The rules bring greater transparency and reduce the administrative burden
More than six years after its publication, Regulation (EU) No 536/2014 on clinical trials (the "EU Clinical Trials Regulation") is finally going to apply as from the end of January 20221. This is no doubt good news as it will simplify the administrative burden of carrying out clinical trials in the EU. There will be other advantages too, like even greater transparency when it comes to the publication of clinical trials results-related information.
To date, under EU law and guidance, registration and publication of clinical trials' summary results is compulsory for phase II-IV clinical trials with adult-only patients/participants; and all clinical trials, regardless of their phase, with paediatric patients/participants.
Sponsors of the above-mentioned clinical trials with adult-only patients/participants must provide the clinical trial summary report, which is part of the end of trial notification (albeit usually submitted only subsequently to the end of trial notification), within one year of the end of the clinical trial. Sponsors of clinical trials involving paediatric patients/participants must submit certain result-related information no more than six months after the clinical trial has ended, pursuant to Regulation (EC) No 1901/2006 on medicinal products for paediatric use.
Once the EU Clinical Trials Regulation applies, sponsors of all clinical trials (irrespective of their phase) will have to submit summaries of the clinical trial results within one year from the end of the clinical trial in all Member States concerned, which will then be made publicly available. In cases where a clinical trial protocol provides for an intermediate data analysis date prior to the end of the clinical trial, and the respective results of the clinical trial are available, the sponsor will have to submit a summary of those results within one year of the intermediate data analysis date. The six-months deadline for clinical trials involving paediatric patients/participants will still apply going forward.
In addition to the steps mentioned above that companies will need to take, the impact of the new requirements should also be considered by companies in the pharmaceuticals and biotech sectors when considering the optimal times in the development process for filing patent applications. The relevance of any such disclosures (in particular, whether such disclosures might render an invention not patentable) will depend on the context, including the details of the publication and the technical background. Nonetheless, the publication of phase I results within one year of completion of the study should not be overlooked.
1 The new regime will be optional for clinical trials starting within the first year after the application of the EU Clinical Trials Regulation.
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