The draft pandemic accord, which was sent to member states of the World Health Organisation by the Intergovernmental Negotiating Body recently, includes several important elements. One of these is the provision for time-bound waivers when it comes to intellectual property- IP rights and benefits for countries sharing information about threatening pathogens.
Both of these problems have been major areas of discord when it comes to negotiations and may be harmed throughout the subsequent negotiations on the initial draft. Currently, there is a preliminary version called the zero-draft created by the INB Bureau, as well as an updated version referred to as the zero draft +.
It is well to be noted that the International Federation of Pharmaceutical Manufacturers and Associations- IFPMA promptly criticised the draft, illustrating it as harmful as well as adverse. They cautioned that it could hinder the progress of medical countermeasure creativity.
Earlier this week, Karl Lauterbach, the German Health Minister, made a clear statement that his country would not support an IP waiver in the pandemic agreement.
Lauterbach stated at the World Health Summit that it is obvious that countries like Germany and most European countries are opposed to an agreement that imposes major limits when it comes to intellectual property rights.
That is an inherent part of our DNA, he added. In order to invest in vaccines, therapeutics, diagnostics, and various related areas, it is crucial to prioritise intellectual property safety.
On social media, Helen Clark, the co-chair of The Independent Panel for Pandemic Preparedness and Response, suggested that prioritising a strict commitment to intellectual property protection during a pandemic can result in the loss of lives.
Double-whammy for the Pharma Sector
Article 11 presents a significant challenge for the pharmaceutical industry. The first part of the agreement urges the parties to make a commitment to time-limited waivers of their intellectual property rights. This is done in order to speed up or grow the manufacturing of products related to outbreaks during a pandemic. The purpose is to ensure that there is a sufficient supply of accessible pandemic-related products available.
The initiative encourages patent holders who are producing pandemic-related products to consider waiving or managing royalties payments by manufacturers through developing countries during pandemics.
Patent holders who have received substantial public financing for the development of their products should be bound to waive their royalty payments.
Mohga Kamal-Yanni, who happens to be the Policy Co-Lead for the People’s Vaccine Alliance, expressed reassurance that the clause on the waiver of intellectual property stays in the text, in spite of intense lobbying by pharmaceutical firms. However, she noted that the current language does not bring about an important shift in the existing situation.
Using qualifiers to the extent necessary to make the use of the waiver discretionary could create challenges in implementing this provision efficiently.
Research and development plus transparency
The draft aims to enhance transparency by urging member states to promote producers within their countries to provide confidential data to authorised third-party manufacturers. This sharing of information should occur when refusing it would impede or obstruct urgent manufacturing efforts.
Furthermore, it is required that countries share the terms of government-funded R&D agreements for pandemic-related products, which includes disclosing the pricing of the end products.
In the past, numerous countries have granted government funds to pharmaceutical companies for the development of medicines without enforcing any restrictions. This has allowed these companies to decide on their own prices as well as access to these drugs.
The Drugs for Neglected Diseases initiative- DNDi, an organisation dedicated to developing treatments for neglected diseases, expressed its deep disappointment regarding the removal of a provision from the zero draft. This provision aimed to attach conditions to public R&D funding.
Rachael Crockett, DNDi’s Senior Policy Advocacy Manager, clarified that while they go on to support the obligation to release contract terms as a distinct requirement, it does not guarantee that public R&D financiers will use their influence to include pro-access conditions in their funding contracts. Additionally, it does not guarantee that funding recipients will actually carry out pro-access activities.
Crockett emphasised the importance of both transparency and terms in order to facilitate the quick and effective development of health tools and their rightful access.
The draft also goes on to suggest the implementation of technology co-creation and joint venture initiatives by means of an open science approach, which promotes teamwork, particularly among scientists and academic centres in developing countries.
Access and benefit-sharing
One of the most challenging sections open for negotiations is Article 12, which addresses the problem of accessing pandemic products and the sharing of benefits that result from expressing knowledge of pathogens.
