Preclinical and Clinical Trial Requirements
Key info on preclinical and clinical trial requirements in Ecuador. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for USD 99.
As a general introduction, Clinical Trials are regulated in Ecuador via Ministerial agreement (MA) 0075-2017 related to regulations for the approval, development, monitoring and control of clinical trials. This regulation was enacted on June 30th, 2017. There are other rules and regulations which make MA 0075-2017 enforceable.
The Constitution of the Republic of Ecuador in subparagraph d), 3, of Section 66, prohibits the use of genetic material and scientific experimentation that violate human rights.
Every person without discrimination has in relation to health the right not to be the subject of tests, clinical trials, laboratory or research, without their knowledge and prior written consent, nor be subjected to tests or examinations diagnoses, except when the law expressly determines it or in case of emergency or urgency in which his/her life is in danger, as determined in article 7, literal l) of the Health Law.
The Code of Childhood and Adolescence, in Section 20 expresses: “Right to life. Children and adolescents have the right to life from the moment of conception. It is the obligation of the State, society and family to ensure by all means, their survival and development. Medical and genetic experiments and manipulations may not be conducted on pregnant women, children or adolescents, nor the use of any technique or practice that endangers the lives or affects the integrity or integral development of any of the aforementioned.”
It is ARCSA’s responsibility “to approve clinical trials of medicines, medical devices, natural products for medicinal use and other products subject to registration and sanitary control based on regulations issued by the HM.”
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
Clinical trials must be conducted under conditions that ensure respect for human dignity, human rights, autonomy, informed consent, precautionary principle, personal integrity, privacy, confidentiality, equality, justice, equity, discrimination, cultural diversity and well-being of people. According to our law, rights, safety and well-being of individuals and society will prevail over scientific and economic interests. Therapeutic benefits and the risks and disadvantages for the subject of the trial and for public health will be evaluated.
2. How are clinical trials funded?
Clinical trials are generally funded privately. In order to carry out a clinical trial in our country, all persons, whether public, private, national or foreign who are sponsoring the trial, must request prior approval from ARCSA, who will also verify and inspect compliance with legal, ethical and methodological aspects for the development of the clinical trial in the country, before, during and after it is carried out, as well as all aspects related to research technology.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
To authorize a clinical trial, ARCSA will request the sponsor to submit the necessary documents in Spanish or its official translation, duly legalized either by Apostille or Ecuadorian Consulate. Requirements for preclinical and clinical trial protocols are those defined in Section 8 of MA 0075-2017.
Approval for conducting clinical trials are made by ARCSA, who must abide by the Constitution of the Republic of Ecuador; the directives contained in the Declaration of Helsinki (PARF network); CIOMS guidelines; and Good Clinical Practices established by agreements to which Ecuador is part of.
4. What are the requirements for consent by participants in clinical trials?
Participants must voluntarily submit to clinical trials. Participants must be previously informed about the trial, which must be accepted through an informed consent document. These people may or may not suffer from diseases. The research subjects will be supplied with the investigational product or the product that is used as a control, once their informed consent or that of their legal representative has been obtained, in the corresponding cases.
Clinical trials conducted with senior people, people with disabilities, people deprived of their freedom and those suffering from catastrophic and highly complex diseases, because they are considered priority or vulnerable care groups, should be of specific interest and limited to those that by their nature can only be carried out with these population groups.
In women of a reproductive age and who have consented to participate in a clinical trial, prior to starting the same, the need to confirm the participant is not pregnant is indispensable. Access to and use of an effective contraceptive method must be ensured during the development of the clinical trial, which will be provided at no cost by the sponsor, during the entire time of their participation in the study, including male subjects.
For clinical studies conducted in indigenous towns and on indigenous peoples, in addition to an individual informed consent, a prior community consultation should be conducted, which should be favorable to the completion of the study. Additionally, approval from the authorities of the community involved in the case must be obtained. Said approval must be included in a document duly signed by these authorities, copy of which will be attached to the procedures for requesting approval to conduct the clinical trial. It will not be possible to carry out clinical trials in villages in voluntary isolation.
In these clinical studies, sponsors and researchers should develop culturally appropriate ways and means with anthropologists, sociologists and translators, to communicate to the participants in the research, all the necessary information regarding the trial and meet the standard required in the informed consent process. In addition, the research protocol should describe and justify the procedure they plan to use to communicate the information to the subjects under investigation.
5. May participants in clinical trials be compensated?
In exceptional cases, clinical trials participants may be compensated economically,
keeping in mind they must be healthy adults.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
Good Clinical Practices (BPC) are regulated by ARCSA and must be observed during trials. ARCSA will periodically inspect and control BPC’s are complied with under penalty of declaring the continuity of the trial. Sponsors must establish a plan to remediate any inconformity or safety of the participant.
A liability insurance policy must be provided by sponsor to participants and in those cases where such policy does not cover/apply, sponsor will be responsible for relief of any harm or damages suffered by participant. Sponsor will guarantee and provide free medical assistance until all health problems are solved, derived from their participation in a clinical trial.
Economic compensation must be provided by sponsor to participant in case of evidence of harm or damage and its causal relationship with the product under investigation.