published March 20, 2013

Science, Human Rights and the Expanding Role of the Private Sector

Jessica M. Wyndham

Associate Director, Scientific Responsibility, Human Rights, and Law Program of the American Association for the Advancement of Science

The human rights obligations voluntarily assumed by governments when they ratify an international treaty are binding on those governments. Neither individuals nor private companies are directly bound by the treaties. What are the implications of this for the significant and increasing role of private companies and institutions in research and development? While it is the responsibility of government to ensure that third parties to do not violate human rights, there is increasing attention being paid to the direct role that business, writ large, can play in promoting and protecting human rights. Outlined below are some examples of how this is occurring in practice.

In 2007, the US Congress passed an amendment to the Food and Drug Administration (FDA) Act aimed at encouraging the development of treatments for globally neglected diseases. The measure involves the issuance of a reward for developing and receiving FDA approval for a novel drug or vaccine targeting one of 16 tropical diseases. The reward takes the form of a transferable voucher that entitles the bearer to a priority review at the FDA for any drug of its choice submitted for US market approval. Priority review leads to an FDA decision in six months (but not necessarily an approval) in contrast to the usual one-year plus review time for a standard review. The six months saved in this process is considered to have a large monetary value.

'Socially responsible licensing' (aka 'humanitarian licensing') provides another example of how private industry can be encouraged to adopt a human rights-consistent approach to development and product pricing. Socially responsible licensing involves the licensing of intellectual assets in a manner conducive to providing affordable access to life enhancing innovations. Licensing strategies include, issuing non-exclusive licenses so that the licensor retains the ability to license a product for a humanitarian purpose while also licensing it for commercial purposes; licensing to a public private partnership for development of a product which may, for example, benefit a neglected market; and conditional licensing that requires social responsibility on the part of the licensee, for example, to sell a product at a reduced cost to poor markets. This approach has been applied to innovations in medicine, agriculture, diagnostic tools and more, and has been adopted by several universities.

A significant challenge in ensuring private sector observance of human rights arises when there is limited or no existing relationship with government, whether through funding, regulation or in some other way. One context in which this is a concern is when companies seek research permissive environments devoid of effective safeguards to protect research subjects. Here, the United Nation's recently adopted Guiding Principles on Business and Human Rights could play a role. The premise of the Principles is that, while business is not legally bound by human rights, there are nonetheless significant steps business can take to protect human rights and to provide remedies for human rights violations. To operate consistently with these principles is to exercise 'corporate social responsibility.' As efforts get underway to determine how business can apply the Guiding Principles, giving attention to private industry involved scientific research and technology development will be important.