Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1697750390800.pdf (Ireland)
Opening Statement to the Joint Committee of Enterprise, Trade and Employment: Proposal for a waiver of certain obligations under the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement and COVID-19 vaccines 11th May 2022 Professor Aisling McMahon, Maynooth University1 A Chathaoirligh, and Members of the Committee, Thank you for this invitation to address the Committee today.
My name is Aisling McMahon, and I am a Professor of law in Maynooth University specialising in intellectual property and health law.

Intellectual property (IP) rights, such as for example, patents, provide rightsholders with an exclusive right over the patented technology for a limited period (generally 20 years for patents).
If the patented technology is an element of a vaccine, rightsholders can control who can access that vaccine and at what price, and who can use that element to produce similar vaccines.
Accordingly, how IP rights are used is a key factor affecting access to COVID-19 vaccines, medicines, and diagnostics.2 The TRIPS Agreement is an international World Trade Organisation (WTO) Agreement which imposes minimum IP obligations that must be offered in all WTO States.3 Due to concerns about the effects of IP on access to COVID-19 health-technologies, and in particular, concerns that low- and middle-income countries (LMICs) were highly likely to fall significantly behind high-income countries (HICs) in securing access to such technologies, in October 2020, India and South Africa proposed the TRIPS waiver.4 This proposal was made and discussed against the backdrop of a lack of 1 Professor of Law, School of Law and Criminology Maynooth University.
I am also a member of Access to Medicines Ireland (AMI) a voluntary membership group of Cómhlamh.

However, the comments made here represent my own personal views, such views are not representative of AMI or any other organisation.

Email: aisling.mcmahon@mu.ie 2 See discussion in Aisling McMahon, ‘Global equitable access to vaccines, medicines and diagnostics for COVID-19: The role of patents as private governance’ (2021) 47 Journal of Medical Ethics 142-148.
3 Prior to the adoption of the TRIPS agreement, some States did not have or had at various points abolished patents for pharmaceuticals, see: G Dutfield, That High Design of Purest Gold: A Critical History of the Pharmaceutical Industry, 1880–2020 (World Scientific Publishing, 2020); G Dutfield and U Suthersanen, Dutfield and Suthersanen on Global Intellectual Property Law (Edward Elgar, 2020), 172.
See also discussion in: Siva Thambisetty, Aisling McMahon, Luke McDonagh, Hyo Yoon Kang, and Graham Dutfield, ‘The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID- 19 Pandemic’ (May 24, 2021).

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4 For a detailed legal analysis in favour of the TRIPS waiver proposal, see: Siva Thambisetty, Aisling McMahon, Luke McDonagh, Hyo Yoon Kang, and Graham Dutfield, ‘The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic’ (May 24, 2021).

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06/2021, Available at SSRN: https://ssrn.com/abstract=3851737 The International Commission of Jurists also published an expert legal opinion in 2021 concluding that “…under international human rights law, States have, at the very least, a duty not to obstruct TRIPS waiver negotiations.
By opposing the negotiations, as many continue to do, these States fail to perform their treaty obligations under international human rights law in violation of the rights to health, life, equality and science.” see: International Commission of Jurists, Expert Legal Opinion, Human Rights Obligations of States to not impede the Proposed 1 sufficient support for voluntary global initiatives to encourage the sharing of IP, data and know-how to radically upscale COVID-19 vaccine production.5 This waiver proposes to temporarily suspend certain IP obligations under TRIPS for COVID-19 health-technologies.6 If adopted, it would suspend WTO States’ obligations at the international TRIPS level.
However, States, like Ireland, could likely maintain IP protections at a national level if they wished.

The main likely effect of the waiver would be to allow LMICs to avail of it, to enable entities within such countries to produce similar COVID-19 vaccines, medicines, or diagnostics without facing IP litigation.

While this waiver is not a panacea,7 it would nonetheless, clear IP hurdles acting as a key step to increase global vaccine production.
More specifically, it would be a key step to enable LMICs to develop sustainable long-term solutions to vaccine supply issues where the status quo model under TRIPS has simply failed such countries.

In doing so, it would help build resilience for future pandemic preparedness.

