Better health and economic prospects depend on the right policy environment, writes Bernard Mallee
Recent figures showing buoyant tax revenues demonstrate the resilience of the economy during the pandemic. As some of the domestic sector struggles, the economy’s overall performance is strong. The biopharmaceutical industry, alongside technology, were major contributors to a corporation tax take of more than €15 billion last year. These revenues, up almost 30% on 2020, are helping the country to come through a crisis.
Covid-19 has been harrowing, with sickness, death and disruption brought to so many lives. But with vaccines and, soon, treatments helping to manage the severity of the disease, and a buoyant economy, there is cause for cautious optimism.
The public’s take-up of Covid-19 vaccines, and the speed of the vaccination roll-out programme, are exemplars for the world. After bringing forward safe and effective Covid-19 vaccines in record time and working on promising new treatments, the global biopharmaceutical industry has achieved a historic scale-up of vaccines manufacturing. In a single year, the industry produced 11.2 billion Covid-19 vaccine doses. By June this year, that figure is expected to reach 24 billion doses.
Ireland is a major medicines manufacturer. The biopharmaceutical industry is spread across the regions, supporting tens of thousands of jobs and generating tens of billions in gross value added for the economy. When the pandemic hit, globally, borders closed, export restrictions arrived and air freight options disappeared. At the same time, demand for some medicines increased exponentially. The global medicines supply chain, with significant parts of it based in Ireland, endured. Patients still got their medicines.
The biopharmaceutical industry, including in Ireland, is investing heavily – from modular manufacturing to cell-based and mRNA technologies. A commitment to sustainable environmental practice characterises expansion plans. The right policy environment is key to drawing new investments and retaining the strength of the existing manufacturing base. Maintaining diverse global supply chains is vital. We source 76% of active pharmaceutical ingredients from inside Europe. The European Union is the world’s largest exporter of medicines, with a market share of 64%. We must avoid blunt instrument policies like ‘reshoring’ that would jeopardise supply chain resilience.
Research and development leads to innovation. Innovation leads to first-mover advantage in advanced production. This is the cycle that supports a jobs-rich industry in Ireland. It is the catalyst for the discovery of new treatments, vaccines and technologies that help sick people.
The cycle of biopharmaceutical innovation is coming under threat. In the 1990s, Europe was the primary destination for research and development. Now, the US occupies that position, with competition intensifying from China, other parts of Asia, Switzerland and the UK.
A review of legislation by the European Commission is key to the future of the biopharmaceutical industry. It is an opportunity to create a pro-innovation policy framework. But there is a risk that, handled badly, it could damage Europe’s attractiveness for biopharmaceutical manufacturing investments, just as some research and development activity has migrated to other global markets.
Under the EU Pharmaceutical Strategy, two key intellectual property rights are in the spotlight – the Paediatric Medicines Regulation, adopted in 2007, and the Orphan Medicinal Products Regulation, adopted in 2000. Intellectual property protection is the basis for the discovery and development of all medicines, vaccines and technologies. Under the Paediatric Medicines Regulation, over 260 medicines have been developed for sick children, with an increase of 50% in clinical trials between 2007 and 2016. Under the Orphan Medicinal Products Regulation, more medicines have arrived for rare diseases. Ireland, through our access to channels of diplomatic and political influence, should press for the protection of the global patents system. With our outsized exposure to a thriving biopharmaceutical industry, it makes sense for us to side with innovation.
We are living in the ‘bio-century’. This is a period characterised by scientific breakthroughs, with the discovery of new medicines catalysed by the intersection of a better understanding of human biology and the new tools of technology, artificial intelligence and machine learning. The shared experience of creating vaccines and treatments for Covid-19 is having a spill-over impact on the development of other medicines. mRNA vaccines, for example, are key in tackling Covid-19. But the technology can be engineered to treat other viruses and diseases, including cancer. More than 18,000 medicines are in development, including cell and gene therapies. For people working in the biopharmaceutical industry, or for students weighing their career options, this is an exciting time.
We recently finalised a four-year medicines supply Agreement with the State. In October’s Budget, the Government allocated €30 million for innovative new medicines, building on €50 million in the previous Budget. With 35 new medicines expected to be proposed this year that would treat a range of medical conditions, patients have the prospect of better health outcomes.
In recent years, our industry has adopted a brand purpose – innovate for life. Although it is the name of our flagship film-led digital campaign, it is more than a slogan. It means our work changes lives for the better. It means, too, that innovation is a life-long endeavour. It is relentless; it never stands still. Scientists tell us to expect more regular zoonotic contagion and many diseases still challenge us to find answers. With the right policy environment, there is hope for human health and for the economy.
Bernard Mallee is Director of Communications and Advocacy at the Irish Pharmaceutical Healthcare Association.
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