In a plan that would have significant implications for the local pharmaceutical industry, the SA Health Products Regulatory Authority (SAHPRA) wants to initiate a localisation policy giving priority to the registration of locally manufactured medicines.
Registration of medicines here takes a long time, and pushing local products to the font of the queue would expedite the process for them, compared with foreign products.
Stavros Nicolaou, group senior executive for strategic trade of Aspen Pharmacare, said this was a significant step towards Africa developing its own capabilities – that if this were not speedily implemented, SA would fall behind other African countries that were gearing up to produce vaccines.
BusinessLIVE reports that Egypt has already seen a significant increase in local production after adopting a prioritisation policy.
Nicolaou added that it was equally important to align government procurement policies with the regulator’s. He was optimistic that the Public Procurement Bill passed by parliament would accelerate this once it was signed by President Cyril Ramaphosa.
The Bill has set-asides for localisation, which generate taxes that foreign producers do not pay even if they can supply cheaper products.
SAHPRA policy under review
SAPHRA recently outlined its draft local manufacturing policy, which is under review by its legal committee. It envisages publishing the draft for comment between July and September and tabling it for approval by the SAHPR board and for implementation at the end of the year.
The terms would include that a company may not move its manufacturing business to another destination after having received priority approval from SAHPRA.
Sahpra is also working on a broad-based BEE policy for the industry, which has expressed concerns about it.
SAHPRA CEO Boitumelo Semete-Makokotlela said the industry would be consulted on the BBBEE qualification criteria to be used in the issuing of licences, and that as an organ of state, it was obliged to comply with the BBBEE Act.
“Compliance to the policy should not affect access to safe, quality and effective health products,” she said in a presentation. “A licence application will never be denied because of not meeting the criteria, as BBBEE will not override the mandate of SAHPRA as per the Medicines Act.”
She also said no applicant would be dispossessed of the licence on the basis of non-compliance with the BBBEE policy. Applicants for licences would not be excluded but those that met the criteria would be prioritised.
Industry had raised various concerns about the proposed policy, noting that under the Medicines Act the different types of licences may only be issued subject to quality assurance principles and good manufacturing and distribution practices that are related to the underlying products.
Vaccine Accelerator
SAHPRA’s focus on localisation coincides with the launch on Thursday last week in Paris of the African Vaccine Manufacturing Accelerator at the Global Forum for Vaccine Sovereignty and Innovation.
The WHO and several African leaders, including French President Emmanuel Macron, announced a planned $1.1bn project to expedite vaccine production in Africa to prepare the continent better for the next pandemic, which many health experts believe is inevitable.
The funding – over 10 years – is planned to provide financial incentives to boost vaccine manufacturing in Africa, which imports about 99% of its vaccine requirements. The aim is for the continent to produce 60% of its vaccine requirements by 2040.
African Union Commission chief Moussa Faki Mahamat said it “could become a catalyst for promoting the pharmaceutical industry in Africa and fostering collaboration between member states”.
“Africa imports 99% of its vaccines at an exorbitant cost,” he told Al Jazeera.
The EU said the bloc and its member states will contribute $800m to the vaccine manufacturing scheme. The programme will offset start-up costs and ensure demand for vaccines made in Africa, it added.
“Importantly, it will also support the sustainable growth of Africa’s manufacturing base and contribute to the AU’s ambition to produce most vaccines required by African countries.”
Helen Rees, executive director of Wits RHI at the University of the Witwatersrand, said the pandemic revealed the lack of equity in access to vaccines.
“By the time we got really good access to vaccines here (in Africa) … many people had immunity from natural infection. The impact of the vaccines was much less … because we got them too late,” she told Al Jazeera.
When the pandemic began, South Africa was the only country on the continent with any ability to produce vaccines, officials say, and Africa produced just a tiny fraction of all jabs worldwide.
WHO failed to help countries agree to a “pandemic treaty” – to improve preparedness and response to pandemics – before its annual meeting last month, mainly due to disagreements over sharing information about pathogens that cause epidemics and the high-tech tools used to fight them.
Negotiators will resume work on the treaty in hopes of clinching a deal by the next WHO annual meeting in 2025.
The Paris event also aimed to give a funding boost to Gavi, the Vaccine Alliance, a public-private partnership that helps get needed vaccines to developing countries worldwide.
Gavi is seeking $9bn to bolster its vaccination programmes in poorer countries from 2026 to 2030, with its chief executive Sania Nishtar saying it wants to move faster and offer more vaccines, including expanding a malaria vaccine roll-out that began in Cameroon this year.
The global vaccine alliance wants to reach “the highest number of children, covering them against the widest number of diseases … in the shortest possible time”, Nishtar said.
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$1bn plan for African vaccine manufacturing
AU pleads for support for African vaccine manufacturers
WHO: Africa urgently needs more COVID-19 vaccine before third-wave hits