Rules that govern advertising and promotion activities of medicines and medical devices in Portugal have been changed recently by the enactment of Decree-Law 5/2017 of 6 January (“Decree-Law 5/2017”).
This new legal act establishes principles that shall be accomplished by marketing authorization holders and distributors of medicines, as well as manufacturers and distributors of medical devices in their advertising and promotion activities.
Decree-Law 5/2017 further provides legal changes that strengthen transparency requirements in the relationships between pharmaceutical industry and medical devices industry, on one side, and healthcare practitioners and healthcare organisations, on the other.
The promotion of good governance practices in health sector is a demand of society and has been a trend that motivated the approval of specific legislation in several countries to tackle the issue of conflicts of interest in the relationships between the industry and the healthcare professionals. The EU Commission initiative on Ethics & Transparency in the pharmaceutical sector, as well as the approval of guidelines in this subject matter by the industry’s representative organisations, notably by EPFIA and MedTech Europe, are noteworthy examples of this trend.
The prevention of conflicts of interest situations in the interactions between players of the industry of medicinal products and medical devices and healthcare professionals and healthcare organizations is also a matter of utmost importance for the Portuguese legislator. The Portuguese Law sets forth transparency requirements in the relations between players of pharma industry and healthcare professionals and organizations since 2013, providing for disclosure obligations of donations, grants or benefits of more than EUR 60,00 in an electronic platform displayed in the Medicines Agency, Infarmed’s, website. The newly enacted Decree-Law 5/2017 further strengthens such requirements.
The major changes brought by Decree-Law 5/2017 are the following:
Express provision of legal principles applicable to advertising activities
Decree-Law 5/2017 sets forth that advertising activities of medicines and medical devices have to observe the legal principles of the primacy of protection of public health, rational use of medicines and medical devices, the principles of integrity, mutual respect, accountability, moderation, transparency and collaboration with competent authorities.
These legal principles substantiate the ethical values underlying advertising activities of medicines. The meaning of the explicit provision of these legal principles, more than a change, it reflects the enhancement of such ethical standards in medicines and medical devices advertising practices.
General prohibition of granting of any benefits or sponsorships to institutions within public healthcare service
One of the most relevant changes introduced by Decree-Law 5/2017 consists in the rules addressing to interactions between services and products providers of medicines, medical devices and other technologies, and the institutions of public healthcare service (“Serviço Nacional de Saúde”, “SNS”).
A broad prohibition is provided in the law for all institutions within the SNS, which includes hospitals, to receive or encourage the granting of any benefits by entities engaged in the supply of goods or services in the areas of medicines, medical devices and other health technologies in a manner that could affect their independence or impartial judgement. The exception to this prohibition refers only to benefits that do not compromise the independence and impartial judgement of the mentioned SNS institutions, and is subject to specific authorization of the Health Minister.
Additionally, scientific venues and other initiatives held in public healthcare services cannot have a promotional approach, and the sponsorship of such venues by manufacturers, distributors or suppliers of medicines and medical devices is forbidden.
This general prohibition does not apply to the access and visits by sales representatives of medicines and medical devices to the healthcare services of SNS to the extent that the applicable regulatory requirements which are laid down in Order nr. 8213-B/2013 of June 24 (II series) are fully accomplished.
Decree-Law 5/2017 extends to medical devices industry the application of the transparency requirements applicable within the health sector that used to be addressed only to the medicines area. This legal approach is justified by the significant growth of medical devices market in the latest years, that currently represents an annual public expenditure of approximately €700 million for SNS, and is in line with international guidelines approved recently, i.e. MedTech Europe’s Code of Ethical Business Practice.
The transparency requirements in the interactions between suppliers of medicines and medical devices, and healthcare organizations and/or professionals, have been further strengthened by this new legal act, which most relevant aspects are outlined herebelow:
- introduction of a broad legal definition of benefit, meaning any advantage or payment whatsoever, including non-monetary, irrespectively of the means whereby it is granted, and thus enhancing the robustness of public disclosure obligations triggered by the granting of any benefits to health institutions or professionals;
- change to the applicable disclosure proceeding, being the granting of any benefits by pharma industry entities or medical devices players to healthcare organizations or professionals subject to mandatory registration in the transparency platform displayed in Infarmed’s website (www. placotrans.infarmed.pt). Instead of a double registration of the benefits by the grantor and the receiver that was applicable formerly, the new legal transparency framework provides for the obligation of the grantor to report the granting of the benefit within 30 days as from the date it becomes effective, and the duty of the receiver to validate the receipt of the relevant benefit. This validation entails an electronic notification to the beneficiary by Infarmed.
- the newly enacted framework also clarifies which are the entities considered as beneficiaries in cases where third parties are involved, notably service providers, when the benefit is granted in the interest of a certain health organization, or of benefits made to a healthcare provider that ultimately are granted in the interest of healthcare professionals. In these cases a successive registration is required, firstly identifying the institution as beneficiary, and then the healthcare professionals as ultimate beneficiaries.
Decree-Law 5/2017 enters into force on 5 February 2017.
The changes brought by this legal act are envisaged to improve good governance standards in the health sector. Nevertheless it should be noted, that this legal framework entails not only the enhancement of disclosure requirements in relation to interactions between the industry and healthcare services and professional, but also the prohibition of granting any benefits, or sponsorship of scientific venues by pharma and medical devices industries, when SNS institutions are concerned.