Which bodies are responsible for enforcing the rules on advertising and the rules on inducement? Please include regulatory authorities, self-regulatory authorities and courts.
Penalties against a company or person can be imposed by administrative authorities or criminal courts (see point 24).
Civil claims (e.g. injunctive relief, damages) are asserted before civil courts. In addition to competitors, various associations can also be considered as plaintiff (see point 23).
The Public prosecutor and the criminal courts are primarily responsible for the enforcement of the pharmaceutical advertising rules (the AMP, RDAMP and the Belgian Criminal Code).
In addition, the pharmaceutical professional associations can also impose a separate set of penalties on their members following a breach of the applicable deontological code.
Supervision is carried out as follows:
(i) In the case of violations of the requirements for the advertising of medicines – by the State Medicines Control Agency;
(ii) In the case of comparative advertising of medicines – by the Competition Council;
(iii) In the case of the Code of Pharmaceutical Ethics – by the Supervisory Committee for the Code of Pharmaceutical Ethics.
Usually, a pharmaceutical company that disagrees with the decisions of the relevant supervisory authority, applies to the court. However, litigations in the area of advertising of medicines are not frequent.
- Authorities: COFEPRIS and Federal Prosecutor for the Consumer Protection ("PROFECO”).
- Self-regulatory bodies CETIFARMA, CONAR and AFAMELA.
- Authorities: Anticorruption Ministry.
- Self-regulatory bodies CETIFARMA.
The HPRA is the main body for enforcing the rules on advertising of medicines. The IPHA may also order the withdrawal of a non-compliant advertisement and make an order in relation to breaches of the Pharmaceutical Industry Code such as inducement to prescribe. The ASAI can enforce rules on advertising against its members.
Prosecutions in relation to advertisements may also be brought by the HPRA, Minister for Health, the Pharmaceutical Society of Ireland, the Broadcasting Authority of Ireland (in relation to radio and television advertisements) and the Competition and Consumer Protection Commission (‘CCPC’).
In certain circumstances, the Irish Courts can enforce the advertising laws.
Infarmed – Autoridade Nacional do Medicamento e Produtos de Saúde, IP, is the supervising and enforcing authority on advertising and inducement infringements to the applicable law. The decisions taken by this authority in administrative offense procedures may be challenged before the Competition, Supervision and Regulation Court, which decision may be challenged before the Court of Appeal.
The infringements to Apifarma´s Codes and respective provisions, namely on advertising and inducement, are committed to Apifarma´s Ethics Council, which mat impose penalties to the associated members.
The public prosecutor's offices are responsible for the enforcement of criminal law.
Regarding the statutory rules mentioned in no. 21, responsibility depends on the relevant legal framework: Provisions of AMG and HWG are enforced by the regional authorities on the level of the German Federal States (as example: The regional authority "Regierung von Oberbayern" is responsible for companies in Munich). Sec. 128 SGB V is enforced by the relevant statutory health insurance company.
Self-regulatory bodies sanction violations with fines and publish the offences.
The governing bodies responsible for enforcing the rules on advertising of medicines and rules on inducement are:
- FDA under the DOH for the provisions of the FDA Act, FDA Act IRR, PPPMD Guidelines, and other regulations it has issued;
- ASC for advertising materials in general;
- PHAP for its members;
- The Office of the Ombudsman, the Department of Justice and the regular courts for inducements involving public HCPs.
- Public courts (anti-bribery, statutory rules on inducements).
- The Patent and Market Court, the Patent and Market Court of Appeal (the Supreme Court – theoretically) (marketing practices under the Marketing Practices Act).
- MPA (supervisory authority under the Medicinal Products Act).
- The Administrative court in Uppsala, the Administrative Court of Appeal in Stockholm and the Supreme Administrative Court (appeals of MPA decisions).
- IGN and NBL (self-regulation; marketing and inducements).
- The Swedish Consumer Agency (supervisory authority under the Marketing Practices Act).
The enforcement body concerning administrative measures are Swissmedic, concerning advertising rules, and the Federal Office of Public Health concerning integrity (i.e. grant/acceptance of benefits) and transparency rules (new Art. 82 par. 1 TPA). Appeals to the Federal Administrative Tribunal followed by an appeal to the Federal Tribunal are possible in general.
