COVID19 Tech Platform – Countries pass up opportunity for a binding mechanism to ensure equitable access to meds

New text on WHO’s call to action on the COVID19 tech platform

Member states of World Health Organization are letting go of an opportunity to enforce binding mechanisms on sharing and pooling technology related to fighting COVID19 that would ensure equitable, affordable access to medicines, diagnostics and technologies. At the best of times, treaty-making is an uphill task, if not impossible, amongst more than 190 countries, but the pandemic could have been the imperative for countries to come together to challenge the status quo on the contentious and high-stakes game of access of medicines. 

WHO is set to announce on May 29,2020, essentially formalizing a proposal for a voluntary mechanism to pool all COVID19 related technologies, first suggested by Costa Rica.

There is palpable excitement and optimism around this mechanism. It is understood that nearly 20 countries have agreed to sign up for this voluntary mechanism. This could not be confirmed, at the time of writing this story.

As discussed earlier on this blog, a section of stakeholders including some members of the civil society believe, that a voluntary pooling mechanism cannot ensure equitable access.

It has also been pointed out that WHO has no powers to enforce a mandatory mechanism. However, WHO is well within its powers to recommend a mandatory mechanism for sharing information – something that the member states should then take up, sources said.

Article 19 and 21 of WHO’s constitution, empowers member states to make binding commitments and fight international spread of disease.

Article 19

The Health Assembly shall have authority to adopt conventions or agreements with respect to any matter within the competence of the Organization. A two-thirds vote of the Health Assembly shall be required for the adoption of such conventions or agreements, which shall come into force for each Member when accepted by it in accordance with its constitutional processes.

Article 21 (a)

The Health Assembly shall have authority to adopt regulations concerning: (a) sanitary and quarantine requirements and other procedures designed to prevent the international spread of disease;

But this opportunity for the World Health Assembly (WHA) to take up this specific proposal has already been lost this year, notwithstanding the adoption of the historic COVID19 response resolution adopted earlier this month by the 73rd WHA.

There is a perception, among critics, that WHO was not keen on pulling together even this mechanism which is voluntary in nature. There is no doubt, battling geopolitics and financing pressures, in addition to leading the international response to the pandemic, must leave very little appetite to administer long, protracted negotiations on highly contentious matters. Countries do look up to WHO for leadership on difficult issues.

To illustrate the diversity and the extent of disagreement on how to address access issues around COVID19, consider this – while civil society and others have lamented the voluntary nature of this mechanism, industry leaders appear disinterested in this voluntary initiative even before it formally takes shape.

At a press conference on May 28th, Thomas Cueni of IFPMA said that it was not clear that the new patent pooling initiative spearheaded by Costa Rica will add to existing initiatives. Health Policy Watch reported that industry leaders are of the view that “infrastructure and supply chains are likely to be bigger access obstacles than patents in the current race for a pandemic vaccine.”

CALL TO ACTION NEW TEXT

Geneva Health Files had blogged about a previous version of the “call to action” here. A new version dated May 26th, has come to light, and is likely close to the version that will be announced on May 29th. This blogpost discusses some features of this text:

  • Calling on governments and other research and development funders, the call to action says “Take action to promote innovation, remove barriers, and facilitate open sharing of knowledge, intellectual property and data necessary for COVID-19 detection, prevention, treatment and response, including through legal and policy measures, and international collaboration on regulatory practices, to ensure availability, affordability and assured-quality of the concerned products”

To a lay reader, “promote innovation”, followed by “remove barriers”, sounds somewhat contradictory.

  • It also asks governments and other research and development funders to

“Promote that all COVID-19 publicly-funded and donor-funded research outcomes are affordable, available and accessible to all on a global scale through appropriate provisions in funding agreements, and include specific provisions regarding accessibility to and affordability of resulting COVID-19 related health products through global non-exclusive voluntary licensing, transparency and, when necessary, other commitments to expand access by sharing, for example, other intellectual property rights, know-how and data;”

“Global non-exclusive voluntary licensing” would mean that the aspiration is that no country will be left behind, sources aware of the proceedings explained. But voluntary licensing, as the model stands today comes with territorial and other limitations, as had been long recognised. Therefore, immediately places limits on equitable access.

