The Right to Enjoy the Benefits of Scientific Progress and its applications (REBSP) is included in Article 27 of the Universal Declaration of Human Rights and Article 15 of the International Covenant on Economic, Social and Cultural Rights. This human right is, despite some attention , little explored. Today’s world is increasingly turning to science and technology for solutions to persistent socio-economic and development problems. One of the possible avenues to reinforce the link between science and human rights is the elaboration of the human right to enjoy the benefits of scientific progress as laid down in international human rights law.
However, little interdisciplinary research has been undertaken to explore and operationalize this human right. To what exactly does it entitle and which obligations result from the recognition of this right?
This project aims to explore what the REBSP means for the realisation of the Right to Health, using primarily the problem of Drug Resistant Tuberculosis (DR TB) as a case study to explore these issues.
Background: In South Africa, TB is the leading cause of death in the country exacerbated as it is by high rates of HIV infection. The burden from Drug Resistant Tuberculosis (DR TB), a form of TB which has become resistant to the usual treatments, is a major problem. DR TB is more difficult, protracted and costly to treat, with poorer outcomes, particularly for Extensively-drug resistant TB (XDR TB), which has a very poor prognosis . As a neglected disease, there has been little new drug development for TB largely as a result of a lack of interest from the private sector due to the absence of a profitable market. Accordingly, many old drugs were brought back into use to treat DR TB because of the lack of alternatives. However, these drugs have many side-effects and are difficult to administer. Although some new drugs for DR TB have recently appeared, they are still not widely available nor is it clear they will alone help to stem the tide of this epidemic. The need for new drug development for DR-TB is thus an imperative, not only to save the lives of those infected, but also to provide tools for the health services to stop the spread in the community.
Could a REBSP-approach based on human rights change that situation? It might help to answer a raft of questions relevant to facilitating access to life-saving medication for people with DR TB, and help strengthen health systems in parts of the world most affected by global health and economic inequalities. For example, have individuals the right to an appropriate new medicine as part of the REBSP? If the development of a new medicine is based on scientific research, who has obligations to engage in scientific research? Governments? The private sector? Joint ventures of universities and private companies? If obligations lie with states, are these the states where the TB patients live, or those states which host pharmaceutical companies? What role do regulatory authorities, such as the Medicines Control Council in SA, play? Do states have obligations to promote the transfer of scientific knowledge to less developed countries and how is this affected by the TRIPS Agreement of the WTO?
The Research Aim is to map the reasons for the lack of available medicines for the treatment of DR-TB in South Africa against human rights standards – specifically, to inquire whether and how the REBSP, in conjunction with the Right to Health (RtH), could provide a framework to enhance access to medicines for DR TB. It is expected the research will generate ideas applicable for other neglected diseases and will help to elaborate how to operationalise the REBSP which can be taken up in international human rights advocacy.
2. The Research Question(s)
Several sub-questions guide the interdisciplinary nature of this research.
a) What is the normative content of the REBSP in terms of entitlements of individuals and duties for other actors?
b) What is the relationship with the RtH?
c) Which measures have been taken in South Africa to implement this right regarding access to medicines, pharmaceutical development, legislation, transfer of knowledge, development of new medicines and co-operation between stake-holders?
d) How should one assess the current situation of DR TB (in South Africa) and the relative balance of benefits and risks when evaluating new drug for registration purposes against the backdrop of the RtH and the REBSP?
e) What is the view of relevant stake-holders on the elimination of neglected diseases, such as DR-TB and the extent of evidence needed to register new drugs?
3. Approach / Methodology
An inter-disciplinary mixed methods approach is being used to address this topic.
The human rights component will entail a normative legal analysis involving finding, analysing, interpreting and applying legal sources and different types of hard law and soft law instruments (national and international) to health and human rights issues; identification of rights and right-holders, duty-bearers and different types of duties; application of the concepts of Availability, Accessibility, Acceptability and Adequacy of medicines, recognising that rights may be subject to resource constraints and progressive realisation. A final element of will apply the principle of non-discrimination and protection of vulnerable groups which must underlie all reasonable policies.
To assess measures taken by governments and other stake-holders, qualitative research involving key informant interviews and document review will be used to conduct a content analysis of policy measures taken. Lastly, empirical research in the form of interviews to determine views of key stakeholders about the lack of progress on medicine availability for the treatment of DR TB patients will complement the methods above.
The research will use South Africa as a case study for analysing and applying the normative and policy framework.
The project is supported by a UCT PhD mobility award for the PhD student undertaking this work.