What is the relationship between procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts/government competent authorities?
Only measures taken by courts/competent government authorities are binding. Self-regulatory measures are binding for members of Pharmig and non-members that voluntarily comply with the rules of the Pharmig Code of Conduct.
The self-regulatory deontological codes are independent rules and means of enforcement. Nonetheless, the pharma.be Code of Deontology explicitly determines that no procedures can be started before the pharma.be deontological bodies if another procedure (on similar grounds) was already conducted in front of another competent authority. If a procedure is initiated before the deontological bodies of pharma.be and a separate procedure is initiated before another competent authority during such procedure, the decision by the pharma.be deontological body will be deferred until the other competent authority has taken a decision (Article 93 pharma.be Code).
It is also a possibility that a deontological organisation notifies a breach by one of its members to the regulatory authorities or the public prosecution (this is, for instance, explicitly provided for in the pharma.be Code of Deontology). Regulatory authorities, courts or the public prosecution will only be competent to decide on a breach of a deontological code if it also constitutes a breach of the applicable legal framework (notably the AMP and the RDAMP).
These procedures are unrelated. Self-regulatory authorities, as well as SMCA, can appeal against the decisions to the courts. In practice, the SMCA takes into account the decision of self-regulatory authorities regarding the ethics of the company when addressing the issue of violation of the laws on medicine advertising.
Government competent authorities’ procedures and measures are administrative acts to enforce the applicable laws and regulations.
Self-regulatory authorities, procedures and measures are based on commercial agreements.
Government authorities and self-regulatory authorities may coordinate in procedures and measures; however, this is not mandatory, nor their procedures or measures are legally bind between each other.
The 2007 Regulations recognises the role of self-regulatory bodies and codes. Complaints can be made to the appropriate bodies mentioned at 22. As mentioned at 24, the IPHA may refer a matter to the Minister of Health. The HPRA monitors advertising of medicinal products and the Pharmaceutical Society of Ireland monitors advertising by pharmacies. Decisions of the HPRA may be appealed to the Irish courts.
An intra-industry complaint may be investigated by the ASAI where the interests of consumers are involved, but the ASAI has the discretion to decide to investigate or refer the complaint to a more appropriate body. The ASAI may not deal with a complaint if a similar issue has been resolved by the Courts or if the complainant has initiated legal action or another alternative dispute resolution process.
None. The national authority on medicines (Infarmed) is the supervising and enforcement entity for medicines and Apifarma is the association of the pharmaceutical industry, the supervise and enforces the respective codes of ethics and conduct before the associated members.
As a general rule, measures taken by the self-regulatory authority are only binding to members of the relevant self-regulatory body. In contrast to this, procedures and measures taken by courts/government competent authorities are binding for every company. If a statutory health insurance company imposes a contractual penalty (see no. 24), the penalty only applies to the contractual party of the health insurance company.
Procedures / measures taken by self-regulatory authorities (such as the PHAP and the ASC) are generally separate and independent from the procedures / measures taken by courts or government authorities. Thus, as a general rule, measures of self-regulatory authorities are not appealable to the courts.
Nevertheless, Philippine law does not prevent parties aggrieved by decisions of self-regulatory authorities from seeking appropriate remedies (e.g., injunctions urgently necessary to prevent irreparable harm) before the regular courts, provided that such parties are able to establish the basis for such remedies. Also, nothing prohibits relevant regulatory agencies (such as the FDA) from administratively penalizing parties sanctioned by self-regulatory authorities, as long as such penalties are justified under applicable laws, rules and regulations.
MPA, as the supervisory authority in the pharmaceutical sector, acts independently from the self-regulatory bodies NBL and IGN. However, MPA can report cases to the self-regulatory bodies, or review the decisions of the self-regulatory bodies by its own initiative. Courts and other authorities, such as MPA, can ask NBL to make a guiding statement about a question. Nothing prevents cases to be investigated concurrently by both MPA and IGN or NBL.
The decisions and statements of IGN and NBL are not legally binding per se, but they are binding on a contractual basis for the parties mentioned under question 2b above, and courts may use LER and the decisions of IGN and NBL to determine what is considered good marketing practices in the healthcare sector.
The decisions of MPA and of the courts are binding and the self-regulatory bodies must follow the developing case-law and not make conflicting decisions in individual cases or in their general guidance statements.
Both procedures are independent, may be conducted simultaneously and order independent measures. If pharmaceutical companies refer conduct to a government authority or to a court, the Code Secretariat shall suspend any proceedings which have already been opened for as long as none of the participating pharmaceutical companies ask for the proceedings to be terminated (Art. 671 Pharma Code; Art. 571 Pharma Cooperation Code).
Nevertheless, pharmaceutical companies which undertake to comply with the Pharma Code and the Pharma Cooperation Code acknowledge the rules of enforcement of those Codes and refrain from referring the matter at the same time to a State authority or to courts, as long as relevant proceedings are pending, unless this is deemed necessary for the safeguarding of rights which may be endangered or defeated by compliance with the above-mentioned principles (Art. 15 Pharma Code/Pharma Cooperation Code).
Measures taken by the self-regulatory authority are separate from measure taken by the government authorities. The procedures before or measures taken by the self-regulatory authority are intended to create an ethical framework, which should be taken by the members. The self-regulatory authority may impose sanctions to members who violate their codes of practice (e.g. suspension of membership or commercial fine). On the other hand, the procedures before or measures taken by government competent authorities or court can be enforced separately. The measures can be taken by virtue of laws that impose legal sanctions (criminal fine and imprisonment) without any relationship to the measures taken by the self-regulatory authority.
The various procedures operate independently from each other and are not dependent on the outcome of other reviews by other authorities or courts. As mentioned above, there are limited actions that can be brought before English courts in relation to breaches of statutory duties.
Judicial reviews are available but only against public bodies (i.e. created by statute).
There´s no relationship between procedures. In fact, self-regulatory boards are usually a measure of private companies to avoid the intervention of a governmental board into matters that companies would like to resolve in a quiet and private fashion.
While the self-regulatory process is “voluntary,” if an advertiser refuses to participate in a proceeding or comply with recommendations, the NAD may refer the advertiser to the appropriate government authority, usually the FTC’s Division of Advertising Practices, which will review the claims at issue and potentially pursue an investigation or enforcement action. This possibility has led most advertisers to participate in the self-regulatory process and comply with NAD recommendations.
Enforcement actions by self-regulatory bodies, such as Medicines Australia and CHPA are completely independent of any enforcement actions by regulatory agencies such as the TGA or ACCC, although complaints to self-regulatory bodies may be referred to regulators for further action where necessary.