Recognising the potential of advocacy to impact South Africa’s innovation system, a group of non-governmental organisations launched the South African Health Technologies Coalition (SAHTAC) in 2016. Through coordinated advocacy, SAHTAC is underscoring the importance of increasing access to lifesaving technologies across the spectrum. SAHTAC is enabling all member organisations to achieve mutually shared goals that support the Research and Development (R&D) of high impact health interventions in South Africa.
SAHTAC advocates for evidence-based policies, funding, and program implementation that support the development and uptake of global health technologies nationally, and within the region.
SAHTAC achieves this through advocating that legislative, regulatory and policy development promote access to quality, affordable, available and sustainable health technologies. The National Health Insurance (NHI) Bill published in Government Gazette No. 42598 of 26 July 2019 (the Bill), is an essential piece of proposed legislation in shaping the public health landscape and the future policies of health R&D in South Africa over the long term. It is vital to ensure that the Bill caters for and incorporates health research and development in South Africa.
WHY IS R&D IMPORTANT TO OUR ASPIRATIONS OF DELIVERING UNIVERSAL HEALTH CARE TO SOUTH AFRICAN’S CITIZENS?
The United Nations Sustainable Development Goal 3 – To ensure healthy lives and promote wellbeing for all at all ages calls for:
- Achieve universal health coverage, including financial risk protection, access to quality essential healthcare services and access to safe, effective, quality and affordable essential medicines and vaccines for all.
- Support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines.
- The world to develop new and improved health technologies to prevent and treat existing diseases and health challenges, address growing drug resistance and make care more affordable, accessible, and effective.
- Substantially increase health financing and the recruitment, development, training and retention of the health workforce in developing countries.
- Strengthen the capacity of all countries, in particular developing countries, for early warning, risk reduction and management of national and global health risks.
In 2007 African Union countries committed to investing at least 1% of GDP into research and development, this commitment recognised the importance of R&D for sustainable development and the need to address Africa’s health needs. This goal has remained unrealised.
The South African government has set a target to increase investment in R&D of 1.5% of GDP over the next ten years. Yet health R&D in South Africa has seen a minimal increase.
Health R&D not only saves and improves lives, but also creates cost savings, drives economic growth, and enhances global security.
COMMENT / REPRESENTATIONS
The Bill speaks to each of the SDG 3 objectives, regional commitments and national targets highlighted above in its preamble. The Bill also seeks to “..provide access to quality health care services by pooling public revenue in order to actively and strategically purchase…” and “…eliminate the fragmentation of healthcare funding…” and “ensure continuity and portability of financing and services.” (our emphasis.)
The National Health Act No. 61 of 2003 defines “health research” to include “any research which contributes to knowledge of –
- The biological, clinical, psychological or social processes in human beings;
- Improved methods for the provision of health services;
- Human pathology;
- The cause of disease
- The effects of the environment on the human body;
- The development of new applications of pharmaceuticals, medicines and related substances; and
- The development of new applications of health technology;”
COMMENTS / CALL FOR AMENDMENTS
Taking the above into account our comments and call for amendments concerning the Bill, include the following items:
Clinical trials for the identification of efficient and effective new diagnostic and treatment modalities are needed to address the disproportionately high burden of communicable and non-communicable diseases in developing countries. However, gross under-representation in global clinical trial platforms contributes to sustained health inequity in these countries, countries like South Africa.
This is especially true for patients with serious or life-threatening conditions. Currently, the Bill does not expressly deal with instances of user enrollment in these types of studies, particularly in how the Fund will reimburse the supportive and complementary products and services that do not form part of the trial but are still required as part of the therapy and care of these patients. Ambiguity in these instances will have a dire financial consequence for users and the ability to enrol in clinical trials.
Submission of health incidence and utilisation data by the private healthcare system.
