Tag: #Vaccination

Supreme Court Directs the Government to Rehabilitate and Vaccinate Beggars

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The PIL regarding the restrain and rehabilitation of the beggars in the wake of this pandemic situation was brought before the court by the petitioner Kush Karla on 27.07.2021, before the bench of Justices DY Chandrachud and MR Shah.

“We can’t restrain beggars. Nobody wants to beg it’s all the situation leading the human to do so. And this restraining them cannot miss out of our eyes but it is an economic crisis of the society that brought them to this situation even it’s their own will to do so”, said the bench.

Senior advocate Chinmoy Sharma, who appeared as the petitioner’s counsel, responded to the bench that our plea is not regarding the restrain of beggars but to provide rehabilitation for them after being vaccinated, And all the people in this country mandatory to be vaccinated but why not the beggars. In light of this, the court sent notice to the national capital territory of Delhi also to the union of India on the prayer regarding the vaccination and rehabilitation of the beggars.

The court ordered that in regards to the plea every citizen in the country means to be safe and secured, irrespective of the rich nor poor. Also, the court highlighted that it is the socio-economic crisis that leads people in the streets to beg, it is not anyone’s choice to opt for such a decision. Restraining them is not a way to decrease this socio-economic crisis, People do beg due to poverty and unemployment. Also, the mentioned that there are many societies to help and protect the homeless people, though the court issued an order to protect them from the spreading of COVID 19 in the traffics and streets due to the act of begging, And directed the union and Delhi to give response for such human situations, and the court asked the Solicitor General to assist the court.

The hearing would be continued two weeks later.

-Report by AJISHA

Zydus Cadila Covid-19 Vaccine For 12-18 Age Group to be Available Soon : Centre Tells Supreme Court

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On May 31, 2021, the Supreme Court of India raised a slew of questions in its order while hearing the suo-motu case related to Covid Management in India. In the said order, the Court criticized the Centre’s Covid vaccination policy and described it as prima facie arbitrary and irrational.

The bench of Justice DY Chandrachud also asked the Central Government to provide the details and information about how Rs. 35,000 crore, which was earmarked especially for procurement and supply of vaccines, has been spent so far and for the Centre to present all the relevant and important documents regarding the covid vaccination policy in front of the court.

The Union Government has stated that as per the projected midyear population of India for 2020, the total population aged 18 years and above is approximately 94 crore, and the administration of 2 doses to each citizen would require an estimated 188 crore vaccine doses.

In a 380-page affidavit, the Centre stated that it expects to procure the estimated requirement of around 188 crore doses from at least 5 manufacturers by the end of the year. It also stated that a poor person and a millionaire are equally entitled to get the Covid vaccine for free and that necessary actions are being taken to ensure the safe, accessible, and effective administration of vaccines. It further contended that along with the two major vaccines of the country, Covishield, and Covaxin, another Russian Coronavirus vaccine named Sputnik V has received Emergency Use Authorisation by the DCGI, India. Some other domestic vaccines from Biological E and Zydus Cadila are also in the final stages of clinical trials and once approved, will further increase the availability of vaccines.

The court, in its order dated 31.05.2021, also asked for the reasons behind the involvement of private hospitals in the process of administering vaccines. To this, the government stated that according to the statistics, almost 55% of the population gets medical care from private hospitals and the remaining 45% gets health care services from government-run hospitals. It argued that private hospitals have a wider range to vaccinate people and also lessens the stress on government facilities during a time of crisis.

The Health Ministry Of India on 26th June informed that Zydus Cadila, an Indian pharmaceutical company, will soon complete clinical trials for the vaccine against Covid-19 for citizens in the age bracket of 12-18 years and that the doses will most likely be available from July end or August.

-Report by Anuj Dhar

Compulsory Licensing And Vaccination

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The present article has been written by Prateek Chandgothia, a 1st year BA LLB student at the Rajiv Gandhi National University of Law, Punjab

Introduction

Under the Indian Patents Act, compulsory licensing is defined as decentralizing the rights over a patented commodity and allowing the production or manufacturing of the commodity without obtaining prior permission from the owner of the patent. Various international treaties and agreements have legislated compulsory licensing as a legal course of action in situations where ramping up the production of a commodity are essential within a shorter period of time. 

  1. Laws Governing Compulsory Licensing 

Chapter XVI (Section 84-92) of the Indian Patents Act of 1970 lays down the provision of compulsory licensing of patents. Section 84 of the Act lays down the following – 

“At any time after the expiration of three years from the date of the [grant] of a patent, any person interested may make an application to the Controller for grant of compulsory license on patent on any of the following grounds, namely: –

  1. that the reasonable requirements of the public concerning the patented invention have not been satisfied, or
  2. that the patented invention is not available to the public at a reasonably affordable price, or
  3. that the patented invention does not work in the territory of India.”

