TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
1. To combat antimicrobial-resistance the Drugs Consultative Committee, which advises the Central and State Governments on conduct of Drug regulation in the country, has, in its 64th meeting recommended amendment to the Drug Rules to regulate sale of antibiotic Drugs to manufacturers who may not have a license under the Drug regulations.
Source: bit.ly/4evHfhA

2. The Punjab and Haryana High Court upheld the position that under the Narcotic Drugs and Psychotropic Substances Act, 1985, upon seizure, the entirety of the bulk of the seized substance need not be sent to the Forensic Laboratory, rather merely a select homogenized sample thereof would be sufficient.
Source: bit.ly/4gx15uL

3. The Supreme Court has ordered the Central Government Ministry of Health and Family welfare, and the Government of Kerala to file counter-affidavits explaining the delayed action in setting up a special committee to study the effectiveness of the Rabies vaccine.
Source: bit.ly/3MXwwAE

4. The High Court of Bombay has struck down the insertion of Rule 3 of Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Amendment Rules, 2023, which empowered the government to set up fact-check units on the ground that this violated the fundamental right to equality and to carry on trade and business.
Source: bit.ly/4diYthg

5. The United States Federal Trade Commission has formally initiated litigation against Pharmacy Benefit Managers which act as middlemen between Drug Companies and Insurers, for deliberately driving the price of insulin higher for consumers and receiving rebates from manufacturers in the process.
Source: bit.ly/3zrNfcq

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

State Consumer Commissions continue to dilute intermediary safe-harbour protection for e-commerce marketplace
A State Consumer Commission in India has held a major e-commerce marketplace company liable for delivery of incorrect goods to customers, on the grounds that since it offered a ‘fulfilling’ service on behalf of the seller, it was not merely an intermediary but also an agent of the seller. The marketplace was made to pay punitive damages, in addition to mental harassment, on grounds that it may have unscrupulously exploited an unknown uncounted number of consumers.
Source: bit.ly/49VuNW0

Kochi and Thiruvananthapuram proposed to be added to the list of airports from where drugs may be imported
India’s Ministry of Health and Family Welfare has issued a draft notification that will add Kochi and Thiruvananthapuram to the list of airports from which pharmaceutical drugs may be imported into India. The Drugs Rules, 1945 specify that pharmaceutical drugs may be imported into India from a specified number of airports only. The clearance of drugs requires the approval of the Additional Drugs Controller (ADC) Customs, who is generally posted at the customs wing of the airport.
Source: bit.ly/49zbUZ8

Dengue Vaccine Clinical Trials to start soon in India
A major Japanese drug maker has reportedly received clearance from India’s vaccine regulator, Central Drugs Standards Control Organization, to start clinical trials of the dengue vaccine. The vaccine will be contract manufactured by a major biotech company in India.
Source: bit.ly/49OyQ7b

Many medical device companies settled allegations of kickbacks given to doctors in 2023: US Department of Justice
The US Department of Justice (DoJ) has issued a press release that it has recorded the highest number of settlements and judgements in its history. Some of major settlements involved allegations of unlawful kickbacks medical device companies to doctors, in form of above-fair market value supervision fees or remuneration for medical directorships and improper donation of capital equipment.
Source: bit.ly/49X0H4H

Fair-use defense against copyright infringement by AI companies will be tested in new trial by media companies against Open AI
In a new set of lawsuits in the US, media companies are not alleging copyright infringement by AI companies to train the algorithm, but instead alleging that before training, the AI companies removed information from the training material which established that the material was copyrighted, such as the name of the author the news. The Digital Millennium Copyright Act or DMCA, law in the US reportedly prohibits the removal of information that can help copyright holders detect infringement, including article titles, author names, and copyright dates.
Source: bit.ly/3Ih1MbA

TOP 5 HEALTH LAWS & POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

New Departmental Guidelines for sampling of Spurious Drugs, Medical Devices and Cosmetics Published
India’s apex regulatory body for drugs, medical devices and cosmetics, the Central Drugs Standards Control Organization, has published revised sampling guidelines for inspectors to follow in various states. All inspectors are required to collect at least 9 samples of drugs, and 1 sample of cosmetic or medical device in each month. The inspectors are supposed to be alert about feedback received from citizens and doctors in deciding which drugs, cosmetics and medical device brands they ought to sample and test for compliance with laws.
Source: bit.ly/3SDnLym

Social Media companies asked by High Court to handover details of persons who fraudulently operated certain accounts and channels
The Delhi High Court has ordered major social media companies including Facebook and Telegram to disclose identities of users accused of misusing trademark of major venture capital firm to cheat users by soliciting bogus investments. The court has also ordered concerned social media companies to provide details on action they will take to prevent further violation.
Source: bit.ly/3HXkxAP

