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Questions 1-5: Answer based on the following passage.
The precarious second wave of COVID-19 infections has hit India with greater ferocity than the first. Despite a year to prepare, we have been caught woefully off guard again. Multiple reports of the scarcity of COVID-19 vaccines and drugs have surfaced from different parts of the country. According to the Observer Research Foundation, till the end of March, India had produced 316 million doses of Covishield and Covaxin — the two COVID-19 vaccines in use in India. Of this, 64.5 million doses have been exported. This suggests that the issue isn’t vaccine production. Perhaps, the problem has more to do with centralized procurement, distribution, and coordination with different State governments and local authorities.
Section 2 of the Epidemic Diseases Act of 1897 empowers the government, during the outbreak of an epidemic, to take measures that it may deem necessary to prevent the outbreak or its spread. Likewise, Section 26B of the Drugs and Cosmetics Act, 1940, empowers the Central government to regulate the sale, manufacture, and distribution of a drug that is essential to meet the requirements of an emergency arising due to an epidemic.
Under Section 100 of the Patents Act, 1970, the Central government has the power to authorise anyone (such as specific pharmaceutical companies) to use any patents or patent applications for the “purposes of government”. Under this provision, the Central Government can licence specific companies to manufacture the COVID-19 vaccines. The other option is to make use of Section 92 of the Patents Act, which allows the Central Government to issue a compulsory licence (a licence issued to manufacture the patented product without the consent of the patent holder) in circumstances of national emergency or extreme urgency or in case of public non-commercial use.
The pandemic is a circumstance of national emergency. Thus, the Central Government, under Section 92, can issue a notification in this regard. Subsequently, any company willing or directed by the government to manufacture the COVID-19 vaccine can be issued a licence.
Extracted with edits and revisions from- https://www.thehindu.com/opinion/op-ed/scaling-up-vaccine-production/article34304767.ece.
1. The Chief Minister of Karnataka taking cognizance of the rising number of cases in the state authorises the pharma company Kovartis to manufacture the COVISHEILD vaccine under section 100 of the Patents act, 1970, in their factory in Bellandur, citing that this is for “the purposes of government”. Is he justified in doing so?
a. Yes, as this is allowed under S.92 of the Patents Act.
b. Yes, as IP laws have to be put aside in the interest of the welfare of people.
c. No, as he is not authorized by law to order this.
d. No, as this does not come under “the purposes of government”.
2. Due to the rising number of cases of Blood clots seen in citizens who had taken the COVISHIELD vaccine, The Government of India decided that a warning about the same be included on the vial containing the vaccine. The manufacturer of the vaccine refused to do so, arguing that the government didn’t have the authority to do so. Going by the principles mentioned above, Decide.
a. The government has the authority to order the manufacturers to put the warning as this is a public health risk and people taking the vaccine should be aware of it.
b. The government is only a buyer of the vaccine and hence has no authority over the
manufacturer.
c. The government has no authority to order the manufacturer to include a warning label as
it cannot regulate labelling and packaging under Section 26B of the Drugs and Cosmetics
Act.
d. The government has the authority to mandate warning labels as it can regulate the sale,
manufacture, and distribution of a drug that is essential to meet the requirements of an
emergency arising due to an epidemic.
3. Cytoxan is a revolutionary new drug that has been found to have a high level of efficiency in curbing the spread of Cancer in the body. However, the IP holder Tipla, who are based in India make most of their sales by exporting to International markets, as they get better prices there. The Government after reviewing the rise in the number of Cancer patients who need the drug in India, decided to impose a restriction that 60% of their total sales had to be made in India. Tipla refused to comply. Are they legally allowed to do so?
a. No, as India is a socialist country and therefore all means of production are in the hands
of the government and they therefore have the right to regulate sales.
b. No, as the Government is empowered by Section 26B of the Drugs and Cosmetics Act to
regulate the sale, manufacture, and distribution of a drug.
c. Yes, as they own the Intellectual Property for the same and can choose how they go about distributing the drug.
d. None of the Above.
4. Across the passage, under how many pieces of legislation can the Government Issue licences without the permission of the IP holder?
a. One
b. Two
c. Three
d. Four
5. The Government decides to ban all forms of public transport in light of the COVID 19 Pandemic. Under which legislation can it do the same?
a. Section 2 of the Epidemic Diseases Act of 1897.
b. Section 92 of the Patents Act.
c. Section 26 (B) of the Drugs and Cosmetics Act, 1940.
d. (a) read with c).
Answers
1. Answer: (c)
Explanation: As the passage clearly states, it is the Central government that has the power to authorize anyone to use any patents for the purposes of government. B) is not mentioned anywhere. We don’t know what “purposes of government” entails so D) is wrong. A) is irrelevant as it talks about s. 92 which deals with something else.
2. Answer: (c)
Explanation: As is evident from the passage, the government can only regulate sale, manufacture and distribution. D) is wrong as it uses this same line of reasoning. B) Does not have any coherent legal principle backing it. A) is wrong for the same reason. It’s a moral answer and not a legal one.
3. Answer: (d)
Explanation: Cancer isn’t infectious and therefore, there is no “cancer epidemic”. The government can use this power only during the outbreak of an epidemic. Cancer isn’t one.
4. Answer: (c)
Explanation: Three instances namely, Section 2 of the Epidemic Diseases Act of 1897, Section 100 of the Patents Act, 1970, Section 92 of the Patents Act. Section 26B of the Drugs and Cosmetics act doesn’t deal with Intellectual property. While section 2 of the Epidemic Diseases Act of 1897 is very broad, it is still included in this.
5. Answer: (a)
Explanation: Refer to the principle of Section 2 of the Epidemic Diseases Act of 1897.
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Source: Lawctopus
