Mr. Shaun Flanagan:

The cost of orphan drugs is automatically reimbursed in Germany. There is no assessment or review and the drug is just paid for. That is how Germany is different in that regard. Ireland has a different legislative framework which requires that the criteria that Mr. Hennessy has previously set out be considered. The Germans automatically pay for orphan drugs.

I am not familiar with the figure of 158 orphan drugs that Senator Colm Burke asked about. I recently downloaded information from the European Medicines Agency and thought it mentioned a figure of less than 100 orphan drugs but I am open to correction on that. It is not a very recent work. I am happy to deal with any query in that regard when I have had a chance to examine the issue further following the meeting.

In regard to savings from generic drugs, €250 million has been saved since 2013 under the reference pricing generic substitution programme in the Health Act.

In terms of international negotiation, my colleagues in the Department of Health are not in attendance but they made efforts to engage with international colleagues in relation to negotiation during the year-long process in regard to Orkambi. It was difficult to get countries to align on the same criteria for all to agree on the decision point. The Department is continuing to engage internationally on that issue to try to get involved in international co-operations. That is actively being worked on. I should not speak for the Department but I am aware it is progressing that issue.

In terms of international comparisons, as Mr. Hennessy said, the OECD publishes data sets regarding purchasing price parities and the cost of medicines reimbursed per patient on an annual basis. As the purpose of today's meeting is mainly to deal with rare diseases, I did not research this particular issue beforehand. I think the most recent data is from 2013 or 2014 and Ireland was at the top in terms of spending per patient.

Those figures did not capture the impact of the Health Act. They also did not capture the fact that prior to 2005 and the setting up of the HSE, the State never challenged pharmaceutical companies on new drugs. At one level, one could argue that prior to the introduction of these processes we were price takers. We are no longer price takers. We seek to aggressively negotiate with pharmaceutical companies when they bring a new drug to market because we know we have a limited budget. The only way we can spread the budget as far as possible is to get the best price we possibly can for every new drug. I assume that is the reason why the Oireachtas requires us to consider cost-effectiveness and budget impacts.

Senator Mullen raised the issue of harmonisation and negotiations. One of the big challenges for harmonisation of decision-making is that not every country may be able to afford the same levels of investment. If a country is signing up to German levels of involvement, it must sign up to German levels of investment. Whether Ireland has those resources available to it as a State is a question I cannot clearly answer. It is a political question rather than a HSE one.

On the national disease plan, in terms of moving and changing the assessment processes around new drugs, as a public servant I would say the Health Act is clear. It has not made any changes that allow the HSE in any way to treat orphan drugs any differently to other drugs. If the view of the Oireachtas is strongly that there should be a separate process, there will be a requirement for legislative change. It is something we have to say. In terms of the 50% longer than ordinary delay in time on orphan drugs, there is no doubt orphan drugs are more challenging for an assessment body to consider. As the levels of evidence are on occasion less robust than they are for other medicines, they present challenges for decision-making bodies but they also come with significant budget impacts. Orkambi was for a rare disease but it came with a budget impact worth hundreds of millions over five years. Decisions to fund such drugs have implications for the rest of the service. Those are decisions that have to be made carefully after robust engagement from pharmaceutical companies on the price and offering they have made.

I will keep going down through the list of questions.