Damien English (Meath West, Fine Gael) | Oireachtas source

I want to address a number of issues that were raised on Tuesday. We are all a little rushed here and I did not have time to go through them all. First, I want to thank everyone for their co-operation on this Bill. The changes are modest but it is an important Bill. It is important that our IP regime is correct because it is of major benefit to us in terms of job creation and winning new products and services. I thank everyone for their work on that. They form part of the incremental improvements required to ensure our legislation remains supportive of the type of high-value and high-tech investment that the economy needs. We all recognise that, and it was recognised in the debate on Tuesday also. I thank everyone for their help on that.

A number of issues were raised. While noting that the Bill deals specifically with veterinary and human medicinal products, Senator Quinn raised the issue of products in the agriculture, agrifood and biotech sectors as well as the GM sector. The original research exemption provided for by section 42(g) and the new broader exemption provided for in this Bill are confined to acts done to obtain a marketing authorisation for human and veterinary medicinal products only. The exemption would not apply to the sectors mentioned by the Senator. The specific sectors identified by Senator Quinn come within the remit of the Department of Agriculture, Food and the Marine and would be subject to regulation by that Department.

Senator Quinn also mentioned counterfeit medicines, which I addressed the other day. The licensing and control of medicines are a matter for the Department of Health and the Health Products Regulatory Authority, HPRA, which regulates the manufacture, distribution, sale and supply, marketing, advertising, etc., of medicinal products for human use.

Counterfeiting of pharmaceutical products is criminalised under various legislative regimes, including the medicinal products regulatory regime that implements EU directives and the Irish trademark and Customs legislative regimes. The Garda and the Customs Service are the enforcement authorities in Ireland. The EU is currently putting in place better action plans to fight against counterfeiting. One proposal is in the nature of a "follow the money" initiative that will cover all forms of IP infringement over the Internet, which aims to include the various stakeholders in the fight against counterfeiting and piracy, the goal being to deprive infringers of IP of their revenue streams.

Senator Quinn also raised the issue of Government services being opened up to private suppliers that can provide a service by a cheaper method. If I understand the Senator correctly, this falls within the remit of the Department of Health and the Health Information and Quality Authority, HIQA. HIQA is responsible for carrying out health technology assessments that generate information about the clinical and cost-effectiveness of health technologies, drugs, medical devices, diagnostic techniques, surgical procedures and public health programmes such as cancer screening programmes. We will write directly to the Minister for Health about the issues the Senator raised, but I also referred the previous day to products and services. The health innovation hub is a place where we can bring the various enterprise and health stakeholders together to tease out new products, ideas and services. The trial, which was based in Cork, has worked quite well. A decision was taken to have a permanent health innovation hub. Where that will be located, who will be based in it and so on will be decided before June or July next year. There is a public consultation on that, but a firm decision has been taken to have it as a permanent feature. That will be a great place for Irish business people who have ideas about a health product or a new initiative or device to come together and involve the consultants, doctors and various players in health to develop something that will be used.

Senator Burke, who is not present, raised the issue of the Unified Patent Court, and I would like to clarify the position on this court. The international agreement setting up the UPC, which Ireland signed in 2013, provides for a central division which will have its seat in Paris but with sections in London and Munich. Signatory states can choose to confer jurisdiction on this central division, join with one or more member states to host a regional division or host a local division. Subject to the passing of a constitutional referendum, the Government has decided that Ireland will host a local division. In addition to hosting the section of the central court that will deal with life sciences, London will also host a local division. All divisions will hear cases on the basis of international rather than national law. That will be a major asset to many of our smaller companies that are developing new products and patents, because currently one would have to go to 28 countries in 28 jurisdictions either to have a case heard or to make a complaint against another company. The new patent court will be a one-stop shop for 25 countries; three decided not to join in. That will narrow down the work an Irish company would have to do, because there is a high cost in protecting a patent or if one is accused of copying somebody else's patent. This will make the process more straightforward and much easier.

It is important that we have a local division. Presentations were made at committee some years ago to the effect that Ireland would have a local division. Thankfully, that advice was listened to and a decision was made in September to make sure we have a local division.

The next issue will be the referendum. It will not be the most exciting referendum but it is important for Ireland that it be passed, because it will have a major beneficial impact on small and medium-sized businesses in Ireland. Some of the larger ones might not like the changes, but I believe the majority of businesses would welcome the changes proposed. I will engage with everybody to see if we can get cross-party support on the referendum, because it is important that we get people to vote for this important issue. European referendums are not the most exciting and it can be difficult to get people behind them, but this one is essential, and I will engage with the Members at some stage in the new year on how we can plan that.

Senator Burke also raised an issue concerning cost-effectiveness in the health service, and he referenced a particular project. I gave the Senator a commitment that I would raise that with the Minister, Deputy Leo Varadkar. It sounds like an important one, and if we can make connections in that regard we will try to do so.

I hope those clarifications have been useful to the Senators. I will send them written correspondence also referring to the various principles to which I spoke. I thank them for their efforts in passing the Bill.