Written answers
Tuesday, 22 June 2021
Department of Health
Medicinal Products
Michael Fitzmaurice (Roscommon-Galway, Independent)
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520. To ask the Minister for Health the work being done with Dutch officials to resolve issues surrounding the GMP certificate of the prescription drug manufactured by a company (details supplied); and if he will make a statement on the matter. [26055/21]
Stephen Donnelly (Wicklow, Fianna Fail)
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The Department has not been informed of any matters referred to by the Deputy. Departmental officials have contacted their Dutch counterparts in this matter and can make further contact with the Deputy when a response has been received.
Michael Fitzmaurice (Roscommon-Galway, Independent)
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521. To ask the Minister for Health the work currently being done with Dutch officials regarding prescription drugs manufactured by a company (details supplied); and if he will make a statement on the matter. [26056/21]
Stephen Donnelly (Wicklow, Fianna Fail)
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The Dutch authorities will not allow the commercial export of oil-based cannabis products to pharmacies or wholesalers. Representations were made to the Dutch authorities about having the products exported to Ireland to facilitate their inclusion in the Access Programme if the producers wished to do so. The Dutch authorities replied that magistral preparations may only be provided directly to patients or their representative on the basis of a prescription, presented for dispensing. Since April 2020 owing to the travel restrictions and quarantine requirements the Department of Health has been collecting patients prescribed products and delivering them to Irish patient’s homes, collections occur approximately every four weeks. In December 2020 the Minister for Health said this this scheme would be made permanent.
Owing to the restrictions the manufacturers of the Dutch products are not in a position to apply to the Health Products Regulatory Authority to have the products included in the Access Programme and treated in the same manner as the products included in the Access Programme.
It is a requirement for patients or their families to pay the dispensing pharmacy in the Netherlands and a reimbursement application can subsequently be made to the Primary Care Reimbursement Service in the HSE.
Pursuant to Section 10B of the Health Act 2004 the Minister for Health shall not give a direction under section 10, or specify a priority or performance target under section 10A, as respects -
(a) any function of the Executive relating to the provision of treatment or a health or personal social service to any particular person,
(b) any function of the Executive relating to a decision concerning
(i) whether or not a particular person is eligible for a particular health or personal social service (including the payment of a grant or allowance),
(ii) the extent to which and the manner in which a person is eligible for any such service.
I have asked Departmental officials to examine this issue further with the HSE.
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