Journal of Infectious Diseases & Therapy
Open Access

In June 2022, the member states of the World Trade Organization unanimously approved to waive intellectual property protections on COVID-19 vaccines, under the pretext that patents and other IP protections were impeding developing countries from accessing the lifesaving shots. This December, the WTO may further undermine the intellectual property framework by expanding the IP waiver to include COVID-19 diagnostic tests and treatments, such as Paxlovid, the antiviral that can reduce patients' risk of death by nearly 90% when taken early in the illness [1].

But that entire assumption that intellectual property is a barrier to equitable access is simply unfounded. The pandemic response was far from perfect, and developing countries are right to call out the fact that the vaccines did not reach them in sufficient quantities fast enough. But myriad other factors not IP protections were the cause for the inequality. Faulting patent protections, the very framework which underpins the decades of innovation which led to developing COVID-19 treatments and vaccines in record time, and which provided the legal basis for setting up hundreds of technology transfer agreements to produce them in both developing and developed countries, could have negative consequences and undermine efforts to win the ongoing fight against this virus and future pandemics that emerge.

Innovation: Essentials for preparedness and response, underpinned by strong intellectual property protections

My organisation, the International Federation of Pharmaceutical Manufacturers and Associations, recently published an analysis of what went right, and wrong, in the global pandemic response. "Applying Lessons Learned from COVID-19 to create a Healthier, Safer, and More Equitable World" provides an overview of the successes of innovation thanks to swift sharing of the SARS-CoV-2 pathogen, manufacturing scale up and partnerships while acknowledging frankly the collective failure of equitable access [2].

The pharmaceutical industry has a responsibility to support equitable access to vaccines and treatments in this and future pandemics. But this should not mean we ignore the indisputable evidence that innovation and manufacturing know how and the partnerships that IP protections facilitated enabled the world to produce 11 billion COVID-19 vaccines in 2021 alone and over 14 billion by the time the vaccine waiver was approved in June 2022. That was more than enough to fully vaccinate every adult in the world.

In fact, the glut of vaccines had grown so large by early 2022 that many developing countries were delaying or cancelling orders. In February, the Africa Centres for Disease Control and Prevention requested a pause in vaccine shipments, so that surplus doses wouldn't expire unused [3]. As a POLITICO article explained, the "primary challenge for vaccinating the continent is no longer supply shortages but logistics challenges and vaccine hesitancy [4]."

Today, there is an oversupply of COVID-19 vaccines, and this is a stunning achievement. Prior to COVID-19, global production of every type of vaccine totalled about 5 billion doses annually [5]. In barely a year, manufacturers in developing and developed countries managed to more than double vaccine manufacturing capacity an achievement that would have been impossible without close collaboration between innovative biopharmaceutical companies and manufacturers around the globe.

To date, over 381 voluntary business-to-business collaborations have been forged to facilitate vaccine production [3].

This same pattern holds true for COVID-19 treatments; over 150 voluntary manufacturing deals are already in place. Thanks to this industry collaboration which would not happen without the IP protections that underpin the framework that enables companies that can be competitors to agree on how they share their respective knowhow and technology the world now also enjoys a surplus of COVID-19 therapeutics. As stated in a communication from Switzerland and Mexico to the WTO: ‘large parts of innovators’ production capacity remain idle due to a ‘lack of demand’ [6]. So far, manufacturers have produced 80 million courses of COVID-19 treatments, yet only 18 million courses have been administered and there is forecasted demand for only 32 million more courses, according to a recent Geneva Network report that draws on data from health analytics firm Airfinity [7]. Governments and NGOs have purchased 35 million COVID-19 treatments for LMIC for 2022 but have only been able to administer 10 million as of September this year [8].

Despite these successes, biopharmaceutical innovation remains a risky endeavour. As an industry, we do not like to advertise when our innovation efforts fail. Some of the world’s leading and largest vaccine makers failed to produce a COVID-19 vaccine, despite decades of experience GSK, MSD and Sanofi have either abandoned their work or delayed it because of disappointing clinical trial results [9]. The same level of risk can be witnessed with COVID-19 treatments. After more than two years of work on a pill once hailed as Japan's biggest contribution to the global coronavirus fight, Fujifilm Holdings ended development of its COVID-19 antiviral candidate [10].

Investors and the stock market track closely investments in R and D and manufacturing scale up, but also the financial incentives that help understand the level of risk companies are taking. For example, hundreds of scientists had worked on mRNA vaccines for decades before the coronavirus pandemic brought a break through [11]. Two decades ago, few scientists or investors seemed interested in the technology. Katalin, the biochemist who is today acknowledged as having discovered the basis for mRNA couldn't get funding for her mRNA work and was demoted from the faculty position. Ultimately, mRNA technology was only proven successful after 30 years of trialand- error. Intellectual property laws provided the framework for decades of collaboration between different researchers. Without that foundation, scientists, universities and research institutes as well as biotech and larger pharmaceutical companies would have never been able to create and mass-produce the vaccines so quickly.

Following months of round-the-clock work involving multiple clinical trials and developing in parallel manufacturing capacity to produce billions of vaccines, the first vaccine was approved within 326 days of the virus sequence of SARS-CoV-2 being shared. Just 55 days later, COVID-19 vaccine doses were being shipped by COVAX to Ghana, marking the beginning of a global rollout. Kenya, Rwanda, Ghana and Japan also soon received their first deliveries.

