Billy Kelleher (Cork North Central, Fianna Fail) | Oireachtas source

I will continue along the same path. I was referring to the national rare diseases plan for Ireland, launched by the Minister in July 2014. The witnesses are aware of it. I tabled a parliamentary question recently which highlighted that quite a number of areas have not been fully implemented. These include recommendations Nos. 30 to 39, inclusive. Quite a number are in their infancy. Recommendation No. 33 is that the HSE develops a publicly available annual report documenting the use of existing and new to market orphan medicines and technologies in Ireland and a summary of applications received and decisions relating to those applications. This has not been commenced. Recommendation No. 38, that early dialogue between the HSE and the companies running clinical trials in Ireland with Irish patients where licence approval is imminent, has not been commenced. Recommendation No. 39, whereby sponsors could be offered an incentive to run trials in Ireland, increasing access to innovation for Irish patients, has not been commenced. Quite a number of areas in the rare diseases plan have not commenced. I ask the witnesses to comment on this.

With regard to how we assess and appraise drugs coming to market, the European Medicines Agency, EMA, makes approvals, as does the Health Products Regulatory Authority, HPRA, in this country. Sometimes there is an application for reimbursement, which goes through the entire process, including the National Centre For Pharmacoeconomics, NCPE and the HSE, and when it is all said and done, it still seems to end up going to the Department of Public Expenditure and Reform, if I am correct. It then goes to the Government and sometimes back to the Dáil where political pressure is exerted and we have a situation where advocacy groups are campaigning outside the Dáil gates. Is there are better way for us to do our business in terms of how we assess the impact a drug would have and its cost-effectiveness, and take it from a situation where people feel they are almost playing God in terms of political decisions having to be made and pressure being exerted? It is extremely distasteful, to be truthful, that we have this type of continual toing and froing, where Ministers go to the Government to try to get money to secure a drug but it is not made available and then pressure comes on, or vice versa, as sometimes Ministers try to get approval for something that has not been approved through the process. I will take Translarna as an example, although there are many other drugs. It is hardly the case that all of the other countries in Europe are wrong. Why are we the outlier so many times when it comes to reimbursement for drugs? Many First World countries with very advanced technologies for the assessment of drugs and their impact, with quality First World health services, can approve drugs. Equally, even in the European context, countries with huge budget deficits, which are far worse off economically than ourselves, are able to approve these drugs. Why are we the outlier so often when it comes to the reimbursement for drugs?