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Subject: Social Justice

  • Scientists see flaws in SUTRA’s approach to forecast pandemic

    About SUTRA

    • SUTRA (Susceptible, Undetected, Tested (positive), and Removed Approach) first came into public attention when one of its expert members announced in October that India was “past its peak”.
    • Unlike many epidemiological models that extrapolated cases based on the existing number of cases, the behaviour of the virus and manner of spread, the SUTRA model chose a “data centric approach”.
    • However, the surge in the second wave was several times what any of the modellers had predicted.
    • The predictions of the SUTRA model were too variable to guide government policy.

    So, what went wrong in the model

    • The SUTRA model was problematic as it relied on too many parameters, and recalibrated those parameters whenever its predictions broke down.
    • The more parameters you have, the more you are in danger of overfitting.
    • One of the main reasons for the model not gauging an impending, exponential rise was that a constant indicating contact between people and populations went wrong.
    • Further the model was ‘calibrated’ incorrectly.
    • The model relied on a serosurvey conducted by the ICMR in May that said 0.73% of India’s population may have been infected at that time.
    • This calibration led our model to the conclusion that more than 50% population was immune by January.
    • The SUTRA model’s omission of the importance of the behaviour of the virus; the fact that some people were bigger transmitters; a lack of accounting for social or geographic heterogeneity and not stratifying the population by age as it didn’t account for contacts between different age groups also undermined its validity.

  • A ‘One Health’ approach that targets people, animals

    The article highlights the need for a holistic approach to animal and human health as more than two-thirds of existing and emerging infectious diseases are zoonotic.

    Need to document the link between environment animal and human health

    • Studies indicate that more than two-thirds of existing and emerging infectious diseases are zoonotic, or can be transferred between animals and humans, and vice versa.
    • Another category of diseases, anthropozoonotic infections, gets transferred from humans to animals.
    • The transboundary impact of viral outbreaks in recent years such as the Nipah virus, Ebola, Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) has reinforced the need for us to consistently document the linkages between the environment, animals, and human health.

    India’s ‘One Health’ vision

    • India’s ‘One Health’ vision derives its blueprint from the agreement between the tripartite-plus alliance.
    • The alliance comprises the Food and Agriculture Organization of the United Nations (FAO), the World Organisation for Animal Health (OIE), the World Health Organization (WHO) and the United Nations Environment Programme (UNEP) — a global initiative supported by the United Nations Children’s Fund (UNICEF) and the World Bank under the overarching goal of contributing to ‘One World, One Health’.
    • In keeping with the long-term objectives, India established a National Standing Committee on Zoonoses as far back as the 1980s.
    • This year, funds were sanctioned for setting up a ‘Centre for One Health’ at Nagpur.
    • Further, the Department of Animal Husbandry and Dairying (DAHD) has launched several schemes to mitigate the prevalence of animal diseases since 2015.
    • Hence, under the National Animal Disease Control Programme, ₹13,343 crore have been sanctioned for Foot and Mouth disease and Brucellosis control.
    • In addition, DAHD will soon establish a ‘One Health’ unit within the Ministry.
    • Additionally, the government is working to revamp programmes that focus on capacity building for veterinarians such as  Assistance to States for Control of Animal Diseases (ASCAD).
    • There is increased focus on vaccination against livestock diseases and backyard poultry.
    •  DAHD has partnered with the Ministry of Health and Family Welfare in the National Action Plan for Eliminating Dog Mediated Rabies.

    Need for coordination

    •  There are more than 1.7 million viruses circulating in wildlife, and many of them are likely to be zoonotic.
    • Therefore, unless there is timely detection, India risks facing many more pandemics in times to come.
    • There is need to address challenges pertaining to veterinary manpower shortages, the lack of information sharing between human and animal health institutions, and inadequate coordination on food safety at slaughter.
    • These issues can be remedied by consolidating existing animal health and disease surveillance systems — e.g., the Information Network for Animal Productivity and Health, and the National Animal Disease Reporting System.

