This article was originally published on Health Policy Watch on February 10, 2020.

“We all have a vested interest to stop this epidemic,” says Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). As WHO on Tuesday convenes a Global Research & Innovation Forum to rapidly ramp up R&D, Cueni spoke with Health Policy Watch  about what he describes as  “the extraordinary willingness of everyone involved – regulators, pharma companies, public health institutes, and many others – to reach out and work collaboratively to respond to the 2019_nCoV.”

Health Policy Watch: In terms of the R&D response to the coronavirus crisis, which has taken China and the world by storm, can you give a broad overview of what is going on the R&D front? 

Thomas Cueni: This is clearly a rapidly evolving situation, one where it is important to acknowledge how quickly things have moved in just a few weeks.  On 9 January 2020, the Chinese health authorities and the World Health Organization (WHO) announced the discovery of a novel coronavirus.  A virus that was confirmed as the agent responsible for the pneumonia cases and for which there are no known effective therapies.

Then in a matter of days, (11-12 January 2020), the Chinese authorities shared the full sequence of the so called 2019-nCoV genome, as detected in samples taken from the first patients.  Sharing the sequence of the virus is crucial for the development of specific diagnostic tests and the identification of potential treatment options.

From that moment onward, the scientific community was able to start getting to grips with the new threat posed by the novel coronavirus.  As a first step, data- sharing channels are a must for researchers to mobilize.  Fortunately, the Global Initiative on Sharing All Influenza Data/GISAID Initiative, set up twelve years ago, was immediately pressed into action to share the information across their network.

From this point, it was possible for collaborative R&D platforms to begin to look at how they could respond.  CEPI (Coalition for Epidemic Preparedness Innovations), announced as early as 23 January 2020, that some companies were already lined up and ready to initiate vaccine development.  Since then, the European Innovative Medicines Initiative (IMI), a European Union public-private partnership with the pharma industry, has also begun looking into establishing collaborative initiative on 2019_nCoV therapeutics and diagnostics.

What characterizes the R&D approach for the novel coronavirus is that we are NOT starting from scratch.  The global collaborative research community has responded to health crises before.  SARS, MERS, and Ebola have, all in their own ways, forged pathways for collaboration to accelerate development of resources to tackle this new outbreak.  The 2016 WHO R&D Blueprint for Action to Prevent Epidemics, which put forward funding & coordination models for preparedness and response has clearly been important in helping pull together this week’s Forum to fast track R&D for the novel coronavirus.

HP-Watch: An important part of the R&D effort will be directed towards identifying/repurposing existing medical treatments –  Are there any promising existing treatments out there so far that have come on your radar – we were hearing about chloroquine and HIV drugs as one alternative last week?

Cueni: One of the main actions that the China government has already started to investigate is whether existing anti-viral drugs could be successfully repurposed to treat this novel type of coronavirus.

It has already authorized to test 30 compounds against 2019_nCoV. One of the key ones being Remdesivir, a new (experimental) antiviral drug by Gilead Sciences Inc. aimed at infectious diseases such Ebola and SARS. We understand that this treatment will be tested by a medical team from Beijing-based China-Japan Friendship Hospital for efficacy in treating the novel coronavirus.

This is just one of the experimental drugs that have not been approved for use to treat the novel coronavirus by drug regulators but that are in the frame to be repurposed.  Scientists in academia and companies are reviewing existing compounds and research. We have learnt about AbbVie’s Lopinavir – Repurposed HIV protease inhibitor (under the trade name Kaletra) as well.  Interferon and Oseltamivir which were used to treat some patients with MERS are also being tested.

Pharma industry associations such as the European Federation of Pharmaceutical Industries and Associations (EFPIA) have issued a call to their members to identify suitable assets in their libraries that could be utilized in the fight against coronaviruses.  Relevant assets include diagnostics and biomarkers, approved therapies, or compounds in development that could be repurposed for use in treating patients with the coronavirus.  EFPIA members have also been asked to identify any ACE inhibitors (used to dilate vessels and lower blood pressure), protease inhibitors (antivirals widely used to inhibit HIV)  or immunotherapies that could be relevant in the context of CoV.

Artificial Intelligence is finding its place in the process, and is being used to mine through medical information to find drugs that might be helpful for tackling the novel coronavirus. Overall, there has been an extraordinary willingness of everyone involved – regulators, pharma companies, public health institutes, and many others – to reach out and work collaboratively to respond to the 2019_nCoV.

