Scientific Colonialism in Rare Diseases: New Ethical Guidelines
In 2018, a transnational initiative approved a new document to ethically guide scientific collaborations involving high- and low-income countries.
The document entitled "Global Code of Conduct for Research in Resource-Poor Settings" (1) aims to combat "ethical dumping", i.e. the conduct of exploratory and unethical research in low-income countries, which often relies on the use of different ethical standards or less supervision.
Unfortunately, for centuries, such predatory scientific practices have been – and continue to be – conducted in the Global South (2).
This scientific colonialism, also known as parasitic science, is practiced by researchers from high-income countries who extract data and samples from regions or populations of low-income countries without establishing an equitable distribution of long-term benefits with local partners (3).
In order to overcome this reoccurring practice, government institutions such as The European Commission, a variety of universities, research centres and renowned journals, such as Nature (2), have begun to incorporate four principles into their guidelines: justice, respect, care, and honesty (2).
The principle of justice determines that imbalances of power, resources, and knowledge between countries of different income levels should be considered, especially in discussions on the distribution of benefits (Article 6). Thus, research that does not produce local benefits should be considered unethical, given that it results in local burden without producing any benefits to the populations involved (Article 1).
The principle of respect stipulates that the cultural characteristics of the host country must be respected in order to avoid violating its usual practices (Article 8).
In situations where regulations protecting participants, animals, or the environment are insufficiently adequate, the principle of care prescribes that scientific research must always be carried out in accordance with the highest ethical standards (Articles 17 to 19).
Furthermore, where investigations cannot be carried out in high-income countries, due to specific local conditions (e.g. in the case of low-prevalence diseases), the principle of care authorises such research to be conducted exceptionally in low-income countries if the "comply or explain" rule is applied (Article 14).
Finally, in accordance with the principle of honesty, employees must clearly understand their roles, responsibilities and conduct throughout the investigation cycle, prioritising the training of local researchers (Article 20).
In the context of rare diseases, whose prevalence affects a low number of individuals, the observance of these principles becomes healthy, since the cycle of pharmaceutical innovation of orphan drugs can involve a network of scientific collaboration of countries with different incomes, generating better results in the approach to rare diseases, according to Fajgenbaum (4).
However, historically, the small size of patients with rare disease and the high cost of research and development of new drugs attracts less investment. This condition makes the current pharmaceutical innovation model for rare diseases unfair and promotes unsustainable scientific practices globally.
Thus, thinking about transnational scientific collaborations for rare diseases that notably observe the equitable sharing of benefits for low-income countries is a current challenge.
Given this scenario, this SPIN Project proposed the term “social pharmaceutical innovation” to designate the “novel forms of collaborative processes, programs, policies, procedures and/or designs, involving diverse sets of actors that break with conventional pharmaceutical innovation practices for the production of safe, effective, and accessible interventions that address unmet societal needs of rare disease patients and that are not primarily market driven” (5).
Therefore, results of this SPIN Project lend themselves to ethically contributing to the realisation of alternative pathways for pharmaceutical innovation that, thereby, promote a higher social purpose.
Trust. Global Code of Conduct for Research in Resource-Poor Settings, 2018. DOI: 10.48508/GCC/2018.05.
NATURE EDITORIAL. Nature addresses helicopter research and ethics dumping. Nature, v. 606, p. 7, 2022.
ODENY, Beryne; BOSURGI, Raffaella. Time to end parachute science. Plos Medicine, v. 19, n. 9, p. e1004099, 2022.
FAJGENBAUM, David C. et al. The collaborative network approach: a new framework to accelerate Castleman's disease and other rare disease research. The Lancet Haematology, v. 3, n. 4, p. e150-e152, 2016.
DOUGLAS, Conor MW et al. Social pharmaceutical innovation and alternative forms of research, development and deployment for drugs for rare diseases. Orphanet Journal of Rare Diseases, v. 17, n. 1, p. 1-13, 2022.
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