Life Sciences and Ireland
Ireland’s Life Sciences sector—including Pharmaceuticals, Biotech, Medical Devices, and Diagnostic technology—has grown from humble beginnings in the 1960s to reach global significance. The sector exports more than €45 billion annually and employs over 50,000 people. Global players with substantial R&D, manufacturing and commercial operations in Ireland include Abbott, Allergan, Boston Scientific, GSK, Johnson & Johnson, Medtronic, Novartis and Pfizer.
The global importance of the Irish Biopharmaceuticals sector in particular is reflected in the capital investment of approximately US$8 billion in new Irish facilities, most of which has been made in the last 10 years. Ireland’s leading presence in the Medical Technology (MedTech) Sector is equally impressive. The Irish MedTech sector employs 25,000 people, with Ireland employing the highest number of MedTech personnel per capita in Europe. Ireland is the second largest exporter of MedTech products in Europe and exports €12.6 billion in MedTech exports every year. The development of the Irish Life Sciences manufacturing sector has also fuelled the emergence of significant Research and Development being carried out by many multinational companies in collaboration with the Irish SME sector and Irish third level institutions.
Why choose Irish Law and Irish lawyers for Life Sciences?
Range of Irish Life Sciences and Legal Experience: both global and indigenous companies based in Ireland have developed broad-based experience, including: regulatory compliance, clinical trials, supply chain, intellectual property protection and licensing.
Over the last couple of decades, the Irish legal profession has developed an in-depth knowledge and expertise in advising on all of the requirements of the Life Sciences sector, including: strategic collaboration agreements, clinical trial and supply chain agreements, as well as providing advice on commercial disputes, compliance, antitrust law, investments, acquisitions and mergers. Ireland already boasts a significant number of lawyers (working in law firms, in-house and at the Irish Bar) who specialise in the Life Sciences sector.
Common law approach and English speaking: Ireland brings the unique advantage of being in the EU (no customs barriers, part of the regulatory regime and a recipient of EU funding), while maintaining a practical common law approach which is of strategic importance to any Life Sciences company, and post Brexit will be the only native English-speaking country in the EU.
Choice of Law for Strategic Alliances and Contracts: life sciences companies have unique requirements to enter into numerous and broad-ranging contractual arrangements, ranging from early stage spinouts to multinationals. Many of these agreements are complex and must act as the foundation for a multi-faceted and long-term relationship. In particular, in recent years there has been a significant increase in the number of activities outsourced by the larger Life Sciences companies, including critical research and development, clinical trial, manufacturing activities and shared services. Many of these agreements have been governed by English law or by a law of a United States state (such as New York or Delaware). After Brexit, there will be significant doubt concerning the attractiveness of English law because of the likely withdrawal of the UK from the EU-wide enforcement of judgments regime. As Ireland is an EU Member State, the judgments of the Irish courts will continue automatically to be recognised by and enforceable before the national courts of all other EU Member States.
Commercial Court: The Irish judiciary is highly regarded, independent as a matter of law, and internationally recognised as being independent and impartial as a matter of fact. Judges with experience of very significant and complex IP litigation—as practitioners and as trial judges—serve on the High Court, the Court of Appeal and the Supreme Court. The bulk of significant IP litigation in the State takes place before the Commercial Court division of the High Court, which provides a fast-track case-managed system with hearings before a limited pool of judges. In 2020, a new Intellectual Property and Tech List will be established as part of the Commercial Court division of the High Court.
How will BREXIT impact on Life Sciences?
The Irish Life Sciences sector is primarily regulated by regulations and directives which have European wide application. Irish manufacturing facilities which are approved by the US FDA to manufacture products for sale in the US are also subject to US Regulation. Biotech products are approved under the European Medicines Agency under a “centralised” procedure. Other Pharmaceutical products are the subject of the EU “mutual recognition” or “decentralised procedures” where products are approved at national level but on the basis of EU legislation. As of February 2020, it is unclear whether the EU and UK will adopt a mutual recognition procedure. The UK formally left the EU on 31 January 2020 and became a third country. A transition period began on 1 February 2020 during which EU pharmaceutical law remains applicable to the UK. This is due to end on 31 December 2020.
Research and Development and Clinical Trials
Another consequence of Brexit is that post-Brexit, UK Life Sciences companies and research institutions may not have access to European funding such as Horizon 2020 (H2020). H2020 has provided almost €80 billion of funding for the seven years to 2020. In addition, investment by the European Investment Bank will no longer be available to later stage UK Life Sciences companies. These two factors are also likely to attract a number of companies to set up their businesses in Ireland.
The UK’s departure from the EU will likely affect Life Sciences companies that seek to attract human talent from other countries: the UK will cease to have the benefits of free movement of workers and visa-free travel within the EU. As a continuing EU Member State, Ireland will retain these advantages.
In 2014, the UK was the third largest country for pharmaceutical Research and Development (with a total annual spend of almost €5 billion). In light of Brexit, however, it is likely that some European Life Sciences companies may prefer to put research teams in other EU countries or to contract out research to EU based companies. Given its preeminent position in the Life Sciences sector, Ireland is a very attractive destination for such research and development activity.
More specifically, the UK is currently the EU’s most popular location for Phase 1 trials (which are earlier stage and smaller in size than later stage clinical trials) and is also a very popular location for both Phase 2 and Phase 3 studies. After Brexit, the UK may become less attractive in this regard, while Ireland will retain its attractiveness. This is because of the continued availability of EU funding in Ireland and uncertainty surrounding the application of the new EU Clinical Trials Regulation (which is expected to be implemented during 2020 and will facilitate pan-European clinical trials) in the UK.
Collaborative Clusters and GDPR
Ireland has an impressive track record in developing collaborative clusters in the Life Sciences sector. Collaborative clusters in Pharmaceutical, Biotechnology, Medical Devices and Diagnostics have been a key element behind the remarkable growth of a sector that directly employs 25,000 people. In respect of the Connected Health sector, the UK’s attractiveness as a location for collaborative clusters after Brexit may be affected by uncertainties around the sharing of personal data outside the EU—including the UK under the General Data Protection Regulation (GDPR).
In relation to GDPR, a transition period began on 1 February 2020 when the UK formally left the EU and became a third country, during which the GDPR continues to apply to the UK. This is due to end on 31 December 2020. It is not yet clear what will happen once the transition period is over but the UK government intends to incorporate the GDPR into UK data protection law from the end of the transition period. Transfers of personal data from EEA to the UK will not be restricted during the transition period. However, the position may change at the end of transition. The UK government has said that transfers of data from the UK to the EEA will not be restricted. However, from the end of the transition period, GDPR transfer rules will apply to any data coming from the EEA into the UK. Organisations will need to consider what GDPR safeguards can be put in place to ensure that data can continue to flow into the UK.