On 6 January 2017, Decree Law 5/2017 was published in Portugal approving the general principles of advertising of medicines and medical devices and establishing the rules concerning scientific actions to be carried out in establishments, services and bodies of the public health service (“Serviço Nacional de Saúde”, hereafter “SNS”).

This law was enacted in response to the need of safeguarding transparency and pursuit of the public interest, more specifically by preventing conflicts of interest in the relationships between pharma industry and healthcare professionals and organizations. It actually follows the guidelines of the European Commission, in particular in the document “List of Guiding Principles Promoting Good Governance in the Pharmaceutical Sector”, which is in line with the need to improve good governance in the health sector.

General Principles
According to the law, the advertising activity must be in accordance with the principles of the primacy of protection of public health, rational use of medicines and medical devices, as well with the principles of integrity, mutual respect, responsibility, moderation, transparency and collaboration with competent authorities. These principles must now be accomplished by distributors of medicines, marketing authorization holders, manufacturers and distributors of medical devices throughout its advertising and promotion activities. All this reflects the enhancing of the ethical standards in this area of health.

Granting of benefits or sponsorships to institutions within SNS
From now on, all establishments and services of the SNS – which does not include natural persons or legal persons other than those, such as health professionals or any other workers of the same establishments, as well as associations, scientific societies or others – are prohibited to receive or encourage the granting of any kind of pecuniary benefit from entities that supply medicines, medical devices and other health technologies. However, there is an exception for this prohibition if such benefits do not compromise the independence and the impartiality of the SNS institutions. But in this case the benefit has to be duly authorized by the Health Minister.
Likewise, scientific or other actions held in these establishments and services cannot have a promotional approach or be sponsored by entities producing, distributing or selling medicines or medical devices. Nevertheless, this prohibition does not affect the visits and access by sales representatives of medicines and medical advices, in accordance with Order No. 8213-B/2013 of 24 June.

Transparency
One of the most important changes introduced by this framework concerns the transparency requirement in the relationship between suppliers of medicine and medical devices, on one hand, and healthcare organizations and professionals, on the other hand, which is now strengthened.
This law introduces the legal definition of “Benefit”, which means any advantage, value, good or duty valuable in cash, regardless of the form of its granting.
Henceforth, whoever grants any benefit to any entity is obliged to report it within 30 days as from the effective date of the benefit in Infarmed’s website (https://placotrans.infarmed.pt/).    After this communication, INFARMED notifies the receiver, who has other 30 days to validate the receipt of the benefit or transmit its non-validation. Actually, it is mandatory to those who receive this benefit to confirm it or to transmit their reasoned non-confirmation to INFARMED. Moreover, the receivers are required to refer this fact in all documents issued in the scope of its activity and intended for public disclosure.

Decree-Law 5/2017 came into force on 5 February 2017.