Healthcare and pharma

Healthcare matters are rarely confined to one proceeding. A single adverse outcome can produce a consumer complaint against the hospital, a professional conduct reference against the treating doctor, an insurance dispute over the claim, and, where a device or a drug is implicated, a regulatory inquiry into the product. Each runs on its own record and its own timetable, and what is said in one is available in the others.

Liability and the record

A claim of medical negligence is decided, in practice, on the clinical record and on whether the standard applied was one a responsible body of practitioners would accept. Consent documentation, the completeness of notes, and the point at which a referral was made carry more weight than the eventual outcome. Proceedings lie before the consumer commissions, with the possibility of parallel proceedings before the state medical council.

Product regulation and price

Drugs and devices are licensed under the Drugs and Cosmetics Act, 1940 and the rules made under it, administered by CDSCO and the state drugs controllers, with clinical trials governed by the New Drugs and Clinical Trials Rules, 2019. Price sits separately, under the Drugs (Prices Control) Order and the National Pharmaceutical Pricing Authority; a ceiling price notification or a demand for overcharging is challenged in writ jurisdiction, and the arguments are about classification and computation.

When the asset is a patent

Life sciences insolvency raises a question the Code does not answer cleanly: what happens to licences, trial data and patents when the corporate debtor holding them enters resolution. Whether a licence is an asset of the corporate debtor, whether it can be assigned in a resolution plan, and how a regulatory approval that is personal to the licensee is treated are each contested, and they determine what the business is worth to a resolution applicant.