Telemedicine in India: Doctor’s Consultation is just a Phone call away!

  • 15 April, 2020
  • Indran M.B

India is making some major headway towards providing universal health coverage. However, a significant challenge is the limited number of qualified doctors and other healthcare professionals available in our country. Telemedicine is a solution to this limitation as it allows consultation, diagnosis, and treatment by healthcare professionals from remote locations with the help of technology

The requirement of telemedicine was starkly visible during the current COVID-19 pandemic and the resultant lockdown. It significantly helped in reducing hospital visits, waiting periods, and long travel to and from the hospital. Other benefits of telemedicine include timely and faster access to healthcare services, convenience, cost-saving, and adequate documentation of health records. Until recently, there was no legislation or guidelines on how telemedicine could be practiced in India. In view of the current pandemic, the Government of India has timely come up with the Telemedicine Practice Guidelines on 25th March 2020.  This guideline forms a part of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, and is numbered Appendix-5. With this, there is now some legitimacy attached to the service and the guidelines would pave the way for statutory legislation on the same lines in the future.

Evolution of Telemedicine in India

From the constitution of a Telemedicine Taskforce in the year 2005 by the Ministry of Health and Family Welfare, India has gradually progressed in telemedicine by budgeting for it, setting up various institutions, connecting Regional Cancer Centers with peripheral centers across India through the ONCO-NET India Project and networking of states and district headquarters and premier institutes as part of Integrated Disease Surveillance Project (IDSP).  The Government has further facilitated it through the establishment of the National Rural Telemedicine Network, mother, and child tracking system (MCTS), the establishment of National Telemedicine Network, National and Regional Resource Centers etc. Various indigenous software has also been developed to provide telemedicine solutions.

Scope of the Telemedicine Practice Guidelines, 2020

The Telemedicine Practice Guidelines introduced on 25th March 2020 provide norms and protocols pertaining to physician-patient relationship; issues of liability and negligence; evaluation, management, and treatment as well as informed consent. The provisions also deal with continuity of care; referrals for emergency services; medical records; privacy and security of the patient records and exchange of information; prescription; health education and counseling. These guidelines also provide information on technology platforms and telemedicine tools available to medical practitioners and how to integrate them into these technologies.

Guidelines for Registered Medical Practitioner

  • Information Exchange: A Registered Medical Practitioner (“Doctor”) is empowered by these guidelines to provide telemedicine consultation to patients from any part of India, and the same professional norms, ethics, and standards apply. All physical examinations cannot be done via video/audio/text messages. Therefore, it is left to the Doctor’s professional judgment as to whether he/she can provide a technology-based consultation or an in-patient consultation. In addition, doctors are restrained from providing telemedicine when the physical examination is critical for consultation. Doctors are also mandated to uphold the same standard of care as in-patient consultation. Both Doctors and patients are required to provide their identification to the other as may be deemed appropriate.   Since prescriptions are based on the age of the patient, a Doctor is required to explicitly ask for the age, and if necessary, seek proof thereof.  In the case of a minor, teleconsultation can only be done when the minor is accompanied by an adult whose identity is also required to be verified.
  • Informed Consent: Patient consent is mandatorily required for a telemedicine consultation. Consent is implied when telemedicine is initiated by the patients themselves. If it is initiated by a health worker, another Doctor, or caregiver, explicit consent of the patient must be procured and recorded.  Health education, counseling, and prescription of medicines can be done through telemedicine. If a caregiver is not present with the patient and does not have authorization, Doctors cannot provide telemedicine consultation. In the case of a health worker, he/she should have obtained informed consent from the patient to obtain consultation from Doctor.
  • Prescription of Drugs: The guidelines categorize drugs into four lists, List O (over the counter medications), List A (can be prescribed during the first consultation and has relatively low potential of abuse), List B (when an in-patient consultation is already done, and drugs have to be prescribed in follow up consultation), Prohibited Drugs (high potential for abuse). Doctors cannot prescribe prohibited drugs. Doctors can only prescribe List A drugs if the consultation is done through video as it involves the first consultation. If the gap between two successive consultations is more than 6 months or if the consultation is for a different health condition, it would be construed as a first consultation. Signed prescription or e-prescription can be sent to the patient digitally (or to the pharmacist after the explicit consent of the patient).
  • Confidentiality, Privacy and Data Protection: Doctors are required to abide by their professional conduct regulations, IT Act, Data protection and privacy laws in India, and other applicable rules. The guidelines specify a certain inclusive list of actions constituting misconduct by Doctors such as insisting on telemedicine when a patient is willing to travel, misusing patient data, prescription of medicine from the restricted list, and solicitation of telemedicine. Further, doctors will not be held responsible for breach of confidentiality if there is a piece of reasonable evidence to believe that patient’s privacy and confidentiality has been compromised by a technology breach or by a person other than the Doctor. However, doctors should ensure that a reasonable degree of care is undertaken during hiring such services. Penalties for violation would be as per the IMC Act, ethics, and other prevailing laws.
  • Documentation: Doctors are required to maintain digital trails and documentation of the telemedicine consultation such as logs of telemedicine interaction; patient records, reports, diagnostic data, etc., utilized during telemedicine consultation, and prescriptions for such period prescribed from time to time. Fees for telemedicine consultation should be treated in the same way as in-patient consultation, and a fee receipt should be provided to the patient.

 

Guidelines for Technology Platforms

It is the responsibility of technology platforms such as websites, mobile apps, etc., assisting in telemedicine services to:

  1. Ensure that the telecommunication is with a Doctor who is duly registered with the national or state medical councils.
  2. Conduct Due Diligence before listing Doctors in online portals. The technology platform should provide the name, qualification, registration number, and contact details of every Doctor.
  3. Report any non-compliance to the Board of Governors of MCI.
  4. Ensure that Artificial intelligence or machine learning is not utilized to counsel patients. However, such technologies can be used to assist Doctors in inpatient evaluation, diagnosis, management, and prescription.
  5. Ensure that the technology platform has a proper mechanism to address the queries and grievances of patients.

Any violation by the Technology Platform would lead to blacklisting of them by the Board of Governors or MCI, and thereafter, no Doctor shall use such a platform to provide telemedicine services.

