Genomic resource centre

Health policy and the Ethical, Legal and Social Issues (ELSI) in genomics

The number of innovations in genomics leading to useful health applications is steadily growing. At this juncture, when this burgeoning field is still in its relatively early states, it is important for countries to develop strategies to ensure that these advances are harnessed to benefit the health of their citizens, and to undertake an appraisal of the potential of genomics for their citizens. This means taking careful account in the creation of policy of not only the scientific and technical aspects of genomics, but also of the not inconsiderable ethical and social implications its development and application may pose.

Genomics is a platform for creating and developing new health products and services. Harnessing its benefits in the fullest sense therefore requires considering the entire process, from discovery, research and development, commercialization, and finally up to application—including mechanisms for financing each of these steps. Genomics can have an impact at each level of this chain. At the research end, investing and promoting local innovation in genomics can promote economic growth. At this level, then, capturing the benefits of genomics means harnessing the capacity of this productive field of technology to spur both economic and human development, as suggested in the United Nations Development Programme’s 2001 Report, Making New Technologies Work for Human Development. Creating policies that encourage investment and capacity building in this field can lead to capturing the benefits of genomics in another way: the generation of innovative new products to address important health concerns. At the local level, a home-grown industry may be provided with incentives to create solutions to local needs. And genomics has already demonstrated its potential to develop solutions to address even the most basic public health needs. Harnessing genomics also implies capturing the benefits of its products and services that are broadly accessible and applicable. This includes, for instance, creating products that can be used in low-resource settings, and that do not necessarily require sophisticated technical training for their delivery. Great strides have been made in this area in relation to the diagnosis of infectious agents, for instance; however, a great deal remains to be done to assure that other applications, such as genetic technologies, are integrated into health systems in an affordable, sustainable, and socially-appropriate way. Policy can have an enormous impact at each stages of this process. Careful and informed decision-making, which takes account of local health needs, capacity, and customs, is essential to harnessing the full potential of genomics and its applications for improved health.

Public Education and Public Engagement

For policies to be sustainable and effective, they need to be socially acceptable. This does not that they ought to be constructed to appease the masses; rather, it means that they should be informed by the views of a public that is itself informed. There is therefore a need to educate ordinary citizens in a balanced manner about advances in the science, including the ethical legal and social implications they pose. Many encouraging examples of successful medical interventions that were preceded by public educational efforts exist today, as demonstrated by the example of genetic screening programmes in the USA, Canada and Italy (Scriver et al., 1984; Cao & Rosatelli, 1993). Mediums of communication like the television, workshops and print campaigns have proved to be effective for raising public awareness. An ongoing analysis of public perception of genomics must be incorporated into policy making so that it truly addresses the areas of public concern, and constructively addresses the apprehensions of society towards genomics.

Countries interested in empowering their citizens to make better choices and to participate in shaping the direction of technological development and its application, will need to do more than educate a passive constituency. Raising awareness is important for providing a general knowledge base, but this heightened awareness has only limited value if citizens are not engaged in public dialogue that encourages their active debate and participation in policy-making. While public engagement, particularly in large and diverse communities, is not easy to achieve, various methods—such as surveys, town halls, citizens’ juries and conferences, collaboration with local leaders and opinion shapers, and even innovative approaches such as interactive theatre and creating modules for classroom discussion in local schools—can be employed in different contexts to inform, generate discussion, and provide important input to policy-makers about how to approach often difficult and controversial issues.

Research and Development

A further area of challenge for policy makers in the case of genomics and policy concerns the funding of research and development (R&D). The source of funding, be it the private or the public sector or a mixture of both, has implications for the affordability and accessibility of research findings, as well as their relevance to local needs. At present there is a great deal of private investment in genomic-based R&D, primarily due to the high costs involved. Universities and other not-for-profit institutions also engage in basic research in genomics, and even in the commercializing of its products and services. It is important to develop national policies that encourage an interplay among the different actors—government, universities, and industry—which encourages innovation and strong research that is ultimately beneficial in addressing the socially relevant health needs. This interplay is part of a complex system that depends on several factors, including the technical capacity that exists within each sector. It has been suggested that the best way to maximize innovation for social benefit is to create partnerships that benefit from the relative strengths that each sector has to offer. Examples of such partnerships include the Multilateral Malaria Initiative (MMI), and the Global Alliance for Vaccines and Immunizations (GAVI).

When establishing private-public partnerships or medical research ventures of any sort, policy-makers should recognise the implications of these frameworks for the ownership of the research findings. Legislative and regulatory mechanisms should be in place to protect the interests of all parties concerned, especially the public, to ensure that the fruits of genomics reap social benefits, rather than exacerbating existing inequities.

Building Capacity

Better training of health professionals in genomics and its ethical implications is essential for assuring that the potential of new technologies is realized for the full benefits of patients. Improving the training of medical researchers, clinical geneticists, genetic counsellors and other core members of the health care team, will enable them to recommend the use of genomic-based applications and genetic services and counselling to their patients, increasing understanding of existing technologies, and ultimately improving their efficacy. This means including science, including the rudiments of genomics, as part of the curriculum in elementary and secondary schools, and creating programmes in genomics at the university level to equip researchers and clinicians with the necessary technical and analytic skills. Students across disciplines need to be sensitized to the ethical, legal, and social implications of genomics, with specific training for those pursuing a career in health policy, research, practice, or related field. Exchange programmes that provide opportunities for students to study abroad in laboratories and other settings, and that encourage foreign faculty to bring their expertise to the local setting, could assist in strengthening capacity through the sharing of knowledge and experience.

ELSI

Several examples of the ethical, legal, and social issues raised by genomics are discussed in some detail in another section. These issues have been debated for a number of years, and several organizations have created international guidelines relating to genomics research and clinical genetics. However, these debates need to expand beyond the relatively limited circles within which they have taken place, in order that they may gain currency and relevance on a wider scale. Existing guidelines can provide helpful direction for national governments and regulatory bodies, who can then adapt them to their local contexts. Creating national standards is therefore the first critical step; however, implementation of these standards further requires building country-level capacity in ethics and related fields, including setting up institutional frameworks for oversight. This requires a long-term approach to institution-building and education aimed policy-makers, health care providers, researchers, patients and ordinary citizens.

In its 2002 report on Genomics and World Health, WHO’s Advisory Committee on Health Research summarizes these policy concerns in its recommendations:

“WHO encourages its Member States to develop clear and concise ethical frameworks to guide the conduct of genomics research and its medical application in conjunction with the social, economic and religious context unique to their countries. These frameworks should build from universal codes of practice, which can be created by partnerships and collaborations between countries. Such partnerships will enhance ethical review structures and build bioethics capacity globally. Member States should also facilitate a two-way dialogue between public and policy makers to guide the development of ethical and regulatory systems. In order to build this capacity, partnerships between academic, public research institutions and the commercial sector are recommended. Member States should develop sufficient numbers of clinicians trained in the field of clinical genetic services and implement educational programmes to raise awareness of genetics among the public.”

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