It is not clear yet, whether existing mechanisms of voluntary licensing (where companies can set the terms of negotiation determining access), will be overhauled in the context of the pandemic, and under this specific platform. 

Supporters of voluntary approaches to patent pooling  (also believers in compulsory licensing), are of the view that TRIPS flexibilities such as Compulsory Licenses are complicated and politically controversial (“drug by drug”, “country by country” as one activist explained). They suggest a combination of voluntary and non-voluntary approaches to holistically determine access to medicines for COVID19.

  • In addition, the call also asks holders of knowledge, intellectual property or data to existing or new therapeutics, diagnostics and vaccines to: 

“Voluntarily license such rights on a non-exclusive and global basis to the Unitaid-established and supported Medicines Patent Pool and/or through other public health research and development mechanisms, consortia or initiatives that facilitate global and transparent access; and/or voluntary non-enforcement of intellectual property rights, as appropriate, during the COVID-19 pandemic, to facilitate the widescale production, distribution, sale and use of such health technologies throughout the world;”

“Voluntary non-enforcement of intellectual property rights” – this is acutely necessary, but will remain to be seen, whether pharmaceutical companies will ensure “voluntary”  non-enforcement of IP rights.

In their recent comments, some companies indicated they would take a “not-for-profit” approach to vaccine development and sale, HPW reported.

  • The call also asks holders of knowledge, intellectual property or data to existing or new therapeutics, diagnostics and vaccines to

“Share voluntarily the relevant knowledge, intellectual property and data to enable widescale and worldwide production, distribution and use of such technologies and necessary raw materials through mechanisms such as the Technology Access Partnership (TAP) hosted by the UN Technology Bank or the Open COVID Pledge Initiative

Not clear at all, why WHO would endorse UN Tech Access Partnership as much as Open COVID Pledge Initiative – one of the many private initiatives.

  • The call asks all stakeholders to

All stakeholders

Place, in the WHO Global Observatory on Health Research and Development, information and analyses on COVID-19 research and development activities, information and analyses to build on existing data and reports from a wide range of data sources, and gather new information, where needed and feasible, with the aim of enabling decisions on priorities in research and development;

Place, in the WHO Global Health Technology Platform or its implementing partner platforms, references to shared information and/or commitments to all relevant technologies, knowledge, intellectual property, and data on terms that facilitate their use in research, development and innovation and manufacturing and that would permit effective technology transfer and early access to key technologies for the detection, prevention, treatment and response of COVID-19;

It is not clear yet what are the other implementing partner platforms. By expanding the sharing of platforms where this information can be stored, could cause fragmentation in innovation, the source said, in addition to raising questions on governance.

  • Critics also pointed out why WHO did not take leadership in housing activities around voluntary licensing and hosting the SARS-CoV-2 genetic sequence information and data, instead of entrusting the responsibility to the Medicines Patent Pool and the Global Initiative on Sharing All Influenza Data (GISAID) respectively. Such activities overseen by WHO, would mean closer supervision by member-states.

To get a sense of challenges around access issues relating to COVID19 – MSF has this helpful document reeeeeleased May 27, 2020.

If you like this story, do consider supporting Geneva Health Files – a reporting initiative run by this journalist. I seek to make this a reader-funded initiative to keep it going. Get in touch with me on how you can help. You can also make a contribution at paypal.me/genevahealthfiles (You will need a paypal account to do so.)

If you wish to share information or have suggestions, write to me: patnaik.reporting@gmail.com

One thought

  1. Governments have plenty of hard power, legal and economic power, to force sharing and open licensing of patents, data, know-how, cell lines, etc. This includes regulation of IP, funding agreements for R&D and purchasing power of products. The WHO has none of these, and has to work with soft power. But that soft power is not unimportant, even if under-used at present. What the focus should be is not so much on the WHO’s failure to wield hard powers it does not have, but on the countries with the most hard power, France, Germany, US, China, Italy, Spain, UK, Canada, Australia, who are not yet supporting the open licensing of technologies.

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