    Conclusion

    As we battle yet another wave of a deadly zoonotic disease (COVID-19), awareness generation, and increased investments toward meeting ‘One Health’ targets is the need of the hour.

  • A WTO waiver on patents won’t help us against covid

    There has been growing clamour across the world for waiver of intellectual property protection for Covid-19 vaccines under TRIPS. The article suggests alternatives to achieve the desired production of vaccines without setting the precedent for a waiver.

    Waiver from TRIPS

    • Last October, India and South Africa moved a motion at the WTO asking its council on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to provide a waiver on intellectual property protection for pharmaceutical patents.
    • Many developing countries have since supported the joint move.
    • While most advanced countries, home to the world’s major pharmaceutical companies, have opposed it.
    • Nobel economist Joseph Stiglitz, along with activist Lori Wallach, penned an opinion piece making a case for such a waiver.

    Voluntary licensing

    • Alternative to waiver could be voluntary licensing arrangements between pharmaceutical companies and countries that wish to make vaccine doses for their own use.
    • This is exactly what has occurred in India’s case, with a licensing agreement between AstraZeneca and Serum Institute of India.
    • The recent difficulties with this arrangement are a result of India diverting some doses intended for export (or for Covax) to its domestic vaccination drive.
    • But India will soon begin making other important global vaccines under similar licence arrangements, and a waiver would do nothing to speed up this process.

    Compulsory licensing

    • In the event that India needs to ramp up production more than is feasible via licences from global manufacturers, there is another alternative available, which is ‘compulsory licensing’.
    • Such an approach would not permit the export of vaccine doses made under a compulsory licence.
    • This approach should be taken by any developing country, if, for some reason, global pharmaceutical companies are unwilling to license a life-saving vaccine for domestic manufacture and distribution in that nation.

    Why TRIPS waiver won’t help

    • India’s limiting factors are a shortage of raw materials and low production capacity, neither of which would be cured with the supposed magic bullet of a WTO waiver.
    • Not only would a WTO waiver not do anything to address the real bottlenecks that constrain the global production and distribution of vaccines, it would also set a bad precedent.
    • It is true that governments, including the US and others, have significantly subsidized or incentivized in other ways the research and development activities of private pharmaceutical companies that now hold patents for major covid vaccines.
    • Yet, these governments required the ingenuity of private enterprise to invent these vaccines.

    Consider the question “What are the legal provisions to ensure the accessibility of life-saving drugs in the country?”

    Conclusion

    While it may seem appealing, a WTO waiver on intellectual property protection is an inappropriate priority. It’s a distraction from the heavy lifting needed to create the capacity to fight the scourge of covid.

  • Supreme Court must oversee vaccination to protect the right to life

    The article highlights the role the Supre Court can play in universal vaccination in India.

    Why Supreme Court needs to step in

    • Amid raging debate over the vaccination strategy, the role the Supreme Court of India can play to safeguard the right to life guaranteed under Article 21, for which it is duty-bound to exercise jurisdiction under Article 32 needs consideration.
    • In this regard, universal vaccination is a glimmer of hope.
    • The Supreme Court of India can facilitate speed and deeper penetration of universal vaccination, which is now commonly accepted as the only possible solution to the pandemic in the long run.

    Issue of patent of vaccine

    • It is time to question patents claimed by vaccines that have been developed with aid from the state in research and development.
    • These patents, if established, must be immediately acquired with just and adequate compensation and made accessible to all manufacturers.
    • This was done for medicines for AIDS and it can be done again under the Patents Act.
    • The Court can also issue mandamus to undertake this exercise on an emergency basis.
    • Thereafter, all pharmaceutical companies with Good Manufacturing Practices (GMP) as per the Drugs and Cosmetics Act must be allowed to manufacture vaccines at a pre-approved price of cost + 6 per cent return on investment.
    • States can also be directed to incentivise the setting up of new manufacturing facilities as a possible third wave, periodic booster doses and the need for ancillary vaccines make it a long-term phenomenon.
    • All this has to be ensured in addition to the free import of vaccines approved by advanced nations.

