prescriptions (upon the discretion of the responsible doctor), thus reducing the required number of HCPs in healthcare facilities. |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) | |
| Industry code(s) of conduct |
The Hong Kong Association of the Pharmaceutical Industry Code of Practice (HKAPI Code of Practice) The Medical Council of Hong Kong Code of Professional Conduct for the Guidance of Registered Medical Professionals (Code of Conduct) Internal Guidelines of the Hospital Authority (for HCPs employed by public hospitals; not available to the public) |
| Other |
Acceptance of Advantages (Chief Executive’s Permission) Notice 2010 (the “Notice”) |
| Topic | Details |
| Relevant statutory law(s) | |
| Industry code(s) of conduct |
Code of Ethics for pharmaceutical marketing communications (only available in Hungarian) Code of Practice of the Association of Innovative Pharmaceutical Manufacturers (AIPM) |
| Other | Joint Committee for Ethical Communication (JCEC) Statement 1/2015 |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
The Ethics in Public Office Acts of 1995 and 2001 Criminal Justice (Corruption Offences) Act of 2018 Medicinal Products (Control of Advertising) Regulations, S.I. No. 541 of 2007 as amended Health and Social Care Professionals Act 2005 (as amended September 2022) |
| Industry code(s) of conduct |
Irish Pharmaceutical Healthcare Association (IPHA) Code of Practice for the Pharmaceutical Industry (IPHA Code) Health Products Regulatory Authority Code of Conduct (HPRA Code) Medical Council Guide to Professional Conduct and Ethics (Medical Council Guide) European Federation of Pharmaceutical Industries and Associations (EFPIA) Ethical Principles |
| Other | Not applicable |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Legislative Decree 219/2006 Royal Decree 1265/1934 |
| Industry code(s) of conduct | Farmindustria Code of Ethics |
| Other | Not applicable |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Act on Prohibition of Private Monopolization and Maintenance of Fair Trade Act against Unjustifiable Premiums and Misleading Representations |
| Industry code(s) of conduct |
Fair Competition Code (concerning Restriction on Premium Offers in Ethical Pharmaceutical Drugs Marketing Industry)("FCC") |
| Other | JPMA Promotion Code for Prescription Drugs (as amended) |
| Topic | Details |
| Relevant statutory law(s) |
Law of 11 April 1983 on market launch and advertising of proprietary medicinal products and prefabricated medicines, as amended The Grand-Ducal Regulation of 15 December 1992 on market launch of medicinal products, as amended On medical devices: Law of 16 January 1990 on medical devices, as amended The amended Grand-Ducal Regulation of 5 February 1993 on active Implantable medical devices The amended Grand-Ducal Regulation of 11 August 1996 on medical devices The amended Grand-Ducal Regulation of 24 July 2001 regarding in vitro diagnostic medical devices |
| Industry code(s) of conduct |
Code of Conduct issued by the Luxembourg Pharmaceutical Association |
| Other | Not applicable |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
General Health Law (Ley General de Salud) and relevant guidelines and regulations for sanitary and/or publicity purposes, among others |
| Industry code(s) of conduct |
Codes of Good Practices of the Pharmaceutical Industry in Mexico (Códigos de Buenas Prácticas de la Industria Farmacéutica en México) Code of Good Practices for Promotion (Código de Buenas Practicas de Promoción) Both issued by the CETIFARMA (Board of Ethic and Transparency of the Pharmaceutical Industry in Mexico) (Consejo de Ética y Transparencia de la Industria Farmacéutica en México), available online. |
| Other | No specific rules |
| Topic | Details |
| Relevant statutory law(s) |
Dutch Medicines Act (Geneesmiddelenwet) Policy Rules Financial Inducement Dutch Medicines Act (Beleidsregels gunstbetoon Geneesmiddelenwet) |
| Industry code(s) of conduct |
Code of Conduct Pharmaceutical Advertising (Gedragscode Geneesmiddelenreclame) |
| Other | Not applicable |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) | |
| Industry code(s) of conduct |
Medicines New Zealand Code of Practice Medical Council of New Zealand 'Statement on Doctors and health related commercial organisations'. New Zealand Medical Association Code of Ethics. Standards and Guidance for Pharmacist Prescribers Nursing Council of New Zealand Code of conduct for Nurses Medical Technology Association of New Zealand Code of Ethics (represents companies that develop, produce, manufacture, and market medical products, technologies and related services and therapies) Other health professions/industries have particular codes, not listed here.
