Pharma Under The Microscope In The COVID-19 Crisis
Colorized electron microscope image of SARS-CoV-2 (yellow), the virus that causes COVID-19
Thomas Cueni

Now, more than ever, the pharma industry has been thrust into the limelight – as the world races to find new drugs and a hoped-for vaccine to beat COVID-19 and ensure universal access to critical treatment. Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), talks about the old-new tensions between profit and public needs and how a fiercely competitive industry is testing new models of cooperation.

Health Policy Watch: There is finally an agreed text on the EU-led resolution on COVID-19 Response, that was passed unanimously at the World Health Assembly on Tuesday.  What is your take on the result?

Thomas Cueni: Resolutions quite often have symbolic meaning. When I look at the outcome, it has the right focus, tasking the global community to work together to contain and one day to defeat COVID 19.   It does address the issues of health systems resilience; it does look at lessons to be learned and it calls for collaboration with WHO.

In the development of the call to action, which has become the ACT Accelerator, there are three pillars: vaccines, therapeutics and diagnostics. But there is also a focus on health systems. We’ve been working on the ACT A for three weeks now, and we are making progress in working together towards a common goal to tackle COVID 19.

There are, however, three references to countries’ rights to override patents with the use of WTO  TRIPS flexibilities in the text – something civil society saw as a modest victory.

What we got was a united, rapid, unprecedented industry response to COVID 19, in terms making decisions collectively, repurposing existing medicines, joining together for development of vaccines. When you look at who holds the keys to these, I think there is a recognition that it is indispensable to partner with the private sector and more specifically the biopharmaceutical industry. There has been a recognition among the broader health community that the industry has responded at amazing speed.  It is scaling up manufacturing, in some cases joining up, and committing to huge collaboration efforts in vaccine development. This is not our normal business model. Companies are putting aside normal rivalry and fierce competition, and working on the basis of high risk for high reward. Here companies are acting very differently, with a deep sense of responsibility. As a founding partner of the ACT Accelerator, pharma joins with it a strong belief in the need for solidarity, equity, and a clear notion that what comes out of our labs needs to be affordable.

[The reference to TRIPS] is symbolic and to some extent concerning. It is thanks to a flourishing, thriving innovation ecosystem based on IP that we have so many treatments and vaccines already being tested. Pharma companies moved really extremely fast opening, for example, their libraries to NIH and IMI [Innovative Medicines Initiative].IP has not been a hindrance to finding solutions, it has been an enabler. Without the IP system, we would not be where we are in just three months.  The pharma industry is teaming up with regulatory agencies around the world. It is sharing data. It did not need to be forced to move into discussions about how we can ramp up. Gilead has already contracted with the Medicines Patent Pool – [for voluntary licensing of remdesivir].  The scale, the size of [pharma’s engagement] is unprecedented. All of this is done voluntarily.

So, I was somewhat concerned that there are institutions or people that try to hijack COVID-19 to pursue the traditional attack on IP.  It’s not necessary right now – because companies are doing the right thing.  Undermining IP will be extremely dangerous, because when we have future pandemics and we will have future pandemics, it sends the signal that your IP won’t count for anything.  Honestly, that would be a dangerous signal because companies are doing the right thing. If somebody is already doing the right thing and is met by threats of coercion that would not be the best way to get them to engage.

HPW: Can you talk a little more about the Gilead collaboration with MPP on remdesivir for voluntary licensing of the treatment and these other industry collaborations?  

TC: Gilead is working with MPP, but they also have bilateral contracts. There are multiple ways of doing voluntary licenses.  Decisions in terms of testing, further ramping up [production], giving away huge doses, all of that, to the best of my knowledge was done by Gilead.

It is also important that companies maintain oversight over who they choose to collaborate. They have a responsibility to pick partners based on quality checks and assurances, because quality does matter.

One initiative that underscores our common goal of solidarity and equity, and I think has not been given adequate attention, is the ACT Accelerator initiative launched on April 24 by Dr Tedros. So many leaders among them: the European Commission President Ursula von der Leyen, French President Macron, German Chancellor Merkel, South African President Cyril Ramaphosa, and others spoke of this as they supported the WHO Conference Call for action that day.

In a matter of weeks, this [ACT Accelerator] has been implemented. We are making great progress in the work of these various accelerators. CEPI and GAVI are in the lead of an effort searching for a vaccine from end to end.  And everyone agrees that WHO should play a major role when it comes to allocation. We know that at the beginning [when a vaccine or hopefully vaccines are available], demand will far outstrip supply. In the industrialized world there are only handful of companies with the skill sets to scale up the manufacturing of vaccines, which are going to be needed in the hundreds of millions and probably billions [of doses]. In the case of vaccines, it is not just a question of IP, it is also a question of know-how and that you acquire over time. We will need global guidance on who should get the vaccine first: health care workers and vulnerable populations. This is why we support the vaccine accelerator.

Similar for a therapeutics accelerator. People are keen to get more guidance in terms of clinical practice. We should not focus on a few countries. We need a global focus on what is the best clinical practice in terms of treating COVID-19 patients.

HPW: Overall, there has been less talk about collaboration in the therapeutics accelerator ? Can you recap.

TC: There are three pillars under the ACT umbrella:vaccines diagnostics, therapeutics.

It is really good to see that there are tremendous dynamics coming out of ACT, based on the understanding that there will be a light touch coordination mechanism. And there will be leading roles for the likes of CEPI, GAVI, The Global Fund and FIND.

The Vaccine Accelerator is by far the most developed in terms of global approach. In therapeutics, you have a lot of progress happening at national level.  In the therapeutics, testing the different treatments is a key preoccupation. For therapeutics you already have leading regulatory agencies involved, and market mechanisms, whereas for vaccines, you need end-to-end collaboration. At the same time [whether for COVID-19 treatments or vaccines] you are confronted with the same problem: you want to know once they work that they also need to be made available to low- and middle-income countries.

HPW: Is IFPMA completely opposed to the use of TRIPS Flexibilities – or are there times this is justified?   

TC: Most countries have national emergency frameworks. In times of war, in times of crisis, countries can sequester production facilities through public interest compulsory license. I see it as a last resort. It would be very dangerous if this was seen as something that should be done systematically. It would send the wrong signal. If the industry engages in voluntary licenses in collaboration, emphasizes the importance of equity, then I believe that a general call for compulsory licensing would frighten them, and it would not be conducive to what needs to be done. Industry is already sharing the data, they are going to member states, WHO, asking for advice in allocation.  For example, UNICEF [which is also involved in the ACT Accelerator] in quite a number of cases has a huge experience in medicines and vaccines deployment and delivery. It is easier to get results if everyone has a common purpose than if you approach it in antagonistic manner.

HPW: What about transparency ?  There have been calls for more transparency around the prices of new COVID-19 drugs and particularly R&D costs for drugs such as remdesivir, which received very large public sector investments?  

TC: We are likely to see that there will be differential pricing. If you want to make sure that everyone who needs has access, there will have to be tiered prices

As for the transparency of R&D costs for new COVID-19 drugs and vaccines. I would expect that the affordability issue is handled through public private partnerships. It does include the know-how of who puts in how much.

Image Credits: NIAID.