This is an exciting time for medicine innovators

Cork’s biopharmaceutical industry is a national geo-strategic asset, writes BERNARD MALLEE, Director of Communications and Advocacy at the Irish Pharmaceutical Healthcare Association
This is an exciting time for medicine innovators

 Pfizer’s plant in Ringaskiddy, Co Cork. Picture; David Creedon

CORK’S research-based biopharmaceutical industry is strong. A county once fêted for making cars, ships, tyres and textiles is now among the most consequential medicines manufacturers in Europe.

Companies like Pfizer, Johnson & Johnson, Eli Lilly, Novartis, MSD, Merck, AbbVie, Gilead, LEO Pharma, GSK, Thermo Fisher and BioMarin directly employ around 10,000 people locally.

In Ireland, the latest count from consulting firm PwC puts the jobs figure in the biopharmaceutical industry at 45,000, with gross value-added to the economy of €15 billion. These figures are likely to underestimate the economic impact since they were taken before the pandemic.

The most recent Government figures for how the economy performed last year show a corporation tax take of more than €15 billion.  Revenues were up almost 30% on 2020. The biopharmaceutical industry, alongside technology, were major contributors to that performance.

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. There is a case to consider the biopharmaceutical industry as a geo-strategic asset.

We are living in the ‘bio-century’. This is a period characterised by profound innovation, 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. 

This is an exciting time for medicines innovators and for students weighing their career options.

Across the industry, demand for skills is high. We want people with knowhow in a range of areas, including biotherapeutic research, bioprocess design and operations, bioanalytics, engineering, chemistry, toxicology, regulation, licensing, commercial operations, digital marketing, and public policy and reputation. We want people with a mix of technical, teamworking and strategic thinking capabilities. A globally networked industry, with a mandate to translate science for the public good, should interest a generation yearning to make a difference in the world.

This year, innovators will propose about 35 new medicines for a range of medical conditions, including arthritis, multiple sclerosis, psoriasis, spinal muscular atrophy and many forms of cancer. These medicines could treat almost 17,500 patients. 

The industry 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. These measures mean patients can hope to have better access to the latest treatments. Much credit is due to Cork’s Cabinet members - Micheál Martin, the Taoiseach, Michael McGrath, the Public Expenditure Minister, and Simon Coveney, the Foreign Affairs Minister - and to Leo Varadkar, the Tánaiste, and Stephen Donnelly, the Health Minister.

We still face headwinds. We need to improve our attractiveness for clinical trials, build our scientific research base, and position as a destination for production and supply chain investments in cell and gene therapies, as well as their adoption for patients.

Even though the biopharmaceutical industry is investing heavily, especially in manufacturing, there are moves, in Europe and globally, to potentially undermine the patents system. 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.

The review of legislation by the European Commission is an opportunity to create a pro-innovation policy framework. 

Handled badly, it could damage Europe’s attractiveness for biopharmaceutical manufacturing investments, just as some research and development activity has migrated from Europe to other global markets. Ireland, through our access to channels of diplomatic and political influence, should have a leadership role in the protection of the global patents system.

We must resist, too, efforts to interfere with free and open trade that is so crucial to the global supply chain for medicines. 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. It has served us well during the pandemic, with no significant medicines shortages.

Similarly, with the industry expected to have produced 24 billion doses of Covid-19 vaccines by June, wealthier countries should share many more surplus doses with lower-income ones. A multilateral approach is needed in helping lower-income countries to absorb, distribute and administer Covid-19 vaccine doses to their populations. We need to empathetically deal with often high rates of vaccine hesitancy in these countries, too. Scientists tell us to expect more regular zoonotic contagion. 

We could face more Covid-19 variants. Other diseases demand new treatments and cures. Improving human health is a permanent campaign that depends on stable intellectual property rights.

Our industry’s brand purpose is ‘innovate for life’. Although it is the name of our flagship film-led digital campaign, it is much more than a slogan. It means our work changes lives for the better - and that innovation is a life-long endeavour. Let us make sure it stays that way.

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