The sponsor`s ability to negotiate such arrangements depends on the size and importance of the process and its financial power. In general, on behalf of sponsors, there may be less appetite to negotiate such arrangements than usual for a standard business transaction – it is more important that the sponsor can properly test their product or equipment by having access to a large number of patients and the NHS infrastructure. The system will support Member States` day-to-day business processes and sponsors throughout the life cycle of a clinical trial in a user-friendly manner. CTA models, which are often used in the UK, correspond to the current regulatory system. Practitioners should therefore ensure that proposals are updated with the new legislation as soon as they enter into force. However, the question on everyone`s lips is how Brexit will affect the regulatory framework. The issues raised by Brexit are beyond the scope of this article, but it is certain that among members of the medical research community there are real concerns that, regardless of when and where the UK will leave the EU, if the UK does not adapt to the EU regime after Brexit, it will be a much less attractive prospect for clinical trials and scientific progress. Sponsors can be companies or state-funded institutions/agencies. Both may perform trials in order to use the data collected to support applications enabling the advertising and marketing of products for the authorised indication(s).
CTAS are distinguished from most commercial agreements in that the intellectual property generated is usually data that can be submitted to a regulatory authority to obtain the authorization of the drug in question. In most cases, they are unlikely to result in potentially patentable subject matter, but intellectual property remains of paramount importance in such agreements. As with most commercial transactions, the main consideration is who owns the intellectual property. The substantive IP should be owned by the party leading it to negotiate and account should be taken of the licences necessary to enable the parties to the agreement to use them for examination. On the other hand, the default position with respect to all IP addresses generated by the study (the “leading IPs”) in uk CTAs is that this IP is the property of the sponsor. It should be recalled, however, that the position may not be so simple and should be considered on a case-by-case and even case-by-case basis. This is because, in reality, there can be several categories of intellectual property – which relates to the product under review, the one that relates to the clinical process and possible improvements to existing intellectual property. Again, parties should consider the licenses that may be required to address the use of such a type of protection that deserves protection. The management of clinical trials in the EU is currently governed by Directive 2001/20/EC (“Clinical Trials Directive”), but changes to the regulatory framework are expected to come into force over the next 12 to 18 months. The new EU Regulation 536/2014 (“Clinical Trials Regulation”) was adopted in April 2014, but has not yet entered into force mainly because the IT infrastructure is simply not yet available to support it. . .