Conclusion

In the wake of the coronavirus pandemic and the heavy toll it is taking on the healthcare sector across the world, the telemedicine guidelines had to be brought in to limit hospital visits and avoid the transmission of diseases significantly. The guidelines are designed to regulate unauthorized use and assist Registered Medical Practitioners to provide their services in an uninterrupted manner and to remote locations.  The provision for blacklisting technology platforms that do not abide by these guidelines is a welcome step to ensure due care from their end and was necessary to inculcate faith in these platforms. However, it is unjust on the part of the Government of India to only empower doctors who practice modern medicine to provide telemedicine services and not bring practitioners of Indian Medicine under its ambit.  As the definition of Registered Medical Practitioner in the guidelines state, it is only for doctors enrolled in the State Medical Register or Indian Medical Register as per the Indian Medical Council Act 1956.  Practitioners of Ashtang Ayurveda, homeopathy, Siddha, Unani, Tibb, or Sowa-Rigpa who are registered under other enactments have been overlooked.

That said, several initiatives by the Government of India on providing greater bandwidth connectivity, optical fiber connectivity, and National Knowledge Network connecting more than 800 institutions including medical institutions would encourage Telemedicine and Telehealth significantly. With people across the country in isolation and quarantine, Telemedicine is a viable alternative for patients to get immediate medical attention for minor health issues. With the assistance of technologies like fitness trackers, smartwatches, and plasters that are capable of monitoring heart rate, breathing rate, body temperatures, and generating ECG reports, it is time to harness Telemedicine for faster and timely access to healthcare services.

 

Image Credits: Photo by National Cancer Institute on Unsplash

In the wake of the coronavirus pandemic and the heavy toll it is taking on the healthcare sector across the world, the telemedicine guidelines had to be brought in to limit hospital visits and avoid the transmission of diseases significantly. The guidelines are designed to regulate unauthorized use and assist Registered Medical Practitioners to provide their services in an uninterrupted manner and to remote locations.  The provision for blacklisting technology platforms that do not abide by these guidelines is a welcome step to ensure due care from their end and was necessary to inculcate faith in these platforms.

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Supreme Court lifts the RBI notification prohibiting banking services to Virtual Currency Business: Analysis

  • 18 March, 2020
  • Pallavi K.P

After providing the reference of more than 50 cases about legality of virtual currency from across the world in its 180-page-long judgement, the Supreme Court, on March 4th, 2020 lifted the RBI notification prohibiting banking services to Virtual Currency (VC) business.

‘Cryptocurrency’ means “a math-based, decentralised convertible Virtual Currency Protected by cryptography by relying on public and private keys to transfer value from one person to another and signed cryptographically each time it is transferred.”[1]

“‘Virtual currency (VC)’ as the name suggests is a digital representation of value that can be traded digitally and functioning as (1) a medium of exchange; and/or (2) a unit of account; and/or (3) a store of value, but not having a legal tender status.” [2]

On a global level, regulatory responses to cryptocurrency have ranged from a complete clamp down in some jurisdictions to a comparatively ‘light-touch regulatory approach.

Though cryptocurrency may not currently pose systemic risks, its increasing popularity leading to price bubbles raises serious concerns for consumer and investor protection and market integrity. The cryptocurrency eco-system may affect the existing payment and settlement system which could, in turn, influence the transmission of monetary policy.[3]

Brief facts:

It was in 2013, for the first time, RBI had noted and discussed the risks of the development of technology and VCs in its Financial Stability Report[4]. In the report, RBI had mentioned VCs as unregulated money and that regulators were studying the impact of the same.  A press release was thereafter issued by RBI on the potential impact and risks associated with VCs. Later that year newspapers reported about the first-ever raid in India by enforcement authorities on two Bitcoin firms.

On 01-02-2017, RBI again issued a Press Release[5] cautioning users, vendors and holders of VCs. Closely on the heels of the Press Release, the Ministry of Finance constituted an Interdisciplinary committee and the committee gave its report on 25-07-2017. The committee recommended issuing warnings to the general public that the Government does not support cryptocurrencies and those offering to buy or sell these currencies must stop such activities. However, it was clarified that there was no restriction on the use of blockchain technology.

RBI issued a “Statement on Developmental and Regulatory Policies[6]” followed by a circular[7] dated April 6, 2018,  directing the entities regulated by it (i) not to deal in virtual currencies nor to provide services for facilitating any person or entity in dealing with or settling virtual currencies and (ii) to exit the relationship with such persons or entities, if they were already providing such services to them. It appears that at around the same time (April 2018), the Inter-Ministerial Committee submitted its initial report, (or a precursor to the report) along with a draft bill known as ‘Banning of Cryptocurrency and Regulation of Official Digital Currency Bill, 2019’.[8]

Challenging the said Statement and Circular and seeking a direction to the RBI not to restrict or restrain banks and financial institutions regulated by RBI from providing access to banking services to those engaged in transactions in crypto assets, these writ petitions were filed. The petitioner in the first writ petition is a specialized industry body known as the ‘Internet and Mobile Association of India’ which represents the interests of the online and digital services industry. The petitioners in the second writ petition comprise a few companies which run online crypto assets exchange platforms, the shareholders/founders of these companies, and a few individual crypto-assets traders.

After detailed analysis, the Hon’ble Supreme Court bench comprising of Hon’ble Justices R.F. Nariman, Aniruddha Bose, and V. Ramasubramanian set aside the impugned circular issued by RBI on “directing  the entities regulated by RBI (i) not to deal in virtual currencies nor to provide services for facilitating any person or entity in dealing with or settling virtual currencies and (ii) to exit the relationship with such persons or entities, if they were already providing such services to them.” [9]

There were two main issues raised before the Hon’ble Supreme Court.

 

  1. Whether RBI had the power to prohibit the activities of trading in VCs?

 

No power at all:

One of the major contention raised by the  Petitioners is that RBI has no power to prohibit VC as it is neither a  legal tender nor comes within the credit system of the country so as to enable RBI to act upon the power conferred in it. Also, that, it does not have any characteristics of money for RBI to have the power to regulate the same.  

RBI in its counter-argument agreed to the fact that VC does not satisfy with being acknowledged as currency, however, stated that VCs do not have any formal or structured mechanism for handling consumer disputes/ grievances. Further, due to its anonymity/pseudo-anonymity characteristic, it is capable of being used for illegal activities. Increased use of VCs would eventually erode the monetary stability of the Indian currency and the credit system. Therefore, RBI has every power to regulate and control the activities of trading in VCs.

