Digitalisation: There are several developing themes that will dramatically change the future of pharmaceutical manufacturing; firstly, the effect of Big Data, its management and clinical impact. The data, whether explored through greater diagnostics, the Internet of Things, neural networks and even through smart phones will have a major impact. The digital world is moving fast so there's a need to recognise and pre-empt this change in dynamics in the industry. Technology is driving change. Cheap, low power microprocessing units linked to the internet and the Cloud will encourage new ways of working. Cyborg implants and wearable diagnostics on data capturing devices will create new dynamics. (Prof Gavin Walker, Director SSPC, Bernal Institute UL)
M&A: Over the past 24 months there has been strong activity levels in mergers and acquisitions in the life sciences sector in Ireland, with a particular focus on the investment in or acquisition of Irish Medtech businesses. There are growing levels of maturity and sophistication in that sector in Ireland, the knock-on effect being more investment-ready opportunities for US and other investors. Following a period of consolidation in the industry, there has been a significant number of new CMO's entering the market, acquiring available plant capacity. (Colin Kavanagh, Partner and Head of Life Sciences, Arthur Cox)
Investigations/regulators: Regulators are expanding their efforts in this sector. For instance, the Health Information and Quality Authority (HIQA) is seeking to extend its remit to the private hospital sector. Also, the Health Products Regulatory Authority (HPRA) is expanding its team and capabilities with a view to playing a greater role as a leading regulator in the EU, particularly as the UK equivalent (the MHRA) potentially bows out. (Joanelle O'Cleirigh, Partner, Healthcare and Litigation, Arthur Cox)
Costs and ADR: In terms of disputes generally, there has been a move in recent times towards alternative methods of dispute resolution, which has the potential to reduce the costs and delays associated with more traditional avenues of dispute resolution, such as litigation. The Mediation Act 2017 was signed into law on October 2, 2017, and applies to all litigation disputes, apart from arbitration and certain matters under tax and customs legislation. In essence, the Act encourages the use of mediation as a collaborative, cost efficient alternative to litigation. From the perspective of potential investors into Ireland (including those in the technology and life sciences sector), this move is to be welcomed, encouraging as it does the speedy and cost-efficient resolution of disputes and enhancing Ireland's reputation as a location promoting growth and innovation. (Joanelle O'Cleirigh, Partner, Healthcare and Litigation, Arthur Cox)
Biopharma: The next big mega-change will be in the use of "biologics". Gene editing and manipulation is going to revolutionise healthcare worldwide. Medicine for everyone on the planet will become a reality within 20 years. Small molecules will still be part of the mix, but patient expectations are driving a new agenda. There is a strong will to have improved early diagnostic intervention and much more is expected in terms of precision molecules. (Prof Gavin Walker, Director SSPC, Bernal Institute UL)
Cost pressures from payers: this is resulting in calls for pricing reform. With an aging patient population, there are a greater numbers of older patients and drug costs are rising. They are looking to pharmaceutical companies to reduce their prices, and there's enormous pressure on industry pricing. Payers want to pay for value on a patient outcomes; this is difficult to measure so relies on enhancements in data analytics in the industry and gathering information about patient outcomes and quality of life. A lot of the payers are saying "you developed a drug, your patient is taking the drug but there is no measurable improvement for us to pay for your product". They have to gather evidence and data to show how they are actually making a difference to the patients' life, in terms of outcome. Drugs are going to be more targeted, leading to better outcomes.