Oireachtas body to study adverse effects of drugs

An Oireachtas subcommittee is being set up to examine the extent of adverse reactions to drugs among Irish patients.

An Oireachtas subcommittee is being set up to examine the extent of adverse reactions to drugs among Irish patients.

The subcommittee of the joint Oireachtas Committee on Health and Children will also look at whether drugs are properly tested before being marketed.

Terms of reference will be drawn up at its first meeting in early May. Members of the subcommittee include Fine Gael health spokesman Dr Liam Twomey, Fianna Fáil TD Dr Jimmy Devins and the Independent Cavan/Monaghan TD, Paudge Connolly.

Dr Twomey said yesterday the initiative stemmed from letters to the committee from concerned individuals. He said the subcommittee would probably hear submissions from the Irish Medicines Board (IMB), the Department of Health, the body representing pharmaceutical manufacturers and patients' groups.

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"If people feel there are unscrupulous practices in the supply of medication to the general public, the health committee would have an obligation to inquire into it," Dr Twomey said. He received a lot of correspondence on adverse effects of drugs on adults and children, he added.

Speaking at a meeting of the joint Oireachtas health committee yesterday, he questioned if the IMB, which licenses medicines in the Republic, was strong enough to scrutinise data presented to it on research carried out on drugs for which companies were seeking a licence.

"We have seen four drugs withdrawn in the last four years," he said. These would include the arthritis drug Vioxx, the manufacturer of which is now facing class action lawsuits in the US.

Eamonn Corcoran, of the Department of Health, said he believed the IMB was adequately resourced to perform its functions. He told the committee that "more than 50 per cent of the medicines used to treat children have not been tested for use in children".

Under proposed EU rules, drug firms will be obliged to submit paediatric studies when applying for a marketing authorisation for a drug, unless a waiver or deferral is granted, he said.

The committee also heard that an EU directive setting out guidelines for the donation, procurement, testing, storage and distribution of human cells and tissues, including stem cells, was transposed into Irish law last Friday.

Under the directive, fertility clinics will have to adhere to certain standards and the IMB is now planning a round of inspections of the clinics to ensure they are meeting these requirements.