Government plans to stem the influence of pharmaceutical companies remain on the shelf, writes John Downes
SERIOUS CONCERNS have been raised that the key recommendations of an Oireachtas health subcommittee, which examined the issue of adverse side effects of pharmaceuticals, have not been implemented.
It also has yet to be placed before the Houses of the Oireachtas, despite the fact that more than a year has passed since the original report was published.
The cross-party report, which was launched in April of last year, labelled the influence of the pharmaceutical industry and the persuasiveness of its promotion of its products as "unhealthy".
It said this also contributes to a "generally excessive" reliance on drug therapies by the professions and the public, and suggested that the high incidence of prescribing errors indicates that some professionals are not keeping up with "fast-moving" developments in the pharmacological education field.
Elsewhere, the report argued that the Medical Council should consider compiling a register of any "significant benefits" which medical practitioners receive from pharmaceutical companies to address the risk of potential conflicts of interest.
On the role of the Irish Medicines Board (IMB), it expressed concern about the fact that it is funded through fees for services to drug companies, meaning it tends to put pharmaceutical companies in the position of "clients of the IMB".
"This is not an ideal position for an agency concerned with public safety," it stated.
The report also noted suggestions that an agency which licenses drugs is likely to be compromised to some degree if the drugs subsequently turn out to be "problematic".
As a result, it suggested there could be merit in "splitting" the IMB into two, with one agency dealing with licensing and a second with post-marketing surveillance.
This second agency would also improve on the current low levels of reporting the adverse side effects of pharmaceutical drugs in Ireland.
While the report stressed that it was not assigning "malicious intent" to industry personnel, it stated that the pressures on the industry impel it to "excessive" promotion.
It also notes concerns that psychiatric drugs may tend to be prescribed "for want of an alternative".
"It is in the absence of a full range of counselling and psychotherapy services that many medicines, intended for moderate to severe psychiatric disorders, are prescribed for minor symptoms," it warned.
More than a year after the publication of the report, a spokesman for the Department of Health confirmed that it was still awaiting presentation to both Houses of the Oireachtas.
He said its progression was a matter for the Oireachtas health subcommittee.
Neither the department nor the minister has any function in that regard, he added.
However, he declined to say whether Health Minister Mary Harney had considered the contents of the report or if she was concerned about any of the issues raised in it. He said that acting on the findings of the report "is primarily a matter for the IMB".
"The report is being assessed by the IMB in its capacity as competent authority and the department understands that it is currently concluding its deliberations," he said.
"These deliberations will be discussed with officials of the Department of Health and Children during one of the regular meetings between the department and the IMB."
But according to Dr Orla O'Donovan, a lecturer in the Department of Applied Social Studies at University College Cork, who made a submission to the subcommittee during its consultation phase, the "ultimate responsibility" for the implementation of the report lies with the department.
She noted that not all of the recommendations it contained relate to the IMB.
Dr O'Donovan, who is also co-editor of a recent book on the regulation of the pharmaceutical industry in Ireland, entitled Power Politics and Pharmaceuticals, stressed that a key finding of the report was that there was a need for much more in-depth analysis of the issues raised.
But she said there appeared to be an absence of political will on the part of the Government to address the "vital" issues which the report raises, and warned that there was "no room for complacency" in this regard.
"We are all consuming more and more medicines for a wider array of conditions," she said.
"We all know about the crisis in the health service, yet more and more money is being spent on pharmaceutical drugs, without adequate consideration of the implications."
For its part, a spokeswoman for the IMB said it was the "competent authority" for regulation of medicines in Ireland, but said it understood that the department had clarified that acting on the report was a matter for the Oireachtas.
"The IMB has undertaken an assessment of those items, raised in the report for further analysis, which are of relevance to its remit," she said.
"The IMB will act on any issues it identifies which will enhance its patient safety functions."
The IMB's "ongoing change management" programme involved a number of new operational system enhancements and one of these was enhancement of the ADR system, she said.
One example is the provision of an online reporting system for the reporting of adverse reactions to medicines and quality defects to the IMB, said Dr O'Donovan.
"As a part of this wide-ranging [change management] programme, many areas have been reviewed, including the issues of pharmacovigillance and ADR reporting as contained in the Joint Oireachtas Committee's report," she said.
Speaking to this newspaper at the time of the report's publication, the then president of the Medical Council, Dr John Hillery, said the overall report, including its suggestions regarding the possibility of a register of significant benefits, would feed into an ongoing review of its ethics guidelines.
A spokeswoman for the council said this review was ongoing, more than a year after the publication of the report.