Patent Privacy

Gilead Raises Privacy Concerns by Collecting Patient Data Regarding Sofosbuvir


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The Economic Times reports that Gilead Sciences is collecting details and keeping track of patients purchasing generic versions of its blockbuster Hepatitis-C medicine Sofosbuvir in an effort to prevent diversion of stocks to outside markets.

In 2014, Gilead had voluntarily licensed the Hepatitis-C drug to seven Indian generic drug companies including Cipla, Ranbaxy, etc. According to the terms of the license, all these companies are allowed to set their own prices provided that royalties are paid to Gilead. The licensees are further allowed to sell the drugs in 91 developing countries. In India, Gilead has launched its own drug as well, at a price substantially lower than its US price. At the time of entering into the agreement, activists raised concerns that the list of countries excluded ‘better off’ developing countries such as China and Brazil, where patients would not be able to afford the $84,000 price tag for a 12 week course.

Now, Gilead has put in mechanisms in place to account for every dosage of the drug sold in Indian markets. As part of the mechanism, Gilead’s partners are collecting names and phone numbers of patients and keeping a record of the same. Economic Times reports that providing these details have been made a pre-condition for patients to access the drugs. In Pakistan and Egypt, the drug is only being sold to patients who return empty bottles. These stringent measures are being taken to prevent the drug from finding its way to markets outside the licensing agreement, into developed countries.

This move by Gilead raises serious questions of patient privacy and doctor-patient confidentiality. The Hippocratic oath which Doctors are morally bound by has the line What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself…”  The principle is embodied in the Indian Medical Council Regulations for Professional Conduct as well. While it is unclear whether doctors are being forced to hand over patient details, if it is the case, it would be a serious breach of confidentiality.

Patient privacy is important to create an atmosphere where patients are willing to seek medical advice especially for ‘controversial’ or ‘embarrassing’ diseases without having to worry about misuse or leakage of their personal data to other realms. It is unfortunately inadequately protected in the Indian framework independent of the rubric of Doctor-Patient confidentiality. While there are safeguards regarding handling patient information in Insurance Law (the IRDA (Third Party Administrators) Health Services Regulations, 2001, for example, strictly delineates under what circumstances Third Party Administrators and Insurance Companies may trade in information about patients), there are no regulations regarding how pharmacists should handle sensitive data. This document by Center for Internet and Society does a great job of analyzing the framework of patient privacy law in India.

In this case, it must be kept in mind that Hepatitis-C patients often overlap with HIV/AIDS patients, making privacy an especially important consideration. In X v. Hospital Z, the Supreme Court allowed the disclosure of a patient’s HIV+ status by the Hospital to the patient’s relatives and (fiancée). However, it was on the ground that it was an exceptional circumstance that involved the life of another individual.

The patient’s right to privacy may only be compromised in exceptional circumstances such as the above. Gilead’s concerns regarding leakage of the drug to developed markets may be valid; however, in the context of patient privacy, it is worrying that there are no regulations regarding what pharmacists can and cannot do with patient information.

 

 

Spadika Jayaraj

Spadika Jayaraj

Spadika is a student of the National Law School of India University, Bangalore. Apart from Intellectual Property Law, she is also interested in Law and Technology issues.

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