This op-ed was originally published on Pharma Boardroom on 25 November 2021.
The World Health Assembly Special Session on a Pandemic Treaty, which will convene health ministries from around the world in Geneva next week, offers a unique opportunity to take a look back and share some important lessons learnt from fighting the COVID-19 pandemic. James Anderson, Executive Director, Global Health, at IFPMA, lays out 3 key lessons: first, an innovation eco-system backed by intellectual property, second, the importance of unhindered access to pathogen genetic sequencing, and third, agile regulatory authorities.
The biopharmaceutical innovation ecosystem supported by strong IP delivered fast solutions to respond to the COVID-19 pandemic. Let’s not undermine what is helping us respond to this crisis.
When scientists started the hunt for a vaccine against COVID-19, the aim of developing one within 18 months – far faster than ever before – seemed hugely ambitious. Targets of 50% efficacy were aspired to. Within a year, several vaccine candidates were approved with efficacy rates of 80-90% or higher. Therapeutics are helping patients and saving lives – initially repurposed medicines were rapidly shown to work against COVID-19 and we now see novel treatments that will hopefully be approved soon.
This unprecedented response was only possible because of the existence of a strong innovation ecosystem. It is anchored in competitive research and development and puts emphasis on a strong protection of intellectual property (IP). Decades-long investment and expertise and our industry’s willingness to take risk have paved the way for completely new technologies such as mRNA and viral vector vaccines. We have seen amazing breakthroughs, but we also faced many bumps on the road, including setbacks from big and small vaccine companies. Despite the risks of failure, we have remained committed to do all that we can to leverage our expertise and knowhow.
To respond to this global crisis, and to scale up manufacturing output at speed, companies were establishing collaborations long before a single new vaccine or treatment was approved. In total, COVID-19 vaccine and treatment innovators have teamed up on over 400 major production and supply chain agreements worldwide: 329 for vaccines and 109 for treatments, including between rivals. Deals have spanned transfer of technology and know-how as well as filling and finishing; and the industry joined forces in distribution and storage of vaccines and treatments. Robust international support of IP protections enabled these successful arrangements, which have boosted COVID-19 vaccine manufacturing output past 10 billion doses so far in 2021, already twice the total volume of all vaccines made in 2020.
The IP waiver proposals tabled at multilateral fora by South Africa and India last year aimed to address a production deficit, but have since been rendered moot. Without the waiver in place companies in China, India, Europe and USA are forecast to produce a total of 24 billion doses of vaccines by the middle of next year. So the proposals are a distraction at best, and would send the wrong signal for future investment into vaccines and treatments targeting pathogens with pandemic risk. The world needs companies to invest proactively into the many other virus families identified as having the potential to cause pandemics in the future. This will help us to be better equipped to stop epidemics before they turn into pandemics.
The unfettered access to pathogens was indispensable to allowing companies to respond as quickly as they did.
Chinese scientists shared the genetic sequence of the SARS-CoV2 virus publicly in January 2020, enabling all researchers to start working on vaccines and treatments. The first COVID-19 vaccines went into clinical trials a few weeks later and went on to be approved within 326 days. Any delays to sharing the original data would have delayed the approval of the first vaccines.
And yet this is a risk we are facing — pathogens may not be shared immediately and without restriction, with all researchers able to access the data at the same time. This is due to misguided implementation of the Nagoya Protocol (NP), which can prevent scientists from sharing the genetic sequence of emerging pathogens, cause extensive negotiations and legal uncertainty for researchers, and incentivize countries to see pathogens as bargaining chips.
Any conditionalities, uncertainties, or negotiations attached to pathogen sharing – such as those under discussion for the World Health Organization BioHub and under certain national legislation implementing the Nagoya Protocol – risk significant delays in the development of countermeasures.
Emerging pathogens must be shared for research purposes immediately, no matter where they are discovered.
Regulatory authorities made great steps that enabled fast access to new COVID-19 products. We must continue to improve regulatory system preparedness.
Since the start of the COVID-19 pandemic, many national regulatory authorities (NRAs) have instituted ‘regulatory agilities’ to facilitate new and ongoing clinical research. It is well-known that inefficient regulatory processes and systems can result in months or years of delay in patients getting access to lifesaving medicines.
Leading regulators established mechanisms to fast-track access to COVID-19 products, allowed e-signatures, expedited scientific advice and ‘rolling review’ processes. New technologies have helped improve the recruitment of volunteers as well as conducting, monitoring, and capturing data for of clinical trials. The combination of these approaches resulted in a significant streamlining of the key steps, saving many months altogether.
Biotech, generic and innovative biopharmaceutical companies involved in developing COVID-19 vaccines and treatments are engaging directly and through their trade bodies with NRAs and regulatory coalitions to provide input, on how well these regulatory agilities worked in accelerating the development and registration of COVID-19 medicines and vaccines.
These lessons learned will help to modernize the current regulatory environment to better adapt to scientific and technical innovations for developing new medicines and vaccines, while also providing best practices for future pandemic preparedness.
What else do we need to do, to strengthen our collective global capability to respond to the next pandemic?
Building a robust and comprehensive global preparedness capability requires aligned actions from many stakeholders and we have published the industry’s perspectives on what is needed. For example, multilateral organizations and governments must be willing to enter into advanced purchase agreements quickly, even prior to regulatory authorization. This is critical to ensure that low- and middle-income countries secure sufficient supply from quality assured manufacturers in a timely manner. It needs confirmed funding, as spelled out clearly by the G20 Independent Panel.
It will be important to ensure the ‘free flow’ of goods, services, and personnel and avoid trade restrictions and supply barriers, to avoid some of the challenges experienced with delivering COVID-19 vaccines around the world. This will also enable countries to import and export raw materials and finished products for pandemic medical products without hindrance.
Finally, governments need to invest in strengthening national health systems and global infrastructure, to deliver the UN 2030 Universal Health Coverage targets. Improved primary care, capability to run population-wide vaccination programmes, including the necessary cold-chain, and planning to meet the unique healthcare requirements during pandemics will all help protect the world against future pandemics.
In order to strengthen our response to the current COVID-19 crisis and start preparing for the next pandemic, we need to nurture:
- Sustainable innovation ecosystem
- Global coordination
- Sustained political leadership
- Regulatory alignment
- Public-private partnerships
- Health system strengthening
- Up-front and on-going financing
Every crisis comes with its learnings and it is critical that we build on the successes achieved in combatting COVID, as well as coming together to tackle the areas that need to be improved. The biopharmaceutical industry will play a key role in future pandemics and we are keen to contribute what we have learned during the current one.