However, no agreement has been reached on the waiver to date, and the EU is a key blocker of the proposal.
Recently, it has been reported that the EU is supporting a so-called QUAD proposal.8 This proposal arose following informal discussions amongst the US, India, South Africa, and the EU.9 However, it is not clear, if India, South Africa, or the US support the text.10 In my view, this QUAD proposal, in its current form, does not offer a useful pathway to upscale COVID-19 vaccine production for four main reasons.
First, it applies primarily to patents, not other IP rights, such as trade secrets which are also vital for vaccines.

It falls far short of the broad package of measures envisaged by the TRIPS waiver.

Second, although often presented as a waiver, it does not waive IP rights.

Instead, it primarily makes modifications to existing TRIPS compulsory licensing mechanisms.
Compulsory licensing can be useful in some contexts, but alone it is not an effective tool to address vaccine access issues during a global health crisis.11 COVID-19 TRIPS Waiver (November 2021) available at https://www.icj.org/global-jurists-call-for-waiver-of- global-intellectual-property-rights-for-covid-19-vaccines-and-therapeutics/ 5 This is discussed in: Susi Geiger and Aisling McMahon, ‘An analysis of the institutional landscape and proliferation of proposals for global vaccine equity for COVID-19: too many cooks or too many recipes?’ (2021) Journal of Medical Ethics Published Online First: 30 November 2021.
6 This was amended in May 2021 to clarify its scope.

References to the original waiver in this statement refers to the text as introduced in 2020 and amended in May 2021.

7 Siva Thambisetty, Aisling McMahon, Luke McDonagh, Hyo Yoon Kang, and Graham Dutfield, ‘The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID- 19 Pandemic’ (May 24, 2021).

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8WTO, Communication from Chairperson IP/C/W/688 https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W688.pdf&Open=True 9‘Quad’s https://www.wto.org/english/news_e/news22_e/trip_03may22_e.htm 10 This is correct at the time of writing 5th May 2022.
11 See Siva Thambisetty, Aisling McMahon, Luke McDonagh, Hyo Yoon Kang, and Graham Dutfield, ‘The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic’ (May 24, 2021).

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06/2021; Aisling McMahon, response made IP COVID-19 3rd May document outcome public’ 2022 on 2 Third, the QUAD proposal introduces various additional requirements for compulsory licenses than TRIPS requires.
For example, it requires a list of all patents relevant to the vaccine before a compulsory license is issued.

This could prove exceptionally difficult in practice.

Fourth, this proposal only applies to eligible Members which is defined narrowly limiting who can use it.
Put simply, the QUAD proposal is not a workable or effective solution for COVID-19 vaccine access issues.12 For these reasons, in my view, States such as Ireland, should advocate at an EU level and internationally in support of the TRIPS waiver as proposed by India and South Africa.

They should actively seek to achieve a workable waiver text based on this proposal in WTO negotiations.

Many thanks for your attention.


‘Global equitable access to vaccines, medicines and diagnostics for COVID-19: The role of patents as private governance’ (2021) 47 Journal of Medical Ethics 142-148.

12 This analysis is based on the draft text outlined by the WTO, Communication from Chairperson IP/C/W/688 on 3rd May 2022.
For a detailed critique of the proposal, see: Carlos M. Correa and Nirmalya Syam, ‘Analysis of the Outcome Text of the Informal Quadrilateral Discussions on the TRIPS COVID-19 Waiver’ South Centre (5th May 2022) available at https://www.southcentre.int/policy-brief-110-5-may-2022/ Others have also highlighted the limits of the QUAD proposal, albeit based on an earlier (although substantially similar text) leaked text, see: Hyo Yoon Kang, ‘Not Much of a Waiver The Leaked Draft Text of the TRIPS Waiver Compromise’ Verfassungsblog 17 March 2022; James Love, The Quad WTO proposal on COVID 19 and TRIPS proposal is tied for the 5th best option for exports (Medium, 20th March 2022); Medicines, Law and Policy, ‘Proposed TRIPS waiver a hollow diplomatic compromise with little practical impact’ (12 April 2022).
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