Topic | Details |
Relevant statutory law(s) |
Therapeutic Goods Act 1989 (Cth) |
Industry code(s) of conduct |
Medicines Australia's Code of Conduct (19th Edition, 30 Mar 2020) (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. |
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) | |
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) |
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 Over-The-Counter Medicines Industry - ABIMIP Code of Conduct |
Other | Not applicable |
Topic | Details |
Relevant statutory law(s) |
Not applicable |
Industry code(s) of conduct | Innovative Medicines Canada Code of Ethical Practices (Annotated Version, 2020) of Innovative Medicines Canada |
Other | Not applicable |
Topic | Details |
Relevant statutory law(s) | |
Industry code(s) of conduct | Chilean Annex Code of Practice of the International Federation of Pharmaceutical Manufacturers & Associations Code |
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 Medical Practitioners |
Industry code(s) of conduct |
Code of Ethics for Chinese Medical Doctors R&D-Based Pharmaceutical Association Committee Code of Practice (2019) ("RDPAC Code") (for member companies only, which include around 42 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 30 international pharmaceutical 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 from 2015 and Law 1474 from 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 withing (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 from 2018 of 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. The Ministry of Health issued Resolution 2881, 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 Hublic Sector (Registro de Transferencias de Valor en el Sector Salud) (hereinafter "RTSVV") 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 from 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.
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Industry code(s) of conduct |
AFIDRO’S Code of Ethics from 2019 (Asociación de Laboratorios Farmacéuticos de Investigación y Desarrollo) (Hereafter "AFIDRO"). ANDI's (Businessmen National Association) (Hereafter "ANDI") Chamber of Pharmaceutical Industry of Code of Ethics and Transparency |
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. 378/2007 Coll., on Pharmaceuticals (Act on Pharmaceuticals) |
Industry code(s) of conduct |
AIFP (Association of Innovative Pharmaceutical Industry) Code of Practice – dated April 2020 |
Other | Not applicable |
Please also see European Union.
Topic | Details |
Relevant statutory law(s) |
Danish Medicines Act Executive Order 1153/2014 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 Guidance on The Pharmaceutical Industry's Code of Practice on Promotion etc., of Medicinal Products aimed at Healthcare Professionals (The Promotion Code) Guide 2014-12-29 no. 10356 about advertising etc. for medicines |
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 |
Industry code(s) of conduct |
Code of Ethics on the promotion of prescription only medicinal products and the disclosure of benefits for healthcare professionals issued by the Hellenic Association of Pharmaceutical Companies |
Other |
Not applicable |
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 Regitered 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 |
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 |
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. |
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 Pharmacy Council of New Zealand Standards and Guidance for Pharmacist Prescribers Nursing Council of New Zealand Code of Conduct Other health professions 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 on the legal framework of medicinal products for human use Decree-Law 5/2017 on the general principles of medicinal products and medical devices advertising |
Industry code(s) of conduct | |
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 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 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) | |
Industry code(s) of conduct | |
Other | Not applicable |
Please also see European Union.
Topic | Details |
Relevant statutory law(s) |
Not applicable |
Industry code(s) of conduct | |
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. Ministerial Resolution No. 1448 of 2017 On Adoption of Code of Ethics and Professional Conduct for Health Professionals. |
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 European Union. Following Brexit, EU legislation as it applied to the United Kingdom on 31 December 2020 is now a part of the United Kingdom’s domestic legislation. |
Industry code(s) of conduct |
The ABPI Code of Practice ("ABPI") PAGB Code of Practice ("PAGB") GMC Code of Good Medical Practice ("GMC") Blue Guide (Advertising and Promotion of Medicines in the UK) ("Blue Guide") |
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
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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:
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Argentina
Topic | Details |
Competent authority/authorities enforcing the above statutory law(s) |
Argentinian Ministry of Health |
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) |
No event should take place outside the Argentine Republic, unless there are logistical or security reasons for holding it abroad (e.g. where most of the participants guests come from abroad and/or where the relevant resource or expertise is located abroad). |
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) |
Luxurious venues should not be selected for hosting events. |
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.) | Accommodation may be provided to HCPs only and it should not include sponsorship or organization of entertainment or leisure activities (e.g. sporting events, musical events, etc.). |
Argentina
Topic | Detail |
Restrictions on air travel (e.g. economy class only; minimum flight duration for business class) | No specific rules |
Restriction on train transportation (class; duration; etc.) | No specific rules |
Other restrictions regarding travel | No specific rules |
Argentina
Topic | Details |
Limitation on providing meals (e.g. only refreshment for events lasting for half a day or more) | No specific rules |
Maximum value for meals (e.g., EUR 60) – please specify by meal (breakfast, lunch, dinner) where applicable | No specific rules |
Restrictions on where meals can be provided? (e.g. no Michelin-starred restaurant) | No specific rules |
Other restriction (e.g. no alcohol may be offered) | No specific rules |
Argentina
Topic | Details |
Rules applicable to family members travelling together with HCPs to the event location. | No specific rules |
Argentina
Topic | Details |
Rules originally designed for traditional events (described in previous points) but applicable also to online conferences | No specific rules |
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 | No specific rules |