Written answers

Friday, 16 September 2016

Department of Health

Medical Goods Regulation

Photo of Clare DalyClare Daly (Dublin Fingal, Independent)
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1276. To ask the Minister for Health his views on potential conflicts of interest in relation to the Irish Cancer Society holding public talks supporting the use of certain drugs while at the same time receiving donations from the makers and licence holders of those drugs; his plans to regulate this situation; and if he will make a statement on the matter. [25552/16]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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There is extensive legislation in place governing the advertising of medicines, including gift, sponsorship of meetings, and hospitality. The Medicinal Products (Control of Advertising) Regulations, 2007 provide for a range of restrictions on gifts and hospitality. For example, a gift must be inexpensive and relevant to the practice of medicine or pharmacy. Hospitality must be reasonable in level, strictly limited to the main purpose or scientific objective of the event, and not extended to persons other than health professionals. Health professionals are also prohibited from soliciting or accepting any prohibited inducement, hospitality or sponsorship.

The pharmaceutical industry operates a voluntary code of practice for the purpose of providing practical guidance to the Regulations. Any individual who believes that a particular promotional activity is in breach of the code may submit a complaint to the Irish Pharmaceutical Healthcare Association. Complaints are heard by committees consisting of industry representatives, independent lay members and chaired by an independent chairman. In addition to this self-regulatory system, breaches of the Regulations may be prosecuted in the courts under section 32 of the Irish Medicines Board Acts 1996 and 2006.

Furthermore, there are a range of legislative provisions in place to protect patients involved in clinical trials for medicines. Every clinical trial involving a patient in Ireland must be approved by the Health Products Regulatory Authority (HPRA), who carry out a scientific assessment, and by a recognised ethics committee whose role is to ensure that trials are ethical and that patients’ rights are protected.

Once a medicine has been authorised (licensed), a pharmaceutical company can make an application to have a medicine reimbursed under the community drugs schemes. Decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts a health technology assessment of pharmaceutical products for the HSE, and can make recommendations on reimbursement to assist the HSE in its decision-making process. In the case of oncology drugs a report is also sent to the National Cancer Control Programme (NCCP).

In view of the above I am satisfied that the current system of regulation is effective in protecting patients and I hope that I have addressed the Deputy’s concerns.

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