To ensure strategic purchasing as contemplated in the Bill, the Fund will need in-depth and robust health data and health technology usage. Data to inform decisions about utilisation, treatment definition problems, admission rates, length of stay and other health technologies usage issues. Data that are collected not only by the Fund, service providers and national and provincial departments of health’ but also potentially by medical schemes, as contemplated in the Bill. In order to have a complete understanding of the country’s utilisation of health technologies and services, it should be compulsory for medical schemes to provide the Fund with anonymised health technology, goods and services utilisation data. Attention to this point raised will negate past effects of withheld data to the National Cancer Registry (NCR) from private health systems on cancer incidence estimates and the challenges faced by the Council for Medical Schemes concerning the Industry Technical Advisory Panel (iTAP) in 2012.
It is our position that the Bill should deal with any gaps in current legislation that preclude the sharing of mortality data amongst data collection agencies, authorities and institutes. The inability of the NCR to access Statistics South Africa cancer-related mortality data is a case in point.
Constitution, establishment and composition of the Board, units and committees
The Bill states, in section 13 (5)(b), that Fund Board members must have “..appropriate technical expertise, skills and knowledge or expertise in health care service financing, health economics, public health planning, monitoring and evaluation, law, actuarial sciences, information technology and communication;…”. We advocate that the Board should also include expertise related to health research and development. Especially in light of the powers of the Fund as contemplated in section 11 of the Bill; especially sections 11(1)(j ) and 15(3)(b), (d) and15(4)(a).
Similarly, section 25 (2) and section 26 (2) make provisions for Benefits Advisory Committee to be established by the Minister of Health to include “…persons with technical expertise in medicine, public health, health economics, epidemiology…” and the Health Care Benefits Pricing Committee to consist of persons with expertise in “actuarial science, medicines, epidemiology, health management health economics, health financing, …” should include a person with expertise in health research. In particular, due to the mandate of the Benefits Advisory Committee to determine and review “…detailed and cost-effective treatment guidelines that take into account the emergence of new technologies…” (our emphasis) as contemplated in section 25 (5)(b) of the Bill.
Section 20(3) of the Bill defines the units that are to be established by the Fund CEO. We propose, in light of the functions, responsibilities and powers of the Fund, that a Health Research Unit be included.
Similarly, we advocate for the establishment of a Health Research and Data Technical Advisory Committee as contemplated in section 24 of the Bill.
Office of Health Products Procurement
Allowance for and the inclusion of innovative and high-value technologies in section 38 (3) of the Bill through the inclusion of a strategy for the consideration of access to high value, high-cost health technologies in the require output of the office to ensure South African’s are afforded access to the most efficient and effective local and international health technologies.
Section 51 of the Bill relates to the statutory reporting requirements of the Fund. To demonstrate the commitment to regional and national obligations and targets concerning health research, we would advocate that the Fund be required to report on investment into health research and the advancement of health technologies for expanding local access to treatment and care for the users of the Fund.
Health Technology Assessment
The linkage between the Health Technology Assessment (HTA) and price determination/decision to reimburse is vague. It is our position that the process of price determination should reflect the value, to both the individual patient and the country’s population, by examining the benefit of the new health technology versus the current standard of care.
The draft Bill speaks to the establishment of an HTA process and makes provision for a future agency. However, it is not clearly defined when the HTA process is realised and how price determination will evolve from the HTA outcomes.
It is also our position that to truly ensure the principles of Universal Health Coverage are upheld the direct linkage between the HTA process and the subsequent price determination and reimbursement has to be defined in the Bill through proven and widely accepted methods. This would include, as per international gold standards, a clinical benefit assessment and/or budget impact analysis which is benchmarked to a standard of care with transparently determined thresholds. The process must be established with an internationally proven and accepted HTA methodology and transparently applied and patient engagement and representation throughout the process must be documented in a revision of the draft Bill.
Section 57 of the Bill deals with the transitional arrangements of the implementation of the Bill in two phases, concerning this process. We submit that the National Governing Body on training and development, contemplated in section 57(3)(b) must include the responsibility of advising the Minister on co-ordination and the alignment of strategy, policy, financing, implementation and the evaluation of the impact of health research to create a foundation for future health research of the Fund.