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TWN Info Service on Intellectual Property Issues (May20/08)
22 May 2020
Third World Network


COVID-19: CSOs, observers push for access to medical products at WHA

Geneva, 22 May (TWN) – Civil society organizations and other observers at the 73rd World Health Assembly (WHA) made strong demands for access to COVID-19 related medical products and technologies in their statements.

Their call included the use of flexibilities in the Agreement on Trade-related Aspects of Intellectual Property (TRIPS) to curb the adverse effects of intellectual property (IP) protection, the promotion of open innovation and local production, transparency in clinical trials and the governance of access to medical products, technology and data.

The WHA met virtually on 18-19 May 2020 with several statements from heads of governments at the high-level segment.

It adopted a resolution that refers to TRIPS flexibilities three times.

First, Operational Paragraph (OP) 4 calls for universal, timely and equitable access to, and fair distribution of, medical products and technologies, and the removal any unjustifiable obstacles consistent with the provisions international treaties including the TRIPS agreement and the flexibilities as confirmed by the Doha Declaration on the TRIPS Agreement and Public Health.

Ideally this should have been a sub-paragraph under the OP that makes specific requests or calls for Member States action. Nevertheless OP4 affirms an important general principle.

Secondly, OP8.2 calls on international organizations and other relevant stakeholders to collaborate for the development, test and scale up of production and to “use existing mechanisms for voluntary pooling and licensing of patents to facilitate timely, equitable and affordable access to them, consistent with the provisions of relevant international treaties, including the provisions of the TRIPS agreement and the flexibilities as confirmed by the Doha Declaration on the TRIPS Agreement and Public Health”.

Thirdly, OP9.8 requests the Director-General of WHO to “identify and provide options that respect the provisions of relevant international treaties, including the provisions of the TRIPS agreement and the flexibilities as confirmed by the Doha Declaration on the TRIPS Agreement and Public Health to be used in scaling up development, manufacturing and distribution capacities needed for transparent equitable and timely access”. These are to be prepared in consultation with Member States and with inputs from relevant international organizations, civil society organisations and the private sector.

The initial draft resolution proposed by the European Union (EU) did not contain any reference to the TRIPS flexibilities. However, insistence from developing countries resulted in the inclusion of these crucial rights of WTO Members.

According to some delegates involved in the negotiations of the resolution, the Permanent Mission of Cameroun for the UN and WTO, on behalf of the African Group, had written to the Permanent Mission of the EU in Geneva to include five points in the resolution. One of the demands was the inclusion of the use of TRIPS flexibilities.

The letter stated: “It is important to highlight and underscore the need for full utilization of the TRIPS Agreement and public health. To actualise these flexibilities, it is equality important this Draft Resolution urges States and the Private sector to collaborate in order to facilitate transfer of technology and the know-how for medicines, vaccines, diagnostics and other commodities, which will ensure that we are able to meet the global demand. Thus the Africa Group would like to support the Chair’s proposal on TRIPS on OP4 or OP7.2 , which read consistent with the Provisions and flexibilities of TRIPS”.

[The EU draft had read “consistent with the provisions of relevant international treaties” with no reference to TRIPS. The accepted compromise that was adopted reads: “consistent with the provisions of relevant international treaties, including the provisions of the TRIPS agreement and the flexibilities as confirmed by the Doha Declaration on the TRIPS Agreement and Public Health”.]

Below are highlights from the statements to the 73rd WHA by CSOs and other observers.

Open Science

The joint statement of Drugs for Neglected Diseases initiative (DNDi) and Médecins Sans Frontières (MSF) called upon the World Health Organization (WHO) and Member States to “commit to open sharing of research knowledge and data, which improves efficiency and accelerates scientific progress. R&D funding should be made conditional on results, data, promising compounds, clinical trial protocols and results, being put in the public domain”.

