Damien English (Meath West, Fine Gael)
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I am grateful to the Senators for having me here again. The House has been like a second home lately.

I am pleased to bring the Intellectual Property (Miscellaneous Provisions) Bill 2014 before the House. Although quite short, it is a significant Bill, amending intellectual property legislation as well as addressing some minor technical issues arising from the implementation of the recently enacted Competition and Consumer Protection Act. The Bill will change patents legislation, giving additional legal protection for medical research carried out prior to obtaining regulatory approval for new or generic drugs for human and veterinary use.

The Bill will also introduce a small number of changes in the area of trademarks to allow Ireland to ratify the Singapore Treaty on the Law of Trademarks. This international treaty aims to reduce the administrative burden on trade mark applicants worldwide. Taken together, the legislative proposals will enhance Ireland's innovative environment making it more conducive for entrepreneurs to exploit their intellectual property. The changes to the media merger provisions in the Competition Act 2002 that were recently amended by the Competition and Consumer Protection Act will ensure there is a robust and coherent media merger assessment process.
I will set out for Members the context in which I bring the Bill before the House. Intellectual property is key to supporting innovation and business. Patents add enormous economic value to new inventions by granting them a 20-year monopoly and enabling the commercial exploitation of novel ideas in the marketplace. Trade marks ensure that businesses can promote brand identity and safeguard hard-won reputations for quality products and services by protecting brands from illegal imitation. The pace of legislative change has accelerated in the area of intellectual property in recent years. It is no longer sufficient simply to update IP legislation once every decade or so. It is now incumbent on Government to ensure that we stay at least level with, if not ahead of, best practice internationally to maintain our competitive advantage. Our strong IP regime and the substantial research and development support Ireland offers greatly contribute to our continued success in attracting and retaining foreign direct investment, or FDI. IP protection is a key factor in attracting FDI and Ireland continues to score strongly in this area. A Grant Thornton report published earlier this year highlighted that key decision-makers involved in making investment decisions stressed the importance of an effective and responsive intellectual property regime, combined with research and development benefits, rating this even more highly than tax incentives.
The current body of intellectual property law in Ireland was drafted in the 1990s and early 2000s. With some significant amendments since that time, it continues to serve our national needs and to meet our international obligations. A 2013 international study carried out jointly by the European offices overseeing patents and trade marks pointed to the fact that in Ireland, intellectual property intensive industries accounted for almost 49% of Irish GDP and some 22% of employment. Future economic growth in Ireland will depend on deepening levels of creativity and innovation at all levels of enterprise. Both indigenous and multinational innovators are key to creating greater asset value and maintaining and creating sustainable jobs and employment.
The section of the Bill amending current patents legislation owes its origin to two EU directives from 2004 which introduced provisions into Irish law protecting medical researchers from patent infringement for acts done while seeking regulatory approval in the course of developing a generic drug. This regime was introduced into Irish law in 2006 by amending section 42 of the Patents Act 1992. Section 42 of the 1992 Act originally protected certain acts such as those done privately for non-commercial purposes or acts done for experimental purposes from prosecution as patent infringements. Section 42(g), inserted in 2006, broadened the provision's scope with the effect that since then any acts done in conducting studies and tests necessary for regulatory approval for medicinal products are also not regarded as patent infringements. The provision allows generic drug manufacturers to carry out the various studies and tests necessary for regulatory approval or marketing authorisation to place generic drugs on the market.
I stress that the proposed changes will not affect the pricing of generic drugs in Ireland or the extent to which they are currently used. Instead, the focus of proposals is on enabling the pharma sector to develop new and generic drugs while protecting them from unnecessary patent litigation. It is also important to emphasise that the transposition of the 2004 directives into Irish law was correctly done in line with EU law and was faithful to their wording. However, several EU member states, including Germany, took a more expansionist approach and adopted a broader research exemption. This enhanced legal certainty for the pharma sector has been cited by the industry as an incentive to undertaking medical research and testing in those jurisdictions which introduced it. The broader research exemption has grown in popularity among member states and is now valued by the pharma sector when investment options in Europe are considered.
Following consultations with our stakeholders, my Department reviewed the existing provisions and drafted legislation aimed at expanding the existing research exemption. I am also conscious that our nearest neighbour, the United Kingdom, recently implemented similar changes to its research exemption. The expanded research provision in the Bill will assist the pharma sector with its substantial employment and export footprint in Ireland to continue to invest and undertake important research and development activities in Ireland within a legal framework that provides greater clarify as to what is possible without fear of infringing existing patents.
Senators may be interested to know that Ireland exported more than €21 billion of medicinal and pharmaceutical products last year.

