Our partner Bisera Andrijašević participated last week in the AIJA – International Association of Young Lawyers conference “Bring Business to Life: M&A and Commercial Transactions in the Life Sciences Industry” held in Belgrade. She spoke on the Panel I “Regulatory challenges in LS sector – does it go too far?”, discussing the challenges investors face when acquiring companies in pharma and MedTech sectors. The most important takeaways are:
📌 Pharma and MedTech are highly regulated industries, so obviiusly, all phases of M&A deals are more demanding compared to M&A deals in non-regulated sectors. This is particularly true when investors are PEs.
📌Due diligence should focus on regulatory compliance, as well as on compliance related to antitrust, data protection, and cybersecurity;
📌Merger control may impact the timeline, value, and even the feasibility of the deal, particularly when the deal concerns an innovation;
📌Different local regulations affect transferability of licences and permits, which also largely depend on the structure of the deal.
📌Complexities of multiple regulatory regimes may impact the timeline and risks, so local regulatory lawyers should be involved in the early stages of the transaction.
As a member, Bisera also participated in the meeting of the AIJA Healthcare and Life Sciences Commission.