With regard to the above contentions and arguments, the Supreme Court after analyzing opinions and definitions of various legislations observed that though VCs are not recognized as legal tender, they are capable of performing some or most of the functions of real currency. The statutory obligation that RBI has, as a central bank, is  (i) to operate the currency and credit system, (ii) to regulate the financial system, and (iii) to ensure the payment system of the country to be on track, would compel them naturally to address all issues that are perceived as potential risks to the monetary, currency, payment, credit and financial systems of the country. Therefore, anything that may pose a threat to or have an impact on the financial system of the country can be regulated or prohibited by RBI, despite the said activity not forming part of the credit system or payment system. and concluded that the users and traders of virtual currencies carry on an activity that falls squarely within the purview of the RBI.

If at all power, only to regulate:

Another contention made by the Petitioners was that, if at all RBI is conferred with any power it is only to regulate, but not to prohibit.  It was contended by petitioners that the power to prohibit something as res extra commercium was always a legislative policy and that therefore the same could not be done through executive fiat.  In support of its contention, the petitioners referred to the definition of the expression “payment system” under the Payment and Settlement Act and contented that VC Exchanges do not operate any payment system and that since the power to issue directions under Section 18 of the Payment and settlement systems Act was only to regulate payment systems, the invocation of the said power to something that did not fall within the purview of payment system was arbitrary.

RBI in its counter-argument stated that the impugned decision of RBI was legislative in character and was in the realm of an economic policy decision taken by an expert body warranting a hands-off approach from the Court.  

In this regard, the Supreme Court observed that the power of RBI was not merely curative but also preventive. Further, in any case, the projection of the impugned decisions of RBI as a total prohibition of activity altogether, might not be correct. The impugned Circular did not impose a prohibition on the use of or the trading in VCs. It merely directed the entities regulated by RBI not to provide banking services to those engaged in the trading or facilitating the trading in VCs. The fact that the functioning of VC Exchanges automatically got paralyzed or crippled because of the impugned Circular, was no ground to hold that it tantamounted to total prohibition.

Supreme court in this issue held that in the overall scheme of the Payment and Settlement Systems Act, 2007, it was impossible to say that RBI did not have the power to frame policies and issue directions to banks who are system participants, with respect to transactions that would fall under the category of payment obligation or payment instruction, if not a payment system. Hence, the argument revolving around Section 18 failed.

  1. If RBI has the power to deal with carrying out activities related to VCs, whether this impugned circular was a proper exercise of that power?

The second issue raised was regarding the mode of exercise of power and the court-tested its appropriateness and validity based on certain well-established parameters.

No application of mind

One of the major contentions by the petitioner was that RBI had not adequately applied its mind. However, SC was of the view that RBI had been brooding over the issue for almost five years without taking any extreme step. RBI had even issued a press release titled “RBI cautions users of Virtual Currencies against Risks”. Therefore, RBI could hardly be held guilty of non-application of mind.

Malice in law

Another contention made by petitioners was that the impugned Circular was a colorable exercise of power and tainted by malice in law, in as much as it sought to achieve an object completely different from the one for which the power was entrusted.

However, SC observed that in order to constitute colorable exercise of power, the act must have been done in bad faith and the power must have been exercised not with the object of protecting the regulated entities or the public in general, but with the object of hitting those who form the target. To constitute malice in law, the act must have been done wrongfully and wilfully without reasonable or probable cause which is not the case here. Hence, SC rejected the argument.

Violative of Article 19 and proportionality

The next ground of issue raised before the Supreme Court was on the basis of Article 19(1)(g) of the Constitution. It was contended by the Petitioners that since access to banking was the equivalent of the supply of oxygen in any modern economy, the denial of such access to those who carry on a trade which was not prohibited by law, was not a reasonable restriction, rather it was extremely disproportionate. It was further contended that the right to access the banking system was actually integral to the right to carry on any trade or profession and therefore legislation, subordinate or otherwise whose effect or impact severely impairs the right to carry on a trade or business, not prohibited by law, would be violative of Article 19(1)(g).

RBI raised two fundamental objections in this regard. The first was that corporate bodies/entities that had come up with the challenge were not ‘citizens’ and hence, not entitled to maintain a challenge under Article 19(1)(g). Secondly, there was no fundamental right to purchase, sell, transact and/or invest in VCs and that therefore, the petitioners could not invoke Article 19(1)(g).

The SC, however, objected to the contentions of RBI for two reasons namely, (i) that at least some of the petitioners are not claiming any right to purchase, sell or transact in VCs, but claiming a right to provide a platform for facilitating an activity of trading in VCs between individuals/entities who want to buy and sell VCs) which is not yet prohibited by law and (ii) that in any case, the impugned Circular does not per se prohibit the purchase or sale of VCs.

SC observed that, despite the fact that the users and traders of VCs are also prevented by the impugned Circular from accessing the banking services, the circular has not paralyzed many of the other ways in which crypto-currencies can still find their way to or from the market. It was further noted by the apex court that if a central authority like RBI, on a conspectus of various factors perceive the trend as the growth of a parallel economy and severs the umbilical cord that virtual currency has with fiat currency, the same cannot be very lightly nullified as offending Article 19(1)(g).

On the question of proportionality, the petitioners relied upon the four-pronged test summed up in the opinion of the majority in Modern Dental College and Research Centre v. State of Madhya Pradesh. These four tests were (i) that the measure was designated for a proper purpose (ii) that the measures were rationally connected to the fulfillment of the purpose (iii) that there were no alternative less invasive measures and (iv) that there was a proper relation between the importance of achieving the aim and the importance of limiting the right.

SC observed that the impugned circular was issued with the aim of prohibiting the trade in VCs. The object of hitting at trading in VCs was to ensure (i) consumer protection (ii) prevention of violation of money laundering laws (iii) curbing the menace of financing of terrorism and (iv) safeguarding of the existing monetary/payment/credit system from being polluted. However, in the process, it has hit VC Exchanges and not the actual trading of VCs, consequently, the volume of transactions in VCs (perhaps through VCEs alone) is stated to have come down.