2. Special Granting of Compulsory Licenses

In addition to the essentials of granting compulsory licensing, Section 92 of the India Patents Act of 1970 allows special powers vested unto the central government to grant compulsory licensing – 

“If the Central Government is satisfied, in respect of any patent in force in circumstances of national emergency or circumstances of extreme urgency or case of public non-commercial use, that compulsory licenses must be granted at any time after the sealing thereof to work the invention, it may make a declaration to that effect, by notification in the Official Gazette.” Moreover, Section 100 of the Act allows the usage of Patented inventions for government purposes. 

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement furthered the emergency granting of compulsory licensing in 1994. Before the TRIPS agreement, India singularly allowed compulsory licensing only for process patents and not product patents which allowed companies to only reverse-engineer the patented products. However, the TRIPS agreement facilitated flexibility in terms of granting compulsory licensing by the government of different countries. Article 31 of the agreement deals with the right of granting compulsory licenses. These flexibilities were clarified by the Doha Declaration of 2001. Clause 5(C) of the declaration clearly recognizes the flexibility that “each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.”

Apart from these provisions and legal agreements, a fairly related case law was laid down in the case of Natco Pharma Ltd. v. Bayer Corporation, wherein the Intellectual Property Appellate Board upheld the decision granting a compulsory license of a life-saving drug for liver or kidney cancer, Nexavar, which was sold by Bayer at an exorbitant cost of Rs. 9 lakhs. Natco Pharma Ltd. offered to manufacture the same drug for Rs 9000. It was held that various international conventions and Indian laws allowed the member countries to grant such compulsory licenses to make medicine cheaply available to the public. The same was reiterated in the Suo Motu Covid-19 Case hearing taken up by the Hon’ble Supreme Court of India recently.

  1. Patent Rights or Access to Essential Medicine?

There has been a long-standing debate on the issue of whether or not, protection of Patent Rights be given priority over the public access to essential and affordable medicine. While the giants of the pharmaceutical industry have constantly argued in favor of prioritizing the protection of patent rights, the governments of various countries have been in the favour of providing public access to essential and affordable medicine. 

A major argument from the side of the Pharma giants has been along the lines of costs of R&D in the development of a ground-breaking invention being the reason for the skyrocketing prices of the drugs. They also argue that excess granting of compulsory licenses stifles innovation in the long run by reducing the period of protection of patent rights. On the flip side, the governments have argued that it is evident that the prices set by the Pharma corporates are highly profit-driven and are solely made to generate increased revenues through sales of the drug rather than accessibility. Therefore, an extension of the period of protected patent rights will only contribute towards increasing the profits of these corporations. Moreover, evidence shows that the level of pharmaceutical patent protection, especially in developing nations, is irrelevant in spurring innovation.

This debate has significantly thrived in the context of the developing nations wherein the income inequalities infest the society at large and directly affect the larger public access to essential medicines in event of skyrocketing prices set by various Pharma Corporates. According to the MDG Gap Task Force Report of 2012, the average availability of essential medicines across the world is an abysmal 51.8 percent in public sector health facilities. This indicates a rather worrying circumstance regarding access to essential medicine.

The classic rationale for allowing compulsory licensing is that public welfare, and particularly health, in the immediate term outweighs the long-term objective of encouraging innovation.24 While this does not, in any manner, indicate an absolute sacrifice of innovation, the pressing nature of public health can necessitate a compromise, placing innovation at a lower priority. Pharmaceutical companies argue precisely against such a compromise. The dealing with this power struggle has varied across different countries. While countries like Brazil have effectively used the provisions of TRIPS for granting compulsory licenses, as a tool to threaten the Pharma Corporates to lower the prices of essential drugs, certain developed countries have argued against this increased practice of granting compulsory licenses and have sided with the Pharma Corporates instead.  

Conclusion

Given the current Covid-19 Pandemic, compulsory licensing of the Covid vaccines is a necessary step towards ensuring fair and affordable access, especially in the Indian Context. The income disparities in India have been at an all-time high as a result of continuous complete lockdowns, increasing unemployment, and poverty. With a population as large as 1.35 billion people, it is essential to ramp up production and supply of the covid vaccine as herd immunity remains a distant reality. Considering the deadly second wave, nationwide and the state-wide lockdown has not resulted in avoiding the resurgence of covid infections and has only facilitated the deferment of the same. Therefore, it is evidently concluded that an efficient and quick-paced vaccination drive is an integral component to ensure victory in the fight against this deadly pathogen.

