Second World Local Production Forum Launches New Collaborations; Civil Society Protests IP Barriers
Lab technicians at work in Cape Town’s Afrigen Vaccines & Biologics, one of the core partners in the WHO co-sponsored mRNA vaccine technology transfer hub, founded by WHO in 2021.  Much more needs to be done to foster local manufacturing of vaccines and health products, said participants at the Second World Forum.

A new Health Technology Access Pool (H-TAP), which aims to broaden the scope of IP and patent-sharing with low- and middle-income countries and a new African Union co-sponsored ‘manufacturing support platform’ were among the initiatives announced this week at the Second World Local Production forum in The Hague.

The global forum, the second ever to be convened, brought together industry, governments, civil society and multilateral organizations, including WHO, in a quest to bolster the local production of medicines and vaccines in underserved regions, particularly Africa, which was last in line to get COVID treatments during the pandemic.

The new H-TAP aims to overcome the shortcomings of the COVID-19 Technology Access Pool, C-TAP, which failed to gain significant buy-in from the industry. It also will include medicines and vaccines beyond COVID products, said Dr Yukiko Nakatani, Assistant Director-General for Access to Medicines and Health Products, at the Forum.  However, whether the new mechanism can really overcome the shortfalls seen in C-TAP, which drew little industry support, remains to be seen.

“Six license agreements for 15 health products have been agreed upon with Covid-19 technology holders – including from one private sector manufacturer. A serological test license from the Spanish National Research Center (CSIC) led to a sub-license to Biotech Africa to develop their diagnostic technology,” said Nakatani at the Local Production Forum, in his review of the slim achievements of the C-TAP pool.

“A review of C-TAP has been undertaken and a new technology access pool operating model is being developed and will be launched end of 2023. Stakeholders consultations will be held to help in the refinement and implementation of the model,” Nakatani said.

H-TAP and the WHO Pandemic Accord – interface unclear

As for further details on the H-TAP initiative, WHO did not comment.  However Ellen ‘t Hoen, head of the non-profit Medicines Law and Policy,  said that she expected the ongoing WHO member state negotiations on a new pandemic accord would also have to “address the need for the expansion of such a mechanism to enable the sharing of IP, including know-how and trade secrets.”

Meanwhile, in an open letter published at the start of the three-day Forum, a coalition of 30 prominent medicines access organizations, including Oxfam, the People’s Vaccine Alliance, Unitaid, and Public Citizen, warned that efforts to strengthen local medicines production in LMICs without addressing IP to “building a bridge to nowhere”.

“Plans and seed resources for building a bridge to local manufacturing abound, but they all have one feature in common – they systematically refuse to address the intellectual property barriers,” the open letter states.

At the World Health Summit in Berlin last month, German Health Minister Karl Lauterbach stated that any agreement without strong IP protections would “not fly” for Germany and its fellow EU countries, comparing IP to part of the EU’s “DNA.”

That stance was further reinforced at the start of the seventh round of INB negotiations on Monday when European countries asserted that any changes to IP rights should be thrashed out at the World Trade Organization (WTO) – not the WHO.

Tedros acknowledges the shortcomings of C-TAP model

WHO Director-General Dr Tedros Adhanom Ghebreyesus and Dutch Minister of Health Ernst Kuipers at the second World Local Production Forum in The Hague, Netherlands.

It took a staggering three years for a vaccine license to be shared with C-TAP, long after its potential to save lives had diminished. Aside from one Taiwanese firm, noit’s some private pharmaceutical company shared vaccines or therapeutics with the platform.

In his opening remarks, WHO Director General Dr Tedros Adhanom Ghebreyesus acknowledged the shortcomings of the C-TAP, the WHO’s ambitious platform aimed at facilitating patent-sharing for COVID-19 vaccines, treatments and medical technologies during the pandemic.

“The COVID-19 pandemic demonstrated the incredible power of vaccines, tests, treatments, and other medical technologies to save lives, but it also exposed the vast inequalities in our world,” Dr. Tedros stated. “Of course, this is not the first time.

“When HIV emerged over 40 years ago, life-saving medicines were developed, but more than a decade passed before the world’s poor got access to them,” he lamented. “When the H1N1 influenza pandemic struck 14 years ago, vaccines were developed, but by the time the world’s poor got access, the pandemic was over.”

However, the wakeup call provided by the pandemic also marked a turning point, Tedros and other speakers noted. That led to the creation of WHO’s mRNA vaccine technology transfer hub, launched in 2021 in South Africa.  Another global training hub in biomanufacturing capacity was also launched by WHO in collaboration with The Republic of Korea.