It is in this context that the Government will continue to prioritise the enhancement of our regulatory environment to sustain this crucial economic sector.
The part of the Bill amending the existing trade mark legislation allows Ireland to take a step towards acceding to the Singapore Treaty on the Law of Trademarks. The Singapore treaty was adopted under the auspices of the World Intellectual Property Organisation at a diplomatic conference in 2006. It revises and updates the previous 1994 trademark law treaty, of which Ireland is already a member. The key objective of the Singapore treaty is to create a modern and dynamic international framework to harmonise administrative trademark registration procedures. Trademarks are important business assets and trademark rights are secured through registration. By agreeing to the common standards in the Singapore treaty, we aim to establish greater certainty and reduce costs for all those seeking to protect their trade marks in Ireland.
Accession to the Singapore treaty compliments Ireland's current participation in the trademark law treaty and reinforces Ireland's ongoing efforts to encourage e-commerce. It is important that Irish legislation and business practices keep pace with international developments in this area. Many of our key trading partners have ratified the Singapore treaty and accession would also enable Ireland to participate in the future direction of the administration of trademark law at an international level.
To date, there are 38 contracting parties to the Singapore treaty, including 17 EU member states. Much of the legislative requirements to accede to the treaty are already in place in Irish law. The only amendment required to current trademarks legislation relates to licences. Currently, the trademarks Act imposes an excessively high penalty on licensees who fail to register their details with the Irish Patents Office within the prescribed time period. The Bill before the House today seeks to correct this imbalance and ensure that an unregistered trademark licensee can join with a registered proprietor in infringement proceedings against a third party and receive part of the proceeds of any damages following a successful infringement action. This will be in line with the provisions of the Singapore treaty.
I now wish to turn to the specific provisions of the Bill and explain what each is designed to achieve. Sections 1 and 5, which deal with the definitions, the Short Title and collective citations, are standard legislative provisions, while sections 2 and 3 are at the core of the Bill. As I have mentioned, section 4 addresses minor technical issues arising from the implementation of the recently enacted Competition and Consumer Protection Act 2014.
Section 2 amends section 42 of the Patents Act 1992. That section provides for limitations on the effect of patent rights. Section 2(1) provides for an additional paragraph in section 42 after paragraph (g), namely, section 42(h) which inserts the key provisions of the expanded research exemption into the Patents Act 1992. It provides that acts done in conducting studies, tests, experiments and trials - we deliberately took a broad, non-prescriptive approach here so as not to inadvertently narrow our new broader exemption - in legitimate pursuit of regulatory approval, will not be considered in violation of a patent. Section 2 extends the limitation of patents to "any act done which is required as a consequence" of the acts required to pursue marketing authorisation, ensuring again that the broader research exemption does indeed fulfil its role and allows for legal certainty and broad protection for such key medical research.
The definitions of a "medicinal product for human use" and "veterinary medicinal product" are derived from the relevant 2004 EU directives but are stated in full in the amendment. This is to guard against any possible future revisions of these definitions in EU law affecting this expanded research exemption in Irish law, as well as ensuring the definitions in the amendment are subject to interpretation by Irish, rather than EU, courts.
I am conscious that the effects of proposed amending legislation, even for a relatively small Bill such as this, can often be unclear. To clarify, the provisions of section 2 will affect the Patents Act 1992 in two principal ways. First, it will broaden the research exemption and bring legal certainty where there was ambiguity, by ensuring that all research on patented medical and veterinary products done for regulatory approval or "marketing authorisation" as it is known in Ireland, will be protected from patent litigation. This change will extend the current protection of research on generic medicines to include new and innovative medicines.
Second, it expands the exemption to cover acts done here in order to obtain regulatory approval outside of the European Economic Area, namely, beyond the EU and Iceland, Norway and Liechtenstein, as currently provided for in EU legislation. We do not intend to limit the opportunities of the Irish-based pharma sector to undertake vital research and development here in order to obtain a marketing authorisation in non-EU or EEA states due to an absence of legal certainty in this area.

Section 3(1)(a) amends section 29(3)(b) of the Trade Marks Act 1996. This amendment will enhance legal certainty by ensuring that the rights of the unregistered licensee in cases of infringement, as set out in sections 34 and 35 of the Trade Mark Act, are not conditional upon the registration or recordal of the trade mark licence on the trade mark register. Section 3(1)(b) amends section 29(4) of the Trade Marks Act 1996. The existing provision
imposes too heavy a penalty on the unregistered licensees and does not comply with the Singapore treaty. Up until now, the unregistered licensee was not entitled to damages or a share of profits in respect of any infringement of the registered trade mark that occurred after the date of the transaction of the licence and before the date of the application of the recordal of that license on the register. It is proposed, therefore, to drop the requirement that recordal of a licence is necessary in order for a licensee to obtain damagesin an infringement action. Instead, it is proposed that recordal will be required in order for a licensee to obtain legal costsin any such action. A less onerous penalty will meet the requirements of the treaty and promote the public policy objective of providing transparency.
Section 3(2)(a) sets the commencement date for the new provisions under section 3 to come into effect. Section 3(2)(b) provides for the definitions of "infringement of a registered trade mark" and "registered trade mark" in accordance with the relevant sections of the Trade Marks Act 1996.
Section 4includes three amendments to the Competition Act 2002. I am happy to facilitate these amendments in the Bill on the basis that they deal with a number of minor technical issues that emerged during the implementation of the media merger provisions contained in the Competition and Consumer Protection Act 2014 Act which, inter alia, amended the 2002 Competition Act. In effect, there are two separate sets of amendments. The first set relate to section 28B(2)(b) and the process around the notification of a media merger to the Minister for Communications, Energy and Natural Resources. As it stands, the Act allows parties to notify that Minister immediately after they have notified the Competition and Consumer Protection Commission. However, while the Act gives that Minister 30 days from the end of the CCPC or European Commission process, whichever applies, to complete his or her initial examination, the Act also currently allows, under section 28D(9), for the Minister to effectively stop the clock on the process while he or she awaits further information requested from parties. However, this ability of the Minister is contingent, at present, on the date of notification rather than the end of the CCPC or European Commission process, meaning that a situation could theoretically arise in which the Minister could lose the ability to request further information while suspending the time limits, given that he or she cannot actually commence examination of the merger until after the end of the previous part of the process. This amendment, to section 28B(2)(b), clarifies that notification can now only occur after the end of the CCPC or European Commission process, thus removing the possibility that the Minister might be deprived of the ability to require further information from the merging parties with the appropriate protections.
There is also an amendment to subsection 4B, as inserted by section 59 of the 2014 Act, which ensures that in circumstances in which parties submit proposals to the CCPC, the timelines and the process are unaffected. Importantly, this amendment has no effect on the length of the process that parties must go through and does not represent an additional time burden for businesses; it merely ensures that the process remains robust and coherent
throughout.
The second set relates to a single amendment to section 28E(13)(b) and corrects an incorrect cross-reference to a subsection. This is a drafting error in the text, and this change ensures that the phase 1 and phase 2 assessment can operate in the same manner. Section 4 also provides clarification on the treatment of media mergers notified during the interim period between 31 October 2014 - when the media merger part of the 2014 Act came into effect - and the coming into effect of these amendments.
Notwithstanding the proposed minor changes to the Competition Act, the focus of the Bill remains on updating the intellectual property regime in Ireland. Other changes to the IP regime are also taking place, particularly at EU level. The EU has long played a central role in the area of trade marks ever since the establishment of a European trade mark back in 1994. Trade mark policy continues to evolve, with the greatest reforms of the EU trade mark system in 20 years close to agreement at EU level. However, progress on agreeing an EU patent has been far more gradual. A patents package has been agreed and is in the process of implementation. This package consists of a unitary patent in Europe to be administered by the European Patent Office, and an international Unified Patent Court to be established between a majority of member states. This means that when the system is in place, innovators will be able to secure a single patent covering up to 25 member states and then enforce their IP rights in a single legal action, saving time and money.

Ireland has long been committed to a unitary patent system within the European Union to provide a streamlined and cost-effective system. Only last month, the Minister for Jobs, Enterprise and Innovation, Deputy Richard Bruton, announced Ireland's intention to establish a local division of the court in Ireland. This will facilitate SME access to the court, saving time and money and lowering the barriers that in the past prevented them from defending their intellectual property rights. All of this, however, is subject to the Unified Patent Court being approved by the people in a constitutional referendum on a date to be agreed by the Government.

These reforms in key areas of intellectual property will require further national legislation in the coming years to embed them in Irish law. They will form a vital part of Ireland's overall IP strategy that will enable researchers, inventors and designers in Ireland to protect and extract value from their ingenuity and creativity. They will also ensure these intangible assets can be leveraged to drive jobs and growth. I re-emphasise that the Bill is a modest but significant enhancement of Ireland's intellectual property regime. The amendments to the Competition Act 2002 will remove any potential ambiguity as to how one should interpret the provisions related to the full media mergers process and particularly the role of the Broadcasting Authority of Ireland when examining such a merger. I look forward to engaging with Senators on all Stages in this House and will be happy to respond to any issue that arises. In the meantime, I commend the Bill to the House.

