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Clinical Trials in Portugal 

by Eduardo Finamore Correia, Ricardo Rocha

Published: April, 2021

Submission: April, 2021

 



Research and development ("R&D") of medicinal products is fundamentally important in peoples’ daily lives. This is true both from an individual perspective – when considering the objective of identifying and treating pathologies (with a consequent increase in the quality of life of patients) – and from a collective perspective, when considering the role of R&D in controlling the spread of diseases and in eradicating them altogether.


In abstract terms, R&D activities can be defined as those carried out in humans (who may healthy or ill) to improve knowledge about pathologies, develop new methodologies for diagnosing them and, possibly, identify forms of treatment.


R&D activities are subject to legal and regulatory frameworks and, to carry them out, it is necessary to comply with certain requirements:


i) respect for the principle of human dignity and fundamental rights;


ii) adopting the measures necessary to protect and safeguard privacy, personality rights and the physical and mental integrity of the trial subjects, which inherently includes obtaining of their consent;


iii) compliance with applicable ethical parameters and applicable good practices;


iv) a prior assessment concluding that the potential benefits associated with the trial outweigh the foreseeable risks and inconveniences; and


v) obtaining the legally required approvals.


In general, clinical trials are a universally recognised method to carry out R&D activities. They must Eduardo be planned and controlled meticulously to ensure the scientific validity of the results.


The legislation applicable to clinical trials conducted in Portugal is currently set out in Law 21/2014 of 16 April (amended by Law 73/2015 of 27 July and Law 49/2018 of 14 August), and it is commonly known as the Clinical Research Law (“CRL”). The CRL includes (i) the rules to conduct clinical trials with medicinal products for human use and which results from the incorporation into Portuguese law of Directive 2001/20/EC of the European Parliament and of the Council of 4 April, and (ii) the legislation on clinical research of medical devices, which results from the partial incorporation into Portuguese law of Directive 2007/47/EC, of the European Parliament and of the Council of 5 September.


Under the CRL, “clinical trial or trial” is defined as “any research conducted into human beings, intended to discover or confirm the clinical, pharmacological or other pharmacodynamic effects of one or more investigational medicinal products, or to identify the undesirable effects of one or more investigational medicinal products, or to analyse the absorption, distribution, metabolism and elimination of one or more investigational medicinal products, in order to ascertain their safety or efficacy”.


 


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