SC further observed that at the time when the impugned Circular was issued, RBI had not obviously addressed many of the issues flagged by the writ petitioners. SC held that RBI failed to pass the test of proportionality due to the following reasons:

  • Even though RBI states that it can adversely impact its regulated entities, consumers, and the economy, RBI has not so far found, in the past 5 years or more, the activities of VC exchanges to have actually impacted adversely, the way the entities regulated by RBI function. Before taking any pre-emptive action against VCs, the RBI is required to show some semblance of any damage suffered to it or regulated entities. Since they don’t have any substantial evidence to show damage, RBI failed in the test of proportionality.
  • Secondly, despite coming out with various circulars, statements against cryptocurrency, RBI has consistently taken the stand that it has not prohibited VCs in the country. Therefore, RBI’s position is still murky.
  • Thirdly, the Government of India is unable to take a call despite several committees coming up with several proposals including two bills. It is also worthwhile to mention that the draft bills also take opposite stands where one bill tries to ban cryptocurrency while the other bill tries to regulate them.

Order:

In light of answering the final issue, SC held that petitioners are entitled to succeed, and the impugned Circular dated 06-04-2018 is liable to be set aside on the ground of proportionality.

Conclusion:

It is only in the last leg that the apex court held against the respondent RBI and ordered to set aside the circular. The ruling was based on the reasons that- (i) RBI has failed to provide any empirical evidence to show that VCs have negatively impacted the banking sector or other entities regulated by the RBI; (ii) the inconsistencies in proposals made by Govt and; (iii) RBIs consistent position that they have not banned VC.

However, notably, this judgement lost the opportunity to answer crucial questions or take a definitive stand on cryptocurrency. The Court could take measures to legalize cryptocurrencies or direct the RBI to come up with more documentation and legal backing to ban the same.   

Even though this judgement held in favour of the cryptocurrency communities, we cannot conclude that that the apex court is for VC it in fact empowered RBI to regulate virtual currency clearly confirming the powers of RBI in this regard.

Till this judgement, RBI wasn’t very sure about whether it has the power to hit VC directly. With that dilemma, RBI issued this impugned (now banned) Circular by ring-fencing them.   This judgement now paves a way for RBI to take a decision on whether to completely ban VC or should it come up with alternate solution capable of dealing with virtual currencies for the stability of the financial system. Though the judgement set aside the RBI circular, it in fact empowered RBI to regulate and even ban VC’s in the future. You can now expect some fresh regulatory steps from RBI or from the government.   

References

[1]  FATF REPORT on Virtual Currencies Key Definitions and Potential AML/CFT Risks(2014) pp.4 Available at : https://www.fatf-gafi.org/media/fatf/documents/reports/Virtual-currency-key-definitions-and-potential-aml-cft-risks.pdf

[2] Ibid n1 pp5

[3] RBI: Annual Report for the year 2017-2018 Available at https://rbidocs.rbi.org.in/rdocs/AnnualReport/PDFs/0ANREPORT201718077745EC9A874DB38C991F580ED14242.PDF pp 48    

[4] RBI: Financial Stability RBI, June 2013, Available at : https://rbidocs.rbi.org.in/rdocs//PublicationReport/Pdfs/FSPI260613FL.pdf

[5] Press Release can be available at : https://rbidocs.rbi.org.in/rdocs/PressRelease/PDFs/PR205413F23C955D8C45C4A1F56349D1B8C457.PDF

[6] RBI Statement on Developmental and Regulatory Policies can be accessed at : https://rbidocs.rbi.org.in/rdocs/PressRelease/PDFs/PR264270719E5CB28249D7BCE07C5B3196C904.PDF

[7] RBI circular dated April 6 2018 can be accessed at:  https://rbidocs.rbi.org.in/rdocs/notification/PDFs/NOTI15465B741A10B0E45E896C62A9C83AB938F.PDF

[8] The draft bill can be accessed at : https://www.prsindia.org/sites/default/files/bill_files/Draft%20Banning%20of%20Cryptocurrency%20%26%20Regulation%20of%20Official%20Digital%20Currency%20Bill%2C%202019.pdf

[9] https://main.sci.gov.in/supremecourt/2018/19230/19230_2018_4_1501_21151_Judgement_04-Mar-2020.pdf

 

 

 

 

 

Image Credits: Photo by André François McKenzie on Unsplash

This judgment lost the opportunity to answer crucial questions or take a definitive stand on cryptocurrency. The Court could take measures to legalize cryptocurrencies or direct the RBI to come up with more documentation and legal backing to ban the same.   

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The Orphan Treatment of Orphan Drugs

  • 10 March, 2020
  • Rohit Kumar

“Orphan drugs” are pharmaceutical products used for the diagnosis, prevention or treatment of rare diseases. The definition of rare diseases varies from country to country. e.g. in the United States, a rare disease is defined as a condition that affects fewer than 200,000 people whereas in Europe it is less than one person per 2,000. Nevertheless, it is generally accepted that a disease having fewer than 100 patients per 100,000 population is a rare disease. It is assessed that internationally, around 6000 to 8000 rare diseases are in existence with new ones being discovered quite regularly. Moreover, it is estimated that there are approx. 4000-5000 rare diseases for which there are no treatments available.

In India, the rare disease and disorder population is between 72 to 96 million and up to 450 rare diseases have been recognized[i]. Because rare diseases affect a very small population of individuals and the profit potential is poor, pharmaceutical companies often do not take much interest in developing molecules for the treatment of these diseases. The shelving of these molecules and ignorance of the small patient pool gave rise to the concept of ‘pharmaceutical orphans.’

Orphan drugs and policies in India

In India, almost all orphan drugs are imported. The primary reason being lack of infrastructure, high cost and time, no cost of return, and no clear policy on orphan drugs and rare diseases. Although the disquiet around the development of orphan drugs resulted in an Orphan Drugs Act as early as 1983 in the United States, India has lagged behind for decades with the first ‘National Policy on Treatment of Rare Diseases’ coming out as late as 2017. Further, there are no epidemiological data, no figures on the burden of rare diseases and morbidity and mortality associated with them. In fact, until last year, India did not even have a definition of ‘orphan drugs.’ The new Drugs & Clinical Trial Rules 2019 finally defined it as “a drug intended to treat a condition which affects not more than five lakh persons in India”.

