COVID-19: time to plan for prompt universal access to diagnostics and treatments

We welcome the G20's recognition that the coronavirus disease 2019 (COVID-19) pandemic “calls for a transparent, robust, coordinated, large-scale and science-based global response in the spirit of solidarity” and note its commitment to “do whatever it takes” to overcome the pandemic, along with relevant international organisations.¹

The G20 has committed to sharing timely and transparent information and materials for research and development and to support the full implementation of the WHO International Health Regulations 2005. They also agreed to expand manufacturing capacity to meet the need for medical products and make them widely available, at an affordable price, on an equitable basis, where they are most needed, as quickly as possible.

However, to achieve what is needed under the current extraordinary circumstances using the ordinary research and development and intellectual property frameworks, which were not designed to address a pandemic of this scale, will be a challenge. Inadequate global manufacturing capacity for emerging diagnostics² might already be forcing public health decisions to compromise health outcomes. The G20's commitments provide an opportunity to rethink intellectual property exclusivity and societal benefits of medical innovations.

Chile, Ecuador, Israel,³ Canada,⁴ and Germany⁵ have already initiated the adoption of national measures allowing the use of compulsory licensing to facilitate access to health products and other technologies for managing COVID-19. However, a global approach must be taken to ensure that all technologies will be simultaneously and promptly available in an equitable and efficient way that is affordable to all.

Therefore, of utmost importance is the appeal made by Costa Rican President Carlos Alvarado Quesada, and endorsed by the Director-General of WHO,⁶ to “pool rights to technologies that are useful for the detection, prevention, control and treatment of the COVID-19 pandemic”. Costa Rica's President envisages a global pool that provides every country with free access or licensing on reasonable and affordable terms, and “should include existing and future rights in patented inventions and designs, as well as rights in regulatory test data, know-how, cell lines, copyrights and blueprints for manufacturing diagnostic tests, devices, drugs, or vaccines”.

President Quesada also requested the establishment of a global database on research and development activities related to COVID-19, including estimates of the costs of clinical trials and subsidies provided by governments and charities to support coordination, transparency, and knowledge sharing.

We, as part of the negotiating group for the adoption of the World Health Assembly Resolution A72/17, equally note the concerns presented in an open letter to the European Commission⁷ by 33 members of the European Parliament about how EU-funded medical technologies for COVID-19 will be made available, accessible, and affordable for patients. The members of the European Parliament requested to leverage EU investment to demand transparency in the research and development pipeline by providing full public oversight and accountability over public and private investment in end-product development.

Finally, to better serve public health interest, WHO announced⁸ the coordination of a large global study (SOLIDARITY trial [ISRCTN83971151]) designed to prove safety and efficacy data on the four treatments that have the strongest scientific rationale for the treatment of patients with COVID-19. The study simplifies procedures enabling even overloaded hospitals to participate. As of March 29, 2020, 45 countries have joined this important initiative. Doing small, individual, national trials under the current circumstances is unethical and disregards the best interest of patients.

In light of all these factors, we urge all Member States who adopted the World Health Assembly 72 Resolution on “Improving the transparency of markets for medicines, vaccines, and other health products”⁹ to formally support the request from Costa Rica's Government and to ensure that any trial done at the national level is part of the global SOLIDARITY trial.

Without pre-agreed frameworks and emergency response plans ready to be deployed at the first signal of a credible global health threat, as originally intended when negotiating the WHO International Health Regulations 2005,¹⁰ political leaders have substantially affected the mitigation of COVID-19 public health crisis.

Unfortunately, pandemics cannot wait for individual political leaders in different countries to understand the science and compromise with lobby groups before making their own judgments. Such delays have already caused needless loss of life that could have been averted if a coordinated global response, as advocated in the WHO International Health Regulations 2005 and now reiterated by G20 leaders, had been taken from the beginning of the outbreak.

Global health security is a shared responsibility; it requires a collaborative collective response based on transparency and trust.