|
| Other |
Not applicable |
| Topic | Details |
| Relevant statutory law(s) |
The Norwegian Health Personnel Act Medicinal Products Act of April 12, 1992 no 132 (Medicinal Products Act) Regulation on HCPs availabilty to receive gifts of 29 August 2005 no. 941 |
| Industry code(s) of conduct |
The Association of the Pharmaceutical Industry (LMI) industry rules |
| Other |
| Topic | Details |
| Relevant statutory law(s) | |
| Industry code(s) of conduct |
INFARMA Criteria of events assessment PASMI Ethics Code (currently not available online) |
| Other | Not applicable |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Decree-Law 176/2006 of 30 August (as amended) on the legal framework of medicinal products for human use, available here. Decree-Law 145/2009 of 17 June (as amended) on the rules to which research, manufacture, marketing, putting into service, survellaince and advertising of medical devices and their accessories must conform, available here. Decree-Law 5/2017 of 6 January on general principles of medicinal products and medical devices advertising, available here. Order 1542/2017 issued by the Secretary of State for Health, available here. Order 5657/2017 issued by the Secretary of State for Health, available here. |
| Industry code(s) of conduct |
APIFARMA’s Code of Ethics for promotion practices of the pharmaceutical industry and interaction with healthcare professionals and health organizations, available here. APIFARMA’s Code of Conduct governing the relations between the pharmaceutical industry and patients’ associations, patients advocates, patients experts, patients and caregivers, available here. APIFARMA’s Communication and Public Relations in the Pharmaceutical Industry - Code of Good Practice for Communication, available here. APORMED’s Code of Good Commercial Practices, available here. |
| Other | INFARMED's Information Circulars |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Pharmacology Professions, Intermediaries and Agents of Pharmaceutical Factors Law No. 3 of 1983 Registration of Pharmaceutical Companies and their Products Law No. 1 of 1986 Regulating Medical Treatment and Health Services within the State Law No. 7 of 1996 Council of Healthcare Practitioners Circular No. 1 of 2019-3 |
| Industry code(s) of conduct | |
| Other | Not applicable |
| Topic | Details |
| Relevant statutory law(s) | |
| Industry code(s) of conduct | ARPIM Code |
| Other | Not applicable |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Article 67.1. (parts 1 and 2) of the Federal Law No. 61-FZ dated April 12, 2010 "On Circulation of Pharmaceuticals" ("Pharmaceuticals Law") |
| Industry code(s) of conduct | Not applicable |
| Other | Not applicable |
| Topic | Details |
| Relevant statutory law(s) |
Law of the General Food and Drug Authority 13/02/2007 |
| Industry code(s) of conduct |
Guideline For Good Clinical Practice (GCP) E6(R2) Drug Master File: Guidance for Submission Guidance for Priority Review of Product Registration Medical Devices and Supplies Regulation Regulations of Tourism Law See sfda.gov.sa and mt.gov.sa. |
| Other | Not applicable |
| Topic | Details |
| Relevant statutory law(s) |
Act No. 362/2011 Coll. on medicinal products and medical devices as amended ("Act on medical products") |
| Industry code(s) of conduct |
Code of conduct of the Association of the Innovative Pharmaceutical Industry ("AIFP Code of Conduct") Code of Ethics of Association of Suppliers of Drugs and Medical Devices ("ADL Code of Conduct") Code of Ethics of Association for Generic and Biosimal Drugs ("GENAS Code of Conduct") |
| Other | Not applicable |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Slovenian Medicinal Products Act (Zakon o zdravilih; ZZdr-2), available in Slovene and English* * The translation in English is not up-to-date with the latest Medicinal Products ActSlovenian Rules on advertising of medicines (available in Slovene) (Pravilnik o oglaševanju zdravil) |
| Industry code(s) of conduct |
Code on cooperation with healthcare professionals (Kodeks sodelovanja z zdravstvenimi delavci – Kodeks OSZRp) of the Forum of International Research and Development Pharmaceutical Companies (Mednarodni forum znanstvenoraziskovalnih farmacevtskih družb, GIZ) (hereinafter the "Code") |
| Other | Not applicable |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Spanish Royal Decree 1/2015 of 24 July, approving the consolidated text of the Law on Guarantees and Rational Use of Medicines, available at (BOE-A-2015-8343 Real Decreto Legislativo 1/2015, de 24 de julio, por el que se aprueba el texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios.) |
| Industry code(s) of conduct |
FarmaIndustria Code available at Sistema de Autorregulación de Farmaindustria (codigofarmaindustria.org) |
| Other | Not applicable |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Interactions with HCPs is not regulated in Swedish law. General rules on anti-bribery could apply which are regulated in the Swedish Penal Code (Sw. Brottsbalken). The Swedish Anti-Corruption Institute (Sw: Institutet Mot Mutor “IMM”), a non-profit organization, has issued the “Code to prevent Corruption in Business”, a self-regulation code which can be viewed as a supplement to Swedish legislation on bribery. The code applies to all businesses and is not specific to the pharmaceutical industry. |
| Industry code(s) of conduct |
Members of the trade association Läkemedelsindustriföreningen (Lif) are bound by the Ethical Rules for the Pharmaceutical Industry. |
| Other | Not applicable. |
Please also see European Union.