WhatsApp and emails may be used to send legal notices for demanding unpaid amounts: High Court
The Allahabad High Court has reiterated that notice in cheque bounce case sent by WhatsApp or e-mail will be considered valid notice for the purposes of recovery under The Negotiable Instruments Act, 1881, and it will be presumed to have been dispatched and served on the same day.
Source: bit.ly/48f8Xf6

Popular Party Drugs added to list of Psychotropic Substances
The Indian Government has added popular synthetic party drugs, ADB-BUTINACA, Alpha-PiHP and 3 Methylmethcathinone (3-MMC), to list of psychotropic substances and notified small and commercial quantity of these substances for the purpose of fixing quantum of punishment for unlawful possession. Possessing psychotropic substances without permission or prescription is an offence under Narcotic Drugs and Psychotropic Substances Act, 1985.
Source: bit.ly/48ghuhM

WHO recommends antibiotics which should be exclusively put to human use to reduce chance of antimicrobial resistance
The World Health Organization (WHO) has updated its Medically Important Antimicrobials for Human Use (WHO MIA List), and reclassified antimicrobial drugs on basis of potential impact on human heath to limit the use of identified antimicrobials in other populations such as in plants and animals. The WHO hopes that reducing use of critical antimicrobial drugs in other population will reduce pace of antimicrobial resistance.
Source: bit.ly/49eVll9

The Liability Conundrum for Telemedicine Platforms in India: Striking a Balance between Vicarious and Intermediary Liability

Telemedicine Vicarious Liability India

Introduction 

The COVID-19 pandemic, coupled with legitimisation of telemedicine in March 2020, has propelled the popularity of telemedicine manifold, with telemedicine platforms at the forefront. A question that arises is what the liability of these platforms is for any mishaps or complaints that patients may have about the consultations that they have with doctors through these platforms. The general perception is that, as technology providers, the platforms are intermediaries and are exempt from liability for consultations that take place on the platform. However, it is not quite that straightforward.

Liability exposure   

The principles of vicarious liability and intermediary liability, though derived from different laws, are closely linked and are both paramount factors for telemedicine platforms to take into consideration while structuring their business and governance policies. Both concepts define the liability of an entity – in this case the telemedicine platform – for the actions of another person. Vicarious liability arises when the platform had the right, ability or duty to control the activities of the violator i.e., the doctor.  Intermediary liability, on the other hand, arises because the platform facilitates the violator’s actions, and would cover violations by both the doctors and patients who use the platform. The former is largely dealt with by the Consumer Protection Act, 2019, while intermediary liability is derived from the Information Technology Act, 2000.

Vicarious liability

A common misconception is that platforms cannot be held vicariously liable since they do not employ the doctors that consult on the platform and there is no master-servant relationship between them; in fact, several platforms are structured as marketplaces, where anyone (subject to their credentials) can list themselves on the platform and offer their services. Further, telemedicine platforms typically make it clear that they are merely facilitating the interactions, not rendering medical advice themselves, so there is no doctor-patient relationship between the platform and patient, and the platform cannot be held liable for any deficiencies in service or negligence by the doctor.

However, these arguments would likely not pass the muster. A parallel may be drawn to hospitals, which typically raise the same defences in cases of medical negligence.

In the case of Smt. Savita Garg vs. The Director, National Heart Institute, the Supreme Court observed that when a patient goes to a private hospital/clinic, he goes by the reputation of the hospital and with the hope that proper care will be taken by the hospital authorities. Since these hospitals charge a fee for the services rendered by them, they are duty bound to bestow the best care, and if the hospital fails to discharge their duties through their doctors being employed on job basis or employed on contract basis, it is the hospital which has to justify.

In Smt. Rekha Gupta v. Bombay Hospital Trust & Anr., the National Consumer Disputes Redressal Commission held that a hospital cannot escape liability by taking the defence that it only provided infrastructural facilities and support staff, and did not perform or recommend any treatment itself. The NCDRC pointed out that the bills for doctor’s consultations are raised by the hospital and they charge a commission before remitting the fee to the consultant.

In Dr. Krishna Mohan Bhattacharjee vs. Bombay Hospital Medical Research Centre, the National Consumer Disputes Redressal Commission further stated that the terms under which a hospital employs the doctors is immaterial insofar as the hospital’s liability towards a patient is concerned, and that the defence that there is no master-servant relationship between the hospital and doctor cannot be taken in cases of established negligence, and held that  patients go and get themselves admitted in the hospital relying on the hospital to provide them the medical service for which they pay the necessary fee.

The same rationale that courts apply to hold hospitals vicariously liable would logically apply to telemedicine platforms as well, and it is thus unlikely that they would be eligible for a blanket exemption from liability for negligence or deficiencies in services offered through the platform by claiming that they are merely technology providers that do not play a role in the actual rendering of medical services.

