Dr. Derick Mitchell:

The Deputy has asked comprehensive questions and I will start with his first question. In terms of compassionate access to innovative drugs that have not received marketing approval or been approved by the European Medicines Agency, that has been a grey area for us. The Deputy is right that protocols should be put in place. It is something we have included as part of our joint work on our Drug Iceberg reports where we feel that any patient who is on trial, as part of a compassionate programme, should have access to that drug for their life. When we talked to other stakeholders in the area there seems to be a reluctance to adhere to that aim for a number of different reasons. Let us consider the environment for clinical trials. A new clinical EU directive is coming down the tracks that will detail how clinical trials will, potentially, be harmonised. The Department of Health is doing a lot of work into research ethics in terms of creating a single committee. The Helsinki Protocol governs how patients should gain access to clinical trials. The area of compassionate access has not been structured in a satisfactory way for patients. Recently the European rare diseases organisation, EURODIS, has compiled a report on trying to get a consistent approach to compassionate access and made a number of recommendations. We could consider those recommendations in order to move the issue forward in Ireland. If there is a potential that Irish patients would get compassionate access, then we should ensure that the company that allows a drug to be available for free adheres to a set of guidelines.

The next issue is biosimilars. In the absence of a national policy on biosimilars, from a patient perspective it makes sense to use these drugs. However, we should do so on the basis that the savings accrued to the system would be reinvested in innovation or similar types of drugs. We have had some discussions on substituting an existing innovative drug for a biosimilar, and who might be involved in that instance. We would like to see greater interaction between clinical and pharmacy communities on those decisions because we feel that pharmacists have a role to play maybe not as the decision-makers but, certainly in terms of the decision itself, there should be more collegiality between the two communities on that aspect.