The importance of clinical research for developing new treatments and discovering cures for diseases is indisputable. However, the degree to which patients benefit from participating in clinical trials and whether they should have post-trial access to experimental treatments are highly disputed, especially in Brazil where free universal healthcare is a constitutional right.
The National Health Council (CNS) has issued important ethical guidelines for clinical research which follow all major global standards, including:
- the Universal Declaration on Human Genome and Human Rights;
- the Declaration of Helsinki; and
- the Universal Declaration on Bioethics and Human Rights.
The CNS National Research Ethics Committee is responsible for implementing the normative guidelines regulating ethical aspects of research involving human beings. The committee has a consultative, deliberative, normative and educational role, acting jointly with a network of local research ethics committees in public and private research institutions.
Generally, ethics committees should review all research protocols – their primary responsibility is safeguarding the integrity and rights of research subjects. The ethical aspects of research protocols must:
- respect research subjects' dignity and autonomy;
- weigh risks and benefits;
- avoid or minimise predictable damages;
- be socially relevant; and
- be fair and equitable.
However, post-trial access is being debated and generates uncertainty for pharmaceutical companies willing to initiate Phase III studies. Under existing CNS regulations, sponsors must grant research subjects access to the "benefits of the trial" (ie, the drug or treatment under research). Therefore, if a patient benefits from a clinical trial that had negative results, he or she may bring the discussion to court and the sponsor may be ordered to grant access to the drug or treatment on a post-trial phase for an indefinite period.
The House of Representatives is discussing clinical research and post-trial access as part of a new legislative bill. Under the existing bill, sponsors must provide their patients with products that benefit their health at no cost and for an unlimited period; however, the supply may be interrupted if:
- the patient or its legal representative ends the treatment;
- the disease is cured;
- safety concerns arise;
- health benefits are unlikely (considering results from an externally conducted risk-benefit analysis);
- an adverse event makes the treatment unfeasible;
- obtaining or manufacturing the drug is justifiably impossible for technical or safety reasons; or
- the drug becomes available through the Unified Health System.
As Congress is likely to propose and make amendments, senators should re-examine the bill before voting on it. Further, it must be sanctioned by the president (with or without vetoes).
When the bill is finally published, sponsors, investigators and research subjects can expect greater clarity on the post-trial access issue and their rights and obligations when conducting or participating in clinical research.
For further information on this topic please contact Elysangela de Oliveira Rabelo at TozziniFreire Advogados by telephone (+55 11 5086 5000) or email ([email protected]). The TozziniFreire Advogados website can be accessed at www.tozzinifreire.com.br.
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