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Distribution of Essential Supplies and Services During Pandemic

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-Report by Manaswa Sharma

Introduction

Proceedings withinside the present suo motu writ petition had been initiated on 22 April 2021, while this Court took consciousness of the control of the COVID-19 pandemic at some stage in the second wave. Subsequently, hearings had been performed on 23 April 2021, 27 April 2021, and 30 April 2021 while submissions had been heard on behalf of the Union of India, States/Union Territories, found out Amici appointed through this Court and a number of the intervenors

Since the remaining listening to on this matter, the second wave of the COVID-19 pandemic has begun out receding throughout the state and the scenario seems to have come to be extra manageable. Hence, a number of the problems mentioned withinside the preceding orders can watch for similar deliberation. However, the problem of vaccination is surely crucial, because fitness professionals globally agree that vaccination of the state’s complete eligible populace is the singular maximum critical project inefficaciously preventing the COVID-19 pandemic withinside the lengthy run. Hence, at some stage in the direction of the court cases on 31 May 2021, this Court has restricted itself to listening to submissions at the UoI’s vaccination coverage and its roadmap for the future. By manner of plentiful clarification, we observe that every one of the problems contained on this Court’s preceding orders nonetheless holds their universal importance, and this Court shall keep to screen them along with the National Task Force and intrude each time necessary.

Submission by Counsel

Tushar Mehta, Solicitor General, based on the affidavit of the UoI dated May 9, 2021, has filed the following additions in the light of recent updates:

  • The vaccination campaign will be completed by the end of December 2021, and the central government is leading at the highest political and level Active diplomatic talks with foreign vaccine manufacturers to ensure sufficient vaccine supplies;
  • It would be wrong to suggest that one consequence of the updated UoI directive on vaccinating 18-44-year-olds is that there will be competition between states / UT; and
  • Anyone over 45 can continue to be vaccinated at a center by registering on-site without pre-booking an appointment through CoWIN.

Mr. Jaideep Gupta and Ms. Meenakshi Arora, discovered Senior suggests and Amici, have raised the subsequent troubles referring to vaccination distribution, augmentation of vaccine manufacturing and differential pricing of vaccines, and the destiny preparedness for handling the COVID-19 pandemic:

  • With admire to the procurement of vaccines, reviews endorse that overseas vaccine producer are commonly now no longer receptive or open to a speak with State/UT Governments on the premise that, as a rely upon company coverage, they handiest cope with federal governments of various countries;
  • The UIP has been changed through the Liberalized Pricing and Accelerated National COVID-19 Vaccination Strategy from 1 May 2021 in segment three of the vaccination force.

National Vaccination Policy

Phase 1 of the National COVID-19 Vaccination Strategy become released on sixteen January 2021 and 1 February 2021 and become centered closer to shielding HCWs and FLWs. Phase 2 become initiated on 1 March 2021 and 1 April 2021, and become directed closer to shielding the maximum susceptible populace withinside the age organization of men and women above forty-five years of age. In sections 1 and 2, the UoI become buying the vaccines and dispensing them to the States/UTs freed from fee for disbursal thru authorities and personal COVID-19 vaccination centers. The personal centers had been now no longer allowed to price a sum above Rs 250 in step with an individual in step with dose (Rs a hundred and fifty for vaccines and Rs a hundred as operational charges) from a beneficiary.

Separation of Powers

First, we try to clarify the nature of the court’s jurisdiction over the administration of the COVID-19 pandemic in India.​​​ The affidavit dated May 9, 2021, listed the following points:

  • The current vaccination policy is in line with Articles 14 and 21 of the Constitution and does not require court intervention, because the administrative department has “room for maneuver” in the face of such a large-scale epidemic;
  • Continue to take measures to deal with the imminent crisis, In the long run, this may be reckless; however, they should be fully evaluated in the short term;
  • Judicial review of administrative guidelines is only allowed in completely arbitrary circumstances. When executives need expert medical and scientific advice to solve a medical crisis, procedures need to be adopted;
  • In the absence of professional advice or management experience, any excessive, albeit in good faith, judicial intervention may lead to undesirable situations. There is almost no room for managers to find innovative solutions.

Issues with the Liberalized Vaccination Policy

1.Vaccine Logistics

We have already stated that attributable to the Liberalized Vaccination Policy, the obligation for the vaccination in segment three is being divided among the Central Government (for the ones above forty-five years of age, HCWs and FLWs) and the State/UT Government together with the non-public hospitals (for the age institution of 18-forty four years). This could suggest that the constrained vaccine logistics to be had in a State/UT could be shared among the State/UT Government and the Central Government. This isn’t the same as the state of affairs beneath neath the UIP, wherein the Central Government buys and allocates vaccines to States/UTs, as a way to make certain that their bloodless garage centers aren’t overwhelmed. Hence, we direct the UoI to offer the subsequent clarifications:

  • The way wherein bloodless garage gadget capability is being balanced among the Central and State/UT Governments. The way wherein the States/UTs are dealing with the logistical burden for vaccinating men and women elderly among 18-forty four years, together with men and women elderly over forty-five years.
  • Whether bloodless garage centers in India have improved for the COVID-19 vaccination drive; the prevailing numbers, and evaluation with the numbers previous to March 2020;
  • Whether the bloodless garage gadget is indigenously synthetic or is imported. If it’s far imported, the stairs that have been taken to begin indigenous manufacturing.

