CHINA Law and Practice Contributed by: Alan Zhou, Charlene Huang, Jenny Chen and Stephanie Wang, Global Law Office
risks directly to the pharmaceutical companies, potentially leading to legal liabilities, reputational damage and loss of patient trust. In addition to the risk emanating from vendors, pharmaceutical companies also face con- cerns related to improper employee actions. If employees deviate from internal policies during the execution of the digital patient management programme, by collecting personal information without consent or by misusing the data col- lected through the platforms, for example, it can expose pharmaceutical companies to legal consequences for the unlawful processing of personal data. These violations not only undermine the integ- rity of the patient management programme but also pose a threat to the privacy and rights of patients, further highlighting the need for strict oversight and compliance within the pharma- ceutical industry’s digital operations. Internal work report Pharmaceutical companies typically require medical representatives to visit healthcare pro- fessionals and document interactions through internal digital systems to track work progress. During these visits, if medical representa- tives collect patients’ personal information (eg, names, diagnoses, treatment outcomes, follow- up plans) and record it in the system, this poses significant risks. Patient data collection in these situations is often framed as part of sales or marketing efforts (eg, visualising patient journeys from the seeking of treatment to drug purchase) but medical repre- sentatives are primarily responsible for docu- menting healthcare professional interactions and not directly gathering patient information. When medical representatives exceed this authority by
collecting detailed patient data, the processing often lacks a valid legal basis (eg, consent, legiti- mate interest or legal obligation). This exposes pharmaceutical companies to risks of non-com- pliance with potential legal liabilities. Prescription Statistics for Commercial Purposes In the current administrative regulatory frame- work, prohibitive provisions have been enact- ed against the practice of collecting prescrip- tion statistics for commercial purposes. These provisions specifically prohibit pharmaceutical companies or their employees from collecting prescription data of healthcare institutions, their internal departments or healthcare profession- als. Enforcement cases have revealed two typical illegal methods of obtaining prescription statis- tics for commercial purposes. • The first involves bribing healthcare pro- fessionals with kickbacks in exchange for access to prescription data. • The second is the unauthorised intrusion into the information systems of healthcare institu- tions to extract prescription-related informa- tion. In recent years, subtler data collection practices that infer prescription statistics have emerged. These are often overlooked by pharmaceutical companies. For example, calculating patient counts using specific drugs under specific healthcare professionals, combined with dosage and administration data, can deduce prescrip- tion volumes. Another practice involves collect- ing institutional drug inventory data by cross- referencing distributor sales records (which companies typically hold) with inventory levels. This allows prescription volumes to be inferred.
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