    Free for all

    • The availability of all the vaccines, whether indigenous or imported, must be free for all the recipients to be paid by GoI.
    • The vaccines can be distributed to states on a pro-rata basis as per population and price adjusted as part of general revenue sharing in GST.

    Vaccine administration

    •  The vaccine administration needs to be ramped up both in state and private facilities.
    • For vaccine hesitancy, we need to incentivise the vaccination through a direct deposit of Rs 500 in Jan Dhan accounts for each vaccinated member of BPL families.
    • This vaccination can be made compulsory for identifiable categories of persons from MGNREGA beneficiaries to Aadhaar Card holders to income-tax payers to bank account holders to driving-licence holders.
    • There must be a strict penalty to be recovered from those who do not get vaccinated without medical reasons.
    • Private efforts can be made eligible for reimbursement of cost.

    Conclusion

    The Supreme Court can steer us, with greater emphasis on the right to life. The pandemic may leave nothing and nobody behind to bicker about.

  • Govt leverage in Covid-19 vaccine pricing

    How government regulate prices of drugs

    • The Supreme Court flagged the issue of differential pricing for vaccines among States and the Centre and directed the central government to clarify it in an affidavit.
    • To ensure accessibility, the pricing of essential drugs is regulated centrally through The Essential Commodities Act, 1955.
    • Under Section 3 of the Act, the government has enacted the Drugs (Prices Control) Order (DPCO).
    • The DPCO lists over 800 drugs as “essential” in its schedule, and has capped their prices.
    • The capping of prices is done based on a formula that is worked out in each case by the National Pharmaceutical Pricing Authority (NPPA), which was set up in 1997.

    So, why the government is not regulating price of vaccines through DPCO

    • This is because the regulation through DPCO is not applicable for patented drugs or fixed-dose combination (FDC) drugs.
    • This is why the price of the antiviral drug remdesivir, which is currently in great demand, is not regulated by the government.
    • To bring vaccines or drugs used in the treatment of Covid-19 such as remdesivir under the DPCO policy, an amendment can be brought.

    What other options government can explore to deal with the vaccine price issue

    1) Patent Act 1970

    • The Patent Act 1970 has two key provisions that could be potentially invoked to regulate the pricing of the vaccine.
    • Section 100 of the Patents Act gives the central government the power to authorise anyone (a pharma company) to use the invention for the “purposes of the government”.
    • It enables the government to license the patents of the vaccine to specific companies to speed up manufacturing and ensure equitable pricing.
    •  Under Section 92 of the Act, which deals with compulsory licensing, the government can, without the permission of the patent holder, license the patent under specific circumstances prescribed in the Act.
    • Section 92 can be invoked in case of circumstances of national emergency or in circumstances of extreme urgency or in case of public non-commercial use.
    • After the government issues a notification under Section 92, pharma companies can approach the government for a licence to start manufacturing by reverse engineering the product.
    • However, in the case of biological vaccines like Covid-19, even though ingredients and processes are well known, it is difficult to duplicate the process from scratch.
    • The process will also entail new clinical trials to establish safety and efficacy, which makes compulsory licensing less attractive.

    2) The Epidemic Diseases Act, 1897

    • Section 2 of this law gives the government “power to take special measures and prescribe regulations as to dangerous epidemic disease”.
    • These broad, undefined powers can be used to take measures to regulate pricing.
    • However, the law lacks the teeth to implement such an important policy framework.
    • Violation of the Act is penalised under Section 188 of the Indian Penal Code, which deals with “disobedience to order duly promulgated by (a) public servant”.

    3) Direct procurement by the Centre

    • Apart from these legislative options, experts suggest that the central government procuring directly from the manufacturers could be the most beneficial route to ensure equitable pricing.
    • As the sole purchaser, it will have greater bargaining power.

  • Antimicrobial resistance

    The article highlights the challenges posed by anti-microbial resistance (AMR) and suggests ways to deal with it.

