Are vaccines enough? To end COVID-19 we need more innovation – and more access

The world has arrived at a precarious juncture in the COVID-19 pandemic. The initial roll-out of vaccines has begun in a few countries, but infections and deaths are still rising globally, and it will be many months – likely more than a year in some developing countries – before vaccines are widely enough available and the virus is contained.

What that means is that COVID-19 will continue to cause a substantial amount of illness and death in 2021 and beyond. To help those who become infected with the virus, scientists, healthcare providers and governments are continuing to develop a diverse arsenal of new options for treating patients, both in the acute phase of their illness and for the growing list of chronic problems many survivors are suffering.

There is hope on the horizon. The US Food and Drug Administration is currently tracking more than 560 COVID-19 drug development programmes. But the challenge of taking a new medication from development in a lab to administration in a clinic is two-fold: first, there is the complex and expensive scientific lift of developing new interventions; second, there is the complicated task of making them accessible and affordable. For example, the most promising treatment advances to date involve monoclonal antibodies (mAbs), which are challenging to produce and distribute, currently in limited supply, and expensive – even in high-income settings.

Accelerating the journey from lab to bedside

The normal market mechanisms and incentive structures that guide the path of treatments from development to access – which are, arguably, sub-optimal in normal circumstances – are not suited to help combat a global pandemic. This is a situation that calls for new alliances that can speed the journey of COVID-19 innovations from the scientist’s bench to the patient’s bedside across all countries.

One positive development recently emerged that offers an example of multistakeholder collaboration. A united group of 21 companies representing a large portion of the world’s generic pharmaceutical manufacturers took a bold step. Though many are often competitors, they have pledged to work together to accelerate access to COVID-19 interventions in low- and middle-income countries via the non-profit Medicines Patent Pool (MPP).

MPP was established by Unitaid in 2010, and is a United Nations-backed public health organization that facilitates the development of and access to life-saving medications in low- and middle-income countries. Over the past decade, the organization has worked with product developers and generic manufacturers to secure agreements that delivered 15 billion doses of affordable breakthrough treatments for HIV and hepatitis C to 141 countries. MPP achieves this through an innovative model of negotiating voluntary agreements with patent holders to license their discoveries to a pool accessible to generic manufacturers capable of producing and distributing high-quality, affordable medical interventions.

The generic firms that have joined the MPP COVID-19 pledge have the capacity to deliver substantial amounts of conventional drugs, as seen in the last decade where the generic manufacturers have delivered over 15 billion doses of treatments through MPP licences.

Many of them are also building the infrastructure to produce more complex “biologics” – a category that includes the COVID-19 monoclonal antibody treatments.

It’s important for the world’s major pharmaceutical companies to join this effort as well. Among other things, patent pooling provides an orderly process for achieving consensus in addressing a familiar tension: generating private sector investments in biomedical innovation while ensuring equitable access to the products that emerge. This tension is especially evident today.

Balancing commercial industry imperatives with public health needs

Yet many pharmaceutical companies may worry about the implications of broadly licensing their IP to a patent pool. They include concerns that agreements designed to serve neglected populations might inadvertently erode market opportunities elsewhere. There also may be misgivings that there will be pressure to provide especially generous licensing terms for COVID-19 interventions, setting a precedent that would be applied to future negotiations for many other medical products.

But if all sides come to the table focused on the same goal – a fair solution for rapidly expanding access to COVID-19 innovations – they will find there is opportunity for crafting bespoke licences that balance commercial industry imperatives while favouring public health needs. Like the COVAX facility for improving access to vaccines and the World Health Organization’s (WHO) Access to COVID-19 Tools Accelerator (ACT A), it can help bridge a growing divide between different countries in securing the means to fight this pandemic. In fact, the WHO is looking to MPP to play a principal role in its COVID-19 Technology Access Pool (C-TAP).

Different from efforts that rely on charitable donations or philanthropic funding, patent pooling seeks a business model that offers a more sustainable solution for increasing access to medical breakthroughs.

Much as a range of treatment options are required to address COVID-19, a range of models should be employed to effectively expand access to these treatments. To be sure, negotiations over product licences, technology transfer arrangements and financing will be complex. Yet multiple stakeholders must come together to take this step if the world is to expand manufacturing, supply and ultimately access to life saving COVID-19 treatments.