Interview

Pharmaceutical innovation: Europe and the American challenge

Stefan Oelrich, President Bayer Pharmaceuticals and President Efpia, on the occasion of Bayer Italia's 125th anniversary: 'We need a change of mentality. The EU cannot only think about containing costs, it must invest in order to play a leading role in the healthcare of the future".

by Francesca Cerati

Interno e attrezzature della moderna fabbrica farmaceutica centro di R&S tecnologia

5' min read

5' min read

On the sidelines of the event for the 125th anniversary of Bayer Italia, celebrated in Milan with a special postage stamp issued by the Ministry of Enterprise and Made in Italy, we met Stefan Oelrich, President of Bayer's Pharmaceuticals Division, member of the board of Bayer AG and President of Efpia, the European Federation of Pharmaceutical Industries and Associations, to discuss the strategic issues affecting the European pharmaceutical industry, as well as the tariffs issue, which is at the centre of tensions between the US and the EU. According to Oelrich: "Imposing tariffs on pharmaceuticals would be a serious political and strategic mistake, which would break a fragile balance that has allowed for decades fair trade between Europe and the United States in such a sensitive sector. Medicines are not just any product: we are talking about public health. Using them as a trade lever would be short-sighted and dangerous. We must avoid a trade war on pharmaceuticals: the losers would not only be the companies, but above all the patients'.

In recent months, Bayer has invested around $250 million in a cell therapy manufacturing facility in Berkeley, California. How does this infrastructure fit into your US strategy, also in the light of new price constraints?

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It is a wonderful example of how important it is where innovation happens. The biotechnology facility we are building in Berkeley to produce pluripotent stem cells is a unique facility, which on a large scale exists nowhere else in the world. We decided to build it in the US because that is also where BlueRock Therapeutics, our company that invented these cells, is located in Boston. There was an industrial logic in creating production in the same place where the whole technology was born. And that is what makes the US market attractive: a cohesive ecosystem where innovation, capital and industrialisation are in the same place.

It is a perfect example of an innovation cycle that works: a cutting-edge technology is born in a US academy, developed by a biotech start-up, incubated in a big biotech, acquired by a big pharma like Bayer, and finally reaches production. This is what we need to be able to replicate in Europe as well.

In the light of Efpia's warning about Europe's 'non-innovation-friendly' environment, how does Bayer assess the impact of local and pan-European regulations on Italy's ability to attract pharmaceutical investments?

This is precisely the crux of the matter. I have just given you a positive example of a virtuous cycle between research, industrialisation and access to innovation. But in Europe we do not have the same ecosystem. Several fundamental elements are missing. We do not have a stock market comparable to Nasdaq, capable of providing capital to innovative start-ups. The European financial infrastructure does not allow for adequate capital allocation and risk-taking. Furthermore, drug prices are lower, intellectual property protection is weaker and regulatory approval times are slower.

A European strategy is needed to close these gaps. Today, only 20% of new drugs are created in Europe, whereas 30 years ago it was 50%. Yet we continue to publish as much academically as the Americans and the Chinese. The science is there, the bridge between academia and industry is missing. We must rebuild the value chain that Europe had and can get back to. We must aim to produce at least one third of the new global medicines. Europe was the pharmacy of the world, it can be again.

What role does Italy play in Bayer's global strategy today?

Italy is a key country for Bayer. It is among the most important European markets for our company, both for its historical presence and for its production and research activities. We are celebrating Bayer Italia's 125th anniversary here, and that says a lot about the solidity of our presence. We have important production facilities and we are also investing in research and development. Italy will continue to be an important part of our European strategy. And precisely for this reason, we hope that the regulatory and market conditions will be created to support innovation here as well. Because pharmaceutical innovation is not just an industrial issue: it is health, it is economy, it is strategic independence. Italy can play a leading role if it really wants to.

In this regard, what do you think of the payback mechanism?

The payback represents exactly what is wrong with the European system. It is almost paradoxical: the pharmaceutical industry invests in innovation, demonstrates with scientific evidence that new drugs bring clinical benefits and savings to the healthcare system, and then finds itself forced to pay back part of the revenues obtained. This is a huge disincentive to investment.

We are the only sector in the health system that is remunerated according to results. The more we innovate, the more we should be rewarded. Instead, the payback system penalises precisely those companies that bring progress. This feeds the idea - also widespread in the US - that Europe does not pay fairly for innovation. And if the value of innovation is not recognised, there is a risk of holding back scientific and industrial development.

Italy, in this sense, is unfortunately a negative example: between rigid spending caps, retroactive rescheduling and payback, the message that passes is that those who innovate are punished. A structural reform is needed to attract investment and enhance pharmaceutical innovation.

In an increasingly complex geopolitical and regulatory environment, what do you think will be the pillars to ensure sustainability, innovation and access to care in the next 5-10 years?

If we really want an innovative Europe, we must create the conditions for ideas to stay here. We must invest in our academies, encourage our young scientists to stay in Europe, provide them with the means to grow. Today, all too often, innovation is born in Europe but is developed and industrialised elsewhere. Why? Because in the United States there are strong stock markets, generous public funding, clear incentives. Think of the NICE: it funds fundamental research, rewards the best.

And in Europe? Are we doing enough? Italy, for example, should ask itself how much it is investing in its researchers. There is no reason why the next big technological leap cannot be made here. We have successful European examples: BioNTech was unknown until a few years ago. Or Novo Nordisk, today a world leader in the treatment of obesity. Innovation is unpredictable but it can change the world. That's why a strategy is needed: because innovation brings growth, prosperity and health. And Europe still has all the potential to play a leading role.

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