Before any medicinal product is given permission to access the Irish market, it must be first tested in a clinical trial to verify that it is safe and fit for use. Any legislation impacting on trials has a considerable effect on the ability of medicinal products to access the market, so we review recent changes in this area.
Clinical trials in Ireland are currently primarily governed by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004. These Regulations transposed European Directive 2001/20/EC. At present, a clinical trial may only be started or conducted in Ireland if:
- the ethics committee of the organisation where the trial is to be carried out has issued a favourable opinion;
- the Health Products Regulatory Authority (“HPRA” – formerly the Irish Medicines Board) has granted an authorisation; and
- the sponsor or legal representative of the sponsor is established within the European Union.
However, this process is set to change due to the adoption by the European Union of Regulation No 536/2014 on clinical trials on medicinal products for human use (“Regulation”), which was published in the Official Journal of the European Union on 27 May, 2014 and can be found here. The new Regulation replaces Directive 2001/20/EC. Given that it is a Regulation, its requirements are automatically applicable in each Member State once it comes into force.
The Regulation harmonises the rules for setting up and conducting clinical trials. It will offer the use of a single, free-of-charge online portal, administered by the European Medicines Agency. This will allow sponsors to submit a single application dossier through a centralised, web-based portal, the EU portal, to all Member States in which the sponsor wishes to conduct a clinical trial. A publicly accessible database will store all information relevant to the clinical trial.
There will then be a single authorisation procedure, with a single decision per member state and a single fee per member state.
The application will then undergo a two stage joint “scientific assessment”. Part I is jointly assessed by all Member States concerned, while part II is assessed by each Member State concerned separately. It is hoped that the first part will strengthen the rules on the protection of patients and informed consent, while the second will ensure greater transparency on the information that arises from these trials. It should be noted that for all clinical trial applications submitted before this Regulation comes into force, the current directive will apply for a further 3 years. The Regulation shall come into force 6 months after the EU portal and database is fully functional, or no earlier than 28 May, 2016. However, currently an implementation date in early 2017 is likely.
The new legislation will also change the role of Ireland’s research ethics committees. The committee will no longer be selected by the sponsor; instead it will have an application assigned to it. The committee will also be involved in the first part of the assessment process and must conduct the second part of the process. This process will also involve various agencies such as the HPRA and the Health Information Quality Authority, to which the Minister for Health’s supervisory body role will be transferred, which will liaise with the ethics committees.
In the new legislation, there is also an effort to make clinical research transparent and open to the public. There will be an obligation on the sponsor to submit a summary of the trial’s results that will be made publicly accessible on the EU database. Details of the results, including a summary in plain language, are to be submitted within one year of conclusion of the trial.
The Irish Department of Health has commenced work to identify what changes will be necessary to implement the new requirements. Although the Regulation will apply directly i.e. Irish implementing legislation will not be required, it is likely that Irish secondary legislation will be required to give further effect to the requirements of the Regulation and that consequential amendments to other medicines legislation will be necessary.