Pharmaceutical sector – how to truly achieve strategic resilience

By Cristian-Silviu Busoï, MEP (EPP Group – Romania), Chair of the ITRE Committee

A strong Union needs a strong industrial sector to promote competitiveness, create jobs and guarantee a high quality of life. And the EU must support the development of sectors that are of strategic importance for Europe’s industrial future, the pharmaceutical sector being one.

In my view, the research & development pharmaceutical industry is an indispensable and critically important industry that the European Union must not do without. The industry in Europe is uniquely placed to play a key role in our economic recovery, our resilience and future growth, but only if the drivers of innovation are in place, and if the appropriate financial support will be accompanying the upcoming legislative frameworks.

COVID-19 crisis has clearly proven European Union’s need for well-defined and adequately-financed policy instruments, and this is what I envisage also for the upcoming pharma package review.

But COVID-19 has revealed also shortages in the supply of equipment in hospitals, has deepen medicines shortage and has revealed the need to reduce the EU’s external dependencies also in the pharma sector.

Moreover, the pandemic has highlighted the need for boosting innovation and investing more in health in general.

The pharmaceutical industry employs 830,000 people in Europe, and directly contributes to more 100 billion euros to the EU economy. Sustaining and growing pharmaceutical investment in Europe depends on creating a policy framework that supports the evolution of the region’s innovation and manufacturing ecosystem and an industrial strategy that ensures Europe remains competitive in the face of intense competition from other regions.

It’s a long-term decision as to where innovation will occur. Will this take place in the Union or outside? And where innovation happens matters. It matters for jobs, resilience and economic growth and last but not least to patients, to health systems in Member States and across the EU. Innovation is not an abstract concept, it means new diagnostics, treatments and vaccines that can transform the lives of patients and protect whole populations.

The EU now has an opportunity to answer to these global challenges but for that, a holistic EU approach is needed for the EU’s pharmaceutical, industrial and trade strategies in coherence with other EU initiatives, like the Intellectual Property Action Plan.

These EU strategies are opportunities to drive Europe’s Health and Growth. They are necessary to compete with other regions in the future in the development of new medical technologies and bringing innovation to EU patients and health systems.

For the research-based industry in Europe that means; an intellectual property framework that protects investment in medical research in the EU and globally, a research infrastructure that helps deliver the next generation of health innovation, a regulatory framework that is stable, fast, effective and globally competitive and faster, more equitable access to innovative treatments for patients across Europe.

We have successes to build on: over the last decades, we have seen the pharmaceutical industry respond to the incentives put in place at EU level, and this precedent should be the basis of how we ensure the industry continues to direct research and innovation in the areas we, as societies, need most. Particularly the EU legislation on medicines for rare diseases and paediatric medicines has been a success story which we should be proud of as Europeans and look to build on.

As we have seen during the COVID-19 Pandemic, when there are vital issues facing our populations, we need vital EU industries to be able to respond effectively. We should focus on how to make sure the Union continues to play a leading role in vital industries, so as to truly achieve strategic resilience. This includes setting an EU research agenda and the prioritisation of R&D in areas of societal interest to the EU, be it anti-microbial resistance (AMR), neurodegenerative disease or rare and paediatric conditions to name a few.

Sustaining and developing pharmaceutical investment in Europe is contingent on creating a policy framework that supports the evolution of the region’s innovation and manufacturing ecosystem and an industrial strategy that ensures Europe remains competitive in the face of intense competition from other regions.

The COVID-19 crisis has underlined the inextricable link between our health and our economic prosperity.

In my view we should focus, in terms of policies on: strengthen global supply chains and keep them open; reduce import dependencies by diversifying sources of supply, and create incentives for R&D and production in the Union in order to reduce dependencies on long-term.

These policies will increase the EU’s agility, competitiveness and pandemic preparedness and help the EU to maintain its attractiveness as a global trade hub. The new EU ‘Open, sustainable and assertive trade strategy’, revised EU industrial policy and EU pharmaceutical strategy have the opportunity to all contribute to these goal.

We must all work together to ensure that Europe remains a world leader in pharmaceutical innovation for the benefit of European citizens. We have a once in a generation chance to future-proof and streamline the pharmaceutical regulatory environment. For that we need all stakeholders around the table and put forward proposals based on data and facts.