    Understanding the severity of challenges posed by AMR

    • Antimicrobial resistance (AMR) is the phenomenon by which bacteria and fungi evolve and become resistant to presently available medical treatment.
    • AMR represents an existential threat to modern medicine.
    • Without functional antimicrobials to treat bacterial and fungal infections, even the most common surgical procedures, as well as cancer chemotherapy, will become fraught with risk from untreatable infections.
    • Neonatal and maternal mortality will increase.

    How AMR will affect low and middle-income countries

    • All these effects will be felt globally, but the scenario in the low- and middle-income countries (LMICs) of Asia and Africa is even more serious.
    • LMICs have significantly driven down mortality using cheap and easily available antimicrobials.
    • In the absence of new therapies, health systems in these countries are at severe risk of being overrun by untreatable infectious diseases.

    Factors contributing to AMR

    • Drug resistance in microbes emerges for several reasons.
    • These include the misuse of antimicrobials in medicine, inappropriate use in agriculture, and contamination around pharmaceutical manufacturing sites where untreated waste releases large amounts of active antimicrobials into the environment.

    Stagnant antibiotics discovery

    •  The Challenge of AMR is compounded by fact that no new classes of antibiotics have made it to the market in the last three decades.
    • This has happened on account of inadequate incentives for their development and production.
    • A recent report from the non-profit PEW Trusts found that over 95% of antibiotics in development today are from small companies, 75% of which have no products currently in the market.
    • Major pharmaceutical companies have largely abandoned innovation in this space.

    Measures to deal with the challenge of AMR

    •  In addition to developing new antimicrobials, infection-control measures can reduce antibiotic use.
    • A mix of incentives and sanctions would encourage appropriate clinical use.
    • To track the spread of resistance in microbes, surveillance measures to identify these organisms need to expand beyond hospitals and encompass livestock, wastewater and farm run-offs.
    • Finally, since microbes will inevitably continue to evolve and become resistant even to new antimicrobials, we need sustained investments and global coordination to detect and combat new resistant strains on an ongoing basis.

    Way forward

    •  A multi-sectoral $1 billion AMR Action Fund was launched in 2020 to support the development of new antibiotics.
    • The U.K. is trialling a subscription-based model for paying for new antimicrobials towards ensuring their commercial viability.
    • Other initiatives focused on the appropriate use of antibiotics include Peru’s efforts on patient education to reduce unnecessary antibiotic prescriptions.
    • Australian regulatory reforms to influence prescriber behaviour, and initiatives to increase the use of point-of-care diagnostics, such as the EU-supported VALUE-Dx programme.
    • Denmark’s reforms to prevent the use of antibiotics in livestock have led to a significant reduction in the prevalence of resistant microbes in animals and improved the efficiency of farming.
    • Finally, given the critical role of manufacturing and environmental contamination in spreading AMR there is a need to curb the amount of active antibiotics released in pharmaceutical waste.
    • Regulating clinician prescription of antimicrobials alone would do little in settings where patient demand is high and antimicrobials are freely available over-the-counter in practice, as is the case in many LMICs.
    • Efforts to control prescription through provider incentives should be accompanied by efforts to educate consumers to reduce inappropriate demand, issue standard treatment guidelines.
    • Solutions in clinical medicine must be integrated with improved surveillance of AMR in agriculture, animal health and the environment.
    • AMR must no longer be the remit solely of the health sector, but needs engagement from a wide range of stakeholders, representing agriculture, trade and the environment with solutions that balance their often-competing interests.
    •  International alignment and coordination are paramount in both policymaking and its implementation.

    Consider the question “Anti-microbial resistance (AMR) represents an existential threat to modern medicine. What are the factors contributing to AMR? Suggest the measures to deal with it.”

    Conclusion

    With viral diseases such as COVID-19, outbreaks and pandemics may be harder to predict; however, given what we know about the “silent pandemic” that is AMR, there is no excuse for delaying action.

  • Undermining vaccination for all

    The article highlights the issues with the new vaccine strategy adopted by the government.

