COVID-19 - Can patent waivers increase vaccine coverage?

COVID-19 - Can Patent Waivers Increase Vaccine Coverage?


With the new virus variant causing a surge in infections, India has been crippled by the pandemic. Apart from the shortage of medicines, oxygen and healthcare staff, several states in India face a shortage of vaccines – one of the most effective tools to end the pandemic.

As of 5 May 2021, 1.1 billion COVID-19 vaccine doses have been administered. However, only 0.3% went to low-income countries. Experts predict that if the vaccine production and distribution are not ramped up, it may take a minimum of 2 years for most income countries to be vaccinated.

In October last year, around 100 countries, led by India and South Africa, requested World Trade Organization members to agree on a time-limited waiver of COVID-19-related intellectual property (IP) rights. As per the request, the vaccine suppliers should share their knowledge so that more countries, especially low-income countries, can start producing vaccines on their own. Waiving the IP is expected to increase the production and the global coverage of COVID-19 vaccines.

US support to waive patents on COVID-19 vaccines

The US until now had opposed the plan to waive the IP related to COVID -19 vaccines, but in a dramatic turn of events, on 5 May 2021, the US trade representative, Katherine Tai, announced that the US would support a proposal to waive patents on COVID-19 vaccines considering the urgent need for more global supply.

The pharmaceutical industry and others have opposed the decision to lift patent protections on COVID-19 vaccines. The opponents argue that waiving patents on COVID-19 vaccines may not ramp up production quickly and could compromise vaccine quality. However, supporters of the waiver disagree and point out that generics drug developers have been supplying the world with high-quality vaccines and drug products for years.

What does the COVID-19 patent waiver mean for India?

Experts suggest that there is a high probability of a third wave of the pandemic in India. Developing affordable generic vaccines can increase vaccine accessibility and help the country prepare for the next surge. If the patents are lifted, it will undoubtedly mean expanding the scale of production and speeding vaccine rollout.

Manufacturing vaccines can be challenging

Manufacturing vaccines is a complex process and is easier said than done. Though the IP waiver may be game-changing, many experts believe that IP is not the real hurdle. Manufacturers in developing countries need to be supported with the technology to actually produce the vaccines. This applies particularly to innovative vaccines such as mRNA. A majority of the COVID-19 vaccines involve an element of genetic manipulation, a highly complex procedure, which may be difficult to reverse engineer.

Manufacturing equipment and raw materials are other bottlenecks. It also requires highly trained staff and the establishment of workflows with stringent quality control.

While the US has proposed to support patent waiver, the export of vital raw materials is still blocked as per the country’s Defense Production Act, which grants US vaccine makers priority access to specialised materials such as filters, tubing and specialised disposable bags essential to making vaccines.

Lastly, any vaccine which is manufactured will have to go through the final step of clinical trials to get regulatory approvals.

Reverse-engineered COVID-19 vaccines will undoubtedly have to go through clinical trials

Vaccine manufacturers who reverse engineer COVID-19 vaccines will have to run the vaccines through clinical trials once again. Clinical trials are necessary to evaluate the reverse-engineered version’s immunogenicity and efficacy.

CliniExperts – Clinical trial services tailored to individual needs

Sharing of technology and IP could increase global vaccine coverage, which would likely increase public and private investment in developing countries like India.

At CliniExperts, we understand the difficulties of conducting clinical trials and the strategies that enable hassle-free launches. CliniExperts brings you innovative clinical trial solutions based on the latest technology.

We offer a wide range of clinical trial services and have the ability to handle challenges and complications in any clinical trial. Our services are specifically tailored to ease the process of getting your products ready for the market.

References

  1. It’s time to consider a patent reprieve for COVID vaccines. Nature. 2021. Available at: https://www.nature.com/articles/d41586-021-00863-w. Accessed: 21May2021.
  2. In shock move, US backs waiving patents on COVID vaccines. . Nature. 2021. Available at: https://www.nature.com/articles/d41586-021-01224-3. Accessed: 21May2021.
  3. Covid-19 vaccine inequity: the debate over patent waivers intensifies. Pharmaceutical Technology. 2021. Available at: https://www.pharmaceutical-technology.com/features/covid-19-vaccine-inequity-patent-waivers/. Accessed: 21May2021.
  4. Iacobucci G. Covid-19: How will a waiver on vaccine patents affect global supply?. BMJ. 2021;373:n1182.


Frequently Asked Questions

What is an “orphan drug” as per the New Drugs and Clinical Trial Rules, 2019?

“Orphan drug” means a drug intended to treat a condition which affects not more than five lakh persons in India.

The extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible if following conditions are met: Similarity with respect to quality has been proven to reference biologic Similarity with respect to preclinical assessment has been proven to reference biologic Clinical safety and efficacy is proven in one indication Mechanism of action is same for other clinical indications Involved receptor(s) are same for other clinical indications New indication not mentioned by innovator will be covered by a separate application.

The permission to initiate clinical trial granted in Form CT-06 or automatic approval in Form CT 4A shall remain valid for a period of 2 years from the date of its issue, unless extended by the CLA.

An audio-video recording of the informed consent process in case of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

The three tier mechanism comprises the following authorities: 1. Institutional Biosafety Committee (IBSC) at the Institute/ company – To ensure biosafety on-site 2. Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology - Managed genetically engineered cell banks 3. Genetic Engineering Appraisal Committee (GEAC) in the Ministry of Environment & Forests (MoE&F)- for genetically modified organisms/ living modified organisms

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial of a biological product can submit application for clinical trial.

After obtaining permission in CT-11 or CT-14 or CT-15 as the case may be, the person, who intends to manufacture the biological product for CT, shall make an application for grant of license to manufacture the biological product by the respective State Licensing Authority (SLA) in accordance with the provisions of the Act and the Drugs and Cosmetics Rules, 1945.

No. For biological product and substances discovered or developed in countries other than India, Phase I data should be submitted along with the application. After submission of Phase I data generated outside India to the Central Licensing Authority, permission may be granted to repeat Phase I trials or to conduct Phase II trials and subsequently Phase III trial concurrently with other global trials for that biological product.

“New drug” means, (i) a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or (ii) a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or (iii) a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or (iv) a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or (v) a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug; Explanation: The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licencing Authority and the drugs referred to in sub-clauses (iv) and (v) shall always be deemed to be new drugs;

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