Mary White (Fianna Fail)
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I welcome the Minister of State, Deputy Damien English, and wish him continued success. During his tenure as Chairman of the Joint Committee on Jobs, Enterprise and Innovation he was so diligent that I foretold his appointment as a Minister of State within a short period.

I welcome the Minister of State's presentation of the Bill which Fianna Fáil supports. As he stated, intellectual property is the key to supporting innovation in business. Patents add enormous economic value to new inventions by granting their inventors a 20 year monopoly, enabling the commercial exploitation of novel ideas in the marketplace. Trademarks ensure businesses can promote brand identity and safeguard hard won reputations for quality products and services by protecting their brands from illegal imitations. As a business person, I had to deal with this issue. Brand identity and the protection of one's brand are the key to the success and growth of one's business and the creation of employment.

Fianna Fáil supports the provisions which provide for the ratification of the Singapore Treaty on the Law of Trademarks. This updates legislation, taking account of developments since the trademarks law treaty was developed in the 1990s. In particular, it reflects the use of trademarks in e-commerce and the development of non-traditional marks such as sound, three-dimensional marks and holograms. In ratifying the Singapore treaty Ireland will be acting in concert with some of the major players in the intellectual property world such as the USA and Australia which have already ratified it.

Ireland has a hard won international reputation in the foreign direct investment area and our success is due to the continued support of different Governments in attracting foreign direct investment into Ireland. There has been no hiccup in this regard. I hope the public will bear this in mind in the context of the Independents seeking to form a Government following the next general election, some of whom come from extreme left-wing groups. Were they to get their hands on the economy, it would send a bad message internationally in the context of foreign direct investment, as stability is critical. Companies must know before coming to Ireland that everything will remain as is.

Ireland also has a hard won reputation in terms of excellence in research and development. We have an excellent base on which to make further progress. Two thirds of Ireland's research and development takes place in the private sector, in creating new products and service innovations that will drive exports, growth and job creation. Productive high calibre research undertaken by highly skilled research teams, working closely with industry partners, must continue to be a priority. Innovation, innovation, innovation is the name of the game. As I said, the protection of companies' intellectual property rights is critical. Ireland needs a research and development framework that is competitive to encourage research and development activity and provide protection for the output of that research.

Any patent system must strike a balance between rewarding innovation and ensuring a high level of competition. Patent holders are entitled to protection for a maximum of 20 years. However, a patent holder can also get an extension for up to a further five years.

A current report on the importance of generic medicines across the EU indicates that over half of the volume of EU medicines are generic, but this represents just 18% in value terms. The report also mentions that, to date, generic medicines in the EU have generated savings worth €30 billion. Ireland was, as the Minister of State knows, late in getting involved in generic medicines. As a state we were slow to realise their full potential for the health budget.

The main benefit of the proposed new legislation would be the creation of a similar level of legal certainty in Ireland to that currently enjoyed in other jurisdictions with a broader research exemption. This would help to level the playing field when it comes to considering locations for future pharma investment. In encouraging innovation in research and development by the pharmaceutical sector, Ireland has greater flexibility to ensure that it maintains its strong position and attracts high value-added investment.

The objective of the Singapore treaty on trademarks is to create a modern and dynamic international framework for the harmonisation of administrative trademark registration procedures. States who have ratified the treaty include France, Spain, Denmark, Poland and the United States of America, and more than 50 countries have committed to ratification. I compliment the clarity of the Minister of State's speech on this issue. It is a complex issue, but the speech was first class. I am not being patronising; I am giving my honest opinion.

As the Minister of State said at the end of his speech, I would like to emphasise that the Bill before us is a modest, but significant, enhancement of Ireland's intellectual property regime. The amendments to the Competition Act 2002 will remove any potential ambiguity as to how one should interpret the provisions related to the full media mergers process, in particular the role of the Broadcasting Authority of Ireland when examining such a merger. I compliment the Minister of State and his staff on the simplification of this quite complex but most important issue.

Diarmuid Wilson (Fianna Fail)
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I thank Senator White. I am sure that, as a result of her opening remarks, quite a few representations will be made by Government backbenchers to the Taoiseach.

Damien English (Meath West, Fine Gael)
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She got me the job.

