Recently, Express Pharma published an article on how the pharma sector is seeking more effective ways to reach out and communicate with prescribers and KoLs by partnering with telehealth and physician-only platforms.
At the end of our article, ‘Why is a romance burgeoning between pharma and telehealth?,’ we promised to bring you the views of some business and legal advisors on the important aspects that need to be considered and the regulations to comply with as India Pharma Inc pursues these strategic alliances.
So, take a look at what business advisors and legal experts counsel the parties involved, i.e. telehealth platforms and pharma companies.
Protocols for telehealth platforms
There has been a dramatic uptake in the number of telemedicine platforms and their use since the COVID-19 outbreak. Though telehealth platforms have been around for some time, their power and potential are being leveraged effectively now. They are not only transforming healthcare but have also emerged as key enablers for the pharma industry. And, several factors indicate that this is a trend that is here to stay, even after the pandemic subsides.
However, adhering with the existing and emerging laws and regulations will be key to the success and long term progress of these platforms.
Arvind Sharma, Partner, Shardul Amarchand Mangaldas & Co cautions that while venturing into alliances with pharma companies, telemedicine/patient/physician engagement platforms should bear the following legal aspects in mind:
- Enrol only registered medical practitioners (RMP) to provide telemedicine services;
- Conduct proper due diligence before listing any RMP on the telemedicine platform;
- Ensure adequate reporting requirements in case of any non-compliance; and
- Prevent artificial intelligence/machine learning-based platforms from counselling patients. Any violation of the above may result in the competent authority blacklisting the telemedicine platform and preventing any RMP from using such telemedicine platform.
He also shares the relevant provisions that form the crux of the Telemedicine Guidelines 2020 which these platforms will have to abide by:
- Transparency of identities between the RMP (Registered Medical Practitioners) and the patients. The RMP is obligated to verify the personal details of patients including – name, age, residential address, e-mail address etc. He is also obligated to reveal and mention his registration number (as granted by the State Medical Council/National Medical Commission), on prescriptions, website or electronic communication.) In such scenarios, the patient is responsible for the accuracy of information provided to the practitioner.
- Recording the consent of the patient to availing such services. Such consent can either be explicit or implicit (as demanded by circumstances).
- The RMP is bound by the duty to prescribe such drugs only on collecting all relevant information and on being satisfied that it is in the best interest of the patient.
Regulations for pharma stakeholders
As the life sciences industry transforms into an increasingly automated and interconnected, pharma companies must ascertain that all their operations are accurate, efficient, risk-averse and compliant with existing regulations and guidelines. While there are no current regulations for pharma marketing, since 2015, the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) are guidelines for pharma companies to adopt voluntarily.
But, as the industry increasingly seeks and embraces newer methods and approaches of marketing such as the alliances with telehealth platforms, it is vital to ensure that no laws and regulations are being neglected or circumvented to avoid legal hassles later.
As Sharma informs, “It is important for the pharma companies to conduct adequate due diligence on the telemedicine platforms and ensure that sufficient safeguards are in place to limit their liability.”
He also advises that pharma companies should also assure that the telemedicine platform ensures that the RMPs:
- Mandatorily procure the consent of a patient for telemedicine consultation;
- Do not prescribe prohibited medicines; and
- Comply with the prescribed guidelines including displaying his/her registration number on prescriptions, website, electronic communication and maintain a digital record of documentation of consultation
He informs, “It may be noted that if any person has unauthorised access (without consent) to information or data of another person, such person would be punished with imprisonment of up to two years or with a fine of up to Rs one lakh or both, per the provisions of the Information Technology Act, 2000.”
He adds, “Adequate provisions should be incorporated in the collaboration agreement (to be executed between the pharma companies and telemedicine platforms) for addressing liability issues for relevant pharma companies arising from the actions undertaken by the telemedicine platforms.”
Dheeraj Nair, Partner, J Sagar Associates, also reiterates, “While the compliance requirements would vary depending on the nature and extent of collaborations between pharma companies and telemedicine platforms, any pharma player participating in a telemedicine platform would have to be mindful of the Telemedicine Practice Guidelines, 2020 issued by the Ministry of Health and Family Welfare.”
He also cautions that pharma companies would have to be mindful that a medical practitioner is neither permitted to solicit or receive nor permitted to offer to solicit or receive, any gift, gratuity, commission or bonus in consideration of or in return for referring, recommending or procuring of any patient for medical, surgical or other treatment. Similar prohibitions exist insofar as gifts, hospitality, travel facilities or monetary grants to medical practitioners are concerned. Therefore these restrictions have to be understood well while venturing into collaborations with telemedicine platforms. They would also have to be mindful of general restrictions insofar as advertising of drugs generally, and advertising to medical practitioners particularly, is concerned.”
Nair informs, “Additionally, pharma companies would have to consider the data protection and privacy implications, and liability that arises under the Information Technology Act, 2000 as well as the Intermediary Guidelines when dealing with sensitive personal information of patients.”
“Platforms which provide digital tools or software for diagnostics, monitoring or treatment of diseases are now classified as drugs and regulated under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017 (MD Rules), with effect from April 1, 2020, and regulated under this scheme. Therefore, pharma companies foraying into digital healthcare would have to be compliant with these statutory provisions as well,” he concludes.
Regular audits and constant surveillance
Jitesh Agarwal, Founder of Treelife, an advisory firm points out that the parties involved in these partnerships must endeavour to delineate basic aspects such as:
- Branding of the collaborated services
- Rights and duties of either party, associated – compliance and fee requirements
- Proprietary rights and duty towards the private data of consumers collected
He counsels that the corporates involved must strive to establish such compliance with provisions about partnerships, especially under the prevalent Data Privacy Regulations. This is in addition to the duty of conducting regular audits and reasonable surveillance to ensure ethical practices and comply with relevant laws applicable.
Playing by the rules
Thus, the game is interesting and can result in significant long-term benefits, not only for pharma companies and telehealth platforms but for doctors and patients as well, provided it is played by the rules. As an evolving endeavour, it is also likely to undergo many alterations and additions. We may see more regulations or guidelines coming up in this area. Therefore, the participants need to be vigilant and match their strategies with the evolutions to maximise potential opportunities.