Mr. Pat O'Mahony:

I am always very frank about these things. In that context, there are much more restrictive regimes in some European countries. The biggest comparator of which people in Ireland are aware relates to the UK, with which we have a common border. Approximately five years ago the UK Government took a principled policy decision to push for the switching of medicines. It encouraged applications for switching and made a very positive move to drive the policy through in order to switch as many medicines as possible. As a consequence of this, it received more applications and it switched more medicines as a result. Cholesterol-lowering medicines are widely used throughout the world and in the UK people can go direct to their pharmacies in order to purchase these products. These medicines are, therefore, largely available over the counter in the UK but in the main are still prescription-only here.

Everyone is now very conscious of costs. As I stated at the outset, the IMB is not immune in this regard. Our procedures are robust and we are bound by timelines. If we receive an application to switch a certain product, we deal with it in the appropriate period. Our judgments are based on benefit-risk factors, namely, whether a medicine can be delivered safely at the level of the pharmacy. Another point which is important to note and of which we are very aware is the fact that regulation of community pharmacies has changed, very substantially, in light of the new pharmacy legislation. There are now much more stringent controls in place in respect of pharmacies. In our view, it is now safer to make certain medicines available in pharmacies than might have been the case five years ago. There is a definite trend in this regard and it will help improve circumstances.

A number of very specific questions were asked in respect of pricing. As already stated, pricing is not my brief. However, we are fully aware of what goes on. In that context, the industry engages in a dialogue with the Department and prices are agreed in respect of on-patent medicines during that period. This exclusivity or patent protection is set under European rules and expires after ten or 11 years. Thereafter, generics are licensed. Most generic products are licensed directly by the IMB and when applications in this regard are received, they are dealt with in a very timely manner. Members are correct: there is very little price differential between generics and innovators in this country at present. In the context of the new Health (Pricing and Supply of Medical Goods) Bill 2012 and generic substitution, our role will be to determine the medicines that are interchangeable. In other words, if there is a patented medicine for a particular indication, if this has gone off-patent and if there are five generic products licensed, our job will be to publish a list and indicate whether all of these six medicines - the original and the five generics - are all interchangeable. We already have in place a list of priority medicines in respect of which decisions will be made, as quickly as possible, when the legislation - in its final form - is enacted. Setting what is called the reference price will not be our function. Responsibility in this regard will rest with the HSE and the Department. If, for example, a medicine costs €10 at present, I have no idea with regard to the level at which the reference price will be set. Our task will be to indicate which medicines are interchangeable.