Use of TRIPS Flexibilities

DNDI-MSF asked the WHA to “Guarantee that health tools are free of intellectual property restrictions, which can obstruct research and large-scale production of affordable health technologies. No new legal rights should be sought, and technology owners should either not enforce their existing IP or share it via non-exclusive licensing globally. Countries must use all legal mechanisms, including TRIPS flexibilities to ensure access.”

Public Services International called on Member States “to consider all research, data, technology, treatments and vaccines relating to COVID-19 as non-proprietary shared global resources, supported with full compulsory licensing”.

Knowledge Ecology International (KEI) opposed the monopoly in medical products for the COVID-19 fight and stated: “There should be no monopolies on patents, regulatory exclusivities, data or know-how in this pandemic. All relevant technology for COVID-19 products should be available either free or openly licensed with non-discriminatory, reasonable and affordable royalties”.

Local Production

The DNDI-MSF statement called on WHA to “Act now to ensure sufficient production, equitable allocation, and affordable pricing. Additional production capacity must be created, including through technology transfer. New health tools need to be equitably allocated both between countries and within countries. Pricing must be as close as possible to cost of production, affordable for health systems, and free to those most in need”.

KEI also stated that Governments “have massive power to ensure technology to fight COVID-19 are open to all manufacturers, and cheap”.

Governance of R&D and Access

Health Action International (HAI) hoped that Costa Rica’s proposal to establish a COVID-19 technology pool would facilitate the sharing and transfer of knowledge and data crucial for the development of medical products required for the pandemic response. HAI urged “governments and actors in all sectors to engage with WHO to establish a structure that guarantees access to global public goods without delay, to everyone, everywhere. The ‘business as usual’ approach, of market exclusivities, opacity, and market-driven R&D will not counter the current crisis and only exacerbate inequalities in access to medicines. We remain, as ever, willing to be part of the solution, as a legitimate global actor”.

KEI emphasised that “Relevant technologies should become global public goods. Where incentives are needed, they should be delinked from prices and exclusive rights”.

Transparency

The Cochrane Collaboration demanded for transparency in clinical trials. In its statement the global network stated that “Now, more than ever, it is vital that WHO’s guidance on public disclosure of results from clinical trials is followed. Without accessible trial data, and proper synthesis and appraisal, it is certain that much of this global research investment will be wasted. We call on WHO Member States to support evidence-informed decision making by taking action to safeguard trial transparency; and to provide adequate funding for evidence synthesis given the challenges ahead”.

The Holy See concluded its statement by stressing that “the heightened research motivated by the COVID-19 pandemic” should be conducted “in a transparent and disinterested way, in order to find vaccines and treatments and to guarantee universal access to essential technologies that will enable every infected person, in every part of the world, to receive the necessary health care”.

Prior to WHA, a letter to health ministers and the Assembly signed by 140 individuals (including current and former heads of government, international civil servants, Nobel laureates and other prominent individuals), called for a “people’s vaccine”.

The signatories of the letter include: President Cyril Ramaphosa of South Africa and Chair of the African Union, Prime Minister Imran Khan of Pakistan, President Macky Sall of the Republic of Senegal, and President Nana Addo Dankwa Akufo-Addo of Ghana.

Also in the list were the former President of Liberia, Ellen Johnson Sirleaf, the former Prime Minister of the United Kingdom, Gordon Brown, the former President of Mexico, Ernesto Zedillo, and the former United Nations Development Programme Administrator and former Prime Minister of New Zealand, Helen Clark.

Notable economists and health advocates included the Chair of the Elders and the former President of Ireland, Mary Robinson, Nobel laureate Joseph Stiglitz, Chairperson of the African Union Commission, Moussa Faki, Director of African Centres for Disease Control and Prevention, Dr John Nkengasong, and the Special Rapporteur on the Right to Health, Dainius Puras.

