Between 29 November and 1 December 2021, all member states of the World Health Organization (WHO) will convene for an extraordinary session of the World Health Assembly (WHA).  There is only one agenda item: whether or not to commence negotiations towards a legally binding, global instrument on pandemic preparedness and response.  Since it was first proposed by the European Union (EU) in November 2020, significant momentum has built towards some kind of International Pandemic Treaty (IPT).  The project is currently backed by the EU and more than 25 countries, though sceptics include the U.S., Russia, Brazil and China.

The IPT will be directly relevant to all pharmaceutical companies developing medical countermeasures (e.g. vaccines, diagnostics, and therapeutics) to most infectious diseases with epidemic or pandemic potential.  This blog summarizes key points that pharmaceutical companies should be aware of.

1. Public-private collaboration in the global system to detect and assess health threats

On 30 January 2020, the WHO Director-General declared the COVID-19 pandemic a “Public Health Emergency of International Concern”  The timeliness of this declaration has been under significant criticism.  As a result, there is consensus that the existing 2005 International Health Regulations (IHR) need to be reformed, and that a new system will be organized to rapidly detect and share information on outbreaks of “disease with pandemic potential.”

High-ranking officials at the WHO expect that this new monitoring system may function comparably to the existing Global Influenza Surveillance and Response System (GISRS).  This network of laboratories has been monitoring seasonal influenza for decades, as well as influenza with pandemic potential under the WHO’s Pandemic Influenza Preparedness (PIP) Framework since 2011.  Since early 2020, the GISRS network of infectious disease experts has been instrumental in the global response to coronavirus.

It is uncertain whether the IPT’s new monitoring system would absorb the GISRS.  In any case, the key message for industry is that most pharmaceutical companies can, will and even must interact with the new monitoring network under IPT.  For instance, under the PIP Framework, pharmaceutical manufacturers have been obliged to sign a Standard Material Transfer Agreement (SMTA) in order to be allowed to receive virus samples as well as sequence or epidemiological information.  In that context, the obligation to conclude these SMTAs was relevant mostly for manufacturers of influenza vaccines, a relatively small and well-defined group.  For the future IPT, it appears likely that its scope will comprise all pathogens “with epidemic or pandemic potential.”

These SMTAs will likely become the key legal instrument to organize public-private collaboration under the future IPT.  Importantly, their drafting is already underway in the context of a SARS-CoV-2 pilot project called the WHO BioHub System.  Without awaiting the outcome of the upcoming WHA Special Session, the WHO Secretariat already started chiseling away at the building blocks for the future IPT.  We zoom in on this BioHub and its draft SMTA, since they provide insight into key topics that will be central to the upcoming WHA Special Session: global equity, intellectual property, and funding the IPT.

2. Equity for global health: concrete impact for industry?

To prepare the Special Session of the WHA, a Member States’ Working Group was convened in July 2021, chaired by Indonesia and the United States.  The group published a so-called “zero draft” already on 28 October 2021, stating that equity is “at the core of the breakdown in the current system” and that equity is “ideally suited for negotiation under the umbrella of a potential new instrument.”  Much can be covered by the umbrella of equity, and pharmaceutical companies are well advised to monitor discussions on e.g. (i) equity as regards access to and distribution of medical countermeasures, and (ii) equity as regards intellectual property, technology transfer and  empowerment of local and regional manufacturing capacity during emergencies.  There are many moving parts, but it is clear that what happens at the Special Session later this month will be connected to parallel discussions and outcomes at the WTO on the TRIPS waiver.

At a more granular level, the SMTAs will likely be the legal instrument to organize the equitable contribution of the pharmaceutical industry under the IPT.  Companies that wish to develop medical countermeasures relating to pathogens of “epidemic and pandemic potential” will likely require physical samples for their R&D, or will need access to the information developed by the global monitoring system.  In order to obtain access to these materials and information, the SMTA will require companies to become “qualified entities” by WHO and agree to “benefit-sharing.”  The pilot phase of the WHO BioHub contains a draft SMTA “for the Sharing of Biological Materials with Epidemic or Pandemic Potential (BMEPP) with a Qualified Entity for non-commercial public health use.”  Article 4 of this SMTA states that “[i]n the event that the use of BMEPP results in  the creation of such material benefits, the Qualified Entity will engage with WHO to distribute and provide such benefits on a fair and equitable basis.”  While there is no clarity yet on what ‘benefit-sharing’ would be expected of companies under an International Pandemic Treaty, the existing regime for pandemic influenza is likely to be an inspiration.  In the SMTAs relating to pandemic influenza, companies have been given the option to agree to e.g. donations of vaccines, antivirals, medical devices and diagnostic kits; affordable pricing; transfer of technology and processes; granting of sublicenses to WHO; and laboratory and surveillance capacity building.

Last but not least, a point on funding.  A consensus has emerged that the cost of the new system should be shared between private and public actors.  Aside from the need for “sustainable resourcing”, there is little detail.  Currently, it is envisaged that the WHO would have a technical and convening role, with support from e.g. the International Monetary Fund (IMF) and the World Bank.  It is worth recalling that under the Pandemic Influenza Preparedness Framework, pharmaceutical companies pay a so-called “Partnership Contribution” which between 2012 and 2021 totaled to more than 227 million USD, on top of the “benefit-sharing” agreed through the SMTAs.  In practice, the contribution itself has not been too controversial, but rather issues such as transparency and accountability on how the monies have been spent by WHO to contribute to pandemic preparedness and response.

3. Next steps

The “zero draft” of 28 October 2021 states front-and-center that “the status quo is not acceptable to anyone.”  Though the legal nature and exact content is in flux, it is most likely that a new international system will emerge, and that pharmaceutical companies should pay close attention.

Covington intends to publish another update once the dust from the Special Session has settled.  In the meantime, do get in touch with Bart Van Vooren, partner in Covington’s life sciences practice.

With the assistance of Kolahta Ioab Asres, intern on global health policy.

 

 

 

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Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive…

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive litigation experience before the EU Court of Justice in dozens of cases.

Over the past seven years, Mr. Van Vooren has developed a niche practice on compliance with the Biodiversity Convention and the Nagoya Protocol, a set of rules to combat bio-piracy worldwide. He has accumulated unique, practical experience in dozens of jurisdictions around the world, and has handled everything from benefit-sharing negotiations, over compliance programs, to inspections by authorities.

Finally, Mr. Van Vooren has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation.