Key legal info on regulatory reform in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
In Ireland, there is currently no mechanism for class actions; however, the Multi-Party Action Bill 2017 is making its way through the legislative system. If this piece of legislation is successful, it will have the potential to dramatically change the landscape in terms of product liability claims.
The European Commission have also proposed a new directive on the protection of the collective interests of consumers. If this is implemented it would introduce a form of class action litigation which can be taken by consumers and most likely would increase the risk of litigation in Ireland.
In 2016, the United Kingdom voted to leave the European Union (Brexit), and their decision will have long lasting effects on the healthcare (and other) sectors. MDR 2017 and the forthcoming Eudamed database is an example of EU cohesiveness and sharing of information. The EU has long shared information in the medical and healthcare spheres in a conscious effort to ensure consumer safety.
Safetygate (formerly Rapex) is the rapid alert system for dangerous non-food products, and it is unknown how systems and shared databases will function post Brexit. The potential loss of valuable information and data from the United Kingdom could have significant effects.
Furthermore, a major issue of concern post-Brexit will be the shortage of NB. When the UK withdraws from the EU, UK NBs will lose their status under EU law and their ability to carry out conformity assessments certifying medical devices safe to be placed in the EEA. The EU Commission has made it clear that UK NBs will be removed from the Commission’s information system on notified organizations (NANDO). This removal has caused mass concern in the industry as the likelihood for delays and a blockage in the system has seemingly become inevitable.
2. When are they likely to come into force?
The MDR came into force in 2017 and as they are in the form of a Regulation rather than a Directive, do not require transposition via specific national legislation, however full application of the MDR will take effect in May 2020.
As regards Brexit, the current deadline is 31 January 2020, but given the unpredictable nature of the negotiations, this deadline may be subject to change.