HP-Watch: As for vaccines, the new Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI) seems to be leading the search.  And it has signed a collaboration agreement with GSK as well as a number of other private sector partners.  However, Anthony Fauci, director of the US National Institutes of Health/National Institute of Allergy and Infectious Diseases, has pointed out that any vaccine would take at least a year to develop and approve, so the real solutions will have to be focused on “good public health measures” for now.  Any thoughts on this and the timeline?

Cueni: CEPI is clearly well positioned to demonstrate what the WHO rightly underscores as the importance of global collaboration among the public and private sector. The funding and research landscape for diseases of epidemic potential has evolved since the SARS and Ebola outbreaks.

Developing and approving repurposed or new diagnostics, vaccines and other treatments will all vary greatly. Clearly, the jury is out in terms of how long it will take; and lest we forget, an essential condition for better R&D preparedness and response is the availability of funding.

That notwithstanding, at least a dozen R&D biopharmaceutical companies are working on vaccines or antivirals and other treatments to help those infected with the fast-spreading contagion.

I’ve spoken to Thomas Breuer, chief medical officer of GlaxoSmithKline’s (GSK.L) vaccine unit, who said it was working with developers by providing a technology that could make their vaccines more potent.  He gives a timeframe of at least 12 to 18 months to develop an effective vaccine.

HP-Watch: With the efforts that are already going on, what more can this urgent  R&D meeting in Geneva called by WHO accomplish to advance critical public-private collaboration on R&D?   

Cueni: This week’s forum is timely, and the agenda will hopefully allow to scope out many of the R&D challenges and help identify the possible gaps.

The fact it was possible to quickly organize and assemble such a gathering of so many experts, including the R&D biopharmaceutical industry, is proof that there is today a clearly identified global health community that can be mobilised at short notice – I guess it is a positive legacy of past epidemics.

I think it would be wise to let the meeting take place before passing judgement on what further public-private collaboration is needed.  We have some good platforms in place such as CEPI and IMI who are as we understand going to contribute to the meeting this week.  Hopefully the resulting research roadmap and governance framework for the tackling of the novel coronavirus that will come out from the forum will recognize the ongoing contributions and role of the R&D biopharmaceutical industry.

HP-Watch: Regarding protective equipment, WHO raised an alarm last week about hoarding and price gouging for specialized masks and other PPE devices that health workers need desperately — and they stressed that this can happen at various points on the supply chain, from rubber plantation upward.  What measures can, or is, IFPMA taking to facilitate industry collaboration on this issue all along the supply chain?

Cueni: Panic, hording and speculation clearly have the potential to undermine the response to this public health epidemic. The R&D biopharmaceutical industry is going to great lengths to respond appropriately with the measured urgency that the situation demands. Many IFPMA member companies responded swiftly in the first week of the epidemic being announced to support the Chinese government with donations for diagnostics and protective equipment.

IFPMA and its members are monitoring the situation in China closely. R&D biopharmaceutical companies are working proactively to monitor their supply chains in order to prevent and mitigate potential shortages through close coordination with national regulatory authorities and other global stakeholders, including the World Health Organization.

HP Watch: In terms of the sharing of vital information about pathogens, to expedite research into therapies and vaccines, you recently noted that the Nagoya Protocol, which aims to ensure a country’s control over the genetic materials of indigenous plants and animals species, as part of biodiversity protection, needs to be urgently amended to exclude pathogens – otherwise this could greatly impede their sharing.  Can you please explain this complex issue.

Cueni: The Nagoya Protocol (NP) on Access and Benefit Sharing (ABS) is a legally-binding, supplementary international agreement to the Convention on Biological Diversity (CBD). Its objective is the fair and equitable sharing of benefits arising from using genetic resources for the conservation and sustainable use of biodiversity. To put it simply, the Nagoya Protocol has the laudable aim of giving each country sovereignty over its biological resources.

Today, more and more countries are moving towards enacting the Nagoya Protocol in national legislation, interpreting it in a way that requires sharing of the genetic resource and their information to be subject to negotiation between two parties.  The inclusion of pathogens (as a genetic resource) under the NP was not directly addressed in the final text, and the decision was made to leave it to each Party to “pay due regard” to potential public health risks when implementing legislation.

As I recently wrote in First Opinion in STAT, applying the Nagoya Protocol in the case of the novel coronavirus could have hindered or even prevented the global collaboration required to find new treatments or vaccines. Luckily, China has seemingly not followed Access and Benefit Sharing (ABS) requirements when it discovered the novel coronavirus 2019_nCoV.  In principle, a country with such a new virus could have embarked on discussions with each country, one by one, about how to share the sequence of this pathogen.