    Revamped vaccine strategy

    • With the second Covid-19 wave reaching catastrophic proportions, the Government of India has acted by unveiling a completely revamped vaccine strategy.
    • Two key elements are the hallmark of this new strategy, which will be implemented from May 1.
    • First, the vaccination drive has now been extended to the entire adult population, namely, to those above 18 years.
    • Second, vaccine manufacturers have been given the freedom to sell 50% of their vaccine production to State governments and private hospitals.
    •  A third element of the vaccine strategy, which was not announced formally, is a grant of ₹45 billion to the two vaccine manufacturers, the Serum Institute of India (SII) and Bharat Biotech, to boost their capacities.

    Issues with the new vaccine strategy

    1) Control over the market for vaccine

    • The central government has given up its control over the market for vaccines, a key feature of the vaccine roll-out plans thus far.
    • This issue assumes further significance since the Government of India is well aware about the significance of vaccinating every citizen in the country; “none of us will be safe until everyone is safe”.
    •  It is, therefore, vitally important that public health authorities in the country take an objective view of the realities of the country before adopting strategies for vaccine availability.

    2) Vaccine export

    • The phased roll-out of the government’s ambitious vaccination drive, beginning with health-care and frontline workers in January was in sync with the availability of vaccines in the country.
    •  But, given that India too saw a degree of “vaccine-scepticism”, the Government of India found itself in a situation where it could promise exports of vaccines to 95 countries, mostly in Africa and Asia.
    • As of April 26, these countries have received more than 66.4 million doses of vaccines from India.
    • Until now, nearly 142 million vaccine doses have been administered in the country, the third highest in the world.
    • However, in terms of population share, less than 2% has received both vaccine doses, while less than 9% has received one dose.
    • But there is one worrying facet, which is that a demand-supply mismatch has begun to appear as the coverage of the vaccine-eligible population expanded.
    • The largest supplier, SII, gave two explanations for its inability to meet its commitments.
    • The first was that the United States Government had restricted exports of vaccine culture and other essential materials.
    • Second, the company complained that it lacked the financial capacity to expand its production, requesting a grant of ₹30 billion from the government.

    3) Onus on the States

    • Central government have allowed vaccine producers to sell 50% of their production directly to State governments and private hospitals.
    • The central government would continue to support vaccination for people above 45 years, and health-care workers and frontline workers.
    • The new strategy shifts the onus onto the State governments, which have to take decisions regarding free vaccination for people above 18 years.
    • The government has not fixed the vaccine prices and has allowed the producers to pre-declare the prices they would charge from the State governments and private hospitals, a sharp departure from the extant strategy.
    • New policy fragments the market into three layers namely, central government procurement, State government procurement and the private hospitals.
    • This layering of the market would allow the producers to charge high prices from the State governments and private hospitals.
    • The new strategy would shift the burden of vaccination of the young population, namely, those between 18-44 years, entirely on the State governments.
    •  This implies that the vaccination of a significant section of the population depends on the financial health of each State government, resulting in inequitable access to vaccines across States. 

    4) Public money given for expanding production capacity

    • In view of the advance of ₹45 billion made by the Government of India to the two vaccine producers in India for expanding their production capacities decision to deregulate the vaccine market raises serious questions.
    • This question is more pertinent in India, where access to affordable vaccines is critical for ensuring “vaccination for all”.

    Way forward

    •  Rather than allowing duopoly in the vaccine market, the government should have ensured a competitive market for vaccines.
    • One positive step that the government has taken in this direction is to increase production of Bharat Biotech’s vaccine through the involvement of three public sector undertakings, including Haffkine Institute.
    • There is a need for more open licensing of this vaccine to scale up production.

    Conclusion

    There can be no alternative to vaccination for all if we want to overcome the Covid and to ensure that government needs to rethink its new strategy.

  • Complexities of herd immunity

    What is herd immunity

    • The herd immunity concept is based on lowering the number of susceptible individuals.
    • If sufficient individuals in the population are immune either through vaccination or a prior exposure, then the number of susceptible individuals drops.
    • For example, if the immune population is 70%, then the susceptible population is 30%.

    Does herd immunity really protect from subsequent waves?

