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Joint Committee on Enterprise, Trade and Employment debate -
Wednesday, 11 May 2022

WTO Agreement on Trade-Related Aspects of Intellectual Property Rights and Covid-19 Vaccines: Discussion

The proceedings of Oireachtas committees will be conducted without the requirement for social distancing, with normal capacity in the committee rooms restored. Committees are encouraged, however, to take a gradual approach to this change. Members and witnesses have the option to attend meetings in the relevant committee room or online, through Microsoft Teams. All those attending in the committee room and environs should continue to sanitise and to wash their hands properly and often, and to avail of sanitiser outside and inside committee rooms, be respectful of other people's physical space and practise good respiratory etiquette. If they have any Covid symptoms, no matter how mild, they should not attend in the meeting room. Members and all in attendance are asked to exercise personal responsibility in protecting themselves and others from the risk of contracting Covid-19. Members are well aware that if they are participating in the meeting remotely, they are required to do so from within the Leinster House complex only. Apologies have been received from Deputy Bruton.

The main item for discussion today is the waiver of intellectual property protection in the context of the World Trade Organization agreement on Trade-Related Aspects of Intellectual Property Rights, TRIPS, as it relates to Covid-19 vaccines. The TRIPS agreement is an international legal agreement between all member nations of the World Trade Organization, WTO, and any proposal for a potential variation or waiver of the current intellectual property protections under the TRIPS agreement is for negotiation at the WTO, of which Ireland is one of 164 members. Furthermore, at EU level, international trade is an EU competence such that the EU, as a single voice, represents the co-ordinated position of the 27 member states, including in discussions on TRIPS at the WTO. Universal and equitable access to vaccines is crucial in the global fight against Covid-19.

I am pleased that the committee has an opportunity to discuss this matter further with a number of representatives from the following organisations. I welcome the following: from Oxfam Ireland, Mr. Jim Clarken, chief executive; from Maynooth University's department of law, Professor Aisling McMahon; from Médecins Sans Frontières, Mr. Dimitri Eynikel, access campaign EU policy adviser; from St. Vincent's University Hospital, Dr. Christine Kelly; from the Irish Pharmaceutical Healthcare Association, Mr. Oliver O'Connor, chief executive; and from BioPharmaChem Ireland, Mr. Matt Moran, director, and Ms Nessa Fennelly, senior executive.

Before we start our discussion, I will explain some limitations to parliamentary privilege and the practices of the Houses as regards reference witnesses may make to other persons in their evidence. The evidence of witnesses physically present or who give evidence from within the parliamentary precincts is protected, pursuant to both the Constitution and statute, by absolute privilege. Witnesses are reminded of the long-standing parliamentary practice that they should not criticise or make charges against any person or entity by name or in such a way as to make him, her or it identifiable or otherwise engage in speech that might be regarded as damaging to the good name of the person or entity. Therefore, if their statements are potentially defamatory in respect of an identifiable person or entity, they will be directed to discontinue their remarks. It is imperative they comply with any such direction.

The opening statements have been circulated to all members. To commence our consideration of this matter, I now invite Mr. Jim Clarken and Professor Aisling McMahon to make their opening remarks.

Mr. Jim Clarken

I thank the Chairman and members of the committee for this opportunity to brief them on the TRIPS waiver as it relates to the Covid-19 pandemic. I am Jim Clarken, CEO of Oxfam Ireland, also representing the People's Vaccine Alliance Ireland. Oxfam is a development, humanitarian and human rights organisation working across 66 countries to end inequality and poverty. The People's Vaccine Alliance Ireland is made up of NGOs, health practitioners across the medical profession, trade unions, academics and faith groups.

We are over two years into the Covid-19 pandemic and huge levels of vaccine inequity persist. Just 13% of people in low-income countries have received two doses, compared with 75% of people in high-income countries. Less than 1% of people in low-income countries are boosted, compared with over 60% of people here in Ireland.

To address this and to prepare for future pandemics effectively, we need diversity of production and supply. Multiple producers should be able to produce vaccines in sufficient quantity and to adapt them to new variants and needs. A TRIPS waiver will help to achieve this.

An example of this potential is the WHO mRNA technology transfer hub in South Africa, which has the potential to lead and to inform the development of mRNA technology in Africa. However, this may be hampered without a TRIPS waiver.

Moreover, Covid-19 therapeutics remain "out of reach of the poor" without a TRIPS waiver, according to the WHO director general, Dr. Tedros, last week. This is particularly egregious given that those who are unvaccinated are those who would benefit most from therapeutics.

Not having control over vaccine and therapeutic production means that low-income countries continue to experience the same devastation we experienced before vaccine roll-out, even though the tools to prevent this are out there. As Wilfred Gurupira, an academic in Zimbabwe recently interviewed by Oxfam, put it:

It's one thing losing those you love to a pandemic where there's nothing that can be done. But it's quite another, losing people when you know there was something that could be done to help them, but you can't access it.

The lack of access to vaccines and therapeutics is translating into huge numbers of deaths. Since the start of the pandemic, The Economist estimates that 19.5 million people have died and over 3 million Covid-19 deaths have occurred since the Omicron variant emerged. The majority of all those deaths occurred in low- and middle-income countries.

Arguments have been made that enough vaccines are coming online to address this issue. Experts have estimated that there will be a 15 billion dose shortfall in mRNA Covid vaccine production in 2022. mRNA vaccines have the highest reported effectiveness against Omicron. This gap is likely to increase due to the need for boosters, especially variant-specific boosters. We cannot expect developing countries to fight today's virus with yesterday's tools.

A TRIPS waiver would not just prevent large levels of mortality and morbidity in low-income countries; it could also help to prevent the emergence of vaccine-resistant variants that have the potential to drag Ireland, this part of the world and the whole world into lockdowns and restrictions again.

Allowing generic production worked before during the HIV-AIDS epidemic, although millions of lives were lost before such production was allowed. I urge the committee not to allow a similar outcome to arise by continuing to delay a TRIPS waiver, which would create a similar level of suffering and damage.

Ireland's continued opposition to the TRIPS waiver is in contravention of Ireland’s human rights obligations and is greatly damaging Ireland’s hard-earned international reputation as a champion of low-income countries and human rights. The need for Ireland’s support of the TRIPS waiver is pressing, as the WTO ministerial conference will be held in June. Low-income countries cannot wait any longer. The TRIPS waiver is supported by more than 100 countries, the WHO, the Seanad and the majority of the Irish public. It is time Ireland supported the TRIPS waiver, helped to save millions of lives and helped to put an end to this pandemic.

Professor Aisling McMahon

I thank the Chairman and members of the committee for this invitation to address the committee today. I am a professor of law in Maynooth University specialising in intellectual property, IP, and health law.

IP rights, such as patents, provide rights holders with an exclusive right over the patented technology for a limited period, which is generally 20 years for patents. If the patented technology is an element of a vaccine, rights holders 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.

The TRIPS agreement is an international WTO agreement which imposes minimum IP obligations that must be offered in all WTO states. 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 were highly likely to fall significantly behind high-income countries in securing access to such technologies, in October 2020 India and South Africa proposed the TRIPS waiver. This proposal was made and discussed against the backdrop of a lack of sufficient industry support for voluntary global initiatives to encourage the sharing of IP data and know-how to radically upscale Covid-19 vaccine production for global needs.

The waiver proposes to temporarily suspend certain IP obligations under TRIPS for Covid-19 health technologies. If it is adopted, it will 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 low- and middle-income countries to avail of it, thereby enabling entities within such countries to produce similar Covid-19 vaccines, medicines or diagnostics without facing IP litigation. While this waiver is not a panacea, it would, nonetheless, clear IP hurdles and act as a key step in increasing global vaccine production. More specifically, it would be a key step to enable low- and middle-income countries 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 to 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 original TRIPS waiver proposal. Most recently, it has been reported that the EU is supporting a so-called quad - comprising the EU, India, South Africa and the US - outcome text proposal. This proposal arose following informal discussions among the US, India, South Africa and the EU. However, it is not clear at this point if India, South Africa or the US support the text.

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 vaccine production. It falls far short of the broad package of measures envisaged by the original TRIPS waiver. Second, unlike the original TRIPS waiver, this proposal does not waive IP rights, as such. Instead, it primarily makes modifications to existing TRIPS compulsory licensing mechanisms. Compulsory licensing can be useful in some contexts but it, alone, is not an effective tool to address vaccine access issues during a global health crisis. Third, the quad proposal introduces various additional requirements for compulsory licensing other than what TRIPS requires. For example, it requires a list of all patents relevant to the vaccine before a compulsory licence is issued. This could prove exceptionally difficult in practice. Fourth, this proposal only applies to eligible members and this is narrowly defined, thereby limiting who can use it. Put simply, the quad proposal in its current form is not a workable or effective solution for Covid-19 vaccine access issues. For these reasons, states such as Ireland should advocate at an EU level and internationally in support of the measures set out in the original TRIPS waiver proposal and work to actively achieve such measures in a waiver text under the current WTO negotiations. I thank the members for their attention.

I thank Mr. Clarken and Professor McMahon. I invite Mr. Oliver O'Connor and Mr. Matt Moran, on behalf of the Irish Pharmaceutical Healthcare Association and BioPharmaChem Ireland, to make their opening remarks.

Mr. Oliver O'Connor

I thank the committee for inviting us to appear before the this committee. The Irish Pharmaceutical Healthcare Association, IPHA, and BioPharmaChem Ireland, BPCI, are here jointly as the representative organisations for the research-based biopharmaceutical industry in Ireland. Our remarks are set against a backdrop of very low Covid-19 case numbers in Ireland, high rates of vaccination and avoided mortality and serious illness from the disease. It is more than 16 months since Annie Lynch, the 79-year-old Dubliner, became the first person in Ireland to be vaccinated for Covid-19. Since then, almost 11 million doses of Covid-19 vaccine have been administered. More than 4 million people are fully protected against the disease through vaccination.

The efficient roll-out of the vaccination programme here attests strongly to the capacity of the Department of Health and the HSE to respond to an emergency. The biopharmaceutical industry, the work of which, along with others, led to the discovery, development and manufacture of Covid-19 vaccines and treatments in record time, is proud of our achievement too. We are aware that there is more to be done. While Ireland has a world-class Covid-19 vaccination rate, much of the world remains unprotected. That must change. We are as committed to this as any other party. We want as many people as possible, regardless of where they live, vaccinated for Covid-19 as fast as possible. The response to this pandemic, to future ones and to all other diseases depends on stable conditions for the discovery, development and production of vaccines and treatments. Speed of delivery and global equity of access to Covid-19 vaccines and treatments, and the protection of IP rights, are not mutually exclusive. They are complementary.

To thrive, innovation depends on IP protection. It is the certainty that shields the risky business of investing in research and development. Most of this fails. The global patents system is the basis for innovation. The proposed TRIPS waiver is a serious risk to the global patents system. Waiving IP rights will not accelerate global Covid-19 vaccines access. Production is not now the problem and has not been. There are already more than enough vaccines for the world. The problem is they are not getting to the people who most need them fast enough.

