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Current crises have highlighted the vital want for Europe to safe and strengthen its place as chief in medical innovation. Because the European Fee works on the following Pharmaceutical Technique, we have to guarantee Europe has the fitting surroundings to convey the following technology of therapies to sufferers. The problem for the approaching a long time is just not if medical innovation will occur however the place it’s going to occur. This text is a part of a sequence explaining that the place innovation occurs issues for sufferers, well being care techniques, the analysis neighborhood, jobs and the economic system.
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On December 13 2021, I used to be out within the chilly air, with a spade in my hand. Having grown up on a farm in Jutland, Denmark, this can be a acquainted feeling for me. However the circumstances that day have been very particular. I used to be breaking floor in Kalundborg, a port city on the Danish island of Zealand. The corporate that I lead, Novo Nordisk, opened a manufacturing unit there in 1969 with 5 buildings. Issues have modified since then, with the positioning using greater than 3,200 folks, and producing about half of the world’s insulin[1].
Issues are about to alter even additional: once I picked up that spade in December, I used to be breaking floor on new services that may contain over 17 billion Danish krone of funding (over €2.2 billion). It’s the greatest complete funding we now have ever introduced. It would assist meet rising demand for our medicines, whereas state-of-the-art manufacturing applied sciences will assist cut back their environmental footprint. Clearly, we’re prepared to take a position right here in Europe.
However Kalundborg wasn’t the one place that Novo Nordisk made a big new funding final yr. We’re establishing a brand new heart for the appliance of synthetic intelligence in drug discovery, at our R&D website in Seattle, U.S.
We’ve additionally invested extensively lately, establishing our analysis and manufacturing capabilities for cell therapies, primarily in California and New Hampshire. The competitors for expertise there may be intense — however there is no such thing as a substitute for the experience we discover within the world-leading ecosystems for digital know-how and regenerative biology.
Subsequent yr, the European Fee will launch essentially the most vital assessment of pharmaceutical laws in a technology. You’ll hear some voices speaking up Europe’s main place in prescription drugs — and others claiming that Europe is doomed to fall behind the U.S. and China, with their enormous scale of scientific funding. Because it stands, each claims have components of reality. We shouldn’t be hopeless — however we should not be complacent.
The current and way forward for a strategic industrial sector in Europe
Prescription drugs signify the biggest share of the EU’s exterior commerce surplus, reaching €118 billion in 2020[2]. Over 830,000 individuals are immediately employed within the sector in Europe. And the sector remains to be rising: pharmaceutical exports from the EU greater than doubled between 2010 and 2020, greater than some other R&D-intensive sector. Employment in our sector in Europe grew by greater than 15 % in the identical interval[3]. Our R&D and manufacturing added greater than €116 billion of gross worth within the EU in 2019[4]. This place has developed over a long time: our capital investments in R&D and manufacturing are made with lengthy time-horizons, and our individuals are our biggest useful resource.
However these lengthy time-horizons, and international competitors for expertise, imply that in the present day’s robust efficiency might be masking a special future. At present, the U.S. is the middle of worldwide pharmaceutical innovation. Approval occasions for medicines are persistently quicker there than within the EU[5], that means sufferers there profit from innovation sooner. Company pharmaceutical R&D expenditure is rising in Europe, however is persistently outpaced by the U.S.[6] The state of affairs for funding in early-stage firms is especially regarding: in case you are an innovator in want of capital, you’ll be way more prone to go to Boston or California than wherever within the EU. China’s progressive capabilities are additionally increasing, with biotech a serious precedence within the Made in China 2025 technique. Between 2018 and 2020, seven out of 10 of the biggest biopharma Preliminary Public Choices originated in China[7].
In the meantime, European populations are growing older, with an rising burden of great persistent illnesses. New international well being threats will emerge. Evidently, Europe wants what our sector is ready as much as provide. Thankfully, the convergence of advances in information and organic science imply we now have unprecedented potential to deal with these challenges — as proven by the exceptional velocity of improvement, regulatory approval and mass manufacturing of COVID vaccines — a big proportion of which has occurred right here. A thriving pharmaceutical sector within the EU is thus important to help well being resilience for the inhabitants.
In these circumstances, the EU wants a regulatory framework for medicines that’s match for the long run. With the forthcoming revision of the pharmaceutical laws, we now have the possibility to make it. However the regulatory surroundings is just one a part of our ecosystem, between analysis and the market. Resilience begins with analysis, and nice analysis wants a viable market whether it is to profit folks. Antimicrobials is one space the place market situations have led to a catastrophic decline in analysis. We don’t need to see different illness areas go the identical method. In one other industrial sector, semiconductors, the European Fee is proposing a ‘Chips Act’ to draw manufacturing again to Europe. Let’s make sure that we by no means get to that stage for medicines. I’m anxious: many European policymakers nonetheless see medicines extra as a finances value, than as an funding of their folks and economies. However I nonetheless have hope that we will make the fitting coverage decisions — that’s the reason I’m participating on this dialogue now, and have taken on the function of vice chairman of EFPIA, the progressive pharmaceutical affiliation for Europe.
In 2023, Novo Nordisk will have a good time its centenary. I’m a short lived custodian of this foundation-owned firm — and solely the fifth in all that point. Our innovation and every day work profit sufferers, job creation, and the broader economic system within the EU. At present, Novo Nordisk employs over 22,000 folks within the EU. We provide diabetes medicines to greater than 34 million sufferers worldwide, and round 5 million within the EU. I consider these numbers can develop additional — however this isn’t assured. When future generations of pharmaceutical leaders choose up a spade, will they be breaking floor in Europe?
[1] Our heritage | Novo Nordisk | Driving change
[2] EUROSTAT worldwide commerce in items information
[3] EFPIA Business in Figures 2021, p.13
[4] Eurostat annual detailed enterprise statistics for companies and industries
[5] CIRS, RD Briefing 70, New approvals in six regulatory authorities 2009-18
[6] EFPIA Business in Figures 2021, p.5
[7] McKinsey, The Daybreak of China Biopharma Innovation, 2021
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