At the end of a paper on international research ethics published in the July-August 2010 issue of the Hastings Center Report, London and Zollman argue the need for grounding our duties in international medical and health-related research within a broader normative framework of social, distributive, and rectificatory justice.Footnote ¹ The same goes for Thomas Pogge, who, in a whole range of publications during the past years, has argued for a human-rights-based approach to international research.Footnote ² In a thought-provoking paper in the June 2010 issue of the American Journal of Bioethics, Angela J. Ballantyne argues that “the global bioethics priority” in medical and health-related research ethics today is how to do research fairly in an unjust world.Footnote ³ Although Ballantyne acknowledges that her maximin model for benefit sharing in medical and health related research “will not undo the macro-level background injustice” that still exists, she seems to share the sensitivity of the three other authors with regard to the need for moving the ethics focus in international research from the microlevel of informed consent and of quasi-consensual transaction procedures to a level of deliberation that includes as well issues of macrolevel distribution of basic goods and opportunities.

Second and third things these four scholars have in common are their mother tongue language (Anglo-American) and their muteness with regard to the fact that there exists today a universal and human-rights-based framework in bioethics, the Universal Declaration on Bioethics and Human Rights. This normative framework was adopted by acclamation in October 2005 by all 192 member states of the United Nations Educational, Scientific and Cultural Organization (UNESCO) and deserves, I believe, more attention than has hitherto been the case in the debates about international research ethics. The aim of this paper is threefold:

• • To illustrate by way of some disturbing facts why there is a need for a universal normative framework in international research

• • To identify current and potential pitfalls on the way toward such a framework

• • To propose a strategy for developing a universal normative framework for international research and benefit sharing which is rooted in—and in compliance with—the principles set out in the Universal Declaration on Bioethics and Human Rights.

As a preliminary to such an investigation I suggest a reading of the famous narrative about the striving for a universal language in Genesis 11, that is, the narrative of the Tower of Babel, and through this reading to draw attention to some of the possibilities as well as unacknowledged pitfalls involved in the attempt at building a universal normative language for international research.Footnote ⁴

My first observation is that the Tower of Babel is not just an allegory about the loss of a unifying language. It is also a narrative about the negative and positive implications of such a loss. Finally, it is a narrative about the potential of hubris embedded in the striving for a world in which nobody falls apart, that is, a world in which everybody is linked to each other through “one language and a common speech,” to quote the Biblical author.

When the descendants of Noah moved eastward and settled in Shinar, they were in the privileged possession of a global community speaking the same language. For this reason, says the Biblical author, they were living unified lives void of any form of confusion. Besides, the common speech functioned as a safeguard against dispersion of lives; everyone became an inhabitant of the global city. Nobody got lost. What this part of the narrative unveils to the reader is the unifying power of common speech: it binds people together; it builds and preserves a community so that nobody falls apart. When we compare this situation of harmony and unity with the language situation of international research ethics, it may seem reasonable to say that the different stakeholders here live in dispersed communities in need of a language that could bridge the gaps between the peoples in the world and do away with the confusions and disparities between them. Consequently, the quest and striving for a universal normative language in international research also seems to be a morally and legally justifiable endeavor.

It is in view of this perception that the second part of the narrative about the Tower of Babel may contain some fruitful clues for further deliberation. That brings me first to an earlier chapter of Genesis, chapter 9, where the author gives an account of God’s Covenant with Noah and his descendants: “Then God blessed Noah and his sons, saying to them, ‘Be fruitful and increase in number and fill the earth’” (Genesis 9, 1).

This, according to the Biblical author, was their prime mission and responsibility. However, instead of pursuing these noble goals, they turned their attention elsewhere: to the building of a tower to empower and glorify themselves. At first sight this may seem to represent a completely irrelevant part of the narrative, as the end result communicated is Jahve’s punishment in terms of linguistic confusion. A second reading, however, may raise the critical question of whether the striving for a universal normative language in international research may take on a role that stands at risk of turning the attention away from the primary responsibilities of such research and of abandoning the normative bedrock of clinical and health-related research involving human subjects. In the second part of my paper, I return to this conception of “normative bedrock.”