The effort to vaccinate the world for Covid-19 is limited by vaccine administration, not by vaccine production. By the end of June, 16.3 billion doses of Covid-19 vaccines will have been produced since the start of the pandemic. At the end of January, there were more than 12 billion Covid-19 vaccine doses produced, including 3.4 billion mRNA vaccines. Of the 12 billion, 10 billion were administered. The speed of Covid-19 vaccines production is outpacing their administration globally.

The cause of global Covid-19 vaccine inequity is the capacity of some countries, mostly developing countries, to absorb, distribute and administer the doses they get. In some of these countries, Covid-19 vaccine hesitancy is high. There are reports of shortages of syringes and medical equipment, as well as the destruction of significant quantities of doses of expired vaccines. Clearly, this is not to blame countries for shortcomings and for their great challenges and difficulties. Rather, it is a signal to us to do more to help in this area of vaccine administration. In essence, the problem is not vaccines, it is vaccination.

By the end of last month, COVAX, Covid-19 Vaccines Global Access, the vaccine distribution programme backed by the WHO, had delivered 1.43 billion Covid-19 vaccine doses to 145 countries. Africa has received around 672 million doses. In January, 96 million doses were shipped to Africa, which is more than double the number shipped six months before that. However, COVAX is now only shipping Covid-19 vaccines to countries on demand to ensure the right volume at the right time. The WHO has reported that up to 3.5 million Covid-19 vaccine doses have had to be destroyed.

Dr. Mike Ryan, the executive director of the WHO's health emergencies programme, whom we all know, has indicated that global vaccines access is affected now more by demand-side challenges than by supply-side ones. Most recently, on 22 April, the Africa Centres for Disease Control and Prevention asked for all Covid-19 vaccine donations to be paused until later this year because hesitancy and logistical hurdles are hampering administration.

Our industry has met the challenge of global production by investing in existing sites and voluntarily entering into over 370 licensing and other agreements with manufacturing partners with the skills and technology needed to produce Covid-19 vaccines to the highest regulatory standards. Further production capacity expansions are planned, especially in Africa. For Covid-19 treatments, over 150 voluntary partnerships are in play.

Often, global supply of vaccines and medicines is managed from a small number of manufacturing sites, with production of the drug substance, known as the active pharmaceutical ingredient, concentrated in one site. Building manufacturing sites across multiple continents is impractical and unnecessary.

Importing and exporting raw ingredients is complex. Early in the pandemic, that process was exacerbated by trade barriers, such as export restrictions. For one mRNA vaccine, there are some 280 raw ingredients. Local regulatory approval is needed where manufacturing sites are located. The right skills are not always available locally. Until 2020, there was no mRNA vaccine manufacturing anywhere in the world.

Waiving intellectual property rights for use in manufacturing sites with very limited capacity, or to be made available to companies with no track record or experience in manufacturing complex medicines such as vaccines, could result in the diversion and hoarding of critical raw materials and the weakening of already strained supply chains. That could lead to fewer, inferior or even unsafe vaccines.

I will hand over to my colleague, Mr. Matt Moran, from BioPharmaChem Ireland.

Mr. Matt Moran

I thank the Chairman and members for inviting us. Following on from Mr. O'Connor, I will continue our contribution.

A draft proposal released in March by the WTO puts forward a limited waiver or modified compulsory licensing provisions for Covid-19 vaccines and treatments. We consider these proposals as serious risks to global public health. Voluntary production partnerships have been shown to work, as Mr. O'Connor outlined. We must avoid dampening research and development, which would damage health outcomes, as well as potentially costing jobs in locations where there is significant biopharmaceutical investment. Members are all aware of the important role of that investment in the Irish economy.

According to the European Patent Office, a waiver would lead to a 37% drop in research and development for Covid-19-related products, such as vaccines and therapeutic treatments. The impact would disproportionately be felt in higher income countries where research and development activity is more likely to be concentrated.

Multilateral solutions are needed to strengthen healthcare system capacity for Covid-19 vaccine administration and to empathetically tackle vaccine hesitancy. Efforts must focus on developing economies. Two thirds of the 1.3 billion people living in poverty are in middle-income countries. Lower and upper middle-income countries are home to 75% of the world’s population and 62% of the world’s poor. A collaborative effort to protect vulnerable populations against Covid-19 must involve a co-ordinated effort between industry, the global health community, governments and non-government organisations to help bridge gaps in cold chain and service delivery, insufficient workforce capacity and challenges with demand and vaccine confidence in some countries. These challenges should not be underestimated. The challenge of making and distributing pharmaceuticals is significant and complex.

Our industry is part of the effort to achieve global vaccines equity. We believe there are six ways to achieve that goal. These are to continue to surge production of Covid-19 vaccines and treatments through in-company investments in sites and voluntary on-boarding of suitable manufacturing partners; eliminate trade barriers so that the free flow of vaccines, ingredients and medical goods and supplies across borders is facilitated in the global supply chain; increase dose-sharing, with developed countries giving developing countries much more of their surplus vaccine doses faster; support country readiness, building the capacity of healthcare systems in developing countries to efficiently absorb, distribute and administer vaccine doses; combat vaccine hesitancy through education and health awareness programmes, empathetic and tailored community outreach and influencer activations in mainstream media and on social media platforms; and drive further innovation in vaccines and treatments and work with healthcare systems on planning to guard against variants of concern and future pandemics.

We cannot afford to undermine innovation. Scientists expect more zoonotic contagion in the future, making IP rights a key part of the public health response. We still have to find answers to the diseases we do not know about. Globally, there are thousands of medicines in development. Among them are cell and gene therapies to treat, prevent and potentially cure some diseases such as cancer. This is the dividend of innovation.

Covid-19 has been harrowing, causing sickness and death for so many people. According to the latest estimates, over 15 million people have died globally and there have been 13% more deaths than are normally expected over two years. However, without vaccines and later treatments, the death toll and lost economic output caused by Covid-19 would have been so much worse.

This is our industry's contribution to the world - saving lives, guarding against severe illness and maintaining economic life. We are proud of that contribution, made possible by science. Let us protect it for the health of all of us and for economic progress. I thank members for listening.

I thank Mr. O'Connor and Mr. Moran. I now invite members to contribute and remind those who are participating remotely to use the raised hand function. More importantly, when they are finished speaking, they should take it down.

I thank the witnesses for coming in this morning and for the information they have shared with us. I will have to leave briefly to speak in the Chamber but I will be back. We have a rota system, so I hope I will also be able to contribute in on the second round.

I am struck by the words of Mr. Clarken. He stated:

We are over two years into the Covid-19 pandemic and huge levels of vaccine inequity persist. Just 13% of people in low-income countries have received two doses, compared with 75% of people in high-income countries. Less than 1% of people in low-income countries are boosted, compared with over 60% of people here in Ireland.

Clearly, there is an issue, which cannot be explained away with words because the facts illustrate that it is a major problem. We all believe, I am sure, that nobody is safe until everybody is safe. We keep saying that but we need to give that some meaning. If we say nobody is safe until everybody is safe, it has to have some substance.

I have done a small amount of reading on this. From what I can see, people with much more knowledge of IP law than I have argue that a TRIPS waiver is necessary and proportion. It clears the IP barriers and facilitates increased supply and development of technologies, etc.

Given the figures I have outlined and the evidence given by Professor McMahon on the protection of income, will Mr. O'Connor explain how a TRIPS waiver would be detrimental to innovation, particularly given that a TRIPS waiver was not detrimental to innovation when the generic production of HIV-AIDS drugs was finally allowed? Mr. O'Connor seems to be suggesting that there is some sort of an administrative problem and that the problem is not vaccines but vaccinations. I believe it is a little more complicated than that. I ask Mr. O'Connor to outline how the TRIPS waiver would be detrimental to innovation given that the evidence available in relation to HIV-AIDS drugs suggests it would not.

Mr. Oliver O'Connor

On the first point, the situation we are at today in which there are more vaccines available than the African countries are ready and capable of accepting shows that the IP rights have not been the barrier to the production of sufficient vaccines to be administered in Africa at this time.

To go to the point about whether the TRIPS waiver would harm innovation, we have evidence on this which we can send to the committee afterwards. The study by the European Patent Office showed that a waiver would lead to a 37% drop in investment in research and development for vaccines and therapeutics and that this effect would be felt in both developing and developed countries. The reason is that vaccines, like medicines, are created, funded and researched by capital that comes from both the public and the private sectors, but predominantly the private sector. Any uncertainty in what are the rules of the game in advance will have a dampening effect on the willingness or ability of companies to raise funds for investment in very risky research. One has to look right back to the earliest part of the process of the development of vaccines and therapies to see that this is where the investment in Europe of €35 billion a year by the pharmaceutical industry happens. It is not sufficient to look at it simply at the point where there is production of the vaccine and all the manufacturing processes that are protected by intellectual property rights. It is not sufficient only to look at a certain point that they are actually developed. One has to look right back to the start to see how does the investment in risky research happen. Creating an uncertainty about the outcome at the end point has a dampening effect on the ability to raise funds to invest in risky ventures, especially where many of the results do not come through. That is the fundamental economic point here about how vaccines and medicines actually get developed.

I thank Mr. O'Connor. It just strikes me often that when economics wins out at the intersection between economics and health, it is invariably people in low to middle-income countries who lose out. I ask Mr. Clarken, Professor McMahon and Mr. Eynikel to comment on what has just been said.

Mr. Jim Clarken

I will respond briefly and then ask my colleagues, who are more expert than I am, to reply.

We all know there is an investment required to develop medication and drugs but it is vitally important for us all to remember that the success of the Covid vaccine research and development is a reflection of public funding, not IP rights.

Public funding accounted for 97% of the research and development cost of the AstraZeneca vaccine. Moderna received $10 billion in government funding, including vaccine preorders. Very unusually, the risk and capital were front-loaded by the taxpayer, or all of us. As a result, this needs to be a public good. My colleagues might elaborate a little on that.

Mr. Dimitri Eynikel

I thank the committee for inviting us to speak at this session. We both work on the Covid-19 response, particularly in peaks of the pandemic and here and there with the roll-out of vaccines. We also work on access to treatments, which we have not talked about but which I hope we can get back to, in addition to vaccines and diagnostics.

On the research and development cost, I disagree a little with the position that has been presented. It is true that the research and development of vaccines is risky and takes much investment. There is a big chance of failure; however, exactly for that reason; we have seen very little investment by the industry in vaccine development in recent decades, except when there were major outbreaks. When there were outbreaks, there was significant public funding. This happened with Ebola. We can see a very similar situation now with the Covid-19 pandemic. It was known that coronaviruses posed a serious threat of pandemic and epidemic outbreaks but there was very little investment. When the outbreak came, significant funding was made available and advance-purchase agreements were signed, etc. That is what created the enabling conditions. The intellectual property rights existed before the outbreak. There could have been investments in that regard but they did not happen. I am happy that, at European level, the European Health Emergency preparedness and Response Authority, HERA, is being created precisely to provide significant funding to enable research and development efforts to protect us from diseases.

