Regulatory framework

Therapeutic Goods Act 1989 (Cth)
Therapeutic Goods Regulations 1990 (Cth), and Therapeutic Goods Advertising Code (No. 2) 2018 (Cth)
Health Practitioner Regulation National Law

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.

Pharmaceutical Act (Arzneimittelgesetz)

Decree Law No. 18 of 1997 concerning the Organization of the Pharmacy Profession and Pharmaceutical Centres, as amended

Decree Law No. 20 of 2015 amending certain provisions of Decree Law No. 18 of 1997 concerning the Organization of the Pharmacy Profession and Pharmaceutical Centres

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

NHRA Circular No. 4 of 2017

Belgian Law of 25 March 1964 on medicinal products

Belgian Act of 18 December 2016 on other provisions concerning health (so-called Sunshine Act)

Mdeon Code of Ethics

Code of Deontology

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

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

Not applicable

Chilean Sanitary Code

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

Drug Administration Law of the People’s Republic of China

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)

Announcement of the National Medical Products Administration on Issuing the Administrative Measures for the Record-filing of Pharmaceutical Representatives(for Trial Implementation)

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: 

• Article 250-A: Corruption in the private sector.
• Article 325-B: Omission of control in the health sector. Basically, it refers to the concealment of acts of corruption to existing monitoring methods and control procedures on the health industry. 

If one of the individuals is a public servant, then other crimes might be applicable. 

• Articles 405, 406 & 407: are all related to briberies. Article 407 in particular alludes to the offering or giving money or utilities to public servants
• Article 411-A: is relevant for private individuals who unduly influence public servants in order to obtain economic benefits.

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

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.

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.

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.

Act No. 378/2007 Coll., on Pharmaceuticals (Act on Pharmaceuticals)

AIFP (Association of Innovative Pharmaceutical Industry) Code of Practice – dated April 2020

Danish Medicines Act

Executive Order 1153/2014 on Advertising for Medicinal Products

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

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")

EFPIA Code of Practice

IFPMA Code of Practice

The Finnish Medicines Act (395/1987) and Medicines Degree (693/1987), available in Finnish and Swedish at www.finlex.fi

Code of Ethics issued by Pharma Industry Finland (PIF)

• French transparency rules set under Articles L. 1453-1 and D.1453-1 et seq. the French Public Health Code (“FPHC”)
• French anti-kick-back rules set under Articles L. 1453-3 et seq. and R. 1453-13 et seq. of the FPHC
• Code of Medical Ethics set under Articles R.4127-1 et seq. of the FPHC
• Ministerial order of January 19, 2017, relating to benefits offered by persons manufacturing or marketing health products or services
• Decree of June 15, 2020, relating to benefits offered by persons manufacturing or marketing health products or services
• Ministerial order of August 7, 2020, setting the amounts above which an agreement stipulating the granting of benefits is subject to authorization
• Ministerial order of August 7, 2020, setting the amounts below which benefits in kind or in cash are considered to be of negligible value
• Ministerial order of September 24, 2020, concerning the thematic typology of benefits and agreements
• Ministerial order of September 24, 2020, on the creation of a tele-procedure to facilitate the transmission of agreements stipulating the granting of benefits called "Ethics of health professionals"

• Leem Code of Conduct (pharmaceutical companies)
• SNITEM Code of Conduct (medical device companies)

• Information Notice n°DGS/PP2/2017/180 of 29 May 2017 published by the French Ministry of Health (relating to the transparency rules)
• Information Notice n°DGOS/RH2/2020/157 of 11 September 2020 published by the French Ministries of Health and Economy (relating to the anti-kick-back rules)
• Q&A from the General Directorate of Competition, Consumer Affairs and Fraud Control (“DGCCRF”) and the General Directorate of health care provision (“DGOS”) (frequently updated)

German Criminal Code ("StGB") – last amended December 21, 2020

German Act on Advertising in the Field of Healthcare ("HWG") – last amended December 09, 2020 (German language) 

German Act against Unfair Competition ("UWG") – last amended November 26, 2020

It should be noted that any interactions permitted or restricted under the applicable German industry codes are indicative only. Particularly, industry codes are not legally binding for German courts and competent authorities. However, under the circumstances of the individual case, they may also consider the industry codes when assessing the compliance of interactions between pharmaceutical companies and HCPs. 