Disturbing Facts about the Normative State of Affairs of International Research

Since 1996, the global community of research policymakers, researchers, and bioethicists has been aware of the so-called 10/90 gap in medical and health-related research. This metaphor was introduced to depict the monstrous inequity in the world with respect to whose diseases are favored in ongoing or planned research programs. In concrete terms, this means that at least 90% of the economic resources spent annually on medical and health-related research are targeting the health needs of the richest 10% of the world’s population, something that implies that the needs of 90% of the world’s population have to be met from the remaining 10% of research funding.Footnote ⁵ Unfortunately, figures from recent empirical studies give reasons for believing that this gap has not diminished, although during the past 15 years the number of people from poor and low-income countries enrolled in clinical trials has substantially increased.Footnote ⁶ On the contrary, evidence from these studies suggests that during this trial period the relative availability of new drugs to populations in poor and low-income countries has not increased, and the gap between wealthy nations and poor and low-income countries with regard to who benefits from the advances of clinical research and development continues to widen.Footnote ⁷ This situation, I believe, makes it justifiable to claim that international research today is not only carried out in a global climate of gross “background injustice,” to use Ballantyne’s wording; by the concerted action of powerful stakeholders in the affluent parts of the world, international research actively contributes in itself to maintaining this injustice instead of reducing it.

I make use of two examples to substantiate this claim. The first relates to the existing regime of intellectual property rights pertaining to medical innovations and their tradable products. The second example relates to the latest revisions of the Declaration of Helsinki, the CIOMS International Ethical Guidelines in Biomedical Research and several other international normative regulations in the field.

To illustrate the relevance of the first example, I make use of some of the observations made and arguments developed by Pogge in his paper “Intellectual Property Rights and Access to Essential Medicines.”Footnote ⁸ Although the existing intellectual property regime for pharmaceuticals, that is, the so-called TRIPS regime (Trade-Related Aspects of Intellectual Property Rights), is presented as the most efficient and cost-effective way of promoting medical innovations, it is for several reasons “morally deeply problematic,” to use Pogge’s wording.Footnote ⁹ To give weight to his argument, Pogge invites the reader to participate in a tentative assessment of the effect of this regime on the four main affected groups: (1) the pharmaceutical industry and its researchers and shareholders, (2) actual and future patients in the affluent part of the world, (3) generic manufacturers of medicines, and (4) actual and future patients in poor and low-income countries.Footnote ¹⁰ The result of his assessment is hardly surprising. The first group of stakeholders benefit grossly from the global enforcement of this regime, whereas the effect on the second group is less clear-cut:

For the third group of stakeholders, on the other hand, the present regime represents a substantial infringement on their possibilities of producing cheaper versions of patented drugs, something which, in turn, reduces the access possibility of cost-saving-oriented patients in the affluent part of the world as well as of patients in poor and low-income countries to cheaper and/or affordable medicines.Footnote ¹² Finally, for the group of stakeholders most in need, the TRIPS regime is undoubtedly “socially harmful” in a dramatic way: “Millions of deaths from AIDS and other treatable or curable diseases,” says Pogge, “are due to the suppression of manufacture and trading of generic drugs.”Footnote ¹³

Taking into account that the TRIPS regime represents an initiative from democratic governments in the affluent parts of the world and enforced upon the global community in ways that do not comply with the principles of transparency and “dominance-free dialogue,” to use Jürgen Habermas’s famous conception,Footnote ¹⁴ it is due time, I believe, to state that these governments—because of their unwillingness to change this regime—should be held accountable for lending support to gross human rights violations in the name of medical and health related research. Or, to formulate this statement from the vantage point of the narrative of the Tower of Babel, the language of the TRIPS regime is not a genuinely universal normative framework that makes everyone an inhabitant of the global city. On the contrary, its effect is that large numbers of the poorest communities and peoples in the world fall outside the possibility of accessing the fruits of medical innovations. Thus it becomes clear that the market economic language of the TRIPS regime gives voice to the medical interests and needs of the most powerful inhabitants of the global city and notably at the cost of essential medical needs of millions of the poorest inhabitants of the same city. Or, to dress the problem even more directly in the language of the allegory of the Tower of Babel, the TRIPS regime is a modern example of hubris, of the attempt at building a “twin” tower to empower science and the richest of the rich inhabitants of the global city.

