This month we hear from Francesca Belli Novak, a life sciences lawyer with an extensive background in serving clients across Europe, the US and Latin America. In this feature she offers a look into her practice and the latest developments in this fascinating sector of law.
As an international life sciences lawyer, what does your day-to-day work look like? What aspects of your work do you enjoy the most?
When you manage your own legal practice, every day looks different. That is one of the reasons why I love my current job so much. There are certainly some areas to be taken care of on a recurrent basis, but that is far from boring: business development, accounting, researching, organising meetings and so on. Each client, however, has different needs and the breadth of the topics touched upon is huge. On a start-up and scale up-level their needs are more towards building up the company structure, developing a sound legal and compliance system and establishing key contractual relationships. For mature companies, legal assistance instead becomes more specialised and tailored to the various business divisions like R&D, market access, medical affairs, commercial operations, corporate administration etc.
Objectively speaking, being an international life sciences lawyer is quite an exciting job for different reasons. First of all, because of the subject itself and the environment: mingling with often groundbreaking science and extremely educated people is fascinating and engaging. Also, dealing with such a highly regulated and constantly evolving industry, you are intellectually stimulated and challenged regularly. On top of that, the relevant market is often global and lawyers have to develop an international knowledge and network. Fortunately, nowadays there are uniform regulations in many areas and technological improvements to eliminate even more barriers, like distance and language.
How are biotech and medical devices regulated in the EU?
Various sectorial laws govern the life sciences arena at an EU level. To name just the most significant ones: the Medicinal Products Directive, the Medical Devices and In Vitro Diagnostics Regulations and the Clinical Trials Regulation.
Moreover, some pieces of horizontal legislation are particularly relevant for companies operating in the healthcare setting, like the GDPR, the Product Liability Directive, anti-competition and transparency rules, as well as the artificial intelligence legislation that is going to be developed in the coming years. Enterprises should also be aware of the many “soft laws” and codes of conduct which may set, if not obligations, then at least best practices to follow in order to maintain high ethical standards and to protect their reputation.
When you manage your own legal practice, every day looks different.
We can see a general trend at a European level of promoting harmonisation by moving to the legal instrument of the “Regulation” which, as opposed to that of the “Directive”, does not need to be transposed into single national laws but is immediately enforceable as it is.
For example, medical devices and in vitro diagnostics now follow the same rules throughout the EU/EEA. Each medical device must undergo a conformity assessment by an accredited notified body designated at a national level to demonstrate that it meets the requirements laid down by the Regulation. In some cases, the EMA at an EU level should release a scientific opinion beforehand.
Different rules and obligations also apply based on the individual risk classification of the medical device. In general, the new regulations introduced more stringent procedures for conformity assessments and post-marketing surveillance and required manufacturers to produce 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.
We can see a general trend at a European level of promoting harmonisation by moving to the legal instrument of the “Regulation” which, as opposed to that of the “Directive”, does not need to be transposed into single national laws
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 non-compliance.
Francesca Belli Novak, Founder
Tel: T: +43 681 10665510
About Francesca Belli Novak
“Since the beginning of my career in 2008, I have been providing counsel to companies operating in the life sciences field. After my legal training in the life sciences department of a renowned boutique law firm in Milan assisting international clients, I spent the following ten years as an in-house lawyer for two global biopharmaceutical companies, first in Italy and then in Switzerland.
One year ago, I fulfilled my professional dream and opened my own law firm, BelliLS (based in Vienna but assisting clients all over the world), both treasuring the experience I gained until then and taking the opportunity to bring in my very personal values and passions: a genuinely modern way to work which is extremely adaptable, quite informal and uses as much as possible the potential of the latest technologies. The main distinctive feature of my business is being as close and accessible to my clients as an in-house lawyer yet maintaining a high degree of freedom and flexibility on both sides.”