FSA Code of Conduct Healthcare Professionals ("FSA Kodex Fachkreise") published by the German self-regulatory organization "Voluntary Self-Regulation of the Pharmaceutical Industry" ("Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V." – "FSA") – edition 2021 

FSA Transparency Code ("FSA Kodex Transparenz") – edition 2020

"AKG Code of Conduct"("AKG Verhaltenskodex") published by the German self-regulatory organization "Pharmaceuticals and Cooperation in the Healthcare Sector" ("Arzneimittel und Kooperation im Gesundheitswesen e.V." – "AKG") – last amended on April 22, 2015. 

(Model) Professional Code for Physicians in Germany ("MBO-Ä") published by the German Federal Medical Association ("BÄK") including the professional codes for physicians published by the local German medical associations – last amended December 14, 2018 

(Model) Professional Code for Dentists ("MBO-ZÄ") published by the German Federal Dentists Association ("BZÄK") including the professional codes for dentists published by the local German dentists associations – last amended November 16, 2019 (German language)

Legislative Decree 96/1973

Circular 27810/2018 of the National Organization for Medicines

Ministerial Decision ∆ΥΓ3α/Γ.Π 32221/2013

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

Not applicable

The Prevention of Bribery Ordinance (Cap. 201) ("PBO")

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).

Acceptance of Advantages (Chief Executive's Permission) Notice 2010 (the "Notice")

Act XCVIII of 2006 on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products

Health Minister Decree 3/2009

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

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

Legislative Decree 219/2006

Royal Decree 1265/1934

Act on Prohibition of Private Monopolization and Maintenance of Fair Trade 

Act against Unjustifiable Premiums and Misleading Representations

Fair Competition Code (concerning Restriction on Premium Offers in Ethical Pharmaceutical Drugs Marketing Industry)("FCC")

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.

Code of Conduct issued by the Luxembourg Pharmaceutical Association

General Health Law (Ley General de Salud) and relevant guidelines and regulations for sanitary and/or publicity purposes, among others

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.

Dutch Medicines Act (Geneesmiddelenwet) 

Policy Rules Financial Inducement Dutch Medicines Act (Beleidsregels gunstbetoon Geneesmiddelenwet)

Code of Conduct Pharmaceutical Advertising (Gedragscode Geneesmiddelenreclame)

Health Practitioners Competence Assurance Act 2003 (HCPA)

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

Royal Australasian College of Physicians Guidelines for Ethical Relationships Between Physicians and Industry

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).

Not applicable

The Norwegian Health Personnel Act 

Medicinal Products Act of April 12, 1992 no 132 (Medicinal Products Act) 

The regulation regarding medicinal products of December 18, 2009 no. 1839 (Medicinal Products Regulation) 

Regulation on HCPs availabilty to receive gifts of 29 August 2005 no. 941

The Association of the Pharmaceutical Industry (LMI) industry rules

Agreements between e.g the pharmaceutical industry (LMI) and the regional hospitals, Norwegian medical association

Polish Pharmaceutical Law of 6 September 2001

INFARMA Code of good practice

INFARMA Criteria of events assessment

PASMI Ethics Code (currently not available online)

PZPPF Ethics Code

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

Order 1542/2017 issued by the Secretary of State for Health

Order 5657/2017 issued by the Secretary of State for Health

APIFARMA's Code of Ethics for promotion practices of the pharmaceutical industry and interaction with healthcare professionals and institutions, organizations or associations comprising healthcare professionals

APIFARMA’s Code of Conduct for the Relations between the Pharmaceutical Industry and Patients' Associations, Patients Advocates, Patients Experts, Patients and Caregivers

APIFARMA's Communication and Public Relations in the Pharmaceutical Industry - Code of Good Practice for Communication

APIFARMA’s Guide for the Utilization of Digital Channels

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

Council of Ministers Decision on the Issuance of the Code of Conduct and Integrity of Public Officials Charter No. 18 of 2020

Order 194/2015 on the legal framework for evaluation and approval of advertising of medicines for human use

Article 67.1. (parts 1 and 2) of the Federal Law No. 61-FZ dated April 12, 2010 "On Circulation of Pharmaceuticals" ("Pharmaceuticals Law")

Law of the General Food and Drug Authority 13/02/2007 

Pharmaceutical Institutions and Products Law 

Tourism Law

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.