It is, however, not only the enforcement of the TRIPS regime that represents an infringement upon fundamental rights of a much larger number of poor people in the world; also the most recent revisions of international declarations and guidelines in medical and health-related research ethics have contributed to a move of this research in a direction that, normatively speaking, builds barriers between people. The history behind these revisions dates to 1997 when a fierce debate broke out about the ethical acceptability of using placebo as a comparative alternative to established effective treatment—standard of care—in trials conducted in poor and low-income countries for the purpose of preventing prenatal HIV transmission.Footnote ¹⁵ It was during this controversy that the expression “double standards” in relation to clinical research came into use through several papers that denounced the use of different standards for research protocols and participants in the first and in third worlds.Footnote ¹⁶ The core of the double standard argument is that it is ethically justifiable under certain socioeconomic conditions to use different ethical standards in international research. It means that a local standard, that is, the status quo of the community, should be the suitable normative baseline for evaluating international research initiatives. Consequently, the basic level to build the ethical norms to evaluate biomedical research is the contextual situation of each community.Footnote ¹⁷

This debate had a direct impact on the latest “development” of the Declaration of Helsinki, in the sense that some of its strongest commitments with regard to protecting the interest and welfare of individual research participants and vulnerable communities came under fierce pressure from different voices that represented research and policy institutions in the USA, in Europe, and the international pharmaceutical industry. For these reasons the Declaration of Helsinki underwent in 2002 and 2008 new substantial revisions to try to accommodate the interests of these powerful voices and facilitate the conduct of clinical trials in poor and low-income countries.Footnote ¹⁸ These revisions, as, for example, the facilitation of the use of placebo, the dilution of the requirements of care in such situations, and the reduction of sponsors’ posttrial responsibilities toward research participants and host communities, have been heavily criticized as ethically untenable, as being contrary to the idea of a human’s dignity and human and social rights, as offending people’s integrity and as injuring the Declaration of Helsinki’s own notion of justice. For these reasons, it has also been suggested to abandon the sixth version of the Declaration of Helsinki and instead embrace the Universal Declaration on Bioethics and Human Rights (2005) as an appropriate ethical and normative frame of reference.Footnote ¹⁹

When we view this situation in light of the narrative of the Tower of Babel, I believe it becomes evident that the revised version of the Declaration of Helsinki cannot any longer be said to represent a universal language that, normatively speaking, binds together all the people in the world. On the contrary, the present version of the Declaration represents a language that gives ethical legitimacy to the research interests of powerful public and private stakeholders in the affluent parts of the world while research participants and populations in poor and low-income countries risk being turned into victims of alterable forms of vulnerability, that is, forms of vulnerability that could have been dealt with through affirmative and context-sensitive forms of actions of a social and remedial kind.Footnote ²⁰ As was the case with the development of the TRIPS regime, the result of the last revisions of the Declarations of Helsinki is therefore not a language of unification but a language that paves the way for new forms of exploitation of impoverished peoples and communities and notably in the name of international research.

Pitfalls on the Way toward a Universal Framework in International Research Ethics and Benefit Sharing

I now turn more directly to the message conveyed in the narrative of the Tower of Babel in the sense that I focus on pitfalls that are related to the power struggle on the level of language in today’s international research.

This brings me back to the dominance of the market-driven language of the TRIPS regime and the insurmountable barriers this language has caused for poor and low-income countries with regard to the possibility of accessing essential medicines. As argued by Pogge, this regime not only reduces the access possibility of existing drugs for millions of people in great need, it also hampers dramatically development of new, essential medicines targeting ailing people in the poorest parts of the world. For this reason Pogge suggests introducing an additional patent language for drug innovation—a patent 2 regime besides the existing TRIPS regime—covering the field of new essential drugs. Pogge discusses two possible models, the push model and the pull model. Here I focus on the second model, because I believe it resonates better with a human-rights-based approach to international research. The first element, which is common to both models, is that essential medicines should no longer be considered private goods protected by the TRIPS regime but as public goods freely accessible to any drug manufacturer in the world to make use of it in terms of generic drug production. This open—and costless—access element must, however, be supplemented with an alternative incentive for research; if not, the original drug producer would lose most of its income from its innovation. For this reason, Pogge suggests the introduction of a global burden of disease (GBD)-oriented research incentive, that is, an incentive that is directly tied to the effect a new essential drug has on the reduction of the global burden of disease. In Pogge’s own words, the idea goes as follows:

