At the recent FT webinar, ‘Supporting Pharma Innovation in Europe’, high-level representatives from Roche, Bayer, and the European Commission weighed in on how European pharma’s competitive position on innovation is being challenged and the policy measures that need to be enacted to solve this issue. Read on for five key trends that emerged from the discussion.
Europe’s Strong Fundamentals
Sandra Gallina, director general for health and food safety at the European Commission (EC) outlined that the pharma sector is a major contributor to the EU economy, worth almost USD 25 billion, and an industry upon which thousands of European livelihoods depend. She added that 20 percent of all research spending in Europe goes into pharma but that “the sector needs to live up to its importance” and contribute more.
Stefan Oelrich, president of Bayer’s Pharmaceuticals division, was keen to highlight European science’s strength. Oelrich explained that the continent is responsible for 20 percent of scientific publications globally, on a par with China and ahead of the US. However, this is not yet being translated into a biotech sector as dynamic as that of the US, primarily due to vastly different funding mechanisms.
For Bill Anderson, CEO of Roche Pharmaceuticals, European pharma has “reasons for optimism” but Europe needs to better value innovation if it wants to be globally competitive. “Companies that are innovating tend to invest in the place where that innovation is most valued and reimbursed,” he noted, warning that as Europe attempts to draft a sophisticated industrial strategy to revitalise its pharma industry, it is in danger of overlooking the obvious – creating a welcoming regulatory environment for new medicines when they arrive.
Anderson also pointed out that the US medicine review cycle lasts 250 days compared to 400 days in the EU, but that this is not the end of the challenge. In many EU countries, the additional period post-approval before a medicine is covered by a healthcare system can add months and years onto the process.
The COVID-19 pandemic has reshaped the world in myriad previously unimaginable ways, and Bayer’s Oelrich feels that it also has the potential to shift how the pharma industry is viewed by public sector stakeholders. “Dialogue with policymakers has never been so intense, constructive and productive as in the past 24 months,” said Oelrich, adding that “when you fight a common enemy and speak to one another, that builds trust and a new level of communication. It is up to us to preserve this, build on it, and do more.” The EC’s Gallina echoed this sentiment, adding “There is a stronger realisation that it is extremely important to have a good relationship with industry, and I think it can be a win/win relationship.”
Although this wider understanding of the value that the pharma industry brings to Europe is welcome, Oelrich warned that once the pandemic is over, other political priorities will kick into gear, meaning that the opportunities available today must be seized.
The Clinical Trials Question
Pushed on why FDA-registered clinical trials heavily outnumber European ones, Oelrich explained that trials will logically be located close to their company sponsors and where value chains are established. Additionally, if a company is pushing for US Food & Drug Administration (FDA) approval for their drug, it makes sense to use US sites. Oelrich contended that market conditions in Europe need to be improved so that an approval from the European Medicines Agency (EMA) is seen as equivalent to one from the FDA.
Anderson added that Europe could improve its clinical trial bureaucracy to improve its global standing, giving the example of cancer trials where images have to be reviewed both at local sites and centrally, increasing costs time, and burden on patients. “Europe has led out on the review and approval of clinical trials and a single approach can streamline things and lead to better access,” he said. “Progress is happening and Europe is capable of leading, we need to come together with authorities and make more of it happen.”
Telling Pharma’s Story
Both Anderson and Oelrich highlighted European pharma’s opportunity, especially in the wake of COVID, to better communicate about its work and bolster its reputation, which in turn should help create a more conducive environment for innovation.
Pushed on what more pharma could be doing towards Environmental, Social, and Governance (ESG) goals, Anderson snapped back that these terms need to be defined more broadly. He stated that while tremendous progress has been made on issues like CO2 emissions, the industry’s biggest contribution is saving lives through vaccines and medicines and that there has never been a faster pace of innovation.
Bayer’s Oelrich supplemented that pharma is taking global inequality into account like never before, creating tiered pricing and access schemes for new innovations and continuing to invest in tropical diseases that do not occur in the rich world. “We need to tell our story a little better,” he admitted, which would strengthen links with policymakers in both developed and developing countries.