clinical safety data. This has particularly impacted apps and software as medical devices. One of the hot topics nowadays is indeed the qualification and classification of a piece of software (typically an app) as a medical device. To this end, the intended purpose as described by the manufacturer plays a key role. In principle, a software which is intended to process, analyse, create or modify medical information needs to be qualified as a medical device if it is driven by a medical intended purpose. One has to bear in mind that the purpose is assigned to a product by the manufacturer not only through the label, the instruction for use and the clinical evaluation, but also through the promotional or sales material or statements. If a software or an app can be regarded as a medical device, then all regulatory requirements must be fulfilled. This also entails that any claims relating to the intended medical purpose of the product must be supported by clinical evidence. Thus far, what has the impact of the Clinical Trials Regulation been on the pharmaceutical industry? The Clinical Trials Regulation, which repealed the previous Directive of 2001, entered into force in the EU/EEA on 31 January 2022 after a long wait, following the centralised Clinical Trials Information System (CTIS) finally becoming operational. In the past, clinical trial sponsors had to submit their applications separately to national competent authorities and ethics committees to gain regulatory approval. Now, sponsors are able to submit one online application via the CTIS to run a clinical trial in up to 30 European countries. Through this system, national regulators can collaboratively process clinical trial applications, request further information, authorise or refuse a trial and oversee an ongoing trial. Although sponsors can already use the CTIS from the beginning, they can still benefit of a three-year transition period. Overall, the Clinical Trials Regulation offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants. How do you expect this to impact pharma over the coming years? Statistics on the authorisation of clinical trials in the EU/EEA are being published on a monthly basis, beginning from May 2022, thus providing an insight into how the new uniform law is transforming this environment. It is still too early to draw any conclusions, and the data published in the first report (referring to the period from 31 January to 30 April 2022) shows that sponsors, for the time being, still prefer to use the old national submission system compared to the new centralised one (590 applications registered by the Member States with the EudraCT versus 56 application submitted directly by sponsors through the CTIS). However, this should not be worrisome and an adaptation period should be regarded as physiological since companies need some time to get prepared and accustomed with the new system. Are there any other legal or political developments that have recently impacted the life sciences sector? Recent events and technological improvements have impacted the life sciences sector and the speed of its innovation probably more than any other. The COVID-19 pandemic has surely given a big push to research and stimulated alternative solutions in many areas such as the conduction of clinical trials, development of diagnostic systems and telemedicine. Artificial intelligence (AI) applied to healthcare is also revolutionising the industry. From the identification of new drug candidates to the detection of diseases passing through mental health therapy and surgical robotics, AI is proving to be a gamechanger in several fields. The blooming of AI-powered medical devices in the form of apps downloaded onto one’s smartphone has been also noticeable in the last years. Entrepreneurs aiming to bring innovation in the medical field must carefully consider the legal and regulatory framework in which their products or services fits in. Beyond this, what other legalities must companies consider before launching new medical products in the EU market? Besides all the general legalities applicable to any organisation, special care should be given to the way products are advertised and to the communication with patients, doctors, public officials and the general public. Since the rules in this sector are intricate, it is strongly advisable to partner early on with an experienced counsel who can help the organisation navigate such complexity, thus making sure that the efforts to build a successful business are not jeopardised because of noncompliance. WWW.LAWYER-MONTHLY.COM | JUL 2022 MY LEGAL LIFE - FRANCESCA BELLI NOVAK 30 When you manage your own legal practice, every day looks different. Contact Francesca Belli Novak Founder, BelliLS Tel: +43 6811066 5510 E: fbellinovak@bellils.com www.bellils.com
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