From the perspective of the principle of benefit sharing (Article 15 of the Universal Declaration on Bioethics and Human Rights, which I will come back to in the last part of my paper), this supplementary patent regime has several attractive assets. First, it would stimulate close collaboration between the patent holder and generic producers to mass produce the drug so as to “enhance affordability and availability of its medicines to poor patients and hence their favorable impact on the GBD”Footnote ²² (p. 22). Second, with such a model in place there would be an incentive for the patent holders to ensure that all patients for whom the drugs would have an essential health impact “have real access to them.”Footnote ²³ Third, it would represent a powerful incentive toward developing not only new treatments for chronic patients (the most lucrative target group under the present TRIPS regime) but treatments, including vaccines, that will “reduce the GBD in the most cost-effective way,”Footnote ²⁴ something that would imply a much more intensive research focus on the ailments of the poorest of the poor in the world. Finally, with the implementation of a patent 2 language to stimulate the development of essential medicines, the drug innovators would in addition have a powerful incentive to help poor and low-income countries to improve their healthcare systems so as “to enhance the impact of their inventions there.”Footnote ²⁵ From the vantage point of the Tower of Babel, this supplementary patent language would mean that large numbers of the poorest communities and peoples in the world no longer would be left out when the benefits of medical innovations are distributed. In addition, it would help to bring together stakeholders that under the present regime live apart from each other and often in sharp opposition to each other, that is, drug developers and the generic drug producers.

The second power struggle between languages I focus on in this part of my paper is the dominance and impact of analytical philosophy and procedural language among bioethicists dealing with the ethics of international research. I start by recalling the values and principles that should underlie and guide all clinical and health-related research, be it national or international research. This leads me first to a formulation that for decades—albeit in slightly different versions—has been considered the normative bedrock of clinical research, that is, that the interests and welfare of the individual should have priority over the sole interest of science or society (Universal Declaration on Bioethics and Human Rights, Article 3.2). In spite of the past years’ multiple revisions of the Declaration of Helsinki, the core of this formulation has prevailed also in this influential normative document, although in the latest revision individuals seem to have been stripped of any other interest in this context than their own well-being!Footnote ²⁶ This formulation demonstrates in a succinct way that in clinical and health-related research not only are the interests of several stakeholders at play, but also that the interest of one of these “players”—the individual research participant—should take precedence over all other interests. Except for the explicit reference made to the welfare or well-being of individual research participants, it is not immediately clear from these formulations what other interests are envisaged or what kind of interests research participants are in the need of being protected from. Recalling the nature of scientific inquiry and the history of clinical research, it is, however, not difficult to understand that although clinical research may be said to be driven by two aims or desires, scientific curiosity and the generation of empirical knowledge that might benefit patients and society, there is always the danger that ethical boundaries might be transgressed in the attempt to achieve tangible benefits. For this reason, it also becomes clear that it is not sufficient for a clinical research project to comply with the epistemological requirements of scientific validity to be deemed ethically justifiable. What is needed in addition is that the project be committed to respecting and protecting the interests and welfare of research participants. In the Universal Declaration on Bioethics and Human Rights this commitment to respecting and protecting the interest and welfare of research participants is given a triple justification, first, as a recognition of the dignity, human rights, and fundamental freedom of research subjects (Universal Declaration on Bioethics and Human Rights, Article 3.1); second, as an institution for protecting the integrity and interests of individuals and groups of special vulnerability against the interests held by the majority or by those in power (Universal Declaration on Bioethics and Human Rights, Article 6.3 and Article 8); and, third, by linking the search for knowledge in clinical research to the principles of harm and benefit (Universal Declaration on Bioethics and Human Rights, Article 4).Footnote ²⁷