Diarmuid Wilson (Fianna Fail)
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It is quite obvious.

Hildegarde Naughton (Fine Gael)
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I welcome the Minister of State to the House. This Bill has two main elements. I welcome the broadening of the Bolar-type exemption for pharmaceutical research and development and the minor legislative changes to allow to us to give effect in Irish legislation to the Singapore treaty on the law of trademarks. I will confine my remarks to the first element, namely, pharma research exemptions.

Ireland is the leading location for the pharmaceutical industry in Europe. For such a comparatively small country, we punch well above our weight. Any contribution to maintaining our competitiveness in this area is very much to be welcomed. As well as our indigenous pharma industry, there are over 120 international pharma companies in Ireland, and eight out of the ten largest pharma companies in the world have a presence here. In fact, approximately six out of ten of the world's top selling drugs are now produced in Ireland.

When we joined the Common Market, fewer than 2,000 people were employed in the industry here, and now approximately 25,000 people are employed directly, with an equivalent number employed in providing services. An interesting statistic is that, as far back as 2008, two out of every five pharmaceutical jobs created in Europe were in Ireland, which illustrates the importance of this Bill.

In expert terms, and using the broader pharmacon measure, pharmaceuticals amount to approximately half of all our exports annually. The figures fluctuate a little year by year, but exports are always around the 50% mark. It is worth noting that when we think of pharmaceuticals we more often than not call to mind the manufacture of drugs for human consumption. However, veterinary medicine, or the research into and production of products to use on animals, is also a major part of the industry in Ireland.

It is said that Ireland is probably the largest net exporter of pharmaceuticals in the world and it is estimated that the replacement value of the sector in the economy would broach €40 billion.

The amendment of the Patents Act 1992 is, therefore, welcome. It is imperative that research into new products be encouraged and fostered. The Minister of State is to be commended on his proposal to end a lacuna in Irish legislation.
In broad terms, the purpose of the legislation is to prevent companies that are based here from being put at a competitive disadvantage. At present, in this jurisdiction, it is unclear whether someone intending to market a generic drug or biosimilar product would be subject to an action for patent infringement if the research into that proposed product was carried out during the patent of the original product. A patent, with extension, can last 25 years.
In order to get what is termed market authorisation - in other words, permission to sell a product - the manufacturer must present detailed data, obtained through research and testing, to the competent authorities. If such research is risking patent infringement, it is clear that research and development is restricted and the lead-in time to the introduction of new generic medicines is lengthened.
The original Directive 2004/27/EC was given a literal interpretation in our legislation, as happened also in the UK. Germany and others in the European Union gave the directive a more liberal interpretation, and, I note, have not fallen foul of the European Commission. In any event, as the laws of the European Union give very limited competence to the EU on matters relating to intellectual property and, in particular, patent infringement, I cannot see an issue here. The amendment will therefore allow research to be completed more quickly as companies will not have to wait for existing patents to expire. This will have the knock-on effect of allowing generic drugs to come to the market more quickly.
I commend the Minister of State on his consultation with the wider industry and the IDA and on taking action to address those difficulties. It is only proper that we do not place companies based here at a disadvantage when remedial action can be taken. Will the Minister of State confirm to the House that this amendment would allow such research to be carried out here even if the finished product were to be ultimately marketed abroad or even outside the European Union?
In a related way, I voice my support for the Cabinet's decision to do away with the so-called double Irish tax arrangement. Given our reliance on inward investment, is the Minister of State satisfied that the elimination of the double Irish has improved our lot in reputational terms while not damaging us in the eyes of investors? It would seem that it has, but I would like to the views of the Minister of State on that issue.
We also have the issue of tax inversion. Earlier this year, we saw pharma giant AbbVie's $53 billion acquisition of Shire, which has its headquarters in Dublin. This was described as the largest tax inversion deal in US financial history. This new entity is seemingly to be tax resident in the UK, so this is not actually an Irish issue in the long term, but it illustrates a point. While it obviously makes economic sense for multinationals to organise their business in such a way as to minimise their tax liability, it can cause disquiet. It is easy to say that if the US insists on taxing corporations at about 22%, the solution is in its own hands in terms of reducing its own tax rate. However, the world does not work that way. The US has far more economic muscle to flex. What is the Minister of State's sense of the attitude of the US, and does he think it might cause difficulties in regard to the transatlantic trade and investment partnership, TTIP, talks? I understand Commissioner Malmströmis in Washington this week to discuss a fresh start to those negotiations.
Again, I commend the Minister of State on his decision that the present Bolar-type exemption was too restrictive and his move to broaden it.