Drugs and Clinical Trials Rules, 2019:

In March 2019 Central Drugs Standard Control Organization (CDSCO) released New Drugs and Clinical Trials Rules, 2019. As per these new guidelines, local clinical trials (data) may not be required for orphan drugs permitted to be imported for sale or distribution. Further, the Expeditious Review Process could be sought for approval of a new drug after clinical development (applicable for Orphan Drugs). Furthermore, no fee shall be chargeable in respect of an application for conduct of clinical trial for orphan drugs.

New Drug Exemption Rule, 2019:

Further encouragement for orphan drug development could be seen in the New Drug Exemption rule released in January 2019. Under this rule, all new drugs patented in India were to be exempted from price control for five years. The five-year window starts from the date when the manufacturer starts commercial marketing in India. The Government has also exempted such drugs from price control that are used for the treatment of a disease that qualifies as Orphan Disease in the opinion of the Ministry of Health and Family Welfare (“Orphan Drug Exemption”). However, these rules are not devoid of shortcomings which may bring about issues during implementation. The requirement of the use of the exemption for five years from the “date of commencement of commercial marketing by the manufacturer in the country” is ambiguous as there is no legal definition of what amounts to ‘commercial or business marketing’ in India. The second issue that needs clarification is the exemption from price control available to ‘manufacturers’ of the patented new drug rather than the ‘drug’ itself. As a result, multiple manufacturers, importers, marketers of the same drug would seek to benefit from the exemption which could pose a challenge when the date of commercial marketing of different manufacturers would vary from each other. The third most important issue with absolute market exclusivity is that cost of orphan drugs per treatment episode could be extremely high.

Rare diseases as a public health issue

When a person contracts a rare disease, it not only puts an emotional strain on him/her, it also puts a heavy financial strain on his family. In addition to this, the unavailability of proper treatment remains a big challenge. Internationally, there are very few pharmaceutical companies, which are actively working on orphan drugs or rare diseases. And in India, the problem is more worrisome because there are hardly any pharmaceutical companies engaged in the development of these drugs. In addition, lack of awareness among the medical fraternity, lack of epidemiological data, lack of dedicated healthcare policies, schemes, and diagnostic facilities are some of the major hurdles that Indian pharmaceutical companies have to deal with.

The new drug exemption policy along with the CDSCO released new Drugs and Clinical Trials Rules, 2019 could provide the necessary impetus to the research and development of orphan drugs in India. However, there are still major strides that could be taken in line with other international governments which provide incentives ranging from tax credits to priority review vouchers in addition to fast track approvals by regulatory agencies, market exclusivity, fee reductions for regulatory approvals. Nevertheless, incentives should be balanced so as not to encourage pharmaceutical companies to exploit them to manufacture drugs for sub-categories of existing diseases to maximize profits by making existing drugs outrageously costly and inaccessible.

Hence, a more robust policy is imperative to devise a multipronged and multisectoral approach to build India’s capacity to tackle rare diseases comprehensively. Particularly, in areas of – obtaining requisite funding, creation of an extensive database, for cost estimation of the treatment; research and development for the treatment and diagnostic modalities, including through international/regional collaborations; training of health care providers; awareness generation; creating a conducive environment for drug development and measures for ensuring affordability of treatment, etc. With the necessary government action, hopefully, the orphan treatment of orphan drugs will minimize to give some respite to the patients.

References

[i] https://mohfw.gov.in/sites/default/files/Rare%20Diseases%20Policy%20FINAL.pdf 

Image Credits: freestocks on Unsplash

A more robust policy is imperative to devise a multipronged and multisectoral approach to build India’s capacity to tackle rare diseases comprehensively. 

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Developments in the Indian Patent Law in 2019

As per the latest WIPO report, India has emerged as one of the top 10 countries in the ranking of filings of intellectual property applications while showing an increase of 7.5% in the number of patent applications.

The year 2019 saw some drastic widening of the scope and horizons of the patent laws. Various rulings and legislations were laid down making the sector more efficient in its functioning. The Patent Law has been liberalised to a great extent thereby providing a conducive atmosphere for start-ups and other small entities to hit the ground running. Also, the offer of 450 patents for free access to industries by DRDO for commercial exploitation was a shot in the arm.

The legislative developments together with the policies and significant case studies instrumental in widening the ambit of the patent laws are listed hereunder:

LEGISLATIVE AND POLICY DEVELOPMENTS

 

  • Publication of A New List of Scientific Advisors by the Patent Office[i]

 As per the Patent Rules, 2003, a list of Scientific Advisors must be released and updated annually. The list was last updated in 2010 and after nearly a decade, the list was issued in 2019 with 37 new enrolments. The list includes 2 Patent Agents. The duty of these advisors broadly includes guiding the Court and providing reports on questions involving technical substance.

 

  • Bilateral Patent Prosecution Programme[ii]

The Government approved the Bilateral Patent Prosecution Highway Programme between India and Japan. This programme enables accelerated examination of applications as it cuts down on duplication of work. Once a patent is granted in one country, the process of approval gets easier when filed in another country as it is assumed that the application must have gone through the rigorous process of exhaustive searches and technicalities in the previous country thereby enabling speedy disposal of applications. The process becomes much simpler, quicker and economical.

Under this pilot programme, Indian Patent Office can receive patent applications in certain specified technical fields only, like electrical, electronics, computer science, information technology, physics, civil, mechanical, textiles, automobiles and metallurgy, however, Japan Patent Office can receive applications in all fields of technology. This programme is initially restricted to a period of 3 years. If there are no major implemental gaps, this will be highly beneficial to Indian inventors including start-ups and MSMEs.

 Accelerated / expedited examination process

The amended rules include additional categories of applicants who can avail of expedited examination of their patent application. Such categories being small entities/MSME’s, Women applicants, Departments of Government, Institutions owned or controlled by the Government, Institutions wholly or substantially financed by the Government, Government companies; and Applicants of those countries whose patent offices are in an agreement / arrangement with the Indian Patent Office.

Fees and documents for start-ups and small entities

The second proviso to sub-rule (1) of Rule 7 has been substituted to clarify that start- ups and small entities must submit Form 28 along with the documents requiring a discount on the official fee. However, this amendment was merely expository in nature as, in practice, the Patent Office had already mandated the filing of the said form.

Medium of transmission of documents by patent agents

Rule 6(1A) was substituted and now provides that patent agents will have to file duly authenticated documents only via electronic medium. However, any document that is specifically asked to be reported/submitted in original by the Patent Office should be filed within 15 days of such request.

Transmittal and certified copy fee no longer applicable

In order to encourage electronic filing of PCT application, the Rules have been amended by deleting transmittal fees which the applicants were required to pay to the Indian Patent Office earlier. However, if the applications are filed physically then the same transmission fee as prescribed under the principal Patent Rule shall be applicable.

SIGNIFICANT CASE LAWS

  • Nuziveedu Seeds Ltd. And Ors. Vs Monsanto Technology LLC and Ors[iv]

The Hon’ble Supreme Court held that cases involving technical and scientific questions about patentability and exclusion of a patent were to be duly considered and examined at the stage of the final hearing. Expert advice and extensive inputs on technical aspects of a patent were purely unnecessary for granting injunctive relief. In the instant case highly complex question regarding the technical aspects of a patent was involved along with the compliance of a sub-licensing agreement between the plaintiff and the defendant. The patentee had terminated the agreement abruptly and filed for injunction restraining the defendants from using the patent as per the agreement. The single judge bench ordered compliance with the agreement and did not allow injunction. On appeal, the Division bench investigated the technicalities and ruled in favour of the plaintiffs. However, when appealed to the Supreme Court, it held that the judgement by the learned Single judge bench was in order and did not merit any interference.

  • Bayer Corporation v. Union Of India & Ors[v]

The Delhi High Court held that export of patented invention is also included under section 107(A) of the Patents Act, 1970 i.e., Bolar exception (rights granted to a patentee-making, using, constructing, selling and importing of their patented invention). However, the inclusion of ‘export’ needs to be duly regulated through the reasonably related test which shall differ from case to case to ensure that such exception is not misused. The ‘export’ should be reasonably related to research, development and submission of the information for obtaining regulatory approval from the authorities. In the present case, the issue was whether export of patented products for the purpose of research and development amounted to infringement and whether the export fell within the Bolar exception. The concept of patent linkage was extensively discussed. The case was decided in favour of the Respondents and exporting of the patented product for R&D was interpreted to be well within the Bolar exception under Sec 107(A).

  • Natco Pharma Limited v. Bristol Myers Squibb Holdings Ireland Unlimited Company and Others[vi]

The Hon’ble Delhi High Court reiterated the importance of considering the three-element test for the grant of an interim injunction (Prima facie case, the balance of convenience, irreparable injury). Such reiteration was considered essential to regulate the grant of injunction orders, especially in cases of pharmaceutical patent infringement. In the present case the respondents filed a suit seeking an interim injunction restraining the appellants from commercialising and initiating the sale of the appellant’s patented product. The Single Judge bench ordered interim injunction but on appeal, the Hon’ble High Court declared that interim injunction could not be granted merely on peripheral consideration of facts without applying the three-element test of interim injunction.

  • Ferid Allaniv Union of India And Ors[vii]

In this case the Petitioner had filed a patent application for a computer-related invention and the same was rejected. On appeal to the IPAB, the application was again rejected on the grounds of lack of novelty and lack of technological advancement or technical effect. The petitioner further appealed to the High Court of Delhi where the scope of Section 3(k) of The Indian Patent Act, 1970 and the term ‘technical effect’ was examined. The Court held that there existed no absolute bar on the patentability of computer-related inventions. However, it was subject to technical effect and advancement derived via such invention. The court directed for a re-examination of the patent application in accordance with the law.

  • Communication Components Antenna Inc. v. Ace Technologies Corp and Ors.[viii]

This landmark judgement emphasised on the necessity of a wide claim. It was further clarified that claims granted in India would take precedence over claims granted in a foreign jurisdiction while determining an infringement suit. In the present case the plaintiff sought permanent injunction claiming infringement of one of its patents that he had acquired in India. The product was granted a corresponding patent in the US. When a conflict over infringement of the Indian claim came up, the High court strictly stated that an infringement in such claim would be strictly confined and viewed in accordance with the claims granted in India and not the foreign claims although they might persist.

  • Pharmacyclics LLC v. Union of India & Ors.[ix]

In this landmark case, the Delhi High Court issued wide guidelines on post grant opposition. In this instance, the court allowed evidence to be produced considering the dates for the final hearing were fixed and evidence was filed prior to the hearing which was eventually adjourned at the request of the party. Further, there existed a reasonable time for the parties to respond to the filings previously made. The Hon’ble court while disposing of the matter laid down certain guidelines to be duly complied with in cases dealing with post grant oppositions. These included the filing of initial pleadings by the parties by relying on various documents and expert testimonies. Moreover, Rule 59 was to be strictly adhered to. Further evidence was not permissible once the material was transmitted to the opposition board. In addition, further evidence would only be entertained prior to the issuance of hearing under Rule 60. Moreover, publicly available documents can be provided 5 days prior to the hearing by highlighting the relevant portions. Also, the authenticity of the document is important.

 

 

References 

[i] http://ipindia.nic.in/writereaddata/Portal/Images/pdf/List_of_Scientific_Advisers_as_on_6Sept2019.pdf

[ii] https://dipp.gov.in/sites/default/files/PressBrief_Japan_21November2019.pdf

[iii] http://www.ipindia.nic.in/writereaddata/Portal/News/569_1_The_Patent_Amendment_Rules_2019_.pdf

[iv] CIVIL APPEAL NOS.4616¬4617 OF 2018

[v] LPA No.359/2017, CM Nos.17922/2017, 20160/2017, 33383-84/2017, 47167/2017 & 660/2018

[vi] FAO(OS) (COMM) 160/2019 and C.M.No.31063/2019

[vii] W.P.(C) 7/2014 & CM APPL. 40736/2019

[viii] CS (Comm) No. 1222/2018

[ix] CM APPL.54097/2019

 

 

Image Credits: Paul Skorupskas on Unsplash

The year 2019 saw some drastic widening of the scope and horizons of the patent laws. Various rulings and legislations were laid down making the sector more efficient in its functioning. The Patent Law has been liberalised to a great extent thereby providing a conducive atmosphere for start-ups and other small entities to hit the ground running.

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Development in Indian Copyrights Law in 2019

  • February 19, 2020
  • Avilash Kumbhar

With the digital movement coming of age, the scope of copyright protection has expanded in the past year to a notch higher and effective regulations have been launched to deal with the expansion.