Unfortunately, in existing declarations and guidelines of international research ethics, there is still no sign of this triple justification; on the contrary several attempts have recently been made at diluting this commitment so as to comply better with the macrolevel interests of science and society. This brings me first to the latest attempts at revising the principle of informed consent by the introduction of “broad” and even “open” consent procedures into the discussion.Footnote ²⁸ These conceptions are now spreading rapidly, especially in international genomic research but also to other branches of international research, and their impact on the normative language of international research will continue to grow if concerted actions by the critics of these language changes are not undertaken. The danger of these conceptions is that, although the official justification for their introduction is that such revisions of the principle or procedural measure of informed consent are necessary to make it comply with a scientific reality undergoing rapid change, the implication of these so-called revisions is a depletion of the procedural measure of informed consent of any moral bearing. “Open consent, if not a contradiction in terms, is a moral illusion disguised as a pragmatic device to serve the narrow interests of closed researcher mindsets. It represents the inevitable end of a language game, which aims at overcoming the moral primacy of the human being in research by installing the priority of scientific and societal interests in its stead.”Footnote ²⁹ As a consequence of this, the normative bedrock of clinical and health-related research is in serious danger of being turned upside down, so as to fit the macrolevel interests of the two most powerful players in the field, that is, science and society.

It is, however, not only through a revision of the principle and procedural measure of informed consent that attempts are made at undermining the normative bedrock of clinical and health-related research. Efficient attempts have also been made, notably through the concerted actions of some of the leading analytical minds in Anglo-American bioethics to rock the normative bedrock of clinical research through focusing the attention on two other key principles in research ethics, benefit and harm, and through the introduction of the so-called fair benefit approach in international research ethics.Footnote ³⁰ At first reading, this approach seems to be restricted to discussing procedures at the microlevel of best achieving mutually advantageous forms of transactions between consenting and collaborative parties. The existing background injustice is taken as a fact of the world, implying that this position “accepts the status quo in the host community as the appropriate ‘normative baseline’ against which proposed research initiatives” should be evaluated.Footnote ³¹ However, as observed by several critiques, this position profits directly from this background injustice by forcing poor communities and impoverished populations to enter into negotiations about the distribution of benefits in “situations of enormous inequality of bargaining power,”Footnote ³² and with little likelihood of producing “outcomes that satisfy the minimal conditions of fairness that the proponents of this view themselves endorse.”Footnote ³³ Negotiations in such a situation of enforced consent can hardly ever be said to comply with the requirements of appropriate consent procedures. The fair benefit approach, however, does not only violate the requirements of informed consent; in addition, it gives legitimacy to the establishment of forms of collaboration that are clearly exploitative on the part of science of impoverished communities and in ways that are at odds even with their own notion of “mutually advantageous exploitation,” as the conditions of an appropriately informed consent to the transaction cannot be said to have been met.Footnote ³⁴ Last but not the least, the fair benefit approach may lead to situations where leaders of impoverished communities are tempted to sacrifice some of their individuals as research participants for the negotiated benefits of the community at large of serving as host for internationally sponsored research projects. Examples of such benefits may be ancillary health services, healthcare capacity development, or even employment and economic activity. Thus it becomes clear that the introduction of the fair benefit approach into international research ethics not only risks undermining the normative bedrock of clinical and health-related research. Contrary to its name, this language also paves the way for a double form of exploitation of impoverished communities, first, on the level of interaction between science and community leaders and, second, on the level of interaction between community leaders and groups of ailing patients in the same communities “encouraged” to enroll in the hosted studies for societal reasons.

The third form of power struggle on the level of language that deserves attention is the dominance of the English language and Anglo-American mindsets in different activities pertaining to international research ethics. This brings me first to the language situation in relation to attempts at obtaining funding for different ethics capacity building projects. Two prominent examples are illustrative. The European and Developing Countries Clinical Trial Partnership (EDCTP),Footnote ³⁵ which is a European funding organization aimed at promoting clinical research and the building of research ethics capacity in sub-Saharan Africa, also requires applicants from the French- and Portuguese-speaking countries in this part of the world to write their ethics proposals in English. The same goes for The Wellcome Trust in London, which also funds ethics projects in poor and low-income countries. Whether the mother-tongue language of the applicants is French, Spanish, or Portuguese, they are all expected to be able to submit proposals that can compete with proposals written by applicants who are fluent in English. This background difference with regard to fluency in English has, throughout the years, given rise to a new form of distributive injustice in the field of international research and ethics.

