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.