Some of the essential legislation and rulings that shaped the Indian Copyrights law in 2019 are stated hereunder:

LEGISLATIVE DEVELOPMENTS

 

  1. Copyright (Amendment) Rules 2019

The Department for Promotion of Industry and Internal Trade (DPIIT) vide its press statement dated May 30, 2019 proposed to introduce the Copyright Amendment Rules, 2019[1].  The draft rules aimed at ensuring smooth and flawless compliance of the Copyright Act in the light of technological advancement in the digital era and to bring them in parity with other relevant legislations. They sought to broaden the scope of issuance of statutory licences under section 31-D of the Act for broadcasting work subject to copyright protection by replacing ‘radio and television broadcast’ with ‘each mode of broadcasting’ under rules 29, 30, 31. This amendment came at the backdrop of  Tips Industries Ltd. vs. Wynk Music Ltd. & Anr.[2], where the need to include streaming under the preview of broadcasting was realised under the statutory licensing scheme. The draft also provided for stricter code of conduct for copyright societies and more. 

  1. Cinematograph (Amendment) Act, 2019

The Ministry of Information and Broadcasting on Feb 12, 2019 introduced Cinematograph (Amendment) Bill 2019[3] which aims to curb film piracy and imposes stricter penalties and punishments in this accord. The scope of unauthorised use of audio-visual recordings has been widened to include unauthorised camcording and transmission thereof. Strict deterrence can be traced in the proposed bill as intense penal provisions are attracted in the case of making and transmitting copies of a cinematograph film or audio-visual recording without acquiring approval from the owner of such work.

Notable Case Laws

Some of the noteworthy copyright cases for the year 2019 would be:

1.      Roger Mathew v. South Indian Bank Limited[4]. 

The Supreme Court of India struck down the Tribunal, Appellate Tribunal, and other Authorities (Qualifications, Experience and other Conditions of Service of Members) Rules, 2017 framed under the Finance Act, 2017 on the ground that it gave excessive and discretionary powers to the government as to the appointment of service persons to the tribunal and it also affected the judicial independence of the Tribunals. The dilution and encroachment on the judicial domain through the appointment of technical and other members, devoid of either adjudicatory experience or legal knowledge, to the IPAB after the merger of Copyright Board and IPAB was a matter of great concern. However, since this development could not be implemented retrospectively, the appointment already made remained unaffected. 

2.      UTV Software Communication Ltd. & Ors. v. 1337X.TO & Ors[5]

The Delhi High Court introduced a dynamic injunction into Indian jurisdiction to curb online piracy. Through this, Plaintiff could get the order executed against mirror/redirect/alphanumeric websites hosting the same infringing content as those already blocked.

  1. Sajeev Pillai v. Venu Kunnapalli & Anr[6]

It was the case of Plaintiff that the storyline of the defendant’s movie titled Mamankam was the result of the extensive research work done by Plaintiff. Plaintiff had assigned his work which included the story, script, screenplay, and dialogue to the defendant. The Kerala High Court held that the author has a legitimate right to claim authorship even after assignment and the later act does not exhaust the moral right of the author within the meaning of section 57(1) of the Copyright Act, 1957. However, since the movie is the distorted version of the plaintiff’s work due to the mutilation and modification of the original script, the court took a balanced view and allowed the movie to be released without crediting anyone as the author thereof till the final disposal of the suit. 

  1. Tips Industries Ltd. vs. Wynk Music Ltd. & Anr[7]

The Hon’ble Bombay High court interpreted section 31D of the Copyright Act, 1957 as an exception to the copyright laws. It is further stated that statutory licensing extends to only radio and television broadcasting and is exclusive of internet broadcasting. Therefore, online streaming services don’t fall within the ambit of statutory licensing. The flaw could, however, be fixed via the new “Copyright Amendment Rules 2019” stated the Hon’ble court. In the instant case, the defendant’s feature to allow its consumers to download music and store the same for unlimited usage amounted to sale thereby not constituting broadcast stated in 31D of the Copyright act. Therefore, the defendant was not required to avail of a statutory license.

  1. Yash Raj Films v. Sri Sai Ganesh Productions[8]

The plaintiff (Yash Raj) instituted a copyright infringement suit against the defendant for the reproduction of the copyrighted work subsisting in the plaintiff’s movie titled “Band Baja Baraat” through a Telugu remake titled “Jabardasth” without taking prior permission of the plaintiff.    

The Hon’ble High court was of the view that “to make a copy of the film‟ did not mean just to make a physical copy of the film by a process of duplication, but it also referred to another film which substantially, fundamentally, essentially, and materially resembled/reproduced the original film. The defendants had blatantly copied the fundamental, essential and distinctive features as well as forms and expression of the plaintiff’s film on purpose and consequently, infringed the plaintiff’s copyright.

  1. Raj Rewal v. Union of India & Ors[9]

The Hon’ble Delhi High court in the instant case dealt with a significant question of copyright law i.e., whether an author’s (architect’s) rights foreshadow the rights of the property owner. It was answered in the negative, i.e. the property owner’s right as per constitutional right under Article 300A shall be held more vital and that he/she can choose to destruct or modify the building on his/her property. Therefore, the Owner’s right shall precede the Author’s right under Sec 57 of the Copyright Act.

  1. Thiagarajan Kumararaja v. M/s Capital Film Works and Anr[10]

The Hon’ble Madras High Court for the first time deliberated a ruling on rights of the producer qua the author of the script with regard to the dubbing of the film and held that the producer of the film has the right to dub the film in any other language provided there isn’t any agreement to the contrary. Under Section 2(d)(v) in relation to a cinematograph film, the producer is the author and since they had taken the initiative and the responsibility for making the work i.e., cinematograph film, they had the right to dub the same. Accordingly, the infringement suit for dubbing the film in another language was dismissed and decided in favour of the producer.

 

CONCLUSION

From defending the right of the producer to dub in other languages, to continuance of the moral right of the author even after the assignment of work, it can be said that the year 2019 has been a busy year for the music and film industry. The introduction of the dynamic injunction against rogue websites was a much-needed change for the empowerment of lawful owners of copyrighted work to battle piracy. Further, the online copyright application system has progressively become filer-friendly in the past year[11]. In addition, increased transparency and stakeholder participation has created a protective environment for enhanced copyright preservation.