In principle, the enforcement bodies concerning criminal measures are Swissmedic, the Federal Office of Public Health or the local public prosecutor’s office (depending on the offence committed) and the criminal tribunal of the canton where the offence was committed. Appeals to the canton Criminal Appeal Court, following by an appeal to the Federal Tribunal are possible in general. However, for active and passive bribery of public officials, the subject-matter jurisdiction may lie with the Federal Office of the Attorney General if the offence was committed abroad to a substantial extent or if it has been committed in two or more cantons with no single canton being the clear focus of the criminal activity (Article 24 Swiss Criminal Procedure Code). An appeal to the Federal Criminal Tribunal, followed by an appeal to the Federal Tribunal is possible in principle.
On the self-regulatory level, the Code Secretariat is the enforcement body concerning the Pharma Code and the Pharma Cooperation Code rules (Art. 6 Pharma Code; Art. 5 Pharma Cooperation Code).
The FDA is the government authority who is responsible under the Drug Act, including the rules on drug advertising. The National Anti-Corruption Commission (the "NACC") is responsible for enforcing and control the rules on inducement and bribery under the Anti-Corruption Act. In addition, the Central Criminal Court for Corruption and Misconduct Cases is the authoritative court for bribery cases.
Enforcement of the rules on advertising and inducement is within the statutory powers of the MHRA who acts on behalf of Health Ministers. The Ministers, defined as the Secretary of State and Minister for Health, Social Services and Public Safety (Article 6), can either act alone or decide to act jointly (Article 278). The MHRA is also responsible for monitoring compliance with the advertising rules and will thus conduct its own review of published advertising.
Anyone can complain before the MHRA for non-compliant advertising of medicines.
Complaints can also be made before the following self-regulatory bodies (i.e. operating their own Codes of Practices):
- The Prescription Medicines Code of Practice Authority administers the ABPI Code of Practice for the pharmaceutical industry;
- The Proprietary Association of Great Britain regulates over the counter medicines and administers the Medicines Advertising Codes and the Professional Code of Practice.
- The Health Food Manufacturers' Association operates the Code of Advertising Practice on behalf of the UK specialist health product industry.
- The Office of Communications is the regulatory and competition authority for the UK communications industries responsible for programme sponsorship and product placement.
- The Advertising Standards Authority and Committees of Advertising Practice administers the UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing.
- Radio Advertising Clearance Centre is responsible for compliance of advertising on radio with the UK Code of Broadcast Advertising.
- Clearcast approves advertising for television with the UK Code of Broadcast Advertising.
The MHRA may refer a complaint back to one of these self-regulatory bodies if it considers it is a more appropriate forum and if the alleged breach is of Articles 286 to 290, or Articles 294 to 300. If an investigation has already been conducted by one of these self-regulatory bodies the MHRA may decide not to conduct its own investigation. However, the MHRA may investigate a complaint that has been submitted to one of the self-regulatory bodies if it has not been dealt with in a satisfactory manner within a reasonable time frame.
There are two types of actions which can be brought before English courts in case of a breach of statutory duty: actions for damages based on private law (tort), and actions for enforcing the performance of a statutory duty which emanates from public law (judicial review).
The former has been further classified in four categories: (a) actions for breach of statutory duty simpliciter, (b) actions based on the careless performance of a statutory duty in the absence of any other common law right of action, (c) actions based on a common law duty of care arising either from the imposition of the statutory duty or from the performance of it, and (d) misfeasance in public office. However, the general principle is that a breach of statutory duty will not give rise to a private law cause of action unless "the statutory duty was imposed for the protection of a limited class of the public and that Parliament intended to confer on members of that class a private right of action for breach of the duty" (X (Minors) v Bedfordshire CC  2 A.C. 633 at 731).
The latter is an action that can be brought against a public body such as the MHRA where the court reviews the lawfulness of a decision in relation to the exercise of a public function. The process is designed to ensure that public bodies act in accordance with their legal obligations and do not abuse their powers.
Ministry of Health and criminal courts, only when it can be supported that health of a patient was compromised.
There are a number of bodies responsible for enforcing the rules on advertising and inducement.
The laws regarding inducement are enforced by various governmental agencies, including the U.S. Department of Justice (“DOJ”), the U.S. Department of Health & Human Services (“HHS”), the HHS Office of Inspector General (“OIG”), the Centers for Medicare & Medicaid Services (“CMS”), and various states attorneys.
