Aisling Gannon, Partner, Head of Healthcare, Eversheds Sutherland
Tony McGovern, Partner, Head of Life Sciences, Eversheds Sutherland
Ireland consistently ranks amongst the best countries in the world to invest in and do business. This is particularly true of the health and life sciences sector. Globally, the health and life sciences sector is fast-paced and innovative. This is particularly evident in Ireland where the life sciences industry is rapidly evolving. According to the IDA
- 10 of the world’s top 10 pharmaceutical companies
- 14 of the top 15 medical technology companies and
- 8 out of the top 10 US technology companies
are situated in Ireland. In addition, some 68,000 people are directly employed in the life sciences sector in Ireland. Life science exports represent 34% of Ireland’s total exports. Government support for research and development in the area remains strong since the creation in 2011 of the National Institute for Bioprocessing Research and Training (NIBRT) to support growth in biotechnology.
Eversheds Sutherland health and life sciences experts believe that global advances in life sciences will revolutionise the delivery of future healthcare services. Europe is making great strides with the digital transformation of healthcare discussed below. Ireland is following suit with positive regulatory developments and continued investment and funding in the sector.
Europe: Digital transformation of healthcare
Key principles for the use of electronic product information for EU medicines
The European Medicines Agency, the Heads of Medicines Agencies of EU Member States and the European Commission recently published key principles outlining a harmonised approach to develop and use electronic product information (ePI) for human medicines across the European Union. This initiative was launched to support the digital transformation of healthcare across the European Union. The ePI will be provided as open access information and will complement the paper package leaflet usually provided in medicine boxes, and sometimes online.
The new German Digital Care Act
In November 2019, the German parliament adopted the Digital Care Act which is intended to enable faster access to data, create added value for patients and foster innovation. Under the Act, patients will be entitled to medical health apps; doctors can fully advertise their services on their website and online consultation is facilitated; and E-prescriptions are being promoted.
Ireland: Important legislative developments
June 2019 saw the introduction by the Irish government of a five year pilot Medical Cannabis Access Programme. The programme is provided for under the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019. The purpose of the Regulations is to allow certain cannabis products or preparations for medical use to be prescribed and supplied under certain circumstances for the treatment of persons with certain medical conditions under the care of a medical consultant. If a product meets the requirements set out in the Regulations, suppliers can apply to the Health Products Regulatory Authority to have the product designated as a specified controlled drug.
In December 2019, two medicinal cannabis products were approved and registered under the programme.
Ireland: Important public policy developments
Sláintecare is the ten year vision and strategy for the health sector in Ireland. Commenced and launched in 2018 it sets out significant milestones to be met by 2021. A key statistic underpinning policy and investment in Irish healthcare relates to population profile. Between 2018 and 2031 it is estimated that the:
- 85+ years population will increase by 97%
- 65+ years population will increase by 59%
Ireland is well placed to be a leading light in the continual evolution of the life sciences industry not least in the aftermath of Brexit. Eversheds Sutherland has the expertise and support structures in place to assist the leading operators in this sector. We work with a varied and significant number of organisations across the pharmaceutical, biotechnology and medical devices industries. We advise on mergers and acquisitions, joint ventures, inquiries, investigations, data protection, privacy, intellectual property, litigation and insurance, corporate governance, and funding related to the healthcare sector.
Our presence across multiple jurisdictions means we can provide effective support to clients wherever they are based. We are strongly aware of the challenges and opportunities that lie ahead in the life sciences sector.
For further information, please contact:
Tony McGovern, Partner, Head of Life Sciences
Aisling Gannon, Partner, Head of Healthcare