On the second element I want to address, let us bear in mind what the waiver is: it is an option for countries. It is not about the abolition of intellectual property rights across the board. The waiver of intellectual property rights is a temporary one that countries can use for a few years. It will not harm intellectual property rights in Europe or in the US, for example.

Professor Aisling McMahon

I agree. I wish to elaborate on what Mr. Eynikel has mentioned. I am actually one of the authors of the paper mentioned. Together with colleagues in the London School of Economics, University of Leeds and University of Kent, we argue that the intellectual property waiver proposed was a necessary and proportionate step in 2020 and 2021 and still is now, for various reasons. In the paper, which was supported by over 200 intellectual-property academics all over the world in an open letter, we highlight that innovation is one of the arguments that is often presented but that when one digs deeper into those details, one notes those arguments could be questioned, particularly in the vaccine context.

First, as Mr. Eynikel has mentioned, intellectual property rights traditionally have been recognised as a very poor incentive for vaccine manufacture, for several reasons on which I will be happy to expand. In the past, as Mr. Eynikel has highlighted in some examples, we have not had vaccines even though we knew a disease was likely. There can be a risk of disease but not necessarily a guaranteed market. In the Covid-19 context, it is important to state there has been very significant public funding, which is very good, and incredible scientific research, which should be acknowledged as excellent. On top of that, however, public funding, advance-purchase agreements and other factors de-risked the production of Covid-19 vaccines. The reality is that if we maintain intellectual property rights without recourse to any interventions for low- and middle-income countries, vaccines will be distributed not necessarily on the basis of health need, as we saw in 2020 and 2021, but rather on the basis of deals done between holders of intellectual property rights and countries that may have more money to facilitate access. Low- and middle-income countries are those that are most likely to suffer, as pointed out. At the moment, we may have more supplies but the situation is in flux because we could face a new variant at any moment or, indeed, a new pandemic. If we do, low- and middle-income countries will not have the capacity built up, which is what they are asking for.

It is important to state that while there may be some supplies of vaccines going to low- and middle-income countries, they do not have a sustainable supply. Many of those countries are asking to be able to have technology-transfer-related intellectual-property waivers so they can produce their own supply of vaccines, as we in Ireland and others have done.

On that, Mr. O'Connor says the skills and ingredients might not be available locally and that certain amounts of product are being destroyed because the capability does not exist. I want to understand that because it strikes me that, if it is true, it is a fairly reasonable explanation. If there is evidence to suggest that is not the full picture, we should hear it.

Professor Aisling McMahon

I disagree with that. If the contention is that some countries are unable to manufacture in some instances because they do not have the skills, I completely disagree. There is evidence to which I could point, and I am sure Dr. Eynikel and Mr. Clarken could add to it. mRNA vaccines have been upscaled since the start of the pandemic. We know that is the case in several countries. We also know that, for example, Afrigen, together with the WHO hub, has recently replicated in South Africa a vaccine similar to the Moderna vaccine. Therefore, we know there are skills there. We also know that over 100 companies are willing to try to manufacture mRNA vaccines. We know the skills exist. The literature points not to Mr. O'Connor's conclusion but to the conclusion that entities are willing and have the skills to produce vaccines if intellectual property rights are waived and if there is a transfer of know-how and technology. I am sure Mr. Eynikel can add to that.

Mr. Dimitri Eynikel

Yes. It was actually our study in which it was identified that there are 100 companies capable of producing mRNA vaccines worldwide. We ascertained this based on an examination of the profiles of the companies that work for Pfizer-BioNTech and Moderna to produce these vaccines.

The question also refers to the roll-out of vaccines, administration and skills that exist. We have to recognise there are challenges. They are predictable. While I agree there are challenges associated with administering vaccines in certain countries and support is needed, let us not whitewash what has happened. The vaccine inequity that we see today is largely the result of what happened last year, whereby very few vaccines were available for most of the world. Eighty percent of the world's population live in low- or middle-income countries. There were very few supplies available. That is the problem we are addressing here today. It is, of course, related to intellectual property rights and trade issues. There was a large concentration of production in a few countries, including the US, European states and India. The countries that could produce had priority access whereas those that could not did not have access to these tools. They had no other source of supply. That is the problem we are discussing here today. We need diversity of production and supply so there will be multiple producers from which countries can source their vaccines now and in the future.

Dr. Christine Kelly

I might be able to pick up on some of those points. The first point, on innovation, is really important. I am an infectious-diseases physician and also work in academia. My job is really to prescribe pharmaceutical interventions to people every day, so I understand the key role of research and development and innovation in driving forward patient health. On that point, I agree with my colleagues from the pharmaceutical industry. However, a pandemic presents a very different scenario, for two reasons. First, an infection, by nature, is transmissible from person to person. An intervention will potentially interrupt transmission chains, which makes it different. Second, when there is a pandemic, you are not dealing with one specific country but with the entire global population. You eventually get to the point where if you are protecting your patent to drive profits for further innovation, the innovation you are protecting will not be capable of being used for certain populations. The key issue I have with the current model is that we have got to the point where the innovation falls into this category in respect of certain populations of people. That is bad for medical ethics, interrupting transmission and public health. There has to be a balance. There has to be a point at which we say enough is enough and that we now need to regulate what happens in terms of protecting the patents and making sure the product is available to everybody who needs it.

I am very conscious that Mr. O'Connor has not had a chance to respond. My time has expired but the Chairman might indulge me by allowing him to respond.

Mr. Oliver O'Connor

I thank the Chairman and Deputy. Let me respond to a couple of points. On the question of the African production of vaccines, it is best to refer members to something I read recently, the African Union's plan entitled "Partnership for African Vaccine Manufacturing". It sets a target for Africa to be able to manufacture 60% of its needed vaccines by 2040. Its target is to be able to manufacture 10% of its needed vaccines on the African Continent by the end of 2025.

It does not include a requirement to achieve this to have a TRIPS waiver. It is a very sophisticated document and it alerts to the importance of regulatory and standards controls and, indeed, the building of the skill sets needed within Africa. It is an important report that would be worth looking at in this context.

On the overall issue of the economics of this, it is an unavoidable issue. We are asking for private as well as public capital to be raised and it is up to the public sector rule-makers - the legislators - to say what are the rules. We want to have a rules-based international system both for the production and the development of vaccines and medicines. To go back, the initial TRIPS was set in the Doha round of trade talks and it allowed for compulsory licensing and so on. Companies invested in their capacities and in their research and development on the basis of the rules that were in place. If we now say those rules are not applied because we are going to have a waiver for vaccines, that changes the rule set. For example, the Chinese want to manufacture mRNA vaccines and they are unhappy with the Quad proposal because they would not be currently allowed, and so on.

The fundamental point about investment is that the rules are set in advance. Companies are raising capital, and the public sector is raising capital too, on the basis of the rules as set in advance. If we change them, and it is open to the public sector to do that, we have to calculate the effects of that for future investment. No company is forced to invest in any circumstances and no company can magic up the capital to invest both in its production capacity and in vaccines and medicines research and development. They can only do so within the context of set international order and set rules. It is a very important thing to ask whether we are changing those rules fundamentally and what effect that might have. As I said, the European Patent Office said there will be a 37% reduction in vaccines.

I am conscious that I am over time. Perhaps Mr. O'Connor's industry is a little bit more resilient than he gives it credit for.

I call Senator Ollie Crowe, who is sharing time with Deputy Joe Flaherty.

It was stated in the contribution that innovation depends on intellectual property protection and it highlighted the risky business of investing in research and development. A vast and unprecedented amount of public money was allocated towards the research of these vaccines. As we are all aware, billions were given by the US Government to Moderna, which almost entirely funded the development, AstraZeneca was funded by the UK Government and the German Government provided in excess of €400 million to BioNTech, which partners with Pfizer, as we are aware. I find it difficult to see this point applying in this case. The estimate I saw was that governments had spent more than €90 billion on vaccines and therapeutics. Is it not disingenuous for pharmaceutical companies to accept in excess of €90 billion from countries across the globe to fund the vast majority of vaccine development and then say innovation is risky so we cannot have a waiver? I ask Mr. O'Connor and Mr. Moran for a response.

Mr. Oliver O'Connor

In all considerations of the interplay between public-private investment and payment for vaccines, we consider that we have to look at the benefits and the value generated. For any vaccine or medicine, the value accrues to the individual and to the state, and some value accrues to companies that produce medicines. That is the balance, and how that is divided up is the constant job of the payment and investment in medicines and vaccines generally.

I would say that, in this case, the value generated by vaccines incalculably outstrips both the value for money investment the public sector has made and the value that is earned by companies. Even within our own economy, we can see that. We have a domestic economy of some €240 billion or €250 billion. If we have a 1%, or 10%, or some other level of fall in that economic output, that vastly exceeds what Ireland would have invested in any part of the European investment in research and development and, indeed, paying for the medicines. In the balance of who gets the benefit globally, it is society that is getting the huge benefit from all of the excellent investment that has been made by the public sector. Along with the reward for pharma companies that did invest, fundamentally, the value that is delivered has accrued to people in their lives and to societies.

Reference was made in the contribution to the capacity issues in countries where a TRIPS waiver could potentially be used. This has often been referenced by pharmaceutical companies since this debate began, and it has been repeatedly said that developing countries lack the capacity to manufacture vaccines. When I was doing research for this meeting, I came across an article by Stephanie Nolen in The New York Times, published on 22 October, which identified ten different locations in developing countries, including India, Thailand, South Africa and Indonesia. It was a detailed, well written piece. Ms Nolen had examined the key criteria, including existing facilities, human capital and so on. Did Mr. Moran or Mr. O'Connor see the piece and what is their reaction to it?

Mr. Matt Moran

Having worked for many years in pharmaceutical manufacturing, I think it is quite easy to do fairly general studies of potential capacity or capability within any country in the world. Normally, what the pharmaceutical industry does and has done is enter into licensing agreements and technology transfer agreements to ensure the capability is present and that they are able to manufacture these products and the ingredients. To underestimate the complexity of what is happening here is a bit of a risk. For instance, to make an mRNA vaccine that is made currently by Pfizer-BioNTech requires in excess of 280 different components, 46 different countries need to supply ingredients and there has to be a laboratory that can conduct more than 50 tests on the product. The capability is not necessarily there. The risk is that if one asks a company that does not have the capability to engage in manufacturing and supply, one is risking diversion of raw materials away from manufacturing and risking producing products which might be substandard, which is a risk to society and health.

The answer really is that, yes, the industry is keen to enter into joint agreements on a voluntary basis, which it has done and there are in excess of 350, as Mr. O'Connor referred to in his presentation. They scour the world all of the time for new arrangements and, recently, joint licensing agreements have been agreed on the African continent between major pharmaceutical companies and local suppliers, and they will continue to do that.

