Mr. John Hennessy:

The vice chairman is getting into a very big question about the model of development for drugs and medicines. The reality is that the model we have at the moment is what we have, and it is based on commercial entities producing medicines under the blanket of patent protection afforded to them by states. The question then arises as to whether the state, on behalf of its patients, get value for money for those products. At the moment the answer is yes in some cases and in other cases no. To change the model would require significant investment, and the affordability of replacing the current system would be a big question. The system that is there is protected by that patent blanket of protection, and it is a good question whether that produces good value. In the long term that question is most likely one for the political domain.

The question as to whether an entirely separate process is now needed for rare diseases on foot of the 2013 Act is a big question that can probably only be settled in the political domain. The measures that we have been taking to try and refine the current system, as laid out in the 2013 Act, have been on the back of the rare diseases report, in order to get a better appreciation for the differences that apply to rare conditions. Arguably the legislation could be amended, and of course we would implement whatever legislation is determined as necessary for that.