Innovation, ethics, and global legal exposure
The life sciences sector — spanning pharmaceuticals, biotechnology, and medical devices — faces an intricate web of legal, ethical, and reputational risks. From intellectual property disputes and clinical trial governance to equitable access to medicines, companies must navigate both global regulatory obligations and increasing public scrutiny.
Key Risks
Intellectual Property Litigation
In August 2022, Moderna filed suit against Pfizer/BioNTech, alleging infringement of several patents related to mRNA technology used in COVID-19 vaccines. Such litigation — often involving billions of dollars — underscores the strategic value and legal fragility of biotech patents in times of crisis.
Non-compliant or Unethical Clinical Trials
In a landmark case, Pfizer was accused of conducting unauthorized clinical trials in Nigeria during a 1996 meningitis outbreak. The antibiotic Trovan was tested on 200 children without proper consent or ethical clearance. Several deaths and severe side effects were reported.
The case was settled confidentially in 2009 and prompted reforms in international trial governance.
Conflicts of Interest and Aggressive Promotion
In 2019, Insys Therapeutics went bankrupt after its executives were convicted for bribing doctors to overprescribe its fentanyl-based spray. The company paid $225 million USD in fines before ceasing operations. This case became symbolic of the opioid crisis and highlights the legal risks in pharma sales models.
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Licensing and Equitable Access
During the COVID-19 pandemic, AstraZeneca and others were pressured to issue low- cost or royalty-free licenses to manufacturers in the Global South. India and South Africa petitioned the WTO for a temporary TRIPS waiver, reigniting global debates on access to life-saving treatments as public goods.
Sector Trends
Patent Governance and Unified Jurisdiction
The Unified Patent Court launched in 2023 across EU member states now enables pan-European IP enforcement, increasing the stakes — and the transparency — of biotech patent disputes.
Clinical Trial Transparency
Global regulators increasingly mandate public disclosure of all clinical trial results — both positive and negative — to fight publication bias and improve patient trust.
Environmental & Social Accountability
ESG investors and watchdogs now scrutinize pharma and medtech firms for their
carbon footprints, waste management, and sourcing of sensitive materials (e.g., cell
lines, reagents).
What This Means for Your Business:
Innovation without compliance is now a liability, not an asset. IP, ethics, and transparency must be integrated from the R&D phase onward.
Failure to manage trial risks, access concerns, or marketing ethics can lead to regulatory shutdowns, class actions, or permanent brand damage.
Investors, regulators, and health authorities expect governance that combines medical integrity with measurable ESG performance.
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Sources
Moderna v. Pfizer/BioNTech, U.S. District Court of Massachusetts, Case No. 22-
11337, August 2022Abdullahi v. Pfizer, U.S. Court of Appeals (2nd Circuit), 2009
U.S. DOJ, “Insys Therapeutics Agrees to $225 Million Settlement,” June 2019
WTO, “Proposal for a TRIPS Waiver,” IP/C/W/669, 2021
European Commission, “Unitary Patent and Unified Patent Court,” 2023
EMA & FDA, “Good Clinical Practice Guidelines,” 2022
WHO, “Fair Pricing and Equitable Access,” 2022
Amnesty International, “Health in Crisis: Global Access to Medicine,” 2021