The Spanish association of pharmaceutical companies (“Farmaindustria”) has updated the Code of Good Practice for the Pharmaceutical Industry (“Code”), which came into force last 1 January 2021. This amendment is mainly aimed to introduce to section 14.2 of the Code a new definition and regulation for non-interventional studies in accordance with the provisions of the new Royal Decree 957/2020, of 3 November, which regulates non-interventional studies with medicines for human use (“RD 957/2020”). The RD 957/2020 came into force last 2 January 2021.
A closer look
As a result of this update, the following changes are introduced:
- Section 14.2 of the Code (non-interventional studies): the Code makes a clearer difference between clinical trials and non-interventional studies with medicines for human use. A new definition is embedded for non-interventional studies with medicines for human use, which coincides with the definition set forth by RD 957/2020. In particular, these studies are defined as those studies which imply collecting health data from individuals, as long as these studies do not meet the conditions to be deemed as clinical trials. Furthermore, the purpose of non-interventional studies is either to: (i) determine the beneficial effects of medicines and their modifying factors; (ii) identify adverse effects of medicines, other risks for patients’ safety and their modifying factors; or (iii) obtain information regarding the usage patterns of medicines. The aim of these studies is to complete the information for medicines of human use without interfering with usual clinical practice.
- Section 17.8 of the Code (Events/gatherings and hospitality): it is reinstated that, in the event that pharmaceutical companies organize or promote events/gatherings out of Spain because the relevant course or expertise to be attended is located abroad, the Deontological Supervision Unit has to grant its prior authorization.