international collaboration, biobanking, benefit sharing, commercialization, informed consent, hepatitis C treatment and prevention, liver cell regeneration, vaccine research, biospecimen storage, patients with liver disease
Collaborative research between high-income countries (HICs) and low- and middle-income countries (LMICs) often raise concerns related to fairness and equity in the distribution of benefits and burdens of research.1 To acknowledge and reconcile power and income inequalities between HICs and LMICs, early discussions about equitable sharing of commercial or other benefits that emerged from research that involves human biological materials is important.2
A HIC-based company conducted research on liver cell regeneration in collaboration with the Ministry of Health in a Southeast Asian country. In this country, the prevalence of hepatitis C and mortality from liver disease is high; a substantial number of individuals die while waiting for a liver transplant. Health officials in the country decided to conduct the research, considering the proposed HIC-company-led research responsive to the country’s high rate of illness and death associated with liver failure. It is not known if the research partners developed and executed any type of benefit-sharing agreement.
As a part of the research, the HIC-based company proposed to store liver cells collected from participants for use in future studies toward developing a cure for hepatitis C. The company built a state-of-the-art laboratory in the country to support the research study while underway, but because of the lack of adequate regulatory systems and trained personnel to maintain comprehensive quality standards, liver cells were shipped to the HIC for long-term storage.
The research team distributed informed consent forms to potential research participants for enrollment in the study as well as for collection and storage of harvested liver cells for future research. Participants were informed about the possibility that stored cells had commercial value and might be patented and licensed in the future. No financial compensation was provided to study participants for taking part in the study or for donating biological specimens.
The study generated significant results. The findings were published in a peer-reviewed international journal, and the regeneration technology was patented by the HIC-based company researchers. The HIC-based company also used the liver cells donated by study participants toward developing a hepatitis C vaccine. As a part of the original collaborative study agreement, the HIC-based company agreed to waive treatment costs for follow-up care until liver transplantation had occurred for all study participants. However, patients with liver failure had to pay full cost for the novel therapy that had been developed as a result of the original study: an unaffordable amount for individuals living in the study country. The country’s Ministry of Health threatened to sue the company since they believed all study participants would continue to access the newly developed treatment at a reduced cost. The government also claimed ownership of the donated liver cells and demanded a share of the profits from the new vaccine.
Questions
Prior to initiating the study that collected biospecimens, logistical and administrative challenges related to storing the cells were not identified. Was it appropriate not to have a protocol in place for sample storage in the host country?
The study’s informed consent form included consent for treatment and long-term storage of biospecimens. What additional information should have been mentioned in the consent form?
What measures should have been taken to avoid the conflict that took place between the host government and the researchers with the HIC-based company? Should there be a standardized ethical guideline for sharing of human biological material in international collaborative research? If so, what should be addressed in such a guideline?
*Facts of the case adopted from the case by Harnawan Rizky.