To this comes the dominance of U.S.-based funding agencies and U.S.-based ethics brain power involved in the building of research ethics capacity in poor and low-income countries. For example, the National Institutes of Health (NIH) and the Fogarty Foundation provide today approximately 80% of all the funding for research ethics training in Africa.Footnote ³⁶ This fact has, unfortunately, led to rapid promotion of the double moral standard in international research ethics discussed in the first part of my paper, something which is seriously jeopardizing the rights of individuals involved in international clinical studies in sub-Saharan Africa, studies funded mostly by the NIH in the United States and the European Commission in close collaboration with international pharmaceutical companies. As a counterreaction to this dominance of the Anglo-American language and way of speaking of ethics, some countries in Africa and Asia have chosen not to give their training in English anymore so as to avoid the “brain drain” of their students to affluent Anglo-American countries and maintain the plurality of languages as a tool to protect national interests from Anglo-American value dominance (personal communication, Professor Mylène Botbol Baum, Université Catholique de Louvain, Belgium).

This brings me finally to the last point with regard to the power struggle taking place on the level of language in international research ethics, that is, the lack of concerted actions and strategies among the critics of the double moral standard of international research in terms of joint publications and joint policymaking activities to counterbalance the Anglo-American dominance in international research ethics. As observed by Pogge in relation to the implementation of the TRIPS regime:

I think this argument has relevance also with regard to explaining the Babylonian situation of today’s international research ethics.

Toward a Universal Normative Framework for International Research and Benefit Sharing

In this part some tentative reflections are made about possible ways of creating a universal normative framework for international research. This is done by reemphasizing the importance of the core principle of clinical research concerning the primacy of the interest and welfare of research participants and by drawing attention to four articles in the Universal Declaration on Bioethics and Human Rights that so far have garnered little attention in clinical research ethics: Article 8 on human vulnerability and personal integrity, Article 10 on equality, justice, and equity, Article 13 on solidarity and cooperation, and Article 15 on sharing of benefits. The principles suggested in these articles have not been taken into much account in existing ethics declarations, guidelines, and policy documents applicable to international research, at least not with the same force in their application. And I strongly believe that an inclusion of these principles in the ongoing debates about international ethical guidelines for research would represent a first important step toward developing a unifying language in international research ethics.

Of these principles, the principle of vulnerability is probably one of the most disputed principles. Since it was indirectly alluded to in 1979 in the Belmont Report, vulnerability has been attributed with a steadily increasing role and prominence in national and international guidelines and policy documents applicable to medical research, healthcare, and bioethics. The culmination in this regard was marked in 2005 by the integration of this concept as a principle into the Universal Declaration on Bioethics and Human Rights:Footnote ³⁸

Also in the scholarly literature in bioethics and healthcare ethics, the principle of vulnerability has been the focus of avid attention and scrutiny. In looking back at these debates, it is possible to trace the emergence of two seemingly conflicting orientations. On the one hand, there is an understanding of vulnerability prevalent in guidelines and policy documents applicable to medical research, healthcare, or bioethics and promoted by Anglo-American scholars in bioethics. This orientation has given rise to a whole range of restrictive or minimalist conceptions of vulnerability aimed at identifying and categorizing individuals, groups, and populations as vulnerable and tracing the different forms of vulnerability that need to be overcome. On the other hand, a human-rights-based approach to vulnerability has emerged, taking its inspiration mainly from continental European philosophy and differentiating between inalterable forms of vulnerability that require state protection and accidental forms of vulnerability, that is, susceptibility, that need to be handled by additional measures of protection. Thus, the formulations in Article 8 of the Declaration may rightly be seen as an attempt to bring under the same hat two competing conceptions of vulnerability and, consequently, also two distinct moral regimes of protection. The first one is a human-rights-based regime aimed at protecting persistent or universal vulnerability, whereas the second regime aims at handling accidental states and situations of fallen vulnerability, that is, forms of vulnerability requiring additional measures of protection as well as identification of the particular persons and populations in need of protection against forms of harms and wrongs not covered by human-rights-based regimes of protection.Footnote ³⁹

As previously mentioned, since 1996 all member states of the United Nations as well as the global community of medical researchers have been aware of the so-called 10-90 gaps in clinical research. In view of this situation, the bioethics debate was marked in the last decade by a much broader focus on the need for protection of the interests and welfare of poor and low-income communities, something that also resulted in the inclusion of the four articles mentioned above in the Universal Declaration on Bioethics and Human Rights. These inclusions raise the question of what the science policy implications for clinical and health-related research of pursuing the principles of justice, solidarity, and benefit sharing could be.