Again, to put this in context, to establish a pharmaceutical manufacturing plant takes approximately two to three years in terms of the capital investment required, the regulatory approval required, the validation required and the training of people. It is not something that is easily accessible. I would congratulate the organisation Mr. O'Connor refers to with regard to establishing manufacturing on the African continent because it needs to be done, but it is not something that is going to happen overnight. It is an area where we need to be very careful in terms of how we manage and deal with it. The industry is keen to do this and has been doing this, and the evidence of that is the number of joint licensing agreements achieved. Indeed, the committee is probably aware of the significant amount of vaccine that has been manufactured in India by the Serum Institute through an agreement it has with AstraZeneca.

Mr. Dimitri Eynikel

AstraZeneca’s agreement with the Serum Institute is the odd one out, to be honest, and is a bit of an exception.

We appreciate, of course, that the Serum Institute did share the technology. There is a major difference between conventional vaccines, the different types of vaccines that existed before, and the mRNA vaccines. The latter vaccines are largely synthetic vaccines and that means they are less complex to produce. In opposition to what has just been said, they can be produced by many pharmaceutical companies that normally produce medicines, because these vaccines are simpler to produce. Equally, the production process is closer to that of certain medicines. In that regard, I disagree with what was said.

It is correct that there are some 300 agreements. I am sure they exist, but to a large extent these are agreements with companies in the US and Europe, or they concern fill and finish deals. These types of deals mean the vaccine substance is produced in the US or Europe and then shipped to some companies in Africa, for example, where the vaccine is just put in the vials and quality tests are done. It is a valuable part of the production and supply chain, but it is not vaccine production. It does not provide an alternative source of supply. We have seen that, for example, in the context of the agreement between Johnson & Johnson and Biovac in South Africa, where the vials were filled in that country but then shipped back to Europe. It means that Johnson & Johnson were still selling these doses that were filled in South Africa back to Europe. Such a process does not provide any solution for African countries seeking to buy access to vaccines. A full production process is needed and we have not seen any commitment in this regard to share the requisite technology widely across the world. This is why companies in India, Indonesia, Thailand and South Africa have been successfully re-engineering and developing mRNA vaccines themselves. There is no reason they cannot do it.

Is Senator Crowe okay with that?

I call Deputy Flaherty.

I thank the witnesses for coming in. In one way, a consequence of Covid-19 is that we are lucky to have a backdrop like it so we can see first-hand the benefits of our discussions today. Licensing agreements, international property rights and all these add great value to companies. We all agree on this aspect. Reference was made to it probably taking two to three years to start up a production process, but in most instances, foreign direct investment, FDI, especially in modern, advanced societies, is aided by state supports. Research and development investment also benefits from state support as well. I appreciate that Mr. Moran and Mr. O'Connor set out in their document some of the initiatives they have taken or they are involved with globally and that companies must make a profit, but at the same time, putting on their humanitarian hats, do they think companies also have humanitarian, ethical and moral responsibilities to fulfil, or how do they marry those aspects?

Mr. Oliver O'Connor

Of course companies have a moral and ethical responsibility and they are very conscious of it. The first way to discharge that is to use what they do to pursue it properly and with standards of excellence, which in the first place is to discover and apply and do research to the highest standards of excellence possible to discover the solutions we want. Two years ago, there were no vaccines. Companies made strong ethical commitments to devote all their resources - every possible one they could - to making that discovery and to organising their global manufacturing processes to deliver the vaccines. That is a very high ethical obligation. Therefore, companies do that and they are very conscious of those obligations. As I said to the committee previously, the question of the balance of reward and value is one that is thought about constantly. It happens in dialogue daily with our public sector, including with the HSE and the National Centre for Pharmacoeconomics. It happens at a global level as well. People are very conscious of their obligations and their role in society.

I thank Mr. O'Connor, but I think it is fair to say there is no pharmaceutical or healthcare company that has not triumphed and profited during the Covid-19 pandemic. Any of them I speak to, it is a bit like the English 700 years ago. They used to go to war when the economy was faltering. It has been a decent period for the pharmaceutical sector.

Some of the initiatives were referred to, including the mRNA technology transfer hub and COVAX. Regarding what is being put into Africa, which is 672 million doses, it probably seems like a large number until we realise 11 million doses have already been administered in Ireland and Africa is a large continent. It was brought into context for me yesterday when a South African lady came into my constituency office. She had waited 18 months for her Irish citizenship to come through and her Irish passport finally arrived this week. She can now go back to South Africa and visit the grave of her son, who died in the early stages of Covid-19 because he did not have access to a vaccine. This woman was in the fortunate position that she was living here in a very advanced society and was able to access her Covid-19 vaccine quickly. That experience showed me at first hand the disparities that exist. While I appreciate what is happening in respect of the transfer of technology and in the context of COVAX, there is an onus on the pharmaceutical sector to do much more. Certainly, the only space where we can see that happening is through the TRIPS waiver.

Would Dr. Kelly like to contribute?

Dr. Christine Kelly

Yes. A good point has been made regarding the human cost of this. Mr. Clarken referred in his opening statement to how bad the scenario is regarding global vaccination now. Many countries still have vaccination rates of less than 10%. WHO guidance is that 10% of a country's population must be vaccinated to cover the most vulnerable people. These are people we started vaccinating here in Ireland in December 2020. We are talking about healthcare workers, elderly people and immunosuppressed people. Those categories of people still have not had any vaccine administered in some countries around the world. This hits me particularly hard, because as a healthcare worker, I understand how difficult it is to grapple with these issues of going in to treat people when you have not been vaccinated yourself and of watching people potentially getting very sick and dying from a vaccine-preventable disease. I am grateful for that context having been brought in because this is the key aspect we must remember.

We now have enough production and things like that, but it is important to note, however, that this delay in rolling out vaccines has already had a major impact. It is fair to say we have failed in global vaccine roll-out. Large parts of the world have not received any vaccines at all. The consequences of this are increased disease and death from a vaccine-preventable disease, increased transmission and prolongation of the pandemic. Also worrying for me is our global health security, our ability to manage infections and prevent new infections and new variants, should they crop up. All of this has been impacted by the delay. It is not okay to sit here and state we had a very good programme in Ireland and we now have lots of production, because we are missing out on that crucial time when we missed doing this properly. It is important for us to understand the impact this has had. It has had an impact not only from a clinical point of view but also from a point of view of confidence in vaccine programmes. Therefore, if we are talking about hesitancy and things like that, much of that has been driven by the fact there has been unreliable vaccine supply for a long time. People were worried that some of the vaccines were expired. Some had to be destroyed. All these things also undermine global confidence in vaccines, which is a real issue for us at the minute too.

I call Mr. Clarken to respond, but he must be brief because the time is up for this slot. He can, though, come back in again.

Mr. Jim Clarken

I appreciate Deputy Flaherty raising the human impact of this because, at the end of the day, that is why we are here. We talked about the huge death toll of an estimated 19.5 million people. Of those, 14% have been in high-income countries, while the rest have been in poor- and middle-income countries. For every life lost in a rich country, four have been lost in a poor country. People in poorer countries are much more likely to die from this disease than those of us lucky enough to have had the opportunity to be vaccinated. Every minute, four children lose a parent or caregiver as a result of the pandemic. Considering this impact in the context of global human development, it is estimated that 90% of the world is worse off due to the effects of the pandemic. Some 160 million people have been pushed into extreme poverty, bearing in mind that we had been making slow progress to rid ourselves of extreme poverty. We had a long way to go, but we were making slow progress. We have now gone backwards and dramatically so.

The impact on women, in particular, has been devastating. Those who are on the front line, working in precarious, low-income jobs, have put themselves hugely at risk. The amount of unpaid care work, 90% of which is carried out by women in the first place, has dramatically increased. We know about the huge growth in violence against women and girls both in this part of the world and throughout the world. There has been a massive human impact to this. I really appreciate the Deputy raising it because at the end of the day it is up to us to minimise the human impact in any way we can. Clearly, a TRIPS waiver does not solve all of our problems but it gets us a long way there.

I thank all the witnesses for their presentations. Mr. Eynikel made the point earlier that we should not whitewash the impact of the intellectual property stranglehold on vaccines. Has Mr. Eynikel an estimate of how many people have died as a consequence of the absence of a TRIPS waiver?

Mr. Dimitri Eynikel

As a figure like this, no. We know the death rate but I cannot say which of these people have died specifically as a result of that. That is an impossible or very difficult calculation to make. Let us be careful about putting numbers to that exactly. This does not mean that the TRIPS waiver will not help to reduce that number, particularly for treatments. Let us not forget to discuss treatments. We have talked a lot about vaccines so far but when we are talking about access to treatments there is a serious problem right now. There are countries particularly in Latin America that are completely cut off from access to Covid-19 treatments. I am sure that Dr. Kelly can talk more about them. They can save lives. They are very easy to produce. They are cheap. People do not have access to them because of intellectual property rights.

We understand it is four times the death rate. That is not solely down to intellectual property, absence of vaccines or treatments or whatever, it is also down to general conditions and so on. Would it not be accurate to say that millions of people have died as a consequence?

Mr. Dimitri Eynikel

Yes, that would be my estimate.

Can Mr. O'Connor estimate how many people have died as a consequence of the absence of a TRIPS waiver?

Mr. Oliver O'Connor

I have not estimated that but we are clear that we have provided a vast amount of life-saving and life-enhancing treatments from the result over the past two years. The value of that can only be estimated from an economic point of view but it is enormous. The lives saved indeed have been evident to us all. Clearly there is no disagreement-----

Excuse me, I must ask the next question as there are only five minutes left. How much public money has been provided globally to the pharmaceutical industry in terms of the development of vaccines?

Mr. Oliver O'Connor

I do not have that figure.

Would it be accurate to say about $100 billion?

Mr. Oliver O'Connor

It may be but what I am saying again is that if we put that aside as we do with all investment, the value delivered would vastly exceed $100 billion. Similarly, it is open of course to governments and authorities to say we will have a situation in the future where we are prepared to invest money but there will be no intellectual property, IP, rights for any private investment company. That is fair enough. If that is what they want to do, that is fine. My only point was that as long as the public sector sets the rules clearly in advance and sticks to those rules, as they were set in the Doha Round that would be the most predictable and indeed order-based, rules-based type of environment in which you could have joint public and private investment. It is not a matter of disputing how much investment; clearly the investment has been made and it is good.

Earlier Mr. O'Connor mentioned where the value of that investment went, saying that it has accrued to people in their lives and societies. Nobody, or certainly very few people, would doubt the extraordinary impact of vaccines and therapeutics in terms of helping us to get out of a phase of Covid-19. Can Mr. O'Connor think of any other group of people, or class of people who have also benefited from that public investment?

Mr. Oliver O'Connor

Clearly there has been both public and private investment in the research and development of vaccines. As I said earlie,r in any of the medicines production the value, if you were to think about it purely in economic terms, accrues to individuals in their lives and in our country the State in terms of the health service budget, the State budget, and a certain value accrues to companies that earned some reward for that investment.

Could Mr. O'Connor put a figure on what value has accrued to the companies?

Mr. Oliver O'Connor

I do not have that figure.

Could Mr. O'Connor give me a figure for the profits being made by the companies he represents?

Mr. Oliver O'Connor

I am not putting a figure on that either.

It has been reported that Pfizer BioNTech and Moderna were together making $1,000 profit a second. Is that in the ballpark?

