Written Answers. - Unlicensed Medicines.
Bernard Allen
Ceist:
606
Mr. Allen
asked the
Minister for Health and Children
if he will make a statement on a recent report (details supplied) that a growing number of hospitals are being forced to use unlicensed medicines; his views on the possible medico-legal consequences; and the plans he has to address this matter.
[22108/01]
The question of unlicensed medicinal products, including the use of authorised medicinal products for indications for which they have not been authorised, is one which health services in all countries in the developed world have to take into account. No country today can have available such a range of authorised medicinal products as to be in a position to effectively treat all the medical conditions and illnesses that are likely to be encountered in their population. For that reason, provision has always been included in the legislative controls for medicinal products so that products that are necessary for the treatment of patients, in the circumstances where the required authorised products are not available, may be obtained.
The primary legislative provisions for this purpose are contained in Article 4 of the Medicinal Products (Licensing and Sale) Regulations, 1998 (SI 142 of 1998) where, in addition to providing certain exemptions for extemporaneous compounding, exemptions have been provided for the importation or sale of a medicinal product by or to the order of a registered medical practitioner or registered dentist for the treatment of a patient under his care.
The controls that are applicable to medicinal products principally set out to control the activities of the pharmaceutical companies that are involved in the marketing and supply of those products. The controls, therefore, do not particularly set out to regulate the practice of medicine and the various exemptions that are provided are intended to preserve the "clinical freedom" of doctors with a view to enabling them to effectively treat their patients. Accordingly, under the existing provisions, doctors, in the exercise of their professional judgment and with a view to the effective medical treatment of their patients, may: prescribe unauthorised medicinal products; use, for a particular "named" patient, an unauthorised medicinal product specially prepared – for example, extemporaneously – specially imported or specially supplied for that patient; use, or recommend the use of medicinal products, for indications or in doses or by routes or administration outside those recommendations set out in the relevant product authorisations; override the warnings and precautions set out in the relevant product authorisations.
The responsibility for prescribing any medicinal product for a patient rests with the prescriber. If, however, an unauthorised medicinal product is prescribed, it is obvious that the responsibility of the prescriber is increased. Pharmaceutical companies, whether as wholesalers or manufacturers, are subject to licence control by the Irish Medicines Board under the respective Medical Preparations (Wholesale Licences) Regulations, 1993 (SI 39 of 1993) (as amended) and the Medical Preparations (Licensing of Manufacture) Regulations, 1993 (SI 68 of 1993) (as amended).
On that basis, if a supply of a medicinal product were to be made and in due course some information became available to that company that the particular product was defective or unsafe, it would be a serious matter for that company and for the continued holding of the required licence if it were shown not to have been in a position to identify the significance of the information concerned and not to have acted promptly and effectively on that information.
In regard to the statement concerning a recent report that a growing number of hospitals are being forced to use unlicensed products I should explain that the review of medicinal products has now been completed for a number of years and arising from this and a number of incidents, for example, blood, there is a much greater appreciation of the value and need for authorisations in the interests of protecting public health. This has resulted in a focus on those medicinal products which are not authorised and companies that previously had been willing and satisfied to be the suppliers of small volume essential medicinal products are no longer willing to continue with those supplies as previously. Such products are then often sold off to other unrelated companies whose primary notice is profit with little regard to the needs of public health and the consequences of the non-availability of those products for patients. Due to the operation of price controls in all European countries, including Ireland, there are often significant price differences between countries. These differences are then exploited by certain companies in the context of parallel exportation resulting in supply difficulties and, as a direct consequence, reluctance on the part of authorisation holders to continue the traditional policy of having "common packs" between this country and the United Kingdom.
Unfortunately, in these situations, the need of the smaller market often gets ignored and unauthorised alternatives are usually sought to meet the need. In some of these cases, apparent differences between the approaches of the licensing authority in this country and in the United Kingdom are given as the reasons for the non-renewal of the authorisations concerned and consequential discontinuations. In this context also, references are frequently made to the costs of maintaining authorisation in this country, particularly for these small volume and often essential products. Where the relevant product authorisations are being maintained in other countries, because of the manner in which fees are applied by the Irish Medicines Board and the flexibility available to that board in appropriate circumstances under the Irish Medicines Board (Fees) Regulations, 1996 (SI 44 of 1966), in respect of the application of those fees, any suggestions that non-renewals and associated discontinuations are as a direct result of such costs are not justified.
While the existing regulations controlling the marketing of medicinal products in this country do not incorporate significant controls on the supply of unauthorised products, it is proposed, in regulations currently under consideration in my Department, to provide for a greater supervision by the Irish Medicines Board over the supply of such products. In this context and in the light of the ongoing need for the availability of such unauthorised medicinal products for the essential treatment of patients, it will remain the responsibility of the prescriber to decide the circumstances in which he-she will prescribe an authorised medicinal product in the best interests of the patient.
