Most lawyers will not be acquainted with the concept of Health Technology Assessment (HTA), although it is now considered a key instrument in health policy decision-making in Europe. It is also a potentially controversial concept as it reviews the cost-effectiveness of health technologies taking into account resource constraints. HTA has been defined as “a multidisciplinary process that uses explicit methods to determine the value of health technology at different points in its lifecycle.” Its purpose is “to inform decision-making to promote an equitable, efficient, and high-quality health system.”
HTA can be used as a policy instrument to decide whether a social insurance policy will cover a new health technology—whether a therapy, medicine, or device. HTA is not restricted to Europe. It has been applied in other parts of the world and is supported by the World Health Organization. One may ask, what’s in it for lawyers? Since HTA decision-making has health policy implications concerning the availability and accessibility of new medical technologies for all, it has human rights implications with respect to the right to health care.
This dissertation questions the role of law and the right to health care. It is grounded in the idea that international law regarding rights to health care can contribute to formulating standards for implementing health policies. The author argues that the role of law is not restricted to procedural issues such as transparency, but also more substantive criteria, including non-discrimination, maximum available resources, progressive realization, and international cooperation. Bottini Filho describes this as “applying the human rights-based approach” (HRBA) in HTA decision-making. The result of that approach, according to the author “should be an accountable process not only to distribute resources but also to create them and thus avoid unnecessary [health care] rationing.” For those who believe health care rationing is inappropriate and that health care is not a social good, a rather bizarre outcome.
Part One of the volume explains the concepts of HTA, its legal relevance, and the meaning of the right to health care in international law. Here, the focus of HTA is on macro-level deliberation from a centralized or governmental position to assess whether the health package should cover a medical technology. However, HTA can also be applied on micro-level, at the bedside. Interpreting the right to health care, the author refers to article 12 of the International Covenant of Economic, Social and Cultural Rights (ICESCR) and General Comment no. 14 defining several State obligations related to the right to health care.
Part Two applies the theoretical concepts by formulating a harmonized set of rules that will steer fair decisions related to resource distribution, and regulate standards in the criteria of HTA. These rules are based on human rights principles: progressive realization, maximum available resources, and the reasonableness standard, as well as the non-discrimination principle and the application of the role of international cooperation.
Part Three presents Brazil as a case study of the substantive policies and legal issues of HTA deliberations grounded in a socio-economic rights framework in international law. Brazil is for several reasons an interesting selection: it is a country with a constitutional right to health; HTA is regulated through law and institutionalized through a public agency; data and reports issued through this process are publicly available; and, finally, there is a large body of literature on the right to health in Brazil, also connected with HTA. As the author explains, however, the human rights dimension in HTA decision-making remains largely absent in practice.
The added value of this dissertation is conceptualizing the human rights-based approach in HTA decision-making processes. Apart from clinical effectiveness and cost considerations, improving the decision-making process requires the use of clear procedures, substantive human rights considerations, and public participation in deliberations. The author has made an important effort to contribute to that deliberative process.