Mr. Oliver O'Connor

I do not know.

Would Mr. O'Connor accept that something important that is happening here is that a huge amount of public money has gone into developing vaccines for the benefit of humanity as a whole - that is why that investment was made - but that a large part of its benefits has been privatised by the companies Mr. O'Connor represents and is being turned into private profit at the expense of millions of unnecessary deaths?

Mr. Oliver O'Connor

I do not accept the language. I do not accept the idea of "at the expense of". What I see is legitimate public investment in research and development and a large amount of private investment. Companies are making huge investment over many years in their own capacities to manufacture, develop and deliver and roll out on a global basis medicines and vaccines. I see them asking investors, pension funds and many other private organisations to invest in their companies, to put their money at risk. I see them getting rewarded for that. Yes of course there are profits in that area. There are also many investments which produce nothing. The public sector, as a matter of public policy, would have to consider whether states, such as Ireland, would be prepared to invest hundreds of millions of euro in investment projects that could produce nothing. The risk tolerance of states and the public sector is quite low for those things. The risk tolerance in private investment is somewhat higher. Therefore it is a blend of the two. My only-----

I am not sure that happened here. Can I move on as I have only one minute left? I have one final question. Mr. O'Connor said earlier that more vaccines are available than African countries are capable of accepting. Can he unpack that for me, in the context of the African Union for example being very clear in favour of a TRIPS waiver, of the reported gap in mRNA vaccines needed between 4 billion and 15 billion? To put it bluntly, is there not a certain racist trope going on there suggesting that African countries are not capable of using these vaccines?

Mr. Oliver O'Connor

Absolutely not. I completely reject that language on behalf of the industry, myself and my colleague, absolutely not. That is totally uncalled for in my opinion.

Mr. Oliver O'Connor

It is totally uncalled for to be accused of any such thing. The evidence I bring to bear for that, if I may, is the statement indeed from the Africa Centres for Disease Control and Prevention from only three weeks ago. Three weeks ago it asked for a suspension of delivery of vaccines. That is really the basis of what I am saying. More is being produced than is capable of being administered currently in Africa. Of course there is a bigger demand. That should be delivered later, and it will be. The industry is scaling up production. It is going to continue to produce and serve the needs of patients in Africa. Absolutely. There is no call whatsoever for such language in this sort of debate.

That is the suggestion; it is that these African people are not capable of using this, even if we give them the technology. That is it. They do not have the facilities and so on. That is part of the line of argument of the pharmaceutical industry to hide behind.

Mr. Oliver O'Connor

It is not my suggestion. The Deputy may read it however he likes and make whatever accusations he wants. We are bringing to the committee the evidence of the actual production numbers and what the Africa Centres for Disease Control and Prevention has said. The Deputy's choice is to overlay that with such accusations.

Mr. O'Connor is the one who was saying that the problem is the capacity of these countries to absorb, distribute and administer the doses that they got, talking about the destruction of significant quantities of doses of expired vaccines, without mentioning the fact that these are end-of-line vaccines and they are getting them because they are nearing their expiry date. It is crumbs from the table from the pharmaceutical companies and the developed world. All this is to distract from the point that they are unwilling to give up the intellectual property rights to allow production in order to continue to make as much profit as Mr. O'Connor's companies can.

Mr. Oliver O'Connor

We have brought our facts and our evidence, and our statements from a reputable organisation in Africa, to this debate. Clearly it is up to the committee and its members to make up their own minds how they want to deal with it.

I welcome our guests. It is a fascinating debate and discussion to date. I will focus on a number of points. In regard to the vaccine hesitancy, I notice that the IPHA has said low update rates are due to hesitancy.

She may correct me if I am wrong but I think Dr. Kelly penned a letter to The Irish Times last January contradicting this, saying there is no more hesitancy in the market than there is in Europe or elsewhere. She also stated that hesitancy in Africa and other countries is due to historical issues with respect to vaccines that were used unethically. Will witnesses comment on the extent of vaccine hesitancy, what can be done about it and the issue of how it may be leading to a lack of uptake in some countries, which we are all concerned about?

Dr. Christine Kelly

I thank the Deputy for raising that really important issue. Vaccine misinformation is one of the biggest challenges we face as physicians in the area of infectious diseases. It is something we need to be really careful about and challenge it properly and not make it worse. By compromising our global vaccine roll-out programmes, we have actually inadvertently contributed to that through decreasing population confidence in vaccines in general.

A lot of data has been published. An excellent paper was published in Nature last year that showed vaccine hesitancy rates in Africa and other low-income countries, apart from those in Africa, were similar overall to higher-income countries. The problem we have is that the current distribution model is based on giving surplus supplies to these countries. Until recently, we did not have enough production, and we still do not have enough production of the right type of vaccines. We have not had reliable supply chains. We have not had the right kinds of vaccines.

NIAC is a fantastic body. It put so much work and effort into meticulously generating guidelines for the Irish public that were evidence-based. Many countries around the world have not been able to do that. They have not been able to sit down and say what is the best, most effective, safest vaccine for their population. They are dealing with what they believe to be leftover vaccines from other countries, so that actually fuels vaccine hesitancy. Because of vaccine inequity, we have made vaccine hesitancy worse. That is one of the big issues at the minute. When we are talking about countries that are not able to absorb vaccines, that is certainly one of the factors in the mix.

We also have to remember that it is not easy for people in many of these countries to get to vaccine centres. They can be travelling for long periods. They might not be able to afford transport and such things, so there are logistic issues. We are not at a point in the pandemic that we are seeing high transmission peaks. That may come again and there may be a time when the pressure is on again to get vaccines rolled out. All those points are in the mix.

It was stated earlier that more than 100 manufacturers globally can now manufacture the vaccine. They were given permission to do so. Even if those vaccines were manufactured in the states Dr. Kelly mentioned, would the challenges regarding hesitancy, supply chains, enough syringes, and getting the logistics in the countries up to speed to administer the vaccines continue?

Dr. Christine Kelly

I am not trying to minimise the fact that there are a lot of challenges. I worked in Malawi for four years and I have seen fantastic vaccine roll-out programmes. If there is one thing a lot of countries in low-income scenarios are very good at, it is rolling out vaccines. We have to be very careful about looking down on countries and saying that are not able to do this, because a lot of the time they are able, but it is about equipment and supplies issues.

The TRIPS waiver would help with the autonomy of a country to be able to decide what vaccines it will introduced and how it will do that. For me, that is the big issues as a clinician. I want to be able to decide what I am supplying based on evidence, not based on the leftovers or whatever is being given to me. The essential point of the TRIPS waiver is clinical autonomy, as well as diversity of production and being able to produce the vaccine within the contingent for the continent, and for it not to be exported.

Perhaps the representative of the IPHA will address those points.

Mr. Oliver O'Connor

I do not have much to add, except from what was in our statement. It is clear a lot of work is going on in Africa and with the Africa CDC about studies on how they can effectively roll out vaccines. A recent study stated that the most effective measure is to target older people earlier than the general population when vaccinating. Studies are being done in multiple countries on how to use the vaccines we have most effectively and more quickly. In that respect, the industry is collaborating with them in doing so.

The US has changed its stance on the waiver but some of our guests said that it did not go far enough. The US trade representative, Katherine Tai, announced in 2021 that the US would support the waiver of IP protections in the context of Covid-19 vaccines that were introduced by the governments of India and South Africa. That is a major step forward. Jorge Contreras, from the University of Utah, stated in Intereconomics that:

...even if a company is legally required to “share” its proprietary trade secrets and manufacturing know-how with others, there are countless ways to delay and subvert the effective transfer of knowledge. In practice, the most effective technology sharing programs are supported by voluntary action rather than governmental compulsion.

Has the industry considered voluntary knowledge transfer to alleviate the global supply shortages? Does the IPHA agree that there are 100 manufacturing sites across the world that are now able to manufacture generic versions of Covid-19 vaccines?

Mr. Oliver O'Connor

This is a matter of technology transfer and, indeed, global trading arrangements. The mRNA vaccine has been developed as a European and American innovation. The vast majority of new medicines and vaccines are developed between Europe and the US. In considering how that is playing out, one has to look at the current discussions on the Quad proposal that has been referred to, and why China is not happy with the Quad proposal because of the 10% limitation on exports. China wants access to the mRNA technology with no IP rights - completely free access. As a matter of the current global political economy and how things have developed in the past year and, indeed, in recent months, the American Government will, no doubt, consider whether it should allow American-European technology to be accessed completely free, with no IP rights, by China. This is an issue that is in play and it is not something the pharmaceutical industry can decide. It is obviously for governments to decide. This is the enterprise committee and, as we all know, it is concerned with international trade and so on and so forth. It is an important aspect of international trade and is relevant to these considerations as we see them played out at the WTO.

My colleague might like to speak about the number and availability of manufacturing sites around the world and what that represents.

Mr. Matt Moran

It was said that a voluntary approach would probably be more productive in the long run, and that is what is happening at the moment. We have said there are 350 agreements, which is a significant number, and they are supporting manufacturing where it can.

The complexity of making mRNA vaccines has been underestimated a bit. For members' information, it actually takes 60 days to make one batch of an mRNA vaccine. In fact, that technology is not off the shelf. The view of the industry still is that they have scoured the world looking for what they believe are suitable partners to enter into agreements with. That probably is the more productive way to go. In the long run, it will enhance the supply of vaccines.

Professor Aisling McMahon

I will respond to some of the points made on the voluntary issue.

It is very important to state that the TRIPS waiver was actually proposed in 2020, apparently in response to the lack of voluntary agreements and support for various voluntary initiatives. In particular, it is very important to note that the Covid-19 technology access pool, C-TAP, which the Joint Committee on Foreign Affairs and Defence previously considered, was an initiative set up by the WHO to facilitate the sharing of intellectual property rights, data, IP, etc., to upscale vaccine and other health technology production for Covid-19. That initiative was one with great promise. It was the idea that industry and states would come together in solidarity. The reality is that industry did not sufficiently support that for vaccines at any stage. It was precisely because of that lack of voluntary support for these types of global initiatives that India and South Africa had well-founded fears, sadly, that low- and middle-income countries would fall behind. In an ideal world, voluntary agreements would have been the solution if there was sufficient engagement at that stage, but there was not.

The TRIPS waiver was proposed and has arguably been a leverage to encourage voluntary agreements. Of those that have happened, we cannot prove that the waiver was definitely what led to them, but certainly waivers and compulsory licensing have been used as leverage in the past. As Mr. Eynikel pointed out previously, many of the voluntary agreements, which are good to have and it has to be commended when such agreements are set up, are fill-and-finish agreements, which means the technology, the know-how, is not necessarily being transferred. The issue with that is we are not building long-term capacity in low- and middle-income countries.

COVAX has been mentioned. While it is a good system for short-term supply, COVAX does not allow countries to upscale their own manufacturing capacity, which is also a real issue. It is the same with some of these voluntary initiatives. It is important that we recognise the waiver debate is in a context in which we have not had sufficient support for those initiatives.

