Bio

Rafael Lorenzo has extensive experience in cross-border M&A transactions between LATAM and Spain, as well as in private equity and corporate operations during his private practice at Uría Menéndez and Deloitte. His expertise encompasses M&A, commercial law, and the pharmaceutical and healthcare sectors, serving both B2B and B2C businesses.

As part of the legal team at Insud Pharma Group, he advised on a diverse portfolio of corporate and pharmaceutical matters across the LATAM and EMEA regions. His responsibilities included R&D, clinical co-development, licensing, supply and distribution, technology transfer, regulatory issues, public tenders, pricing and reimbursement processes, and various sale and purchase portfolio transactions. He also led legal matters related to manufacturing sites and external contract manufacturing organisations. Subsequently, he provided legal assessments on pharmaceutical matters for the APAC, Middle East, and North Africa regions, leading to his promotion as the legal head of Mabxience and a member of the Executive Committee.

Additionally, he served as associate legal director at Astellas Pharma for Spain, Portugal, and Eastern Europe, while also leading and advising on strategic and optimisation transactions, projects, and partnerships in the LATAM region. Currently, he is part of the legal department of Merck as legal head of cardiovascular, metabolism, and endocrinology global business, with a worldwide scope.

What strategies do you employ to ensure your legal advice is effectively aligned with the unique regulatory environments and cultural nuances of different LATAM countries?

A thorough preliminary legal analysis and alignment with all involved teams – particularly commercial, regulatory, logistics, and medical – are essential for addressing the various scenarios in all affected territories in an orderly manner. However, the action plan must be adapted across these territories in accordance with the specific legal and regulatory frameworks, as well as the diverse cultural practices applicable on a case-by-case basis.

What are your organisations plans in the LATAM region over the next 12 months and how will your legal expertise help to achieve these plans?

We plan to increase sales in LATAM territories and further implementation of new commercial strategies and partnerships.

What specific challenges have you encountered when managing legal issues related to Latin American markets from a European perspective, and how has your team addressed these challenges?

While the legal framework may be similar in some cases to that of a European perspective, practices and marketplace standards can vary significantly from one country to another. In these scenarios, it is crucial to have a solid understanding of these differences and the commercial partnerships involved. Collaborating with key stakeholders, including commercial teams and other legal colleagues in the LATAM region who possess specific knowledge, is essential for supporting the legal department in navigating these ever-changing situations. Additionally, legal advice from external LATAM legal counsel is sought for specific legal concerns and the implementation of action plans, while considering budget constraints.