Local manufacturing has become more prominent on agenda now

Mapping of existing and planned manufacturing initiatives in Africa, as of December 2022.

The issue of local manufacturing was ignored for decades when UN-backed initiatives like The Global Fund to Fight TB, HIV/AIDS and Malaria, and Gavi, The Vaccine Alliance, channeled most contracts to a handful of large, well-established manufacturers in China, India, Europe or North America – ostensibly to reduce costs.  The concentration of their procurement, however, also tended to disadvantage local startups in other low- and middle-income countries, which could not compete with pharma giants in economies of scale, or pricing.   

Technology transfer and local production of medicines was first included on the agenda of the World Health Assembly (WHA) in 2018. During the WHA that year, Medecins Sans Frontières representative Elena Villanueva-Olivo condemned the failure of global research and development efforts and unequal access to affordable health technologies as “crises of international concern.”

Belatedly the pandemic cast a sharp light on the dearth of local manufacturing, particularly in Africa. It highlighted the long-term damage of concentrating procurement amongst only a handful of manufacturers, and highlighted how over time, more local manufacturing of essential medicines and vaccines could offer greater affordability and improved access to life-saving treatments, as compared to reliance on imports.

Since then, a flurry of new initiatives have been announced by WHO, the African Union and pharma companies themselves, including giants like Pfizer.  Big questions remain, however, regarding the durability and sustainability of the new projects in planning or already underway. 

New platform launched to support African manufacturers

The new Health Products Manufacturing Support Platform, launched at the Forum by Unitaid, the African Union Development Agency, and WHO aims to address some of those sustainability issues.

The platform will provide technical assitance to African manufacturers along the entire “health products manufacturing value chain,” its promoters said.

The support could range from technical assistance in “business management, sales and operations”, to support for the acquisition and development of active pharmaceutical products, and preparation of drug dossiers to ensure compliance with regulatory standards, the project initiators said.

The initiative calls upon African manufacturers, R&D centers and centers of excellence, as well as “market actors” including industry associations to collaborate in the initiative.

Over 79% of African pharma products are imported, while Africa supplies only 3% of global production of medicines and vaccines, it’s developers note.

Sidestepping IP issues? 

Filling vials for vaccine R&D at South African’s vaccine manufacturer Afrigen.

While developed countries and the private sector have emphasized the need to create a broad “ecosystem” to foster local manufacturing of health products, including investments in training, knowledge transfer and procurement preferences of global agencies and countries, civil society have long contended that IP restrictions constitute the key barriers:

“All of these hopes for local and regional production hinge on whether low- and middle-income countries (LMICs) have access to IP-protected research tools, technology platforms, product and process inventions, trade secrets, regulatory data, biologic resources (such as cell lines), and other knowledge essential to product development,” said the CSO  signatories to Monday’s letter. 

“We cannot be complacent – or resigned – to the siren song of purely voluntary measures and continued private hegemony over tools and knowledge by which the right to health is realized,” the letter states.

“We learned the painful costs of knowledge privatisation during the COVID-19 pandemic when major vaccine producers, including leading participants in the World Local Production Forum, refused to license their IP and share their breakthrough technologies and manufacturing know-how with capable producers in LMIC regions,” the coalition of civil society groups wrote in their letter to the forum.

Instead of building bridges to nowhere, international and multilateral institutions … must finally commit to supporting countries in their collaborative efforts to overcome IP barriers that will otherwise stifle local manufacturing,” the signatories added.

A draft set of recommendations from the Forum, seen by Health Policy Watch recommends “four interrelated elements to an ecosystem that need to be present,” to stimulate local manufacturing, including:

  • The essential components of supplies, infrastructure, skills and technologies for manufacturing capacity.
  • Financial investments for procurement, the scaling up of production and the equitable distribution of health products.
  • Skilled and trained policy makers and regulatory authorities for product quality, safety and predictability.
  • Information on, for example, actual production capacity and market demand.

It also recommends the “establishment of a network for synchronizing training resources and facilities for building private and public sector capacity in manufacturing, technology transfer, R&D, policy, regulation and implementation. For the moment, access to IP and other know-how needed for R&D and manufacturing is not on the map.

Stefan Anderson contributed reporting for this story. 

Image Credits: Rodger Bosch for MPP/WHO, Netherlands MoH, Clinton Health Access Intiative , Health Products Manufacturing Support PlatformMSP , Rodger Bosch/ MPP & WHO.

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