Finian McGrath (Dublin North Central, Independent) | Oireachtas source

I did not know what was going on.

I thank the Leas-Cheann Comhairle for giving me the opportunity to speak to the motion which deals specifically with the Intellectual Property (Miscellaneous Provisions) Bill 2014. I welcome this debate as the entire sector to which we are referring is vital to the economic future of the country and also because the huge talent in the sector is often ignored by wider society. It is also important to say that when we address the words "intellectual property", we need to focus on the need for high standards and outside independent assessment, as in the case of the row about the junior certificate examinations. Students and graduates have high standards because they came through a second level education system in which they were assessed independently and professionally and that had their trust and that of parents. International companies come to Ireland because of our excellent workforce. It is important to say this in this debate in which we are talking about intellectual property. We have many high quality, skilled individuals in the State who are making a massive contribution. It is also important to emphasise our quality workforce as we often get carried away with the tax issues relating to international companies.

The Intellectual Property (Miscellaneous Provisions) Bill 2014 will amend existing patent law in order to extend a research exemption to the developers of innovative medicinal and veterinary medicinal products. The Bill will also make changes to the current trademark law to make it compatible with the Singapore Treaty on the Law of Trademarks.

In my introductory remarks on the Bill I also mentioned the importance of the pharmaceutical sector and the fact that we had highly qualified graduates. These are excellent young people who are delivering quality services. We all know that the pharmaceutical industry in Ireland has been transformed in recent decades, since the 1960s.

In fairness to the IDA and the people who work in this sector, they went around the world to target the fine chemicals industry. They brought a number of multinationals to Ireland and today Ireland is the eighth largest pharmaceuticals producer in the world, with nine of the world's top ten pharmaceutical companies locating substantial operations here. The pharmaceutical sector makes an important contribution to the Irish economy. It accounts for approximately one quarter of total Irish exports and it is a significant employer. The IDA estimates that 24,500 people are directly employed in the sector, with a further 24,000 people indirectly employed in support services. In the region of 120 pharmaceutical companies are located in Ireland. This is why I support the legislation. It is important to play to our strengths, particularly when we are trying to exit a recession. I know many of the people working in the sector, whether directly or indirectly, from my constituency of Dublin Bay North, in areas like Marino, Artane, Coolock, Clontarf, Howth and Killester.

The legislation gives legal certainty to the research exemption in Ireland and introduces a more liberal exemption than is currently provided. This legal certainty should reassure developers of innovative medicinal and veterinary products that Ireland remains a good place to conduct pharmaceutical business. That is a key element of the legislation. It also makes changes to Irish trade mark law, but these are not related to the research exemption.

It may not be politically correct to raise a different issue pertaining to intellectual property but it is worth warning the Government about it because the State could face costs of hundreds of millions of euro if we do not watch what is going on in the broader sector. I refer to the Public Health (Standardised Packaging of Tobacco) Bill 2014. In early 2014, the new EU tobacco product directive, TPD, was adopted. It included a ban on the sale of packs of ten cigarettes and methanol cigarettes, and mandatory 65% health warnings. After the European Parliament specifically voted against including plain packaging in the new TPD, the Commission decided to revisit the issue in five years' time. Ireland took a different view, however, and the Government proceeded with reform. Questions arise about the legality of this approach in regard to the deprivation of intellectual property, breaches of existing WTO agreements and whether it would lead to similar legislation for other products, such as alcohol. It is also questionable whether plain packaging actually works. I raise these questions because a number of documents circulating in the European Commission suggest that plain packaging was abandoned because of serious concerns among stakeholders. A more balanced approach has been chosen as a result and the Commission plans to review the issue after five years. Our Minister for Health takes a different view. By rushing to become the first country in Europe to adopt plain packaging, Ireland is set to make itself a guinea pig for lawsuits brought by tobacco companies. Is it not a more prudent course of action to let the UK or France, both of which have greater resources, to introduce plain packaging and defend any subsequent legal challenges before Ireland introduces its own measures? I may be a lone voice in this House but similar concerns have been raised by nine EU member states, namely, Bulgaria, the Czech Republic, Greece, Italy, Poland, Portugal, Romania, Slovakia and Spain, in detailed opinions submitted to the Commission under the TRIS notification procedures. Should these opinions not be shared with the Oireachtas before it is asked to vote on the legislation? I raise this issue in the context of our debate on intellectual property because I do not want us to face the prospect of a massive legal bill in several years time. We cannot afford it and we should not hammer the taxpayers of this country once again. I advise the Government to keep its eye on this ball because one never knows what is going to happen.

The Intellectual Property (Miscellaneous Provisions) Bill 2014 amends existing patent law to extend the current research exemption to developers of medicinal and veterinary products. It amends section 42 of the Patents Act 1992 to expand the research exemption provision to include all studies, tests, experiments, clinical and field trials and the consequential practical requirements for obtaining marketing authorisation for new and generic products. The exemption will apply to tests carried out in Ireland or any state in the European Economic Area. The 2012 Action Plan for Jobs tasked the Department of Jobs, Enterprise and Innovation with a review of section 42 of the 1992 Act with the aim of clarifying research actions that do not constitute patent infringement under Irish law in order to maintain and attract high value-added bio-pharmaceutical investment. The research or Bolar exemption is an exemption to the rights conferred by patents. This is particularly important for manufacturers of medicinal products. It will also allow manufacturers to prepare generic drugs prior to expiry of a patent.

Manufacturers of medicinal products must get regulatory approval that the products are safe and effective before they can be marketed or sold. This is very important in the context of international health. We have seen many mistakes in the past in respect of drugs like thalidomide. Product safety will be ascertained through clinical studies, tests and trials. Producers of generic medicines will be able to use the original manufacturer's regulatory approval if they can demonstrate that the generic version is bio-equivalent to the approved medicine. However, the generic producer runs the risk of patent infringement if it conducts clinical trials on a patented product before the patent has expired. The Bolar exemption means these necessary trials will not amount to a patent infringement.

The Bill has two distinct objectives. All EU member states require that prior to a drug being put on the market, the manufacturer must apply for marketing authorisation by submitting data that approve the safety of the product concerned. I welcome the Bill, although I would have preferred more detailed preparation, and I will be supporting it.

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