The letter made the following demands for a global agreement under WHO that:

  • Ensures mandatory worldwide sharing of all COVID-19 related knowledge, data and technologies with a pool of COVID-19 licenses freely available to all countries. Countries should be empowered and enabled to make full use of agreed safeguards and flexibilities in the WTO Doha Declaration on the TRIPS Agreement and Public Health to protect access to medicines for all.
  • Establishes a global and equitable rapid manufacturing and distribution plan – that is fully-funded by rich nations – for the vaccine and all COVID-19 products and technologies that guarantees transparent ‘at true cost-prices’ and supplies according to need. Action must start urgently to massively build capacity worldwide to manufacture billions of vaccine doses and to recruit and train the millions of paid and protected health workers needed to deliver them.
  • Guarantees COVID-19 vaccines, diagnostics, tests and treatments are provided free of charge to everyone, everywhere. Access needs to be prioritized first for front-line workers, the most vulnerable people, and for poor countries with the least capacity to save lives.

UNAIDS in its statement expressed support the above letter. According to the Executive-Director of UNAIDS, Winnie Byanyima, fighting COVID-19 needs a fight against inequality.

She stressed that “pandemics feed on and widen inequalities. That is why I’m backing the calls by over 100 current and former world leaders and experts to unite behind a people’s vaccine. Together, we want all leaders to guarantee that when a safe and effective vaccine is developed, it is produced rapidly at scale and made available for all people, in all countries, free of charge. Unite behind a people’s vaccine to protect all of humanity”.

South Centre stated that all COVID-19 related drugs, diagnostics, vaccines and health products, existing or future, should be considered global public goods, as clearly expressed by the UN Secretary General on 24 April.

It stressed that this is the only way to make these products available to everyone, everywhere, at the same time, adding that “Pharmaceutical innovation must be structurally linked to access. It is necessary to rethink the model of research and development to focus on health rather than on commercial interests supported by patents and other intellectual property rights. A new model must be designed under the auspices of the WHO and implemented through mechanisms already provided for in the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.”

CSO call for governance mechanisms & binding commitments for equitable access

An open letter dated 18 May from the International Treatment Preparedness Coalition (ITPC) with the endorsement of 86 CSOs and networks globally was sent to the WHO Director-General and Member States as well as the Unitaid Executive-Director and Unitaid Board on the opening day of the WHA.

It expressed concerns regarding the lack of governance mechanisms and binding commitments for equitable access and sharing of technology, knowledge and data, management and licensing of IP for medical tools needed for COVID-19 detection, prevention and treatment.

It stated that “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”.

“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 letter stressed.

Concern was also expressed that the WHO’s Access to COVID-19 Tools Accelerator (ACT-Accelerator) “was conceptualised through a closed-door process on the basis of a White Paper developed in part by the Gates Foundation”.

The letter called for transparency in the governance of ACT-Accelerator and for the meaningful participation of CSOs in shaping global initiatives concerning access to COVID-19 medical tools, pointing out that “pharmaceutical companies have been integrated into the governance of the ACT-(Accelerator)”.

It registered apprehension that the decision to hand over control of the governance control of the ACT-Accelerator to several global health funding agencies that are funded by only a few governments means that it will not truly be a global mechanism.

What is needed is “proper oversight and management of the ACT-Accelerator, through agreement of Member States, and under the overall guidance of the WHO”; only this can ensure that the ACT-Accelerator can act on behalf of all countries – low, middle and high income”.

The letter called for concrete binding mechanisms with respect to equitable allocation, as well as mandatory commitments for unhindered global sharing of IP, technology and know-how and establishing platforms for open innovation and technology transfer.

The letter also expressed concern with WHO’s continued reliance on voluntary approaches to the detriment of commonly agreed on TRIPS flexibilities.

According to the letter “voluntary mechanisms are insufficient in these extraordinary times of dire global need” with many global health agencies and foundations within the ACT-Accelerator being “reluctant, unwilling or hostile to appropriately support the right of countries to use [TRIPS] flexibilities to address intellectual property barriers that undermine equitable and affordable access to health technologies”.+

 


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