References 

[1] Available at http://copyright.gov.in/Documents/pdfgazette.pdf

[2] Commercial Suit IP (L) No. 114 of 2018

[3] https://prsindia.org/sites/default/files/bill_files/Cinematograph%20%28A%29%20Bill%2C%202019.pdf

[4]  Civil Appeal No. 8588 of 2019, SLP No. No.15804 of 2017

[5] CS(COMM) 724/2017

[6] FAO.No.191 OF 2019

[7] Commercial Suit IP (L) No. 114 of 2018

[8] CS (COMM) 1329/2016

[9] CS (Comm) No. 3 of 2018

[10] Original Side Appeal No. 22 of 2017

[11] http://www.ipindia.nic.in/writereaddata/Portal/IPOAnnualReport/1_110_1_Annual_Report_2017-18_English.pd


Image Credits: Noor Younis on Unsplash

From defending the right of the producer to dub in other languages, to continuance of the moral right of the author even after the assignment of work, it can be said that the year 2019 has been a busy year for the music and film industry. The introduction of the dynamic injunction against rogue websites was a much-needed change for the empowerment of lawful owners of copyrighted work to battle piracy.

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Development in Indian Trademark Law in 2019

  • February 18, 2020
  • Avilash Kumbhar

India moved up one spot up in terms of trademark filings from its previous year’s ranking according to the World Intellectual Property Indicators published in October 2019. The report also pointed out a large increase in trademark filing activity in India i.e. more than 20.9% with resident filing activity overwhelmingly contributing to the double-digit growth. Having remained below 100,000 until 2006, India’s trademark annual filings now exceed 320,000.

The year also saw some judicial and policy development enabling efficient functioning of the trademark laws in the said context. Legislations have also tried to catch up with the ever-increasing activity in the digital space. Some of the essential enactments and pronouncements are stated hereunder:

 

LEGISLATIVE & POLICY DEVELOPMENTS

 

  1. National E-Commerce Policy [Draft]

The Department for Promotion of Industry and Internal Trade (DPIIT) on February 23, 2019 released the National E-commerce Policy[1] to prepare and enable stakeholders to fully benefit from the opportunities that would arise from progressive digitalization of the domestic digital economy. The draft policy laid special emphasis on the compulsory adoption of anti-counterfeiting and anti-piracy mechanisms by E-commerce platforms. Such adoption would not only curb piracy and counterfeiting but would further make the transactions explicit for the sellers, trademark owners and consumers enabling the system to work transparently.

  1. Trade Mark Registry’s Proposal to Restrict Access to Certain Documents

The Ministry of Commerce & Industries on September 06, 2019, issued a public notice[2] inviting suggestions on the categorization of documents put up on their official website as :

  1. Full access documents which can be viewed and downloaded by the general public.
  2. Documents with description but viewing and downloading restricted.

Several confidential, personal and exclusive information was being put up via documents that needed to be protected and access to them had to be duly regulated. Hence the proposal.

 

NOTABLE CASE LAWS

Some of the noteworthy trademark cases for the year 2019 would be:

1.      Crocs Inc Usa v. Bata India Ltd & Ors[3]

The plaintiff (Crocs) after an unsuccessful attempt in the lower court to sue the Defendant (Bata) for design infringement, approached the Delhi High Court pressing for an injunction on the ground of passing-off action under common law. The High Court considered the legislative intent of the Design Act of providing monopoly over the design vide registration only for a limited period, thereby making it available for public use after the tenure of the registered design. This objective would be lost if the design was allowed to be used as a trademark since the exclusive rights would then last till perpetuity. However, the court clarified that if there was an additional feature that had been extensively used as a trademark other than what has been protected as design, and goodwill had accrued in relation to the use of such feature as a trademark, it is only those features which could be protected as a trademark.

2.      Amway India Enterprises Pvt. Ltd. v. 1MG Technologies Pvt. Ltd. & Anr.[4]

In another important case, the plaintiff (Amway) sought a mandatory and perpetual injunction restraining the defendant from using the plaintiff’s trademark and selling products online without the plaintiff’s consent. The Delhi High Court restrained e-commerce platforms from selling products falling under the direct selling category without the consent of the proprietor of the registered trademark. The court held such an act enabling the sale of the product on the defendant’s website as not only infringement of the plaintiff’s trademark leading to dilution, passing-off and misrepresentation but also ultra vires the “direct selling guidelines 2016”. The court further observed that the intermediaries (e-commerce marketplace) should fulfil the due diligence requirements in order to avail the safe harbour protection.

  1. Amrish Agarwal v/s Venus Home Appliances Pvt Ltd[5]

It was ruled that in cases alleging trademark infringement, a legal proceedings certificate (LPC) ought to be mandatorily filed along with the plaint. In the said case, the LPC was filed at the stage of final arguments. It was objected on the ground that LPC filed in the last leg of the case ought to be disallowed. The said objection was counter-argued stating that a renewal certificate was brought on record and duly exhibited. In this regard, the Court held that in a trademark infringement case, the Court must be able to see the mark, and therefore an LPC or the certificate of registration along with the journal extract ought to be submitted at the initial stage itself.

 

The increased trademark filing activity illustrates an increased awareness among emerging entities regarding their intellectual property rights and the necessity to protect them as early as possible. With increased competition, the availment of trademark registration is also becoming a tough nut to crack. Further, the fluid nature of the digital environment poses a continuous challenge to the IP domain. Conducive policy changes and judicial decisions in the past year have dealt with some of these threats but for adequately serving the public interest implementation challenges have to be appropriately addressed

 

References 

[1] Available at https://dipp.gov.in/sites/default/files/DraftNational_e-commerce_Policy_23February2019.pdf

[2] http://ipindia.nic.in/writereaddata/Portal/Images/pdf/Catergorization_of_Docs.pdf

[3]CS(COMM) 569/2017

[4] CS (OS) 410/2018, 453/2018, 480/2018, 531/2018, 550/2018, 75/2019 & 91/2019

[5] CM (M) 1059/2018

 

 

Image Credits: Lukas Blazek on Unsplash 

Conducive policy changes and judicial decisions in the past year have dealt with some of the threats but for adequately serving the public interest implementation challenges have to be appropriately addressed.

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