During the recently concluded EU Pharmaceutical Law Forum, I had the pleasure of catching up with many GCs and senior lawyers in the life sciences space. On top of the high-quality presentations we attended, my conversations with these lawyers revolved around 3 key areas which will require extra vigilance and resourcing:
Competition Enforcement Risks
There is increased appetite for government intervention in the areas of merger control (see Illumina/Grail and Amgen/Horizon) calling for early-stage competition analysis of proposed combinations and newfound criteria, and in the marketing and promotional area, with respect to competitive claims and denigration of competitors’ products. There will also be a need for additional legal regulatory support given the pending reduction in the period for regulatory data exclusivity from 8 to 6 years and establishing whether companies have met the criteria for extensions to this time limit.
Corporate Governance Obligations
Legal departments are playing catch-up with mandatory corporate disclosures linked with ESG and CSR. Companies are weighing the comparative merits of locating the latter function within Legal or Compliance (see my recent post on the merits of locating ESG within the Legal Department).
AI & Data Privacy Risks
Last but not least, the combination and overlap of concurrent legislation (The European Health Data Space, The Data Act, and the e-Commerce Directive among others) are prompting pharma, biotech, and medical device companies to bring additional support in-house to meet the emerging legal, compliance and privacy challenges brought by generative AI and omni-channel marketing. A major and continuing concern raised among the privacy specialists is regulating data flow governance within their companies.
All in all, 2023 will not lack for excitement and challenges. More on these topics in future posts!