IPHA and IDA Ireland slam EU for making US more attractive than Europe

By Chris Wheal

April 03, 2024

The US will take investment away from Ireland the EU.

Top brass at the Irish Pharmaceutical Healthcare Association (IPHA) and IDA Ireland have slated the EU’s clampdown on pharmaceutical and life science firms and medical device makers.

Eimear O’Leary, director of communications and advocacy at the IPHA told PharmaLifeScience the EU was damaging Ireland’s whole economy and the nation’s health.

“Europe falling behind in the global life sciences race negatively impacts our economic prosperity and strategic autonomy. But most critically, it also undermines patients’ timely access to innovation. Just 25 years ago, 50% of all new treatments came from Europe. Today that figure is just one in five (20%). Furthermore, the US conducts two times more clinical trials for cell and gene therapies, and China three times more,” she said.

Damaging investment

O’Leary warned: “In the past 20 years, Europe has lost a quarter of its global pharma investment, while research has also moved to the US and Asia. For example, in 2002 the investment gap to the US was €2bn; by 2022 it had increased to €25bn. Europe is also facing increased competition from China, which had three times higher growth of R&D spending between 2018 and 2022.”    

Lohan and the IDA are charged with tempting foreign investment directly into Ireland. He told London’s Financial Times (FT), that new rules proposed by last year and the 2017 restrictions on medical devices make the US more attractive to investors than the EU.

Michael Lohan, chief executive of IDA Ireland, was quoted in the FT saying that US regulation “has become more agile, more responsive”, while the EU “has moved in the opposite direction”. He warned: “That could impact innovation.”

MedTech Europe research

IDA Ireland confirmed to PharmaLifeScience that Lohan stuck by his FT interview. It flagged up the Future of Europe’s Medical Technology Regulations report from European lobby group MedTech Europe. That report warned that the Medical Devices Regulation (MDR) and the In Vitro Diagnostic (IVD) Regulation (IVDR) are killing the industry.

It said: “Structural deficiencies make the regulatory framework unpredictable, complex, slow and costly and create a growing vacuum for medical technology innovation within the EU market.”

MedTech Europe’s research found: “At least 17% of today’s IVDs and 20% of the MD product portfolios are expected to be discontinued in Europe due to the expectation that costs of the transition to the IVDR or MDR outweigh product revenue, particularly among SMEs”. 

It claimed: “28% of IVD manufacturers and 48% of medical device manufacturers are deprioritising the EU market (or plan to do so) as the geography of choice for first regulatory clearance of their new devices due to the unpredictability (time, cost, changes) of the IVDR and MDR.

No longer location of choice

IDA Ireland’s Lohan said: “Europe has lost its position as being the location of choice for new medical devices.”

Under the EU’s proposed new rules for the pharma sector, manufacturers would have to market new drugs in all 27 EU countries within two years. Failure to do so would cut the time they were safe from generic copies from 10 to eight years. The EU claims this will cut the price of medicines and make them more widely available – some companies do not get access fast enough, it reckons.

IDA Ireland’s Lohan warned this could damage research and delay life-saving drugs and technology getting to market.

Can be reversed

The IPHA believes the trend could be reversed. “The innovative biopharmaceutical industry relies on a strong and predictable intellectual property (IP) and incentives system. Europe needs to show it is serious about being a global life sciences powerhouse, attracting investments in complex and high-risk R&D projects,” O’Leary said.

“At EU level, we must make sure the regulatory framework and IP system send the right signals to potential biopharmaceutical innovators, by offering predictability and stability, reducing bureaucracy and showing that the European Union is open for investments.

“This can be achieved through the EU pharma package by increasing the Regulatory Data Protection (RDP) baseline, de-linking RDP from unimplementable access obligations; and providing internationally best-in-class IP rights for those investing in tackling unmet medical needs, rare and paediatric diseases, and anti-microbial resistance.”

O’Leary said Ireland’s pharma sector would work to make that happen. “Industry stands ready to play its part in creating a more competitive pharmaceutical ecosystem and we look forward to working with policymakers to ensure a competitive pharmaceutical sector which serves all our patients,” she said.

Is the threat of losing investment to the rest of the world just scaremongering or is your company considering the US or China as a better option? Let us know.