Numerous laws exist regarding inducement in the United States. For instance, criminal penalties for the Federal Health Care Program Anti-Kickback Statute, 42 U.S.C. § 1320a-7(b)(b) (the “AKS”) are enforced by the DOJ, and the OIG may impose civil monetary penalties and/or exclusion from federal health care programs for violations of the AKS. The OIG pursues such penalties through administrative proceedings. The respondent is entitled to review by the Departmental Appeals Board of the HHS, then judicial review in federal court. Additionally, an AKS violation may be subject to penalties under the Federal False Claims Act (“FCA”), 31 U.S.C. § 3729-3733, which are ordinarily prosecuted by the DOJ, but also have unique qui tam provisions that permit a private individual to sue on behalf of himself/herself and the government. Pharmaceutical companies and device manufacturers may potentially be subject to FCA liability for causing health care providers to submit false claims to Medicare, Medicaid or other federal health care programs. Furthermore, the DOJ and the Securities Exchange Commission are charged with enforcing the Foreign Corrupt Practices Act, 15 U.S.C. §78dd-1, et seq.
The DOJ has the authority to bring claims under the Anti-Kickback Act of 1986, 41 U.S.C. §§ 8701-8707, for the payment of a kickback to any federal prime contractor or subcontractor to improperly obtain or reward favorable treatment. Additionally, pursuant to the Physician Self-Referral Law, also known as the Stark Law, 42 U.S.C. § 1395nn, physicians are prohibited from referring patients to receive designated health services payable by Medicare or Medicaid to an entity that the physician or the physician’s immediate family members have a financial relationship. The Criminal Health Care Fraud Statute, 18 U.S.C. § 1347, makes it a criminal offense to knowingly and willfully execute, or attempt to execute, a scheme or artifice in connection with the delivery of, or payment for, health care benefits, items or services to either defraud any health care benefit program or obtain (by means of false or fraudulent pretenses, representations, or promises) any of the money or property owned by, or under the custody or control of, any health care benefit program. The Exclusion Statute, 42 U.S.C. § 132a-7, requires the OIG to exclude individuals and entities convicted of various offenses, including, but not limited to, Medicare or Medicaid fraud, from participation in all federal health care programs. The Civil Monetary Penalties Law (“CMPL”) authorizes the OIG to seek civil monetary penalties and sometimes exclusion for a variety of health care fraud violations, including, but not limited to, remuneration to a Medicare or Medicaid beneficiary. 42 U.S.C. § 1320a-7a(a)(5), i(6). In addition, several states have anti-kickback laws that would apply to things covered by Medicaid and other state government health care programs, which could be enforced by states attorneys.
With regard to advertising, there are a number of bodies responsible for enforcing the rules. The FDA regulates the advertising of prescription drugs and devices. Additionally, the FDA works with the Department of Justice to seek judicial review and action with regard to new drugs. The FTC has the authority to address any deceptive or unfair advertising regarding over-the-counter drugs.
False advertising claims can be brought in federal court by a competitor under the Lanham Act if a competitor believes that it is likely to be damaged by the advertising claims. 15 U.S.C. § 1125(a)(1)(B). In addition, there are a number of state consumer protection laws that may apply with regard to advertising and anti-trust issues. Claims under these state consumer protection laws can be brought by states attorneys, competitors and/or consumers.
Furthermore, the National Advertising Divisions (“NAD”) of the BBB National Programs, Inc., is a self-regulatory body that monitors national advertising in all media and examines advertising claims for a wide variety of goods and services, including pharmaceuticals. The NAD provides an alternative to litigation for resolving advertising disputes. An advertiser may choose not to cooperate with NAD proceedings or not to comply with the NAD’s decision. In that case, however, the NAD may forward the claims against the advertiser to the FTC, FDA, or applicable regulatory body for action.
Advertising regulations for therapeutic goods are primarily enforced by the Therapeutic Goods Administration. This includes non-compliance with the TG Advertising Code and, until 1 July 2020, non-compliance with pre-approval requirements.
Issues relating to advertising which breaches the ACL, e.g. misleading or deceptive advertising, are enforced by the Australian Competition and Consumer Commission. However they can also be the subject of court actions brought by competitors and consumers.
The Medicines Australia Code and ASMI Code are enforced by Medicines Australia and Consumer Healthcare Products Australia respectively. This includes enforcement of rules relating to advertising, sponsorship, inducements and company conduct generally. Medicines Australia and CHPA may refer matters to the TGA or ACCC as appropriate.
Breaches of the Healthcare Practitioner Regulation National Law are enforced by the Australian Health Practitioner Regulation Agency.