Parallel Regulatory – HTA reviews: implications for improving access to medical devices in South Africa

Abstract

The South African Health Products Regulatory Agency (SAHPRA) although technically proficient, has challenges with timely reviews of medicines despite significant improvements. The recent regulation of medical devices may detract from SAHPRA’s improved performance trajectory. The economic evaluation of medical devices, a form of health technology assessment (HTA) by a separate entity, is complex due to its attributes. HTA in South Africa is fragmented and lacks a national HTA body. Timely access will be dependent on efficient regulatory and HTA reviews, and harmonization synergies seen globally. HTA recommendations in terms of outcome and efficiency is the de facto barrier to access. No literature exists on SAHPRA adopting harmonization with HTA bodies. A literature search strategy was conducted using defined keywords on electronic databases, to find countries that currently undertake parallel regulatory-HTA reviews in some manner or form, within an established framework. As the grounded theory approach was used in research extraction, the initial findings highlighted an even more critical process impacting access to health technologies, termed the HTA outcome or recommendation procedure, resulting in an additional analysis of this principal function and impact thereof on the regulatory-HTA timeline. This study demonstrates that adoption of a parallel regulatory-HTA review framework with the soon to be established national HTA body in South Africa, can improve access to medical devices, and align with other strategic objectives such as universal healthcare coverage. In preparation for such an alliance, there needs to be consideration given to immediate dialogue and workshops between existing public and private sector HTA bodies and SAHPRA, for learnings and future collaboration with the national HTA entity. It would be ideal if appointments can immediately be made to the leadership structure, to ensure early and effective synergies are enhanced.