Source: http://www.inhouselawyer.co.uk/wgd_question/which-bodies-are-responsible-for-enforcing-the-rules-on-advertising-and-the-rules-on-inducement-please-include-regulatory-authorities-self-regulatory-authorities-and-courts/
Timestamp: 2020-02-24 05:14:33
Document Index: 65633192

Matched Legal Cases: ['Art. 82', 'Art. 6', 'Art. 5', '§ 1320', '§ 3729', '§78', '§ 8701', '§ 1395', '§ 1347', '§ 132', '§ 1320', '§ 1125']

Which bodies are responsible for enforcing the rules on advertising and the rules on inducement? Please include regulatory authorities, self-regulatory authorities and courts. | The In-House Lawyer
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.
(ii) Inducement:
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.
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).
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.