Second Opinion:Medical devices are central to the success of modern medicine. Innovations such as heart stents, pacemakers, joint replacements and heart valves have dramatically improved the lives of millions.
Quietly, Ireland has played a major role in the production of these devices. Major multinational medical technology industries, which employ up to 25,000 Irish people, have located here.
In addition, many smaller companies, led by Irish entrepreneurs, have also been very successful.
Key international people in the industry also view Ireland as the natural route into the European market.
However, new therapies cannot be developed without assessing how they behave in the people they are designed to help. The research and development (R&D) needed before these objects can be successfully and safely used in patients is prolonged and complex, and Ireland is struggling to match its European neighbours.
The risk is that, because of this, companies may choose to relocate elsewhere.
To stop this happening we need to improve our hospitals and put in place the equipment and policies needed to allow more clinical trials to take place. This is not simply to assist business but, more importantly, this is in the interest of Irish patients.
Irish patients would experience two particular benefits from the Government supporting clinical trial infrastructure. Firstly, hospitals that participate must demonstrate a standard of care, which is comparable to the best medical centres worldwide. These rigorous standards inevitably benefit the patients using the hospitals.
In addition, clinical trials allow Irish patients to benefit from the latest medical innovations.
For example, one 58-year-old female patient suffers from a disabling lung condition for which there is no useful therapy. Following detailed discussion she decided to take part in a research study of a medical device which was to be placed in her lung.
She entered the study and, as a participant, was subject to intensive surveillance and support.
One year later, at the end of the study, she had the option to be one of the first patients in the world to receive the treatment device. As a result, her condition has improved enormously and the quality of her life has been transformed.
While the Government has recognised the importance of clinical trials, we still have progress to make. Ireland spends only one-third of the EU average on R&D, and the UK, for example, spends 0.104 per cent of GDP on R&D, compared with 0.015 per cent here.
Although extra funding is needed there are also a number of other problems. At present, highly trained consultants, many of whom have spent years working in major institutions abroad, are not afforded the necessary time or resources to participate in research.
At a time when a new contract for medical consultants is being developed, there is a need to ensure that medical specialists have protected time to take part in research.
This time should not be academically remote from the patients, rather it should be central in the provision of quality healthcare.
For example, a consultant specialist may be contracted to spend two-to-three days per week devoting time to patient research in hospitals, rather than remote laboratories.
In addition, hospital ethics committees require greater professionalisation. Increasingly sophisticated medical treatments mean that the dedicated and well-informed individuals sitting on the committees find it is difficult to keep abreast of often complex new issues.
It is necessary to remunerate ethics committee members, which will allow them the time to develop skills and the experience needed. This is especially important because the decisions made by ethics committees are central to indemnity for the hospital and the State.
There are examples where hospitals have been sued because of errors made by an ethics committee.
Finally, there is also a need to develop better career paths for those involved in research and development.
Nursing pay structures, for example, mean that many are dependent on over-time to sustain their day-to-day living. This makes a career in research much less attractive.
Ultimately, the entire clinical trials environment in Ireland needs an overhaul. Only then will the range of medical treatments that we can offer sick patients increase, and the ability of the medical devices industry to innovate improve.
Dr Jim Egan is clinical trial taskforce spokesman with the Irish Medical Devices Association, part of business lobby group Ibec.
He is also a consultant respiratory physician, Irish national lung and heart transplant programme, Mater Hospital and St Vincent's University Hospital and an honorary consultant at Our Lady's Hospital for Sick Children, Dublin.