Feargal Quinn (Independent)
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I welcome the Minister of State, who comes to the House regularly. We miss him as the Chairman of the Joint Committee on Jobs, Enterprise and Innovation. This legislation arises from the Action Plan for Jobs 2012. I welcome the Bill.

I note that the Bill deals specifically with medicines and veterinary products. Will this affect developments in other fields, such as health? If a company was developing a certain product in the agricultural or agrifood sector, would this or other legislation cover the agricultural or biotech sector? That is part of the overall jobs strategy. We need to help the agricultural bio sector. We could also help SMEs in this sector through provisions similar to those contained in the Bill.

There are opportunities in terms of commercialisation of products, especially in the genetically modified sector. According to Professor David Baulcombe of Cambridge University, there are now plants with resistance to blight and other types of disease, seeds that could reduce the amount of fish meal used in fish farming, drought-resistant crops, and fruits that do not start rotting before they get to the supermarket. Such innovations could be of massive benefit in helping to alleviate world hunger. We need to examine the opportunities in this area. It is also important given the developments in the genetically modified sector in Europe and the fact that many scientists are coming forward to say that if we do not allow the genetically modified sector to develop it will cause further food shortages and starvation around the world. I would like to hear the Minister of State's reply on this subject.

I wish to avail of this opportunity to ask about counterfeit medicines, which the Minister of State mentioned. Counterfeit medicines can be branded or generic medicines. The Bill aims to ensure that Ireland is an attractive base for future development by pharmaceutical companies. Senator Mary White has also spoken about this. Part of that attractiveness is how we secure the market. What are we doing to counter fake medicines? Fake drugs are massively on the increase and the Internet is making such drugs much more available. I am aware that the European Union is making moves in this area, but perhaps we are moving too slowly. Track-and-trace systems - I know something about this in the agricultural area - for medicines are really useful in combatting fake medicines and are used in several European countries as well as the US, but we appear to be lagging behind in this regard. I would like to hear the Minister of State's comment on what is being done and when are we likely to see a track-and-trace system in place here for medicines.

I wish to raise a topic related to innovation on intellectual property. Rather than always talking about how the State can spur innovation, we must consider the State itself, by which I mean the public sector. It could be argued that trade unions have often managed to prevent governments from even publishing the performance indicators which, elsewhere, have encouraged managers to innovate. Most people would agree that there is vast scope for information technology to boost productivity in areas such as education and health care. However, it is sometimes hard for the private sector to get involved in bringing innovation to the public sector and improving productivity.

On the specific subject of medicine and health care, why are we not opening up government services competitively so that if a private company can provide a service by a cheaper method it will be given a chance? The HSE could declare that it will pay for any diagnostic test or device outside of hospital that can be proven to save money over, say, five years - for example, for use in detecting cancer at an early stage, when it is cheaper to treat, versus the late stage, when it is expensive and often fatal. Of course, some inventions will prove worthy while others will not. However, it may be seen as self-correcting. That is, if a test or device does not save money, then the reimbursements to the company providing the service will help focus the efforts of the entrepreneur, and the resulting innovation will both save money and create private sector jobs. We need to see much more of this type of arrangement, which would be a real encouragement to innovation. When we talk of innovation and protecting intellectual property, I reiterate that we need to open up the public sector itself to innovation. There is no point in the Government telling others to innovate if it does not innovate itself.

I support what the Minister of State is doing. As Senator Mary White said, I liked the words he used towards the end of his contribution. His enthusiasm, commitment and dedication to solving these challenges are welcome. I welcome the Bill and wish it well.

John Kelly (Labour)
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I welcome the Minister of State. I will be brief, because previous contributions have covered every issue that I could have raised. The Bill makes unrelated changes to current intellectual property legislation in regard to patents and trade marks.

It aims to ensure Ireland remains an attractive location for the pharmaceutical sector, which makes an important contribution to the Irish economy. It accounts for approximately a quarter of total Irish exports and is a significant employer. In 2012, a total of €55 billion worth of pharmaceutical, biological and chemistry products were exported from this country. Ireland is the eighth largest pharmaceutical producer in the world, with 25,000 direct jobs created in this country. Indeed, it is a big employer in my native County Roscommon with pharmaceutical facilities in Monksland, Castlerea and many other areas.

