The draft pandemic accord sent to WHO member states by the Intergovernmental Negotiating Body (INB) last week was met with mixed reaction, being welcomed by some, but labelled “bad and damaging”, by others.
Of particular concern was the inclusion of time-bound waivers of intellectual property (IP) rights and benefits for countries sharing data about threatening pathogens.
These two issues have been bones of contention until now, and could be revised during negotiations on the first official draft. (So far, there has been a “zero-draft” drawn up by the INB Bureau and a “zero draft +”.)
Already, writes Kerry Cullinan in Health Policy Watch, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has called it “damaging”, warning of its “chilling effect on the innovation pipeline for medical countermeasures”.
And earlier, German Health Minister Karl Lauterbach said his country would not countenance an IP waiver in the accord.
“For most European countries, such an agreement will not fly if there is a major limitation on intellectual property rights,” he said. “…We need intellectual property security, to invest in vaccines, therapeutics, diagnostics, and so forth.”
However, Helen Clark, co-chair of the the Independent Panel for Pandemic Preparedness and Response, countered on social media that “maintaining pure adherence to intellectual property protection in a pandemic costs lives”.
Big blow to pharma
Article 11 contains a double-whammy for big pharma. First, it calls on parties to commit to “time-bound waivers of intellectual property rights to accelerate… the manufacturing of pandemic-related products during a pandemic, to the extent necessary to increase the availability … of affordable … products”.
It also “encourages” patent-holders producing these products “to waive or manage” royalties’ payment by developing countries during pandemics, while patent holders who receive “significant public financing” to develop products will waive their royalties.
R&D and transparency
Member states are urged to “encourage” manufacturers in their countries to “share undisclosed information” with qualified third-party manufacturers if withholding it “prevents or hinders urgent manufacture”.
In addition, countries “shall” publish the terms of government-funded research and development (R&D) agreements for pandemic-related products, including pricing of end-products.
In the past, many countries have not imposed conditions on companies receiving government grants to develop medicines, leaving them to determine their own prices and access.
The draft also proposes “technology co-creation and joint venture initiatives” using an “open science” approach encouraging collaboration, particularly with scientists and research centres from developing countries.
Access and benefit-sharing
One of the thorniest sections is Article 12, regarding access to pandemic products and benefit-sharing arising from sharing information about pathogens.
It proposes the establishment of the WHO Pathogen Access and Benefit-Sharing System (WHO PABS System) to “ensure rapid, timely risk assessment” and “rapid development of, and equitable access to, pandemic-related products”.
National laboratories and health authorities will be required to upload the genetic sequences of pathogen material to “one or more publicly accessible database(s)” in “a systematic, timely manner”.
They will need to be part of a WHO-co-ordinated laboratory network to receive material from other bodies and cannot seek IP rights on any of the material they receive. A standard material transfer agreement (a PABS SMTA) will govern the material transfer.
“Benefits, both monetary and non-monetary, arising from access to WHO PABS materials, shall be shared equitably.”
WHO should get “a minimum of 20%” pandemic-related products” for distribution, with 10% being donated and 10% sold “at affordable prices”.
Each country with manufacturing facilities to produce pandemic-related products “shall take necessary steps to facilitate the export of the products”, the draft adds.
Manufacturers from developed countries should be “encouraged” to collaborate with manufacturers from developing countries “through WHO initiatives to transfer technology …and strengthen capacities for the scale-up of production of pandemic-related products”.
The draft also proposes options like tiered pricing and “no loss/ no profit” arrangements for pandemic products, that take into account countries’ income levels.
Even if a manufacturer does not opt for a PABS SMTA, if it produces pandemic-related products from WHO PABS materials, it will be required “to ensure their fair, equitable allocation”.
But Kamal-Yanni of People’s Vaccine Alliance said while the language on PABS was improved, “we disagree with the logic that allocating a percentage of production to WHO can ensure equitable access”.
“Sharing technology, knowledge and intellectual property by manufacturers accessing pathogens and data should be mandatory for equitable access to all medical countermeasures during a pandemic.”
Country obligations
Countries are also required to strengthen animal disease preventive measures to prevent zoonotic spillover, strengthen laboratory biosafety to curtail lab accidents and address antimicrobial resistance.
Developing countries will get “financial and technical support, assistance and cooperation” to strengthen and sustain a skilled, competent public health workforce.
“While it is positive that many equity provisions are included, their language is inadequate and unnecessarily vague to achieve their goals,” warns Kamal-Yanni. “The ability to apply transparency, technology transfer or intellectual property measures could be undermined by qualifiers and limiting language.”
“We urgently need transparency on how to address the barriers to equity that were so evident in the global response to the pandemic,” said Aggrey Aluso, the Pandemic Action Network’s Africa director.
“Key aspects now are the inclusivity of the negotiating process, political engagement, and transparency on the… transformation to tackling the barriers.”
But IFPMA director-general Thomas Cueni would prefer to dump the draft: “It would be better to have no treaty than a bad pandemic treaty,” he said.
“The private sector’s ability to develop new vaccines and treatments in response to Covid-19 was driven by decades of R&D investment and scientists’ ability to rapidly access data on pathogens. This treaty would undermine both … we urge governments to make significant revisions to the text.”
See more from MedicalBrief archives:
Big Pharma seeks protection for IP rights
Developing nations plead for fairer treatment access
Outrage over COVID-19 vaccine inequities: Rich world hogs supplies and patents
IP waivers will stifle medical innovations in SA – IRR