Lawyer Monthly - July 2022

The Cutting Edge of Life Sciences JUL 2022 | WWW.LAWYER-MONTHLY.COM 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, aswell 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. We can seea general trendat aEuropean 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 themedical device. In general, the new regulations introduced more stringent procedures for conformity assessments and post-marketing surveillance and required manufacturers to produce 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. 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. MY LEGAL LIFE - FRANCESCA BELLI NOVAK 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. As technology in life sciences races ahead – and regulation races to keep up – it takes expert legal advice to steer both large and small organisations in this space. In this feature she offers a look into her practice and the latest developments in this fascinating sector of law. 29

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