The Bill amends existing patent law to extend the current research exemption to developers of innovative medicinal and veterinary products. It will amend section 42 of the Patents Act 1992 to expand the research exemption provision. This exemption will now include all studies, tests, experiments, clinical and field trials and consequential practical requirements which are necessary for the purpose of obtaining marketing authorisation for a new as well as a generic product. It also amends sections 29(3) and 29(4) of the Trade Marks Act 1996. The amendments will allow Ireland to accede to the Singapore Treaty on the Law of Trademarks. This is a world intellectual property organisation treaty and aims to harmonise administrative trademark registration procedure and takes changes in new technologies into account.

I support the Bill.

Colm Burke (Fine Gael)
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I thank the Minister for bringing forward this legislation, which I very much welcome. Cork is hugely reliant on the pharmaceutical industry. Eight of the top ten pharmaceutical companies in the world are based in the Cork region, within a 50-mile radius of Cork city, which emphasises the importance of the industry to Cork. Anything that can help to copperfasten that industry and grow it further is welcome.

It is extremely important that there is certainty in legislation. It appears there was a question over the transposition of an EU directive whereby we did not cover all of the angles that had to be covered in terms of giving it the proper interpretation. When the directive was transposed in Germany it was given a wider interpretation, and that is what this amending legislation does. The issue in respect of research and development is very important. This country is lucky to be producing a huge number of well-qualified graduates and it is important that we do everything possible to keep them in this country. The only way to do that is to ensure we can grow the research and development sector. This is important legislation in that context.

An issue that concerns me is the establishment of the European patent court. I have commented on this previously. It has been decided that there will be one patent structure for 25 countries but my understanding is that the patent court would be located in the UK. I am aware we are setting up a local court here as well, which will feed into that. A proposal has been put forward to me by somebody who is expert in patent law and is strongly involved in it in Ireland. He previously worked with a big law practice and is now working in a private capacity as a counsel in our courts. The proposal is to set up a division of the court in the UK in this country, as opposed to a local patent court. The person made the point that there are strong grounds for doing that on the basis that as this is a common law jurisdiction, it would be very similar to the UK and there is no reason that a divisional court of the patent court based in the UK could not be established here. I have raised this matter with the Taoiseach, as we should not walk away from it. It is very important now because, although many people do not like to hear this mentioned, there is some uncertainty about the UK's plans regarding its involvement with the EU. It would be important from our point of view, therefore, to ensure that we can remove that uncertainty and that a divisional court of that overall court is based in Ireland. It is something we should consider.

The other issue I wish to mention follows on from what Senator Quinn said regarding cost effectiveness in our health service. Again, it is a matter I have raised previously and relates to haemochromatosis. I know somebody who is prepared to put in place a system whereby general practitioners could do the work that is now being done in the hospitals. All that is required is a research project with University College Cork, UCC, costing less than €25,000, but we cannot get the Health Service Executive, HSE, or the Department of Health to come on board. If somebody has haemochromatosis, which is an excess of iron in the blood, he or she must go to a hospital clinic to have blood taken once every three months. There is a cost factor in that. If they go to the clinic under health insurance, the health insurer is paying €300 to €400 for each visit. A number of GP practices in the Cork area are very interested in this and are prepared to provide the service for €100. The advantage is that not only is the patient not cluttering up outpatient services, but the service can be provided to a greater extent at a local level. This is something that involves a small amount of research but which could yield a good end result. I realise it is not the Minister's area of responsibility, but it is something that could be done. It is a very simple solution to that problem and we should use it.

There are many other good ideas, as Senator Quinn said. In the area of medicine and research, we should not ignore ideas when they are brought forward and we should not impose or create more paperwork, which appears to be what we are doing. Where there are simple solutions for problems we tend to put them on the back burner. This is something we should examine more carefully.

However, I welcome this legislation. It is good to provide certainty and this will help us to grow the research and development area further and, hopefully, grow the pharmaceutical industry in this country.

Damien English (Meath West, Fine Gael)
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I thank all the Senators for their contributions and Senator White for her kind comments and for her support in the early part of my career, which was a major addition and pointed me in the right direction. That applies to my party colleagues as well.

This is an important Bill and we have had the opportunity to have a good engagement on it. On Thursday we will discuss any proposed amendments or changes. I will start with Senator Burke's contribution and work back through the others. I am surprised to hear that a proposal is not getting a proper hearing. It is something I will raise with my colleagues across the Departments because, as Senator Quinn said, if we are expecting private industry to research innovation and to use new products, ideas and processes, we should do the same ourselves in all Departments. As the Senator is probably aware, the Health Innovation Hub was set up in Cork and hopefully it will commence full operation in July 2015. That is a place where ideas can be brought and can be implemented in the Department of Health and the HSE. The proposal should get a hearing, so I will check it out. The innovation hub is the place to tease it out to see what is wrong and why it is not moving forward. Where possible we are trying not only to save money but also to give the patients a better service, which is what is outlined in that proposal. I will check it out because that is not good enough overall.

