Big pharma companies warn against loosening rules on intellectual property

Patients and Europe’s medicines industry will suffer under EU plans to weaken intellectual property rights, the pharmaceuticals industry body has warned.

The European Commission will publish a new pharmaceutical strategy later this month, with a focus on improving affordability and access to new medicines across the EU which the industry expects will involve some reform of EU intellectual property (IP) rights.

Speaking ahead of its annual conference in Dublin, Oliver O’Connor, chief executive of the Irish Pharmaceutical Healthcare Association (Ipha) said EU policy needed to support the IP rights that are required for the development of new medicines.

“We need robust IP rights to incentivise investment in the development of innovative new medicines and clinical trials aimed at delivering better outcomes for patients with life threatening diseases and other serious medical conditions.”

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Ipha says the new EU strategy comes at a pivotal moment as Europe “struggles to regain the ground it has lost to the US and China for cutting-edge science and investment”.

It noted that Europe now accounts for just one in five new medicines, down from half in 1990, adding that where the US spent $2 billion more on pharma R&D back in 2002, it now spends $25 billion more. China, the industry group said, had seen employment in its pharma sector explode by 800 per cent since 2021.

The industry believes it can offer solutions on access and affordability without loosening IP rights, saying that measures already proposed could deliver results by next year.

“By contrast, the proposed changes to IP rights would have the immediate effect of degrading the European environment for long-term investment and it would be well into the 2030s before they delivered any potential impact on national health systems,” Ipha warned.

Ipha president Michael O’Connell said the industry was Europe’s largest high-tech industry, employing 840,000 and investing €42 billion each year in European R&D.

“We are calling for Government support to unlock its health, innovation and economic potential,” he said. He welcomed proposals for Minister of Health Stephen Donnelly to establish a working group where all stakeholders can look at new ways to improve the delivery of innovative medicines for patients.

The initiative comes after a report by Mazars found that more than a third of all new drug approvals take more than two years to complete, despite a legal requirement allowing 180 days for the process, unless additional information is required from an applicant.

The report was published last week by the Department of Health over two years after it was submitted by the consultants.