Will Generic Supply Of Bedaquiline Be Accessible?

Relevance: GS2 - Government policies and interventions; Issues relating to development and management of Social Sector/Services relating to Health; GS3 - Issues relating to Intellectual Property Rights

(Source: The Hindu, 07/24/2023)

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Why in the news?

• Recently, the expiry of J & J’s Patent on Bedaquiline Drug will allow generic manufacturers to supply the drug which will help in reducing the drug prices in India. However, J&J appears intent on maintaining its monopoly over the bedaquiline market.
• Tuberculosis is one of India's major public health problems. India has about 2.8 million cases, making it a national public health emergency.
• According to World Health Organization (WHO) estimates, India has the world's largest tuberculosis epidemic.

Key Highlights regarding generic accessibility of Bedaquiline

• Researchers estimate that with the introduction of competition from India, the price of bedaquiline will fall in the range of $48-$102 for a six-month treatment course, which is three to six times less than the current globally negotiated price paid by countries ($272) when procured through the GDF.
  • DR-TB drugs like linezolid have decreased in prices by over 90% with generic competition once Pfizer’s patent expired in 2015.
  • Hence, national TB programmes are waiting for the generic supply of bedaquiline from Indian manufacturers in order to reduce prices.

What are the global concerns?

• The Global Drug Facility (GDF) deal, aims to extend coverage to a significant portion of low- and middle-income countries, but some of the hardest-hit nations by DR-TB have raised concerns.
• Eastern Europe and China, appear to be left out of the agreement.
• Some countries like South Africa are not purchasing from GDF and with the ever-greening patent inforce till 2027, it will not get access to generic Bedaquiline.
• As a result, excluded countries are voicing their concerns to J&J, highlighting the challenges posed by patent restrictions and their inability to benefit from generic competition.

What is Bedaquiline?

• Bedaquiline is a drug used to treat active TB.
• It is specifically used to treat multidrug-resistant tuberculosis (MDR-TB) in conjunction with other tuberculosis drugs.
• Bedaquiline is an important medicine in the treatment of multi-drug resistant tuberculosis patients whose first-line pharmacological therapy with isoniazid, rifampicin, pyrazinamide, and ethambutol has failed.
• History of Bedaquiline:
  • Bedaquiline was discovered by a team led by Koen Andries at Janssen Pharmaceutica and was approved for medical use in the United States in 2012.
  • It is manufactured by Johnson & Johnson (J&J), who sought accelerated approval of the drug, a type of temporary approval for diseases lacking other viable treatment options.

• Tuberculosis (TB) is an infectious illness caused by bacteria (Mycobacterium tuberculosis) that mostly affects the lungs. Tuberculosis is transmitted from person to person through the air.

India’s effort regarding Tuberculosis

• National TB Elimination Programme
• National Strategic Plan for TB (2017-2025)
• The Nikshay Ecosystem (National TB information system)
• Nikshay Poshan Yojana (NPY- financial support)
• TB Harega Desh Jeetega Campaign
• Ayushman Bharat Digital Health Mission

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FAQs

MCQ

Question: Consider the following statements: (UPSC 2019)

1. According to the Indian Patents Act, a biological process to create a seed can be patented in India.
2. In India, there is no Intellectual Property Appellate Board.
3. Plant varieties are not eligible to be patented in India.

Which of the statements given above is/are correct?

(a) 1 and 3 only

(b) 2 and 3 only

(c) 3 only

(d) 1, 2 and 3