| Topic | Details |
| Relevant statutory law(s) |
Federal Law No. 8 of 2019 On Medical Products, the Profession of Pharmacy and Pharmaceutical Facilities (as amended by Federal Law No. 4 of 2022 and Cabinet Decision 111 of 2021). Ministerial Resolution No. 1448 of 2017 On Adoption of Code of Ethics and Professional Conduct for Health Professionals. Ministerial Decision No. 1412 of 2017 On the Approval of the Code of Practice of the Marketing and Trading of Medical Products. |
| Industry code(s) of conduct | UAE Ministry of Health & Prevention ("MOHAP") Code of Ethical Practices for the Promotion and Distribution of Medical Products. ("MOHAP COE"). |
| Other | No specific rules. |
| Topic | Details |
| Relevant statutory law(s) |
The Human Medicines Regulations 2012 Please also see the Global Compliance Guide as it relates to the European Union. Following Brexit, EU legislation as it applied to the UK on 31 December 2020 is now a part of the UK’s domestic legislation. The UK Bribery Act 2010 |
| Industry code(s) of conduct |
The ABPI Code of Practice (ABPI Code) – this code reflects the statutory requirements concerning the engagement of healthcare professionals, whilst also incorporating additional "best practice" guidance from the Blue Guide (see below) and from the ABPI itself. Given its scope, the ABPI Code is the primary source of guidance in this area. PAGB Code of Practice (PAGB Code) – applies to advertising of over-the-counter medicines, aimed wholly or mainly at persons qualified to prescribe or supply (and people working for them), where the object of the advertising is to influence sales and/or recommendations to the public. GMC Code of Good Medical Practice (GMC Code) – sets out the standards expected of HCPs themselves in the UK when it comes to accepting/receiving hospitality and other such benefits from industry players. Blue Guide (Advertising and Promotion of Medicines in the UK) (Blue Guide) – explains the provisions and requirements of UK legislation concerning advertising and promoting medicines. |
| Other | Not applicable. |
| Topic | Details |
| Relevant statutory law(s) |
Federal Laws & Implementing Regulations, & Government-Issued GuidanceVarious federal laws and implementing regulations may be implicated in connection with providing anything of value to healthcare professionals ("HCPs"), under laws designed to prevent fraud, waste, and abuse ("FW&A") in government healthcare programs. Enforcement action and settlement history provide insight on the federal government’s perspective on these matters. The federal government also issues guidance that may provide insight on the way it views transfers of value to HCPs. Examples: Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)): Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h) and Implementing Regulations (42 C.F.R. Part 403, Subpart I): Federal (Government-Issued) Guidance: State Laws & Implementing RegulationsFW&A Laws Including Any Payor Statutes: Marketing and Gift Laws:
Other Points to Consider (Not Addressed in this Survey): In some cases even cities (for example, the City of Chicago) may issue requirements governing marketing to HCPs;[9] and there may be other state laws applicable more broadly to gifts or other items of value (including hospitality) to state employees, with whom the life sciences industry may interact (for example, Louisiana). Further, healthcare professionals are governed by state professional licensure and related ethical requirements, the specifics of which may vary from state-to-state, and in addition the American Medical Association ("AMA") Code of Medical Ethics provides guidance regarding industry-provided gifts and subsidies for physicians. Further, healthcare institutions may have their own internal policies that prohibit or limit the receipt of hospitality. Footnotes
|
| Industry code(s) of conduct |
PhRMA Code on Interactions with Healthcare Professionals (last revised September 2019) AdvaMed Code of Ethics (effective January 1, 2020) |
| Other |
As explained, because a number of the standards cross-reference and incorporate others by reference, it is prudent to consider the landscape as a whole when approaching the US market. General Principle in the US: US government- and industry-issued guidance generally distinguish between two categories:
|
Argentina
| Topic | Details |
| Relevant statutory law(s) |
Law 16,463 Resolution of the Ministry of Health 627/2007 Disposition of the National Administration of Drugs, Food and Medical Technology (ANMAT) N°6516/2015 |
| Industry code(s) of conduct |
Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) This Code outlines the principles and general guidelines governing interactions between CAEME members and healthcare professionals (HCPs). CAEME is a private chamber comprised of multinational laboratories, and the provisions of this Code are mandatory solely for its members. The Code covers various topics concerning the interactions between HCPs and laboratories, including:
Local laboratories are primarily organized under a different chamber, CILFA, which does not impose these principles. |
| Other | Not applicable. |
Argentina
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
