A new era of healthcare collaboration in South Africa

• Generic and Biosimilar Medicines of Southern Africa (GBMSA)

• Innovative Pharmaceutical Association South Africa (IPASA)

• Pharmaceuticals Made in South Africa (PHARMISA)

• Self-Care Association of South Africa (SCA)2

The Black Pharmaceutical Industry Association (BPIA), and the South African Health Products Regulatory Authority (SAHPRA) issued a joint media statement declaring a common commitment to structural, long-term cooperation.

For the past two decades, South Africa’s pharmaceutical sector operated under the rigid constraints of the Single Exit Price (SEP) framework, which limited pricing flexibility and overall access. The government's formal commitment to establish a permanent, structured engagement mechanism signals a historic pivot. This shift moves the industry away from historical friction and toward open dialogue, joint problem-solving, and a sustainable, future-ready healthcare system.

Key breakthroughs and their broad significance

• Alternative Reimbursement Models (ARMs): The explicit commitment to ARMs moves South Africa away from a rigid pricing paradigm toward flexible, value-based healthcare solutions. For patients, this lowers financial barriers to specialised therapies; for society, it builds a resilient, sustainable health system; and for Roche, it aligns policy to bring our pipeline of high-value, innovative medicines to those who need them most.

• SEP & Pricing Reforms: By considering an extraordinary Single Exit Price (SEP) adjustment and conducting a joint review of SEPA regulations, the government acknowledges the severe economic pressures facing healthcare delivery. This protects the long-term security of medicine supply for society, ensures economic viability for industry partners, and gives Roche a predictable framework to operate and invest sustainably in the region.

• Regulatory Acceleration: SAHPRA’s commitment to reduce administrative red tape and streamline approval pathways will directly compress the time it takes for

  breakthrough science to reach patients. Faster time-to-market strengthens public health outcomes and enables Roche to bring next-generation diagnostics and treatments to market sooner.

• Public Procurement & Investment: Institutionalising predictable procurement rules and fostering local investment safeguards South Africa’s healthcare ecosystem against global supply chain vulnerabilities. It fuels wider economic growth while offering Roche a stable basis for long-term strategic planning and healthcare partnerships.3

Championing Roche’s leadership to drive healthcare progress

This policy evolution validates Roche’s dedicated efforts to shape a more equitable healthcare ecosystem. Through active involvement within the Pharmaceutical Task Group (PTG) and leadership of the IPASA Patient Access Working Group, both Fakir Chavoos and Refilwe Magano serve as trusted co-creators and advisors.

Furthermore, the South African affiliate’s mid-term outcome—securing rapid patient access to clinical breakthroughs while mitigating International Reference Pricing (IRP) risks via Section 36 SEP exemptions or co-created legislation—now directly reflects industry and NDoH priorities. By aligning therapeutic innovation with these strategic policy reforms, Roche is not just observing this regulatory shift—we are actively driving it to secure faster patient access and create sustainable, long-term health impact across South Africa.