That being said, there are safeguards that can be put in place to minimise the risk of prosecution.  Courts have recognised that a hospital – and therefore, by extension, a telemedicine platform – can mitigate their liability by showing that they had undertaken due diligence and adopted appropriate measures to prevent negligence or deficiencies in service. For a telemedicine platform, this would mean verifying the credentials of all doctors or healthcare professionals listed on the platform, ensuring that the doctors are: sufficiently well-versed with the practicalities, legalities and limitations of telemedicine; are aware of the functionalities of the platform; are following proper documentation processes, are compliant with the platform’s policies, etc.

The platform would also have to follow measures to mitigate their direct liability for medical negligence, such as ensuring that only qualified professionals are listed, the data protection systems are secure and compliant with the law, the technology supports smooth consultations.

It is also important to keep in mind the quality of care to be expected (and hence the liability for falling short of the expectations) of a medical establishment is directly proportional to its reputation. Thus, for a platform that makes claims of (facilitating) quality consultations, it is especially important to have stringent quality control measures in place, especially as they grow.

Dilemma of quality management vs. “control”: A threat to intermediary status

Implementing quality control measures to mitigate risk is essential for telemedicine platforms to mitigate risk of being held vicariously liable for negligence and deficiencies in service on the platform. However, it also poses a challenge to telemedicine platforms – it could potentially weaken their position as an intermediary that can avail of safe harbour protections under the Information Technology Act.

It is important to understand that telemedicine platforms are a kind of e-commerce entity. An e-commerce entity may either be set up as an inventory or a marketplace entity. An inventory e-commerce entity “owns” i.e. exercises control over the service provider doctors, whereas a marketplace entity merely provides the technological infrastructure to facilitate consultations. In case of the latter, the entity could be considered an internet intermediary that can avail of safe harbour protections, which is why most telemedicine platforms are structured as “aggregators”.

Essentially, the law recognises that an intermediary does not control what third-parties do on the platform and they cannot reasonably be expected to monitor every single transaction. Thus, provided that the intermediary complies with certain requirements, they are exempted from liability for wrongdoings done by third-parties on the platform without their knowledge.

In order to be eligible for the protection, the intermediary must follow the due diligence requirements stipulated in the Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021, which include publishing and complying with a privacy policy and terms of service which specifies the types of content and activities that is prohibited on the website and/or mobile application, taking action against violators upon receiving knowledge of wrongdoings, cooperating with governmental authorities, etc, as well as certain compliances under the  Consumer Protection (E-Commerce) Rules, 2020  such as executing an undertaking with service providers to ensure that the descriptions and other contents pertaining to the services offered through the platform is accurate.

Thus, the law envisages a fairly “hands-off” and reactive approach to managing third-parties on the platform, and adopting more prescriptive policies and quality control measures could be viewed as the platform exercising control over the service providers, which would threaten their position as an intermediary.

Add-on services: changing dimension of intermediary status.

Most telemedicine platforms nowadays also offer value added services such as algorithmic matching of doctors/healthcare providers and patients, facilitating payments, electronic health record management, etc.

As per Section 79 of the Information Technology Act, the exemption from liability would also apply only if the intermediary is merely a passive conduit of the information, and is not involved in the initiation of the transmission, selecting the receiver of the transmission, and does not modify the information. Questions have been raised as to whether the value-added services dilute their role as a passive conduit, and result in the platform playing an active role in the transaction, which would mean that they cannot avail of the protection.

In the case of Amazon Sellers Services Private Limited vs. Modicare Limited & Ors. the Delhi High Court recognised that the FDI Press Note 2 of 2018 allows marketplace e-commerce entities to offer value added services to businesses, and held that Section 79 does not appear to differentiate between active and passive intermediaries. When an intermediary provides services in addition to access, it must comply with the requirements of Section 79 i.e. must remain a passive conduit in relation to the information. So long as that is complied with, the intermediary may avail of the protection.

It is important to note that the Intermediary Guidelines recognises not only human editorial control, but also automatic and algorithmic control. This means that a platform would not be able to take the defence that any service which dilutes their position as a passive conduit is entirely algorithmic and hence does not amount to active involvement.

Key Takeaway

If a telemedicine platform was to lose its status as an intermediary and the protections conferred by the law, they would be required to proactively monitor everything that takes place on the platform, since they would be liable for any non-compliances or wrongdoings. For platforms dealing with large volumes of consultations, this would be logistically challenging, if not impossible. The cost of operations and litigations that would arise would make it an untenable business.

Thus, it is essential that telemedicine platforms closely evaluate their structure, policies, features and service offerings to strike a balance between ensuring that high quality services are offered through the platform, while still minimising their liability.