Article 15, paragraph 1, of the Universal Declaration of Bioethics and Human Rights states that sharing of benefits is a duty that all member states of the United Nations have committed themselves to.Footnote ⁴⁰ Besides, the article states that affluent countries have a particular duty in this respect vis-à-vis poor and low-income countries:

If governments in the affluent part of the world were willing to take the political consequences of such a commitment, this could have profound implications for the way future science policies and research strategies for clinical and health-related research are formulated and implemented. One implication already signaled in the article on benefit sharing is that even when clinical research is conducted in affluent countries in Europe and in the United States these member states of the UN have committed themselves to sharing the benefits of this development not only among themselves, but in particular with poor and low-income countries. Pogge’s suggestion for a supplementary patent regime for essential medicines would represent one way of making such a duty something more than words on paper.

For a sustainable ethics of benefit sharing to become reality, it is, however, not sufficient to develop a global medical science policy and research strategy that takes into account the particular research for health needs of poor and low-income countries. What is needed in addition is the development of national research policies in the richer part of the world that include sustainable plans for how the benefits resulting from these research programs can be shared efficiently with poor and low-income countries. This raises the question of how affluent countries can assist in the coevolution of a fair and global policy on medical forms of scientific literacy and benefit sharing. Six answers will be suggested here.Footnote ⁴¹

The first suggestion is that by focusing attention on ways of involving stakeholders from poor and low-income countries in the design, conduct, and evaluation of their own national research programs (academic stakeholders, members of National Bioethics Committees, and policymakers) affluent countries could contribute to such a development. Second, such a development could be facilitated by giving priority to national research programs in the affluent part of the world that aim at forms of benefit also transferable to poor and low-income countries. A third possibility would be to give priority to national research programs that aim at investigating the role and risks of respect for cultural diversity and pluralism (Universal Declaration on Bioethics and Human Rights, Article 12) in the design, conduct, and evaluation of national research programs. In addition, affluent countries could assist poor and low-income countries in the establishment of economically and socially robust, independent National Ethics Committees with the task of not only supervising the systems of ethical review of research, but also of identifying national research for health needs and of proposing national priorities in clinical research. Fifth, by contributing financially to the creation of a Global Health Research Fund targeting clinical research needs in poor and low-income countries, affluent countries could contribute substantially to the development of a fair and sustainable ethics of benefit sharing in clinical research.

Finally, through the establishment of a North–South and a South–South collaboration between national ethics advisory bodies, a forum could be created where representative ethics stakeholders from poor and low-income countries could work together with equivalent representatives from the affluent parts of the world to create a global medical science policy and research for all strategy that could lay the foundation for a fairer distribution of available resources for clinical and health-related research in the world as well as of the research benefits that hopefully will be generated from such a redistribution. Out of such a collaboration one could also hope that a human-rights-based framework of international research ethics would see the light of day and the promotion of scientific advances committed to human needs and within the framework of respect for human dignity and the promotion of global solidarity become a tangible reality.Footnote ⁴² The vision conveyed in the narrative of the Tower of Babel would then no longer only be dreamers’ dreams.

Epilogue

“Not calculable by algebra, not deducible by logic, but mysterious, effectual, mighty as the hidden process by which the tiny seed is quickened, and bursts forth into tall stem and broad leaf, and glowing tasseled flower. Ideas are often poor ghosts; our sun-filled eyes cannot discern them; they pass athwart us in thin vapour, and cannot make themselves felt. But sometimes they are made flesh; they breathe upon us with warm breath, they touch us with soft responsive hands, they look at us with sad sincere eyes, and speak to us in appealing tones; they are clothed in a living human soul, with all its conflicts, its faith, and its love. Then their presence is a power, then they shake us like passion, and we are drawn after them.”Footnote ⁴³