While we are today focusing on putting all our efforts on the novel coronavirus; there are other examples where difficulties can arise.  For example: in the case of seasonal influenza vaccines, the WHO acknowledged that there have been instances where sharing of seasonal influenza virus samples with WHO has been hindered, or halted altogether, on the grounds of conflicting or unclear local ABS legislation. This is concerning. If the WHO cannot fully see what strains of influenza viruses are circulating, the probability of them being able to make an incorrect recommendation with regards which strains to include in seasonal vaccines, increases quite substantially.

I firmly believe it is in the world’s best interests to promote trust and fairness for the sake of global public health by making the sharing of pathogens swift and predictable.  We must question the sense of retaining pathogens within the scope of the Nagoya Protocol and associated national legislation. It is in the interest of global public health and epidemic and pandemic preparedness for the international community to work towards an effective and internationally coherent approach to exempt pathogens from the protocol.

HP-Watch: As for the WHO’s Pandemic Influenza Preparedness (PIP) framework – which the WHO Executive Board (EB) also reviewed at its meeting last week – how does that framework fit into the current crisis?  Is it relevant, or not, in expediting needed R&D?

Cueni: The main objectives of the PIP Framework are to improve pandemic influenza preparedness and response, and strengthen the protection against the pandemic influenza by improving and strengthening the WHO global influenza surveillance and response system WHO GISRS, which includes a global network of national influenza centres, WHO collaborating centres and other research laboratories. The novel coronavirus brings the advantages of this network sharply into focus.

The PIP framework has as its objective to provide a fair, transparent, equitable, efficient, effective system for all.  In addition to ensuring that it operates on equal footing for all, it underscores the need for the sharing of H5N1 and other influenza viruses with human pandemic potential; as well as providing access to vaccines and sharing of other benefits.

The PIP Framework was adopted in 2011, but we have not yet seen its principles put into practice. It should also be noted that influenza is quite a unique situation, where potential manufacturers of a pandemic vaccine can leverage on developing and distributing seasonal vaccines annually, with global pandemic preparedness being underpinned by seasonal vaccine coverage; no other emerging virus can claim the same.

As the PIP Framework itself is not legally-binding for Member States, so far very few countries have made specific provisions for it in their national legislation. This means that, in the event of a pandemic, a country could refuse to immediately share their pandemic virus samples on the grounds of conflict with local ABS legislation.  This could lead to delays as bilateral contracts are negotiated,

This creates a situation of inequity where some countries include public health provisions in their local legislation, and are willing to share with the global community, but others do not on the basis that the Nagoya Protocol is an environmental piece of legislation.  The fear I have is that many legislators are not even aware in passing this legislation that public health could be impacted.

HP-Watch: Any other observations from the recent WHO EB debates on PIP, Ngoya and emergency preparedness ?

Cueni: I think that we cannot under-estimate the importance of having systems in place to make sure that the global health community can act fast to tackle threats to public health. The need for collaboration and alignment that are underpinned by effective networks and sharing platforms are key.

While the Executive Board had to deal with many tough questions, let us not lose sight of what is happening in Wuhan and beyond. My first thoughts are with all those affected by the outbreak of the novel coronavirus (nCov-2019).

The World Health Organization is clearly pulling out all the stops to handle this public health emergency.   The R&D biopharmaceutical industry is supporting the global community and the WHO; as an industry we are fully committed to joining global efforts to care of those affected, contain the outbreak and develop resources to tackle future outbreaks.

HP-Watch:  Other issues you would like to address at this critical moment – in terms of how to ensure what Tedros described as “solidarity, solidarity, solidarity” between public and private sectors.   

Cueni: Since the WHO declared the coronavirus a Public Health Emergency of International Concern on 30 January 2020, their continued leadership will be crucial in helping ensure an effective and appropriate response to this public health threat.

As a science-driven industry that aims to address some of the world’s biggest health care challenges, the R&D biopharmaceutical industry clearly has a role to play in developing new and improved medicines and vaccines to help respond to this epidemic.  The industry is fully supportive of efforts that will ensure the scientific community can respond quickly to the challenges this epidemic faces.

There are a number of factors today that give me hope that the situation can be managed.  Firstly, rapid access to the virus has speeded up the process of kick starting the search for solutions, secondly, there is global recognition, funding and structures in place to share the burden of R&D.  Last but not least, there are tried and tested sharing platforms in place for influenza that can be leveraged.

Epidemics are a time when we are all starkly reminded that putting up fences across the global health community does not work.  We all have a vested interest in trying to stop the epidemic from spreading, especially to countries with weaker health systems – this would be an absolute tragedy.  We all have a vested interest in finding treatments and preventative vaccines as soon as possible.

Thomas Cueni is Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

Author

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  Thomas Cueni Director General info@ifpma.org