Comment: The route to global vaccine equity is not through a waiver of IP rights

A Trips agreement waiver would lead to a drop in research and development for Covid-19-related products like vaccines and treatments

‘The evidence shows that there are already more than enough doses to vaccinate the world. The real problem is the capacity of some countries, mostly developing nations, to absorb, distribute and administer Covid-19 vaccines.’ Picture: Getty

On December 29, 2020, 79-year-old Annie Lynch from Dublin became the first person in Ireland to be vaccinated for Covid-19. Since then, some 10.5 million doses of Covid-19 vaccine have been administered. Ireland’s Covid-19 vaccination rate is world-class. As a community we clearly believe in the power of science. The efficient rollout of the vaccination programme attests to the capacity of our health services to respond to an emergency.

All of us want as much of the world as possible protected against Covid-19, as fast as possible. Although vaccination has helped society to avoid the worst effects of the disease, there are concerns that that, in time, a Covid-19 mutation could occur that is more infectious and more deadly. The more freely infections are allowed to circulate, the more likely this possibility becomes. We must maximise community protection, no matter where people live.

Among the most vital catalysts for the discovery, development and manufacture of vaccines and treatments, for any disease, is intellectual property. The global patents system, underpinned by stable and predictable intellectual property rights, is the basis for innovation in medicines. The proposal, led by India and South Africa, to waive intellectual property protection for Covid-19 vaccines and treatment under the World Trade Organisation’s Trips Agreement is a profound risk to the global patents system. It will not accelerate global Covid-19 vaccines access. Production is not the problem, there are already more than enough vaccines for the world. The problem is they are not getting to the people who most need them fast enough.

By June, 18.5 billion doses of Covid-19 vaccines will have been produced since the start of the pandemic, according to Airfinity, the independent health analysts. At the end of last month, there were 12.1 billion Covid-19 vaccine doses produced, including almost four billion mRNA vaccines. Of the 12.1 billion, just 9.2 billion had been administered. The speed of Covid-19 vaccines production is outpacing their administration.

The central argument for waiving intellectual property protection for Covid-19 vaccines is to boost production. But even if the removal of patent protections for the design and manufacture and Covid-19 vaccines were a solution, the evidence shows that there are already more than enough doses to vaccinate the world. The real problem is the capacity of some countries, mostly developing nations, to absorb, distribute and administer Covid-19 vaccines. In some of these countries, Covid-19 vaccine hesitancy is high. There are reports of shortages of syringes and medical equipment, as well as the destruction of expired vaccines.

The challenge of supply has been met by the industry investing in our own existing sites and in voluntarily securing 357 manufacturing partners globally with the skills and technology needed to produce Covid-19 vaccines to the highest regulatory standards. Further expansions by manufacturers of production capacity are planned, especially in Africa. It is often the case that global supply of vaccines and medicines is managed from a small number of manufacturing sites, with production of the drug substance, known as the active pharmaceutical ingredient, concentrated in one site. Building manufacturing sites across multiple continents is impractical and unnecessary. Importing and exporting raw ingredients is complex. In the case of one vaccine, there are some 280 raw ingredients. Local regulatory approval is needed where manufacturing sites are located. The right skills are not always available locally.

Covax, a World Health Organisation-backed Covid-19 vaccines distribution programme, has so far delivered more than 1.1 billion doses to 144 countries. Europe has donated more than 350 million doses, with at least as many pledged this year. The US has donated over 400 million doses. Of the 675 million vaccine doses so far supplied to Africa’s population of 1.2 billion, between three and 3.5 million have had to be destroyed, according to the World Health Organisation. Covax has adjusted its approach to deliver vaccines according to demand rather than on the basis of population size.

According to the European Patent Office, a Trips agreement waiver would lead to a 37 per cent drop in research and development for Covid-19-related products like vaccines and treatments. The impact would disproportionately be felt in higher-income countries where research and development activity is more likely to be concentrated. Just 5.9 per cent (33 out of 554) of all Covid-19 vaccines and 1.9 per cent (32 out of 1,708) of all Covid-19 treatments in development have been approved for use so far.

Multilateral solutions are needed to strengthen healthcare system capacity for Covid-19 vaccine administration empathetically tackle vaccine hesitancy. Developed countries must give developing ones much more of their surplus Covid-19 vaccine doses faster. These moves would would help the 1.2 billion unvaccinated people aged 15 and over in developing countries and reduce undistributed stocks of Covid-19 vaccine doses.

Covid-19 has been harrowing. Beyond sickness and death, it could take years for hospitals to work through the backlog of patient cases for other diseases. All of us have work to do to deal with the human fallout from the pandemic, to get more of the world’s population protected, and to prepare for the potential of more regular pandemics.

Bernard Mallee is director of communications and advocacy at the Irish Pharmaceutical Healthcare Association