Mr. Dimitri Eynikel

I will respond to the point on China. When it comes to the mRNA technologies, it is quite interesting that the example of China is used, because one of the only agreements BioNTech has to voluntarily share its technology is with Fosun in China. I do not know where this threat or risk from China suddenly comes from if BioNTech actually shares its technology with a Chinese company. China is, by the way, one of the only countries that has the ability to lift and get access to trade secrets out of public interest. BioNTech did it voluntarily despite that risk being there. It does not jeopardise any voluntary agreement. That is the first aspect on China.

The second aspect is that China is not happy with being forced out of the Quad text because that is what it actually entails. China is forced out of using that text but it has said that it is not interested in using it. Lately, it has been commenting that it voluntary wants to opt out of using that text, will say it is not interested in the use of the text and will form a licence as well. The issue of China is not at all a serious concern for us in that respect. However, we support the idea that any country that wants to use this text, or the waiver that will potentially come at the end of the process, should have the text available to it because any country is at risk of the pandemic. It is of shared interest to have this option available.

The Oxfam submission states, "Experts have estimated that there will be a 15 billion dose shortfall in mRNA Covid vaccine production in 2022." The IPHA has said that 12 billion doses have been produced and 10 billion administered. There seems to be a conflict with respect to the number of vaccines required and the number available. Will the two sides comment on that?

Mr. Oliver O'Connor

I am not sure I caught all the details of the question in terms of the numbers.

In the submission from Oxfam, it is maintained there is an estimated 15-billion dose gap in mRNA Covid-19 vaccine production in 2022. Mr. O'Connor said 10 billion doses had been administered and the "speed of Covid-19 vaccines production is outpacing their administration". There seems to be a contradiction there in that the need, according to Oxfam, etc., is for 15 billion doses for this year. Does Mr. O'Connor agree with that?

Mr. Oliver O'Connor

I do not know if there is as much of a contradiction as might appear. We have not said that the entire demand has already been met. Clearly, it has not been met in Africa and globally. Clearly, the companies producing different types of vaccines are continuing to produce at great pace and scale. We are confident demand can be met. What is clear is that the capacity to administer the production so far, at this point, is not there. That is why Africa CDC has asked for a pause. Certainly the need is there. African countries and the centres for disease control and prevention, CDC, are estimating and making their own calculations about the best way to roll it out and how they should prioritise within their own countries to meet that need. Their advice is now to prioritise older people in Africa. There is not that much of a contradiction in the numbers.

Mr. Dimitri Eynikel

We acknowledge that the overall production and supply of vaccines have significantly improved and there is quite a substantial supply available of all vaccines. However, the Oxfam figure singles out the supply of mRNA vaccines because they are most effective and are easier to adapt to variants. They are most effective when it comes to Omicron and that is what the number refers to. What we also have to bear in mind is whether we are prepared for a potential next wave. Are we prepared for new inequities when new, more potent vaccines adapted to new variants arrive? If a new wave of variants comes, we are not there. We will have the same inequity all over again if we do not address the structural issues. That is the point of discussion today.

I thank the witnesses for their time and work to date and the success we have had in Ireland and other countries. In some ways, I feel bad that I have had three vaccines at this stage while, during a global pandemic, many millions have had none. I feel guilty about that. As of December 2021, only 27% of healthcare workers on the African continent had been fully vaccinated. The public money invested in vaccine development is estimated at approximately €93 billion. In December 2021, the Seanad passed a motion calling on the Government to publicly support and lobby the European Commission to support a TRIPS waiver.

With regard to the innovation of vaccines, is it not the case that public and political concern and public funding was key to the innovation of Covid-19 vaccines? If that was the driving force, where is the public benefit of it globally? Legal and IP scholars have argued that the TRIPS waiver is a necessary and proportionate legal measure for clearing IP barriers to facilitate increased supply of Covid-19 vaccines and other health technologies. In these circumstances, is it not the case that high-income countries will continue to be markets for innovation regardless of the TRIPS waiver? Is it not also the case that innovation of HIV-AIDS drugs continued after generic production was allowed in low-income countries?

It is not as if we have not been very successful, thanks to big pharma, governments and public funding. We all know what happened with the HIV and AIDS epidemic. The pharmaceutical industry rolled out similar talking points to the ones the witnesses have been providing today, but allowing generic production of HIV-AIDS medicines was what it took to get increased production, lower prices and millions of lives saved. On a very simple scale, looking at what we did around AIDS in terms of what big pharma and public funding did, I do not understand why we are not doing the same here.

Vaccine manufacturing projections include vaccines that are not as effective as mRNA vaccines. Why should low-income countries accept vaccines with lower effectiveness when the people of Ireland are no longer using them? I was kind of on the fence about this a while back but I trust Trócaire, Oxfam and Amnesty Ireland. These are organisations that are work with developing countries all the time. Big pharma does not do so, and nor do I. I trust these organisations. If they are asking for this, maybe it is time we listened. Maybe we and big pharma do not know best. It is brilliant that the pharmaceutical companies came up with the vaccines, thanks to public funding, and rolled them out successfully in some countries. However, can we put our hands on our hearts and say we are doing right by everybody globally? It is very unfair. There is already such a struggle for clean water and to meet basic human rights. We know we can turn this around. We have done it with AIDS.

Mr. Jim Clarken

I could not agree with the Senator more strongly. We are constantly being bombarded with messages that it is too complex, too difficult and cannot be done or that it will collapse the entire global system, medicines will never be developed again and the world will not benefit. The Senator's example is the perfect example of what was done about HIV and AIDS.

After many years of campaigning by Oxfam, Médecins Sans Frontières, MSF, and many others, the world forced the global pharmaceutical industry to allow general production. After the loss of millions who should not have died, it transformed the lives of millions more and still does to this day. That is an example of how these things can work. The suggestion here is that if there is an agreement on TRIPS, it will collapse the system in future. It is important to remember that TRIPS is part of the rules-based system. It is built into the agreement and is there for a reason. This is the reason. We have an extraordinary, once-in-a-generation health crisis. We have the tools available to us to create a temporary waiver. It is important to remember that the waiver described is temporary. It can transform the production and roll-out of vaccines for the rest of the world, while those of us sitting comfortably here have been vaccinated.

There is no strong counterargument to stand up to that. The examples given prove that it works. We can do it and support developing countries in the roll-out. As Dr. Kelly mentioned, we have seen just how effective developing countries are at rolling out vaccines. I worked on vaccine distribution in remote parts of rural South Sudan. People queued for days. There is a significant appetite. The hesitancy is no stronger than it is anywhere else in the world. We need to address these issues. The tools and the solution are staring us in the face. It is time for Ireland and the EU to move their position to support the TRIPS waiver so that everybody who needs to be vaccinated can be and we can finally start to bring this pandemic to an end.

Mr. Oliver O'Connor

In response to Senator Garvey, we too have high regard for NGOs in this area, particularly Irish NGOs, Oxfam and others that have a presence in the country. We respectfully disagree on the role of IP in the solution. The solution and desired outcome is for people's health to be protected, with a vaccination for those who need and want it around the world. Our industry is doing everything it can, as evidenced by the production, to deliver that. Our fundamental point remains, that a change to the TRIPS waiver is a change to the rules set up after the discussions on HIV. It changes the rules to IP protections. In some people's eyes, it would change the rules for everything, including production processes, the formula for the vaccine, therapeutics and so on. If the public sector, State and international organisations want and choose to proceed on that basis in the future, they are entitled to do so, but it changes the rules. We have not used words like "collapse".

We brought forward evidence from the European Patent Office. There has been a 37% drop in investments in this area. We think the rule change will have an effect. We caution that the idea that IP protections are a barrier to vaccination being made available is simply incorrect. Fundamentally, we want vaccinations to be developed. From my point of view, I can see how many companies will think twice about the level of investment they put into what is a risky venture on their part if they are told they will not have any rights to their production processes, formulation or anything else if they do this.

I probably have to stop talking now, because my time is up. I understand that big pharma makes a lot of money on many things. Vaccines are not their big win. I do not know if it is fair to say that these will become generic products and the IP will be sorted out. We all know that big pharma makes money from many different drugs. It does not rely on vaccines to make profits. Am I correct that Mr. O'Connor said the rules changed since the issues with HIV and AIDS? Did we have to change the rules to address AIDS? I am not clear on that point. I do not buy into the fact that big pharma might not want to produce vaccines if it has to relinquish the IP.

Mr. Oliver O'Connor

IP rights apply to all levels of the discovery, from small biotech companies up to mid-sized and larger companies. The TRIPS waiver is a change of rules that will have an effect.

Professor Aisling McMahon

I will respond to the point about whether the TRIPS waiver is a change of rules. The TRIPS agreement was adopted in 1995. It is a WTO framework that sets out minimum standards. Prior to that, some countries had abolished patent systems for pharmaceuticals. Other countries did not have them. They had different effects. The TRIPS waiver required minimum standards. The Doha declaration was a direct acknowledgement of the need to take into account public health issues when considering IP rights. Paragraph 4 of the declaration highlights that intellectual property rights should not be used in a way that would damage public health. That is built into the TRIPS agreement. If adopted, the waiver has to be negotiated and discussed with the WTO states. It can only be adopted subject to the WTO rules. That is built into the system. It is a temporary waiver. The TRIPS framework has always provided for waivers. The Doha declaration was a waiver itself. This would be no different.

We have to be careful about what the waiver would do. Much would depend on how it is negotiated, whether a text is adopted and what happens in that context. The waiver originally proposed by India and South Africa was a comprehensive waiver, but it was a temporary suspension of IP rights. The other important point is that it would suspend such rights at the TRIPS level, so states would not have to comply with TRIPS requirements if they so wished. However, it is likely that many states like Ireland and other high-income countries with access to Covid-19 vaccines and other health technologies, thankfully, would not need recourse to that waiver. The effect of the waiver is likely that it would be used by lower-income countries. It may have impacts, but it will not necessarily have impacts in high-income countries. As Senator Garvey pointed out, precedents for this exist. Antiretroviral drugs are made on a generic basis. Medicines Patent Pool makes products on a generic basis, primarily for lower-income countries. There are different markets in high-income countries. It is important to see it in that context.

I thank the witnesses for attending. I thank the Chair for facilitating this debate, which many of us have pushed for for a long time. I thank People's Vaccine Alliance Ireland for its persistence, including all the involved groups and those who have campaigned for a TRIPS waiver to ensure we can have this hearing. The Labour Party supports the TRIPS waiver. It is unacceptable that low- and middle-income countries would effectively be deprived of the ability to build up their own capacity to develop vaccines, particularly when millions of lives are at stake.

There was a discussion about rules and the changing of rules. I acknowledge what Mr. O'Connor said, but it is important that we all accept that there will always be resistance from industry to the changing of rules. We see this with the corporate tax rate. The Irish Pharmaceutical Healthcare Association made comments about resisting changes to the 12.5% rate. It is only when state actors make decisions such as the Clinton Administration on HIV medication the 1990s that we see radical change. While we can ask the IPHA and the pharmaceutical industry to step up to the mark, change only happens when our Government, the European Union and other global actors make decisions.

