In a significant move for the local pharmaceutical industry, the South African Health Products Regulatory Authority (SAHPRA) has proposed a new localisation policy to prioritise the registration of locally manufactured products. This policy aims to expedite the lengthy medicine registration process for local manufacturers compared to their foreign counterparts.
Stavros Nicolaou, group senior executive for strategic trade at Aspen Pharmacare, Africa’s largest pharmaceutical manufacturer, welcomed the proposal. He emphasised that prioritising locally manufactured products is crucial for developing Africa’s pharmaceutical capabilities. Nicolaou warned that without such prioritisation, South Africa risks falling behind other African countries, like Egypt, which has seen a surge in local production following a similar policy.
Ensuring the security of medicine supplies
Nicolaou also highlighted the importance of aligning government procurement policies with regulatory priorities to ensure the security of medicine supplies. He expressed optimism that the Public Procurement Bill, recently passed by Parliament and awaiting President Cyril Ramaphosa’s signature, would support this alignment. The bill includes provisions for localisation, generating tax revenues that foreign producers do not contribute, even if they offer cheaper products.
SAHPRA’s focus on localisation aligns with the launch of the African Vaccine Manufacturing Accelerator at the Global Forum for Vaccine Sovereignty and Innovation in Paris. This initiative aims to invest $1.2 billion over ten years to boost vaccine manufacturing in Africa, which currently imports about 99% of its vaccine needs. The goal is for Africa to produce 60% of its vaccine requirements by 2040.
Broad-based Black Economic Empowerment policy for the industry
At a recent industry meeting, SAHPRA outlined its draft of its local manufacturing policy, which is currently under legal review. The draft, expected to be published for public comment between July and September, will be tabled for SAHPRA board approval and implementation by year-end.
SAHPRA CEO Boitumelo Semete-Makokotlela stated that the policy would prioritise local manufacturers addressing critical public health needs while ensuring medicines’ safety, quality, and efficacy. The policy defines a local manufacturer as a licensed entity domiciled in South Africa. It also specifies that vaccines’ fill-and-finish activities would be considered local manufacturing.
According to the draft policy, companies receiving priority approval for their products from SAHPRA would be prohibited from relocating their manufacturing businesses. Additionally, SAHPRA is developing a broad-based Black Economic Empowerment (BEE) policy for the industry. Although the industry has raised concerns, Semete-Makokotlela assured that compliance with the BEE Act would not compromise access to safe, quality, and effective health products.
Licenses will not be denied based on BEE criteria alone, nor will non-compliant applicants lose their licenses. However, those meeting the BEE criteria will be prioritised. The industry has expressed concerns regarding the proposed policy, emphasising that licenses should be issued based on quality assurance and good manufacturing practices as mandated by the Medicines Act.