Argentinian Ministry of Health (AMH) National Administration of Drugs, Food and Medical Technology (ANMAT) |
| Competent authority/authorities enforcing the above code(s) of conduct |
Argentine Chamber of Medical Specialties (CAEME) |
| Competent authorities enforcing any other provisions indicated above | Not applicable. |
Argentina
| Topic | Detail |
| Restrictions on event locations (e.g., events abroad, touristic locations, mountain or beach locations during winter/summer season, etc) |
Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to Event Location: Companies that are members of CAEME cannot organize or sponsor events outside Argentina (international events) unless this makes more sense from a logistics and/or security viewpoint, such as that the majority of invited participants are foreigners and/or multiple countries participate or that a relevant resource or expertise that is the main purpose of the event is located abroad. If international events are organized or sponsored, in addition to the CAEME Code, member companies must also observe the specific provisions of the Codes of Practice of the country in which the event is held. |
Argentina
| Topic | Details |
| Restrictions or requirements regarding event venues (e.g., resorts, castles, SPAs, proximity to transport connections or centers with relevant medical expertise, etc) |
Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to Event Venue: All events should be held in an appropriate venue that is conducive to the scientific or educational objectives and the purpose of the event or meeting. Companies that are members of CAEME should avoid using luxurious venues. Hospitality must not include the sponsorship or organization of entertainment or leisure activities (such as sports events, music events or other). When companies that are members of CAEME organize or participate in events, this fact must be disclosed in all documents regarding the invitation as well as in any published paper, speech or document related to such event. Companies that are members of CAEME must duly document, pursuant to their internal procedures, any transfer of value, they directly or indirectly make to the healthcare system stakeholders. This includes, among other, fees paid for services provided, collaboration given for the organization of scientific and professional events, expenses for hospitality offered due to an event, comprising travel, registration, accommodation and meals expenses, and the provision of scientific or medical publications. |
Argentina
| Topic | Details |
| Restrictions or requirements regarding accommodation provided to HCPs (e.g. five star hotels, maximum number of nights, minimum duration of events, etc.) |
Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to Accomodation: Accomodation expenses must be reasonable and limited to the days on which the scientific or professional event is planned to be held. Accomodation cannot be extended beyond a reasonable period after the Event. Companies that are members of CAEME should avoid providing luxurious accomodations. Hospitality must not include the sponsorship or organization of entertainment or leisure activities (such as sports events, music events or other). |
Argentina
| Topic | Detail |
| Restrictions on air travel (e.g. economy class only; minimum flight duration for business class) |
Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to travel expenses: Payment of reasonable fees and reimbursement of out-of-pocket expenses related to the Events, including travel for speakers and moderators at meetings, conferences, symposia and similar scientific or professional events, is acceptable. Travel expenses must be reasonable and limited to the days on which the scientific or professional event is planned to be held. There are no specific rules or restrictions on air travel. |
| Restriction on train transportation (class; duration; etc.) |
The principles related to air travel also apply to train transportation. There are no specific rules or restrictions on train transportation. |
| Other restrictions regarding travel | Not applicable. |
Argentina
| Topic | Details |
| Limitation on providing meals (e.g. only refreshment for events lasting for half a day or more) |
Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to meal expenses: Payment of reasonable fees and reimbursement of out-of-pocket expenses related to the Events, including meals for speakers and moderators at meetings, conferences, symposia and similar scientific or professional events, is acceptable. Meal expenses must be reasonable and limited to the days on which the scientific or professional event is planned to be held. |
| Maximum value for meals (e.g., EUR 60) – please specify by meal (breakfast, lunch, dinner) where applicable | The principles related to meal expenses described in the first box, also apply to this point. |
| Restrictions on where meals can be provided? (e.g. no Michelin-starred restaurant) | The principles related to meal expenses described in the first box, also apply to this point. |
| Other restriction (e.g. no alcohol may be offered) | The principles related to meal expenses described in the first box, also apply to this point. |
Argentina
| Topic | Details |