Act No. 362/2011 Coll. on medicinal products and medical devices as amended ("Act on medical products")

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")

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 Act

Slovenian Rules on advertising of medicines (available in Slovene) (Pravilnik o oglaševanju zdravil)

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")

Spanish Royal Decree 1/2015 of 24 July, approving the consolidated text of the Law on Guarantees and Rational Use of Medicines

FarmaIndustria Code

Not applicable

Ethical Rules for the Pharmaceutical Industry

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.

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.

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") 

Federal Laws & Implementing Regulations, & Government-Issued Guidance

Various 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)):

Prohibits providing remuneration in any form with the intent to induce or reward for, the prescribing, or arranging for or recommending the prescribing, of a product or service that is reimbursed by a federal healthcare program.  Does not establish specific appropriate amounts to be spent on HCPs related to accommodations, travel, or meals.

Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h) and Implementing Regulations (42 C.F.R. Part 403, Subpart I):

Requires applicable manufacturers to track and to submit information regarding payments made to certain US HCPs.  Does not establish appropriate amounts to be spent on HCPs related to accommodations, travel, or meals; rather, addresses tracking and transparency obligations.  Individual payments of de minimis value (adjusted annually; currently $11.04) are exempt from the reporting requirement, although tracking is required because reporting is triggered if the aggregate payments to a particular HCP exceed a certain amount (adjusted annually; currently $110.40).

Federal (Government-Issued) Guidance:

US federal agencies issue guidance (e.g., OIG guidance including the HHS-OIG Compliance Program Guidance for Pharmaceutical Manufacturers (the "HHS-OIG Guidance", available here), Advisory Opinions, Special Fraud Alerts, etc.) to the life sciences and healthcare industries on various activities that may include guidance and interpretation relative to items of value provided to HCPs.  

State Laws & Implementing Regulations

FW&A Laws Including Any Payor Statutes:

Nearly all states have adopted FW&A laws that are generally analogous to the federal laws, but which in some cases apply more broadly than the federal laws (e.g., regardless of payor).

Marketing and Gift Laws: 

State marketing and gift laws should be considered. The exact applicability and scope will vary, and the landscape is subject to change, but a number of states have established compliance program requirements and/or impose restrictions on (and/or requirements related to) items or transfers of value being offered to HCPs in a particular state. Examples of jurisdictions with laws of this type:

• California[1]
• Connecticut[2]
• District of Columbia[3]
• Maine[4]
• Massachusetts[5]
• Minnesota[6]
• New Jersey[7]
• Vermont[8] 

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

[1] Cal. Health & Safety Code § 119402.
[2] Conn. Gen. Stat. § 21a-70e.
[3] D.C. Code § 48-833.01.
[4] Me. Rev. Stat. tit. 32 § 13759; 02-392 C.M.R. ch. 12, § 7.
[5] Mass. Gen. Laws ch. 16 § 111N.
[6] Minn. Stat. § 151.461.
[7] N.J. Admin. Code § 13:45J.
[8] Vt. Stat. tit. 18 § 4631a.
[9] Chicago Municipal Code § 4-6-310(h)(1).

PhRMA Code on Interactions with Healthcare Professionals (last revised September 2019)

AdvaMed Code of Ethics (effective January 1, 2020)

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:

• The potential for an industry role relative to travel and hospitality expenses (payment for, or reimbursement for, such expenses) in connection with company-sponsored events, meetings, or HCP services. This may include some meetings with educational or scientific content, but the content is controlled by the company. This category may also include travel and hospitality associated with HCPs engaged to provide services for the company (e.g., consultants or clinical investigators).  This category is the focus of the US responses for this survey.
• The potential for industry financial support in connection with independent continuing medical education ("CME") or similar third-party conferences or events where the company does not control or influence content. This category is further explained in Online Conferences. Under industry codes, any financial support should be provided to conference organizers, and the conference organizers in turn should apply appropriate standards to its use.