In order to tackle this issue, the draft suggests the creation of the WHO Pathogen Access and Benefit-Sharing System, or WHO PABS System. Its main goals are to promptly assess risks and help with the development and equitable access to pandemic-related products.
National laboratories as well as health authorities have to promptly and systematically submit their genetic code of pathogen material to one or more publicly accessible databases of their liking.
In order to receive material from other organisations, they must be part of a laboratory network that happens to be organised by the WHO. It is important to note that they will not be able to claim IP rights on any of the data they get to have. The material transfer will be governed by a typical material transfer agreement, to be exact a PABS SMTA.
The draft notes state that the benefits, including both monetary as well as otherwise, that come from obtaining WHO PABS materials should be divulged in a fair and equitable manner.
The distribution of pandemic-related products should prioritise individuals or groups who are in need, guaranteeing that they receive a minimum of 20% of the products. Out of this distribution, 10% should be donated to those who cannot afford them, while the remainder, or 10%, should be given at reasonable costs to make them available to a wider set of population.
The draft goes on to state that every country with manufacturing facilities when it comes to pandemic-related products should take any necessary steps to support the export of these products. This clause is likely included to prevent circumstances like India’s refusal to let the Serum Institute of India ship COVID vaccines abroad during the period of the pandemic.
It is important to encourage wealthy nations’ manufacturing setups to collaborate with producers from nations that are developing via WHO initiatives. This collaboration will facilitate the exchange of technology and know-how, as well as bolster capacities for the prompt scale-up of manufacturing pandemic-related goods.
The draft goes on to suggest options like tiered pricing and no-loss/no-profit arrangements for pandemic products, depending on the income level of countries.
Kamal-Yanni from the People’s Vaccine Alliance expressed their disagreement with the notion that allocating a percentage of production to the WHO can guarantee fair and equal access, despite acknowledging the improved language regarding the Pandemic Emergency Financing Facility- PEF.
She emphasised that manufacturers should be required to share technology, knowledge, as well as intellectual property when obtaining pathogens and data. This is needed to guarantee equal access to all medical countermeasures throughout a pandemic.
The obligations of a country
The draft document also outlines the responsibilities of countries in terms of preventing, preparing for, and reacting to pandemics. This emphasises the importance of the commonly used phrase that nobody is safe until everybody is safe.
All countries are required to detect, identify, as well as characterise pathogens that pose major hazards. They must also conduct risk evaluations of these pathogens as well as vector-borne diseases in order to avoid their spread to human and animal populations, as they can cause serious diseases that may lead to pandemic situations.
Kamal-Yanni warns that although there are several equity provisions included, the language they use is insufficient and excessively ambiguous in order to effectively achieve their goals. Qualifiers and limiting language have the potential to undermine the efficacy of applying transparency, technology transfer, or intellectual property measures.
She added that provisions that right now only call for the promotion and encouragement of measures that guarantee equitable access to medical countermeasures should be changed to become obligations and commitments.
Helen Clark, from the Independent Panel, expressed her appreciation for the progress made towards a pandemic agreement. She believes that this agreement, along with the transformed International Health Regulations, presents a one-of-a-kind opportunity to ensure a safer world that is better prepared to handle pandemic threats.
Aggrey Aluso, the Africa Director of the Pandemic Action Network, emphasised the urgent need for transparency regarding the steps that will be taken to address the barriers to equity that were clearly observed during the global response to the COVID-19 pandemic.
However, the Director General of IFPMA, Thomas Cueni, would prefer to discard the draft. Cueni said in a media statement that having no pandemic treaty would be preferred to having a flawed one, as evident from the draft shared with member states.
The private sector’s capacity to develop new treatments and vaccines in the aftermath of COVID-19 was fuelled by decades of investment in research and development, as well as the capacity of researchers to quickly access pathogen data. As per him, if the draft treaty is adopted, it would weaken the position and make them more vulnerable to future pandemics; hence, it has been urged to revise the text.