Michelle Mulherin (Mayo, Fine Gael) | Oireachtas source

I appreciate the opportunity to debate this critical issue. From the information I have garnered it appears that if the matter is not addressed it will seriously and adversely impact on our current and emerging indigenous clinical research industry and our ability to grow the sector. That will, in turn, affect our ability to engage in research and development for veterinary medicines, medical devices and human pharmaceuticals. We are a big player in the latter area given the number of multinational pharmaceutical companies in this country.

I congratulate the new Minister for Health, Deputy Varadkar, on his appointment. I wish him a fruitful tenure. I think this might be his first time in the Chamber in his new position. There is an urgent need for a review of the new authorisation procedure, which commenced on 1 January this year, for the conduct of clinical trials on animals being operated by the Health Products Regulatory Authority, HPRA, formerly the Irish Medicines Board, which arises from the transposition of EU Directive 2010/63 into Irish law.

The European Union (Protection of Animals Used for Scientific Purposes) Regulations 2012, which give effect to the directive, will severely impede the ability of existing Irish companies to compete for such work internationally, as licences which they hold for this activity under the previous regime expire. As we speak, it is crushing the ability of fledgling and start-up companies to get business at all.

Affected individuals and companies explained to me that the physical care and treatment they give to the animals will not change under the new regulations so there will not be any changes affecting animal welfare. They already operate to the highest animal welfare standards and under the previous licensing regime companies conducting such clinical trials were regularly inspected by the Department of Agriculture, Food and the Marine. In fact, from the point of view of standards, Ireland is a very desirable place to have the necessary clinical trials conducted. In a recent interview with The Irish Times, Mr. Pat O’Mahony, chief executive of the Health Products Regulatory Agency set out his belief that we should "ramp up Ireland’s presence in clinical trials where we should be running about four times our current level". He said we should be big players in the sector.

The problems with the new authorisation process are excessive and inappropriate costs and difficulties with the timelines for processing applications and paperwork. In effect, what is at issue is additional red tape and bureaucracy on an existing system of checks and monitoring for animal welfare. The regime does not appear to be implemented in such a burdensome manner on business in other EU jurisdictions. The business conducted by Irish companies is now beginning to go to eastern Europe and further afield.

The issues of concern which are affecting competitiveness include the fees which became operative on 1 January - €1,000 to process an application, €2,000 for an ethical review and a further €2,000 to fast-track an application. When the Minister hears the timelines involved he will understand the need to fast-track applications. Every job requires authorisation, regardless of size, and the same cost applies. Let us contrast that with the previous regime in which companies operated where no fees applied and a five-year licence was issued. Regular inspections were part of the system. The new regime involves major additional expense that companies must pass on to customers, and it is disproportionate for small projects. For a job worth €800 a company would have to potentially add €5,000. Companies have said work is going abroad as a result. The timeframe of 54 days can be reduced to 21 days on payment of an additional €2,000 but that is still not fast enough. One company described to me how it lost out to a company in the Czech Republic which can do the work in two weeks. Therefore, we seem to be out of synch.

The HPRA requires an ethical review is provided. That, in itself, is acceptable but eight people are required to perform it, which is not feasible for small companies. Such an approach is not prescribed in the directive. While, in theory, such work could be farmed out, due to the sensitive nature of the information companies do not wish to engage the services of a third party. There also appears to be a disparity between the approach being taken in this country and what is required by the EU Commission. The Commission says one thing and we appear to have interpreted matters in another way.

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