Marc MacSharry (Fianna Fail)

I welcome the Minister to the House and thank him for bringing forward this legislation. In one way it is a shame it has taken so long. I acknowledge, as the Minister did, the savings that have been made through negotiations with the various representative organisations and other measures dating back to 2006, and particularly 2009. I welcome the aspiration with which this Bill sets out that cheaper and better prescribing and dispensing will take place in terms of the provision of reference pricing and the supply of generic drugs, etc.

I have concerns about the Bill, despite the fact that on the Order of Business my colleague, Senator Byrne, wished to have all Stages taken this evening to prevent undue delay in implementing the provisions. This is effectively the second last day and as Committee and Remaining Stages will not be taken in this House until the autumn. I ask that in the intervening period some consultation would be entered into by the Department with patient advocacy groups and with the manufacturers and suppliers, both wholesale and retail, to further refine aspects that may need to be visited.

As no doubt the Minister will be aware, last week there was an effort here by Senator Crown and myself under the guise of the Access to Cancer Treatment Bill 2012 to put a relatively clear process on the provision of cancer drugs. It was voted down. One of the reasons given in the speech which was delivered on the Minister's behalf was that the current Bill was due and it would put people in no doubt as to the clear process that would be available to them in terms of the provision of drugs that would come online. I suppose Ipilimumab is the most recent example but there are others. Having read the Bill, I cannot find that clear process. It seems at least as obscure and unknown as it was before the Bill was published. There is nothing in this Bill that gives a patient or a patient advocacy group any recourse to a decision that is made to provide a drug, to have a drug provided or anything like that. If one is not a party to it, if one is not a drug manufacturer or supplier, one has no role at all. In fact, the Bills Digest, sometimes prepared in advance of debates in the Houses here on a non-partisan basis by the Library, states that the Bill does not provide a system where potentially affected third parties are able to make submissions. That is a concern which, on Committee Stage, must be dealt with by way of amendment.

Even if one is a stakeholder or one of the parties that can be consulted or has recourse, it will take 194 days following application before it will receive a decision. Therefore, it will be more than six months before a drug could be available. If the answer is "No", the only recourse is to appeal to the High Court. Depending on one's ailment, sadly, one would be dead while we deliberate on whether a drug should be available. Perhaps that process was followed for Ipilimumab because it was the approach on the Joe Duffy radio show that had to be adopted ultimately to secure the provision of that drug. Senator Crown and I tied to ensure that while preserving the State's necessary right to say that a drug is too expensive when measured against the outcomes, a decision could be taken quickly and the buck would stop with the Minister.

The Bill will make the HSE, or whatever replaces it, all powerful in this area. The Minister referred to a task force on prescribing and dispensing to be headed up by the Chief Medical Officer. Who else will it include? What is the decision-making process? How long will it take them to make that decision? Will it be within the 180 days or do the 180 days only start when somebody applies? If, for example, the National Cancer Control Programme, NCCP, decides that Ipilimumab or the next such drug is to be supplied, can it circumvent that process to have a drug added to the list of those being provided? In the event that the programme makes such a recommendation, does the national task force on prescribing and dispensing take the decision? Is it the task force, the office of the Minister or one of the directorates to be established, such as primary care or mental health, that the NCCP would ask to provide a certain drug? What will the decision-making process be? If, for example, a patient knows there is an EMA approved drug in Germany and the physician and oncologist - if it is an MS drug, it would be the neurologist - wants to prescribe it, and because Ireland is only 1% of the market the drug company concerned has not taken an interest in supplying here and has not yet applied to the 194-day process to get a decision, this Bill does not tell the patient how he or she can gain access to that drug. The Bill is obscure. It is ad hoc. In many ways, it replicates the approach that is being taken to the HSE at present. I would like further clarification on that aspect.

My party will not oppose the Bill on Committee Stage but it contains many defects in terms of putting the patient first. In the first couple of paragraphs of his speech, the Minister stated this was patient-centred. I stated the same last week on another piece of legislation. I do not believe this is patient-centred.

We all are in favour of cheaper drugs. The Minister will have the full support of Fianna Fáil with that aspect of the legislation but in terms of security of supply and a process to get a drug in this country, I am none the wiser today than I was two weeks ago. As I stated, the Bills Digests clearly states that the patient is not fully included in this process. That is why I would hope that, in the month or however long it will be before Committee Stage in the House, there would be consultation with a number of persons. I am sure Senator Crown would be available. I am certainly available to give my views as a consumer on what should be done.

On a minor aspect of the process, the EU Council transparency directive requires the publication of objective and verifiable criteria for deciding whether or not to include medicinal products. I do not see that anywhere in this list. I do not see anything clear or verifiable. I only see that there will be a task force. We do not know who will be on it or what criteria will be followed in the determination other than a list of basics, such as value for money and subject to resources of the HSE. What is meant by value for money? How does one determine the cost per year of life saved when experts, such as Senator Crown, would say that such is too crude a methodology in its own right because drug A might give me a week in terms of remission but might give the Minister an period? As a result, we cannot merely clinically state that the cost per year of life saved will be the one included there. Bearing in mind that we have obligations under the EU transparency directive to have a clearly verifiable criteria, which is clearly absent from this legislation, what on Committee Stage can be brought forward to alleviate the concerns of patients? While welcoming that those drugs that will be available and approved for distribution will be cheaper and we can have generic brands, what is being done to ensure clear processes are in place to address issues arising around those that are not? What are we doing to bring clear processes? I am sorry to be bringing it back a week. I welcome the positive aspects to the Bill in terms of cost. It was a policy that followed on from the previous Government, as the Minister has acknowledged. However, I am concerned about this other aspect and I would like him to address it if not in his closing remarks then on Committee Stage.

While we want the cheapest medicines available to the State given our resource situation, it would be remiss not to mention the contribution of pharmaceutical industry to the country in terms of employment and our health care. I ask the Minister to take on board to the extent possible the industry's concern over continuity in the Irish market. At the end of the day we all want to get the best value for the consumer. The Minister will have wholehearted support in that regard. However, I ask him to take those other issues on board.