asked the Minister for Health if he will make a statement on the implications for this country of the recent decision of the Council of Ministers in regard to the free movement of pharmaceuticals within the European Community.
Ceisteanna—Questions. Oral Answers. - Free Movement of Pharmaceuticals.
15.
The recent decision of the Council of Ministers concerned two new directives aimed at taking further steps towards the free movement of pharmaceuticals within the Community. There is already a directive— Directive 65/65—on this matter. This directive requires each member state to have provisions for the licensing of pharmaceutical products put on the market in its country. We have such provisions under our existing regulations.
The two new draft directives will carry the approximation of laws on pharmaceuticals further. One of them —known as the "norms and protocols" directive—aims to standardise as between the member states procedures for applying for licences and for the requisite testing and clinical trials. The second of the two new draft directives aims to standardise the rules in the member states which will govern the manufacture and marketing of pharmaceutical products. For example, the directive will provide that manufacture must be under the control of a qualified person.
These directives were considered by the Council of Ministers at a meeting in February and were generally agreed. It is expected that they will come up for formal approval within the next few months and will thus come into operation by the end of 1976.
The existing directive and the two new directives represent steps towards the ultimate aim whereby a pharmaceutical product licensed in any one of the nine member states will thereby be automatically marketable in the other states. However, directives towards this ultimate end have not yet reached a stage of detailed consideration.
Does the Minister regard this process as satisfactory from our point of view in that it is likely to lead to cheaper drugs generally eventually? Have these directives been considered and examined by the Minister and his Department in relation to the misuse of drugs legislation before the House? Have these directives any implications from that point of view?
I cannot say whether they will lead to cheaper drugs being available but that would be a good outcome.
Is that not what it is all about, to have them more freely and more cheaply available throughout the Community?
Free access to each of the member states of these products. As far as I am aware there has not been any consideration of these directives in connection with the Misuse of Drugs Bill.