The year 2020 was a bittersweet for the pharma industry. Despite drug companies bringing vaccines to market in record time, the patent system has come under fire for delaying equitable access to medicines.
For Komal Kalha, head of intellectual property at trade lobby group International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), this past year has meant focusing on how to advise policy makers, companies and international bodies about the necessity of IP incentives to develop COVID vaccines and therapies.
IFPMA works with non-governmental organisations (NGOs), the UN, governments and philanthropy groups on behalf of pharma companies. The trade group lobbies for the pharma industry, and facilitates dialogue and collaboration within the industry and with international stakeholders.
“For the past year, there has understandably been a great deal of focus on the development of COVID therapeutics and vaccines and how these need to reach patients. However, the basics haven’t changed, just amplified,” she says.
“My role is to equip policy makers with the explanation of the important role of IP incentives in the larger innovative ecosystem and understand if there are any IP or trade barriers which would hamper patient access.”
But although the industry has responded to the crisis in record time, civil society groups and NGOs have argued that patents and other IP-related rights, including data and know-how, could potentially keep COVID vaccines and therapies out of reach of many developing countries.
In an interview with Managing IP, Kalha explains the misconceptions around IP rights and how incentives are vital for innovation.
As head of IP for IFPMA, what sort of issues have you confronted over the past year with COVID? Did COVID have its own set of challenges, with pharma cast so abruptly in the spotlight?
Two main things we have had to contend with in the past year follow each other. We’ve been working to show that the IP incentive system works. And we’ve been explaining to experts and policy makers how disclosure requirements for patents, scope of protection, and the TRIPS system work.
IP has been an enabler to bring solutions to COVID-19. Without it we would not be where we are today with vaccine rollouts, therapeutics and diagnostics being used.
The next question that follows, and what has taken up the lion’s share of the discussion, is to explain how fair and equitable access to new COVID-19 vaccines and treatments can be achieved. The concerns around access need a broader stakeholder approach, need certain policies and, most importantly, should support the collaborative effort underway rather than relaying a rhetoric that IP is a hindrance.
To achieve a goal you need the right policies and collaborations.
Were you surprised at the amount of collaboration that went into the industry’s response to the pandemic, and do you think there are any lessons that can be carried over into a post-COVID world?
The lessons that I think will carry over into the post-COVID world are greater collaboration, a number of breakthroughs in science and manufacturing, and a renewed focus on health security.
Many civil society groups point fingers at IP as a culprit for restricting access to medicine. How do you see the balance of IP rights and the need to get medicines to where they are required most?
Unfortunately, IP protections and access issues have got entangled in each other over the years. For a patient to get access to the right medicine at the right time, an entire system needs to work, with each stakeholder playing a different yet critical role in this system.
In fact, we are dependent on other players to get that medicine to the patient, these being those making laws and policies, procuring, deploying, selling, diagnosing and administering the medicine, to name a few.
If any step goes wrong, access will be hampered, none of which is remotely related to IP. This is why the industry keeps on making the point that greater access is dependent on healthcare system strengthening.
IP, on the other hand, allows you to take the risk to go forward and explore possibilities of cures; not all will succeed, but if one does, it is a step forward in science worldwide. Secondly, it gives you a limited time period to be able to carry out further research, safety checks and recover, to some extent, the cost of the risks of investment in innovation.
COVID is a classic example: if our companies had not invested in research on Ebola, SARs and MERs, it would have taken much longer to get to where we are at today. Furthermore, doing away with IP rights, as some have suggested, would not lead to greater access – on the contrary, it would have a chilling effect on innovation across all sectors.
Are there any misconceptions about the pharma industry and its response to COVID-19 that you have come across?
The pharma industry has always been viewed with a weary eye and COVID has been no different.
However, I hope we have been able to demonstrate that we are a responsible industry and have risen to the occasion. We have collaborated with universities, governments, small and large companies across the globe and we have not compromised on science and safety. We are in it together; this is a public health emergency like no other. And it requires that we show that science and solidarity are our way out.
We conducted a multi-country reputation survey last September among the general public – what was heartening was that two out of three people agree that our industry is more effective at discovering new medicines and vaccines; and nearly as many agree that we make a positive contribution to society and the economy.
I would also like to believe that this pandemic has shown the fundamental role an innovation ecosystem supported by incentives plays in society.
Other than finding vaccines and therapies for COVID in record time, are there other challenges the pharma industry is facing?
I think in the policy-making world, views are very polarised. It’s easy to paint us as only out for ourselves and our shareholders. That is simply not the case. We have responsibilities to patients and society while at the same time making sure we have a sound business model so that we can take risks over the long term to hopefully eventually find the breakthrough that generations before had been hoping for. We are solution partners, not adversaries.
During this pandemic, what is easily forgotten is that apart from our responsibility to find and manufacture at scale COVID treatments and vaccines, we have a responsibility to those that need other vaccines and medicines as well. We cannot just ignore non-COVID patients.
We also need to carry out research and development not just for the next pandemic but also for ailments of existing patients. All this is done by investing at risk, relying on our experts to get the job done and a strong incentive system.
Currently, there is a push to uproot the incentive system, which has worked and allowed us to provide several solutions for a pandemic the likes we have not seen before. Do you know, an IP holder has to – at every stage, all the way from filing an application to the end of term of protection – defend their IP, whether it be administrative, legal or enforcement challenges.
Despite these hurdles, the industry is willing and ready. I would like to see that concern erased by way of our actions and that science be put before politics.
