Legal alert no. 12 | CTSU | News & Resources has been added to your bookmarks.
Legal alert no. 12
On January 6th, it was published, in the Official Gazette of the Republic of Portugal, the Decree-Law no. 5/2017, which establishes general principles of advertising medicines and medical devices.
Advertising medicines and medical devices includes several activities, namely, simple promotional actions, strictly scientific activities, and commercial events. The addressees of such activities are varied, such as the general public, healthcare professionals, and institutions, departments and bodies of the National Health Service (NHS). Thus, in this field, advertising requires the establishment of a set of rules aimed to regulate and to ensure the protection of each of the above mentioned groups, with a special emphasis on the promotion of a culture of transparency and accountability.
Accordingly, the above mentioned Decree-Law approves general principles of advertising medicines and medical devices, namely the principle of integrity, the principle of respect, the principle of responsibility, the principle of moderation, the principle of transparency and the principle of collaboration, which are based on the guidance of the European Commission, in particular, on the List of Guiding Principles Promoting Good Governance in the Pharmaceutical Sector, and aim to guide the activity of all the parties involved in the advertising sector related to medicines and medical devices.
Furthermore, this Decree-Law sets rules regarding the scientific activities to be performed in the institutions, departments and bodies of the NHS, which cannot have a promotional nature, nor be sponsored by companies which manufacture, distribute or sell medicines and medical devices.
Moreover, the Decree-Law no. 176/2006, of August 30th (establishes the legal framework applicable to medicines for human use) and the Decree-Law no. 145/2009, of June 17th (establishes the rules applicable to the investigation, manufacturing, commercialization, placing in service, vigilance and advertising of medical devices and relevant accessories) are amended once again, in accordance with the new legal framework.
Lastly, the legal provision of the legal framework applicable to medicines for human use which foresees the National Council of Advertising Medicines is revoked, taking into account that this Council is currently foreseen in article no. 9 of the Decree-Law no. 46/2012, of February 24th, which approves the organic statute of INFARMED – National Authority of Medicines and Health Products, P.I.
To access the wording of the Decree-Law, please click on the following hyperlink: http://data.dre.pt/eli/dec-lei/5/2017/p/dre/pt/html