Vaccine nationalism and trade restrictions undermine global

Of course, developing countries faced real barriers to vaccinating their populations it's just that IP protections weren't one of those obstacles. The lack of solidarity between countries was a far more common problem.

For instance, in March 2021, India imposed a ban on COVID-19 vaccine exports in an effort to prioritise its own needs amid a new wave of infections. This impacted exports from the Serum Institute of India for months, with the ban only being lifted in October 2021. The USA's Defence Protection Act also seriously impeded both the scaling up and sharing of vaccine doses. Vaccine nationalism and lack of funding severely impacted COVAX's ability to support lower income countries.

In May 2021, when the manufacturing output reached around 1 billion vaccines a month, we sadly saw that due to the export bans, many lower income countries, especially in Africa, were no longer receiving them. My organisation called out for dose sharing between rich countries and the rest of the world, which we communicated in our five steps to urgently advance COVID-19 vaccine equity, a message we repeated throughout 2021.

It took far too long to get vaccine distribution to lower-income countries back on track. But by December 2021, the IMF, World Bank Group, WHO, and WTO started calling for a shift from "Vaccines to Vaccinations," allaying concerns around scarcity and supply constraints of vaccines, and rightly shifting the focus onto getting vaccines into the arms of those who need them, wherever they are in the world [12]. Vaccine equity efforts then turned to addressing issues such as absorption capacity, country readiness, limited number of healthcare workers and vaccine hesitancy.

Ensuring equitable access

Having a strong sustainable and diverse innovation sector to build on has enabled, from the first days of the pandemic, unprecedented partnerships tapping into the manufacturing capacity in industrialised and developing countries [13]. During the pandemic, most companies are using voluntary licensing, technology transfer and differential pricing to help improve access. We have seen them price their vaccines and therapies in a way that helped governments ensure that there is little to no out-of-pocket costs for their populations based on the principles of volume, advanced commitment, equity and affordability. This approach has been applied to all agreements whether bilateral agreements or with organisations like COVAX, which has a best price clause as a standard in its contracts [14]. Similarly, we have seen companies step up to fill the gap when supplies to COVAX were not arriving from their initial contracts.

Questionnaire

Yes, we need to have a debate about why the world failed in providing equitable access to COVID-19 vaccines.

Would we have done better if all vaccine or drug development had been done on a non-profit basis? I very much doubt it. Would there have been more COVID-19 vaccines or treatments faster without the intellectual property protection? Certainly not.

While we must urgently address the bottlenecks that resulted in vaccine inequity, it is indisputable that we all need to do more and go further. This includes how to achieve more equitable allocation faster in the future, with more geographic dispersion of manufacturing capacity as an important component of that. It is with this in mind that biotech firms, vaccine manufacturers in developing countries, and innovative pharmaceutical companies, have united behind a proposal offering a practical solution for better access to vaccines for future pandemics. They have agreed to jointly endorse the Berlin Declaration framework which outlines how the industry would reserve an allocation of real-time production of vaccines for distribution to priority populations in lower-income countries for future global pandemics.

The vaccine innovators and manufacturers also outline their support for collaborations, a geographically diverse sustainable manufacturing footprint and mechanisms for rapidly scaling-up supply in a future pandemic. They agree to build on existing manufacturing partnerships, business-to-business agreements set up in advance, ongoing capability development and voluntary licensing and voluntary technology transfer where this will facilitate rather than impede scale up and global supply. These efforts rely on having a strong innovation ecosystem and the removal of regulatory and trade barriers to export. For the proposal to succeed, the health systems in lower-income countries need to be better prepared to absorb and deliver vaccines and treatments, and high-income countries need to provide the necessary political and financial support. The solution proposed has the potential, if the G7 and G20 embrace it, to become a new social contract that would ensure equitable access in future pandemics.

1. Biotech and Pharma (2021) Pfizer says Covid-19 pill near 90% effective in final analysis.

2. IFPMA (2022) Applying lessons learned from COVID-19 to create a healthier, safer, more equitable world.

3. IFPMA (2022) Research-based biopharmaceutical industry on the TRIPS waiver discussions at WTO Ministerial Conference (MC12).

4. Politico (2022) Africa CDC to ask world to pause Covid-19 vaccine donations.

5. COVID-19 Vaccine Production (2020) Forecasted production for 2021 is twice total non-COVID vaccines.

6. World Trade Organization (WTO) (2022) Trips council discussions on covid-19 therapeutics and diagnostics: Evidence and questions on intellectual property challenges experienced by members.

7. Mark S, Philip S (2022) Five reasons the trips waiver should not be expanded to COVID therapeutics.

8. Pharma Research Group (2022) Expanding the TRIPS waiver is unnecessary and harmful .

9. Jordan B F (2022) Why the world’s largest trio of vaccine makers failed on Covid-19.

10. Reuters (2022) Japan's Fujifilm stops work on Avigan as COVID drug.

11. Dolgin E (2021) The tangled history of mRNA vaccines. Nature 597:318-324.

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12. World Trade Organization News (2021) International organizations discuss how to improve access to COVID vaccines, countermeasures.

13. Airfinity (2021) Snap shot COVID-19 data.

14. World Health Organization (WHO) (2021) Explanatory note: Legal agreements with COVAX facility self-financing participants.