The new EU Clinical Trials Directive will have major impact on medical research and patient care, according to Irish charities representing patients.
The charities have come together to caution the Minister for Health on the likely impact on medical research led by hospital consultants when an the Clinical Trials Directive is written into Irish law in May 2004.
Their concerns largely centre around the impact of the Irish legislation on so-called "academic or investigator-led" research, as opposed to research by multi-national pharmaceutical companies as they bring new drugs to the market.
In investigator-led research, the investigator provides established medication (i.e. medicines that have been on the market for some time) to patients using new treatment protocols - for example, using a medication for an indication that it had not been previously licensed for.
This type of research has little commercial benefit for the pharmaceutical company that markets the medication but it has, however, provided breakthroughs in a wide range of therapeutic areas, has improved survival rates and has benefited many patients.
Examples of such research advances include the discovery of the benefits of aspirin in treating heart disease and benefits of using tamoxifen in prevention of breast cancer.
In the draft Irish legislation implementing the EU directive, the cost of medications in these investigator-led trials and the legal and administrative costs would have to be paid for by the investigator as he/she will now be defined as the sponsor, making the research prohibitive to undertake, the charities claim.
Previously these costs were borne by the pharmaceutical company and the health service.
Commenting on the likely impact of the legislation Dr John Kennedy, consultant medical Oncologist at St James's Hospital and chairman of the Irish Cancer Society medical committee, said: "While the translation of the EU Clinical Trials Directive into Irish law will bring many benefits to the Irish clinical research environment such as ensuring research has to be carried out to a particular standard, the implications for investigator-led research will be disastrous."
This directive may well cause investigators to abandon important clinical research, according to Dr Kennedy.
"It is essential that there is a supportive environment for the continuation of clinical research in all therapeutic areas at all levels and that any legislation introduced recognises this."
Members of the Medical Research Charities Group have made submissions to the Department of Health and Children with regard to the wording of the new legislation in the area of academic research to ensure that this type of research can be facilitated and that Irish patients continue to have access to and benefit from vital clinical research.
The 12 charities, which are part of the Medical Research Charities (MRC) group, are: Alpha One (Antitrypsin deficiency) Foundation; The Arthritis Foundation; The Asthma Society, Fighting Blindness; The Irish Brain Research Foundation, The Irish Cancer Society, The Children's Medical and Research Foundation, The Cystic Fibrosis Society, DEBRA Ireland, Diabetes Federation of Ireland, The Irish Heart Foundation and The Mater Foundation.