GBMSA plays a crucial role in shaping pharmaceutical policies in South Africa.
We actively:
- Advocate for greater adoption of generic and biosimilar medicines to reduce healthcare costs.
- Engage with government regulators, healthcare professionals, and policymakers to drive industry transformation.
- Support evidence-based healthcare policies that align with international best practices.
By working closely with regulatory bodies, medical institutions, and industry stakeholders, we ensure that South Africans benefit from a cost-effective and sustainable pharmaceutical sector.
Why Join GBMSA?
Joining GBMSA gives your company a strong, unified industry voice, ensuring greater visibility, influence, and impact within the pharmaceutical sector. As a member, you gain access to key stakeholders, policy discussions, and industry insights that shape the future of generic and biosimilar medicines in South Africa.
Lobbying – Advocacy & Industry Representation
- GBMSA is a consensus-driven association that fosters a collaborative industry perspective.
- We engage proactively with regulatory bodies, government agencies, and policy stakeholders to drive meaningful change.
Our mission is to create a favourable environment for the growth and sustainability of the pharmaceutical industry. - We work to influence healthcare policies and reforms, ensuring that industry input is represented at both strategic and regulatory levels.
- Leveraging industry expertise and strategic partnerships to drive meaningful improvements in the healthcare sector.
- Our advocacy efforts support fair pricing models, promoting industry viability while ensuring affordable medicines for South Africans.
Policy & Regulatory Support
- We provide expert guidance on legislation, scientific and technical, pricing regulations, trade, and tender processes.
- Our team helps members navigate complex regulatory frameworks in South Africa and Southern Africa, reducing compliance burdens.
- We continuously monitor market trends, policy changes, and regulatory developments, keeping members informed and prepared.
- GBMSA actively participates in pharmaceutical policy discussions, ensuring that industry perspectives shape regulatory decisions on generic and biosimilar medicines.
- We collaborate with other lobbying associations to amplify industry representation, maximize stakeholder engagement, and strengthen our influence.
- Members receive detailed updates and reports on the activities of our sub-committees, ensuring transparency and industry-wide participation.
Intellectual Property & Innovation
- GBMSA supports a balanced intellectual property framework that protects innovation while ensuring timely access to generic medicines post-patent expiry.
- Our policy initiatives promote research and development, ensuring that both innovation and affordability are prioritised in the healthcare system.
Enhancing Regulatory & Operational Efficiencies
- Collaborating with Government – GBMSA actively engages with South Africa’s regulatory and registration bodies to streamline processes and improve approval timelines for generic and biosimilar medicines.
- Expanding Market Share – We advocate for increased registration, accessibility, and uptake of generics and biosimilars to drive wider adoption in the healthcare system.
- Shaping Best Practices – GBMSA works to establish effective public policies, regulatory frameworks, and service standards that benefit both the industry and consumers.
- Ensuring Fair & Equitable Operations – We advocate for policies that allow our members to operate in a transparent and competitive environment.
- Lobbying for Industry-Friendly Regulations – Through direct engagement with government and regulatory authorities, we work to ensure fair regulations that support the sustainability and growth of generics and biosimilars.
Strong Industry Representation & Collective Advocacy
- Representing a Diverse Membership – GBMSA brings together local manufacturers, importers, and multinational companies operating in the generics and biosimilars sector.
- As a trusted communication platform, we facilitate strong engagement between industry players, government, and stakeholders.
- Advocating at All Levels – GBMSA ensures that all members are represented equally, addressing industry concerns on policy, regulation, and market access.
- Expanding Networking and Collaboration Opportunities – Members gain access to valuable networking events, industry discussions, and collaborative initiatives that shape the future of pharmaceuticals in South Africa.
Position Statement
Generic and Biosimilar Medicines as Enablers of National Health Insurance
Issued by: Generic and Biosimilar Medicines of Southern Africa (GBMSA)
The Context
South Africa’s pursuit of National Health Insurance (NHI) reflects a national commitment to universal health coverage, equity, and access to quality healthcare. The success of NHI, however, will depend not only on policy intent but on financial sustainability, supply resilience, and operational feasibility.
Medicines are a structural and recurring cost driver in any health system. How medicines are selected, priced, and procured under NHI will be decisive in determining whether the system is viable and durable.
GBMSA’s Position
Generic and biosimilar medicines are foundational to a sustainable National Health Insurance system. They are not secondary or transitional products — they are the backbone of affordable, scalable healthcare delivery in universal coverage systems globally.
International experience consistently demonstrates that successful universal health systems rely on systematic use of generics and biosimilars, competitive multi-supplier markets, and strong regulatory assurance rather than originator brand based dependence. South Africa is no exception.
Why Generic and Biosimilar Medicines Matter for NHI
- Financial Sustainability
Generics and biosimilars deliver substantial cost savings compared to originator medicines, enabling broader population coverage within finite budgets, expansion of benefits without rationing, and long-term protection of the NHI fiscus. - Access and Equity
They enable rapid and equitable access to treatment across acute and chronic diseases. - Supply Security and Continuity of Care
A competitive generic and biosimilar market reduces dependence on single suppliers, mitigates the risk of shortages, and protects continuity of patient care during global and local disruptions.
What NHI Must Get Right
For generic and biosimilar medicines to deliver their full value under NHI, policy design must include:
- Generics and biosimilars as first-line therapy where clinically appropriate
- Multi-supplier procurement models to enhance resilience
- Sustainable pricing frameworks, not lowest-price-only contracting
- Predictable and efficient regulation, particularly for biosimilars
- Alignment with government’s local manufacturing and health security objectives for identified disease entities
Short-term cost minimisation that undermines supplier viability will increase systemic risk and long-term costs.
The Risk of Getting It Wrong
Failure to properly integrate generics and biosimilars into NHI design risks:
- Escalating medicine expenditure
- Increased supply disruptions
- Supplier exits from the market
- Reduced treatment coverage
- Erosion of local pharmaceutical manufacturing capacity and global investment strategies for South Africa
These outcomes would materially undermine NHI’s objectives.
GBMSA’s Commitment
Generic and Biosimilar Medicines of Southern Africa (GBMSA) supports the objectives of National Health Insurance and stands ready to partner constructively with government and the NHI Fund, provide technical expertise on medicines policy and procurement, support evidence-based decision-making, and contribute to a resilient, sustainable and affordable medicines system.
A credible and sustainable NHI system is not possible without a strong, competitive generic and biosimilar medicines sector.