3.Digital Divide

In our order dated 30 April 2021, we had highlighted the issues regarding the cap potential of the marginalized participants of society to avail of vaccination, completely via a virtual portal within side the face of a virtual divide. The UoI’s affidavit made the subsequent submissions in terms of the accessibility of the CoWIN portal:

  • The CoWIN portal allows one individual to sign in four folks the usage of the equal cellular wide variety;
  • Walk-ins can not be accredited because of the shortage of vaccines and fears of overcrowding at centers. The online registration requirement counters this worry and additionally efficaciously video display units the management of the second dose. The coverage can be re-taken into consideration in the end whilst extra vaccines are to be had.

It has been delivered to our be aware that the CoWIN platform isn’t handy to folks with visible disabilities. The internet site suffers from positive accessibility obstacles which have to be addressed. These encompass:

  • Audio or textual content captcha isn’t to be had;
  • The seven filters, which inter alia, encompass age group, call of vaccine, and whether or not the vaccine is paid or free, aren’t designed accessibly. This problem may be addressed with the aid of using the introduction of a drop-down list;
  • While visually challenged folks can decide the wide variety of to be had vaccine slots, one can not discover the day the ones slots correspond to. This may be resolved with the aid of using making sure that desk headers correspond to related cells.

Conclusion

We direct the UoI to report a testimony, which shall cope with the troubles and questions raised in Section E, in which it shall make certain that every problem is answered to in my opinion and no problem is neglected out. We additionally direct that the affidavit ought to offer the subsequent information:

  • The records on the proportion of populace that has been vaccinated (with one dose and each dose), as towards eligible folks withinside the first 3 stages of the vaccination drive. This shall encompass records relating the proportion of rural populace in addition to the proportion of city populace so vaccinated;
  • The whole records at the Central Government’s buy records of all of the COVID-19 vaccines until date (Covaxin, Covishield, and Sputnik V). The records ought to make clear: (a) the dates of all procurement orders positioned via way of means of the Central Government for all three vaccines; (b) the number of vaccines ordered as on every date; and (c) the projected date of supply.

We additionally notice that UoI’s said to function in its affidavit dated nine May 2021 is that each State/UT Government shall offer vaccination freed from fee to its populace. Person State/UT Governments must confirm/deny this function earlier than this Court. Further, if they have determined to vaccinate their populace free of charge then, as a rely upon principle, it’s far critical that this coverage is annexed to their affidavit, so that the populace inside their territories may be confident in their proper to be vaccinated free of charge at a State vaccination center. Hence, we direct every of the State/UT Governments to additionally report a testimony within 2 weeks, wherein they shall make clear their function and place on file their policies.

……………………………………J. [Dr Dhananjaya Y Chandrachud]

……………………………………J. [L Nageswara Rao]

……………………………………J. [S Ravindra Bhat]

New Delhi.

Near-to-Door Vaccination is Better than Door-to-Door Vaccination: Center Informs Bombay High Court

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In an affidavit filed with the Mumbai High Court on Tuesday, the Department of Health and Family Welfare stated that vaccination near-to-door would be a more appropriate solution than door-to-door vaccination, On May 20, the Bombay High Court granted the National Expert Group on Vaccine Administration for Covid-19’s (NEGVAC) time until June 1, 2021, to determine on a door-to-door coverage for residents who might now no longer be capable of going to vaccination centers.

All the participants who participated with inside the assembly agreed that covid-19 vaccination couldn’t receive at domestic because of the troubles and dangers stated through the Expert Committee, which became constituted beneath the chairmanship of Dr. NK Arora, Executive Director Inclen Trust to observe the door to door vaccination policy.” the affidavit states.

It cited the following reasons against door-to-door vaccination:

  • Treating adverse events after vaccination (AEFI) in a timely and appropriate manner.
  • Carry out the observation protocol of each beneficiary for 30 minutes after vaccination.
  • Danger of infection by Covid-19 Vaccinators and mobilizers.

The court hears a PIL of two lawyers, Dhruti Kapadia and Kunal Tiwari, asking for instructions from the central and state governments to initiate a door-to-door vaccination campaign for citizens over 75, people with physical disabilities, and bedridden people.

-Report by Manaswa Sharma