Some of the issues raised related to different Departments, including the Department of Health. Senator Quinn, in particular, raised a number of issues that are relevant to the Department of Health so I will refer them as well.

The amendment to the Patents Act is intended to cover the acts done here in order to obtain a marketing authorisation anywhere else. The work is done here but it will cover anywhere else as well. The patents are a form of intellectual property rights that reward innovation, which is the key, and reward what can be years of experience and research. These rights are only limited in certain circumstances, where there is a public interest. There was a worthwhile discussion on this in the Dáil. There is protection for the public interest and that is important.

The counterfeit drugs issue was raised. We had a long discussion on this and the black market in the committee as well. There is a difficulty with usage through the Internet.

We are looking at different things, like awareness campaigns, which seem to work quite well in the UK, to get the message out that dealing in counterfeit goods and black market products is not victimless. Apart from the health effects of using the products, there are a lot of losses including loss of jobs and finances for the State through taxes. The message that there are victims when it comes to the black market does not appear to be getting through. From talking with the pharmaceutical sector, I am very concerned about the influx of products being brought into the country. We have to do more in this area and I will raise this issue with the Department of Health. It is a concern and we should all be part of the solution.

I was asked if the "double Dutch" has affected our reputation. Clarity has been brought on what is going to happen. We were being drawn into a lot of debate, unnecessarily and unfairly. Tax evasion and tax avoidance are always going to happen. Companies are under strict competition and for whatever reason will try to legally avoid paying tax, as opposed to evasion. It is a global problem. There are different tax regimes in different countries and opportunities arise to do this. We have put to bed the concept of the "double Irish". We were innocent in this. We were getting drawn into the wrong debate, especially in the US. It puts the matter to bed and our reputation will not be damaged further, but it also brings great clarity. We have set out the scene up until 2020. Companies that have made decisions to locate here and have based themselves here have long-term plans. This is a long-term decision for them. They now know they have three or four years to get ready for this.

It does not seem to have affected the numbers of other companies looking to come to Ireland. In fact, the last two trade missions to America by the Minister for Jobs, Enterprise and Innovation, Deputy Bruton, were quite positive, including the feedback on all of the issues relating to tax. More important, the reasons these companies are coming here is our intellectual property, IP, regime, our skills and the innovation of our people. The companies speak to us about the great passion the Irish have when it comes to research, innovation and development policies. We seem to stick out as a country in that regard. This reputation is helping us to win business. The focus has moved on from tax, the cost base and so on to what we can produce, as a people. Many companies are making definite decisions. They see both the previous Government and this one pumping money into the research agenda. This is feeding through the system. The research community and its ecosystem is being developed. Many new products, services and ideas are also being developed. Companies like this and want to locate here because of it. I am not concerned about the double Irish. I am glad it has been put to bed. A firm decision was made there and we can move on from it.

There are other solutions to the global tax problem. Companies should pay their fair share of tax. There is a duty on us all to act globally and to work with the base erosion and profit shifting, BEPS, process to try to rectify this to ensure everyone pays their fair share. Taxes are needed to run countries. During this debate, we have spoken about some people on the left claiming that all research should be carried out by the State and wanting to have no investment in it from anyone else. What we are trying to do as a country, and referring back to successive Governments, is build the relationship between taxpayers' money, the Government, the State and industry. We want to put the best money together to develop smart products and smart ideas.

Some people want the State not to impose taxes, not to have water charges, not to have any charges, yet they want the State to control everything. It does not add up. It is not possible to do all these things on one page. A person cannot own all the research if he or she has no money to pay for it in the first place. These same people do not have any solutions on how to raise money in this country. Their arguments do not add up when put on the one page. We are getting it right. This research agenda and this legislation will build and strengthen that community to make it easier to develop products and services in Ireland.

There were a few other issues mentioned that I can return to at a later stage and on Committee Stage. I will also contact the Senator directly with some answers as well.

Imelda Henry (Fine Gael)
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When is it proposed to take Committee Stage?

Hildegarde Naughton (Fine Gael)
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Next Thursday.

Imelda Henry (Fine Gael)
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When is it proposed to sit again?

Hildegarde Naughton (Fine Gael)
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Tomorrow at 10.30 a.m.