Pearls and Irritations

Australia must fall in behind the US and New Zealand in promoting wider production of Covid-19 vaccines.

There will be a pressing need for extensive technology transfer if the TRIPS waiver goes ahead and Australia would benefit from taking a lead in this process.

The US has agreed to text based negotiations on the possibility of a waiver of intellectual property protections under the TRIPS Agreement in order to scale up Covid-19 vaccine production.

Over 100 developing countries have joined with South Africa and India since their October 2020 call for a waiver to enable the scale up of production of all Covid-related technologies including medicines and tests as well as vaccines.

Hundreds of civil society organisations and thousands of public health and fair trade activists globally have also urged member countries of the World Trade Organisation to support the proposed waiver. In Australian a wide range of organisations have all urged the Minister for Trade, Dan Tehan to support the waiver at the WTO.

The proposed waiver, if adopted at the WTO, would allow individual countries to suspend national intellectual property laws, which give effect to the TRIPS agreement, insofar as they affect the production of Covid technologies and only for the duration of the Covid-19 pandemic.

While the rich countries have advance purchase agreements with vaccine suppliers sufficient to vaccinate their populations several times over, projected vaccine production globally is insufficient to ensure full vaccination of low and middle income countries until well into 2022 or 2023.

The shortfalls in projected production volumes is a direct result of large Covid vaccine manufacturers (with some exceptions) refusing to offer voluntary licenses to producers with capacity, in order to maintain control of supply and thereby ensure prices and profits into the medium and longer term.

In May 2020 WHO proposed a scheme for voluntary pooling of Covid related intellectual property in order to put in place production capacity as safe and efficacious vaccines emerged from their clinical trials. WHO was derided by large pharmaceutical companies and the scheme was not supported by the club of rich countries.

When the Covax scheme was introduced as a subsidised purchaser on behalf of low and lower middle income countries, the pharmaceutical industry insisted on its being restricted to no more than 20% of country populations, leaving them to the open market to procure sufficient doses for herd immunity.

Up until this week the opponents of the waiver were refusing to open text based negotiations to explore how the proposal might be implemented at the WTO and in relation to national intellectual property law.

The US has now agreed to participate in such text based negotiations but only in relation to vaccine technologies; not for medicines, tests or other technologies.

The global advocacy (public and private) around the waiver proposal has been impressive and diplomats and activists are enjoying some well earned vindication of their efforts.

However, the decision reflects a range of considerations beyond the call for solidarity.

Public health advisors within the US administration know that the US will not be safe, notwithstanding a full roll out of vaccination, while the pandemic rages in low and middle income countries and variants proliferate, including variants which escape the first generation of vaccines. The continuing reluctance of the big vaccine manufacturers to widen their networks of voluntary licenses is in no one’s interest except that of pharma to control supply and maintain prices and profits.

The emergence of China as a major vaccine supplier to the developing world is also of concern to the anti-China strategists of the Biden administration. China has deliberately curbed the pace of its domestic vaccination program in order to upscale its export volumes in keeping with Xi Jinping’s commitment in May 2020 to treat Covid technologies as global public goods. WHO is presently considering applications for ‘prequalification’ for both the Sinopharm and Sinovac products. If these are approved many more countries in the Global South will be considering Chinese vaccines.

The comparison with the vaccine nationalism and pursuit of national herd immunity by the rich Western countries has been brought out clearly in the debate and advocacy around the proposed TRIPS waiver.

There may also be some concern in Washington that the whole edifice of extended intellectual property protection introduced with TRIPS (with pharma the leading advocate from the late 1980s) may be in jeopardy. The resolution in the Brazilian senate for an immediate suspension of patents could be a warning sign.

Within hours of the US announcement New Zealand has indicated that it also supports proceeding to text based negotiations regarding vaccines. Australia should definitely follow New Zealand’s moral and practical leadership.

However, while the prospect of a waiver would remove the intellectual property barriers to vaccine production, other barriers remain, such as specialised cell lines and technical knowhow.

There will be a pressing need for extensive technology transfer if the potential benefits of the proposed waiver are to be realised. Australia would have a lot to gain in terms of its own capacity building if it were to commit to supporting such technology transfer.

One of the provisions of the TRIPS Agreement which would be covered by the waiver concerns compulsory licensing for export. Thus Canada sought to use this provision to export an anti-AIDS preparation to Rwanda in 2007 but found the provisions clumsy and difficult to use.

In the event of a waiver being approved it would be open for Canada (or Australia) to enact the waiver provisions and commence the manufacture of one or more vaccines for export to developing countries in our neighbourhood and beyond.

Finally, we need to reflect on the pressure on academic researchers to patent their discoveries and innovations and to agree to exclusive licenses with big pharma rather than offering open licenses. Much of the know how embedded in Covid vaccines has been generated in the public sector and/or funded through tax payer grants. Universities Allied for Essential Medicines presents a powerful case for the wider use of open science. If our universities were properly funded they might be more willing to consider open science, particularly for global public goods such as vaccines and medicines.

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