Much has been made of how future innovation will be threatened by a TRIPS waiver, yet we understand that on foot of the breakthrough in South Africa, which is an mRNA hub, patents were lodged to effectively scupper the roll-out of the generic vaccine developed there.

Aggressive tactics were used by pharmaceutical companies to block the South African experiment. I ask the contributors to go into detail about what happened in that instance and I ask the IPHA to also comment.

Mr. Dimitri Eynikel

I can explain quite a bit about the project because we have been supportive of the initiative since the start. Faced with a lack of access to Covid-19 vaccines the WHO, together with a consortium in South Africa, developed a manufacturing and technology transfer hub. The idea was to produce Covid-19 mRNA vaccines and, potentially, use the technology afterwards for other diseases. That initiative asked two pharmaceuticals, BioNTech-Pfizer and Moderna, that use mRNA technology and have a product on the market, to share their technology and the rights with the initiative so they could set up a production network with different companies in Africa - so not only in South Africa but in other African countries - and share their technology and teach people how to use, produce and develop these vaccines. Moderna and BioNTech-Pfizer refused to share their technology, data and production knowledge. As a result the hub, in particular Afrigen, which is a small or medium-sized enterprise in South Africa, started together with the University of the Witwatersrand in Johannesburg to re-engineer the Moderna vaccine and see whether they could develop and produce a vaccine. Against the odds and expectations within six months they have succeeded in producing a test patch, which looks quite good, but now they will go into clinical trials, and this is another issue. The fact that data is not openly shared means that this whole production process and clinical trial on whether this product is safe and effective now must be done again, which already exists if Moderna or BioNTech-Pfizer had shared some of their technology and data. This will cost a lot of time and money but the reality will be that there will be independent production. Moderna has three patents on mRNA technology in South Africa so they can block the initiative at any time when they start to produce the vaccines.

Were the patents lodged after the breakthrough by the mRNA hub in South Africa?

Mr. Dimitri Eynikel


So it is not something that happened in advance. Was it in response to the South African initiative that they lodged the patents?

Mr. Dimitri Eynikel

No, it was tabled before. Interestingly, the Moderna patents were filed and granted while Moderna does not sell its vaccine in South Africa. So they basically blocked the mRNA production and access in the country while the vaccine is not even available.

Mr. Oliver O'Connor

I will clarify a few points. On the broader point, I have been the chief executive of the Irish Pharmaceutical Healthcare Association since January 2015 and in that time we have never issued a statement that resists Government policy on corporation tax at 12.5% and so on. We work with the Government in that respect and we have not been resisters in that sense. We have always worked closely with the Government to encourage investment in the country and successfully so. I am sure that goes for our colleagues in BioPharmaChem Ireland.

On the question about specific actions and instances, I am not briefed on that and I do not have responsibility in this area. I cannot answer for the actions of particular companies here today. I would say that some companies have invested large amounts of their capital that they raised, which was not in their plans two and a half years ago. If it is the case that the rules or the environment changes where the entirety of that investment and the entirely of their manufacturing capability to deliver medicines and vaccines globally in this respect is to be shared and given for nothing then one has to consider the following. If that is what the public authorities want then that is fine and it is a policy that one can choose. However, if we were running the circumstance again, and there is no doubt that there will be another pandemic at some point, can one expect those companies to engage in the same type and level of investment with their capital at risk if they have the level of uncertainty about the intellectual property rights that will govern that investment after it is done? That is simply the question that we would ask the committee and the Government to consider. Our answer is clearly "No". We believe that there would be a diminution, to put it in the most neutral word, in the capacity and willingness of companies to make the investment and make their processes available for anyone else around the world to take. That is our position.

On the corporation tax rate, the IPHA statement firmly supports the continuation of the 12.5% rate. I am open to correction but I feel sure that the Department of Finance has received letters that highlight the fears of the IPHA member companies unless the 12.5% rate exists.

The submission mentions six ways to achieve the goal global vaccine equity. It reads that there should be more charity from developed countries and more vaccine sharing. Is that really the IPHA vision for developing countries? What message is sent by saying that we are prepared to deprive developing countries the capacity to build up their own resilience? I expect that the industry will say that one must protect one's own interests. As the industry has benefited greatly from public finance in developing these vaccines then the pharmaceutical industry must step up to the mark, make a very significant contribution and ensure that capacity and resilience is built up in developing countries to withstand the current pandemic.

Mr. Oliver O'Connor

On the contrary, Senator, the industry would like to see capacities developed. We will work in partnership with countries and companies globally to develop capacity to manufacture, voluntary licensing arrangements and so on. We are absolutely not against the development of Africa's capability to manufacture vaccines. In fact, we are very much in favour of that.

Earlier I explained the reason for my absence and if I ask a question that has already been asked let me know and I can read the transcript.

Mr. O'Connor has said that the industry wants to see the development of capability in Africa but he did not advance suggestions as to how that could happen or happen quickly. I am not saying that the industry is hesitant or hostile to doing the right thing but we all know what the right thing is, which is to ensure there are vaccines and treatments. Let us not forget the treatments because there is a danger that we will focus all of our energy and efforts on vaccines and the train has moved on because increasingly treatments are being spoken about.

In terms of the change of rules, Mr. O'Connor has said that the change in rules will have an impact. Of course they will. I know that, everyone seated in this room knows that and anyone watching this discussion knows that. Mr. O'Connor called it a change in rules and Professor McMahon described it as not so much a change in rules but a temporary suspension of them. I can see Mr. O'Connor nodding. A temporary suspension is a change but it is not a change in rules. Mr. O'Connor said that there will be an impact. Is there a potential for the impact to be very positive? Will the impact move the figures that we have looked at? We all agree that the figure is too low and I refer to the 1% of people in low-income countries who are boosted compared with 60% here. Is there a chance that 1% could move closer to 60%? If so, would that not be a very good thing? If everything stays as it is then we are dealing with the figures whereby 13% of the people in low-income countries have received two doses compared with 75% of people in high-income countries. That is not good and the situation must change. If change involves a changing of the rules, as described by Mr. O'Connor or what Professor McMahon has described as a temporary suspension of the rules with some of those to be negotiated at the level of each individual State, is that not a good thing?

Mr. Oliver O'Connor

There is no disagreement. We agree that we want to see vaccines developed, produced and delivered to the people who need them in Africa and globally.

The issue is finding the most effective way to do that. We believe, and the evidence so far supports this - that the IP rights, such as they are without a waiver, are not acting as a barrier to the production to sufficient capacity in time to meet demand, given the capacity locally in many countries to administer vaccines. The industry will continue to do that.

I am sorry, but I cannot accept that. I know it is not intended that way, but it is verging on the disrespectful to say that low rates of vaccination are caused by a lack of infrastructure, or whatever. There is absolutely no disputing the fact that people in low- to middle-income countries want the vaccines and the treatment. When I say "vaccines", I mean both. These countries want the vaccines, so they will make it happen. Surely Mr. O'Connor would agree that in circumstances where they are facilitated, they will make it happen. It is not just something that people in low- to middle-income countries want, but something that they absolutely need. If we leave things as they are, we are all sitting here and saying that the 1% figure for people who are boosted is grand. We cannot say that. We all agree. At the start of this, I said that nobody is safe until everybody is safe, and everybody nodded. We all established that. However, it is just a slogan if we cannot put a bit of weight behind it. It strikes me that the capacity can be there. I am aware that the issue has been spoken about. I will give other contributors a chance to speak on it as well. If we do not change the rules, or temporarily suspend them, is it not the same as saying that we accept that things will change? The experience from HIV-AIDS is that nothing changed, to any substantial extent, until the technology and the drugs became more freely available. With the greatest of respect, all of the available evidence supports making a change. All of the available evidence suggests that if we do nothing, we will stay where we are, which is not where any of us want to be. If we are going to put some weight behind, and meat on the bones of, the idea that nobody is safe until everybody is safe, surely there has to be some form of a change that is different from how things have been done up to now. The way things have been done up to now has resulted in the figures that we all agree are unacceptable.

Mr. Oliver O'Connor

We fully respect everyone in the situation. With great respect to members of the committee, the facts are that there are more vaccines produced than the African countries can currently accept. That has been said by the Africa Centres for Disease Control and Prevention, not us. That is the evidence for the position we hold at the moment. If they were crying out for more to be delivered and the industry was not delivering, that would be a different case all together. However, that is not the case at the moment. Where we are right now is that the level of production is there. The industry will continue to develop and increase that level of production so that demand can be met. On the question of changing the rules, we think it is a change of the rules, obviously. It certainly changes the environment. That affects the environment for investment in the future, as well as the environment for the current production. They are distinct issues to discuss and debate. The future is something to be thought about very carefully in terms of whether we will see the solutions emerge, in any event. It is up to public policymakers to make their choice on that and to have whatever risk tolerance they want for that. My point is that it is very difficult to expect companies to invest, on a constant basis, in their capacity to manufacture and deliver vaccines and medicines on a global basis, with all the regulatory requirements and quality control environments needed, if we are going to change the rules suddenly in respect of a large amount of investment and in respect of every aspect of the production which they have invested in over many years.

It strikes me that if we do not change, we will stay where we are. We all agree that is not acceptable.

Mr. Oliver O'Connor

We are not-----

I am conscious of the time and I want to give the other witnesses the opportunity to contribute, particularly those who are joining us remotely.

I think Dr. Kelly wanted to come in there.

Dr. Christine Kelly

I will make a quick point. I agree it is really important that we think about the need for change. Production has been an issue all the way through this, and it will be an issue again. We may have a new variant of SARS-CoV-2. We may have a completely new virus that is capable of causing a pandemic. The chances of that are probably going to increase over time. Climate change, urbanisation and global mobility are all increasing the risk of a new viral pandemic. The current model that we have, whereby bilateral agreements between governments and the pharmaceutical industry are prioritised and leftover supplies are given to those with lower buying power, has to change. It will change eventually. The question for us is whether we want to do it sooner rather than later. I feel that Ireland is in a really good position to stand up and take leadership on that now. We have to drive forward a new global vaccination distribution model that is centrally based and clinically prioritised. With the current model, pandemics will go on for longer and more people will die. Global health security is at risk.

Professor Aisling McMahon

I wish to respond and add to some of the points just made. Most people would agree that the current TRIPS status quo model has really failed low- and middle-income countries not just in the context of Covid-19 but also in other contexts, such as infectious diseases like malaria and other diseases where the incentives for innovation do not necessarily match the health need. On the question of current supplies, it is true that there are more supplies at the moment. That is a very good and positive thing. However, the difficulty is that when we look back at this, we see that in 2020 and 2021 when we were at the height of Covid-19, vaccines were being distributed on the basis of bilateral deals, not necessarily on the basis of health need. That is exactly how the TRIPS framework is set up. The problem, as Dr. Kelly has pointed out, is that if we have a new variant, the same is very likely to happen. The other issue is that even though there may be more vaccines in some states, as we have already discussed, many low- and middle-income countries want the ability to make their own vaccines so that they can have a secure and stable supply. Charity and donations do not do that. Indeed, many activists in the global south have highlighted that countries do not necessarily want to rely on charity or donations. They have their place. It is important to recognise the contribution of COVAX in the short term, in particular, but COVAX charity donations just do not provide long-term sustainable supply. The other point that we should be clear on is that Covid-19 is a global pandemic. It is probably the worst health crisis that we have faced in our lifetime, in terms of its global impact. The TRIPS waiver is being discussed in that context, and in a context where voluntary mechanisms such as C-TAP were suggested by the WHO. Sadly, they did not have enough support from states and industry to be successful. It is in that context that we are discussing mandatory solutions like the waiver. Let us be clear, IP is not the only issue. There are other issues as well. However, if we do not address the IP obstacles, we will not have those other solutions. That is what I would add.