| Rules applicable to family members travelling together with HCPs to the event location. |
Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to family members: Hospitality offered by companies that are members of CAEME should not be extended to persons other than HCPs. |
Argentina
| Topic | Details |
| Rules originally designed for traditional events (described in previous points) but applicable also to online conferences |
Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines related to traditional Events, which are also applicable to online conferences: When member companies organize or participate in events (including online Events), this fact must be disclosed in all documents regarding the invitation as well as in any published paper, speech or document related to such event. This includes any documents, papers or speeches published in the website platform running the Event. |
| Additional rules applicable specifically to online conferences (incl. communication / advertising rules in relation to events attended by multinational audience) | No specific rules. |
Argentina
| Topic | Details |
| Specific rules applicable to promotional events organized by/on behalf of MAH in comparison to independent scientific events described in previous points (incl. event location, venue, accommodation, transport, meals, family members, online conferences |
Events are neither legislated nor regulated by local authorities. The Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) described in previous points (incl. event location, venue, accommodation, transport, meals, family members, online conferences), apply also to Promotional Events. No medicinal product or therapeutic indication may be promoted prior to approval by the competent regulatory authority, ANMAT. At Promotional Events, any material and/or information related to medicinal products and their uses, sponsored by a company, should clearly indicate that it has been sponsored by such company. Whenever a member company finances, ensures, or directly or indirectly organizes the publication of promotional material related to Promotional Events, it should be expressly stated that such material and/or information is not presented as an independent editorial topic, and the sponsoring company should be included in a visible place. Information on medicinal products should be accurate and not misleading, precise, balanced, fair, objective and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned. Information should be based on an adequate evaluation of scientific evidence and clearly reflect that evidence; and it should not mislead by distortion, undue emphasis, omission or in any other way. Promotion should be supported by scientific studies and the qualities of the medicinal product and not by the weaknesses of competitors. Comparison will be acceptable provided it is objective, true and does not contain statements affecting the reputation of third parties. Comparisons must be drawn on analogous or comparable products and should have scientific backing in a publication. No gifts, bonuses, benefits in cash or in kind, or incentives may be given, offered or promised to healthcare professionals to induce prescription, recommendation, dispensation, supply, sale, administration or consumption of medicinal products. Gifts for the personal benefit of HCPs (including, but not limited to, entertainment CDs and/or DVDs, sports or entertainment tickets, electronic items, cultural items, among other) should not be offered to HCPs. Promotional items offered at events must be related to scientific and/or educational activities attended by HCPs such as items serving as containers of scientific information and/or that may be used by the HCP at the event. Moreover, promotional aids that can be delivered in the course of medical visits may also be offered at events. |
Argentina
Events are neither legislated nor regulated by local authorities. However, the Code of Good Practices of the Argentine Chamber of Medical Specialties (CAEME) which is mandatory to its members, provides the following guidelines with respect to medical devices that can be offered or delivered to HCPs at Events:
Companies that are members of CAEME may offer or deliver medical utility items or devices provided they have a modest value, they are not items that the HCP should provide for itself or should be provided by the institution in which it exercises its regular professional activity and are beneficial to the improvement of the provision of medical services or patient care. These items may not be offered more than two times per year per HCP. Medical utility items may include the name or logo of the member company but not the name of the product, unless the name of the product is essential for the correct use of the item by the patient.
Companies that are members of CAEME may provide information or educational items to healthcare professionals for their education or for the education of patients on diseases and their treatments, provided such items are mainly intended for educational purposes. Information or educational items may include the name or logo of the member company but not of a product, unless the name of the product is essential for the correct use of the item by the patient.
Argentina
