Bayer's pharma chief hopes EU takes time to improve drug rules reform

By Ludwig Burger and Patricia Weiss

FRANKFURT (Reuters) - The European Union's decision to postpone rule changes for the pharmaceutical industry could open the way for a rethink of a decision to cut intellectual drug property protection, the head of Bayer's pharmaceuticals division said.

The European Commission said this week that the publication of a first draft of a planned revision of drug legislation in the bloc would be "slightly later" than March 29, as initially planned.

A version that was leaked earlier this year showed that Brussels was preparing to shorten an additional period of intellectual property protection, known as data exclusivity, which comes on top of drug patent protection.

"I hope that this delay means that there is an opportunity that this draft ... is not the final version," the head of Bayer's pharmaceuticals business, Stefan Oelrich, told Reuters on Friday.

"The duration of data exclusivity, which may be reduced, could actually have a catastrophic impact for Europe," he said.

Shaving one or two years off the exclusivity period could mean that pharma companies pull the plug on certain development projects for the region, he added.

He said the intentions of Brussels lawmakers - improving patient access to innovative drugs while making the European pharma sector more competitive - were noble but any shortening of intellectual property protection would have the opposite effect.

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'HIGHLY ATTRACTIVE'

In the United States, a different set of drug market rule changes are underway, with some of the highest-selling products set to see negotiated price discounts under the Inflation Reduction Act (IRA).

Oelrich said even so the U.S. market would remain "highly attractive, relative to Europe".

Bayer is looking to boost the U.S. share of its global pharmaceuticals sales, now at about 25%. Among the biggest drivers was the company's decision to prepare a U.S. launch of its next-generation stroke prevention drug asundexian on its own.

With asundexian, which will likely see pivotal trial results in 2025 or 2026, Bayer is seeking to follow up on the success of its blood thinner Xarelto, a drug for which the company ceded most of the U.S. rights to partner Johnson & Johnson.

But Oelrich said upcoming U.S. legislation to regulate the prices of best-selling drugs after nine years or 13 years, depending on the drug category, would have an affect on the industry's strategy to develop several uses for a given drug, known as indications.

The IRA could "have an impact on whether additional indications are to be developed for certain products. People will look into whether they bring this forward or just refrain from further development" said Oelrich.

(Reporting by Ludwig Burger; editing by Jonathan Oatis and Jane Merriman)