Mr. Dimitri Eynikel

I agree that we cannot have a pandemic response based solely on donations. It is just not a feasible model. We need a stronger and more effective model. I want to go back to the principle that we are discussing here, which is basically to provide governments with the tools available to protect their populations in the middle of a pandemic. It is about telling them that they have the freedom to operate and produce the tools they need to protect their people. I hear, from the industry side, that there is a change of rules. Let us go back for a moment. What happened 20 years ago was that patent rights could be overruled with compulsory licensing. That principle was already there. As Professor McMahon explained, it was there in the Doha declaration and the TRIPS agreement. What happened afterwards was that the industry started to push for other tools to protect its intellectual property, by protecting the data related to the products and protecting the trade secrets on how to produce certain complex products etc., in addition to the patents, which was not so much the case 20 years ago. There was a change in the rules that happened over those 20 years, with additional protections. These are exactly the barriers we are discussing today with the TRIPS waiver. We are saying that compulsory licensing is a valuable tool, but it falls short because there are other elements that have been added over the course of the 20 years that make it more and more difficult to reproduce some of these medicines when they are needed. That is where a waiver for a certain period of time will cut through the red tape. Countries will be able to produce and supply the medicines, and import and export any tools and raw materials as well. The issue of raw materials has been brought up. It also falls under the same category. The waiver will resolve the raw materials issue as well.

There is a genuine concern we will find ourselves back in another pandemic situation, where we were in 2020-2021, which is that the global south was prioritised for whatever reason. Perhaps "prioritised" is the wrong word but there is no disputing the facts and the evidence on the levels of vaccination. If that is repeated in respect of the level of treatment, we will see low- to middle-income countries fall even further behind. That is not a space any of us should be looking to get into.

I have a question for Mr. Clarken. There is a view we should not be having this discussion here and that it is not a matter for the Committee on Enterprise, Trade and Employment. I think it is, but sure what would I know about it. Our witnesses are the experts. Perhaps they might be able to enlighten us on this. It is up to the Chair and I again thank him for facilitating this debate. On where this issue now goes, where does the decision lie with Government? Who is the senior and chief decision-maker and to whom should we be speaking if we are persuaded that a change in rules, a temporary suspension or whatever might be a good idea?

Mr. Jim Clarken

I thank the Deputy very much for her question. Before I get to that answer, on this constant referring to the big threat to pharma created by this, the reality is that pharma has never seen profits like it has seen in recent years, and many new billionaires have been created in the pharma industry. While it did extraordinary work and everybody wants to give the credit for it, the idea that somehow this temporary waiver which we keep reiterating, which is a waiver based within a rules-based system that already exists, will somehow greatly and detrimentally damage pharma and the development of medications into the future is just not believable, to be perfectly honest. I give tremendous credit to the industry to adapt, evolve, move within the spaces that are there, and make profits, because is what it does. There is nothing wrong with that. Let us just not keep knocking that one back that it will somehow lead to devastation of the industry. It will not.

On the question that this must be on a human rights and health needs basis rather than some charitable act where, when we are ready to provide vaccines to poorer countries, we will, we know what happened at the start of this. Wealthy countries raced to push others out of the way to get as many vaccines as they could, even fighting among themselves, let alone with countries in the global south. We cannot have a system that allows that to happen again because everybody will be affected.

Let us remember that even from a self-interest point of view, which should not be the way we think about these things, the longer this goes on, the greater the possibility of new variants arising and the more it will affect everybody. Even economically, if that is the way one wants to look at it, the International Chamber of Commerce reckons that $9.2 trillion is going to be lost because of the pandemic and because of our inability to get our hands around it fast enough. This will roll on and on. The countries we are talking about are vital countries for us and for the world. I am just putting that argument, which would not be of our core argument, just to put it out there.

On this issue, Ireland has traditionally shown tremendous leadership and courage. We were speaking to our colleagues at the UN Security Council earlier this week about the work they are doing in pushing into very difficult spaces and trying to resolve issues by using the Irish moral standing and respect the country has across the world to push agenda items. Here is another one where Ireland can make a difference. We know it is a European decision, but to answer the Deputy’s question directly, it will be decided by the trade element of Government, and in this case the Minister for Enterprise, Trade and Employment, Deputy Varadkar, will be the representative in that space. This is the right place as far as we are concerned to be discussing this issue and I know the Chair appreciates that.

We emphasise that if every country sits back and waits for this to happen, it will not happen. Ireland can make a difference, is very credible, has deservedly built up this very strong reputation, has sacrificed as a result of it and is willing to do so. We plead with the committee to urge the Minister and the Government to make a decision to support the TRIPS waiver or the elements to it that are essential in order for vaccines to be created locally to give that autonomy of supply to ensure the rest of the world will be vaccinated. There is no doubt in my mind that we will be waiting for years if we are to continue on the current basis. We have a solution. It is not perfect but we know it can work. We have the examples of what happened in the past where a transformation can be made when the political courage is there. We plead with the committee and the Government to move, to agree to the TRIPS waiver and to bring its voice to the table in Europe to try to have it change its position also.

Does Deputy Stanton wish to make further brief contribution?

Very briefly, I will refer to a number of things. On the final point as to whether we are the correct committee to deal with this, I note the Department has issued a note stating we may not be. Perhaps our secretariat could check that out. I believe the Department is saying it is the Committee on Health that should be dealing with this, which is somewhat frustrating if that is the case.

I also refer to the letter from Africa, which has been referred to more than once, mentioning that delivery be stalled. That seems to be on a separate track to the production and availability because that leads to what we discussed earlier about hesitancy, supply lines and so forth, which needs to be sorted out in any event. Would it be in order, Chairman, for a copy of that letter to be sent to the committee?

It has also been said that there are 100 experienced manufacturers all over the world who say they can start manufacturing the generic versions. It would also be useful for us to get a list of those various manufacturers and locations.

Mr. Oliver O'Connor

In response to Mr. Clarken, the industry is not using words like “devastation” nor is it raising scares and fears and all of the rest of it. We are inviting the committee to consider that a change in incentives or in intellectual property rights may cause a change in the likelihood of capital being invested to invent, create, deliver, manufacture and provide vaccines and other medicine solutions in pandemic situations. We have as evidence a study by the European Patents Office, EPO, to show that in its view and analysis there would be a diminution, and quite a serious one, in investment in this area. We work very closely in every country and in every medicine to deliver human health. If we do not deliver human health, there is no business for pharmaceutical companies. In that respect, we support and deliver human rights. There is no opposition within the pharmaceutical industry to human rights or to human health. We are not in the business of raising barriers to the delivery of healthcare solutions here in Ireland or globally, and we want to work on that.

To answer Deputy O’Reilly’s question, we are certainly not saying that everything should stay the same. There will have to be new solutions, but we invite members to consider the critical role of intellectual property rights in the discovery, development, production and delivery of the solutions we seek to massive healthcare problems at all times and to be very careful about protecting those rights. I have heard it mentioned that there is no incentive for malaria or that it is insufficient. Our principal point is that if you diminish incentives, you will diminish the results that you are seeking to achieve. That is very important.

That is our position and we hope we are being respectful and are not exaggerating, and we are certainly not threatening anyone. We want to be involved in human health. We are, I believe, and we have certainly been involved in the delivery of new solutions and in the development and delivery globally of vaccines and therapies for Covid-19.

Mr. Dimitri Eynikel

The monopoly rights the industry pursues globally affects the access to treatments today, as I have said before. I can give a concrete example. Pfizer has in fact lobbied on the Covid-19 Bill, as it has also been described in the media. It is applying for patents worldwide and has signed a voluntary agreement for generic production, which is good for certain countries. The supply at Pfizer itself has been bought up almost until the end of the year. Half of the world does not have access to the generic production. That means this other half of the world has almost no access to any supply at all. That is very problematic, obviously, for a disease that is so lethal at this stage and is still being widely transmitted.

I can give another example of a Roche drug that is given to severe Covid-19 patients. There is a severe lack of supply. Médecins Sans Frontières tried for several months to place an order with Roche and never succeeded so we did not get access to the treatments because of a lack of supply. Where it is available, it is over $700 per treatment in India, which is a huge amount for people there to pay. I could go on for a list of treatments and vaccines. That is one element. The case is there. It is definitely needed. We are 100% certain of that.

I disagree with the lack of incentives. There is no discussion about lack of incentives. There are more discussions about future incentives so I do not think there is any risk in that regard. Negotiations have also gone forward. Discussions are materialising within the WTO about a potential outcome. Unfortunately, the discussion that is on the table is a completely watered down version of the original TRIPS waiver that is very weak and not very effective and puts at risk some of the public health safeguards referred to by Professor McMahon. We are particularly concerned about it. We call for Ireland to support the original TRIPS waiver, in particular to ensure that the essential elements of it are maintained throughout the negotiations.

Professor Aisling McMahon

I will comment on the role of intellectual property rights. I disagree regarding the incentive intellectual property represents. Traditionally, it has been problematic in the vaccine context for various reasons. More broadly, while intellectual property rights exist, other human rights also exist. Many UN committees have already considered the impact of lack of access to vaccines on low- and middle-income countries. Many of them have highlighted that we also have the right to health and life and we also have a duty to co-operate at an international level. Many of those committees have highlighted that companies and states should not block a comprehensive waiver if there are global access issues in this context and there are.

At the international level, we see the human rights obligations that companies and states have. In 2021, the International Commission of Jurists, a group of over 85 experts, highlighted that states that continue to block a comprehensive global waiver are in breach of several of their obligations under various international human rights treaties that go beyond intellectual property rights. We have obligations under the WTO at an intellectual property level but we also have human rights obligations, which we are likely to continue to be in breach of by not supporting a waiver and certainly by obstructing discussions in this context. It is important to also recognise those issues in this context.

That concludes our consideration of the matter. I thank all the witnesses. A significant number of groups wished to attend and we received a significant number of submissions, which we condensed into a paper we circulated to members. Following today's meeting, with the agreement of the committee, we will write to the Tánaiste and Minister for Enterprise, Trade and Employment to express our views on how to progress this matter. I propose that the committee go into private session to consider other business. Is that agreed? Agreed.

The joint committee went into private session at 11.44 a.m. and adjourned at 11.55 a.m. until 9.30 a.m. on Wednesday, 18 May 2022.