Dr Luke McDonagh (LSE) - Transcript of Presentation at QMIPRI/FISAUM Event

‘Waiving IP for Covid-19 related health products & technologies: prospects and solutions’

We are faced with the problems of insufficient vaccine production and unequal distribution. Ideally, we would have solved these problems via voluntary solutions; but we must admit that up to now these have failed the global south. The voluntary COVAX donation scheme has administered less than 90m doses out of a promised 2 billion. The voluntary C-TAP hub for knowledge-sharing has been ignored by pharmaceutical companies. If you go back now and read the October 2020 report by Human Rights Watch on sharing vaccines, it makes for scary reading. The global south knew in 2020 that - even though the WHO had recommended vaccinating all healthcare workers worldwide - they would nonetheless be left to their fate in 2021, without even enough vaccines for healthcare workers. This is the context in which the waiver proposal was made by India and South Africa.

The TRIPS waiver debate is now - without question - the most important international intellectual property issue for a generation. When more than 100 countries, primarily those in the global south, are calling for a TRIPS waiver, we - as IP scholars - must listen and we must respond.

And we must not be defensive in our response – the call for a waiver is not an attack on us personally, nor is it an attack on our profession or on the concept of intellectual property.

We must understand that the call for a waiver comes from those for whom the status quo has failed. We must not defend IP uncritically by claiming that the Covid 19 vaccine inequity in the global south has nothing to do with IP. It does. Like it or not IP - and the TRIPS system - is part of the status quo.

When manufacturers such as Teva in Israel, Biolyse in Canada, Bavarian Nordic in Denmark, and Incepta in Bangladesh, have sought IP licences to produce vaccines and have been refused, or who have offered productive capacity and been rebuffed, we cannot in good conscience say that the insufficient global production of vaccines has nothing to do with the power of IP holders to refuse such offers.

When lower-income countries such as South Africa, Uganda, and Bangladesh have reportedly been charged higher prices than rich countries for the Oxford-AstraZeneca vaccine we cannot say that IP monopoly power has nothing to do with pricing inequalities.

And when this monopoly pricing power offers incentives to manufacturers to sell high-priced boosters to rich countries, rather than first doses to lower and middle-income countries, we cannot say this has nothing to do with IP.

When we know that within many of our own life-times countries such as Germany (until 1968), Japan (until 1976), Switzerland (until 1977), and Spain (until 1992) - as well as India and Brazil before TRIPS – built up their pharma capacity in the absence of pharma patents, we cannot say that IP always offers the right incentives to build up capacity.

Knowing this – that IP is a problem, not the only problem by any means, but still a problem for boosting production – the case for the waiver is in principle compelling as a way to create the right combinations of incentives and mandates to end the pandemic. In short, the waiver gives the global south leverage.

To argue against the waiver, and defend the international IP system against the claims of the global south, is to defend a status quo that has failed, and continues to fail, the global south. Whether intentioned or not, it can often read like a defence of the powerful against the weak.

My colleagues, Siva, Hyo, Graham, Aisling and I have written a long working paper explaining the case for the waiver in principle and in practice. We deal with all the major issues from patents to trade secrets and to data exclusivity and regulatory data issues. I cannot give all the details in this short presentation but the entire paper is freely available on ssrn – please read it and engage.

We argue for the waiver as part of a re-evaluation of the current TRIPS framework and its effects. We argue the current IP framework is inadequate for addressing a civilisational challenge such as COVID-19.

For instance, we cannot claim the compulsory licensing system provides an adequate practical solution when it is slow, burdensome and problematic - product-by-product, country-by-country - as shown by Bolivia’s current attempt to use Art31bis to import from Biolyse, which, as I mentioned, was refused a licence from J&J. This process has only ever been used successfully once, by Rwanda in 2007.

On trade secrets we argue for a combination of incentives and mandates. Companies should be encouraged, even paying them, if necessary, to enter into voluntary technology transfer agreements through the existing WHO C-TAP scheme and the newly announced mRNA technology transfer hub in South Africa. The public pressure and media attention generated by the waiver is already pushing governments and pharma companies to do more to boost production. The Biden administration is pursuing this ‘carrot’ and ‘stick’ approach. The admin is paying Pfizer for 500m doses while also pursuing the waiver at the WTO. Carrot and stick. Incentive and mandate. This is how the waiver is already helping achieve a solution.

The world’s most prestigious scientific publication Nature recently backed the waiver, giving us the great honour of citing our research, noting that out of a promised 11billion doses, at most 6bn will be produced by the end of 2021. Companies keep missing their targets – AZ and J&J have missed almost every target they’ve set; Curevac will produce 0 usable doses this year. The experience of the last year tells us that left to the status quo neither the market, nor voluntary action will solve this problem.

Indeed, the WHO’s Independent Panel for Pandemic Preparedness and Response makes a recommendation (which we support) that appears to envisage precisely this: utilising the waiver as leverage by legal threat. The Panel recommends that the WHO and WTO convene with the relevant parties and seek voluntary agreement to facilitate technology transfer and voluntary licensing for COVID-19 vaccines; and in the absence of this agreement within 3 months, a TRIPS waiver should come into effect immediately. Currently, there is no legal incentive or mandate for key players to see this crisis as an opportunity to articulate a more equitable and ethical mode of practice of global solidarity.

That is why the TRIPS waiver, rather than the (current) burdensome compulsory licensing system, is needed. The alternative is the status quo – nationalistic and opportunistic behaviour and the quest for what The Serum Institute CEO has called ‘super profits’ amid inequalities of production and distribution.

Beyond a legal text, the TRIPS waiver has become a masthead signalling a lot of different kinds of political-economic actions that now need to flow. We need a multi-pronged approach: addressing the over-ordering of doses and hoarding in rich countries; co-ordinating supply chains to increase production globally; investing in C-TAP and WHO’s mRNA technology transfer hub; streamlining regulatory approval processes and sharing exclusive data from regulatory dossiers. All of this now needs to happen simultaneously.

If we get this right, the broken technology transfer promise of the TRIPS agreement can now be fulfilled.

To do this we must interpret and understand intellectual property law in its original broader public purpose. Patents are not ends in themselves; they are a means to an end: a public good. In the midst of a pandemic, we argue that in the absence of adequate voluntary action, that good can be better served globally by utilising the threat to waive patents and other IP rights. Unlike human life, IP rights are not – nor have they every been - inviolable.

That we have several viable vaccines is an outstanding human achievement but our collective failure to share doses ought to shame us into action. Resolving the global vaccine production and supply problem is a matter of extreme urgency. It is a tremendous challenge, but it is not insurmountable. The waiver provides the necessary leverage for doing solving this. As scholars, we should not be silent. In my view, as IP scholars we should seize this moment and offer the waiver our support.

Thank you for your time.

23-6-21

The full recording of this event is now on YouTube

Luke McDonagh

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