Clinical research is a “real opportunity” for Ireland but the sector needs more investment to ensure this potential is not squandered, believes the head of the country’s Health Research Board (HRB).

Speaking at last week’s annual meeting of the Irish Pharmaceutical Healthcare Association (IPHA), HRB chairman Professor Des Fitzgerald pointed to the quality of clinical care and research in Ireland, the size of its population, the level of investment in academic research and the government’s commitment to investing in a knowledge economy as the foundations for a thriving clinical research environment.

The government itself is keen to move the pharmaceutical industry up the value chain While tax breaks, a skilled and cost-effective workforce and proximity to Europe have traditionally attracted manufacturing investment from Big Pharma players like Pfizer and GlaxoSmithKline, Minister for Enterprise, Trade and Employment Michael Martin told the IPHA meeting that Ireland needed to bring in high-end manufacturing focused on research and development, process development and drug discovery.

IPHA president John McLaughlin agreed that stepping up clinical research in Ireland was essential to the health of the pharmaceutical sector. He urged Martin to support the industry’s efforts with IDA Ireland, Enterprise Ireland, Science Foundation Ireland and other interested parties to build a case for locating the co-ordinating office for the Innovative Medicines Initiative (IMI) in Ireland. This joint project between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA) aims to tackle bottlenecks in medicines development along the lines of the US Critical Path initiative.

Clinical studies in Ireland are “not where they need to be if we are serious about attracting a worthwhile programme of trials and world-class researchers”, McLaughlin warned. He identified three prerequisites for raising the bar on clinical development:

- Standardisation of, and increased predictability in, the system of ethics committee approval.

- Full compliance with existing legislation on clinical trials.

- Sufficient funding to employ dedicated researchers throughout the health services.

These concerns echoed recommendations in a government-commissioned report on health research policy published last week by Ireland’s Advisory Council on Science Technology and Innovation. They included boosting funding for health research in Ireland to the levels of benchmarked health systems; making the country a hub for translational research; introducing new centralised structures to drive national health research policy; and the immediate appointment of 30 extra clinical scientists with protected time for research.

The estimated €140 million in taxpayers’ money due to be spent on health-related research in Ireland this year would have to be raised “substantially” if the Advisory Council’s ambitions were to be realised, said chair Mary Cryan.

Specifically, the report called for streamlining of the approvals procedure for clinical trials in Ireland, which it described as “fragmented, slow and under-resourced”. The inefficiency of the ethics committee system was one of the main reasons Ireland was losing clinical trials business to other countries, it argued. Each of the country’s 13 ethics committees used different procedures, membership was voluntary and no formal training was provided to members.

Instead, the Council proposed, the current structures for ethical approval of clinical trials should be compressed into four regional ethics committees, with professional paid members, sectoral specialists, standard operating procedures (SOPs) and a well-resourced secretariat. The Department of Health and Children should establish a co-ordination mechanism for the revised ethics committee structure, which would be the first point of contact for companies and academics wishing to conduct a clinical trial.

The Advisory Council also recommended enabling the electronic submission of applications for clinical trial approval, with parallel review by the Irish Medicines Board and Ethics Committee as standard practice.

The IPHA is still analysing the Advisory Council’s report in depth but said in general it was “very happy” with the recommendations. It stressed, though, that the structural changes envisaged by the Council needed to be implemented “right now” if they were to help iron out the problems highlighted by McLaughlin. Discussions on specific funding to improve the clinical research environment would come later.

The current network of ethics committees already had guidelines and SOPs in place but they were not adhered to, the IPHA told PharmaTimes. This made the industry apprehensive that even a streamlined system of ethics approval would operate as it should do.

According to the latest annual report of the Irish Medicines Board (IMB), there were 119 applications for clinical trials in Ireland during 2005, down significantly from the 162 applications seen in previous year but on a par with the 116 applications in 2003. The IMB attributed the surge in 2004 to companies filing ahead of the new regime introduced by implementation of the European Union’s clinical trials directive, 2001/20/EC. By Peter Mansell