COVID-19 – CSO open letter to UNITAID, the World Health Organization (WHO) and its Member States

15 May, 2020

To:

Dr. Tedros Adhanom Ghebreyesus

Director-General, World Health Organization

Geneva, Switzerland

WHO Member States

Marisol Touraine

Chair, Unitaid Executive Board

Dr Philippe Duneton

Executive Director a.i, Unitaid

Re: Civil society concerns regarding lack of governance mechanisms and binding commitments for equitable access and sharing of technology, knowledge and data, management and licensing of intellectual property for medical tools needed for COVID-19 detection, prevention and treatment. 

Dear Excellencies, Dr. Tedros, Ms. Touraine, Dr. Duneton,

As initiatives, commitments, principles and resolutions for the research and development of new COVID-19 medical tools and health technologies takes shape between member states, WHO and philanthropic institutions, we the undersigned, are writing to share our concerns and recommendations.

While there is great hope as new diagnostics, therapeutics and vaccines for COVID-19 make their way through the development process, there are growing concerns regarding how these will be made available and affordable for the people and vulnerable communities who need them most.

Funding and voluntary approaches for intellectual property licensing alone are not sufficient to guarantee that life-saving health technologies and medical tools will be delivered into the hands of health ministries, treatment providers and patients around the world.

This is apparent with Gilead’s approach to remdesivir, which creates a disturbing precedent for the pharmaceutical industry on COVID-19 technologies and medicines. Even as publication of data is awaited on the safety and efficacy of the drug, Gilead has opted to pursue secret voluntary licenses of its IP and technology to specific manufacturers while excluding others despite the potential need to ramp up global production. There is no transparency or accountability with respect to its actions or the terms of the license agreements, in particular how and whether they are aligned with global public health needs. The US Corporation also recently announced that it was donating a significant portion of its entire supply of 1.5million doses to the US government for distribution, with no further explanation on supply guarantee to the other countries. This means that if remdesivir is proven effective, most countries will have limited, delayed or no access to the medicine.

In these extraordinary times, this “business as usual” approach simply cannot be accepted. There needs to be oversight to ensure transparent allocation of existing limited resources based on public health needs and special protection for vulnerable countries, with increased production of COVID-19 medical tools including medicines and vaccines to achieve equitable access.

The Access to Covid-19 Tools Accelerator (ACT) was launched as an opportunity to address some of the challenges that have emerged with the management of supply and access to COVID-19 medical tools including new drugs like remdesivir.  This will only be possible if the ACT is more than just a collection of global health agencies that seek to distribute funds and set out production timelines.  Ensuring timely development and access to these medical technologies is fundamentally a political challenge that requires the agreement and backing of governments to work cooperatively to overcome long-standing barriers to equitable access.

Therefore, we would highlight the following commitments that must be made:

1. Leadership of Member States and the World Health Organisation:While we understand that some Member States are engaged in the governance of the ACT, and that WHO has a role to play in the operation and management of ACT, the decision to hand over control of the ACT to several global health funding agencies that are funded by only a few governments and primarily serve the needs of low-income countries, means that the ACT will not truly be a global mechanism.  Only the proper oversight and management of the ACT, through agreement of Member States, and under the overall guidance of the WHO, can ensure that it can act on behalf of all countries – low, middle and high income.

2. Concrete binding mechanisms with respect to equitable allocation: There must be more than just a commitment to equitable access.  We note the first commitment of the ACT is “the shared aim of equitable global access to innovative tools for COVID-19 for all”. However, there is no concrete mechanism that defines “equitable global access” and holds manufacturers and other stakeholders accountable to this commitment. Nor is there any clear plan on how equitable global access will be achieved.

3. Mandatory commitments for unhindered global sharing of intellectual property, technology and know-how and establishing platforms for open innovation and technology transfer:We also recognize the Accelerator’s commitment to collaboration and solidarity but it is truly lacking in the ability for concrete action given the absence of clear mechanisms that guarantee the sharing of technology, know-how, data and intellectual property, needed to counter Covid-19 and ramp up global manufacture of needed medical products. We express concern with WHO’s continued reliance on voluntary approaches at the detriment of commonly agreed on TRIPS flexibilities. Voluntary mechanisms are insufficient in these extraordinary times of dire global need. We also note that several of the global health agencies and foundations within the ACT are reluctant, unwilling or hostile to appropriately support the right of countries to use such flexibilities to address intellectual property barriers that undermine equitable and affordable access to health technologies.

4. Ensure transparency governance and oversight of the ACT:The original ACT was conceptualised through a closed-door process on the basis of a White Paper developed in part by the Gates Foundation.  This paper has still not been published, thereby limiting any understanding of the basis for choices that have already been made, and what other approaches may have been considered as the ACT was developed.   At present, while pharmaceutical companies have been integrated into the governance of the ACT, there has been no role or engagement of civil society in the development, oversight and operation of the ACT.  These choices seem to have reversed the role of civil society and industry over the last two decades in ensuring innovation and access to medicines.  We request full transparency of international policy making process and meaningful participation of civil society organizations in shaping global initiatives concerning access to COVID-19 medical tools.

As the multilateral response takes shape, these are concrete steps that governments and WHO need to take to ensure their good intentions turn into tangible medical tools in the hands of treatment providers and patients.

We look forward to hearing from you on how WHO and member states will address our concerns regarding the lack of governance mechanisms, binding commitments and transparency to ensure equitable and timely affordable access to critical health technologies and products for COVID-19 for people across the world.

Signatories (alphabetical order)