Marc MacSharry (Fianna Fail) | Oireachtas source

As we made clear during the debate on the Access to Cancer Treatment Bill 2012, which we brought forward in this House, there are concerns that the process for gaining access to particular medicines and treatments seems very obscure and secretive. There is little or no transparency for patients in regard to decisions as to whether or when a product will be made available. This is particularly distressing for patients when the decision is that a particular treatment is not to be provided. That is why we sought, in amendment No. 4, to ensure there would be clear criteria in this regard.

I accept that there must be some boundaries and parameters and some level of discretion for the executive. That is merely common sense. However, section 20 defines protocols in regard to the supply, quantities and periods of availability of medicines as well as restrictions on the purposes for which they can be prescribed and the classes of prescribers. This means, for example, that a situation could arise whereby only consultants in St. Vincent's and St. James's hospitals are permitted to prescribe a particular treatment. While I accept that such a scenario is highly unlikely, that type of vast power is being given to the executive under this section, without any recourse for patients or stakeholders. To reiterate, we support the legislation and have not tabled an amendment to this section. We are arguing, however, that in the interests of patients, a clear process should be defined which would ensure transparency in the matter of access to drugs. Patients should not be left in fear that by way of some obscure and secretive decision-making process, they will be denied access to treatment.

One of my amendments was ruled out of order on the basis that it would involve a cost to the Exchequer. However, the entire Bill is concerned with costs to the Exchequer.

My concern is that while we all want cheaper drugs for patients, somewhere in the provisions in section 20 the health of the patient will be sacrificed in the interests of saving costs. When one sees the pressures on the Department, the default position for the decision maker will be to find an angle so as not to make a certain drug available. What protocols will be put in place? Will it be like the joke in that a certain drug will only be available to all people accompanied by both parents over 90? Will there be terms and conditions for particular drugs which happen to be expensive so that it will only be available in a few scenarios?

There are previous examples of this with drugs such as ipilimumab. After patients highlighted how it was not available on the Joe Duffy show and had the Seanad up in arms about it, the Government said it would ultimately make it available. The buck needs to stop with the Minister. While difficult decisions have to be made – the Minister is no stranger to this – we need to have a starting point that all drugs are available but the health service can opt out of a drug’s availability based on proper and reasonable criteria such as pharmoeconomics and those contained in the Schedule. The new drug for treating cystic fibrosis which is rumoured to be very effective should be made available in Ireland subject to terms and conditions which are reasonable.

In fairness, this Bill does not provide a process for stakeholders or the patient directly to get involved in the process. Where is their recourse? Will they still have to go the Joe Duffy route or lobby Oireachtas Members to get the provision of a certain drug on the agenda? Rather than providing the Health Service Executive, HSE, with a set of tools to opt out of the provision of a drug due to financial pressure, maybe we should examine a process whereby all drugs are available and there will be opt-outs as is necessary. There certainly has to be an opt-out clause on costs and other criteria. I hope the Minister of State will consider these points with her officials.