    • The number of daily cases depends on three factors: The number of infectious people in the population, the number of susceptible individuals, and the rate of transmission of the virus.
    • The rate of transmission is dependent on the nature of the virus and the extent of contact between individuals.
    • So, if the rate of transmission increases due to change in social behaviour and increased contact then even with a large percentage of the immune population, a significant number of daily cases can result.
    • The “herd immunity” number is not a static number but it changes depending on the rate of transmission of the virus and the extent of virus present.

    Estimating exposures in metro cities

    • Serosurveys indicated that Covid had touched 56% of population in Delhi by January; 75% in some slums Mumbai in November, and about 30% in Bengaluru in November.
    • The population touched by Covid can also be estimated by the Infection Fatality Rate (IFR).
    • This is the total number of deaths divided by the total people infected. In India, the estimate is 0.08%.
    • So this number can be used to back-calculate the number of infections based on the number of deaths in the different cities.
    • The table given below shows the number of people exposed to Covid in some metros until January 31 using the method above.

    What are the reasons behind the recent surge

    • The reasons behind the recent surge are not fully understood.
    • The one factor that is not in doubt, however, is that interaction and contact with the population has increased since February.
    • Such increased contact increased the virus in circulation and led to increased cases in the susceptible population.

  • Centre uses Disaster Management Act to restrict liquid oxygen use for non-medical purposes

    Order under Disaster Management Act 2015

    • Invoking the Disaster Management Act, the Centre ordered States that all liquid oxygen shall be made available to the government and will be used for medical purposes only.
    • The order said that under section 10(2)(I) and section 65 of the DM Act, States had to ensure that “liquid oxygen is not allowed for any non medical purpose”
    • The order was passed after the review of oxygen supply situation in the country.

    Dealing with the shortage

    • On April 22, Centre issued order under the DM Act, making the district magistrates and senior superintendent of police personally liable to allow unhindered inter-State movement of vehicles carrying medical oxygen.
    • Despite MHA’s orders and letters, States continued to flag shortage of oxygen supply.
    • Medical oxygen to States are being provided as per daily quota decided by an empowered group of officers in central ministries.

  • Understanding infections after Covid-19 vaccination

    Breakthrough infections

    • There have been several cases of Covid-19 vaccinated people, even those who have received both doses, testing positive for the virus.
    • Such cases are referred to as “breakthrough” infections, indicating that the virus has been able to break through the defences created by the vaccine.
    • Such cases have led to some doubts being expressed about the effectiveness of the vaccine, and contributed to the already prevailing vaccine hesitancy. 
    • However, vaccines protect not against the infection, but against moderate or severe disease and hospitalisation.
    •  It typically takes about two weeks for the body to build immunity after being vaccinated.
    • So, the chances of a person falling sick during this period are as high — or as low — as the chances for any person who has not been vaccinated.
    •  Also, those in the priority list of vaccination, such as healthcare workers and frontline workers, have been prone to getting infected due to prolonged occupational exposure to the virus

    Full protection not possible

    • It is very well understood that no vaccine offers 100% protection from any disease.
    • However, according to the Centers for Disease Prevention and Control (CDC) in the United States, vaccinated people are much less likely to get sick, but it is never entirely ruled out.
    • Then there is the emergence of new variants of the virus.
    • Some variants of the virus are able to evade the human immune response, and therefore have a greater chance to break through the defences created through the vaccine.

    Breakthrough cases in India

    • Among 10.03 crore people who had taken only the first dose of Covishield vaccina, 17,145 had got infected.
    • That translates into a 0.02% prevalence.
    • Among the 1.57 crore people who received the second dose as well, 5,014, or about 0.03%, had got infected later.
    • About 1.1 crore doses of Covaxin have been administered until now.
    • Of the 93.56 lakh who took only the first dose, so far 4,208 have got the infection.
    • That is about 0.04% of the total.
    • Among the 17.37 lakh who have taken the second shot, only 695 had been infected, again 0.04%.

    Challenges

    • “Given the scope of the pandemic, there’s a huge amount of virus in the world right now, meaning a huge opportunity for mutations to develop and spread.
    • That is going to be a challenge for the developers of vaccines.