Challenging the Degrading of New Medicines

Annual Conference assesses innovation pipeline and supportive policies

Proposals from the European Commission to weaken intellectual property rights will degrade the development and delivery of innovative new medicines for patients in Europe, according to the Irish Pharmaceutical Healthcare Association (IPHA).

“Making this a reality, not just for a few wealthy patients, but for everyone, requires a strategic partnership between the State, universities, research institutions and industry. It means ensuring adequate funding from Government is matched with an understanding from industry that there must be value for money in procurement. We need this to protect public funding for new treatments, orphan drugs and initiatives like the new Genetics and Genomics Strategy which I launched in December.”

The appraisal and approval process

IPHA, which represents the biopharmaceutical industry in Ireland, set out its position ahead of its Annual Conference, which took place in Dublin last month and the publication of the new EU Pharmaceutical Strategy later the same month.

It is urging the Government and other EU member states to request the Commission to amend its proposals and to back science, jobs and innovation by supporting the protection of the IP rights that underpin R&D investment and the scaled-up manufacturing of innovative new medicines in Ireland and Europe.

The IPHA Conference heard keynote speeches from Minister for Health, Stephen Donnelly, T.D., Tánaiste, Micheál Martin, T.D. and numerous industry experts. It explored the economic and clinical impacts of innovation, the promise of new technologies in the pipeline and the importance of supportive polices.

IPHA has described the imminent publication of the new EU Pharmaceutical Strategy as a key moment for European competitiveness and Europe’s struggle to regain the ground that it has lost to the US and China for cutting-edge science and investments. IPHA highlighted that:

• In the 1990s, half of all new treatments originated in Europe, that figure is now just one in five.

• In 2002 the US spent ¤2bn more than Europe on pharmaceutical research and development, today the US is spending ¤25bn more.

• Employment in the pharmaceutical sector in China has risen by 800% since 2021.

IPHA understands that the Commission has been motivated to overhaul the EU’s legislative framework for the pharmaceutical industry in a bid to improve affordability and reliable access to new medicines for less well-off member states. It believes that specific measures can be taken to assist these states in their national health systems, rather than changing Europe-wide IP rights.

It said that the biopharmaceutical industry has already brought forward proposals which set out how improving equity of access across the EU can be achieved by well-chosen, targeted initiatives and co-operative industry agreements. Such targeted measures can have an impact in 2024. 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 2030’s before they delivered any potential impact on national health systems.

Giving a keynote speech, Minister for Health Stephen Donnelly discussed the future of medicines, investment and the appraisal process.

The future of medicines and the need for partnership

Minister Donnelly stated, “Last year I visited the Texas Medical Centre in Houston. I asked the guy running it what the biggest changes were likely to be to patient care over the next decade. It will come as no surprise to any of you that he referenced personalised medicine – the ability to develop and deliver medicines tailored to individual patients, to identify tiny changes in a patient giving several years warning that they might develop a serious disease, and then intervene to stop it happening.

The Minister added that he wanted to see improvements in the transparency of the process and divulged that he has asked the HSE to bring forward proposals in that regard.

“I want to see greater engagement with stakeholders, including patient groups, to ensure that patients are aware of the process and have sight of various steps and timelines,” he said.

“I have asked the HSE to introduce an application tracker on their website, detailing how applications progress. I have also asked the HSE to introduce indicative timelines for a medicine to complete the application/ approval process.”

He added that an Implementation Group is being established between the Department of Health and the HSE to consider and progress the various recommendations contained in the Report as well as other options to improve the process.

“That Group will engage with stakeholders, including patient groups and industry, in seeking to bring about further improvements to the reimbursement process. That Group will also be open to new ideas.”

Future investment

“Of course, an improved and more transparent drug appraisal and approval process only matters if