Who should pay for the continuity of post-trial health care treatments?

Abstract

Background The bioethical debate in the world on who should pay for the continuity of post-trials treatment of patients that have medical indication remains obscure and introduces uncertainties to the patients involved in the trials. The continuity of post-trial treatment was only incorporated in the 2000s by the Helsinki Declaration. The Universal Declaration on Bioethics and Human Rights, published in 2006, points out that post-trial continuity may present a broader scope than just the availability of the investigated medicine. In the latest version of this Declaration, in 2013, it was stated that “prior to the start of the clinical trial, funders, researchers and governments of the countries participating in the research should provide post-trial access for all participants who still require an intervention that was identified as beneficial. This information should also be disclosed to participants during the informed consent process”. However, a systematic review on the registration of phase III and IV clinical trials, from the clinical trials website, demonstrated that the understanding of the various guidelines and resolutions is conflicting, generating edges in the post-trial setting. For the health authorities of countries where clinical trials take place, the uncertainties about the continuity of the treatments generate gaps in care and legal proceedings against health systems, which are forced to pay for the treatments, even if they are not included in the list of medicines available to the population. Methods Fifty-one representatives from the health, judicial, legislative, patient and academic organizations of eight countries of Latin American and South Korea took part in a meeting in Chile, in 2017, to discuss the responsibility of the treatment continuation after clinical trials. From a hypothetical case of development of a new drug and its studies of efficacy and safety, the participants, divided in groups, proposed recommendations for the problem and pointed out the pros and cons of adopting each recommendation. The groups were, afterwards, confronted by a simulated jury and, finally, issued a final recommendation for the problem. Then, an analysis was made on the content of the recommendations and the pros and cons in adopting conservative or liberal positions, besides the possible impacts of a restrictive regulation regarding the conduction of clinical trials, pointed out by the groups, before and after the simulated jury. Results The theme was widely discussed and about 12 recommendations were proposed by the participants. The main ones took into account aspects related to patients’ rights, economic factors and the development of new technologies, above the position of industry and research institutes, as well as the legislation in force in each country. Conclusion The countries of Latin America and South Korea, currently, do not have laws that address patients’ rights, moreover, there is no...

Realizing the right to health in Latin America, equitably

“…Third, papers analyzing the role of judicialization as a mechanism to ensure the right to health of populations and what it is currently playing across some of the countries in the region in this area [ 2 , 16 , 23 , 26 ]. Fourth, the summary presents the studies that try to elicit underlying policy factors to the equitable realization of the right to health across countries [ 14 , 15 ].…”

“…Judicialization has begun to be complemented by upstream mechanisms that could aim to reduce, upstream, potential inequalities within and across countries in the Latin America and Caribbean Region [ 14 , 15 ]. Used a participatory research approach with representatives from eight countries in Latin America and South Korea to explore the role of confidentiality agreements as a tool for market regulation and recommendations for their use.…”

“…This paper calls for international regulation, so all countries have access to the same information and not restricted by confidentiality agreements. The stakeholders participating in the research suggest the establishment of standardized processes agreed across countries, for the negotiation of drug prices that replace confidentiality agreements and foster transparency of drug prices and improve cross-country equity [ 14 , 15 ].…”

“…Additionally, the pros and cons of continuity of payment for post-trial care, was explored by [ 14 , 15 ], also through a participatory research approach. Mechanisms ensuring the continuity of post-trial health care treatments, preventing financial ruin of individuals and families participating on clinical trials, have been proposed in the region for progress towards an equitable realization of the right to health.…”

“…Mechanisms ensuring the continuity of post-trial health care treatments, preventing financial ruin of individuals and families participating on clinical trials, have been proposed in the region for progress towards an equitable realization of the right to health. The final consensual recommendation was a World Health Organization resolution recommending all countries call for the medicine and medical device industries, governments, or the sponsors of the clinical trials, to ensure the continuity of care and prevent cross-country inequity as well as detrimental effects on patients and their families once trials end [ 14 , 15 ].…”