Novo Nordisk warns EU that new rules will push it to expand faster in US

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Novo Nordisk, Europe’s most valuable drugmaker, will accelerate its US expansion at the expense of the EU unless Brussels changes a plan to reform regulation of the industry, the company’s chief executive has said.

Lars Fruergaard Jørgensen said much of the Danish company’s research was now done in Boston and “the journey of expanding in the US would be further accelerated” if the EU implemented its new pharmaceutical rules that would cut drugmakers’ years of market exclusivity.

Jørgensen, president of EFPIA, the industry association, spoke on Friday as he launched a study outlining the dramatic impact the plan would have — creating what he called a “negative ecosystem”.

The report by Dolon, a research firm, found that pharmaceutical research and development in the EU would drop by €2bn annually, with about 50 out of 225 expected new treatments forecast to be undiscovered over the next 15 years because they would not be economically viable. 

Novo Nordisk, which makes weight loss and diabetes drugs Wegovy and Ozempic, said innovation increasingly came from smaller start-up companies that would struggle to get funding if the new plan was adopted.

The industry is concerned by a cut in the number of years of market exclusivity — the period before a drugmaker faces competition from generic manufacturers — from 10 to eight years.

Under the new rules, companies will be able to regain two years if they make new medicines available in all 27 EU member states within two years of approval. This is currently rare because poorer and smaller countries cannot always afford them.

They will also be able to win an extra two years of exclusivity by fulfilling certain conditions, such as addressing unmet medical needs, running comparative clinical trials or creating drugs that treat more than one condition.

However, the Dolon report found that because companies would assess possible returns on the shorter, guaranteed period of exclusivity they would back fewer drug ideas, or develop them elsewhere.

The report predicts the EU’s share of global R&D investment, already falling, would reduce by a third by 2040, from 32 per cent to 21 per cent.

Jørgensen said many of Novo’s new medicines were already being developed in the US at its Cambridge, Massachusetts, campus near Boston. “When we start clinical development, we start in the US. When we start commercial activity, we always start in the US. 

“And the success in the US means that we are slower getting going in Europe because it’s just less attractive.”

North America accounted for half the company’s sales in 2022, twice as much as Europe, the Middle East and Africa. Earnings in North America grew 21 per cent year on year, compared with 15 per cent in Emea. 

That trend will accelerate if the reform is adopted, he said. 

“If it leads to fewer products in Europe, it means fewer clinicians involved in clinical development of new science and it will mean fewer key opinion leaders based in Europe,” he said, referring to senior clinicians who influence best medical practice.

“And it also means that there would be fewer spinouts from universities and less biotech. So this negative ecosystem means that there would be a further acceleration out of Europe. And we’ve already seen that Europe is missing out on clinical development.”

A commission spokesman said:  “We provide the most generous regulatory incentives [in the world]. Our reform will keep an advantageous regulatory protection regime for innovation, and reward especially companies that ‘go the extra mile’ to provide EU-wide access to new products.”